EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2012)108679 DG(SANCO) 2011-8903 - MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN ARGENTINA FROM 13 TO 23 SEPTEMBER 2011 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.
Executive Summary This report describes the outcome of a Food and Veterinary Office (FVO) audit in Argentina, carried out from 13 to 23 September 201 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 live animals and animal 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 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. It is concluded that the residue monitoring plan fulfils the requirements of Directive 96/23/EC and has been amended since the previous FVO mission in 2008 to include a broader range of substances which better reflects the veterinary medicinal products authorised and used in Argentina. The laboratory network for the analysis of residues samples operates to a high standard and the competent authority can have confidence in the results provided. However, the effectiveness of the implementation of the plan has been undermined by significant under-sampling for most commodities in 2010 and incomplete and delayed follow-up actions when non-compliant sample results were detected. There is no supervisory mechanism currently in place which can prevent the recurrence of these issues though the problems identified are mitigated to a certain extent by the preventive listing of establishments and farms where non-compliances are detected and prevention of export to the EU pending enhanced official controls. With regard to other residue testing programmes, the pre-export testing of all batches of honey destined to be exported to the EU provides additional reassurances regarding the residue status of this commodity. With regard to veterinary medicinal products, the prohibition of the use of hormones, betaagonists and thyrostats for growth promotion purposes in food producing animals and restrictions on the use of other pharmacologically active substances which are prohibited in the EU, combined with controls throughout the distribution chain for veterinary medicines, collectively reduce the likelihood that veterinary medicines will be used inappropriately. The legal framework for the authorisation, distribution and use of veterinary medicinal products has recently been strengthened, most notably by the requirement that on-farm treatment records must be maintained for the lifetime of all food producing species. Once implemented in 2012, this measure should provide a useful tool for official controls on-farm and allow the accuracy of animal movement document owner affidavits on the use of medicines to be verified. In particular, this will go some way to addressing weaknesses in the current system regarding the identification and treatments of equidae destined to be slaughtered and exported to the EU for human consumption. The report makes a number of recommendations to the Argentinean competent authorities, aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place. I
Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES...1 3 LEGAL BASIS...1 4 BACKGROUND...2 4.1 COUNTRY STATUS IN RELATION TO EU-APPROVAL OF RESIDUE MONITORING PLANS...2 4.2 SUMMARY OF PREVIOUS FVO AUDIT RESULTS...2 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS FOR PRODUCTS OF ANIMAL ORIGIN FROM ARGENTINA CONCERNING RESIDUES...2 4.4 PRODUCTION AND TRADE INFORMATION...2 5 FINDINGS AND CONCLUSIONS...3 5.1 RESIDUE MONITORING...3 5.1.1 COMPETENT AUTHORITIES INVOLVED...3 5.1.2 PLANNING OF RESIDUE MONITORING PLAN...3 5.1.3 IMPLEMENTATION OF THE RESIDUE MONITORING PLAN...5 5.1.4 OTHER RESIDUES MONITORING PROGRAMME, INCLUDING ESTABLISHMENTS' OWN-CHECKS...7 5.1.5 FOLLOW-UP OF NON-COMPLIANT RESULTS...7 5.2 LABORATORIES...11 5.2.1 GENERAL DESCRIPTION...11 5.2.2 ON THE SPOT VISITS IN THE LABORATORIES...11 5.3 VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS...15 5.3.1 AUTHORISATION, DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS...15 5.3.2 CONTROLS ON THE DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS...17 5.3.3 IDENTIFICATION OF EQUIDAE AND MEDICINES RECORDS REQUIREMENTS...20 6 OVERALL CONCLUSIONS...23 7 CLOSING MEETING...24 8 RECOMMENDATIONS...24 ANNEX 1 - LEGAL REFERENCES...25 II
ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AAS AOZ and AMOZ, AHD and SEM CCα / CCβ COFIAL CREHA plan CRL DAPFyV DG(SANCO) DIL AB DNFA DNSA Explanation Atomic Absorption Spectroscopy Marker residues of the nitrofuran drugs furazolidone, furaltadone, nitrofurantoin and nitrofurazone respectively Decision Limit / Detection Capability Coordinación de Fiscalización de Establicimientos de Alimentos para Animales (Compound Feed Inspection Department) Plan de Control de Residuos e Higiene de los Alimentos (Residue and Food Hygiene Control Plan) Community Reference Laboratory Dirección de Agroqumicos, Productos Farmacológicos y Veterinarios (Agrochemicals, Pharmacological and Veterinary Products Directorate) Health and Consumers Directorate-General Dirección de Laboratorios y Control Técnico (Official Laboratory and Technical Control Directorate) Dirección Nacional de Fiscalización Agroalimentaria (National Agrifood Inspection Directorate) Dirección Nacional de Sanidad Animal (National Animal Health Directorate) DIRTE Documento Individual para el Registo de Tratamiento de Equideos individual treatment record for equines DTA / DTe EAR list EC ELISA EU EU RL FVO GC - ECD GC - FPD Animal movement document / electronic animal movement document List of Establishments with Residue Findings European Community Enzyme-linked immuno-sorbent assay European Union European Union Reference Laboratory Food and Veterinary Office Gas chromatography electron capture detection Gas chromatography flame photometric detection III
