EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2013)46178 DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN ECUADOR FROM 12 TO 21 SEPTEMBER 2012 IN ORDER TO EVALUATE THE MONITORING OF RESIDUES AND CONTAMINANTS IN LIVE ANIMALS AND ANIMAL PRODUCTS, INCLUDING CONTROLS ON VETERINARY MEDICINAL PRODUCTS In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

2 Executive Summary This report describes the outcome of a Food and Veterinary Office (FVO) audit in Ecuador, carried out between 12 to 21 September 2012, as part of the published programme of FVO audits on the monitoring of residues in live animals and animal products in European Union (EU) Member States and in third countries. The objective of the audit was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in aquaculture, in order to assess whether these systems offer adequate assurance that the products and animals concerned are within the specified residue limits laid down in EU legislation. Since the authorisation, distribution and use of veterinary medicinal products and feed additives have an impact on the monitoring of residues, the national rules governing the control systems in these areas were also part of the audit. The audit assessed the performance of the competent authorities and other officially authorised entities involved in residues and veterinary medicinal product controls and the legal and administrative measures put in place to give effect to the relevant EU requirements. Attention was also paid to examining the implementation of corrective actions promised in response to recommendations made in the report of a previous FVO residues audit to Ecuador (DG (SANCO)/ MR-FINAL) in October It is concluded that the residue monitoring plan of Ecuador generally satisfies the requirements of Directive 96/23/EC. Improvements have been made to the plan and to written procedures relative to the 2008 FVO residues audit. The effectiveness of the residue monitoring is underpinned by a high level of sampling coverage, distribution of samples over the year, instructions and sample integrity, as well as good performance of the laboratories. However, there are several serious shortcomings in the implementation which undermine the chances of detecting illegal use or MRL violations, and thus the effectiveness of residue monitoring: publishing the residue monitoring plan in detail; providing food and feed business operators the opportunity to evade detection of illegal use by not paying for analysis and through negotiating the substances which are tested for in a sample; inadequate targeting; and taking less samples than the minimum calculated. This has been aggravated by providing food business operators the opportunity to delete evidence prior to on-site investigations in case of noncompliant test results. A large number of own checks carried out by industry provide additional assurances on the residue status of aquaculture products exported to the EU, although occasional residue findings have not been reported. Labelling of veterinary medicinal products and the keeping of treatment records on farms is weak, whilst official controls in this area are ineffective, increasing the risk of residue violations. However, overall the situation with regard to the (un)availability of substances or veterinary medicinal products which are not permitted in the EU has clearly improved relative to the 2008 FVO audit, and this can partly mitigate for shortcomings mentioned above. The report makes a number of recommendations to the competent authorities of Ecuador, aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES LEGAL BASIS BACKGROUND COUNTRY STATUS IN RELATION TO EU-APPROVAL OF RESIDUE MONITORING PLANS SUMMARY OF PREVIOUS FVO AUDIT REPORT RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATION FOR PRODUCTS OF ANIMAL ORIGIN FROM ECUADOR CONCERNING RESIDUES PRODUCTION AND TRADE INFORMATION FINDINGS AND CONCLUSIONS RESIDUE MONITORING COMPETENT AUTHORITIES INVOLVED DEDICATED PRODUCTION SYSTEM FOR EXPORT PLANNING OF RESIDUE MONITORING PLAN IMPLEMENTATION OF THE RESIDUE MONITORING PLAN INDUSTRY'S OWN CHECKS FOLLOW-UP OF NON-COMPLIANT RESULTS LABORATORIES GENERAL DESCRIPTION ON-THE-SPOT VISITS IN THE LABORATORIES VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS AUTHORISATION, DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS CONTROLS ON THE DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS RECOMMENDATIONS MADE IN PREVIOUS FVO REPORT ON RESIDUES (DG (SANCO)/ MR- FINAL) OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...22 ANNEX 1 - LEGAL REFERENCES...24 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CCα / Ccβ DG(SANCO) EC EU FVO GC-MS/MS Group A, B HACCP ILAC INP ISO LC-MS/MS LOD / LOQ Explanation Decision Limit / Detection Capability Health and Consumers Directorate-General European Community European Union Food and Veterinary Office Gas Chromatography-(Tandem) Mass Spectrometry Categories of substances listed in Annex I to Council Directive 96/23/EC: Hazard Analysis and Critical Control Points International Laboratory Accreditation Cooperation National Institute for Fisheries / Instituto Nacional de Pesca International Organisation for Standardisation Liquid Chromatography-(Tandem) Mass Spectrometry Limit of Detection / Limit of Quantification MAGAP Ministry of Agriculture, Animal Husbandry, Aquaculture and Fisheries / Ministerio de Agricultura, Ganadería, Acuacultura y Pesca ML MRL MRPL RASFF SOP Maximum Level Maximum Residue Limit Minimum Required Performance Limit Rapid Alert System for Food and Feed Standard Operating Procedure III

