MISC Circular

Subject: Escherichia coli O157: H7 Testing for Bulk Manufacturing Beef in

US-Listed Slaughter Premises and Packing Houses: SPECIFICATION
FOR T ECHNICAL PROCEDURES

Reference No: 99/MISC/5

Date: 12 May 1999

Distribution: US-Listed Slaughter Premises and Packing Houses; US Exporters;

Approved Laboratories; MISC Members.

This Circular consolidates and cancels Circulars 98/MISC/6, 98/MISC/7,

98/MISC/8, 98/MISC/12 and 99/MISC/1

Please note the following significant changes:

1. A revised Monthly Report Sheet has been included.

Background

1.1 New Zealand bulk manufacturing beef eligible for use by United States grinders
is to be sampled and tested for Escherichia coli O157:H7 as part of routine
production in all boning operations of US -listed premises.
1.2 The Meat Industry Standards Council on behalf of the New Zealand industry has
developed the following Protocol. The use of the protocol is not a legal
requirement and remains a commercial choice for individual exporters.
1.3 The E. coli O157:H7 test programme is in addition to, but integrated within, New
Zealand’s current mandatory national quality assurance programmes, the
National Microbiological Database (NMD) and MILAB Approval Limited laboratory
approval scheme, so as to benefit from those infrastructures and make best use
of current laboratory and sample collection resources.
1.4 Samples are to be collected from boxed manufacturing beef at the end of the
production system, immediately prior to freezing, and analysed in MILAB
approved laboratories using methods that meet the requirements set out in the
Appendices to this Circular.
1.5 A certification system has been put in place to indicate to United States
importers and grinders that product manufactured on the stated date has been
sampled and tested for E. coli O157:H7 according to the New Zealand testing
protocol, and that the test result was negative.
1.6 Premises must establish a detain/recall procedure to ensure that any suspect
product is withheld from United States production systems, pending confirmation
of any positive screen test result.
1.6.1 The transport time from New Zealand to the USA provides further assurance that
contaminated product cannot enter US production systems.

2 Objectives
2.1 To provide assurances of testing of raw materials to importers, grinders and
users of bulk manufacturing beef in the United States of America.
2.2 To operate a monitoring programme for E. coli O157:H7 testing, within the
framework of the Na tional Microbiological Database (NMD).
2.3 To provide a specific pathogen-testing component for verification of HACCP
plans.

3 Application
3.1 An E. coli O157:H7 testing programme shall be implemented by all US-listed
boning operations (ME & PH) exportin g manufacturing beef which may be used
in the preparation of hamburger patties to the US.
3.2 This programme was implemented across the industry on Monday, 29 June
1998.
3.3 The programme will be ongoing and dynamic. It must continue to satisfy New
Zealand industry’s market access and national food safety goals, and,
consequently, may alter in intensity relative to such goals. Whatever the
situation, industry will negotiate a programme designed to facilitate trade, assure
food safety, and meet customer demands in a cost effective manner.

4 Procedure for Product Testing

4.1 Product to be sampled, procedures for sampling, and procedures for
transportation to the laboratory shall be as described in Appendix I.
4.2 All E. coli O157:H7 analyses shall be performed in MILAB Approved laboratories
operating to the required physical containment level
(Appendix II).
4.3 Each E. coli O157:H7 analysis shall be performed according to the methods
described in Appendix III.
Modification or substitution of methods is not permitted unless approved by
MILAB, and documented in the MILAB Rules (ML102, Attachment 4).

5 Procedure for Certification of Product

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5.1 Testing laboratories shall provide to the licensed premises a certificate for each
set of samples of product tested according to the procedures outlined in
Appendix IV.
5.1.1 The certificate shall state that the bulk manufacturing beef produced on the
stated date has been tested for E. coli O157:H7 according to the agreed testing
protocol, and that the test result was negative.
5.2 Licensed premises shall provide to the US importer, and thereby to individual
grinders and their customers, a certificate on company letterhead for each
consignment, according to the procedure outlined in Appendix IV.
5.2.1 The certificate shall state that all bulk manufacturing beef within the consignment
has been produced in premises which operate and test according to the New
Zealand protocol for E. coli O157:H7, and that the test result was negative.