GC-MS/MS Group A, B Gas Chromatography-(Tandem) Mass Spectrometry Categories of substances listed in Annex I to Council Directive 96/23/EC: HPLC DAD/Fluor High Performance Liquid Chromatography with Diode Array Detector / Fluorescence Detector HPTLC HPLC UV/Vis ICP-MS ISO LC-MS/MS ML MRL MRPL NRL OAA QA RASFF RMP SENASA SOP URO UVO High performance thin layer chromatography High Performance Liquid Chromatography with Ultraviolet / visible light wavelength detector Inductive Coupled Plasma Mass Spectrometry International Organisation for Standardisation Liquid Chromatography-(Tandem) Mass Spectrometry Maximum Level Maximum Residue Limit Minimum Required Performance Limit National Reference Laboratory Organismo Argentino de Acreditación (Argentinean Accreditation Body) Quality assurance Rapid Alert System for Food and Feed Residue monitoring plan Servicio Nacional de Sanidad y Calidad Agroalimentaria (National Service for Health and Food Quality) Standard Operating Procedure Regional Operational Unit Operational Surveillance Unit IV
1 INTRODUCTION The audit took place in Argentina from 13 to 23 September 2011. The audit team comprised two inspectors from the Food and Veterinary Office (FVO). The audit was undertaken as part of the FVO's audit programme, evaluating control systems and operational standards in the residues sector. Representatives from the central competent authority responsible for control of residues in animals and animal products the Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA) accompanied the audit team during the audit. An opening meeting was held on 13 September 2011 with the central competent authority responsible for implementing residue monitoring in live animals and animal products and representatives of the competent authority responsible for the authorisation of veterinary medicinal products. At this meeting, the objectives of, and itinerary for, the audit were confirmed and the control systems were described by the authorities. 2 OBJECTIVES The objective of the audit was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in live animals and animal 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 at central and regional levels, 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 Argentina (DG (SANCO)/2008/7779) in June 2008. The table below lists sites visited and meetings held in order to achieve that objective. Meetings/Visits n Comments Competent Authorities Central 4 Regional 1 Opening and closing meetings with SENASA and meetings with the Plan de Control de Residuos e Higiene de los Alimentos (CREHA) plan office and the SENASA Operational Surveillance Unit (UVO) Meetings at the Regional SENASA Office in the Province of Cordoba Local 2 Meetings in two SENASA local offices Laboratories 3 1 governmental and two private laboratories Farms 2 One cattle and one poultry farm authorised to export to the EU Establishments 2 Two slaughterhouses (cattle and horse) Other sites 5 Two feed mills producing medicated feedingstuffs; two veterinary pharmacies; one wholesaler of veterinary medicines 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, and in particular: 1
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; 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 Argentina's residue monitoring plan (RMP) is approved in accordance with Council Directive 96/23/EC for bovine, ovine / caprine, equine, poultry, aquaculture, milk, eggs, rabbit, wild game, farmed game and honey. 4.2 SUMMARY OF PREVIOUS FVO AUDIT RESULTS The residues sector was inspected by the FVO in 2004 (DG(SANCO)/7283/2004 MR Final) and 2008 (DG(SANCO)/2008-7779 MR Final). The reports of both missions (henceforth referred to as the 2004 and 2008 FVO reports respectively) have been published on the website of the Directorate General for Health and Consumers here: http://ec.europa.eu/food/fvo/ir_search_en.cfm. The most recent report concluded that considerable improvements had been made to the system of residues controls since the 2004 audit and the RMP and performance of the laboratory network was generally equivalent to that required by Council Directive 96/23/EC. However, the effectiveness of the system in place was undermined as sampling was not carried out throughout the year and follow-up investigations were not always unforeseen by operators. In addition, there were limited controls in place regarding the distribution and use of veterinary medicinal products. 4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS FOR PRODUCTS OF ANIMAL ORIGIN FROM ARGENTINA CONCERNING RESIDUES Since the 2008 FVO mission, there has been one RASFF notification for residues of enrofloxacin in honey and one for the presence of oxytetracycline in horse meat. 4.4 PRODUCTION AND TRADE INFORMATION According to data provided by SENASA and the Ministry of Agriculture, in 2009 and 2010, the main exports of animals and animal products form Argentina to the EU were beef (60 100,000 tonnes); meat from 9-12,000 equines, poultry meat (18-22,000 tonnes), wild game (mainly hares) and honey (32 42,000 tonnes from a total production of 55-60,000 tonnes). In addition, each year relatively small quantities of farmed game, rabbits eggs and milk are exported to the EU. Although approximately 170,000 tonnes of fish and aquaculture products (90,000 tonnes of fish and 80,000 tonnes of crustaceans and molluscs) are listed as being exported to the EU, SENASA stated that this is all wild caught and that no aquaculture products are actually being exported to the EU. 2