5 1 INTRODUCTION The audit took place in Ecuador from date 12 to 21 September The audit team comprised two auditors from the Food and Veterinary Office (FVO) and one expert from a European Union (EU) Member State. The audit was undertaken as part of the FVO's audit programme, evaluating control systems and operational standards in the residues sector. An opening meeting was held on 12 September 2012 with the central competent authority responsible for implementing residue monitoring in aquaculture and the authorisation of veterinary medicinal products in this sector. At this meeting, the objectives of, and itinerary for, the audit were confirmed and the control systems were described by the authorities. Representatives from the competent authorities accompanied the audit team during the audit. 2 OBJECTIVES The objective of the audit was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in aquaculture products, in order to assess whether these systems offer adequate assurance that the products and animals concerned are within the specified residue limits laid down in EU legislation. Since the authorisation, distribution and use of veterinary medicinal products and feed additives have an impact on the monitoring of residues, the national rules governing the control systems in these areas were also part of the audit. The audit focussed on the roles of the competent authorities, the legal and administrative measures in place to give effect to the relevant EU requirements, controls with regard to residues and veterinary medicinal products and their operation, and the performance of residue laboratories. Attention was paid to examining the implementation of corrective actions promised in response to recommendations made in the report of a previous FVO residues audit to Ecuador (DG (SANCO)/ MR-FINAL) in October The table below lists sites visited and meetings held in order to achieve that objective. Meetings/Visits N Comments Competent Authorities 3 Opening, interim and closing meetings Laboratories 2 The competent authority laboratory and a private laboratory Farms 4 A shrimp hatchery and farm, a tilapia hatchery and farm Establishments 3 Two establishments processing shrimp and one processing tilapia Other sites 7 Six distributors of veterinary medicinal products and one feed mill 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, and in particular: Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products, and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC; Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules; 1

6 A full list of the legal instruments referred to in this audit report is provided in the Annex and refers, where applicable, to the last amended version. 4 BACKGROUND 4.1 COUNTRY STATUS IN RELATION TO EU-APPROVAL OF RESIDUE MONITORING PLANS Commission Decision 2011/163/EU indicates that the residue monitoring plan of Ecuador is approved in accordance with Council Directive 96/23/EC for aquaculture. 4.2 SUMMARY OF PREVIOUS FVO AUDIT REPORT The residues sector was audited by the FVO in October 2008, henceforth referred to as the 2008 FVO audit. The report of the 2008 FVO audit (DG (SANCO)/ MR-FINAL) has been published on the website of the Directorate General for Health and Consumers here: The main areas for improvement identified in this report concerned the controls on distribution and use veterinary medicinal products, the scope of testing in the residues monitoring plan and the follow-up on non-compliant test results. 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATION FOR PRODUCTS OF ANIMAL ORIGIN FROM ECUADOR CONCERNING RESIDUES There were no RASFF notifications for residues of veterinary medicinal products or contaminants in aquaculture products from Ecuador since the 2008 FVO audit. 4.4 PRODUCTION AND TRADE INFORMATION Ecuador exports shrimp and tilapia to the EU. Production data for 2010 and 2011 were supplied by the competent authority as indicated in the following table. national production (tonnes) exported to EU (tonnes) national production (tonnes) exported to EU (tonnes) Shrimp Tilapia * * filleted fish 2

7 5 FINDINGS AND CONCLUSIONS 5.1 RESIDUE MONITORING Competent authorities involved Within the Ministry of Agriculture, Animal Husbandry, Aquaculture and Fisheries (MAGAP), the National Institute for Fisheries (INP) is inter alia responsible for residues monitoring and traceability in aquaculture. The INP's area of responsibility is regulated by Ministerial Agreement No A (Official Gazette No. 302 of 29 June 2006). The INP operates throughout Ecuador from its office in the city of Guayaquil. Legal powers for enforcement measures are with the Subsecretary for Aquaculture, as laid down in Ministerial Agreement No. 138 (Official Gazette No. 418 of 4 September 2008). MAGAP Aquaculture & Fish undersecretary Subsecretary of Aquaculture Subsecretary of Fisheries INP Findings Dedicated production system for export In Ecuador food and feed business operators involved in the production of aquaculture products for export to the EU shall be approved in the framework of the National Control Plan (Plan Nacional de Control), which includes inter alia the official residue monitoring plan (henceforth referred to as the residue monitoring plan) as well as food business operator's own checks on residues and contaminants in the context of HACCP. Approved establishments can only process shrimp and tilapia from approved farms, and these farms can only source larvae and fry from approved hatcheries and feed from approved suppliers. Lists of approved food and feed business operators are published on the INP website. At the start of the audit there were 22 fish meal producers, 12 feed mills, 148 hatcheries, 1194 aquaculture farms approved, 10 primary processors of shrimp and 30 processing plants approved. Prior to approval a food or feed business operator needs to be registered and inspected with a satisfactory result. The INP has set control frequencies for the various types of business. The control pressure increases if inspection results are (partly) non-compliant, as indicated for the main categories in the following table. 3

