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2454 final report.pdf - Agra CEAS Consulting

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Evaluation of the Community Plant Health Regime: Final Report<br />

DG SANCO Evaluation Framework Contract Lot 3 (Food Chain)<br />

As indicated in section 3.9.2, in the plant health domain, no network of EU and National Reference<br />

Laboratories currently exists – unlike the animal health and food safety domains where legal<br />

obligations for such laboratories are in place. Also, laboratories in the plant health sector do not have<br />

legal basis to demand accreditation, as foreseen for laboratories in the animal health and food safety<br />

fields by Reg. 882/2004, and this – in view of an expert – created a legal vacuum to take actions in this<br />

sector.<br />

In recent years there has been support for the option to establish NRLs to focus on some pests. Since<br />

2004 there have been discussions between the Chief Officers Plant Health and the EPPO on improving<br />

international cooperation and coordination between diagnostic laboratories. In order to promote<br />

harmonisation, reliability and efficiency of diagnostic work and laboratories activities, the COPHS<br />

concluded that criteria, tasks and responsibilities of NRLs should be determined. A commission Expert<br />

Working Group was set up in July 2007 and in September 2007 a Commission Expert WG developed a<br />

Guidance paper containing the main elements for the establishment of NRLs and criteria to this effect.<br />

The Guidance document was accepted by the heads of NPPOs in December 2007 301 (‗Madeira‘<br />

declaration).<br />

The Guidance paper formulated conclusions on the following points:<br />

1. Reasons for the establishment of National Reference Laboratories (NRLs);<br />

2. Tasks of NRLs;<br />

3. Main criteria for, and possible requirements, of NRLs required to ensure that the tasks can be<br />

performed; and<br />

4. Priority list of individual pests or groups of pests for which NRLs are needed.<br />

Among the main criteria listed under point 3, the Guidance Paper established that the NRLs should<br />

follow relevant EPPO standards (PM 7/84: Basic requirements for quality management in plant pest<br />

diagnosis labs), use diagnostic methods according to ISPM no. 27 (Diagnostic Protocols for Regulated<br />

Pests), and have <strong>final</strong> aim to be accredited according to ISO/IEC Standard 17025:2005. The<br />

EUPHRESCO initiative is working on the basis of these principles. Some new detection techniques and<br />

ring testing are developing from this work already.<br />

In particular, with reference to issue 4, four criteria were established to decide for which pests NRLs<br />

should be encouraged. The pests should:<br />

Have specific regulation for control (e.g. EU control Directives) and/or official monitoring;<br />

Require regular official testing;<br />

Require complex and specific diagnostic tests/procedures; and<br />

Have a severe impact (currently or potentially) on plant health and trade.<br />

The Guidance paper also identified some organisms, for which NRLs should at least be established, as<br />

follows:<br />

301 The establishment of NRLs is however on a voluntary basis.<br />

Food Chain Evaluation Consortium 372

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