DG(SANCO)/ MR

Transcription

1 1 Ensure that sampling is unforeseen and unexpected and that the sampling is not clustered, i.e. that the actual sample numbers are reflected in the national residue control plan to ensure that the national residue control plan provides guarantees equivalent to those under Annex III and Chapter 3 of Annex IV to Council Directive 96/23/EC. 2 Ensure that all of the analytical methods used for official residue samples are: (i) validated to a standard equivalent to that required by Article 3 of Commission Decision 2002/657/EC and are (ii) demonstrably fit for purpose. The previously proposed National Residue Control Plan (NRCP) for 2010 has been reorganized to overcome the deficiencies identified by the Mission during their visit. In the reformed NRCP, the actual numbers of sampling has been accommodated which will be equivalent to the planned individual testing parameters taken into consideration. The sampling procedure will ensure to be unforeseen and unbiased involving both the Inspector of FIQC and Local Competent Authority (i.e. SUFO/UFO) and avoiding prior information to the concerned farmers in advance. It is expected that the reorganized sampling plan for National Residue Control Plan-2010 will comply with Annex III and Chapter 3 of Annex IV to Council Directive 96/23/EC. A central level Policy Guideline for planning and implementation of the NRCP is under preparation which will be approved and circulated to the regional authorities within a short period of time. FIQC Laboratories: a. The FIQC Laboratory, Dhaka has completed the method validation of Chloramphenical and Nitrofuran metabolites for shrimp matrix as per requirement of the Article 3 of Commission Decision 2002/657/EC and is demonstrably fit for purpose. It is also expecting that the method validation for the dyes and anthalmintics will be completed within December The required method validation of Chloramphenical and Nitrofuran metabolites for fish and feed matrices are expected to be completed within April, b. It is planned by the Competent Authority that all the tests (for NRCP and Pre-export) which could Page: 1

2 be done by ELISA will go for screening test first. The samples found to have positive results of contaminants will be sent to LC-MS/MS at Dhaka FIQC Lab for micro level quantification. c. The UNIDO International Consultant (Laboratory Technical Adviser) prepared plans for the validation process for ELISA at Khulna and Chittagong regional FIQC Labs. Accordingly the test method selection, SOP for the validation and method validation guidelines of the quality management system has been drafted. Laboratory teams have already started work on validation of different parameters and expect to complete validation between April and June BCSIR Laboratory: BCSIR confirmed that Tetracycline and Oxytetracycline method validation has been completed but the Chlortetracycline method validation needs to be verified. Verification for Chlortetracycline method validation is underway; hopefully it will be completed by end of March BAEC Laboratory: BAEC Authority informed that methods for analysis of heavy metals using Atomic Absorption Spectrometer are validated according to Eurachem guide and are fit for the purpose. BARI Laboratory Authority (responsible for the testing of pesticides) informed that they are working to validate methods for the testing parameters and the validation is expected to be finalized by December Accordingly it is expected that all of the analytical methods used for sample analysis will be: (i) validated to a standard equivalent to that required by Article 3 of Commission Decision 2002/657/EC Page: 2

3 3 Ensure that the there is sufficient analytical equipment in place and an appropriate number of adequately trained laboratory staff in order to satisfy the analytical and quality control requirements of delivering both the national residue control plan and preexport testing programme in order to offer guarantees with an effect equivalent to that provided for by Article 29 of Council Directive 96/23/EC. 4 Ensure that a consistent policy of correcting for analytical recovery for residues of veterinary medicinal products is and (ii) demonstrably fit for purpose within December DoF has already initiated procurement of one more LC-MS/Ms machine and one GC-MS/MS machine along with other required supporting equipment and standards to strengthen the FIQC Laboratory. A reformed organogram of the FIQC manpower is under consideration for approval. A proposal has been placed to the higher authority to reorganize the posting of trained and skilled manpower at respective FIQC labs and to involve some new competent officers to build Chlorqamphenical and Nitrofuran metabolites for shrimp matrices them up as skilled laboratory analysts under the FIQC future career plan. BAEC: For analysis of heavy metals, three analysts (two analytical chemist) and three trained laboratory staff are involved and three Atomic Absorption Spectrometers (Graphite, Flame and Hydride-Generation) are used to fulfill the analytical requirements. As internal quality control measures, they run blank, duplicate samples, spike samples and control samples in every analytical run and maintain control charts. BARI: The BARI Lab authority informed that they have sufficient analytical equipment for pesticide residue analysis. FIQC: FIQC laboratory, Dhaka has adopted a policy to correct analytical recovery for antibiotic test methods which will assure the comparability of results and increase confidence in laboratory performances in line with the rules set in Commission Decision 2002/657/EC. A similar policy will be followed for correct analytical recovery of the remaining test parameters when their method Page: 3