8 Category Compliance Periodicity Number Processing plants (exporters) Primary processors Farms Feed mills non-compliant partly compliant compliant traceability non + partly compliant compliant traceability non + partly compliant compliant non + partly compliant compliant traceability 15 days 3 months 6 months 1 month 15 days 6 months 4 months 15 days 12 months 15 days 6 months 3 months 100% 40% 100% The audit team noted that: the food and feed business operators visited were approved and had been inspected by the INP. Commodities were traceable to recipients and approved suppliers of feed, fry, larvae, shrimp and tilapia; template inspection reports / check lists were available and used. The inspection reports examined were generally complete in terms of covering all required topics. However, noncompliances in the area of veterinary medicinal products (see section 5.3.2) and companies' own checks (see section 5.1.5), observed by the audit team at establishments and farms visited, were not mentioned in the inspection reports. Conclusions on the dedicated production system for export The National Control Plan provides guarantees that shrimp and tilapia produced for export to the EU are subject to residue controls. Inspections carried out by INP are adequate to ensure that only shrimp and tilapia from approved food business operators are exported to the EU Planning of residue monitoring plan Legal Requirements Third countries which export live animals or animal products to the European Union are obliged to submit to the European Commission a specific plan setting out the guarantees which it offers as regards the monitoring of the groups of residues and substances referred to in Annex I to Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products. The residue plan should take account of the results of monitoring from the previous year and should be revised annually and updated at the request of the Commission, particularly when checks carried 4

9 out by the Commission render it necessary. Article 29 of said Directive states that guarantees must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 and meet the requirements of Article 11(2) of Directive 96/22/EC. Articles 3 to 7 of Council Directive 96/23/EC deal with the requirements for residue monitoring plans. The levels and frequencies of sampling for residues are specified in Annex IV to Council Directive 96/23/EC and Commission Decision 97/747/EC. Article 11 of Regulation (EC) No 178/2002, laying down the general principles and requirements of food law, specifies that food and feed imported into the EU for placing on the market within the EU shall comply with the relevant requirements of food law or conditions recognised by the EU to be at least equivalent thereto. In relation to maximum levels of residues and contaminants in food, Regulation (EC) No 470/2009 of the European Parliament and of the Council lays down Maximum Residue Limits (MRLs) for residues of pharmacologically active substances in food which are listed in Table 1 of the Annex to Commission Regulation (EU) No 37/2010. Regulation (EC) No 396/2005 lays down maximum residue levels of pesticides in or on food and feed of plant and animal origin. Commission Regulation (EC) No 1881/2006 lays down Maximum Levels (MLs) for contaminants in food. Minimum Required Performance Limits (MRPLs) are defined in Article 4 of Commission Decision 2002/657/EC. In accordance with Article 29 of Council Directive 96/23/EC, Commission approval of every third country s residue monitoring plan is necessary if that country is to remain on the list of third countries from which EU Member States may import animals and animal products. The list of countries and commodities with approved residue monitoring plans is in the Annex to Commission Decision 2004/432/EC. Findings The INP establishes the annual residue monitoring plan. The 2012 plan and previous plans were based on Directive 96/23/EC. The audit team noted that: the residue monitoring plan is ready at the start of the year, allowing for prompt implementation; the full residue monitoring plan is published on the INP website, thus reducing the element of surprise with regard to the substances tested for. Point 2.1 of the Annex to Commission Decision 98/179/EC requires that whenever official samples are taken, sampling must be unforeseen and unexpected, and competent authorities must take all the precautions necessary to ensure that the element of surprise is constantly maintained. The same finding was made in the 2008 FVO audit (recommendation 3) and the corrective measures proposed in INP's action plan have not been implemented in ; the residue monitoring plan applies to (applicant) food and feed business operators in the dedicated production system. The plan covers farms and establishments as foreseen in Chapter 3, Annex IV of Directive 96/23. In addition hatcheries and feed mills are included; production data serve as a basis for calculating the minimum sample numbers, one per 1000 tonnes of annual production in accordance with Chapter 3, Annex IV of Directive 96/23. 1 In their response to the draft report, the competent authority noted that the INP removed the residue monitoring plan from its web-page; instructions have been issued not to upload the residue monitoring plan. 5

