# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998

# A Guide to HACCP Systems in the Meat Industry

# Appendix X.4: Manufacture of Raw Beef Patties Page: X.4.1

Appendix X.4: Generic HACCP Plan for the Manufacture of Raw

Beef Patties

1. Prerequisite Requirements

The following are documented prerequisite programmes/sanitation standard operating procedures

(SSOPs):

C sanitary design;
C potable water quality;
C sanitation and cleanup procedures for edible areas and food contact surfaces
(preoperational and operational);
C personal hygiene (protective clothing requirements, personal equipment and use of
amenities);
C hygienic processing (processing techniques and procedures, damaged carton procedure,
dropped meat);
C rework procedures;
C supplier quality assurance (ingredient specifications, supplier audits, certifications, product
testing);
C food contact materials (specifications, handling and storage);
C product testing procedures;
C training;
C repairs and maintenance of equipment;
C control of chemicals;
C vermin control;
C waste disposal;
C refrigeration management;
C handling and disposition of detained and nonconforming products;
C recall procedures.

2. Scope of HACCP Plan

HACCP application: Food safety

Product: Raw beef patties

Process: Processing of raw beef patties from receiving raw materials and other
inputs to loadout of packaged frozen products.
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3. Product Description and Intended Use

Form 1: Product description and intended use

1. Product name(s) Frozen raw beef patties

2. Important product characteristics Product meeting company and regulatory specifications for
sensory and microbiological quality, foreign objects,
temperature and packaging.

3. How is it to be used:
a. By a further processor, retailer or food a. Cooked in food service outlets
service outlet

b. By the consumer b. Cooked

4. Intended consumer General public ( "high-risk" groups not specified for this
plan)

5. Packaging Company/regulatory specification

6. Shelf life and storage requirements Company/regulatory specification

7. Where it will be sold

a. Export market List countries, if applicable
b. Local market

8. Labelling instructions Company/regulatory specification

9. Special distribution controls required Refrigerated distribution as per company/regulatory

specification
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Raw Beef Patties Page: X.4.3

4. Initial Food Safety Objectives

(To be confirmed after hazard identification and analysis, and CCP determination. See Section
8 for confirmed objectives.)

To ensure that meat and non-meat ingredients are in compliance with agreed specifications, and
that meat is sourced from suppliers that have an effective HACCP plan which achieves specified
microbiological and chemical residue targets.

To minimise the transfer of microbiological hazards to the product, and their redistribution, so
specific microbiological targets are met.

To minimise the growth of pathogens on the product, by the use of an effective refrigeration
system, so specific microbiological targets are met.

To remove foreign objects so specific targets are met.

5. Process Flow Diagram

Form 2: Raw materials / other inputs

Product name: Frozen beef patties

Raw material/other inputs Description/specification

1
Beef cuts/trimmings Slaughtered, dressed and processed under a HACCP
plan.

Non-meat ingredients, e.g. salt, spices 1 As per company specifications and the New Zealand Food
Regulations 1984

Food contact packaging materials2 Suitable for use as food contact materials.

1. These inputs and their hazards must be addressed by a prerequisite programme/SSOP (i.e. Supplier Quality
Assurance (SQA) programme), or specifically considered during hazard identification in this HACCP plan.

2. Specifications and hygienic handling of these materials are covered by premises prerequisite programme for
food contact materials.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
# A Guide to HACCP Systems in the Meat Industry
# Appendix X.4: Manufacture of Raw Beef Patties Page: X.4.4

Form 3: Process flow diagram

Premises that allow rework of products must clearly reflect this practice in the process
flow. The impact of rework at the relevant steps must be considered during hazard
analysis and CCP determination. Strict compliance to documented rework procedures
must be observed .

Process: Manufacture of raw beef patties

Inputs Process steps Edible outputs

Frozen and chilled < 1. Receiving meat 1a. Receiving non-

beef cuts/trimmings, and ? meat ingredients
non-meat ingredients ? ?
2. Chilled/frozen storage of meat 2a. Storage of non-meat
? ingredients
? ?
3. Tempering meat ?
? ?
4. Weighing meat 3a. Weighing non-
? meat ingredients
? ?
5. Decartoning ?
? ?
6. Pre-grinding meat ?
? ?
7. Mixing = = =
?
8. Final grinding
?
9. Forming
?
10. Perforation
?
11. Freezing
?
12. Metal detection
?
Packaging materials< 13. Packaging
?
14. Labelling and weighing
?
15. Storage of frozen products
?
16. Loadout < Frozen beef patties
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Raw Beef Patties Page: X.4.5

6. Job Descriptions
Form 4 must be completed and confirmed for each step in the particular process.

Form 4: Template for job description

Job description

Process step no:

Summary list of food safety responsibilities of operator: (confirm after HACCP plan completed)

Reference:
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Raw Beef Patties Page: X.4.6

7. Hazard Analysis and CCP Determination

7.1 Raw material hazard identification

Form 5a: Hazard identification for meat and non-meat ingredients 1

Raw material Biological hazard Chemical hazard Physical hazard

Meat ingredients 2

Chilled /frozen beef cuts B1 % Enteric pathogens C13 % Unidentified chemical P1 % Bone
and trimmings associated with residues, e.g. P1 % Metal
contamination from faeces, anthelmintics, antibiotics,
ingesta, hides, e.g. environmental
Salmonella spp., E. coli contaminants.
O157:H7, Campylobacter
jejuni, Clostridium spp.

