EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/8237/2006 MR Final FINAL REPORT OF A MISSION CARRIED OUT IN JAMAICA FROM 5 TO 11 JULY 2006 IN ORDER TO ASSESS THE PUBLIC HEALTH CONTROLS AND THE CONDITIONS OF PRODUCTION OF FISHERY AND AQUACULTURE PRODUCTS AND MARINE GASTROPODS 06/11/06-31643
TABEL OF CONTENTS 1. INTRODUCTION...3 1.1. Background...3 1.2. Trade and production information...3 1.3. Mission objective and proceeding...4 2. MAIN FINDINGS...4 2.1. Legislation...4 2.2. Competent authority...5 2.3. Official control...5 2.4. Laboratories...7 2.5. Sites visited by the mission team...8 2.6. Production of marine gastropods...9 3. GENERAL CONCLUSION...12 4. CLOSING MEETING...13 5. RECOMMENDATIONS...13 6. COMPETENT AUTHORITY RESPONSE TO RECOMMENDATIONS...14 ANNEX...15 2
1. INTRODUCTION 1 The mission took place in Jamaica from 5 to 11 July 2006. The mission team comprised three inspectors from the Food and Veterinary Office (FVO) and a national expert from an EU Member State. This mission was scheduled as part of the FVO s planned mission programme. 1.1. Background Two missions were carried out in Jamaica in 1999 (ref. XXIV/1085/99) and 2000 (ref. DG(SANCO)/1166/2000). These reports are available on the Internet at: http://ec.europa.eu/food/fvo/ir_search_en.cfm As result of these inspections, Jamaica is presently listed in part I of the Annex to Commission Decision 97/296/EC 2 and also listed in part I of the Annex to Commission Decision 97/20/EC as third country authorised to export fishery products (FP) and aquaculture products and marine gastropods (MG) respectively into the European Union (EU). The country is authorised to export FP and MG by the specific Commission Decisions 2001/36/EC and 2001/37/EC respectively. There were no Rapid Alerts in relation to such exports in recent years. 1.2. Trade and production information Imports of FP and MG from Jamaica at the time of the mission were authorised from a total of eight establishments and eight freezer vessels 3. The Jamaican competent authority (CA) stated that the total production exported to EU Member States in 2005 was 827 tonnes. These exports were composed of frozen conch (Strombus gigas) 600 tonnes, and fresh tilapia (Oreochromis spp) from aquaculture 227 tonnes. Jamaica exported conch to France, Martinique and Guadalupe. This gastropod feeds only on sea-grass (where some benthic toxic producing dinoflagellates - such as ciguatera producing ones - or other microrganisms, can be found). The harvesting area Pedro Banks, is a submarine plateau which lies approximately 70 kilometres south-west of Jamaica. According to the CA, the only possible source of human contamination is located in the Pedro Keys (3 inhabited small islands, where about 1000 fisherman live for three to four months of the year). The harvesting of conch takes place normally from January to July. The owners of the vessels are allocated a quota that, most of the times, is used before the end of the harvesting season. According to the CA, this was the case this year (all the quotas have been used) and, as it usually happens, the harvesting of conch is to be resumed in January/February of the following year. 1 2 3 A list of abbreviations and special terms is drawn up in the Annex of this report. Legal acts quoted in this report refer, where applicable, to the last amended version. Full references to the acts quoted in this report are given in the Annex. List of establishments last amended on 8.3.2006 3
Divers work from 10 to 20 metres where they break the top of the conch shell and, with a knife, cut the conch. Only the rest of the body is put into bags and brought up to the vessel. On board of the vessel, the hepatopancreas and the base of the foot are removed, before freezing the remaining part of the conch. 1.3. Mission objective and proceeding The objective of the mission was to assess whether the CA is capable of guaranteeing that the special conditions governing imports into the EU of FP and MG originating in Jamaica, as laid down in Commission Decisions 2001/36/EC and 2001/37/EC, are met. The evaluation covered the whole FP and MG production chain involved in the export to the EU. In pursuit of this objective, the mission team proceeded as follows: an opening meeting was held on 5 July with the CA. At this meeting the inspection team confirmed the objectives of and itinerary for, the mission and requested additional information required for its satisfactory completion; the following sites were visited: 2. MAIN FINDINGS COMPETENT AUTHORITY VISITS / MEETINGS Central Competent authority 2 LABORATORY VISITS Fishery Products and Marine 2 Gastropods PRIMARY PRODUCTION Vessels 5 Aquaculture farms 1 Tilapia farm Landing site 2 FOOD PROCESSING FACILITIES Establishments 8 One tilapia, one shrimps, one lobsters and 5 conch establishments representatives of the CA accompanied the inspection team during the whole mission. 2.1. Legislation The Aquaculture, Inland and Marine Products and By-products Act 1999 is the law governing the production, storage and transport of FP and MG. The Aquaculture, Inland and Marine Products and By-products Regulation 2000 lays down the specific hygiene conditions for FP and MG. These two main legal texts constitute the legal bases that enable the CA to carry out controls on FP and MG and for Food Business Operators (FBOs) to produce FP intended for national market or for export. This legislation applicable to FP and MG exports to the EU contains most of the essential provisions and principles included in Community legislation. However, these legal provisions are not fully in line with all Community standards as the mission team noted in particular the following discrepancies: 4