10 Since national production data are used, the calculated numbers in the residue monitoring plan are higher than what would be required for the total output of the dedicated production system (which may be higher than the export volume to the EU). However, for tilapia the production data relate to fillets, which make up approximately 40% of the weight of the fish 2 ; the residue monitoring plan includes all substance groups for aquaculture as indicated in Annex II of Directive 96/23/EC. The scope of testing within the groups generally covers relevant authorised and/or unauthorised substances, and in this regard recommendation 1 of the 2008 FVO audit has been satisfactorily addressed. Room for improvement remains, however, in relation to testing for steroids (A3) in tilapia. The steroids currently included in the plan (nortestosterone, 17β estradiol, ethinyl estradiol, estradiol benzoate, trenbolone) are of less relevance than the steroids actually used (17α-ethinyl-testosterone, see section 5.3.1) and which are not included 3. Antimicrobial substances authorised for use which are not included in the plan are cloxacillin and trimethoprim, but evidence of use of these were not seen at the sites visited; the action limits indicated in the 2012 residue monitoring plan are generally consistent with those applicable in the EU. Only in the case of emamectin in shrimp is the listed action limit higher than the EU limit (1000 versus 100 μg/kg (Regulation No (EU) 37/2010)); the residue monitoring plan indicates one limit of detection of the screening method and one of the confirmatory method per substance, although up to three different laboratories can perform the analysis. Since the laboratories do not have the same analytical performance, the limits of all the laboratories or the values of the laboratory with the highest limits should be indicated. Moreover, it was noted at the laboratories visited that the residue monitoring plan has not been fully updated with regard to the laboratories' current levels of detection, and there is no method in place for danofloxacin although this substance is included in the plan. Conclusions on planning of the residue monitoring plan Improvements have been made to the scope of testing in the residue monitoring plan relative to the 2008 FVO audit and the 2012 plan generally satisfies the requirements of Directive 96/23/EC, except for the sample numbers for tilapia. Nevertheless, the effectiveness the residue monitoring plan is potentially compromised by publishing the detailed scope of testing, and by not taking fully into consideration the veterinary medicinal products authorised for use in aquaculture Implementation of the residue monitoring plan Legal Requirements Article 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid 2 In their response to the draft report, the competent authority noted that the production data for tilapia includes fillets as well as whole fish given that establishments process and export fresh and frozen fillets as well as fresh and frozen whole fish. 3 In their response to the draft report, the competent authority noted that the INP authorised, by means of the Technical Protocol, an external laboratory to carry out the hormone and steroid tests. This laboratory is accredited for the relevant parameters and 17α-ethinyl-testosterone testing has been included in group A3. 6

11 down in Article 7. Article 4(2)(b) and (c) of Council Directive 96/23/EC lays down the requirements for central competent authorities in co-ordinating the activities of all bodies involved in residues controls. Articles 5 and 12 of Council Directive 96/23/EC deal with aspects pertaining to the implementation of the residue monitoring plan. Sampling requirements are specified in Annex IV to Council Directive 96/23/EC and Commission Decision 97/747/EC and Commission Decision 98/179/EC lays down the rules for official sampling under the residue monitoring plan. EU methods of sampling for the official control a wide range of residues in products of animal origin are laid down in several pieces of EU legislation: Commission Directive 2002/63/EC (pesticides); Commission Regulation (EC) No 1883/2006 (dioxins and dioxin-like PCBs); Commission Regulation (EC) No 333/2007 (certain chemical elements); Commission Regulation (EC) No 401/2006 (mycotoxins). Findings All sampling is carried out by INP inspectors. The audit team noted that: in 2011 the calculated minimum number of samples was 1465 for shrimp and 85 for tilapia. The target indicated in the 2011 residue monitoring plan was 2000 for shrimp and 100 for tilapia. The number of samples taken was 1092, out of which 19 from tilapia and 45 from fish feed. The situation in 2012 is similar. This considerable level of under-sampling has been caused by the fact that the INP reads the numbers indicated in the residue monitoring plan as tests rather than samples. Chapter 3 of Annex IV to Directive 96/23/EC clearly refers to samples and not tests in relation to establishing the minimum sampling levels. The number of tests performed was 3338 versus 2100 planned 4 ; 73% of the hatcheries, 65% of the farms and 100% of the establishments and feed mills in the dedicated production system were sampled in 2011, thus meeting the requirement that at least 10% of the farms should be sampled each year (Chapter 3 of Annex IV of Directive 96/23/EC ); in line with the sampling requirements laid down in the Annex to Commission Decision 98/179/EC, samples are taken throughout the calendar year, sampling visits are unannounced, samplers use adequate sampling materials and samples remain in the custody of the competent authority until arrival in the laboratory or up to the moment of shipment from the INP office to a laboratory; the sampler decides on the spot which substances a sample should be tested for. This has the advantage that the sampler can take into consideration available information, as foreseen in the Annex to Commission Decision 98/179/EC. However, it was noted that the choice of analytical tests was discussed with the food or feed business operator, potentially providing him the opportunity to influence the tests carried out and thus to evade detection in the event that he had been using substances illegally; samples of larvae, fry as well as shrimp and fish not ready for consumption have been regularly tested for authorised substances. This is not in line with the rules for targeting laid down in point 2.3 the Annex to Commission Decision 98/179/EC. The results of such tests have no relevance for determining compliance with maximum residue limits in the products 4 In their response to the draft report, the competent authority noted that since October 2012, instructions have been issued to spread the sampling over various batches rather than focussing on a single batch. 7