Non- meat ingredients

Food grade salt None None None

Spices (decontaminated) 4 B2 % Spore forming C2 3 % Chemical residues, None

organisms e.g. herbicides, pesticides,
e.g. Bacillus cereus, fumigant
Clostridium spp.

1. The following codes are used in this generic plan:

B Biological B1 Microbiological hazards associated with meat ingredients
B2 Microbiological hazards associated with non-meat ingredients
B3 Microbiological hazards associated with other inputs
B4 Microbiological hazards associated with contamination due to a process step
requirement not being met (sporadic occurrence)
C Chemical C1 Chemical hazards associated with meat ingredients
C2 Chemical hazards associated with non-meat ingredients
C3 Chemical hazards associated with other inputs
C4 Chemical hazards associated with contamination due to a process step requirement
not being met (sporadic occurrence)
P Physical P1 Physical hazards associated with meat ingredients
P2 Physical hazards associated with non-meat ingredients
P3 Physical hazards associated with other inputs
P4 Physical hazards associated with contamination due to a process step requirement
not being met (sporadic occurrence)

2. Hazards listed for meat are those that have been identified in the Generic HACCP Plan for Cooling and
Boning of Beef as food safety hazards that may be reasonably associated with beef cuts and trimmings. Note
that new codes have been used in this generic plan. Biological hazards associated with beef are discussed in
Sections 1 and 2 of the Annex to Appendix IX.2: Background Information to the Generic HACCP Plan for
Slaughter and Dressing of Cattle.

3. If a supplier can give an assurance that there are adequate controls for chemical hazards in their HACCP plan
(e.g. by providing producers or manufacturers guarantees whereby compliance can be verified under the SQA
programme), then these hazards need not appear in this raw material hazard identification.

4. Powdered spices used in commercial processing of beef patties are generally decontaminated to reduce
microbiological contaminants. Included in their specifications is that they are free from foreign objects.
Compliance to these specifications should be verified under the SQA programme.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.7

7.2 Hazard analysis and CCP determination (raw material, other inputs and process steps)

Hazard analysis may result in changes in the initial food safety objectives set in Section 4. See Section 8 for confirmed objectives.

Form 5b: Hazard analysis and CCP determination (raw material, other inputs and process steps)

Process step Inputs (i) Process Q1. Could the hazard be Q2. Is there a Q3. Is there a CCP
step hazards present in or on the product1 at control measure control measure No.
unacceptable levels2 at this at this step that available at a
(ii) Potential step? would prevent previous step?
Raw material Other inputs impact of unacceptable
If yes, answer Q2 and Q3. If yes,
process step levels of the
retrospectively
on existing hazard?
assign the
hazards
Component Hazards Component Hazards Yes/No Justification If yes, then this previous step as a
step is a CCP. If CCP.
no, not a CCP.

Receiving and preparation of non-meat ingredients

1a. Receiving Salt

non-meat
ingredients Spices B2. Spore forming No
organisms

C2. Chemical No
residues

2a. Storage Salt

of non-meat
ingredients
Spices B2. Spore forming No
organisms

C2. Chemical No
residues

3a. Weighing Salt

non-meat
ingredients
Spices B2. Spore forming No
(To step 7) organisms

C2. Chemical No
residues
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.8

Process step Inputs (i) Process Q1. Could the hazard be Q2. Is there a Q3. Is there a CCP
step hazards present in or on the product1 at control measure control measure No.
unacceptable levels2 at this at this step that available at a
(ii) Potential step? would prevent previous step?
Raw material Other inputs impact of unacceptable
If yes, answer Q2 and Q3. If yes,
process step levels of the
retrospectively
on existing hazard?
assign the
hazards
Component Hazards Component Hazards Yes/No Justification If yes, then this previous step as a
step is a CCP. If CCP.
no, not a CCP.

Main process

1. Receiving Beef cuts/ B1. Enteric No

meat trimmings pathogens

C1. Chemical No
residues

P1. Bone Yes Refer to Annex, No No

Section 4.1.

P1. Metal Yes Refer to Annex, No No

Section 4.1.

2. Chilled/ Beef cuts/ B1. Enteric No

frozen trimmings pathogens
storage of
meat C1. Chemical No
residues

P1. Bone Yes Refer to Annex, No No

Section 4.1.

P1. Metal Yes Refer to Annex, No No

Section 4.1.

3. Tempering Beef cuts/ B1. Enteric No

meat trimmings pathogens

C1. Chemical No
residues

P1. Bone Yes Refer to Annex, No No

Section 4.1.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.9

Process step Inputs (i) Process Q1. Could the hazard be Q2. Is there a Q3. Is there a CCP
step hazards present in or on the product1 at control measure control measure No.
unacceptable levels2 at this at this step that available at a
(ii) Potential step? would prevent previous step?
Raw material Other inputs impact of unacceptable
If yes, answer Q2 and Q3. If yes,
process step levels of the
retrospectively
on existing hazard?
assign the
hazards
Component Hazards Component Hazards Yes/No Justification If yes, then this previous step as a
step is a CCP. If CCP.
no, not a CCP.

P1. Metal Yes Refer to Annex, No No

Section 4.1.

4. Weighing Beef cuts/ B1. Enteric No

meat trimmings pathogens

C1. Chemical No
residues

P1. Bone Yes Refer to Annex, No No

Section 4.1.

P1. Metal Yes Refer to Annex, No No

Section 4.1.

5. Beef cuts/ B1. Enteric No

Decartoning trimmings pathogens

C1. Chemical No
residues

P1. Bone Yes Refer to Annex, No No

Section 4.1.

