Conditions for appointment as an analyst

1. The appointed analyst will nominate specific staff to act as the:
   1. nominated contact person or official representative
   2. e–Results contact person.
2. The appointed analyst will notify the department’s laboratory contact officer immediately of any changes to these nominated personnel. The names and details of all contacts and any changes should be supplied in writing (for example email) as soon as practicable.
3. The appointed analyst will nominate two registered email addresses:
   1. To enable the department to send Electronic Imported Food Inspection reports (eIFIRs).
   2. For correspondence between the nominated contact officer and the department laboratory contact officer.
4. The appointed analyst nominated contact must respond to any correspondence from the department by the due date as outlined in the correspondence to the appointed analyst.

1. The appointed analyst, including any laboratory sub–contracted by the appointed analyst, must maintain the NATA scope of accreditation for the activity and testing methodology used to test food submitted for analysis under the Act.
2. The appointed analyst’s NATA scope of accreditation will cover any testing carried out by the appointed analyst under the Act. Testing that may be required is outlined in the Testing capabilities application form supplied at the time of appointment, re-appointment or anytime through the duration of the appointment to add/ remove tests or to change subcontracting arrangements. Information on testing and reporting requirements is specified in the Importing Food Testing Guidelines.
3. Testing by an appointed analyst under the Act needs to be undertaken using methods appropriate to the activity for which the appointed analyst has NATA accreditation, unless otherwise approved in writing – refer to the policy on infrequent tests in Supplementary policies.
4. The appointed analyst will inform the laboratory contact officer within three business days of any change to evidence of accreditation previously provided as part of their application for appointment, either for the appointed analyst or any laboratory subcontracted by the appointed analyst, as applicable (for example accredited test rendered partly or completely inoperative that impact on analysis reports).
5. It is recognised that the appointed analyst’s NATA scope of accreditation may not cover new testing that may be required from time to time. In such cases, the following conditions apply:
   1. The appointed analyst may be requested to submit a proposal regarding an appropriate alternative testing methodology and arrangements for consideration.
   2. Where the proposal to carry out alternative testing is approved, the contact officer will notify the appointed analyst in writing and will include:
      1. a start date in relation to the alternative testing;
      2. a timeframe for lodgment by the appointed analyst of an application for accreditation in relation to the alternative testing with NATA; and
      3. a timeframe in which accreditation must be obtained by the appointed analyst.
   3. The appointed analyst must not commence any alternative testing unless and until it is approved in writing and, only then, in accordance with any such notice.
   4. In the event that NATA accreditation for approved alternative testing is not obtained in the timeframe specified, the appointed analyst must immediately:
      1. notify the contact officer in writingnotify the contact officer in writing
      2. cease testing unless and until such accreditation is obtained by the appointed analyst and
      3. comply with any reasonable direction issued in relation to the testing conducted prior to that point.

1. The appointed analyst is responsible for arranging the transportation of food samples from the department’s sample depot to the appointed analyst for testing under the Act. The appointed analyst may use a third-party provider to transport the samples, however the appointed analyst is responsible for ensuring the integrity of the food sample is maintained so that the nature of the sample does not change during transportation, the sample is not contaminated and the sample is transported at appropriate temperature controls.
2. The appointed analyst must ensure transport services have adequate, clean and well maintained equipment including insulated storage units and ice bricks and are fit for purpose. If the transport service fails to supply adequate equipment or there is reason to believe the samples will be compromised during transportation, the samples will not be released from the sample depot.
3. If the appointed analyst receives a sample they believe has been compromised during transport from the sample depot to the appointed analyst premises they must contact the department immediately.
4. The appointed analyst must handle, process and store samples of food that have been submitted for analysis under the Act, to ensure sample integrity commensurate with the testing required. Where applicable Australian Standards apply, these must be followed.
5. The appointed analyst will keep samples secure and free of further contamination.
6. The appointed analyst must register and acknowledge the receipt of a sample submitted under the Act via the electronic messaging service e-Results, within three business days from when a sample was taken. Note: the department may request the appointed analyst not to test samples after they have been registered at the laboratory.
7. The appointed analyst must store all unused samples for 30 days following testing, noting 3. 4.
8. All unused and partially processed samples should be disposed of in a manner that ensures the destruction of infectious agents where detected, noting 3.7.
9. Documented traceability of the sample (from receipt to destruction) is to be maintained by the appointed analyst at all times. All records are to be kept on file and made available to the department or other relevant authorities upon request (in accordance with clause 12).
10. The appointed analyst must report any suspected tampering of a sample immediately to the laboratory contact officer.