5 FINDINGS AND CONCLUSIONS 5.1 RESIDUE MONITORING Findings 5.1.1 Competent authorities involved The operational de-centralisation of the major activities of SENASA such as Animal Health, Agrifood Inspection, Plant Protection and Laboratories and Technical Control which is described in the 2008 FVO report has been completed in the last year with the establishment of six national directorates which were previously established at regional level. Through these national directorates it is intended to reduce bureaucracy and improve efficiency and co-ordination. In addition, the Residues Control Unit has been recently set up at national level, which is separate from the National Directorates and it reports directly to the president of SENASA. According to SENASA, the functions of this unit are being established and it is likely that its tasks will include ensuring that the RMP is implemented properly and that follow-up investigations are effective. In this respect, it will work closely with the CREHA plan office and the National Directorate for Regional Operations. As described in the 2008 FVO report, there are 14 Regional Centres each with Thematic Coordinators for each area of work. Supervisory offices which report to the regional centres oversee the work of local SENASA offices which are responsible for implementing most controls within the scope of this audit. Controls on the distribution and use of veterinary medicines are also carried out by the UVO (part of SENASA) while the Co-ordination Unit for Feed mill Inspection (COFIAL) is responsible for the co-ordination and implementation of controls on feedingstuffs, including medicated feed. The audit team noted that: the Residue Control Unit has begun to function only recently and its role and means of operation have yet to be clearly defined. Similarly, the Director of the National Directorate for Regional Operations was appointed only two weeks before this audit and, as such, it is not yet possible to evaluate the potential impact of these changes on the implementation of controls relevant to the scope of this audit; on-farm sampling of honey has been delegated to the Provincial authorities. SENASA regional and local officials are involved in the follow up of any non-compliant sample results. 5.1.2 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 RMP 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 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 3
deal with the requirements for RMP. 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 2011/163/EU. Findings As described in the 2008 FVO report, the CREHA plan office is responsible for planning the CREHA plan (which includes the RMP) and overseeing its implementation. In addition, it is also responsible for maintaining files relating to follow-up and for liaising with the Co-ordination Office for Infringements and the National Directorate for Regional Operations. Criteria taken into account in the planning process include production data, previous non-compliant results, laboratory capability and sales of authorised veterinary medicinal products. The legal basis for planning the RMP remains as described in the 2008 FVO report. The audit team noted that: the number of samples to be taken for each commodity is largely based on CODEX Alimentarius principles (CAC/GL 71-2009) while the substance groups to be tested include those given in Directive 96/23/EC; the distribution of samples is based on a matrix which ranks the potential risk to public health of chemical residues based on three levels of consumption; the samples to be taken for live cattle are sent to the regions every two months, while an annual plan is prepared for other commodities. In this case, the plans specify the frequency at which a sample should be collected which typically ranges from 1 sample every 1,200 animals up to 1 every 4,400. Difficulty in meeting these criteria was partly blamed for the partial implementation of the CREHA plan for slaughtered cattle and horses (see section 5.1.3.); the CREHA plan office determines which farms should be sampled and provides a list of alternatives should it not be possible to take the sample on the first choice farm; the 2010 and 2011 CREHA plans for each commodity include all substance groups required to be tested by Directive 96/23/EC with the exception of dyes in aquaculture. According to SENASA, analytical methods for substances belonging to group B3e are available but no samples are taken owing to the very limited amount of aquaculture production and as exports to the EU have been suspended voluntarily; the range of substance groups included in the CREHA plan has been increased since the 2008 4