P1. Metal Yes Refer to Annex, No No

Section 4.1.

6. Pre- Beef cuts/ B1. Enteric (ii) Transfer and No

grinding of trimmings pathogens redistribution
meat
C1. Chemical No
residues

P1. Bone Yes Refer to Annex, No No

Section 4.1.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.10

Process step Inputs (i) Process Q1. Could the hazard be Q2. Is there a Q3. Is there a CCP
step hazards present in or on the product1 at control measure control measure No.
unacceptable levels2 at this at this step that available at a
(ii) Potential step? would prevent previous step?
Raw material Other inputs impact of unacceptable
If yes, answer Q2 and Q3. If yes,
process step levels of the
retrospectively
on existing hazard?
assign the
hazards
Component Hazards Component Hazards Yes/No Justification If yes, then this previous step as a
step is a CCP. If CCP.
no, not a CCP.

P1. Metal Yes Refer to Annex, No No

Section 4.1.

(i) P4. Metal Yes Refer to Annex, No No

Section 6.2.

7. Mixing Ground beef B1. Enteric No

and non- pathogens
meat
ingredients B2. Spore forming No
organisms

C1/C2. Chemical No
residues

P1. Bone Yes Refer to Annex, No No

Section 4.1.

P1/P4. Metal Yes Refer to Annex, No No

Sections 4.1 and 6.2.

8. Final Mixture B1. Enteric No

grinding pathogens

B2. Spore forming No

organisms

C1/C2. Chemical No
residues

P1. Bone Yes Refer to Annex, Yes % bone No 1

Sections 4.1. eliminator

Refer to Annex,
Section 6.2.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.11

Process step Inputs (i) Process Q1. Could the hazard be Q2. Is there a Q3. Is there a CCP
step hazards present in or on the product1 at control measure control measure No.
unacceptable levels2 at this at this step that available at a
(ii) Potential step? would prevent previous step?
Raw material Other inputs impact of unacceptable
If yes, answer Q2 and Q3. If yes,
process step levels of the
retrospectively
on existing hazard?
assign the
hazards
Component Hazards Component Hazards Yes/No Justification If yes, then this previous step as a
step is a CCP. If CCP.
no, not a CCP.

P1/P4. Metal Yes Refer to Annex, No No

Sections 4.1 and 6.2.

(i) P4. Metal Yes Refer to Annex, No No

Section 6.2.

9. Forming Mixture B1. Enteric No

pathogens

B2. Spore forming No

organisms

C1/C2. Chemical No
residues

P1/P4. Metal Yes Refer to Annex, No No

Sections 4.1 and 6.2.

10. Patties B1. Enteric No

Perforation pathogens

B2. Spore forming No

organisms

C1/C2. Chemical No
residues

P1/P4. Metal Yes Refer to Annex, No No

Sections 4.1 and 6.2.

11. Freezing Patties B1. Enteric No

pathogens

B2. Spore forming No

organisms
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.12

Process step Inputs (i) Process Q1. Could the hazard be Q2. Is there a Q3. Is there a CCP
step hazards present in or on the product1 at control measure control measure No.
unacceptable levels2 at this at this step that available at a
(ii) Potential step? would prevent previous step?
Raw material Other inputs impact of unacceptable
If yes, answer Q2 and Q3. If yes,
process step levels of the
retrospectively
on existing hazard?
assign the
hazards
Component Hazards Component Hazards Yes/No Justification If yes, then this previous step as a
step is a CCP. If CCP.
no, not a CCP.

C1/C2. Chemical No
residues

P1/P4. Metal Yes Refer to Annex, No No

Sections 4.1 and 6.2.

12. Metal Frozen B1. Enteric No

detection patties pathogens

B2. Spore forming No

organisms

C1/C2. Chemical No
residues

P1/P4. Metal Yes Refer to Annex, Yes % metal No 2

Sections 4.1 and 6.2. detector.

Refer to Annex,
Section 6.3.

13. Packag- Frozen B1. Enteric No

ing patties pathogens

B2. Spore forming No

organisms

C1/C2. Chemical No
residues

Packaging None
materials
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.13

Process step Inputs (i) Process Q1. Could the hazard be Q2. Is there a Q3. Is there a CCP
step hazards present in or on the product1 at control measure control measure No.
unacceptable levels2 at this at this step that available at a
(ii) Potential step? would prevent previous step?
Raw material Other inputs impact of unacceptable
If yes, answer Q2 and Q3. If yes,
process step levels of the
retrospectively
on existing hazard?
assign the
hazards
Component Hazards Component Hazards Yes/No Justification If yes, then this previous step as a
step is a CCP. If CCP.
no, not a CCP.

14. Labelling Packed B1. Enteric No

and weighing frozen patties pathogens

B2. Spore forming No

organisms

C1/C2. Chemical No
residues

15. Storage Packed B1. Enteric No

of frozen frozen patties pathogens
products
B2. Spore No
forming organisms

C1/C2. Chemical No
residues

16. Loadout Packed B1. Enteric No

frozen patties pathogens

B2. Spore No
forming organisms

C1/C2. Chemical No
residues

1. Product is defined as the edible component of final product.

2. Unacceptable as demonstrated by data (scientific literature, applied research or on-site experience) associated with achieving the FSOs e stablished for the process. In
the determination of unacceptability, hazards should be considered in terms of level, frequency, transfer and redistribution, and severity of effect on consumer.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.14

8. Confirmed Food Safety Objectives (FSOs)

FSO1: To ensure that meat and non-meat ingredients are in compliance with agreed
specifications, and that meat is sourced from suppliers that have an effective HACCP plan that
achieves specified microbiological and chemical residue targets.

