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Accreditation of Pesticide Residue Laboratories in Spain

V Convegno sui Residui di Antiparassitari Istituto Superiore di Sanità Roma, 26-27 Novembre,2001. Accreditation of Pesticide Residue Laboratories in Spain. Antonio Valverde Pesticide Residue Research Group University of Almería (Spain). The Spanish Accreditation Body.

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Accreditation of Pesticide Residue Laboratories in Spain

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  1. V Convegno sui Residui di Antiparassitari Istituto Superiore di Sanità Roma, 26-27 Novembre,2001 Accreditation of Pesticide Residue Laboratories in Spain Antonio Valverde Pesticide Residue Research Group University of Almería (Spain)

  2. The Spanish Accreditation Body • In Spain, the only accreditation body established to recognize the competence of testing and calibration laboratories is the “Entidad Nacional de Acreditación” – ENAC (National Accreditation Body)

  3. The Spanish Accreditation Body • ENAC is a private, independent, non-profit-making body founded and overseen by the Spanish Ministry of Science and technology. • It was set up pursuant the Industry Act 21/1992 and Royal Decree 2200/95 approving the Regulation for the Infraestructure of Industrial Quality and Safety.

  4. International Dimension ENAC takes active part in all world accreditation fora • EA (European Cooperation for Accreditation) • ILAC (International Laboratories Accreditation Cooperation) • IAF (International Accreditation Forum) ENAC has now endorsed all the “Multilateral Recognition Agreements” set up within European Cooperation for Accreditation (EA).

  5. Organization and Activities • ENAC´s organization and operational procedures adibe all the times by the criteria and standards laid down by the European Union (EN 45003 and EN 45010) and also by the accreditation criteria and guides that are applied internationally. • ENAC accredits bodies that carry out conformity assessment activities, whichever sector they operate, whatever their size, wheter they are private or public, and wheter belong to associations, companies, universities or research organizations.

  6. Structure and Technical Advisory Committees • Testing Laboratories • Calibration Laboratories • Inspection Bodies • Certification Bodies • Environmental Verifiers

  7. Technical Direction Areas • Food / Agriculture • Health • Environment • Industry / Construction • Electricity / Telecomunications • Metrology • Management Systems

  8. Accreditation Criteria • Labs have to meet the “ENAC General Criteria for the Accreditation of Laboratories According to the Norm EN-ISO/IEC 17025” (CGA-ENAC-LEC). • These Criteria are just the General Requirements established in the EN-ISO/IEC 17025, but clarified or specified in some points. • Before 1/January/2001, accreditation was carried out according to the EN 45001.

  9. Control of records (4.12.1.2): ... Retention time of records shall be established. Internal audits (4.13.1 Note): The cycle for internal auditing should normally be completed in one year. Non-standard methods (5.4.4 Note): ... Should contain at least the following information ... (11 points) Control of records (4.12.1.2): Records shall be retained , at least, for 5 years ... Internal audits (4.13.1 Note): Internal auditing shall be carried out, at least, once a year. Non-standard methods (5.4.4 Note): This Note is a requirement for accreditation. Examples of some ISO 17025 requirements specified by CGA-ENAC-LEC ISO 17025 CGA-ENAC-LEC

  10. Sampling (5.7.1, Note 1): Sampling is a defined procedure whereby a part of material is taken to provide for testing of a representative sample of the whole .... Sampling (5.7): The laboratory must demonstrate that the material to be tested is homogeneous ... Examples of some ISO 17025 requirements specified by CGA-ENACLEC ISO 17025 CGA-ENAC-LEC

  11. Assuring the quality of tests... (5.9): ... quality control procedures ... may include ... participation in interlaboratory comparison programmes. Assuring the quality of tests... (5.9): ... the laboratory shall participate in interlaboratory comparison programmes. Examples of some ISO 17025 requirements specified by CGA-ENAC-LEC ISO 17025 CGA-ENAC-LEC

  12. Accreditation Process • The ENAC´s accreditation process is based on the operational procedures and guides that are applied internationally. • The “assessment” of the laboratory is normally carried out by an “assessor in chief” and one “technical assessor”. • Until now, ENAC has qualified four “technical assessors” for the accreditation of pesticide residue tests.