1. Samples subject to biosecurity control must only be handled, tested and stored by an appointed analyst at an Approved Arrangement site. The appointed analyst will be advised by the eIFIR when a sample is under biosecurity control.
2. Appointed analysts with an Approved Arrangement site are responsible for ensuring that the sample is transported directly from the department’s sample depot to the Approved Arrangement site. Samples subject to biosecurity control cannot be transshipped via another laboratory site that is not an Approved Arrangement site.
3. Where laboratories are handling material under biosecurity control, they must be an Approved Arrangement site and adhere to requirements for disposal of biosecurity waste, noting 3.8.

1. The appointed analyst must analyse a food sample in line with the test(s) that have been requested on the eIFIR that accompanies the sample. Additional testing of food samples outside of those tests requested must not be carried out.
2. Compositing of different sample IDs is strictly prohibited and all laboratory method limits of reporting (LOR’s) are to be for a single sample analysis only. Note: compositing of subsamples from one sample ID is permitted in some circumstances where specified in the IF Testing Guidelines.
3. The appointed analyst must perform the laboratory testing services with due care and professional skill and in accordance with industry best practice, the scope of its NATA accreditation and to the requirements of the IF Testing Guidelines.
4. The materials supplied by the appointed analyst for the purpose of providing services, must be fit for that purpose.
5. The appointed analyst must test only a portion of the original sample, with the remaining portion stored so as to ensure its integrity (refer to requirement 3.4). If there is insufficient sample for the initial screen and subsequent confirmatory analysis (should it be required), the sample should not be analysed and a replacement sample must be requested from the department as soon as possible.
6. The appointed analyst must provide a detailed method summary of sample analysis to the department on request and to overseas regulators at the request of the department.

1. For laboratories to be eligible to be added to the list of appointed analysts under the Act, laboratories must use Australian Standard methods or other methods that have been fully validated consistent with the requirements for accreditation against ISO/IEC 17025 and be able to demonstrate appropriate analytical performance through:
   1. use of appropriate controls and standards in conjunction with every analytical session; and
   2. participation in relevant proficiency testing programs, if available; and/or
   3. implementation and satisfactory performance in a relevant intra–laboratory program; and/or
   4. satisfactory performance for analysis of suitable certified matrix reference materials.
2. In addition, the laboratory must be able to demonstrate satisfactory performance for the analysis of any ‘blind’ samples that may be submitted by the department and in any on–site or desk–top audit of all data associated with the analytical results reported.
3. The appointed analyst must establish method performance criteria to address the relevant standards of the Code and IF Testing Guidelines. If no other minimum required performance limits exist, then the minimum performance limits listed in the relevant European Commission requirements (for example 2003/181/EC), if specified, should be followed if appropriate for the tests being performed.

1. The appointed analyst must inform the laboratory contact officer as soon as they identify that an incorrect, invalid or suspicious test result has been reported, clearly stating the nature of the issue.
2. If the appointed analyst wishes to repeat the analyses and they no longer hold sufficient sample at their laboratory, the analyst must immediately contact the regional office responsible for the sample of food and request in writing that additional samples of food are required for analysis, citing the reason(s) for more samples/repeat testing.
3. Where available information indicates that a test result is incorrect or invalid, the department reserves the right to investigate the matter with the responsible appointed analyst, appropriate accrediting body or any other relevant person- refer to the policy on retesting in Supplementary policies.

Appointed analyst laboratories must follow requirements for confirmatory testing as outlined here:

Chemical testing

Where the test result indicates that the food has failed this should be confirmed by analysing the remaining portion of the original sample. Methods for analyte confirmation should fulfil the requirements of European Commission Decision 2002/657/EC part 2.3: Confirmatory methods for organic residues and contaminants. Upon confirmation of the failed result, the appointed analyst should then provide the result to the department. Where the appointed analyst decides they require a new sample, they are to contact the contact officer (note: this should be a rare event).