FSO2: To minimise the transfer of microbiological hazards to the product, and their
redistribution, so specific microbiological targets are met.

FSO3: To minimise the growth of pathogens in the product so specific microbiological targets
are met.

FSO4: To prevent and/or remove foreign objects from the product (e.g. bone pieces, metal) so
specific targets are met.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.15

9. Completion of the HACCP Plan

Full documentation is required for the remaining elements of the HACCP plan:

C critical limit setting;

C monitoring procedures;
C corrective action procedures;
C verification procedures including validation;
C documentation and record keeping procedures.

Refer to Sections 9-13 of the Template for Establishing a HACCP Plan for Further Processing
of Meat and Meat Products for detailed requirements.

Form 6 provides a summary of the plan. References to documented procedures located

elsewhere should be shown on this form.

10. Verification of the HACCP Plan

10.1 Validation of the HACCP plan

Validation of the HACCP plan involves the initial confirmation that the HACCP plan is
complete and will achieve each of the FSOs. Identified CCPs should be evaluated to ensure that
the control measure applied at that particular process step will achieve or contribute to the
achievement of the relevant FSO. Some FSOs may be dependent on prerequisite programmes
rather than the HACCP plan itself.

An example of how this generic HACCP plan may be validated is given below:

FSO1: To ensure that meat and non-meat ingredients are in compliance with agreed
specifications, and that meat is sourced from suppliers that have an effective HACCP plan
that achieves specified microbiological and chemical residue targets.

FSO1 is expected to be primarily achieved by implementing an effective Supplier Quality

Assurance programme. Supplier compliance to agreed specifications may be verified by testing
meat/non-meat ingredients (e.g. microbiological analysis), reviewing suppliers processing data
and inspection of ingredients at receiving. Reviews of incoming material records and supplier
HACCP plan audits could be used to validate that meat is sourced from preferred suppliers that
have an effective HACCP plan.

FSO2: To minimise the transfer of microbiological hazards to the product, and their
redistribution, so specific microbiological targets are met.

FSO2 is expected to be achieved by effective prerequisite programmes (e.g. sanitation and

cleanup procedures, personal hygiene, hygienic processing, rework procedures). Prerequisite
programmes should be validated in accordance with the requirements in IS 8. Microbiological
testing of products may also be used to validate this FSO.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.16

FSO3: To minimise the growth of pathogens in the product so specific microbiological

targets are met.

FSO3 is expected to be addressed by an effective prerequisite programme on refrigeration

management which should be validated in accordance with the requirements in IS 6 and IS 8.
Microbiological testing of products may also be used to validate this FSO.

FSO4: To prevent and/or remove foreign objects from the product (i.e. bone pieces, metal)
so specific targets are met.

FSO4 is expected to be achieved by the removal of bone chips at CCP1 (final grinding), the
removal of metal objects at CCP2 (metal detection), and effective prerequisite programmes (e.g.
the SQA programme, repairs and maintenance, personal hygiene and hygienic processing).

The performance of the metal detector to consistently detect and reject specified metal objects
should be evaluated against the target set for the FSO. It is important to take into consideration
the types of metal likely to occur in the product, the capability of the machine, and the
characteristics of the product. The processor will need to establish a detailed test methodology
for checking the performance of the detector. This should include specifying how the test piece
is mounted and passed through the search head with or without product being present,
examination procedure for reject material, frequency and interval for testing.

The effectiveness of the bone eliminator should be evaluated against the target set for the FSO.
A method for the analysis of bone chips in meat mixtures is mentioned in the Annex, Section 6.2.

Prerequisite programmes should be validated in accordance with the requirements in IS 8.

10.2 Ongoing verification

Ongoing verification activities confirm whether the HACCP plan is operating effectively and
according to documented procedures. Examples of these activities are internal and extrinsic
audits, HACCP review, and product testing programmes.

10.3 Revalidation

A revalidation of the HACCP plan is required, whenever changes are made (e.g. changes to
premises, product, process, intended use of the product) or process failure that may compromise
product safety occurs.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.17

Form 6: HACCP plan summary spreadsheet for the manufacture of raw beef patties

Process step Hazard ID CCP no. Critical limits Monitoring Corrective actions1 Verification HACCP records3
procedures/tools procedures2
(consider who, what,
when and how)

Receiving and preparation of non-meat ingredients

1a. Receiving
non-meat
ingredients

2a. Storage of
non-meat
ingredients

3a. Weighing
non-meat
ingredients

(To step 7)

Main process

1. Receiving
meat

2. Chilled
/frozen storage
of meat

3. Tempering
meat

4. Weighing
meat

5. Decartoning

6. Pre-grinding
meat

7. Mixing
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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Process step Hazard ID CCP no. Critical limits Monitoring Corrective actions1 Verification HACCP records3
procedures/tools procedures2
(consider who, what,
when and how)

8. Final grinding Bone pieces 1 Bone eliminator Operator to visually check (a) Stop grinding and FSO validation Validation record
functioning as per performance of bone notify supervisor.
specifications. eliminator at (b) Retain affected ground Product testing for bone Daily monitoring record
predetermined frequency. meat until cleared by chips
Refer to Annex, Section Supervisor. Product testing record
6.2. (c) Disassemble and clean Calibration of bone
bone eliminator and/or eliminator Corrective action
correct setting of bone report
eliminator. Internal audit
Calibration record
Extrinsic audit (e.g.
regulator, client) Internal audit report