4 implemented in all of the laboratories in order to assure comparability of results and increase confidence in laboratory performance in line with rules set in Commission Decision 2002/657/EC. 5 Ensure the use of appropriate internal and external quality control measures in the laboratory network in order to provide guarantees on analytical performance equivalent to those laid down in Article 5 of Commission Decision 2002/657/EC. In particular these internal quality control measures should include running negative and positive control spiked samples in every analytical run validation will be completed. In the FIQC lab at Chittagong and Khulna, the policy is already included in the quality management system of the laboratory. The preparation on correcting for analytical recovery for residue of veterinary medicinal products is underway and is planned to be commenced in May 2010 right after most of the test methods have been validated. BARI: The percent recovery for pesticide residue analysis varies from FIQC Dhaka: The laboratory has a plan to implement a policy for internal quality control and for external quality control measures such as proficiency testing. Lab authority has already started communication with FAPAS for participating in proficiency tests. FIQC (Chittagong/Khulna): The overall guideline for the internal and external quality control measures has already been included in the quality management system of the laboratory. Detailed SOP and quality control plan would be prepared for consistent implementation and expected to be received in two weeks time. Calibration of measuring equipment has already been requested to the National Metrology Laboratory under BSTI. Page: 4

5 at appropriate spiking levels, maintenance of control charts, adoption of a harmonized approach for the acceptance or rejection of analytical results. External quality control measures should include participation of the laboratory network in proficiency tests or inter-laboratory comparisons for residues of veterinary medicinal products in food of animal origin. 6 Ensure that laboratories involved in carrying out official residues testing (both NRCP and pre-export) will be accredited to ISO before the end of 2012 in order to increase confidence in the reliability of results and provide guarantees equivalent to those foreseen in BAEC: For external quality control measures, BAEC informed that they have a plan to participate in proficiency tests or inter-laboratory comparisons within this year. FIQC Dhaka: The quality manual of FIQC Laboratory, Dhaka is in draft form. Hope that in this year it will be finalized but needed to involve an external expert to check all the documents whether these are up to the mark of ISO Standards or need to have some revisions. FIQC Laboratories (Chittagong and Khulna): Gap analysis of the FIQC two laboratories have been conducted by QSDT composed of FIQC and BQSP. The gap report has clearly revealed that there are structural problems and technical gaps in the laboratory. The (organizational) structural problems including the need for restructuring, allocation of adequate manpower, empowerment of FIQC (in terms of recruitment and procurement) are planned to Page: 5

6 the EU Member States as described in Article 5 of Commission Decision 2002/657/EC and Point 1.2. of the Annex to Commission Decision 98/179/EC. be addressed at DOF level with the technical support of UNIDO (through BQSP and the upcoming BEST project). The technical gaps are to be tackled under the ownership of the DD FIQC with technical support from BQSP/UNIDO. As it has already mentioned in response to the recommendation 3, DoF has already begun to reorganize the manpower to increase the competency and reliability of lab testing protocols. Addressing the technical gaps has commenced and progressing very well. The Quality Manual is scheduled to be completed by April, Related SOPs, instructions and forms are in the process of preparation. The combination of the endeavourer to address the technical and structural gaps will enable the FIQC laboratory to be accredited by BAEC: As they have completed their quality manual and related documents, they expect that BAEC laboratory will be accredited to ISO before the end of But they expressed their need to involve an external expert to check all the documents whether these are up to the mark of ISO standard or need to have some revision. 7 Review and clarify the current national framework governing the use of antibiotics in aquaculture production and, if such use is permitted, ensure that testing for residues of the most commonly used antibiotics The current national framework governing residue control suffer from insufficient legal authority to impose controls on the use of antibiotics in aquaculture fish/shrimp feed or imported feed ingredients. Government initiated a massive awareness campaign and motivational training of all stake holders in the value chain to prevent use of hazardous antibiotics but lack appropriate regulatory control of importers, manufacturers and distributors of fish feed and VMPs. Recently Parliament has approved the Fish Feed and Animal Feed Act 2010 and Hatchery Act These two Acts will enable FIQC to set the safety and quality standard of feed and make it obligatory for Fish Feed Business Page: 6

7 is included in the national residues control plan in order to provide guarantees with an effect equivalent to those foreseen by Article 7 of Council Directive 96/23/EC. 8 Improve the effectiveness of follow-up investigations on farm when non-compliant results have been detected, in order to provide guarantees with an effect at least equivalent to that described in Articles 16-19, 22 and 23 of Council Directive 96/23/EC. Operators (FBOs) to maintain that standard under the registration and licensing process of all in the value chain. The successful enforcement of the newly passed Acts and regular monitoring by FIQC, DLS and BDA is expected to be successful in imposing the required control over the use of antibiotics from producer/importer level to farmers/users level. FIQC will investigate and review the distribution and use of different antibiotics, VMPS and medicated feedstuffs from the retail outlets to the farmer s door and will try to trace back the producers, wholesale /distributors of the concerned products. After reviewing, if any new banned or restricted drug item found, necessary administrative measures will be introduced to ensure control through the BDA and FIQC regulatory framework. If any essential drug item needs to be allowed in addition to the existing approved drugs list, it will be included in the list with admissible limit (MRL) in FIQC rules and obviously taken into consideration under NRCP in order to provide guarantees with an effect equivalent to those foreseen by Article 7 of Council Directive 96/23/EC. The follow-up investigation on farm had been improved as per recommendations of the EU FVO Missions with more involvement of the LCA (SUFO/UFO). Particularly, follow up investigation hascontinued to trace back the sources of contamination and corrective action had been taken to avoid further such contamination risks. Similar follow-up investigation and required corrective action has been taken when non-compliances has been detected for any instances for RASFF, NRCP and preexport test results. Since three years Government has addressed the problem of antibiotic contamination in shrimps and non-compliance identified by analysis of NRCP and Pre-export samples as well as RASFF Notifications received from EU. During last 2 years, government has made extensive efforts to identify the sources and routes of the antibiotic contaminations in shrimp/fish. Page: 7

