Conditions for Appointment as an Analyst

Imported Food Program: Conditions for Appointment as an Analyst under Section 34 of the Imported Food Control Act 1992

Imported foods are subject to the Imported Food Control Act 1992 (the Act). The Act requires that imported foods must meet the food standards set out in the Australia New Zealand Food Standards Code (the Code). These standards apply equally to all food offered for sale in Australia whether produced domestically or imported. The Australian Quarantine and Inspection Service (AQIS) is responsible for administering the Act and carry out inspections, which may include the taking of food samples for analysis.

Laboratories that conduct testing of these imported food samples are required to be appointed under Section 34 of the Act. Once appointed, they become known as an appointed analyst. The following conditions are to be complied with at all times by the appointed analyst to remain appointed.

1. The appointed analyst must hold National Association of Testing Authorities (NATA) (or International Accreditation New Zealand (IANZ) for New Zealand Appointed Analysts¹) accreditation in the appropriate field with an appropriate scope² unless otherwise approved by AQIS.
2. The appointed analyst must have the ability to electronically interface with AQIS according to e–Results messaging system interface requirements.
3. The appointed analyst must comply with all of the AQIS appointed analyst service requirements as detailed in Attachment 1.
4. The appointed analyst must provide AQIS with:
   1. documentary evidence of current NATA accreditation, the scope of accreditation of the appointed analyst (for the tests required by AQIS under the Act) and any other laboratory(s) used under sub–contract to service AQIS Imported Food Inspection Scheme (IFIS).
   2. a list of NATA signatories who will be signing analytical reports and reference to the scope of their signatory status.
   3. on request, provide evidence that demonstrates appropriate analysis performance as detailed in Attachment 1, requirement 5.
5. Appointment as an analyst under Section 34 of the Act will be reviewed by AQIS on a 24–monthly basis. Suspension or revocation within the 24 month period of the appointment may also occur where the appointed analyst fails to comply with requirements as detailed in Attachment 1.

The AQIS contact officer for these conditions of appointment is:
Laboratory Contact Officer
Phone: (02) 6272 5488
Fax: (02) 6272 4023

Attachment 1 – AQIS Appointed Analyst Service Requirements

1. Nomination of Contact Personnel

   1. The appointed analyst will nominate specific staff to act as
      1. nominated contact person or official representative
      2. e–Results contact person
   2. The appointed analyst will notify the AQIS laboratory contact officer immediately of any changes to these nominated personnel. Names and details of all contacts and any changes should be supplied in writing (e.g. email) as soon as practicable.
   
   

2. NATA Accreditation

   1. The appointed analyst, including any laboratory sub–contracted by the appointed analyst, shall maintain the NATA scope of accreditation for the class of test 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. Required testing is outlined in the Testing Capabilities Matrix supplied at the time of Appointment and maintained on the AQIS website, with background information for testing specified in the IFP Testing Guidelines.
   3. Testing by an appointed analyst under the Act needs to be undertaken using methods appropriate to the class of test for which the appointed analyst has NATA accreditation, unless otherwise approved by AQIS in writing – refer to AQIS’ policy on infrequent tests (which is in the Information for appointed analysts document on the AQIS website).
   4. The appointed analyst will inform the AQIS laboratory contact officer within 72 hours of any change to evidence of accreditation previously provided as part of their application for appointment, either for the appointed analyst or any laboratory sub–contracted by the appointed analyst, as applicable (e.g. accredited test rendered partly or completely inoperative or changes in signatory status that impact on AQIS analysis reports).
   5. AQIS recognises 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 by AQIS to submit a proposal regarding an appropriate alternative testing methodology and arrangements for consideration by AQIS.
      2. Where the proposal to carry out alternative testing is approved by AQIS, it will notify the appointed analyst in writing and will include:
         1. a start date in relation to the alternative testing;
         2. a timeframe for lodgement 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 by AQIS 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 by AQIS, the appointed analyst must immediately:
         1. notify AQIS in writing;
         2. cease testing unless and until such accreditation is obtained by the appointed analyst; and
         3. comply with any reasonable direction issued by AQIS in relation to the testing conducted prior to that point.
   
