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AQIS MEAT NOTICE
NUMBER: 2006 / 02 Escherichia coli O157:H7 testing of raw ground beef
products for export to the USA
NSFS Ref 16, 17
Contact Officer:
Date of Effect: Date of Expiry: Anand Deo Paul Vanderlinde
Ag Food Safety Manager Manager Microbiology
20 February 2006 Until Further Meat Operations Technical Standards Branch
Notice 02 6272 5864 07 3246 8712
Distribution Category Last Notice this Distribution Category Last Notice this
Category Category
Central & Regional Meat Notice Managers, Export Meat
Office Establishments 1998/23
1998/23 States
OIC Inspection Staff
Meat Establishments
IMPLEMENTATION SCHEDULE (to be completed by the On Plant Supervisor on the AQIS
file copy)
Date Received: Date Discussed With Management:_________________
Initial Implementation Date: Date Completed:
Initials:
1. PURPOSE
To advise exporters of revised requirements for testing for Escherichia coli O157:H7 in raw
ground beef products for export to the United States (US) or its Territories. This notice replaces
AQIS Meat Notice 1998/23.
2. SCOPE
The Food Safety and Inspection Service (FSIS) requires all raw ground beef products entering into
the US be:
• tested prior to its export by the country of origin; and
• subject to testing by the FSIS’s inspection personnel at port of entry/on-plant in the US.
Export of raw ground beef products (see 5.3 for definition) to the US market is prohibited unless
sampling and testing for E. coli O157:H7 has been completed. This notice does not replace but
adds to the requirements in AQIS Meat Notice 99/12 ‘Salmonella testing of ground beef for export
to the US’.
3. BACKGROUND
In recent years, some isolates of the E. coli Serotype O157:H7 have been associated with fatal food
poisoning cases in a number of countries around the world. In response the USDA implemented a
policy that non-intact raw beef products contaminated with E. coli O157:H7 are adulterated.
Exemptions that previously applied (which meant that FSIS did not collect samples for testing
in certain circumstances) have been rescinded. FSIS are conducting a baseline study at
supplying establishments and port of entry to determine prevalence levels and identify where
the risk is. Once this is complete, FSIS may require testing of components (e.g. trim) at
import and supplying establishments.
4. REQUIREMENT
As part of their purchase specifications establishments producing mince beef and beef patties
for the US markets are advised to include a requirement for their suppliers of boneless beef
used in the manufacture of mince beef and beef patties to:
• certify that each lot received has been tested for E. coli O157:H7,
• use validated pathogen reduction interventions on beef carcasses, routinely verify the
interventions effectiveness through testing for E. coli O157:H7, and prevent the use of
boneless beef or carcasses from outside sources.
Establishments producing mince beef and beef patties for the US markets must also conduct
routine daily testing of their raw ground beef products or boneless beef to be used in raw
ground products for E. coli O157:H7. In addition establishments must demonstrate that they
meet the Salmonella performance standard detailed in AQIS Meat Notice 99/12.
All testing undertaken as part of these requirements (including Salmonella testing under
AQIS Meat Notice 99/12), must be carried out in an AQIS approved laboratory using AQIS
approved methods.
5. DEFINITIONS
5.1 Lot
For the purposes of testing cartons of ground beef or ground beef patties for E. coli O157:H7,
it is the responsibility of the establishment to define a lot, taking into account processing
criteria, cleaning schedules, the principle of ‘same source materials’ and other factors that
may result in contamination of final product with pathogenic microorganisms. The
establishment must have a supportable basis for defining the sampled lot. This basis should
consider the possible connections between lots including lots produced from the same source
material (source lots).
5.2 E. coli O157:H7
E. coli O157:H7 is an enterohaemorrhagic, Shiga toxin producing strain of E. coli. For the purpose
of this document, it is defined as an organism which:
• gives a positive test for detection of E. coli serotype O157 from an enrichment broth, and
• an isolate from the enrichment broth is confirmed with biochemical, and serological tests
as E. coli O157, and the presence of Shiga toxin(s) and/or one or more of the Shiga toxin
producing genes is demonstrated.
NOTE:
The following terminology is used by FSIS and this document:
Potential positive: positive on a screening test
Presumptive positive: BAX positive or serologically positive O157
Confirmed isolate: contains stx gene/s or produces Shiga toxin
5.3 Raw Ground Beef Products
Raw comminuted (chopped or ground) meat food products made from cattle carcasses (beef
and/or veal), such as ground beef, hamburger, veal patties, and beef patty mix, that may be
distributed to consumers as such. Raw product comprised only of beef from advanced meat
recovery (AMR) systems is not considered a raw ground beef product. Raw ground or
chopped products made from both beef and other meat or poultry products and beef sausage
products are not subject to the FSIS requirement for E. coli O157:H7 sampling and testing.