6 Procedure for Detaining Produc t

6.1 In accordance with the definition as applied to USDA spot testing of premises, a
single “lot” consists of all bulk manufacturing beef produced in the period
between full hygiene cleanups of the boning facility. Such hygiene clean ups
need not be consecutive, but must not be more than 24 hours apart.
6.2 Product from any period as defined in 6.1 for which samples return a positive
screen for E. coli O157 shall be immediately detained according to the
procedures described in Appendix V.
6.3 Product from any period as defined in 6.1 for which samples return a confirmed
positive for E. coli O157:H7 shall be further detained and reworked according to
the procedures described in Appendix V.
6.3.1 This product shall not be released for export to the US.

7. Reporting of Results to the National Microbiological Database

7.1 MISC has agreed that it would be of value to maintain results from the E.coli
O157:H7 test programme in a central national repository in order to:

• Enable the development of a national profile for prevalence of E. coli

O157:H7 in bulk manufacturing beef;

• Facilitate the development of a national case opposing ongoing lot-based

testing of bulk manufacturing beef for E. coli O157:H7;

• Facilitate improvement to the E. coli O157:H7 test programme through

understanding of the rate of false positive screen and non-confirmed O157
tests.

7.2 The central repository shall be the National Microbiological Database (NMD)
currently administered for MISC by MAF Reg.
7.3 MISC has agreed that provision of results to the NMD is voluntary, but highly
recommended.

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7.4 A Monthly Report Sheet for reporting of E. coli O157:H7 test results to the
National Microbiological Database is attached in Appendix VI. Alternatively,
premises may enter results directly to an electronic database (available from
MAF Regulatory Authority).

8. References (available on request)

MILAB (1998) Rules of the Laboratory Approval Scheme. MILAB Approval
Limited, Wellington, New Zealand.

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 Appendix I

Product to be Sampled, Procedures for Sampling, and Procedures

for Transport of Samples to the Laboratory

1 Product to be Sampled

1.1 Samples shall be collected solely from boxed, non-frozen boneless

manufacturing beef (National Microbiological Database Specification for
Technical Procedures (MAF, 1997b) [NMD], Sections 3.3.1, 3.3.2 & 3.5.1).
1.1.1 Core samples may be collected from frozen boxed meat, transported frozen to
the laboratory, and analysed directly from the frozen state, where unforeseen,
but exceptional, and foreseen circumstances prevent testing of product
according to this protocol (e.g. exceed time and temperature parameters).
Samples must not be collected from fresh meat, and subsequently frozen.
Thawed samples must not be analysed.
1.2 Product type (e.g. trim, BFH) sampled shall be rotated (NMD, Section 3.5.1)

2 Collection of Samples
2.1 This sampling plan utilising random on-line sampling is process-based, and meets
the expectations of a validation process and ongoing verification for HACCP plans
(MAF, 1997a). All premises to which this programme applies shall have HACCP
plans in place, as per the requirements of the US Pathogen Reduction / HACCP
Final Rule.
2.2 Five (5) cartons per period between two full hygienic clean-ups shall be sampled
(at least 5 cartons per processing day, including weekends).
2.3 The time of sampling shall be varied randomly across the period/day.
2.4 Cartons to be sampled shall be selected randomly from the production line. In
order to spread sampling over several mobs, and hence ensure that the sample
is somewhat representative of the days kill, it is recommended that a single
carton be removed from the line for sampling, and that the next carton not be
selected until sampling of the previous carton is completed.
2.5 Samples shall be collected in the boning room immediately before the cartons
are closed (NMD, Section 3.6.5.2).
2.6 Five whole tissue sub-samples of not less than 5g shall be collected from each
carton and composited to form a single sample of 25g per carton. Samples shall be
collected as described in NMD, Sections 3.7.6 and 4.4.
2.6.1 In the event that frozen samples are required to be collected, the core samples
shall be aseptically collected using an 18-25 mm drill bit, or equivalent. A
minimum of two cores per carton shall be collected from diametrically opposite
corners. The total sample weight shall be no less than 50g.
2.6.2 It should be noted that current "trained samplers" might not have been trained in
core sampling. “Certified Trainers” have been trained in core sampling.
Laboratories and premises must ensure that their sample collection personnel
are trained in core sampling.