FVO report to include all but two of the substances authorised for use in honey bees, nitromidazoles in eggs and heavy metals in sheep and honey. However, according to the results of the 2010 CREHA plan, no analyses of nitroimidazoles in eggs or of heavy metals in honey were actually carried out (see section 5.1.3.); as noted in the 2008 FVO report, the scope of testing for some substance groups is narrow. For example, only phenylbutazone is listed in the CREHA plan for the non-steroidal antiinflammatory drug (NSAID) (group B2e) although NSAIDs such as flunixin are authorised for use in horses. Conclusions on planning of the residue monitoring plan The RMP has been strengthened since the 2008 FVO audit to include a broader range of substance groups and it now fulfils the requirements of Directive 96/23/EC. 5.1.3 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 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 RMP. 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 RMP. EU methods of sampling for the official control of 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 SENASA is responsible for the implementation of the CREHA plan. The National Animal Health Directorate (DNSA) is responsible for the on-farm sampling of live animals and feed and the DNFA is responsible for the sampling of slaughtered animals and products of animal origin. In response to recommendation 2 of the 2008 FVO report, the instructions for the implementation of the CREHA plan have been amended to clarify that farmers and other food business operators should only be informed shortly before a control visit where necessary to ensure that someone is present during the control. It is further specified that farmers and operators should not be told about the purpose of the visit. In order to avoid taking multiple samples from the same animals (and to address recommendation 3 of the 2008 FVO report), the sample forms have been modified to require the number of animals sampled to be indicated, along with their ear tag numbers. It is required that the bi-monthly plans be implemented within 72 hours of receipt and that samples are sent to the relevant testing laboratory within seven days. The audit team noted that: the CREHA plans for 2010 and 2011 had been distributed to the regions in March or each 5
year and cross checks in the laboratories and regions visited showed that sampling was carried out throughout the year; SENASA officials met in the local offices were aware of the requirements relating to prior notification of farmers and food business operators and, as far as it was possible to tell, these had been respected; in the establishments and laboratories visited, it was possible to confirm that the bi-monthly sampling plans were generally implemented within 72 hours of receipt as required. Samples taken in the establishments visited had generally been sent to the laboratories within seven days but there was often a considerable delay (30-60 days) in sending samples taken from live animals to the testing laboratory. According to one local official, this was partly due to transportation difficulties; the CREHA plan office monitors the implementation of the CREHA plan and can reallocate samples which have not been collected using the next bi-monthly plan. Progress made in fulfilling the annual plans, where the number of samples taken depends on the throughput of the establishments, is also monitored and a note can be issued advising, when considered necessary, of potential problems in fulfilling the plan. However, shortfalls in sampling were often not apparent until late in the year; according to SENASA, there has been a decrease in the number of cattle and horses being slaughtered and this has had an impact on the number of samples taken annually as the number taken is dependent on the throughput of the slaughterhouses. In one horse slaughterhouse visited, the official stated that it had not been possible to take the number of samples allocated as insufficient animals had been slaughtered; in the region visited, the four district supervisory offices, which are responsible for overseeing the work of the 36 local offices, had developed a database which enabled the implementation of the CREHA plan to be monitored. The system highlighted those samples which had not been collected and comments were made when these had been re-allocated. However, the effectiveness of this system was limited as it was not always possible to verify that planned samples had actually been taken. This system was also only used in this particular region and that it was not known if similar systems were in use elsewhere; according to the results of the 2010 CREHA plan, only the sampling programme for sheep had been implemented fully while shortfalls and excesses in sampling were evident for other commodities; the plan for live cattle was generally fully implemented with the exception that only 50% of samples to be checked for the presence of 17beta-oestradiol had been collected. In slaughtered cattle, fewer samples had been taken than planned for certain substances including trenbolone (65%) and nitrofurans (75%); for horses, 75% of samples planned for beta-agonists had been taken and 66% of those for zeranol (where previous non-compliances had been detected). In slaughtered horses, less than 40% of the samples planned for nitrofurans, ivermectin and NSAIDs had been taken and only 6% (23/360) of those for trenbolone. For other substance groups only 23 out of 60 planned samples had been taken; in eggs, no results had been provided for analyses of nitrofurans and macrolides (30 samples for each were planned) and only one of 20 samples for quinolones had been taken; in milk, no macrolides (120 samples planned), quinolones and aminoglycosides were checked; in honey there was amixed picture with 350% of the planned samples for analyses of tylosin 6