Customer complaints Extrinsic audit report

HACCP review Customer complaints

file

HACCP review record

9. Forming

10. Perforation

11. Freezing
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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Process step Hazard ID CCP no. Critical limits Monitoring Corrective actions1 Verification HACCP records3
procedures/tools procedures2
(consider who, what,
when and how)

12. Metal Metal 2 Metal detector Daily calibration checks of (a) Hold products FSO validation Validation record
detection functioning as per detector against test produced since last
specifications. pieces at predetermined satisfactory check of the Calibration of metal Daily monitoring record
frequency. metal detector. detector
Product characteristics (b) Correct metal detector Calibration record
(e.g. temperature) as Examination of all or product characteristics Internal audit
per specifications for rejected products. affecting machine Corrective action
which detector sensitivity. Extrinsic audit (e.g. report
sensitivity has been (c) Repass the product regulator, client)
adjusted. through functioning Internal audit report
detector. Customer complaints
Refer to Annex, Section (d) Hold any Extrinsic audit report
6.3. noncomplying product for HACCP review
further analysis. Customer complaints
(e) Identify source of file
metal and take preventive
action. HACCP review record

13. Packaging

14. Labelling
and weighing

15. Storage

16. Loadout

1. Corrective actions should reflect an escalating response when ongoing noncompliance occurs.

2. Verification procedures apply to all aspects of the HACCP plan.

3. HACCP records apply to all aspects of the HACCP plan. Refer to IS 8, Section 4 regarding requirements for documentation and record keeping.
# MAF Regulatory Authority (Meat & Seafood) HACCP Steering Group Amendment 4: November 1998
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# Appendix X.4: Manufacture of Beef Patties Page: X.4.20

Annex to Appendix X.4: Background Information to the Generic

HACCP Plan for the Manufacture of Raw Beef Patties

The processes covered by the Generic HACCP Plan for the Manufacture of Raw Beef Patties
continue on from where cooling and boning end. The raw material hazard identification for this
plan is based on the assumption that the beef was processed under a HACCP plan which covers
slaughter and dressing, and cooling and boning. Hazards identified in the Generic HACCP Plan
for Cooling and Boning of Beef as those that may be reasonably associated with beef cuts and
trimmings are carried through to the manufacture of beef patties.

1. Foodborne Illness Associated With Ground Beef Products

Salmonella, Staphylococcus aureus and Clostridium perfringens are the main aetiological agents
associated with foodborne illness attributed to ground meat, including hamburger meat (Varnam
and Sutherland, 1995). In recent years, E. coli O157:H7 in ground beef products, hamburger in
particular, have been implicated in a number of outbreaks of human illness in several countries
(Doyle et al., 1997).

Twenty-five percent of beef-related foodborne outbreaks in the USA, from 1968 to 1977, were
attributed to ground beef products (Bryan, 1980), whereas 21% of beef-related incidents of
foodborne illness in Canada in 1983 were attributed to hamburger (Todd, 1989). In New
Zealand, there is no evidence that ground beef or beef patties is a common cause of illness.

Beef patties are usually cooked at, or shortly before, the point of consumption. Foodborne illness
associated with beef patty consumption is therefore only likely to occur as a result of conscious
raw consumption, undercooking or contamination of the cooked product.

2. Biological Hazards

2.1 Meat

Enteric pathogens, such as Salmonella spp., E. coli O157:H7, Campylobacter jejuni and
Clostridium spp. are the biological hazards of major food safety concern that may be present on
beef cuts and trimmings, the raw material commonly used in the manufacture of beef patties.

Pathogens associated with meat that can grow at chiller temperatures, such as Listeria and
Yersinia, have also been identified in recent years. Although these cold-tolerant pathogens may
pose some health risk, this has not been quantified and is considered by Gill (1993) to be
insignificant.

Biological hazards associated with the consumption of beef patties are briefly discussed below.
Refer to Annex to Appendix IX.1: Background information to the Generic HACCP Plan for the
Slaughter and Dressing of Cattle for more details on these biological hazards.
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Salmonella spp.

Salmonella spp. is the primary bacterial aetiological agent responsible for beef-related foodborne
outbreaks in the USA and Canada (Bryan, 1980; Todd, 1989; Bean and Griffin, 1990). Examples
of beef products that have been implicated in outbreaks are roast beef, jerky and ground beef.
Raw hamburger meat has been identified as a vehicle for outbreaks of human salmonellosis in
the United States (Fontaine et al., 1978; Bryan, 1980). Contamination of the raw beef combined
with improper food handling practices were found to be important factors in a substantial
proportion of the Salmonella cases (Bryan, 1980).

E. coli O157:H7

E. coli O157:H7 was first recognised as a foodborne pathogen after two outbreaks of
haemorrhagic colitis in the USA in 1982, attributed to the consumption of undercooked
hamburgers from a fast-food restaurant chain. Since then, several beef-related outbreaks caused
by E. coli O157:H7 have been reported in other countries, including the USA (Bean et al., 1990;
Tarr, 1994), Canada and the UK (Chapman et al., 1993). The principal vehicle implicated in
outbreaks has been ground beef and evidence suggests that in most instances the meat was
undercooked (Doyle, 1991; Doyle et al., 1997). One of the notable outbreaks, affecting 16
people in the USA in July 1997, resulted in the recall of 25 million pounds of hamburger meat.
Evidence suggests that the pathogen came from any one of 10 slaughterhouses that supplied the
raw material to the manufacturing plant.