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2.7 Cartons sampled shall be identified either by their unique formal identifier, or by
a mark applied by the sampler. Cartons sampled shall be traceable to their
product type, and to the day and time of production.
2.7.1 In the event it is foreseen that testing of frozen samples will be required, the 5
cartons chosen from a "lot" shall be selected as per the premises randomisation
plan and identified such that they can be easily identified. The day’s production
shall then be frozen as per usual procedures.
2.7.2 Cartons sampled prior to freezing (as per the usual test programme), but
requiring resampling due to failure to meet transportation/analysis requirements
shall be identified as in the above paragraph.
2.7.3 The 5 cartons of frozen product that represent the "lot" shall be sampled as
soon as possible after production (courier schedules favourable) and analysed
within the time period described in section 3.2.

3 Transportation to the Laboratory

3.1 All samples shall be transported to a MILAB Approval Limited approved
laboratory as described in NMD, Section 5 (on-plant, day shift) and Section 6
(on-plant, night shift and off-site).
3.1.1 In the event that frozen samples are required to be tested all samples shall be
stored and transported in a manner than ensures that they remain frozen.
3.2 Preparation and analysis of a sample (both fresh and frozen) shall be initiated
within 24h of collection of the first sample.
3.2.1 Should delivery to the laboratory be delayed, or processing within the laboratory
compromised preparation and analysis of the samples may be initiated within
30h of collection of the first sample.
3.2.2 Samples must be refrigerated at all times (NMD, Section 6.2). The premises of
origin shall be notified as soon as a problem is identified, and the laboratory
certificate endorsed with a statement attesting to the period of, and reason for,
the delay.
3.2.3 Should delivery to the laboratory not be achieved, or achievable under
foreseeable but exceptional circumstances, within 30h of collection of the first
sample or temperature requirements are exceeded, the samples shall be
deemed “void” and shall not be tested. Frozen product from the same “lot” may
then be sampled as described above and analysed as per this protocol.

4 References (available on request)

MAF (1997a) Equivalence with the Pathogen Reduction/HACCP Final Rule:
E.coli Testing. Submission to USDA FSIS.
MAF (1997b) National Microbiological Database (Bovine and Ovine Species):
Specification for Technical Procedures. MAF Manual 15. [Available from
http//www.maf.govt.nz]

12/05/99 99/MISC/5 6
 Appendix II

Requirements for Physical Containment Level 3 (PC3)

1 Background
1.1 Laboratories currently approved under the MILAB Approval Ltd laboratory
approval scheme generally meet the requirements for working with pathogens of
Risk Group 2. Risk Group 2 includes pathogens that can cause human disease,
but are unlikely to be a serious hazard to laboratory workers or the community.
Laboratory exposures may result in infection, but effective treatment and
preventative measures are available, and the risk of spread is limited. E. coli
O157:H7 is currently classified both internationally and in New Zealand within
Risk Group 2, but with additional special precautions.
1.2 Classification in Risk Group 3 provides “safeguards to minimise risk of infection
to individuals, the community and the environment”, and requires the human
disease to be serious, the hazard presented to laboratory workers to be serious,
and the risk of spread to the community to be present. While incidents of serious
infection of laboratory personnel and spread to the community from the
laboratory have not been reported in New Zealand, several reported incidents of
serious infection in laboratory personnel have been recently reported in the UK.
1.2.1 Consequently, the EC has been required to re-classify E. coli O157:H7 to Risk
Group 3, with implementation by 30 June 1998. It is understood that New
Zealand will follow suit and reclassify E. coli O157:H7 within Risk Group 3.
1.3 MILAB Approval Ltd strongly recommends that laboratories testing for E.
coli O157:H7 comply with the requirements for testing of pathogens of
Risk Group 3, i.e., physical containment level 3 (PC3).

1.4 In addition to the safety considerations addressed above, there are serious
commercial considerations that must be considered when assessing approval of
laboratories that are physically situated within the legal boundaries of a
“licensed” meat slaughter (ME) and/or packing (PH) premises”. Contamination of
a premises with E. coli O157:H7 and consequential frequent occurrence of
positive screens for E. coli O157 would rapidly fill cold-stores with detained
product, absorb significant financial and personnel resources in obligatory
process reviews, perhaps result in an inability to meet shipment dates and, at
worst, cause the loss of a market and/or failure of a company.
1.5 MILAB Approval Ltd requires that laboratories testing for E. coli O157:H7
that are physically situated within the legal boundaries of a “licensed”
premises comply with the requirements for testing of pathogens of Risk
Group 3, i.e., physical containment level 3 (PC3).