12 exported to the EU 5 ; a standardised form is filled-in at the moment of sampling and this form accompanies the sample to the laboratory. Copies are kept by the sampler and the food for feed business operator. The sample form includes a standard list of different tests which can be ticked. Florfenicol, one of the three antibiotics for which most marketing authorisations have been granted in Ecuador did not feature in the list. In 2011 only 11 samples were tested for florfenicol; the food or feed business operator has a choice of laboratory, out of three laboratories listed in the residue monitoring plan, subject to the analytical tests the laboratory is authorised for. Some samples were tested in laboratories authorised for the residue monitoring plan, but not for the particular substance/matrix combination (see 5.2.1); two of the laboratories have the policy to require upfront payment before a sample is analysed. The laboratories are paid in most cases within two weeks after sampling. Tests are generally performed within a week after payment. If no test result is received within six weeks after sampling due to non-payment, the inspector can propose withdrawal of the approval of the food- or feed business operator under the National Control Plan, propose a new sample to be taken or decide not to take further action taking into consideration the 'reputation' of business operator. Good scores in National Control Plan inspections (mainly in relation to HACCP and traceability) count towards a good reputation. The laboratories discard the (unanalysed) samples after three months or earlier. Information retrieved from the laboratories showed that 61 business operators did not pay for the analysis of a sample in 2011, out of which 28 were de-listed and 33 still listed as approved on the INP website at the time of the audit. Among these some had been re-sampled later on, but the samples had been tested partly for other substances than the refused samples. Others had not been re-sampled at all; the samples and the test results are recorded in a database at the INP. A monthly check is carried out on the results received, whether these are (non) compliant. It is, however, not checked whether samples have been tested in accordance with the instructions on the sampling form. The audit team observed that some examples had been (partly) tested for substances other than those indicated on the sampling form 6. Conclusions on the implementation of the residue monitoring plan A high level of sampling coverage of food and feed business operators, an appropriate distribution of samples over the year, sampling instructions and sample integrity are strong points in the implementation of the residue monitoring plan in Ecuador. However, the ability of the competent authority to detect the use of unauthorised substances is undermined by several factors, including the fact that food and feed business operators can avoid detection of illegal use by not paying for analysis or by negotiating the substances which are tested for in a sample, by sampling inappropriate matrices and by taking less samples than the minimum calculated. 5 In their response to the draft report, the competent authority noted that since October 2012, instructions have been issued to test larvae, fry and farms (during production) for unauthorised substances. 6 In their response to the draft report, the competent authority noted that currently, the monthly checks include a review to determine whether the analyses are carried out in line with the instructions on the sampling form. 8

13 5.1.5 Industry's own checks Legal Requirements Article 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive. Article 11 of Council Directive 96/23/EC gives the option of conducting other residues testing, particularly in relation to detection of illegal treatment of food producing animals. Article 9 of Council Directive 96/23/EC foresees the application of own-checks by food business operators. Findings Farms, establishments and feed mills are required to carry out own checks on residues in the framework of the National Control Plan. There are no particular written requirements in relation to the number of tests and the substances to be tested for. Food or feed business operators are however required to report non-compliant test results to the INP and the Sub-secretary for Aquaculture according to Ministerial Agreement 138. The audit team noted that: INP inspectors expect a food or feed business operator to have at least one sample tested per year; all food or feed business operators visited had frequently carried out a variety of residue tests. The substances tested for were relevant to export market demands; samples were tested both in laboratories which were clearly accredited for the tests concerned and in laboratories for which accreditation of any sort could not be demonstrated from the documentation provided; the vast majority of test results seen by the audit team was compliant. However, repeated findings of low levels of (leuco) malachite green in tilapia, below the EU Minimum Required Perfomance Limit (MRPL) of 2 μg/kg but above the detection limit of the laboratory, had not been reported to the INP. The establishment was of the opinion that findings below the MRPL do not need reporting 7. Such findings do, however, require an investigation in the EU; a finding of crystal violet in tilapia confirmed at a level of more than 3 μg/kg was also not reported because a test on a follow-up sample resulted in a level of 0.5 μg/kg, which was interpreted as below the MRPL, even though no MRPL has been established for crystal violet in the EU 8 ; the finding of dyes was not spotted by during routine inspections on the establishment by the INP, which included examination of the company's own checks. 7 In their response to the draft report, the competent authority noted that by means of Ministerial Agreement No 138, establishments and laboratories must notify the INP when a result does not meet the criteria. The INP shall monitor the results reported. 8 In their response to the draft report, the competent authority noted that the INP monitors all the test results of malachite green and leuco malachite green, even if the findings reported are not above the required minimum performance limit of 2 μg/kg. 9