taken and 115% of those planned for sulphonamides. However, shortfalls in sampling were seen for amitraz (222 samples taken out of 300 planned) and fluvalinate (178 out of 300); sample submission forms seen in the establishments and laboratories visited included the number of animals sampled and their ear tag numbers as appropriate. There was no evidence that samples were clustered or that multiple samples had been taken from the same animal. Thus recommendation 3 of the 2008 FVO report had been addressed. Conclusions on implementation of the residue monitoring plan Steps have been taken to ensure that the CREHA plan is implemented throughout the year and that sampling is unforeseen and not clustered. However, the significant under-implementation of the CREHA plan in 2010 highlights that there is no effective mechanism in place to ensure that planned samples are actually taken and that deadlines for their submission to the laboratory and reporting of results are respected. These factors undermine the ability of SENASA to provide assurances regarding the residue status of animals and their products which are equivalent to those provided for in EU legislation. 5.1.4 Other residues monitoring programme, including establishments' own-checks Legal Requirements Article 29 of Council Directive 96/23/EC states that guarantees offered by RMP 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 The audit team noted that: according to SENASA there are no official sampling programmes which are additional to the RMP. However, each batch of honey intended for export to the EU is tested for the presence of nitrofurans and tylosin. Export certificates are only issued by SENASA if the results are compliant. According to data provided by SENASA, in 2010 nitrofurans were detected in one out of 6858 samples of honey tested; in addition, it is obligatory for all export-approved honey collection centres to apply good manufacturing practice and to have HACCP procedures in place which may include tests for residues. Operators are required to notify the competent authorities of any non-compliant results. Conclusions on other residues monitoring programmes The pre-export testing of all batches of honey destined to be exported to the EU provides additional reassurances regarding the residue status of this commodity. 5.1.5 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 non- 7
compliant residues results are described in Articles 13, 16, 17, 18, 19, 23, 24, 27 and 28 of Council Directive 96/23/EC. Findings The actions to be taken following a non-compliant sample result are broadly as described in the 2008 FVO report. Non-compliant sample results are notified to the CREHA plan office by the testing laboratory and also via the Chief Veterinary Inspector in the establishment concerned. According to Resolución No 125/98, the official veterinarian has 48 hours to provide relevant information concerning the source of the affected animals. Once this information has been provided, the CREHA plan office issues an alert to the SENASA local office and requests that this is communicated to the producer. The holding concerned is then placed on the list of Establishments with Residue Findings (EAR list) and, in case of prohibited substances, also on the list of holdings excluded from export to the EU. Inclusion on the EAR list results in movement restrictions for live animals and compulsory sampling of animals and products delivered to an EU-approved establishment. Sampled animals and products are held and released for EU trade only if the results are compliant. The EAR list is updated regularly and is provided to relevant SENASA staff and is also available on the SENASA website. Information is also entered into the SENASA animal health database SIGSA. The holding can be removed from the EAR list if samples taken during the controlled slaughter of five animals are all compliant. Holdings excluded from EU trade must however remain on the relevant list for a minimum of two years and can only then resume exports if samples taken during the controlled slaughter of at least 10 animals are all compliant. Local SENASA officers are responsible for carrying out investigations on farm to identify the source of residues and for returning the original inspection report to the CREHA plan office. Files relating to all such investigations are maintained by the CREHA plan office which forwards cases to the Coordination Office for Infringements for decisions regarding the imposition of sanctions. The audit team noted that: in response to recommendation 2 of the 2008 FVO report, the instructions for follow-up investigations have been modified to require that farmers and operators are not informed of the non-compliant sample prior to the on farm investigation by the local SENASA office. Local officials met were aware of these procedures and documents relating to the on-farm visits indicated that these had been followed in practice; documentation provided to the audit team showed that the results of follow-up investigations are forwarded to the Co-ordination Office for Infringements for the imposition of sanctions to be considered and that progress is monitored by the CREHA plan office. It could be seen that sanctions ranging from an official warning to fines had been imposed; instructions for the interpretation of findings of zeranol in the urine of live animals were issued in February 2010. These reflect the approach taken in the EU, where the presence of mycotoxins (Fusarium spp.) in the same sample is considered to indicate there has been no use of zeranol, unless there is other evidence of illegal use. Documents seen in one of the laboratories visited, showed that samples were checked for both zeranol, the marker residue taleranol and mycotoxins and that conclusions were based on this instruction. Findings 5.1.5.1 Non-compliant results in the 2010 and 2011 residue monitoring plans 8