Microbiological testing

Where the test result means the food will fail the relevant standard, the appointed analyst must conduct an investigation to confirm that failures are not the result of contamination at the laboratory. The initial test results will stand as true when such an investigation has ruled out contamination or cross contamination within the appointed analyst laboratory.

Results that fail the relevant standard should not be reported prior to conducting the internal investigation detailed above. Where the investigation indicates that there has been some contamination within the appointed analyst laboratory, the appointed analyst must contact the appropriate regional office as soon as possible so that another sample can be taken for analysis, if this is deemed necessary.

1. The appointed analyst must report results using eResults with the results in a format capable of being used to verify compliance with the IF Testing Guidelines. Where an appointed analyst receives error messages from eResults, they are to make the necessary changes to the message and re–send. Where the second message also receives an error message, the appointed analyst should contact the regional office for assistance correcting the reporting problem. Note: laboratories with an Approved Arrangement (AA) site must include the AA site number when reporting test results for samples subject to biosecurity control. Refer to the policy for reporting requirements for samples that are subject to biosecurity control for further detail.
2. Where the appointed analyst elects not to register the receipt of a sample, the analyst is to advise the appropriate regional office and the importer within three business days from collection that the sample(s) will not be tested, and that an alternative laboratory will need to be arranged. The sample is to be stored appropriately until collected (noting 3.4).
3. After registering the receipt of a sample into e–Results (note 3.6), the appointed analyst must report the test results for this sample within 10 business days from receipt of the sample.
4. The appointed analyst must report detections of pathogens to the department via eResults as soon as a detection is confirmed.
5. Appointed analysts are not to withhold sample collection or reporting of test results because of payment issues between the analyst and the importer.
6. The appointed analyst must immediately advise the regional office if a finalised test result for a sample will not be reported within the maximum permitted time of 10 business days from receipt of the sample.
7. An extension will only be deemed valid if the request for extension is in writing (for example email), is received prior to the due date (10 business days from receipt of the sample) for results and outlines valid reasons for the extension request. Consideration will be given in circumstances where extensive transit time causes extended turnaround times.
8. The appointed analyst must provide a certificate of analysis in an approved form (as indicated in Section 34.2 of the (Imported Food Control Act 1992) on request.
9. The appointed analysts must distribute laboratory reports directly to importers as part of their commercial obligations.
10. Where the appointed analyst has problems reporting via e–Results and results will not be received electronically for a period of time, the appointed analyst should contact the contact officer in Canberra with estimated time of outage and advise that results will be emailed until the issues are rectified.

11. The appointed analyst must comply with the reporting requirements outlined for a risk category food where requested:

    • a risk test plus single or multiple surveillance tests or
    • multiple risk tests or
    • multiple risk tests plus single or multiple surveillance tests

    to be undertaken on the food.

    Scenario 1:The risk category food requires a single risk test plus surveillance test/s Defer reporting the surveillance test result/s until the risk test result has been finalised and reported.

    Scenario 2: The risk category food requires multiple risk tests. Defer reporting risk test results until all risk test results have been finalised and report all of them at the same time. Do not report single risk test results as they are finalised.

    Scenario 3: The risk category food requires multiple risk tests plus surveillance test/s. Defer reporting risk test results and surveillance test results until all risk test results have been finalised and report all of the risk test results at the same time along with any finalised surveillance test results.

12. Risk foods or foods that are perishable are to be prioritised for analysis and reporting.

1. Appointed analysts are required to include the following information on all invoices that are submitted to the department for payment:
   • the entry number and line number that the testing relates to
   • a description of what food was tested
   • what tests were applied
   • the costs for each test applied
   • the dates for when the services were provided and
   • the total to be paid (including GST details).

1. The appointed analyst must ensure that any subcontract testing performed under the Act is arranged only with other appointed analysts.
2. Where the appointed analyst subcontracts work to another laboratory, the appointed analyst is responsible for the subcontractor’s work including the electronic reporting of the subcontractor’s results. The appointed analyst will remain responsible for the laboratory services performed by subcontractors to the same extent as if those laboratory services were performed by the appointed analyst laboratory.
3. The appointed analyst must notify the contact officer in writing of all subcontracting arrangements, including the NATA scope of accreditation for these laboratories as evidence that they can conduct the testing.

