N Recommendation Action Action Proposed by the Competent Authority

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1 Ref. Ares(2015) /08/2015 Response of the competent authorities of Malaysia to the recommendations of Report ref. DG(SANTE)/ MR of the Audit carried out from 09 March 2015 to 17 March 2015 in order to evaluate the animal health controls in place for aquaculture animals destined for export to the European Union N Recommendation Action Action Proposed by the Competent Authority 1 To ensure compulsory notification of relevant diseases of aquatic animals and that unresolved increased mortality in the aquatic animal export sector are reported to the competent authorities and adequately investigated Points II.1.2, II.3 (i) and II.4(i) of part A, and points II.1.2, II.3(i) and II.5 of part B of Annex IV to Regulation (EC) No 2008/1251 Based on conclusions (17), (65), (86), (87) and associated findings (2), (39), (78), (79), (80), (81) The Fisheries (Quality Control of Fish for Export to the European Union) Regulation 2009 empowers CA to exercise all EU regulations and directives to any premise and culture system that intend to export to EU. Under the Fisheries Act 1985 [ACT 317] a new Inland Fisheries Rules (Aquaculture) 2015 has been drafted to strengthen monitoring, control and surveillance of aquaculture production business (APB) with the help of Norwegian Authorities. The final draft of Inland Fisheries Rules (Aquaculture) 2015 has been sent to Attorney General Chamber Malaysia on 30 July Once adopted, it will give the necessary legal provision to CA at federal level and to be adopted at state level. The draft has been developed and has adopted animal health requirements from Council Directive 2006/88/EC. This regulation also includes compulsory notification to the CA of relevant diseases of aquatic animals. Two (2) awareness programmes has been conducted in two states (Perak and Pahang) in order to explain the content of the Rules. The briefing session in Perak was conducted on 28 October 2014 and Pahang on 13 November These two states were selected because both are the main producers for aquaculture in Malaysia. DOF shall conduct more awareness programmes in the future. 1

2 DOF will fully implement Fisheries Regulations (Fish Disease Control Compliance for Exports and Imports) Regulation 2012 by strengthening requirements for fish exports through awareness at farm and exporter/ importer premise level. The main content of this regulation is the need to comply with disease control measures established by Director General of Fisheries in order to obtain Health Certificate. In Fisheries (Fish Disease Control Compliance for Exports and Imports) Regulation 2012 under section 2.Requirements for fish export it is also stated under 2(a), that any person who exports fish shall comply with the measures for fish disease control prescribed by the competent authority. DOF also will ensure Fisheries Biosecurity Laboratory shall notify without delay suspects/positive results of OIE Listed Diseases to State Fisheries Biosecurity Unit and Fisheries Headquarters for control measures. 2 To review the situation in authorised farms and establish a system regarding introduction of fish, movement restrictions in case of suspicion of confirmation of relevant disease, in order to ensure that all introduction of species susceptible to the relevant disease(s) come from an area declared free. To establish a mechanism for introduction of fish into registered farms in order to ensure that they originate from farms which are under the supervision of the competent authority. Point II.1.4, point II.4 (ii) and point II.7 (ii) of part A, and point II.3 (ii) and point II.5. (ii) of part B of Regulation (EC) No 2008/1251 Based on conclusions (36), (38), (68) and associated CA has conducted a workshop on July 2015 to discuss, review and improve on the checklist by including specific requirements for ornamental fish farms. The reviewed checklist has been developed to approve farms, importers and exporters premise. CA also has set condition that every approved farm shall provide quarantine facilities at the farms. CA shall develop SOP on Quarantine Requirements for APBs. APBs and CA staffs will be trained with quarantine requirements and. APBs shall implement the SOP at the farm level. CA to supervise the implementation of the SOP. CA has plan to strengthen existing traceability system for the movement of fish from approved farm to approved farm and from approved farm to approved exporter premises (cold water and tropical fish) interested to export to EU. 2