The results of the 2010 RMP showed that out of 1800 samples taken from live cattle, 32 tested positive for zeranol and two for nor-testosterone. Similarly, nor-testosterone was detected in two out of 118 samples from live horses. Boldenone was found in 14 out of 76 samples from pigs. Nitrofurans were detected in four out of 3184 samples of poultry, nine out of 77 samples of eggs, two out of 259 milk samples and one out of 28 samples from slaughtered horses,. Avermectins were detected in eight samples (seven below the MRL) of slaughtered cattle and in one sample from slaughtered horses. In slaughtered cattle, endosulfan was detected in 278 cases (including ten above the MRL) out of 1540 samples; organophosphate pesticides were detected in 25 out of 528 samples and 210 samples (two above the MRL) were found to contain pyrethroids. In slaughtered horses, one sample tested positive for Ethion. In honey, tetracyclines were detected in 21 out of 666 samples (two above the MRL), tylosin in 115 out of 2240 samples (23 above the MRL) and seven out of 712 samples were found to contain sulphonamides. Organophosphate pesticides were detected in 158 out of 248 samples. Nicarbazin was detected in approximately 447 out of 1063 poultry samples (93 of which were at levels above the MRL) and in nine samples of eggs. Aflatoxins were detected in 158 out of 387 samples of milk. To date in 2011, there have been four reported findings of boldenone in pigs and 75 samples of poultry have tested positive for nicarbazin. Oxytetracycline has been detected in two samples of honey and one of milk. There have been 22 findings of zeranol in bovine urine. In addition, there have been two findings of cadmium in horse muscle, eight samples of bovine fat contained endosulfan and maduramicyn was found in four poultry samples. The audit team noted that: a special multi-disciplinary investigation has been carried out in response to the on-going detection of zeranol which has included a detailed survey of all files relating to noncompliant samples, followed by targeted investigations by the UVO. According to SENASA, there has been a significant decrease in the number of non-compliances detected in the last three years as a result of the additional controls. It is planned to undertake further work with the assistance of external experts; regarding nicarbazin violations, although the levels found exceeded the national MRL of 200 µg/kg, none exceeded the EU MRL of 15,000 µg/kg set down in Regulation (EU) No 875/2010 and so would not have been be considered as non-compliant in the EU; The implementation of follow-up procedures in five cases were randomly selected by the audit team and it was noted that: in most cases the laboratories had analysed the samples within the 30 day turnaround time and had promptly notified the non-compliant sample results to the CREHA plan office. However, in one case relating to a finding of nor-testosterone in live cattle, it took more than three months for the laboratory to perform the analysis and notify the result; non-compliant sample results are only sent by the laboratories to the establishments concerned once the operator has paid for the tests. Delays caused by this practice were blamed for the time taken to provide the CREHA plan office with relevant information concerning the source of affected animals. In all cases seen, this took longer than the 48 hours stipulated in Resolución No 125/98. In one case, information was not sent for nearly three weeks following notification of the non-compliant sample result, whilst in another, the CREHA plan office had requested that the local SENASA office to send the information on 14 June 2011 but nothing had been received at the time of the audit; 9
in one case, administrative delays in creating the file within SENASA meant that it took more than three weeks from the time the official veterinarian in the establishment sent the relevant information to the CREHA plan office before an alert was issued, placing the affected establishment on the EAR list; there was no evidence in any of the cases examined that any on-farm investigations had been carried out to try to identify the reason for the non-compliant sample result. In one case, a horse collection centre where a non-compliant sample was collected had been visited by the local SENASA office but the farm supplying the horse to the centre had not been identified in the report sent to the CREHA plan office; one horse collection centre had been placed on the EAR list on 8 February 2011 following the detection of the pesticide ethion in one animal. Animal Movement Documents (DTA) seen in the horse slaughterhouse visited showed that five horses from this centre had been subject to controlled slaughter on 14 February