1. The appointed analyst will keep for a period of not less than three years a copy of all records and other documentation (whether in hard copy or electronic form) relating to:
   • the results
   • quality assurance procedures
   • analytical and testing methods.

1. The appointed analyst must comply with:
   • any other reasonable requirements specified by the department
   • all current Imported Food Notices that are applicable to analysts and the analysis of imported food under the Act.
2. The eIFIR that accompanies food samples is an official record and must be incorporated into the appointed analyst’s Laboratory Information Management System (noting 12.1).
3. Where an appointed analyst receives a sample of food in error the analyst must:
   • immediately advise the appropriate regional office responsible for the sample of food about the inappropriate despatch; and
   • document the receipt of the sample; and
   • not analyse the sample; and
   • store the sample appropriately (noting requirement 3.4).

1. The appointed analyst must be aware of all provisions listed under Section 34 of the Act.

1. The appointed analyst must consult the contact officer regarding all matters concerning conditions of appointment and appointed analyst service requirements.
2. If these conditions of appointment are not complied with, the appointment of the analyst may be revoked.
3. The nature of the non-compliance will determine whether a suspension or a revocation is warranted. Non-compliances can include but are not limited to, failure to notify the department of changes to NATA accreditation, failure to notify the department of concerns over validity of the test results, or failure to comply with the policy on retesting. Appeals against the decision must be made within 21 days and should be communicated in writing, addressed to the Director, Imported Food.
4. If the nature of the non–compliance does not warrant revocation of the appointment, the department may suspend the appointment until such time that the non–compliance has been rectified. If an appointed analyst is suspended, they cannot conduct any testing under the IFIS until the non-compliance is corrected and they receive notice from the department that they may resume testing. Industry will be notified of the suspension or revocation and the analyst’s appointment status will be removed from the list of food testing laboratories on the department website.
5. The department or a nominated representative or other persons as specified by the department may audit at a mutually agreed time any aspect of the laboratory service provided. If a notice of intent to conduct an audit is issued, the audit is generally to be organised within 28 days of the date of issue unless other factors are specified. The department, or nominated representative, will notify the laboratory of the date of assessment prior to visit.
6. The appointed analyst must provide all details of analytical results (that is chromatograms and sample preparation) to the department on request.
7. The appointed analyst must provide unused portions of samples to the department on request subject to requirement 3.7.
8. The department will review these conditions of appointment and may amend them from time to time. Appointed analyst laboratories will be notified in writing of any changes made and will be expected to comply with any changes within 6 months of such notification.

This policy provides guidance to appointed analysts on tests which have been deemed to be an infrequent test. The tests identified in this policy are not subject to the requirements for NATA accreditation.

Background

The problems associated with infrequent tests were raised at the National Laboratory Working Group meeting in April 2007. The main problem is that over a 12 month period, only a small number of tests on some products are required under the Imported Food Inspection Scheme (IFIS). In these cases it is not commercially feasible for an analyst to maintain NATA accreditation for these infrequent tests.

An infrequent test is defined by the department as a test which is applied six or less times in a calendar year. Where a test is run less than once per quarter, additional procedures will be required prior to and during the testing to ensure the integrity of the result.

Policy

If a test is not under an appointed analyst’s NATA accreditation, the appointed analyst must have written authorisation from the department prior to conducting the infrequent test.

Option 1 (extension of scope of existing NATA accreditation to cover new analytes)

Where an appointed analyst has some of the analytes in the specific food matrix covered by the scope of NATA accreditation, then the appointed analyst may apply to the department to undertake testing for other similar analytes and then report on all the analytes required under the IFIS. For example, if there are multiple antimicrobials required in a specific analyte/food matrix combination, but the appointed analyst’s NATA accreditation only covers some of them, an application may be submitted to permit this laboratory to test and report on all of the antimicrobials.

The testing laboratory will be required to adopt the following requirements for such testing and should outline how these requirements will be addressed in their application:

• All relevant QA/QC practices required under the existing NATA accreditation must be followed (except for full method validation).
• Appropriate validation must be undertaken and the results made available to the department. For chemical analysis this validation will include being able to supply information concerning analysis of a reagent blank, a suitable matrix control sample and a spiked recovery sample. Details of the procedure used to qualitatively confirm the identity of the compound detected should also be provided.

Where there are appointed analysts that can meet the requirements of Option 1, Option 2 will not be considered.