   

3. Sample Integrity, Receipt and e–Results Notification, Chain of Custody, and Optimising Recovery/Detection

   1. The appointed analyst is responsible for arranging transport of food samples from the AQIS sample depot to the appointed analyst laboratory for testing under the Act and must ensure that the integrity of every food sample is maintained commensurate with the testing required.
   2. 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.
   3. The appointed analyst will keep samples secure and free of further contamination.
   4. Compositing of samples is strictly prohibited and all laboratory method limits of reporting (LORs) are to be for a single sample analysis only.
   5. The appointed analyst must register and acknowledge the receipt of a sample submitted under the Act via the AQIS electronic messaging service e–Results, as soon as practicable, but within 72  hours of collection from the AQIS sample depot.
   6. The appointed analyst must store all unused samples for 30 days following testing, noting 3.2.
   7. All unused and partially processed samples should be disposed of in a manner that ensures the destruction of infectious agents where detected (noting clause 3.6). Where laboratories are handling quarantine material, they must be a Quarantine Approved Premise (QAP) as appropriate for that material and adhere to requirements for disposal of quarantine waste.
   8. 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 AQIS or other relevant authorities upon request (in accordance with clause 11).
   
   

4. Sample Analysis

   1. The appointed analyst must analyse a food sample in line with the test(s) that have been requested by AQIS on the Imported Food Inspection Report (IFIR) that accompanies the sample. Additional testing of food samples outside of those tests requested by AQIS must not be carried out.
   2. Where a standard in the Food Standards Code stipulates:
      • that a specific test method should be used to analyse a food; or
      • the part of a food to be analysed; or
      • how a level should be determined/reported; or
      • any other testing requirements;

      The appointed analyst must analyse food in line with the requirements of the Code.

   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 IFP 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 3.2). If insufficient sample for the initial screen and subsequent confirmatory analysis, should it be required, is not received, the sample should not be analysed and a replacement sample must be requested from AQIS as soon as possible.
   6. The appointed analyst must provide a detailed method summary to AQIS on request and to overseas regulators at the request of AQIS.
   
   

5. Performance assessment including proficiency testing and intra–laboratory check sample programs

   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 AQIS 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 IFP Testing Guidelines. If no other minimum required performance limits exist, then the minimum performance limits listed in the relevant European Commission requirements (e.g. 2003/181/EC), if specified, should be followed, if appropriate for the tests being performed.
   
   

6. Invalid Results and Retesting

   1. The appointed analyst must inform the AQIS laboratory contact officer as soon as they identify that an incorrect, invalid or suspicious test result has been reported to AQIS, clearly stating the nature of the issue.
   2. If the appointed analyst wishes to repeat the analyses and they no longer holds sufficient sample at their laboratory, the analyst must immediately contact the AQIS 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, AQIS reserves the right to investigate the matter with the responsible appointed analyst, appropriate accrediting body or any other relevant person.
   
   

7. Confirmatory Testing

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

   1. 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 AQIS. Where the appointed analyst decides they require a new sample, they are to contact the AQIS laboratory contact officer (note: this should be a rare event).

   2. 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 AQIS regional office as soon as possible so that another sample can be taken for analysis, if this is deemed necessary.

   3. For pathogen testing all presumptive positive results must be confirmed by a reference laboratory (e.g. serotyping where speciation is specifically required) if required to be reported by the IFIR.
   