14 Conclusions on industry's own checks Industry's own checks provide assurances on the residue status of aquaculture products exported to the EU in addition to the residue monitoring plan. However, non-reporting of residue findings of non-authorised substances reduces the effectiveness of the own checks in ensuring that potentially contaminated product is not exported to the EU, This also means that the competent authority does not have relevant information information at its disposal in a timely fashion in order to facilitate an investigation and to prevent future cases Follow-up of non-compliant results Legal Requirements Article 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive. Measures to be taken by competent authorities in response to the finding of noncompliant residues results are described in Articles 13, 16, 17, 18, 19, 23, 24, 27 and 28 of Council Directive 96/23/EC. Findings Following the 2008 FVO audit audit (recommendation 2) the INP promised in its action plan to develop procedures for investigations. The 2012 residue monitoring plan describes the procedure to be followed in case of non-compliances for three different scenarios. The first scenario is the possession of non-authorised substances or veterinary medicinal products. The INP informs the Sub-secretary for Aquaculture, which is responsible for the investigation, measures and sanctions (if applicable) according to Ministerial Agreement No The second scenario relates to the detection of forbidden substances (see section 5.3.1). The third scenario concerns the finding of (other) residues or contaminants above the action level. In scenario two and three the INP is responsible for an investigation at the establishment(s) and farm(s) in order to find the reason for the violation and to ensure the withdrawal of implicated products. The approval of the food business operator will be suspended pending the follow-up investigation in case of forbidden substances. Follow-up samples will be taken, and if the presence of the forbidden substance is confirmed, the Sub-secretary will be informed with a view to the application of sanctions. There were no non-compliant test results reported in 2012 up to the time of the audit. The INP reported the following non-compliant test results for 2010 and Year Matrix Substance Concentration (µg/kg) * 2010 shrimp muscle metronidazole shrimp muscle metronidazole shrimp muscle furazolidone shrimp muscle furazolidone tilapia muscle enrofloxacin Three values for: the initial sample, the counter sample and the determination sample. The audit team examined the follow-up files of all above cases and noted that: the levels of enrofloxacin found in tilapia are below the MRL applicable in Ecuador and the 10

15 EU. There was no need to take any action; analysis of counter and determination samples started promptly after the initial sample tested non-compliant. Food business operators were informed upon receipt of the determination sample results in order to block the product. However, on-site investigations were conducted about two weeks later. Contrary to EU Member States obligations laid down in Article 17 of Directive 96/23, it was consequently not ensured that the shrimp concerned was immediately placed under official control whilst it did not bear an official mark or identification. This time delay could give food business operators the opportunity to delete evidence of illegal use; the investigations on farms and establishments covered relevant aspects in relation to the potential source, such as medicine records and medicine storage, and follow-up samples were taken except on one small farm where the ponds were empty. No metronidazole or furazolidone was found and the food business operators denied its use. It was seen in one case that different ponds were sampled from those where the original monitoring sample was taken, reducing the likelihood of confirming illegal use. Implicated products were traced and it could be demonstrated that these had not been exported to the EU. As the results of the counter samples were compliant, the suspension of establishments' approvals and the blockage of goods were lifted; the Sub-secretary for Aquaculture was not involved in any of above cases. No sanctions (based on Agreement 138) have been applied for residue violations since the 2008 FVO audit 9. Conclusions on follow-up of non-compliant results Whilst there have been only a few non-compliant test results in the residue monitoring plan, shortcomings in the implementation of the residue monitoring plan (5.1.4) reduce the chances of detection. Relative to the 2008 FVO audit progress has been made in the development of procedures for follow-up investigations. Investigations of non-compliant results were generally comprehensive and implicated products were not exported to the EU. However, current procedures provide food business operators the opportunity to delete evidence prior to on-site investigations, and follow-up samples are not always taken from the implicated ponds. Both have the potential to undermine the effectiveness of the follow-up investigations. 5.2 LABORATORIES Legal Requirements Article 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive. Article 15 of Council Directive 96/23/EC requires that official samples are examined in approved laboratories. Requirements for accreditation of laboratories are laid down in Point 1.2. of the Annex to Commission Decision 98/179/EC. The rules for analytical methods to be used in the 9 In their response to the draft report, the competent authority noted that with regard to follow-up of non-compliant results, the INP has requested that the Sub-secretary for Aquaculture, through the Directorate for Aquaculture Supervision, to participate in the investigation of non-compliant results. 11