- There are no equivalent requirements to those set out in Commission Regulation (EC) No 466/2001. In particular, there are no limits fixed for cadmium and lead in the Jamaican national legislation. - Although requested by the mission team, the CA did not provide any evidence that Jamaica has legislation covering water for human consumption equivalent to Council Directive 98/83/EC. 2.2. Competent authority 2.2.1. Structure, organisation, competencies The Central Competent Authority (CCA) is the Veterinary Services Division (VSD) under the Ministry of Agriculture and Lands. At establishment level public health inspectors from the Ministry of Health carry out routine inspections under the supervision of the VSD officials. Staff performing official controls, laboratory staff and establishment staff met during the mission have a very limited knowledge/awareness of relevant Community standards. 2.3. Official control 2.3.1. Approval procedure Establishments intending to export to the EU must submit an application to VSD for approval. Officials from VSD visit the establishments. A standardised checklist is used covering structure, hygiene conditions, Good Management Practice (GMP) and Hazard Analysis Critical Control Points (HACCP). If an establishment complies with the requirements, an export code number is allocated and the CCA issues an approval certificate to export which is valid for one year. 2.3.2. Checks and inspections The CCA has established a general programme for the supervision of production of FP and MG intended for export to the EU, which includes authorisation, inspection and reporting procedures and the use of the checklist referred to above. FP establishments are visited by public health inspectors from the Ministry of Health on a daily basis when production takes place. A standard checklist is filled out every day. VSD officials carry out establishment audits at least quarterly. However, the mission team identified shortcomings in establishments visited neither reported by VSD nor by public health officials. These frequency targets of visits had been achieved by the CA in all establishments visited by the mission team. Files (approval certificates, inspections reports, official sampling results, etc.) related to establishments approved for export to the EU were in general available at CA headquarters and in the establishments themselves. However, although investigated by the mission team, copies of the VSD audit reports were not available at the establishments. HACCP plans are assessed and approved by the CA for their suitability before approving establishments. However, some discrepancies and a lack of consistency were noted in the HACCP plans of the establishments visited 5
(setting up of certain critical limits which exceed levels foreseen in Community legislation, no monitoring of the determined CCPs). Samples for official control are taken regularly over time (these include samples of water and FP). Typically, these samples are tested for microbiological parameters and heavy metals (lead and cadmium). However, mercury is not yet included, as prescribed in Annex III, Chapter II to Regulation (EC) 854/2004 of the European Parliament and of the Council and Annex I, Section III to Commission Regulation (EC) No 466/2001. Furthermore, the official in charge of the establishment does not receive the laboratory result in due time to take the necessary actions (heavy metals, contaminants, marine biotoxins) as these results are reported yearly at the end of the harvesting season. Fishing vessels that provide fish to establishments intending to export to the EU are inspected by VSD officials at the time of landing. A checklist is used to inspect fishing vessels. No official control is carried out in most of the establishments visited to control the quality of the water used. When official samples of water for human consumption are taken (most of the times only for total coliform research), the standards used are not in line with those of Council Directive 98/83/EC. 2.3.3. Sampling and special checks a) Organoleptic checks Official organoleptic checks are carried out at all stages of production, processing and distribution, as set out in Annex III, Chapter II to Regulation (EC) No 854/2004 of the European Parliament and of the Council. b) Other checks required in Annex III, Chapter II to Regulation (EC) No 854/2004: Official checks regarding contaminants are carried out but not as is prescribed by Commission Regulation (EC) No 466/2001. Mercury is not tested (cf. see above). Limits for cadmium and lead above those established in the above mentioned Community regulation. Microbiological analyses are carried out as on a regular basis. Parasite checks are carried out. c) No official checks are carried out to test for the level of sulphites in shrimp (European Parliament and Council Directive 95/2/EC). The 2006 Jamaican residue national plan for aquaculture was assessed by the relevant Commission services. Deficiencies were identified in relation to the implementation of the requirements of Council Directive 96/23/EC. A deadline of two months has been given by those services to correct the deficiencies detected. 2.3.4. Official certification Export health certificates are serially numbered. Officials from VSD are authorised to sign the certificates. 6
