Imported Food Program - Information for Appointed Analysts

Purpose

This document is designed to give the requirements to current appointed analysts for adhering to their conditions of appointment and provide information on the AQIS Imported Food Program (IFP).

Scope

Where information is required to support the Conditions of Appointment.

Appointed Analyst Responsibilities

• Appointed analysts distribute laboratory reports directly to importers as part of their commercial obligations.
• Appointed analysts are not to withhold results to AQIS because of payment issues between the analysts and importer.
• Appointed analysts that sub-contract testing are responsible for the reporting of results back to AQIS for those tests within the 10 business day turnaround time; and
• Importers or AQIS may request the appointed analyst not to test samples after they have been registered at the Laboratory.
• Analysts are required to supply the courier or agents with suitable equipment. Samples must be transported under appropriate temperature control so that the nature of the sample does not change in transit to the laboratory.

AQIS policy for infrequent tests

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 AQIS IFP 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 AQIS 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 AQIS 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 put to AQIS 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 AQIS. For chemical analysis this validation will include being able to supply AQIS with 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 by AQIS for any analyst.

Option 2 (where the test is not covered by the scope of the laboratories 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 AQIS to conduct the analysis for the specific analyte/food matrix combination. An example of such a situation may be where AQIS 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 AQIS.
• 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 17025:2005.

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

Schedule of infrequent tests this policy applies to

Re-testing Protocol

On occasion, an importer may dispute the results of analysis and these claims may be assessed by AQIS to verify the result. Cases that warrant investigation by AQIS are rare. When an importer provides highly compelling evidence to support their claim against the validity of a result, AQIS will initiate an investigation into the importers claim.

If a laboratory has concerns about the integrity of a sample received, or the validity of test results obtained, they are to advise the relevant regional office as soon as possible. AQIS will investigate all notifications from appointed analysts and will consider each issue on a case by case basis.

For more information see Appendix 1 – Re-testing Protocol Policy.

Suspension and/or Revocation of an Analyst’s Appointment

The appointment of an analyst under Section 34 of the Imported Food Control Act 1992 (the Act) can be suspended or revoked if the Conditions of Appointment are not complied with.

The nature of the non-compliance will determine whether a suspension or a revocation will be applied. Non-compliances can include but are not limited to, failure to notify AQIS of changes to NATA accreditation, failure to notify AQIS of concerns over validity of the test results, or failure to comply with the re-testing protocol policy. Appeals to the decision must be made within 21 days and should be communicated in writing, addressed to the Program Manager, Imported Food Program.

If an appointed analyst is suspended, they will not be permitted to conduct any testing for AQIS under the IFIS until such time as the non-compliance is corrected and notification in writing from AQIS of the lifting of the suspension is received.

Industry will be notified of the suspension or revocation and the analysts’ appointment status will be shown on the list of food testing laboratories on the AQIS website.

AQIS Contacts

Appendix 1 - AQIS Imported Foods Retesting Protocol

It is important to note that as a regulatory authority dealing with food safety, AQIS adopts a conservative policy in dealing with test results that indicate consignment failure.
Responsibilities in cases where an investigation is warranted:

1. Appointed Analysts

   Inform AQIS IFP, Canberra 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 6 of the Conditions of Appointment as an Analyst. The appointed analyst must advise AQIS 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, AQIS 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 AQIS and any decision on this matter would be at AQIS’ discretion.
   
   The Act specifies that a person must not ‘deal with’ an examinable food unless authorised to do so by AQIS (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 AQIS. Therefore, in all circumstances, it is inappropriate for appointed analysts to advise importers to provide further samples of their food for analysis without consulting AQIS. 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 AQIS Regional Office and AQIS will consider each situation on a case-by-case basis.

2. AQIS
   
   
   • AQIS officers must inform their regional FSM if they believe that an importer’s claim against the validity of results warrants an investigation by AQIS.
   • FSM’s must liaise with AQIS IFP, Canberra, in cases where they believe that an importer’s claim against the validity of results warrants an investigation by AQIS.
   • In cases where AQIS agrees that an investigation is warranted, AQIS will investigate the sampling and transportation to the testing laboratory to determine whether or not appropriate procedures were followed.
   • In cases where AQIS agrees that an investigation is warranted and the claim against the validity of results relates to the laboratory that performed the analysis, AQIS will contact the appointed analyst and request an investigation into the results and if appropriate, a written report.
   • At the completion of the investigation, AQIS will as soon as practicable, provide the importer with the result of the investigation and any review of decision. The final decision will be at AQIS’ discretion.
     
3. 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 DAFF 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 Appeals Tribunal (AAT) to review the matter.

4. Claims that do not warrant an investigation by AQIS

   In some cases, importers fail to provide evidence that warrants an investigation into their claim against the validity of results. The FSM should liaise with AQIS IFP, Canberra.

5. Review of results

   The final decision on any review into a test result will be at AQIS’ discretion. AQIS will consider a variety of factors 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, AQIS may decide that it is appropriate for a new sample of food to be taken for analysis.

Document History