6. SAMPLING
6.1 Selection of cartons
Cartons are to be selected at random to ensure the full range of raw ground beef is sampled
over time. A minimum of 5 cartons must be sampled per lot. Cartons should be selected and
sampled at a point before they are lidded.
6.2 Lot identification
Samples collected from cartons need to be clearly identifiable to the lots from which they
came for purposes of traceability, retention and recall.
6.3 Removing a sample
Randomly collect a minimum of five sub-samples (total weight of no less than 325 g per lot)
that are representative of the entire lot. Random samples may be taken by either of the
methods outlined below.
6.3.1 Grab sample
From each carton to be sampled, remove a sample of ground meat or meat patties such that
the total combined weight is no less than 325g i.e. if five (5) cartons are sampled collect a
minimum of 65g from each carton.
OR
6.3.2 Core sample
Using equipment that has been sanitised by immersion in water at 82 °C for at least 10
seconds or by other acceptable means, remove cores from each test carton to provide a
minimum of 325g total weight i.e. if five (5) cartons are sampled collect a minimum of 65g
from each carton.
NOTE:
All equipment used in sampling must be washed and sanitised after sampling of each lot has
been completed.
6.4 Labelling
Label the sample with adequate detail for identification. The label must include the following
details:
• Establishment number (if samples to be sent to an external laboratory)
• Date and time of sampling
• Packing line
• Lot identification
• Product description (including Chemical Lean)
Where testing is not going to commence immediately samples should be transferred to active
refrigeration (not frozen and no higher than 4°C) without delay.
6.5 Sample dispatch to external laboratory
Follow the procedure described in AQIS Meat Notice 2003/06,”Revised ESAM Notice”,
Section 5 “Transport of Samples to NATA Laboratory”
7. SAMPLE TESTING
Instruction for Laboratories
There are two distinct stages of testing:
• Screening
• Confirmation
The test method used should generally follow the procedure below:
United States Department of Agriculture, Food Safety and Inspection Service
Microbiology Laboratory Guidebook (MLG5.03) Detection, Isolation and
Identification of Escherichia coli O157:H7 and O157: NM (Non-motile) from Meat
Products (http://www.fsis.usda.gov/Ophs/Microlab/Mlg5.03.pdf)
7.1 Screening
Screening tests must be performed in a laboratory approved by AQIS for the test, which may
be on-site or off-site.
From the sample provided collect five 65 ± 2 g sub-samples (total of 325 ± 10 g) that are
representative of the entire sample. Process each 65 ± 2 g sub-sample separately following the
approved test methodology.
All samples with a positive screening test must either undergo further testing for confirmation
of E. coli O157:H7 by a laboratory approved by AQIS for such testing or be treated as a
confirmed positive.
Transportation of enrichment broths, that test positive using screening tests, must follow
current Dangerous Goods Regulations. The enrichment broth must be handled as being
suspected of containing a pathogen in risk group 2.
NOTE:
Information on the transportation of infectious substances can be obtained from the
Australian Government, Department of Transport and Regional Services website.
http://www.dotars.gov.au/transreg/dgoods.htm
7.2 Confirmatory testing
Confirmatory tests must be performed in an AQIS approved laboratory using an AQIS
approved method.
Confirmatory testing must include isolation of colonies using an immunomagnetic separation
technique followed by plating on a selective, differential medium (for example Rainbow
Agar, or CTSMAC). Up to five typical colonies should then be tested serologically for the
O157 antigen. Positive colonies should be tested for the presence of Shiga toxins or stx genes
and/or biochemical reactions.
A confirmed positive is reported when at least one colony conforms to the definition of E. coli
O157:H7.
8. MEASURES IN RESPONSE TO A POSITIVE RESULT
In the event of a potential or presumptive positive test result, the production lot represented
by the sample is retained until the confirmatory test results are available or treated as if
confirmed positive.
AQIS must be notified and if the test is confirmed positive, disposition of product is to be
made in accordance with the provisions specified in the Approved Arrangement and must be
approved by AQIS. Currently disposition of the lot must be by rendering, approved heat
treatment at an authorized plant or disposal at landfill. Establishments with product that is
confirmed positive for E. coli O157:H7 must retain records to verify that the affected product
has received appropriate disposition. The product is not eligible for export.