1.6 The requirements for physical containment level 3 (PC3) for testing of
pathogens of Risk Group 3 are described in AS/NZS 2243.3/AMDT 2/1998,
Safety in Laboratories, Part 3: Microbiology.
1.7 The following are specific modifications to AS/NZS 2243.3/AMDT2/1998 agreed
by the MILAB Approval Limited expert panel as appropriate to the testing of E.
coli O157:H7 within the context of the New Zealand meat industry.

2 Modifications to Specific Clauses of AS/NZS 2243.3/AMDT 2/1998

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Clause Number
3.6.2 (a) The pathogen laboratory shall be physically separated from other areas of the
laboratory (i.e. a sealable room) and shall not be accessible by the general
public. Entry to the pathogen laboratory should be via an ante-room with a
double-door system. The doors shall open outwards, be self-closing and
lockable and, where possible, should contain glass panels so that occupants can
be seen.
Where a laboratory within the legal boundaries of a licensed premises has a
PC3 pathogen laboratory without a double-door system, the laboratory as a
whole shall be well separated from the food factory and from general foot-traffic.
In addition, the door to the pathogen laboratory shall not be opened when in
use.
3.6.3 (b) The pressure differential shall be achieved by means of an independent room
exhaust fan discharging to the outside. A variable speed drive on the exhaust
fan is preferred to facilitate room pressure control adjustment. Filtration is not
required on the exhaust since the mandatory Class I or Class II biological safety
cabinet is HEPA filtered.
3.6.3 (c) Clause deemed unnecessary.
3.6.3 (d) If fitted to the room exhaust, the filter shall be a HEPA type as specified.
3.6.3 (e) Continuous measurement of negative air pressure is not required. Pressures as
described in 3.6.3 (a) shall be verified prior to use of the pathogen laboratory,
re-verified annually, and following modification to the pathogen laboratory.
3.6.5 Clause deemed unnecessary.
3.6.6 (b) All staff shall have specific training in handling pathogenic organisms and in the
use of safety equipment and controls. The laboratory staff shall be supervised
by MILAB Signatories who are experienced in working with pathogenic agents.
3.6.6 (e) All pathogen laboratory procedures shall be conducted in a biological safety
cabinet of Class I or Class II (highly recommended).
3.6.6 (f) The pathogen laboratory shall not be accessible by the general public. Specific
personnel with access to the pathogen laboratory shall have limited access, and
with the following restrictions.
• Sample collectors: Shall be subject to all clothing and decontamination
requirements. Documented requirements shall be strictly enforced.
• Maintenance staff/trades-persons: Shall have restricted access to the
pathogen laboratory only after fumigation, or shall be subject to all clothing
and decontamination requirements. Documented requirements shall be
strictly enforced.
• Cleaners: Shall have access to the pathogen laboratory only after
fumigation. Only laboratory personnel shall perform routine cleaning.
• Administrators/visitors/assessors: Shall have restricted access to the
pathogen laboratory only after fumigation, or shall be subject to all clothing
and decontamination requirements. Documented requirements shall be
strictly enforced.
Authorisation shall be obtained from the Laboratory Manager (or similar
authority) prior to entry to the pathogen laboratory.
3.6.7 Clause deemed unnecessary.

3 References (available on request)

12/05/99 99/MISC/5 8
 AS/NZS 2243.3/AMDT 2/1998, Safety in Laboratories, Part 3: Microbiology,
Standards New Zealand, Wellington, NZ.