  13. The “Assessment”: Critical Thoughts • Does the laboratory “say” what they do?(Do they have written documents that meet the ISO 17025 requirements?). • Does the laboratory “do” what they say?(Are they in compliance with ISO 17025?). • And can the laboratory “probe” it with their records?

  14. Accreditation: Critical “Technical” Factors • Competent Laboratory Personel • Adequate Equipment • Written Methods Adequately Validated • System to Ensure Quality of Results

  15. Pesticide Residue Analysis(Requirements for Methods Validation) • ENAC has not established specific validation requirements for pesticide residue tests. • Important “reference documents” for the “technical assessors” are: a) EU Guidance Document on Residue Analytical Methods(SANCO/825/00) b) Guidelines for Single-Laboratory Validation of Analytical Methods for Trace Level Concentrations of Organic Chemicals (AOAC/FAO/IAEA/IUPAC Expert Consultation, Miskolc, November-1999)

  16. Pesticide Residue Analysis(Requirements for Quality Control) • ENAC has not established specific quality control requirements for pesticide residue analysis. • An important “reference document” for the “technical assessors” is: - EU Quality Control Procedures for Pesticide Residue Analysis (A. Hill et al.) (SANCO/3103/2000)

  17. Pesticide Residue Analysis(Assuring the Quality of Tests) • One of the ENAC requirements for the accreditation is that laboratories “shall” participate in interlaboratory comparison programmes. • Until now, pesticide residue laboratories accredited in Spain have participated in proficiency tests organized by FAPAS, European Commission, or MAPA.

  18. Pesticide Multiresidue Analysis(Fixing the Scope of Accreditation) • Critical discussion point during the “assessment”. • Usually, the validation data and quality control procedures initially presented do not justify the scope of accreditation proposed by the laboratory. • In many cases, the particular criteria of the “assessors” are decisive at the time of fixing the final scope of accreditation.

  19. Testing Laboratories Catalogue • The accredited Testing Laboratories and their accredited scopes are published in the ENAC catalogue (www.enac.es) • Pesticide residue tests are catalogued into the group of “Chemistry Tests”. • The “Scope of Accreditation” in the catalogue is defined by: a) Material to be tested; b) Test (analytes, levels, and analytical technique); c) Reference of the test procedure.

  20. Pesticide Residue Testing Laboratories Accredited by ENAC • Nowadays (November-2001), 19 laboratories are accredited by ENAC for tests of pesticide residues in foods. • 18 labs in Spain / 1 lab in Argentina. • 13 “official” labs / 6 private labs.

  21. Pesticide Residue Testing Laboratories Accredited by ENAC • Official Labs belong to: • Agricultural/Food Administrations (4) • Health Administrations (3) • Foreing Trade Administration (3) • Municipal Administrations (3) • Private Labs belong to: • Producer/Exporter Associations (6)

  22. Pesticide Residue Tests(Examples of Scopes Accredited by ENAC) a) Products to be Tested • Fruits and Vegetables • Citrus Fruits • Vegetables (water >75%; fat <2%) • Lettuce • Plants • Hihg Water Content Plants • Foods • Animal Fats • Vegetal Oils

  23. Pesticide Residue Tests(Examples of Scopes Accredited by ENAC) b) Test • Pesticide Residues by GC-ECD/NPD/FPD • OP Pesticide Residues by GC (listed 19) • Pesticide Residues by GC-MS • Multiresidue of Insecticides and Fungicides by GC-MS (listed 12 pesticides) • Dithiocarbamate Residues by GC-ECD • N-Methylcarbamates Residues by HPLC-Fl • Imidacloprid Residues by HPLC-UV • Benzimidazols Residues by HPLC

  24. Accreditation of Pesticide Residue Laboratories in Spain(Summary) • In total, 18 accredited laboratories. • Almost all the laboratories are accredited to analyse a determined number (from 1 to 75) of GC-amenable pesticides, using GC (10 labs) or GC-MS (7 labs). • Only 3 laboratories are accredited to analyse dithiocarbamates (by GC or UV).

  25. Accreditation of Pesticide Residue Laboratories in Spain(Summary) • Few (or none) laborarories are accredited to analyse important non GC-amenable pesticides using HPLC: • N-methylcarbamates (1 lab) • Benzimidazole fungicides (5 labs) • Phenylurea herbicides (1 lab) • Imidacloprid, Abamectine (1 lab)

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