8 9 Improve the effectiveness of controls on the retail sale of veterinary medicinal products and medicated feeding stuffs in order to support the guarantees offered by the national residue control plan thus providing guarantees at least equivalent to those foreseen in Council Directive 96/23/EC. 10 Ensure that all aquaculture farms producing fin fish or shrimp for the EU market are registered under a system allowing adequate traceability in line with Article 6 (2) of Regulation (EC) No 852/2004. Department of Fisheries already has requested BDA and DLS to increase their field staff and strengthen field monitoring to impose effective control in line with the FIQC regulatory framework. The findings of the recent investigation revealed that fish/shrimp feed and feed ingredients used in the aquaculture farms are the most likely sources of antibiotic contamination. In addition, it is suspected that some antibiotics are used in Shrimp/fish hatcheries. Accordingly, further precaution and prevention measures are introduced to control antibiotic contamination from time to time as will be informed to the EU-FVO. The national, regional and local monitoring team strengthened their surveillances to ensure the effective control on VMPs at all stages. FIQC will maintain the chain of that monitoring and control from producer level to user level, involving central, regional and local authorities under FIQC and Extension wings of DoF. The recently strengthened official control through field monitoring and implementation of newly reformed NRCP 2010 is expected to provide a guarantee at least equivalent to those foreseen in Council Directive 96/23/EC. The export volume/quantity of aquaculture farm produced fin fish from Bangladesh is minimal. The aquaculture farms producing shrimp have almost all been registered by this time and registration is continuing to include all new farms. The number of ponds in Bangladesh might be more than 2.5 million, most of which are very small household ponds having average area of <0.1 ha and commonly used for household purpose as well as homestead aquaculture for family fish consumption. In the regular fish supply chain to the local and distant fish market, these ponds make no significant contribution. A few (<1%) of comparatively Page: 8

9 11 Ensure that national public health legislation is up to date and contains the appropriate maximum limits for certain contaminants i.e. heavy metals as described in Commission Regulation (EC) No 629/ Ensure that the official monitoring of hatcheries and larger aquaculture farms (average area >4.0 to 10 ha or more) are commercially producing fish which are regularly harvested and sold in the local market. The registration process has been started for the commercial fish farms regularly supplying fish/shrimp to the local market. Those farms intending to supply fish/shrimp raw materials for export concern will be registered as a priority. The training sessions have started for the SUFO/UFOs and concerned officials who will be engaged in the registration process as well as the nationwide implementation of the traceability system in the shrimp farming regions and finfish farms in other areas. A pond record book is under preparation which will be supplied to all registered farmers along with training provided for traceability implementation and Good Aquaculture Practice. Under the forthcoming EU-UNIDO assisted BEST Project intensive support is planned for all shrimp and fin fish aquaculture farmers under forty export-related sub-districts. Through the implementation of the above program it is expected to allow adequate traceability in line with Article 6 (2) of Regulation (EC) No 852/2004. The proposed national public health legislation 2010 has been up dated as per suggestions and recommendations provided by last EU-FVO Mission which will covers deficiencies concerning the appropriate maximum limits for certain contaminants (i.e. heavy metals) and other important issues needed to comply with Commission Regulation (EC) No 629/2008. The updated draft National Regulations have been submitted by the expert committee to the Central Authority and are now under review. It is expected that this FIQC Regulation will be approved by the authority on or before June Enforcement of the recently approved feed law and hatchery law will enable the FIQC officers to monitor and increase the effectiveness of the follow-up investigation which will provide guarantees Page: 9

10 aquaculture farms, producing for the establishments approved for export to the EU, is carried out according to provisions at least equivalent to those mentioned in Annex I of Regulation (EC) No 852/2004. with an effect at least equivalent to that described in Articles 16-19, 22 and 23 of Council Directive 96/23/EC. All the hatcheries will be placed under the registration and licensing process after complying with the prerequisite set of standards and the code of conduct (CoC) which would be obligatory to get the license. The activities of the hatcheries will be periodically reviewed and annually evaluated before renewal of license. Similarly, aquacultures farms will also be gradually placed under restriction to ensure safety and quality of the products when they would be imposed to go under license process in near future. Abbreviations: BAEC- Bangladesh Atomic Energy Commission BARI- Bangladesh Agricultural Research Institute BCSIR- Bangladesh Council of Scientific & Industrial Research BDA - Bangladesh Drug Administrations DLS - Department of Livestock Services DoF - Department of Fisheries FIQC- Fish Inspection & Quality Control QSDT - Quality System Development Team Page: 10