12/05/99 99/MISC/5 9
 Appendix III

Sample Analysis

1. Sample Analysis
1.1 All analyses shall be performed in MILAB Approval Limited approved
laboratories.
1.1.1 Laboratories that are IANZ accredited to perform Escherichia coli O157:H7
analyses shall be granted full approval on application to MILAB Approval Limited.
1.1.2 Laboratories that are not IANZ accredited to perform E. coli O157:H7 analyses
shall initially be granted transitional approval on application to MILAB Approval
Limited.
1.1.3 If the laboratory complies with all MILAB requirements, full approval shall be
granted following the next scheduled MILAB assessment.
1.1.4 Applications from laboratories that are not IANZ accredited shall include:
• A copy of the documented method from the laboratory’s methods manual.
• A resume of competency for personnel eligible to perform the analyses,
and for those for whom Signatory status is requested.
• Written assurance that the laboratory, if situated within the legal boundary
of a licensed premises, complies with physical containment level three
(PC3) requirements (Appendix II).
• Written evidence that the method has been validated according to the
procedures outlined in 1.1.5
1.1.5 Validation consists of five (5) replicates of the following trials:
• Broth culture: E. coli O157:H7 (<10 org/ml) + E. coli (10 org/ml) + APC
mixture (~1000 org/ml).
• Spiked meat: E. coli O157:H7 (<10 org/ml) + meat flora (?).

Note: First time users of TECRA technologies should become proficient at their
use prior to performing the above validation trials.
1.2 Each analysis shall be performed according to the methods described below.
1.2.1 The method for detection of E. coli O157:H7 in meat samples is based on that of
the USDA/FSIS.
1.2.2 Modification or substitution of methods is not permitted unless approved by
MILAB, and documented in the MILAB Rules (ML102, Attachment 4).
1.2.3 An ILCP shall be provided as soon as possible.
1.3 As required under the MILAB Rules, quality assurance functions and quality
control procedures for methods and media outlined in Chapter 2 of MIRINZ 873
(Cook, 1991) shall be used.
1.3.1 Controls: A non-toxigenic E. coli O157:H7 positive control (e.g. NZRM 3614) and
negative control (E. coli NZRM 480 or NZRM 916) shall be run with each batch of
samples analysed.

2 Preparation of the Sample Suspension

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2.1 All samples shall be prepared independently of those for the National
Microbiological Database (NMD).
2.2 The whole tissue sample (5 x >5g) from one carton shall be placed onto a sterile
chopping board, and finely dice (size reduce) with a sterile knife, or other
suitable aseptic means (e.g. blending).
2.2.1 Re-sterilised, or separate sterile chopping boards, knives, and blender
components, etc, shall be used for each sample (not necessary for samples to
be composited).
2.3 Twenty five grams (25g) of diced tissue from each sample shall be aseptically
weighed directly into individual stomacher bags, or blenders.
2.4 Two hundred twenty five millilitres (225 ml) of sterile modified EC broth
containing 20mg/L novobiocin, pH 6.9 (mEC+n) shall be added to each bag, or
blender.
2.5 Each suspension shall be stomached for 2 minutes, or blended for an equivalent
period.

3 Enrichment
3.1 The enrichment suspension shall be incubated at 37±1°C for 18-24 h.
Note: Laboratories currently using the TECRA procedure may continue to
incubate at 42±0.5°C until advised otherwise.
3.2 Each enrichment suspension may be incubated individually, or as one (1)
composited sample consisting of 125g of meat (5 x 25g samples) and 1125ml of
mEC+n broth (5 x 225ml).
3.2.1 Sub-sampling of the 125g composited sample is not allowed. All sample material
shall be analysed.

4 E. coli O157 Screen

4.1 Enriched cultures shall be screened for E. coli O157 using test procedures
currently in use by the FSIS or kits that meet or exceed the following
characteristic: sensitivity ≥98%, false negative rate ≤2%, specificity ≥90%, false
positive rate ≤10%, and efficiency≥ 94%.
4.2 Kits currently used in New Zealand or that have been validated by MIRINZ to
meet this specification, include;
• BioControl Visual Immuno Precipitate (VIP) test kit (New Zealand Medical
& Scientific). DynaBead immuno-magnetic beads (Dynal Pty, Australia).
• TECRA E. coli O157 Visual Immunoassay kit, immuno-magnetic beads
included (TECRA Diagnostics)
• Neogen Reveal kit, 24h enrichment, immuno-magnetic beads included
(InterMed Scientific)