Option 2 (where the test is not covered by the scope of the laboratory’s NATA accreditation)

Where there are no current appointed analysts with the proposed testing within the scope of their NATA accreditation, the appointed analyst may apply to conduct the analysis for the specific analyte/food matrix combination. An example of such a situation may be where the department introduces new testing under the IFIS.

The testing laboratory will be required to adopt the following requirements for such testing and should outline how these requirements will be addressed in their application:

• Appropriate validation must be undertaken and the results made available to the department.
• Appropriate QA/QC samples must be included in each sample run.
• All relevant QC practices required under existing NATA accreditation and the laboratories quality manual must be followed consistent with ISO/IEC 17025:2017

All other requirements for an appointed analyst will remain in place.

It is important to note that as a regulatory authority dealing with food safety the department adopts a conservative policy in dealing with test results that indicate consignment failure.

Responsibilities in cases where an investigation is warranted:

Appointed analysts

Inform Imported Food Canberra office immediately if an importer makes a claim against the validity of a result directly to an appointed analyst and the analyst concludes that a quality system failure has caused an unacceptable result, refer to section 7 of the conditions for appointment as an analyst. The appointed analyst must advise the department of the pertinent details regarding the laboratory investigation into the questionable result and the reason(s) for the laboratory decision about the result. In all cases, the department requires a written report from the appointed analyst.

It is important that appointed analysts inform the importer that the issue of acceptance of any subsequent results of analysis would need to be discussed with the department and any decision on this matter would be at the discretion of the department.

The Act specifies that a person must not ‘deal with’ an examinable food unless authorised to do so (refer Part 2, Division 1, Section 9 of the Act). This means that it is an offence for an importer to sample food for further analysis unless authorised by the department. Therefore, in all circumstances, it is inappropriate for appointed analysts to advise importers to provide further samples of their food for analysis. This includes situations where an insufficient quantity of original sample remains to allow additional or complete analysis. In all cases, if an appointed analyst requires further samples of a food to analyse, the appointed analyst must advise the regional office and the regional Food Safety Manager will consider each situation on a case-by-case basis.

Department of Agriculture, Fisheries and Forestry

In cases where the department agrees that an investigation is warranted on an importer’s claim against the validity of results, the department will:

• investigate the sampling and transportation to the testing laboratory to determine whether or not appropriate procedures were followed
• contact the appointed analyst, where the claim relates to the laboratory that performed the analysis, and request an investigation into the results and if appropriate, a written report
• upon completion of the investigation, as soon as practicable, provide the importer with the result of the investigation and any review of decision. The final decision will be at the discretion of the department.

Importer

Section 42 of the Act makes provision for reconsideration of decisions. Where an importer decides to appeal the decision to fail a food, they must, apply in writing to the Secretary of the Department of Agriculture, Fisheries and Forestry for a reconsideration of the decision (Note: this is usually delegated to a senior officer to reconsider on behalf of the Secretary). If the Secretary or delegate upholds the initial decision, the importer may then apply to the Administrative Review Tribunal (ART) to review the matter.

Claims that do not warrant an investigation

In some cases, importers fail to provide evidence that warrants an investigation into their claim against the validity of results.

Review of results

The final decision on any review into a test result will be at the discretion of the department. A variety of factors will be considered when deciding whether or not to accept a result from the re-analysis of an original sample. Factors include:

• claim against the validity of a test result
• follow-up remedial action taken by appointed analyst
• original sample integrity, security, conditions of storage, chain of custody
• analyte and matrix stability
• distribution of micro-organisms
• shelf life of product

Upon considering all of these factors, the department may decide that it is appropriate for a new sample of food to be taken for analysis.

Laboratories must include their Approved Arrangements site number (the five digit identification code ex ‘AA A0001’) when reporting test results to the department via eResults for imported food samples that are subject to biosecurity control (for example, uncooked pig meat).

This is done by including the Approved Arrangements site number in the ‘Analyst Comments’ field of Sample Result Request Letter (F0005) messages when reporting test results. The AA site number does not need to be reported when registering a sample via a Sample Registration Request Letter (F0003).

Questions on Approved Arrangements site requirements can be emailed to AA Canberra and questions on the location of the ‘Analyst Comments’ field for eResults should be directed to your software provider.