   

8. Reporting of Results

   1. The appointed analyst must report results using eResults with the results in a format capable of being used to verify compliance with the IFP Testing Guidelines. Where an appointed analyst receives error messages from eResults, they are to make the necessary changes to the message and re–send to AQIS. Where the second message also receives an error message, the appointed analyst should contact the AQIS regional office for assistance correcting the reporting problem.
   2. Where the appointed analyst elects not to register the receipt of a sample, the analyst is to advise the appropriate AQIS regional office and the importer within 72 hours 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 3.2).
   3. After registering the receipt of a sample into e–Results (note 3.5), the appointed analyst must report the test results for this sample to AQIS within 10 working days from the receipt of the sample.
   4. The appointed analyst must contact the AQIS regional office that the food sample originated from within 24 hours to report the detection of a pathogen and that it has been sent for serotyping. Test results will follow once the serotyping confirms the pathogen’s presence.
   5. The appointed analyst must immediately advise the AQIS regional office if a finalised test result for a sample will not be reported to AQIS within the maximum permitted time of 10 business days from receipt of the sample.
   6. An extension will only be deemed valid if the request for extension is in writing (facsimile, email etc) and received prior to the due date (10 business days from receipt of the sample) for results.
   7. The appointed analyst must provide a certificate of analysis in an approved form to AQIS (as indicated in Section  34.2 of the Imported Food Control Act  1992) on request.
   8. Where the appointed analyst has problems reporting via e–Results and results will not be received electronically by AQIS for a period of time, the appointed analyst should contact the AQIS laboratory contact officer in Canberra with estimated time of outage and advise that results will be faxed until the issues are rectified.

   9. The appointed analyst must comply with the reporting requirements outlined in the table below for a risk category food where AQIS has 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 number	Scenario	AQIS requirement
      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 to AQIS.
      2	The risk category food requires multiple risk tests.	Defer reporting risk test results to AQIS until all risk test results have been finalised and report all of them to AQIS at the same time. Do not report single risk test results to AQIS as they are finalised.
      3	The risk category food requires multiple risk tests plus surveillance test/s.	Defer reporting risk test results and surveillance test results to AQIS until all risk test results have been finalised and report all of the risk test results to AQIS at the same time along with any finalised surveillance test results.

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

9. Invoicing AQIS for tests where AQIS is the client (i.e. surveys)

   1. Appointed analysts are required to include the following information on all invoices that are submitted to AQIS 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).
   
   

10. Sub–contract Testing

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

11. Copy of Records

    1. The appointed analyst will keep for a period of not less than 3 years a copy of all records and other documentation (whether in hard copy or electronic form) relating to:
       • the results
       • quality assurance procedures and
       • analytical and testing methods.
    
    

12. General Procedural Compliance

    1. The appointed analyst must comply with:
       • any other reasonable requirements specified by AQIS
       • all current Imported Food Notices that are applicable to analysts and the analysis of imported food under the Act.
    2. The AQIS IFIR that accompanies food samples is an official AQIS record and must be incorporated into the appointed analyst’s Laboratory Information Management System (noting 11.1).
    3. Where an appointed analyst receives a sample of food in error the analyst must:
       • immediately advise the AQIS 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 3.2).
    
    

13. Knowledge of Section 34 of the Imported Food Control Act 1992

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

14. Consultation on matters concerning Appointed Analyst Requirements and Service Conditions

    1. The appointed analyst must consult the AQIS laboratory 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. If the nature of the non–compliance does not warrant revocation of the appointment, AQIS may suspend the appointment until such time that the non–compliance has been rectified.
    4. AQIS or a representative nominated by AQIS or other persons as specified by AQIS may audit at a mutually agreed time any aspect of the laboratory service provided. If the notice of intent to conduct an audit or assessment is given to the appointed analyst, the audit is to be organised within 28 days of the date of issue of the notice or such lesser period as may be required. If possible, AQIS or other persons undertaking the audit will try to give 60 days notice, but also in some cases immediate audits without notice may be undertaken. The accreditation body or AQIS will notify the laboratory of the date of assessment prior to visit.
    5. The appointed analyst must provide all details of analytical results (i.e. chromatograms, sample preparation etc) to AQIS on request.
    6. The appointed analyst must provide unused portions of samples to AQIS on request subject to requirement 3.6.
    7. AQIS 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.