The certificates comply in format with all the requirements of Decision 2001/36/EC. 2.4. Laboratories The mission team visited two laboratories, the VSD laboratory and the University of the West Indies (UWI) laboratory. The mission team observed that the VSD laboratory for biotoxins control performs only the extraction of the samples for Paralytic Shellfish Poisoning (PSP) and lipophilic toxins (LT) (extracted samples are sent to UWI laboratory to perform the mouse bioassay), and VSD also do the complete analysis of ASP. The laboratory does not have a tracking system for the control of analyses and of results. They have draft Standard Operating Procedures (SOP), and there was no evidence of in-house quality controls. During the visits to these laboratories performing analyses of samples taken during official controls, the mission team noted that they: have the equipment/facilities to perform the required testing methods; have a sufficient number of staff. However, the mission team noted a lack of knowledge of the analyses methods recommended or prescribed by the relevant Community standards; have SOP for most of the testing methods; are not yet accredited according to the standard ISO 17025, although the majority of the documentary requirements for accreditation to ISO 17025 standards are currently being implemented as part of the quality system; do not have, in some cases (e.g. biotoxins), quality controls in place; follow testing methods that were not compared/validated against the Community reference testing methods (e.g. microbiological analyses of water and conch), as prescribed in Annex II, Chapter II to Regulation (EC) No 854/2004 of the European Parliament and of the Council; do not always define the characteristics of the methods of analyses (according to the requirements of Annex III to Regulation (EC) No 882/2004 of the European Parliament and of the Council); do not participate in proficiency tests with other laboratories in Jamaica or abroad, even for physicochemical contaminants; do not follow the performance criteria for heavy metals (Commission Directive 2001/22/EC). The laboratories are not yet accredited, although the majority of the documentary requirements for accreditation to ISO 17025 standards are currently being implemented as part of the quality system. However, methods have not been completely validated. Proficiency tests are not carried out for physicochemical parameters. 7
2.5. Sites visited by the mission team 2.5.1. Fishing vessels Jamaica has eight freezer vessels authorised to export directly to the EU. Five freezer vessels and two landing sites were visited by the mission team. These freezer vessels transport the conch from the harvesting areas to the landing sites. From a general point of view, these freezer vessels were in a good state of maintenance and cleanliness; furthermore, they had adequate facilities and equipment, for the proper handling and storage of conch. However, storage holds are not equipped with a temperature-recording device as is required in Annex III, Section VIII, Chapter I, part I. C (2) of Regulation (EC) No 853/2004 of the European Parliament and of the Council. 2.5.2. Establishments processing fishery products The mission team visited all eight establishments approved to export FP to the EU: Shrimp establishment: this establishment processing shrimps from aquaculture was found to be in compliance, but with minor deficiencies. This establishment has not yet exported to the EU. Lobster establishment: it was not in operation at the time of the visit. This establishment presented good layout and structure to process lobsters. This establishment has not yet exported to the EU. Tilapia establishment: this establishment processes fresh tilapia from aquaculture. It was found to be only partially compliant as some maintenance was not done. Storage conditions in cold store could also be improved. Marine gastropods establishments: the mission team visited the five establishments approved for export to the EU. At the time of the visit only one out of five was in operation (as this is a seasonal activity). The one in operation was in compliance with Community requirements. The four establishments visited not in operation, were in general compliant with minor deficiencies mainly related to structure maintenance. Cold stores in most of the establishments visited are not equipped with a