E. coli O157:H7 infection was first identified in New Zealand in 1993. Between then to the end
of June 1998, there have been a total of 61 reported cases of infection by the pathogen (ESR,
1998). A source of infection has not been reported for any of these cases.

Campylobacter

In New Zealand, the most significant factors associated with cases of campylobacteriosis are the
consumption of raw or undercooked foods (notably poultry, but also unpasteurised dairy
products) and the consumption of untreated drinking water (ESR, 1996). Campylobacter is far
less frequently associated with red meat. This appears to be due to the lower carriage rate of
mammals compared to birds and the fact that the bacteria appear to die off on the dry carcass
surface (Hasell, 1994). Freezing also significantly reduces the number of viable organisms
(Hasell, 1994). There has been one reported outbreak associated with undercooked hamburger
meat in the Netherlands (Blaser et al., 1983).

A survey of 27 retail outlets in New Zealand showed that campylobacter was not detected in 50
samples of commercially ground beef obtained over a period of two months (Gill and Harris,
1984). Failure to detect C. jejuni in commercial ground meat was expected based on the low
incidence and degree of Campylobacter contamination of red meat carcasses. Freezing to -18
EC for 7 days reduced numbers of C. jejuni in artificially contaminated hamburgers by one log
cycle. Minimal cooking, even when meat at the centre of hamburgers remained raw, rapidly
eliminated the organism. The absence of campylobacter in retail samples of ground beef and the
minimal cooking requirements for the destruction of the organism led Gill and Harris (1984) to
conclude that under New Zealand conditions, ground meat dishes are unlikely vectors for human
Campylobacter enteritis.
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Staphylococcus aureus

Staphylococcal food poisoning results from the ingestion of food containing the enterotoxin
produced by certain strains of Staphylococcus aureus. The organism competes poorly with other
bacteria and thus seldom causes food poisoning in raw meat products (ICMSF, 1996).
Foodborne illness due to S. aureus enterotoxin is primarily a result of contamination by food
handling personnel and is generally associated with temperature abuse of cooked products
(Bryan, 1980; Bergdoll, 1989). Animal strains of S. aureus have rarely been associated with
outbreaks of staphylococcal food poisoning in man (Wilks and Humble, 1997).

There is little manual handling of product during semi-automated, large scale production of beef
patties. Product is also kept at low temperatures (< 3 EC) during the whole process. The
presence of unacceptable levels of S. aureus in frozen raw beef patties is therefore likely to be
due to contaminated incoming raw material rather than from contamination during the
manufacturing process.

2.2 Non-meat ingredients

Spices

Spices are not major contributors to foodborne disease; however, they occasionally contain
bacteria that can cause foodborne infections (ICMSF, 1998).

Spore-forming organisms that are capable of causing gastroenteritis when ingested in large
populations are found in spices, but usually in small populations. Out of 110 of various spices
tested for prevalence and levels of Bacillus cereus, the organism was found in 53% of the
samples (Powers et al., 1976). A recent survey on several spices found B. cereus in all samples
at levels of 1 102 to 1 106 cfu/g (Giffel et al., 1996). A relatively high incidence of
Clostridium perfringens has also been found in several spices (Powers et al., 1975).

Spices have also been implicated in several outbreaks of salmonellosis (ICMSF, 1998). The New
Zealand microbiological reference criteria for Salmonella in herbs and spices (Ministry of Health,
1995) is zero in 25 g. Commercial suppliers of treated spices in New Zealand normally provide
a guarantee that their products meet this criteria.

As bacterial spores may survive cooking temperatures and will grow in many foods at
temperatures of 3-50EC, spices harbouring these spores must be considered as a potential health
hazard if the foods in which the spices are added are not properly prepared and handled (ICMSF,
1998). Under normal operations of beef patty manufacture and GMP, where the temperature of
the product is unlikely to rise above 3 EC, bacterial spores are unable to grow and form toxins.

If the introduction of pathogens from spices is of concern, then the use of spices that have been
treated to reduce microbiological levels may be advisable. The effectiveness of decontamination
methods such as fumigation or irradiation is dependent on the initial microbial load of the spices
and the treatment parameters. Alternatively, the use of essential oils and oleoresin can avoid
spices being a source of microbial contamination.
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The above points stress the importance of sourcing spices from preferred suppliers, setting of
correct quality specifications and managing the procurement of spices under an effective Supplier
Quality Assurance (SQA) programme.

3. Chemical Hazards

3.1 Meat

Chemical hazards that could be present in beef and meat products include agricultural chemicals
(i.e. pesticides, herbicides, veterinary drugs) and environmental contaminants (i.e. heavy metals,
organochlorines). New Zealand MAF maintains a National Residue Testing programme that
monitors the residue status of animals slaughtered for human consumption.

Chemical hazards associated with identified chemical residues (e.g. suspect lines) are addressed
under the Generic HACCP Plan for Slaughter and Dressing for Cattle. Carcasses and products
from chemically suspect animals are sampled and detained according to MAF Reg specifications.
Suspect products are stored separately until their disposition is determined by the regulator.

Chemical hazards associated with unidentified chemical residues (e.g. antibiotics, environmental
contaminants) are addressed outside the HACCP plan, under the National Residue Testing
programme. Sporadic chemical residues at some level will always occur, but recent results from
the programme indicate that residue levels in meat are generally in compliance with national
requirements.