If the affected product is transferred to another facility, eg for heat treatment, this must be
done under AQIS control and the original establishment must obtain records from that facility
to verify that appropriate disposition was undertaken. The establishment performing the heat
treatment must address E. coli O157:H7 in their HACCP plan to ensure adequate lethality
treatment has been performed to eliminate or reduce the pathogen to undetectable levels.
Consideration must be given to connection between lots and appropriate tracing of product.
The company must maintain adequate records and control over movement of product to
enable required tracing for all product implicated by a confirmed positive test result.
A review of the HACCP arrangements must also be undertaken to ensure appropriate
corrective action/sanitation procedures have been undertaken. If appropriate actions have not
been taken or if multiple positives occur, AQIS may require further review of sanitation and
testing procedures, corrective action and increased testing to verify the problem has been
addressed. Adequate records must be kept to verify appropriate review and actions have
occurred.
If confirmatory testing is not undertaken, the lot as defined in Section 5.1 above must be
treated as though it were confirmed positive for E. coli O157:H7.
If confirmatory testing finds the sample negative for the presence of E. coli O157:H7 the lot is
considered negative and can be released.
9. RESPONSIBILITIES
9.1 Management Responsibilities
Intending exporters of raw, ground beef to the US market should provide full details of their E. coli
O157:H7 testing program to the respective AQIS ATM for approval prior to commencing
production for this market. Full details of the approved program should then be incorporated in the
establishment’s HACCP program/Approved Arrangement.
Management must:
• Develop and implement a testing program (SOP/WI) based on this meat notice and it’s
Approved Arrangement.
• Authorise testing laboratories to provide all relevant test results to the OPS at the same time
they are supplied to plant management.
• Ensure that all products can be traced and retained in the event of a positive result.
• Where company staff are authorised request for permit (RFP) validators they must not validate
an RFP unless processed product complies in full with the specific provisions of the Approved
Arrangement, the daily record review (pre-shipment review) is completed and satisfactory
and, the product complies with the microbiological standards of this notice
9.2 AQIS OPS Responsibilities
• Inspection Service staff must not validate an RFP unless processed product complies in full
with specific provisions of Approved Arrangement, the daily record review (pre-shipment
review) is completed and satisfactory and, the product complies with the microbiological
specifications of this notice.
• Verify testing is performed in accordance with the company’s Approved Arrangement and
meets the requirements set out under ‘management responsibilities’ above.
• Record results in the ESAM database, which is being modified to allow this to happen.
During the interim period, results must be sent to Mid-Operations by e-mail:
(Mid.OpsCoord@aqis.gov.au)
2H
• Check results weekly.
• Following a positive test result ensure proper disposition of product in accordance with the
company’s Approved Arrangement.
• The AQIS OPS must supervise and verify that the correct procedure is performed in the
sample collection, preparation and submission to an AQIS approved laboratory that has been
approved for E. coli O157:H7 testing.
• Ensure that Independent Product and Process Examination (IPPE) and Check the Checker
(CTC) findings are recorded in the AQIS National Plant Management System (NPMS),
discussed with management and reported to the ATM.
• Raise Corrective Action Requests (CAR) for any errors in technique(s) detected during these
checks and ensure it is rectified and signed off by the company management.
• Where continued non-conformance in technique(s) is detected for the sampling operation, an
intensified level of monitoring/supervision will be instituted.
9.3 AQIS ATM Responsibilities
• Ensure the OPS has read this notice, understood the requirements, discussed the notice with
establishment management, and that management are complying with the direction.
• Review and approve HACCP and testing program prior to commencement of production for
the US.
• During routine audits, ensure that these requirements are documented in the establishments
Approved Arrangement and are being adhered to.
• Critically assess the contributing factors and effectiveness of preventive and corrective action
that has been taken.
• Endorse NPMS entries by the OPS as valid by signing and dating relevant monitoring records.
10. EXPORT DOCUMENTATION
When submitting an export permit (RFP) for uncooked ground beef or patties, product code “AP”
must be used and the cut type be one of the following:
• 2580 Minced Beef (Ground)
• 2580 N Beef Burger (includes extenders and additives)
• 2580 P Beef Burger
• 3966 Minced Veal.
Where the destination is the US or its Territories, the following declaration will also have to be
included in the exporter comments field “Testing for E. coli O157:H7 completed with satisfactory
results” (a satisfactory result means the test for E. coli O157:H7 was negative). If this declaration is
not included then the RFP will be rejected.
Endorsement on Health Certificate
"This product has been subject to an E. coli O157:H7 prevention and/or testing program that was
monitored by the inspection system of the exporting country."
Carol Sheridan
Manager
Meat Program
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