3 findings (23), (25), (33), (34), (50), (51), (52) 3 To develop and implement a traceability system and its control at and from exporters premises in order to ensure the integrity of the export certificate in relation to the origin and identification of the species, and to ensure that health status of relevant species certified from free compartments is protected by adequate biosecurity measures. Point II.6 of part A and point II.4 of part B of Regulation (EC) No 1251/2008; Based on conclusions (105), (106),(107) and associated findings (89), (90), A meeting has been conducted with the industries (exporters to EU) on 5 th August 2015 to inform on the new measures on total separation for quarantine area for live fish export to EU and other countries that will be imposed by CA. CA has established a traceability system to control fish from registered farms to the exporter premises. CA also has developed and implemented a SOP on traceability for live fish and aquaculture products. The scope of the traceability shall be expanded to include from approved farms to approved farms. As been mentioned above, during a meeting with the industries (exporters to EU) on 5 th August 2015, CA has requested a total separation on quarantine area for export to EU and for domestic use. This measure is to ensure that all fish exported to EU are not associated with any diseases and has a good traceability system so that CA can ensure that health status of relevant species certified. In order to strengthen the traceability system and the integrity of export certificate, CA has planned to establish transport standard for transportation of live fish in order to comply with the requirements of the relevant elements in the certificate (Point II.6 of part A and point II.4 of part B of Regulation (EC) 1251/2008. CA shall notify live fish exporters to comply with the requirements. The CA s (DOF and MAQIS) shall also have regular technical meetings, trainings, information sharing and discussion to solve technical problems regarding live fish export. The CA s (DOF and MAQIS) also has established mechanism on cross audit and joint audit to ensure the integrity of both agencies in conducting their job. 3

4 4 To make arrangements so that when needed, certification of freedom from Spring viraemia of carp is supported by a surveillance programme using a method fit for the purpose, recommended and validated as necessary. Point 6 of Chapter of the OIE Aquatic Code, Chapter of the OIE Aquatic manual, Article 12(3) of Regulation (EC) No 882/2004 Based on conclusions (84), (85), and associated findings (76) and (77). Based on the given recommendation, laboratory shall use recommended gold standard method which is Cell culture technique for SVCV under Chapter Spring Viraemia of Carp Cell culture/artificial media in OIE Manual (Aquatic Animals). This method shall be used to fit the purpose of SVCV disease surveillance and certification of disease freedom. The laboratory in KLIA, Sepang has prepared a Test Method for SVCV analysis using Cell Culture Method according to OIE requirements. The laboratory has planned to start using the recommended method for approved farms under disease surveillance program in this year. CA also plans to conduct a surveillance programme on wild fish for SVC in collaboration with researchers starting from next year. 5 To put measures in place to ensure adequate conditions for, and documentation of, aquatic animal health controls at border inspection posts. Article 23(3)(b), (d) and (i) of Directive 2006/88/EC Based on conclusions (70) and (107), and associated findings (60), (61),(100). 6 To take appropriate corrective action to ensure that aquatic animal health rules for importation are complied with; in that sense, to analyse the cause for the non detection of the absence of enforcement of the rules. Article 23(3)(b) and (i) of Directive 2006/88/EC Based on conclusions (19) and (70), and associated findings (15) and (61) DOF to provide sufficient documents and procedures to MAQIS to implement for border and post border inspection and MAQIS shall implement the procedures accordingly. DOF and MAQIS will collaborate closely on inspection activities including having internal meeting. Malaysia has made a notification to WTO on import conditions of live fish G/SPS/N/MYS/20 dated 6 July 2009 on imports of live fish. Adoption date of the notification was January 2010.The main contents of the notification are as follows: a) Exporting country shall ensure that the fish are sourced from approved farm and under official control of the Competent Authority (CA) 4

5 b) Health Certificate shall be issued by the Competent Authority of the exporting country c) Exporting country shall ensure that the fish consignment originated from OIE listed diseases free zone. There should not be any disease outbreak for a period of two years prior to export. Malaysia sent another notification to WTO on Health Certification Requirements for Import of Ornamental Fish Into Malaysia G/SPS/N/MYS/26. DOF shall request MAQIS to publish list of Competent Authorities of exporting countries in e-permit system for reference. DOF has carried out audit on the import compliance at MAQIS office and has rectified problem on the non-compliance import health certificate. Based on the audit report issued by DOF, MAQIS has strengthened on import inspection on Health Certificate documentation. MAQIS shall refuse entry for the consignment with non-compliance import Health Certificate. 7 To put arrangements in place ensuring that each certificate consist of single sheet of paper or, where more text is required, it is in such a form that all the sheets of paper are part of an integrated whole and indivisible certificate as foreseen by point (e) of Annex V to Regulation (EC) No 1251/2008, unless additional features described in point (g) and (h) of the same Annex are included. Based on conclusion (109) and associated finding (104). Malaysia has made a notification to WTO on G/SPS/N/MYS/25 The notice of the Model and Applicability of the new Health Certificate of Live Fish. The health certificate format is referred to OIE format in Aquatic Animal Health Code. DOF will implement security measures by using rubber stamp (position and signature) and insert Health Certificate Number at each of attachment (Annex of detail list of species). 5