temperature-recording device as is required in Annex III, Section VIII, Chapter III, part B of Regulation (EC) No 853/2004. With regard to own-checks as prescribed in Annex I, Sections 7 and 8, Chapter V, to Regulation (EC) No 853/2004 of the European Parliament and of the Council, the mission team noted the following: Microbiological checks were not carried out in the establishments visited as part of own-checks programme as is required in Article 4 paragraph 3 (a) and (e) of Regulation (EC) No 852/2004 of the European Parliament and of the Council and Commission Regulation (EC) No 2073/2005; Organoleptic checks of incoming fish were carried out taking into account various criteria for freshness; Checks for sulphites are not made in establishments where crustaceans are processed; 8
Water and sometimes ice were checked. However, analyses are not carried out in accordance with the standards of Directive 98/83/EC; No marine biotoxins tests are carried out on MG to determine that their levels in final product are in accordance with those prescribed in Annex III, Section VII, Chapter V to Regulation (EC) No 853/2004; Cleaning and disinfection of surfaces and equipment using authorised substances were carried out. Efficacy of cleaning and disinfection was verified by swab tests; Pest controls were performed; Staff training had been carried out in the establishments visited. 2.6. Production of marine gastropods 2.6.1. Follow up of the previous mission recommendation From the five recommendations addressed to the CA in 2000 FVO mission report, three of them have been clearly dealt with (although not fully implemented): 1) the parameters and trigger levels for switching from the periodical to the intensive monitoring programme; 2) the criteria for the closure and re-opening of production areas; and 3) the use of the Diarrheic shellfish poisoning (DSP) bioassay method suggested by the Community Reference Laboratory for Marine Biotoxins. However, no evidence was produced as regards to the classification of the production areas and regarding the period of time between the receipt of the sample and the availability of results in the case of biotoxins analyses (see below). 2.6.2. Classification and microbiological monitoring Although requested by the mission team, the CA provided no evidence to the mission team of the classification of the Pedro Banks. Furthermore, there is no inventory of the sources of pollution of human or animal origin likely to be a source of contamination, there is no examination of the quantities of organic pollutants which may be released during the different periods of the year and there is no determination of the circulation of pollutants for the Pedro Banks. The only information made available, at the time of the mission, relates to: a) microbiological analyses (Staphylococcus aureus, Pseudomonas, Enterobacter spp.) and heavy metals analyses (chromium, lead) of seawater, and b) heavy metals analyses (copper, cadmium, lead, cobalt), and pesticides analyses of conch, all performed in 1998 and not repeated thereafter. These analyses do not cover E. coli 4 as required by the relevant Community standards for the production area classification and the classification of the Pedro Banks with its five sub-areas classified as "A areas" has never been reviewed. Inspectors collect samples of conch upon landing by freezer vessels, and at the processing establishments. However, although requested by the mission 4 Or even faecal coliforms, as required at the time under the now repealed Council Directive 91/492/EEC. 9
team, no evidence had been provided by the CA that samples had been taken by staff performing official tasks at the Pedro Banks. Furthermore, the results of analyses seen by the mission team do not indicate the sampling point or do not describe the sample, i.e. all body of conch, raw material or end product. The results of E. coli analyses of conch are not precise enough as they are expressed by "gram" and not by "100 grams" (as required in Annex I, Chapter I, Food Safety Criteria, to Regulation (EC) No 2073/2005). Although it has been included in the Programme for the Monitoring of Production Areas for Fishery Products (PMPAFP), no mercury analysis has been performed since 2001. Results of cadmium analyses performed in 2005 showed values within the maximum limits of Annex I, Section III to Regulation (EC) No 466/2001. 2.6.3. Monitoring of plankton According to the programme for the monitoring of production areas for MG, the frequency of sampling of seawater and analysis of dinoflagellates is monthly in normal circumstances and weekly for intensive sampling. However, during the visit to the UWI laboratory, the mission team was informed that: samples of the water column were taken but no investigation took place of the bottom of the Pedro Banks, including in the sea-grass eaten by conch; under a joint research project with VSD, which took place in 2001and 2002, UWI sampled seawater and analysed for the presence of toxic plankton. After that, in 2005, only two seawater samples had been analysed and revealed the dominance of diatoms, with very few dinoflagellates (up to 100 per litre). In 2006, only 6 seawater samples have been analysed, which confirmed the conclusions of the previous year; from this partnership, the CA concluded that there is a presence of Pseudo-Nitzschia sp. that may cause domoic acid (DA) intoxications, although they have never checked if this dinoflagellate actually produces DA in Jamaica (even if, as mentioned in the study, the cell count is within acceptable limits). They do not describe the presence at all of other potentially toxic plankton; there is currently a trained expert capable of analysing any sample that arrives at the laboratory. the plankton analysis results exceeding the maximum limits (when available) are not used by the CA to close the harvesting area(s). 