following a request from the operator to be removed from the EAR list. The records showed that on the same day 32 horses were sent from the same centre for routine slaughter for export to the EU on another DTA. This latter DTA did not indicate that the establishment was on the EAR- list and no evidence was seen that the additional samples required to be taken, had been. According to SENASA, the system relies on official veterinarians cross-checking the EAR list in order to know which establishments are subject to increased surveillance and it is not possible for the CREHA plan office to verify that this has been done as specific analytical results are only received in the case of non-compliances. The establishment concerned was removed from the EAR list on 18 March 2011. Findings 5.1.5.2 Non-compliant results reported under the RASFF Since the 2008 FVO mission there has been two RASFF alerts concerning enrofloxacin in honey (RASFF 2010.1075) and oxytetracycline in horse meat (RASFF 2010.0912). The audit team noted that: documents provided to the audit team showed that SENASA had initiated prompt follow-up investigations on receipt of the RASFF to identify reasons for the residue findings; follow-up investigations in response to the RASFF for honey were unable to identify a source of the residues. SENASA had concluded that the contamination had arisen when a batch of honey from another country had been blended with the Argentinian honey in the EU Member State concerned prior to it being placed on the market. Conclusions on follow-up investigations/actions Although procedures are in place which foresee follow-up investigations which are equivalent to those provided for in Directive 96/23/EC, these are not always followed in practice and are only initiated after lengthy delays. As a consequence, the source of residues is often not identified. There is currently no mechanism in place which could prevent these issues from continuing. However, the situation is mitigated to some extent as establishments and farms where non-compliances are detected are placed on lists which either prevent them from exporting products to the EU or allow them to do so only under enhanced surveillance. 10
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 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 5.2.1 General description The residue laboratory network consists of one National Reference Laboratory (NRL), La Dirección de Laboratorios y Control Técnico (DILAB), and eight routine control laboratories. DILAB is mandated by inter alia SENASA Resolución No 805/2010 to approve analytical methods used in each of the laboratories and also for carrying out audits and organising proficiency tests to assess the performance of these laboratories. Accreditation of laboratories according to ISO 17025 is required by SENASA Resolución No 736/2006. The audit team noted that: all of the laboratories bar one a recently approved provincial laboratory - are accredited to ISO 17025 by the Argentinean Accreditation Body (OAA). According to SENASA this latter laboratory is in the process of being accredited by OAA. Thus recommendation 5 in the 2008 FVO report has been largely addressed; in all cases residue testing methods are included in the laboratories respective scopes of accreditation, though not all methods used for the CREHA plan are accredited. However all have been validated and approved for use by DILAB. Thus recommendation 6 in the 2008 FVO report has been addressed; all methods are required to be validated according to national standards including Resolución No 138/2002, Disposición No 6/2004, and Disposición No 125/2006, the latter specifying in detail how within-laboratory validation should be performed (number of samples to be tested, spiking levels to be used, number of analysts, number of days on which validations are to be carried out, how CC-alpha and CC-beta are to be calculated etc). In general the approach taken is very similar to that described in Commission Decision 2002/657/EC; there is an agreed 30 day turnaround time from sample reception to the report of the result. For those samples deemed to be putative non-compliant (i.e. screening positive), a further 30 days is permitted for chemical confirmation. 5.2.2 On the spot visits in the laboratories The audit team visited three laboratories, DILAB and two privately owned facilities and noted that: 11
in each of the laboratories visited a computerised laboratory information management system was in place and the ownership of samples was unknown to the analyst; all of the samples taken under the CREHA plan had been submitted using the appropriate sampling forms and were adequately sealed and identified. Findings 5.2.2.1 DILAB Laboratory DILAB functions both as an NRL and also as a routine testing laboratory, being responsible for all of the testing of urine samples for Group A substances taken from live animals on farm. 