5 Confirmation as E. coli O157

5.1 Samples returning a positive E. coli O157 screen shall be confirmed as E. coli
O157.

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5.2 In-house
5.2.1 E. coli O157 shall be isolated from the enrichment broth using immuno-magnetic
beads, with plating to CT-SMAC (preferable) or SMAC agar plates.
5.2.2 Typical colonies shall be confirmed as E. coli O157 using commercially available
kits (instructions supplied with kit).
5.2.3 A list of commercially available immuno-magnetic beads may be obtained on
request to MIRINZ.
5.3 New Zealand Communicable Disease Centre (NZ-CDC), Porirua
5.3.1 Samples returning a positive E. coli O157 screen may be confirmed as E. coli
O157 by submitting the positive enrichment culture directly to the NZ-CDC.
Note: Samples shall be transported in full compliance with NZS 5433 Code of
Practice for Transport of Hazardous Substances on Land.
5.3.2 Confirmation procedures shall be as described in the NZ-CDC procedures
manual.

6 Confirmation as E. coli O157:H7

6.1 Cultures confirmed as E. coli O157 shall be submitted to the NZ-CDC for
confirmation as E. coli O157:H7.

7 References (available on request)

nd
Cook (1991) Microbiological Methods for the Meat Industry, 2 edition. The
Meat Industry Research Institute of New Zealand Inc., Publ. 873, Hamilton, New
Zealand.
MAF (1997) National Microbiological Database (Bovine and Ovine Species):
Specification for Technical Procedures. MAF Manual 15. [Available from
Http//www.maf.govt.nz]
MILAB (1998) Rules of the Laboratory Approval Scheme. MILAB Approval
Limited, Wellington, New Zealand.
NZS 5433 Code of Practice for Transport of Hazardous Substances on Land,
Standards New Zealand, Wellington, NZ.

12/05/99 99/MISC/5 12
 Appendix IV

Certification

1. Background
1.1 A certification system is to be put in place to indicate that product manufactured
on the stated date has been sampled and tested for Escherichia coli O157:H7
according to the agreed testing protocol, and that the test result was negative.
1.2 Testing laboratories shall provide to the licensed premises a certificate on
Laboratory letterhead for each set of samples of product tested.
1.3 Licensed premises shall provide to the US importer, and thereby to users within
the United States, certification on company letterhead for each consignment.

2 Laboratory Procedure
2.1 Testing laboratories shall prepare test reports on in the normal manner.
2.2 Laboratories shall also provide to companies a certificate on Laboratory
letterhead in the form set out below (See page 13). They shall ensure that all
such Laboratory Certificates are related to the test reports for the specific test or
tests.
2.2.1 In the event that frozen samples are tested laboratory certificates shall indicate
that the samples were frozen on receipt and from frozen meat. Reports to the
NMD shall indicate that the samples were from frozen meat.
2.3 Laboratories shall agree with Companies the range of tests to be included on a
single Laboratory Certificate. They shall also agree the method and timing of
transmitting the Certificate to the Company.
2.4 Copies of Laboratory Certificates may be sent by electronic means (e-mail) or by
facsimile.

3.0 Company Procedure

3.1 Licensed premises shall provide to the US importer, certification on company
letterhead, for each consignment in the manner described below (See page 14).
Company certificates need not indicate that frozen samples have been tested.
3.2 Certificates shall be signed by company officers delegated with that
responsibility.
3.3. Copies of all Laboratory Certificates shall be matched with the corresponding
Company Certificates.

12/05/99 99/MISC/5 13
 LABORATORY LETTERHEAD

Laboratory Identity Code

This Laboratory has been approved by MILAB Approval Ltd to perform Escherichia coli
O157:H7 analyses. The MILAB Approval system is audited by the New Zealand Ministry of
Agriculture and Forestry. The sampling activity including methodology, preservation,
identification, and transport is part of the MILAB protocol.

This is to certify that the sample(s) of bulk manufacturing bee f from:

Premises licence number(s): ____________________________________________

Production date(s): ____________________________________________________

___________________________________ ___________________

has/have been tested according to the protocol described in Meat Industry

Standards Council circular 99/MISC/5.

This test / These tests were negative for Escherichia coli O157:H7.