2.6.4. Monitoring of marine biotoxins According to the programme for the monitoring of production areas for MG, the frequency of sampling of conch and analysis of biotoxins is defined as monthly, in normal circumstances, and three times per week for intensive sampling. However, during the visit to the UWI laboratory, the mission team was informed that samples collected over the year are usually pooled and sent by the VSD once a year to the UWI laboratory (where PSP and LT analyses are carried out). During the visit to the UWI laboratory, the mission team noted that: 10
a) For Paralytic Shellfish Poisoning (PSP) The mouse bioassay protocol used for PSP toxins permits the identification of saxitoxins and analogues. PSP analyses have always shown negative results, which however indicated no dates of analyses (45 analyses in 2003, 148 analyses in 2004, 34 in 2005, and 26 in 2006). the commercial PSP standard test in use is of low quality and cannot be considered as fit for the purpose. b) For Lipophilic Toxins (LT) The mouse bioassay protocol used for LT permits the identification of Okadaic Acid and dinophisistoxins (Yasumoto, 1978). However, this protocol does not rule out the presence of Azaspiracids, Yessotoxins (YTX), and Pectenotoxins as there is no differential extraction and determination of the time at which the mice died, two tests which would allow the detection of YTX. The analysis for LT is carried out only on the conch's hepatopancreas (which is discarded by fishermen), but not on the rest of the body. A few LT analysis have been performed, which however indicated no dates of analyses or any other traceable information: six analyses in 2003 (two of which were positive), 5 analyses in 2004 (all of which were positive), 33 analyses in 2005 (all of which were reported as "not detected), five analyses in 2006 (three of which were positive). However, for these results, which were claimed to be false positives, the presence of other toxins such as ciguatera cannot be ruled out, since MG feed on sea-grass, and ciguatera are liposoluble, in a similar fashion as LT. According to the information presented to the mission team, since 2003 the results suggest either the presence of LT or incomplete extraction of solvent from the extract. However, no follow-up or corrective action had been taken by the CA and the product continued to be exported to the EU. c) For Amnesic Shellfish Poisoning (ASP) During the visit to the VSD laboratory the mission team noted that: the High Performance Liquid Chromatography (HPLC) protocol used for ASP permits the identification of DA (Quilliam); there is no in house validation of the HPLC method in use for the testing of ASP; there are no results of ASP from 2000 to 2004, and no ASP had been detected in any of the 16 samples analysed in 2005; there is no written evidence of the analyses carried out in the laboratory, no quality control sheet, or any other quality control. The biotoxins analysis results exceeding the maximum limits (when available) are not used by the CA to close the harvesting area(s). 11
3. GENERAL CONCLUSION The Jamaican standards applicable to export FP to the EU are not fully equivalent to the relevant Community requirements (cf. 2.1.). The presence of certain deficiencies in some establishments not reported by officials, indicate an insufficient knowledge of Community standards. Furthermore, establishments HACCP are not assessed on the basis of HACCP principles, as they are described in Article 5 of Regulation (EC) No 852/2004. In addition, the CA does not pay sufficient attention to the completion of corrective actions by export-approved establishment FBOs in due time to correct deficiencies, especially with regard to the own-checks, recorded in VSD audit visit reports. VSD and public health officials did not react adequately when analysis results were not in conformity with Community standards. No official control is carried out in most of the establishments visited to control the quality of the water used. When checked the standards used were not in line with those of Directive 98/83/EC. Official control of FP as such is not carried out in accordance with Annex III, Chapter II to Regulation (EC) No. 854/2004, in particular, regarding contaminants. No official control to check the level of sulphites in shrimp is carried out (Directive 95/2/EC). The laboratories visited by the mission team do