16 testing of official samples taken pursuant to Article 15(1) of Council Directive 96/23/EC are laid down in Commission Decision 2002/657/EC in particular Articles 3, 4, 5 and 6 which cover inter alia, validation requirements and quality control. More specific requirements for analytical methods for certain substances are laid down in the annexes to Commission Regulation (EC) No 1883/2006 (dioxins and dioxin-like PCBs in foodstuffs), Commission Regulation (EC) No 333/2007 (chemical elements in foodstuffs) and Commission Regulation (EC) No 401/2006 (mycotoxins). Findings General description Three laboratories are involved in the analysis of samples for the residue monitoring plan. These are INP's own laboratory and two private laboratories, henceforth referred to as Laboratory A and Laboratory B. Laboratory A is listed in the plan as testing for all substances, while the other two laboratories test for a part of the substances only. All three laboratories also test private samples for residues. The INP has a procedure for the authorisation of laboratories involved in the residue monitoring plan. Among other requirements, the laboratory must be accredited for those parameters and ranges for which it seeks authorisation. The authorisation is granted following a process of review of requested documentation and verification in situ of the laboratory capabilities. The audit team noted that: all three laboratories are accredited by accreditation bodies that are signatories to the ILAC Mutual Recognition Arrangement. In this regard recommendation 4 of the 2008 FVO audit report has been satisfactorily addressed; there is an agreed turnaround time of 7 days from sample reception to the report of the result. The recorded date of sample reception is in practice not the physical receipt but the date of payment (see also below and section 5.1.4) The audit team observed that the turnaround time was mostly adhered to; the methods of analysis were adequate for screening and confirmatory analysis, based on LC-MS/MS for non-authorised substances and florfenicol, LC coupled with ultra violet or fluorescence for antibiotics, atomic absorption for chemical elements and GC-MS/MS for organochlorines; although Laboratory B was not visited, it was observed during the audit that this laboratory was authorised for chloramphenicol despite the fact that the method performance characteristics were not adequate as the limit of detection was 5 μg/kg (the EU MRPL is 0.3 μg/kg). This laboratory is not listed in the residue monitoring plan for chloramphenicol, however a small number of residue monitoring samples had been received and analysed by this laboratory for this substance. This laboratory also accepted and tested samples for substances for which it was not authorised such as anthelmintics and chemical elements On-the-spot visits in the laboratories The audit team visited the INP laboratory and Laboratory A. 12

17 INP laboratory Findings The audit team noted that: all of the requisite quality assurance documents, including a Quality Manual and relevant standard operating procedures (SOPs) were in place; the most recent accreditation audit was on the 23 March A number of minor non-conformances were noted in the report and there was documentary evidence that corrective actions had been taken by the laboratory; the laboratory has validated the method for chloramphenicol but has not been able to include it in the scope pending participation in a proficiency test as this is a requirement of its accreditation body; samples are stored pending the receipt of payment for the analysis. If the payment is delayed the INP is notified and the samples are discarded. There was one unanalysed sample for this reason to date in 2012; sample traceability was ensured. Samples did contain provenance information, but freedom from conflict of interest was regulated by declarations by staff members; there was an SOP in place for validation of analytical methods, covering all of the requirements of Commission Decision 2002/657/EC including criteria for acceptance of analytical results, repeatability, within laboratory reproducibility, linearity and robustness testing. With regard to CCα and CCβ, whilst these parameters were calculated, they have not been used as action limits. The limit of quantification (LOQ) of the confirmatory method is used instead; method SOPs and validation files for nitrofurans and chloramphenicol were examined by the audit team and found to be of a very high standard. Method performance was in line with the levels recommended by the EU Reference Laboratories. The LOQs reported were in line with the EU MRPLs; positive (fortified blank samples) and negative (blank samples) are run in every assay, as well as five replicate samples to calculate repeatability. Quality control charts are maintained for all methods and those checked by the audit team demonstrated that the methods had been in control; the laboratory has participated in a number of externally-organised proficiency tests with mostly satisfactory performance. The laboratory explained to the audit team that they have faced difficulties in the provision of proficiency test materials and also in the customs clearance, with some materials being not fit for analysis due to long holding times at customs. The accreditation body requests at least one proficiency test for each accredited method every four years; the laboratory carries out audits on private laboratories. A report of an audit carried out in Private Laboratory was comprehensive and detailed in respect of the 13