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 last accreditation audit by OAA was carried out in December 2010. A number of minor non-conformances were noted in the OAA report and there was documentary evidence that corrective actions had been taken by the laboratory and approved by the OAA; there are nine chemical methods included in the scope of accreditation out of a total of 34 provided to the audit team. Three of the unaccredited methods have been submitted to the OAA and are due to be assessed on-the-spot during the forthcoming accreditation audit scheduled for October 2011. None of the commercially available radioimmunoassay (RIA)- based screening assays for stilbenes, steroids and beta-agonists are accredited. According to laboratory management it is planned to replace the RIA method with multi-analyte screening/confirmation by LC-MS/MS and, in the case of steroids, one such method is in the final stages of development; all of the samples taken from live animals on-farm (urine, serum and hair for anabolics and beta agonists) and additionally feed samples (for nitrofurans) are tested in DILAB. According to staff interviewed most of the samples are received between May and August however, it could be seen from the sample registration database that samples were received throughout the calendar year. The laboratory receives approximately 3,300 CREHA plan samples annually; there is a written procedure in place to deal with samples which are not suitable for analysis. It was seen that in such cases (approximately 10% of the total number of samples received), that the CREHA plan co-ordinator and the sampling officials had been informed in writing. Staff stated that the rate of sample rejection has been decreasing in recent years; in many cases selected at random by the audit team it was seen that samples were not screened within the 30 days target period. In some cases delays of up to two weeks were seen in the registration of samples in the laboratory (after receipt); staff have received training in analytical methods in several EU reference laboratories and have participated in international conferences and workshops on residues issues; the laboratory is well equipped with state of the art equipment including inter alia, HPLC- DAD/FL/UV, AAS, high resolution GC-MS, four GC-MS, four LC-MS/MS (and is in the process of acquiring a further five LC-MS/MS). The institute is in the process of expansion and the residues laboratory is due to move into a new facility by the end of 2013; there is an SOP in place for validation of analytical methods. This covers all of the requirements of Commission Decision 2002/657/EC including criteria for acceptance of 12
analytical results and robustness testing. With regard to CC-alpha and CC-beta, whilst these parameters are required to be calculated, they are not used as action limits. The limit of detection of the screening method (LOD) and limit of quantification of the confirmatory method (LOQ) are used (the instructions for calculation of which are laid down in Disposición No 125/2006); method SOPs and validation files for a number of analytical methods were examined by the audit team (zeranol (+ taleranol and alpha and beta-zearalenol) in urine by GC-MS, clenbuterol and mabuterol in liver by GC-MS, nortestosterone in urine by RIA); all were validated and, in the case of the MS methods, deuterated internal standards were used, four diagnostic ions were used for identification and estimates of CC-alpha and CCbeta had been calculated, the results of which were in line with the levels recommended by the EU Reference Laboratories; the validation file for the RIA method predated 2006. CC-beta had not been calculated, nevertheless the LOD of the method (0.37 ppb) is in line with what would be expected of this method; quality control charts are maintained for all methods. Positive (fortified blank samples) and negative (blank samples) are run in every assay. Control charts for 17 beta boldenone in urine by GC-MS, 17 alpha nortestosterone in urine by GC-MS, zeranol, taleranol and alpha and beta-zearalenol in urine by GC-MS, and clenbuterol and mabuterol in liver by GC-MS. All demonstrated that the methods had been in full statistical control; the laboratory has participated in 17 externally-organised proficiency tests for a range of residues and contaminants since 2008 to date with the vast majority having been completed satisfactorily; in its role as an NRL DILAB carried out four audits of other residue laboratories in 2010 and the same number in 2011. Audit reports were observed by the FVO audit team on-the-spot. These were extensive and very detailed in respect of the operation of approved methods and quality control criteria applied. Evidence was seen that deficiencies identified by the DILAB audit had been acted upon promptly; since 2008 DILAB had also organised 20 different proficiency tests for the laboratories in the network. These tests covered a wide range of analytes residues of veterinary medicinal products and contaminants. Evidence was seen that in those (relatively few) cases where laboratories had not performed satisfactorily, DILAB had actively followed this up and provided further samples for analysis. Findings 5.2.2.2 Private Laboratory A This laboratory is responsible for testing the majority (25,000 to 30,000 samples ~ 70%) of samples taken under the CREHA plan annually. Of 95 DILAB approved methods in place, two are currently within the scope of accreditation - nitrofuran metabolites in muscle and honey by LC-MS/MS. Five more methods are in the process of being accredited (they were examined on-the-spot by the OAA during an audit in June 2011). The audit team noted that: the laboratory is extremely well equipped in modern and spacious premises and has an extensive range of state of the art equipment including LC-MS/MS (6), GC-MS/MS (2), GC- ECD and FPD (7) and HPLC-DAD/FL/UV (13); 13