not have the appropriate quality controls and do not always follow the required Community reference testing methods for the analyses of conch. FBOs cannot guarantee that final product is in accordance with Community standards due to the lack of own-check analyses (water, sulphites, biotoxins, microbiology, etc). Sampling of seawater (for the detection of toxic plankton) and conch (for the detection of biotoxins) is programmed, is supported by standard SOP used in the analysis of marine gastropods and is based on an acceptable geographical distribution (where harvesting of conch usually takes place). In relation to the harvesting of conch in the area of Pedro Banks, Jamaica does not follow the requirements of Annex II, Chapter II to Regulation (EC) No 854/2004, as: the mission team saw no study on the basis of which the Pedro Banks harvesting area had been classified or revised after 2000; samples taken over the harvesting season are not periodically analysed but pooled and sent to the laboratory once a year; the plankton and biotoxins analysis results exceeding the maximum limits (when available) are not used by the CA to close the harvesting area(s); there is no risk assessment study to define whether a weekly sampling of MG to test for marine biotoxins should take place or whether a different sampling frequency could be justified (as required in Annex II, Chapter II, point B (5) to Regulation 854/2004). Therefore, the current sampling programme in place by the CA cannot be considered as satisfactory. 12
The contaminants (e.g. heavy metals), microbiological, plankton and the biotoxins monitoring programmes put in place do not allow the CA to demonstrate that conch is safe for human consumption. However, the 2006 MG harvesting season finishes officially on 31 July and, at the time of the visit, most of the establishments processing MG were not in operation as they have exceeded their harvesting quota. Therefore, the risk for consumer health to be affected by MG imported from Jamaica in the EU is not likely to occur until the next harvesting season. 4. CLOSING MEETING A closing meeting was held on 11 July 2006 with representatives of the CA. At this meeting, the main findings and conclusions of the mission were presented by the inspection team. The CA representatives did not express any major disagreement, and expressed their willingness to address all deficiencies noted. The CA also undertook to a) start a weekly sampling regime soon after the mission and to set up a new MG monitoring programme before resuming the export to the EU (the harvesting season is to resume in January 2007), and b) to send to the Commission services the revised MG monitoring programme. 5 5. RECOMMENDATIONS The CCA should provide Commission services with an action plan, including a timetable for its completion, within 25 working days of receipt of the report, in order to address the following recommendations: 5.1. The CA should provide appropriate guarantees that the Jamaican standards applicable to FP and MG exports to the EU are fully equivalent to Community standards as is established in Article 48 of Regulation (EC) No 882/2004. 5.2. The CA should ensure that VSD officials and public health inspectors with responsibilities in control of establishments approved to export to the EU have adequate knowledge of Community standards, as required by the health certificates annexed to Commission Decisions 2001/36 and 2001/37. 5.3. The CA should ensure that, when assessing export-approved establishment HACCP, this assessment is based on the HACCP principles as they are described in Article 5 of Regulation (EC) No 852/2004. 5.4. The CA should ensure that corrective actions are taken by export-approved FBOs in due time to correct establishment deficiencies, especially with regard to the own-checks, reported by VSD. 5.5. The CA should ensure that appropriate actions are taken by officials in due time when unfavourable analysis results are reported by the laboratories. 5.6. The CA should ensure that potable water (as described in Directive 98/83/EC) is to be used to ensure that food-stuff are not contaminated as required in Annex II, Chapter VII of Regulation (EC) No 852/2004. 5 In their letter dated 27 July 2006, the Jamaican CA forwarded a draft action plan, containing corrective actions already undertaken or to be undertaken, addressing most of the deficiencies identified during the mission, and especially those related to MG production. 13