18 operation of approved methods and quality control criteria applied, and it also included the analysis of blind samples. Evidence was seen that deficiencies identified by the audit had been addressed Laboratory A Findings This laboratory is responsible for testing the majority of samples taken for the residue monitoring plan annually. The audit team noted that: the most recent accreditation audit was on the 5 May 2011 and accreditation was valid until April A number of minor non-conformances were noted in the audit report and there was documentary evidence that corrective actions had been taken by the laboratory and approved by the accreditation body. Of 16 Competent Authority approved methods in place, 11 are currently within the scope of accreditation and one more is validated; the Competent Authority approved methods were under the scope of accreditation of the laboratories with the exception of stilbenes, steroids, nitroimidazoles, organochlorine compounds and the anthelmintics ivermectin and emamectin. This laboratory was not accredited for these compounds but was authorised to analyse them for the residue monitoring plan. Of these only the method for stilbenes was fully validated. Recommendation 5 of the 2008 FVO audit report has therefore not been fully addressed 10 ; depending on the customer agreement the laboratory does not commence testing of the samples that are not paid in advance. The samples are stored pending payment and if the payment is delayed the INP is notified and the samples are discarded. For this reason 61 samples were discarded in 2011 and 13 to date in 2012; sample traceability was ensured. Samples did not contain information of the ownership of the sample and freedom from conflict of interest was also ensured by declarations by staff members; in the sample preparation area the plastic cups and chopping boards in which samples were prepared for homogenisation were not adequately cleaned and thus accidental cross contamination of samples could not be ruled out. This deficiency was also observed in the 2008 FVO audit, however the low proportion of positive samples indicated this has not had an impact on the results; there is an SOP in place for validation of analytical methods. This mentions Commission Decision 2002/657/EC and includes criteria for acceptance of analytical results and procedures to determine repeatability, within laboratory reproducibility, linearity, accuracy, selectivity, specificity, LOQ and limit of detection (LOD). With regard to CCα and CCβ, whilst these parameters are not mentioned in the SOP, they had been calculated in the validation reports examined 10 In their response to the draft report, the competent authority noted that since October, the INP has issued instructions for steroid and hormone, and anthelmintic and nitroimidazole tests to be carried out in the laboratory accredited to do so. 14

19 by the audit team; method SOPs and validation files for nitrofurans and nitroimidazoles were examined by the audit team. The limits reported were in line with the levels recommended by the EU Reference Laboratories or with EU MRPLs with the exception of steroids; in the reports of analysis, the laboratory does not state if the result is compliant/noncompliant, but it gives details of the CCα and MRPL for chloramphenicol, nitrofurans, stilbenes, (leuco)malachite green and nitroimidazoles. For the rest of susbstances the report indicates the LOQ and the MRL. Some mistakes were observed in the MRL levels quoted in the report, i.e. ivermectin MRL was entered as 100 μg/kg, florfenicol as 1000 μg/kg for shrimp and oxolinic acid as 600 μg/kg; positive (fortified blank samples) and negative (blank samples) are run in every assay and quality control charts are maintained for the methods checked; these demonstrated the methods to be within control. Acceptance criteria are set on recovery values, which must fall between 70 and 120%. In the case of confirmatory analysis of substances found to be above the action limit, the laboratory does not check ion ratios or relative retention times to ensure that the substance is unequivocally present in the samples, as required by Commission Decision 2002/657/EC. This can affect the reliability of confirmatory results, as it could lead to false non-compliant results; the audit team checked two non-compliant results found in the 2011 residue monitoring plan, one for nitroimidazole and another for furazolidone. After a sample is found non-compliant, a counter-sample and the determinant sample have to be tested and the sample is considered non-compliant when two or three of the results are non-compliant. The laboratory does not require payment for these samples prior to analysis, and the cases checked demonstrated that samples had been received and analysed timely after the first sample had been deemed non-compliant; the laboratory has participated in a limited number of externally-organised proficiency tests for a range of residues of pharmacologically active substances and contaminants since 2010 to date. Of the list of methods for which the laboratory is authorised for the residue monitoring plan, the laboratory has not taken part in externally-organised proficiency tests for nitroimidazoles, sulfonamides, florfenicol, antihelmintics, stilbenes, steroids and aflatoxins. As in the case of the INP, Laboratory A management explained to the audit team that they have faced similar difficulties in the provision of proficiency test materials. The accreditation body requests at least one proficiency test for each accredited method every four years. Some failures were observed, and in one of the cases reviewed the documentation regarding the corrective action could not be found, while in other case the investigation concluded that the cause of the non-conformance was a calculation mistake and the corrective action was the repetition of the proficiency test. However, there had not been an available proficiency test for this element, cadmium, so far and the closing of this corrective action was still pending after 9 months. Conclusions on laboratories Accreditation to ISO17025 and the generally high standard of the laboratories underpin guarantees 15