2454 final report.pdf - Agra CEAS Consulting

Evaluation of the Community Plant Health Regime: Final Report
DG SANCO Evaluation Framework Contract Lot 3 (Food Chain)
development of reliable validated (or equivalent) diagnostic protocols, accepted and used by
all MS should have a very high priority, as well as accreditation (quality assurance) of the
laboratories. One MS also indicated that the equivalence for importing of propagating
material is not determined at EU but at MS level, thus causing variability among MS.
Harmonized protocols are necessary for export (to agree on what is a pest free situation) and
for import purposes. The lack of harmonisation on the testing methods is also a source of
strong discussion when talking about what is an appropriate performance for a laboratory. The
EU Reference Laboratory 187 concept, as developed in the animal health and food safety
domain, offers harmonisation (guidance on EU protocols) as well as flexibility (amendment
of EU protocols according to scientific developments without recourse to comitology
procedures).
For a range of HOs, EPPO and IPPC have issued standards for diagnostic methods and
procedures. To date, some 97 protocols have been developed by the EPPO, of which 4 general
standards 188 . EPPO did a survey in 2008 189 on the use of these protocols and had positive
results. Only in the case of the pests of Annex 1.A.1 (pests not present in Europe), were
protocols not used due to the fact that the laboratories have not come across any samples in
this case. EPPO is currently working on improving the availability of validation tests – which
is one of the requirements for laboratory accreditation. For some tests, where available, the
EPPO includes validation data in the protocols (e.g. on the limits of detection of tests,
sensitivity, appropriateness). The aim is to avoid duplication of efforts. Many laboratories are
currently in the process of preparing for laboratory accreditation, and EPPO is working to
share the information and experience gained with accreditation between laboratories 190 .
Conclusions
Overall, in the majority of MS the existing capacity is considered to allow only partially the
rapid and reliable diagnosis of all regulated HOs, and this is mostly due to the relatively
limited and decreasing financial and human resources. Gaps for the detection (in terms of
methods and reference materials) are indicated by several MS, particularly with regards to
rare or new HOs, as well as increasing difficulties to find experienced experts in specific
fields as expertise is generally eroding especially in classical subjects (as also noted under
previous section). Resources for diagnostics are in many cases limited even with regard to
HOs for which detection is possible and in terms of activities that the laboratories would
technically be able to carry out.
The divergence in diagnostic capacity across the EU is largely due to the inherent
characteristic of research on plant health which explains the difficulties of attracting financial
support in this field: plant science is not a high priority compared to other scientific fields
such as nanotechnology, engineering etc., and commercial interest remains limited. In those
MS where plant health is important for trade and production, the diagnostic sector is more
developed, with significant resources devoted to research, a clear structure and organisation in
187
EU-RL; previously Community Reference Laboratory (CRL).
188 Accreditation, general quality assurance, purpose of diagnostic protocols, reporting and documentation.
189 F. Petter and Suffert, M. (2010), ―Survey on the use of tests mentioned in EPPO diagnostic protocols‖,
OEPP/EPPO Bulletin 40, 121–126.
190 The EPPO workshop on quality assurance in 2007 presented the state of the art in the EU
FCEC 174