5.7. Monitoring arrangements should be set up to control the level of contaminants in FP and MG in line with the standards of Regulation (EC) No 466/2001. 5.8. Official checks should be carried out to test that levels of sulphites in crustaceans are not above those fixed in Directive 95/2/EC. 5.9. Laboratories, designated by the CA to perform analyses as part of official controls should be in line with Article 12 of Regulation (EC) No 882/2004 (taking into account Article 18 of Commission Regulation (EC) No 2076/2005). 5.10. In the context of official controls, the CA should use analyses methods that comply with relevant Community rules, in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004. In particular, this concerns methods used regarding contaminants (Commission Directive 2001/22/EC), marine biotoxins (Annex III to Commission Regulation (EC) No 2074/2005) and E. coli (Annex I, Chapter I, Food Safety Criteria, to Regulation (EC) No 2073/2005). 5.11. The CA should ensure that only MG for human consumption that meet the microbiological criteria and the health standards laid down in Annex I to Regulation (EC) No 2073/2005 and Annex III, Section VII, Chapter V, to Regulation (EC) No 853/2004 respectively, are presented by FBOs for export certification. 5.12. The CA should ensure that the production of MG intended for export to the EU undergo official controls as described in Annex II, Chapter II, to Regulation (EC) No 854/2004 for the classification and monitoring of the relevant production areas. 6. COMPETENT AUTHORITY RESPONSE TO RECOMMENDATIONS The competent authority s response to the recommendations can be found at: http://ec.europa.eu/comm/food/fvo/ap/ap_jamaica_8237_2006.pdf. 14
ANNEX 1. Abbreviations and special terms ASP Amnesic shellfish poisoning CA/s Competent Authority/ies CCA Central Competent Authority DA Domoic Acid CRL Community Reference Laboratory DG SANCO Health & Consumer Protection Directorate General DSP Diarrheic shellfish poisoning EU European Union FP Fishery Products FBO/s Food Business Operator/s FVO Food and Veterinary Office GMP Good Manufacture Practices HACCP Hazard Analyses Critical Control Point HPLC High Performance Liquid Chromatography ISO International Standard Operation LT Lipophilic toxins MPN Most Probably Number MG Marine Gastropods PMPAFP Programme for the Monitoring of Production Areas and Fishery Products PSP Paralytic Shellfish poisoning SOP Standard Operating Practices UWI University of the West Indies VSD Veterinary Services Division YTX Yessotoxins 2. Community Acts quoted in the report European legislation Official Journal Title Council Directive 91/492/EEC OJ N L268, 24.9.1991,p. 1 Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs. European Parliament and Council Directive 95/2/EC OJ N L 61, 18.3.1995, p. 1 European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners. Council Directive 96/23/EC OJ N L 125, 23.5.1996, p. 10 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. Commission Decision 97/296/EC Commission Decision 97/20/EC OJ N L 122, 14.5.1997, p.21 OJ N L 06, 10.1.1997, p. 46 Commission Decision 97/296/EC of 12 April 1997 drawing up the list of third countries from which import of fishery products is authorised for human consumption. Commission Decision 97/20/EC of 17 October 1996 establishing the list of third countries fulfilling the equivalence conditions for the production and placing on the market of bivalve molluscs, echinoderms, tunicates and marine gastropods. Council Directive 98/83/EC OJ Nº L 330, 5.12.1998, p. 32 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Commission Decision 2001/36/EC OJ Nº L 10, 13.1.2001, p. 59 Commission Decision 2001/36/EC of 22 December 2000 laying down special conditions governing imports of fishery products originating in Jamaica. 15
Commission Decision 2001/37/EC Commission Regulation (EC) No 466/2001 Commission Directive 2001/22/EC Regulation (EC) No 852/2004 of the European Parliament and of the Council Regulation (EC) No 853/2004 of the European Parliament and of the Council Regulation (EC) No 854/2004 of the European Parliament and of the Council Regulation (EC) No 882/2004 of the European Parliament and of the Council Commission Regulation (EC) No 2073/2005 OJ Nº L 10, 13.1.2001, p. 64 OJ N L 77, 16.3.2001, p. 1 OJ N L 77, 16.3.2001, p. 14 OJ N L 139, 30.4.2004, p. 1 Corrected and re-published in OJ No. L 226, 25.6.2004, p 3 OJ L 139, 30.4.2004, p. 55 Corrected and re-published in OJ N L 226, 25.6.2004, p 22 OJ N L 139, 30.4.2004, p. 206 Corrected and re-published in OJ N L 226, 25.6.2004, p 83 OJ N L 165, 30..4.2004, p 1 Corrected and re-published in OJ N L 191, 28.5.2004, p. 1 OJ N L 338, 22.12.2005 p 1 Commission Decision 2001/37/EC of 22 December 2000 laying down the special conditions governing imports of marine gastropods originating in Jamaica. Commission Regulation (EC) No. 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs. Commission Directive 2001/22/EC of 8 March 2001 laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs. Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. Commission Regulation (EC) No 2074/2005 Commission Regulation (EC) No 2076/2005 OJ N L 338, 22.12.2005 p 27 Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implemented measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No. 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No. 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004. OJ N L 338, 22.12.2005 p 83 Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004. 3. Legal basis for the mission The mission was carried out under the general provisions of Community legislation and, in particular: Article 46 of Regulation (EC) No 882/2004; Commission Decision 98/140/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries (OJ N L 38, 12.2.1998, p. 14). 16