Name ______________________

Signed _____________________
(Approved signatory)

Date ________________

12/05/99 99/MISC/5 14
 COMPANY LETTERHEAD
This is to certify that the bulk manufacturing beef described below has been produced in a premises which
operates and tests according to the New Zealand testing programme for Escherichia coli O157:H7. Samples have
been tested by

[Name of Laboratory]

This laboratory has been approved by MILAB Approval Ltd to performEscherichia coli O157:H7 analyses. The MILAB
Approval system is audited by the New Zealand Ministry of Agriculture and Forestry. The sampling activity including
methodology, preservation, identification, and transport is part of the MILAB protocol. Processing is under the
surveillance of the Inspector in Charge of the premises.

This test / These tests were negative for Escherichia coli O157:H7.
Means of transport Port of loading Serial Number of This Certificate

Port of Discharge Final destination (if on carriage)

Marks and brands: No and kinds of packages: Description of product: Net weight (state unit):

Container No: Seal No:

Cold store: Processed at: Dates of Production:

Species: Slaughtered at: Disclaimer: This Certificate refers solely to the results of tests
conducted on samples collected during the production period.
Testing of this nature is not conclusive evidence about the state of
the product.

Name

Copies of all test Certificates relating to this  Position
shipment are held at 
 Signed

Date
 Appendix V

Procedures for Withholding of Product Returning a

Positive Screen

1. Background
1.1 A system of detain/recall is to be put in place to ensure that any suspect product
is withheld from USA production systems, pending confirmation of any positive
screen test result.
1.1.1 The transport time from New Zealand to the USA provides further assurance that
contaminated product cannot enter US production systems.
1.2 Product from a period as defined in 2.1 for which samples return a positive
screen for Escherichia coli O157 shall be immediately detained according to the
procedures described in Appendix V.
1.3 Product from a period as defined in 2.1 for which samples return a confirmed
positive for E. coli O157:H7 shall be further detained and reworked according to
the procedures described in Appendix V.
1.3.1 This product shall not be released for export to the US.

2 Definition of a Lot
2.1 In accordance with the definition as applied to USDA spot testing of premises, a
single “lot” consists of all bulk manufacturing beef produced between full hygiene
cleanups of the boning facility.

3 Response to a Positive Screen for E. coli O157 (Suspect Lot)

The company shall:
3.1 Immediately identify, isolate, and mark as “detained” the whole of the “lot” to
which the samp le applies, including that already moved off the premises.
3.1.1 Arrangements shall be made for product at sea to be diverted to bond storage
pending confirmation of presence or absence of E. coli O157:H7;
3.2 Immediately inform the Inspector-in-Charge;
3.3 Review process hygiene, and, if found necessary, review the HACCP plan for the
process. This may result in the revalidation of the HACCP plan;
3.3.1 Due to the time delay between a positive screen and confirmation as E. coli
O157:H7 (up to two weeks), it is considered necessary to implement review
procedures on a positive screen.

4 Response to a Confirmed Presence of E. coli O157:H7

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 The company shall:
4.1 Immediately implement procedures to withdraw eligibility for sale of the whole
“lot” to the USA;
4.2 Immediately arrange for the destruction or appropriate reworking prior to release
(e.g. cooking or rendering) of the whole of the “lot” to which the sample applies,
including that already moved off the premises;
4.3 Immediately inform the Inspector-in-Charge.

5 Response to a Confirmed Absence of E. coli O157:H7

The company shall:
5.1 Release for export the whole of the “lot” to which the sample applies, including
that already moved off the premises;
5.2 Immediately inform the Inspector-in-Charge.

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 Appendix VI

Reporting of Results to the National Microbiological Database

1 Monthly Report Sheet

1.1 The Monthly Report Sheet for reporting of E. coli O157:H7 test results to the
National Microbiological Database is attached to this Circular.
1.2 This report sheet replaces the one issued in 98/MISC/7. It includes the following
amendments:
• Production date (rather than date of test): More than one row can be used
for each production date;
• Run: Code added for “mixed” runs;
• Product Class: “Prime” code consolidates premium, steer and heifer. Code
for “mixed” product class per carton has been added;
• Product Type: Code for “mixed” product type per carton has been added;
• Facility for one row to be dedicated to one class/type with number of
cartons stated; and
• Return fax number is now 04 474 4239.

2 Reporting to the National Microbiological Database

2.1 The Monthly Report Sheet, or electronic database, shall be forwarded to the
National Microbiological Database (NMD) as soon as possible after the end of
each calendar month.

12/05/99 99/MISC/5 18