Chemical hazards associated with visible injection site lesions (ISLs) are usually addressed at
post mortem inspection and at cutting and boning. Deep-seated ISLs may remain undetected in
some cuts, but this is expected to be a rare occurrence.

3.2 Spices

Chemical residues of pesticides, herbicides and fumigants may be present in herbs and spices.
Of particular concern are residues of methyl bromide, a fumigant used to control insect
infestation in spices, and ethylene oxide, a chemical used for reducing microbial contamination.
The SQA programme should ensure that chemical residue levels in non-meat ingredients are
below the maximum permissible levels specified in New Zealand and importing country
regulations.
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4. Physical Hazards & Foreign Objects

4.1 Meat

The presence of foreign objects, such as metal and bone pieces, is of major concern to meat
manufacturers (Archibald et al., 1993; 1995) because of their potential for causing injury such
as cuts, broken teeth, choking (Rhodehamel, 1992), and intestinal perforation (Gunn, 1966).

Manufacturers in Japan, the United States and New Zealand have reported finding metal objects
in manufacturing meat produced in New Zealand. These objects included shotgun pellets, a
MAF stamp, knives, hooks, bolts and nuts. There is agreement among manufacturers that meat
suppliers should install a preventive programme for physical contamination, and a metal
detection system to address the metal hazards.

One major New Zealand manufacturer now insists that their meat suppliers have an effective
metal detection system in place. They claim that their problem with metal contaminants has been
greatly reduced since they instituted this policy.

Although the use of metal detectors in boning premises may greatly reduce metal contaminants
in beef cuts and trimmings, it probably will not completely remove metal objects that would be
of concern to patty manufacturers. This is because metal detectors used in cutting and boning
premises are generally set at limits higher than those used in patty manufacturing plants.
Therefore, metal pieces with sizes smaller than the detection limit of the machine can still be
present in beef cuts and trimmings.

Bone chips are a frequent problem in ground beef. According to Sebranek et al. (1989), about
0.1% of raw meat ingredient weight is likely to be bone or hard particles. These result from
normal deboning operations where knives occasionally scrape or knick bone surfaces and result
in bone particles in the meat. Unfortunately these bone chips are unlikely to be picked up by
controls available under a cooling and boning HACCP plan because of their size, and they are
frequently carried through to the finished product. Legal litigation by consumers concerning
dental damage from hard particles in meat is not an unusual event in the US (Sebranek et al.,
1989) .

4.2 Salt and spices

The New Zealand Food Regulations 1984 requires that salt shall be free of dirt, and that spices
shall not contain foreign organic and inorganic matter, or any other unsuitable or inferior
material. Specifications for commercially available spices normally include a requirement that
they be free from foreign objects. Powdered spices are generally sieved and sometimes undergo
metal detection to remove foreign objects. The SQA programme should ensure that non-meat
ingredients are free from foreign objects which may pose a food safety hazard.
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5. Supplier Quality Assurance (SQA) Programme

The microbiological quality of patties is largely affected, if not wholly determined, by the
microbiological levels of the manufacturing beef from which the patties have been prepared (Gill
et al., 1997). When patties are manufactured from raw material from multiple suppliers, the
microbiological level of the product is probably determined by the raw material from the supplier
having the poorest hygienic performance, i.e. raw material with satisfactory microbiological
levels will not adequately dilute out raw material with unsatisfactory microbiological levels.

In order to make safe products, it is important that the hazards associated with raw materials are
clearly understood and controlled to acceptable levels. The raw materials should either contain
no hazards at unacceptable levels, or any hazards must be controllable by the process. In the case
of raw patty manufacture where there is no destruction step for microorganisms, manufacturers
should place special focus on receiving raw materials and ingredients from preferred suppliers
and having an effective SQA programme in place.

Some of the elements which form part of an effective SQA programme include having agreed
specifications, auditing suppliers and certificates of analysis (Mortimer and Wallace, 1994).
Manufacturing plants should also have procedures in place for the verification of compliance to
agreed specifications, such as physical inspection and microbiological testing of incoming
materials based on statistically valid sampling plans.

6. Key Process Steps: Hazards and Potential Impact on Existing Hazards

It is assumed that the quality of incoming materials are adequately addressed under the SQA
programme. Therefore, control measures applied during the manufacture of patties are primarily
aimed at preventing the redistribution and uncontrolled growth of mesophilic pathogens in the
product; and the prevention and/or removal of foreign objects to specified targets.

6.1 Receiving

Beef used for patty manufacture may be chilled, frozen or a combination of both. Large scale
patty manufacture commonly involves the grinding of manufacturing beef from two or more
sources for each batch. Chilled product is usually obtained in bulk bins from premises which are
geographically convenient to the manufacturing plant. Frozen product is usually obtained in
New Zealand in 27 kg boxes.

Meat temperature is commonly measured as part of incoming material inspection. A slight

increase in temperature of frozen products during transport and handling prior to receiving,
although undesirable, is not expected to compromise product safety. However, temperature
increases in chilled products above 7 EC for a sufficient amount of time may allow mesophilic
pathogen growth. Measuring the temperature of chilled beef at receiving may not be sufficient
on its own to indicate whether temperature abuse occurs during transport. Transit time may also
need to be considered. The use of temperature recorders may help in verifying temperature
profiles during transport and this could be made part of the SQA programme.
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Aside from temperature measurements, most manufacturing plants also inspect incoming raw
materials for compliance with other agreed specifications such as package integrity, odour and
appearance of chilled meat, age of product, and the presence of foreign objects.

6.2 Mincing, mixing and forming

Potential impact on existing microorganisms

Grinding is the most common and traditional comminution method for patty making. Meat is
usually ground through a coarse plate (about 8-12 mm), followed by a fine plate (about 2.5-6
mm). Mixing may take place after grinding or alternatively grinding can be carried out in two
stages, with an intermediate mixing stage.

During the grinding process, the temperature of the product tends to rise. For tempered meat,
the latent heat of melting limits temperature rise (Varnam and Sutherland, 1995). Any
temperature increase in chilled meat should not pose a problem because the temperature is
immediately brought down during mixing.

Mixing temperature is very important for proper forming and is generally kept at about -3 to 0EC
(Mikkelsen, 1993). The required low mixture temperatures are achieved by using frozen meat
in the formulations, or adding ice or CO2 snow to the mixture. Mixing times for patties are very
short; just sufficient for the mechanical action during mixing, sometimes together with NaCl, to
bind the product before and after cooking. Beef patties are quick-frozen immediately after
forming and perforation.

Therefore, normal temperature conditions during the manufacture of beef patties do not favour
microbial growth.

Bone chips

Bone chips are a potential problem with all methods of comminuting meat, and some mincers
are fitted with bone removal systems (Varnam and Sutherland, 1995 ). These exploit differences
in the density of bone and meat to force the bone into separate channels at the exit plate. Meat
temperature should be adequately controlled to within the range that will allow the bone removal
system to function effectively. Several systems are currently available with varying
effectiveness. Consequently, it is useful to be able to determine hard particle content in a
particular mixture. Sebranek et al. (1989) provides a method for the analysis of bone chips and
connective tissue in meat mixtures.

Metal

The presence of metal fragments in meat patties is not an unusual occurrence. These can come
from incoming raw material or can be produced as a result of metal-to-metal contact, specially
during grinding or mixing. Metal parts that can break loose from equipment, such as moving
wire mesh belts, can also contribute to metal contaminants in the finished product.
Preventive measures, such as regular repair and maintenance of equipment and periodic checking
of equipment for damage and missing parts, can help reduce the occurrence of metal objects in
the product.
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6.3 Metal detection

Most patty manufacturers, if not all, have metal detectors for 100% inspection of finished
products prior to packaging.

When installing a metal detection system, it is important to take into consideration the types of
metal likely to occur in the product, the capability of the machine, and the characteristics of the
product. The limitations of the detector should be clearly understood and reflected in the food
safety objective set for metal objects. The detection capability of metal detectors is generally
influenced by the type, size and shape, and orientation of the metal, and the characteristics of the
product (e.g. moisture content, temperature) (Shapton and Shapton,1991). Some processors set
their critical limits for metal based on the limit of detection of the machine.

The processor will need to establish a detailed test methodology for checking the performance
of the metal detector. This should include specifying how the test piece is mounted and passed
through the search head with or without product being present, examination procedure for reject
material, frequency and interval for calibration and testing.

6.4 Freezing

The extensive research carried out by MIRINZ on microbial growth at sub-freezing temperatures,
clearly indicates that meat or meat products stored at product temperatures below -8 EC will not
support any microbial growth (Winger, 1984). However, if present, some pathogens will survive
freezing temperatures.

The different pathogens that could be present on meat and meat products prior to freezing show
different sensitivities to freeze damage. Freezing causes damage to Salmonella, but it does not
guarantee its destruction in food. Salmonella has been detected in products that have been stored
frozen for years (ICMSF, 1996). Staphylococci are relatively resistant to freezing temperatures.
Vegetative cells of C. perfringens are very sensitive to freezing, but its spores are highly resistant
to cold. E. coli survives well in frozen food. Little change was observed in the numbers of E.
coli O157:H7 in beef patties during 9 months storage at -20 EC (Doyle and Schoeni, 1984). It
is therefore important that meat products are within acceptable microbiological levels prior to
freezing.

7. Cooking Beef Patties

Although the cooking step is outside the scope of this HACCP plan, a brief discussion is given
because of the major importance of proper cooking in the destruction of pathogens, such as E.
coli O157:H7, in beef patties. In the case of any meat product that is not marketed as a ready-to-
eat product, the food preparer has to use responsible precautions to ensure that the food is
properly and safely prepared.
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The primary method for destroying pathogens, such as E. coli O157:H7, in hamburger patties
is by cooking them to a proper internal temperature (Singh et al., 1997). A number of
recommendations for cooking beef patties have been made after disease outbreaks were caused
by E. coli O157:H7 in ground beef. During a large outbreak in 1992-93 in the US, the FDA
issued interim advice to cook all parts of hamburgers to 68.3 EC. Later in 1993, the USDA-FSIS
issued an order requiring specified cooking times and temperatures for uncured meat patties (e.g.
66.1 EC for 41 s, 68.2 EC for 16 s, 69.4 EC for 10 s). Advice in the UK is to cook to a minimum
internal temperature of 70 EC for 2 minutes, or equivalent (Desmarchelier and Grau, 1997).
Factors which should be considered when establishing cooking time and temperatures include
composition of patties (e.g. amount of fat), cooking method (i.e. equipment, procedure), and
patty shape and thickness.

Consumers have been advised that the absence of internal pink colour can be an indicator of
thorough cooking. However, studies have shown that this is not reliable (Van Laack et al., 1996;
Warren et al., 1996). Expressible juice colour is considered to be a more reliable visual indicator
of thorough cooking than internal colour (Warren et al., 1996).
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