1 To ensure that all official veterinarians have sufficient power in order to apply the legislation effectively (Article 8 of Council Directive 2002/99/EC). 2 To ensure adequate supervision of the inspection services including the approved veterinarians who perform official duties (Article 8 of Council Directive 2002/99/EC). The Government of Santa Catarina State has already has initiated the processes for the hiring, trough public exams, of 120 official veterinarians to work at the Veterinary Local Units (UVLs). 1) Internal Audit Program: A General Audit Coordination is being created in the Central Unit. This Coordination will be responsible for standardization of procedures, training of auditors and enforcement of norms, aimed at correction of nonconformities observed during the auditing process. Based on the statute of CIDASC sanctions and penalties for noncompliance with recommendations will be enforced. 2) Audit Program for Approved Veterinarians: Local Veterinary Unit (UVL) will be responsible for supervision and monitoring of approved veterinarians. The finding of relevant non-compliances will entail notification of the approved veterinarians, who, in turn, shall forward justification within a period not exceeding 15 days. Failure to follow the recommendations may result in suspension and even cancellation of the license. Internal audits and audits of approved veterinarians will be implemented as from July/2010. 3 To build up a traceability system for pigs in order to be in the position to guarantee that the pig meat intended for export to the EU was obtained from animals, which remained in SC since birth or for at least the last three months prior to slaughter as required by the certificate "POR" in the Annex II to Council Decision 79/542/EEC. Detailed information may be found in Annex "A", of answer to recommendation "1" of Mission Report 8360/2009 (food safety and public health control systems in place as well as certification procedures in relation to the export of pig meat). By joining the "Program of segregation for ractopamine hydrochloride in swine production (PSRS), the dedicated production units will be audited by the Official Veterinary Service of the State, which will report to the Federal Inspection Service (SIF) an updated list of the compliant production units. All pigs entering or leaving the dedicated production units should be identified with the specific code that identifies the producing unit of birth. This code will be provided by the Page: 1
4 To consider strengthening diagnostic procedures for CSF suspect cases by increasing the use of laboratory examination to rule out the possibility of atypical CSF or CSF exhibiting mild symptoms, so as to guarantee that CSF has not occurred within the last 12 months in SC as required by the certificate "POR" in the Annex II to Council Decision 79/542/EEC. Official Veterinary Service of the State and shall be made up of numeric characters that identify the state, ownership and herd of origin. Pigs should be identified until weaning through tattoo, earring or electronic chip. Compliance with the pig identification process will be the responsibility of the veterinarian technically responsible for the dedicated production unit and audited by the Official Veterinary Service, which will assess, during the annual visit, the controls for animal identification in place at the dedicated production unit. During the movement of animals from the piglet production unit (UPL) to nursery, and from nursery to finishing unit, the respective identification codes should be included in the Animal Movement Permits (GTA). When the pigs are moved from finishing units to slaughter, their identification codes should be included in the Health Bulletin which, in turn, is linked to the GTA accompanying the animals. It is the responsibility of the Federal Inspection Service (SIF) to check the identification code of the batch of pigs intended for the slaughterhouse. If any non-compliance is detected regarding identification or animal transit documents (GTA or Health Bulletin), the SIF will carry out inspection of the establishment and the animals, and report the occurrence to the Official Veterinary Service of the State, which will investigate the non-conformities found. In the State of Santa Catarina, pigs have not been vaccinated against classical swine fever (CSF) for over 10 years and there has been no record of cases of the disease for 20 years. In this scenario, the likelihood of atypical CSF or with mild symptoms is minimal. Furthermore, the procedures implemented by the Internal Norm DSA N. 05/2009 ("Health Surveillance System in PSC Free Zone ), which are complementary to the surveillance actions conducted by the official veterinary service (see answer to recommendation 5), allow detection of infection through serological tests, if there is any occurrence of atypical CSF. This Norm establishes the collection of samples for laboratory testing of pigs on farms where there is notification of increased mortality; of discarded breeders (males and females) at slaughterhouses, of the establishments of origin of the slaughtered animals that presented lesions compatible with hemorrhagic diseases, and every two years in a sample of establishments selected randomly in the State s municipalities. As suspeitas relacionadas com PSC continuarão sendo rigorosamente investigadas, tanto Page: 2
5 To provide guarantees that the CA are able to certify the statement contained in the certificate "POR" in the Annex II to Council Decision 79/542/EEC concerning ASF and SVD. no acompanhamento clinico рею médico veterinário, como peia realização de provas laboratoriais. Apesar da remota possibilidade de ocorrência da Peste Suína Clássica atípica em área onde não se vacina há mais de 12 anos, o Brasil propõe a realização de teste serológico ELISA em todos os casos suspeitos de PSC no Estado de Santa Catarina, No caso de suspeitas fundamentadas de PSC, haverá coleta de material (órgãos, sangue e soro) que será remetido ao LANAGRO-PE. Nos casos de suspeita não fundamentada, haverá coleta de soro dos animais da propriedade aplicando-se a tabela de amostragem da Norma Interna DSA n 5/200a Os soros serão testados em laboratório credenciado e o teste será o ELISA. Caso resulte positivo o soro será encaminhado para teste confirmatorio no LANAGRO-PE e medidas de defesa sanitária animal cabíveis serão imediatamente aplicadas. African swine fever and swine vesicular disease are exotic diseases in the Americas (OIE's World Animal Health Information Database and Handistatus). In Brazil, the official service carries out surveillance of priority diseases by grouping them into syndromes, which increases the sensitivity of the surveillance system. The main syndromes investigated are: vesicular, nervous, swine hemorrhagic syndrome, and avian respiratory and nervous syndrome. For the swine hemorrhagic syndrome, the target diseases are classical swine fever and African swine fever, since both are clinically indistinguishable. The state of Santa Catarina is free from classical swine fever, and the surveillance system in place is able to identify the occurrence of these diseases, and the information is released through the Continental Surveillance System - SIVCONT, developed and managed by the Pan American Foot and Mouth Disease Centre (PANAFTOSA). A técnica de biologia molecular para peste suina Africana está sendo implementada, em fase de validação. Para os casos suspeitos de doença vesicular em suínos provenientes de Santa Catarina, as amostras serão testadas para febre aftosa e caso resultem negativas, as mesmas serão remetidas a laboratório de referência internacional para doença vesicular suína. Page: 3
6 To review the laboratory tests for brucellosis so that these are in accordance with methods which are internationally recognised in order to provide guarantees about the reliability of the statement in the certificate "POR" in the Annex II to Council Decision 79/542/EEC: animals are coming from holdings where no outbreaks of porcine brucellosis have occurred during the previous six weeks. 7 To ensure that the notification requirements to the OIE in respect of notifiable animal diseases are met (Article 8 of Council Directive 2002/99/EC). 8 To ensure that the principles of certification equivalent to those laid down in Council Directive 96/93/EC are in place, in particular concerning Article 3 of this Directive. The methods employed for serological diagnosis of brucellosis are based on Normative Instruction N. 6, January 8, 2004 which approves the Technical Regulation of the National Program for Animal Brucellosis and Tuberculosis Control and Eradication. The first test is rapid plate seroagglutination test with tamponated acidified antigen (rose Bengal test). The reagent samples are then submitted to the slow tube seroagglutination test (SAT and 2-ME) or Complement Fixation test (CFT). Os animais provenientes de granjas certificadas (GRSC - instrução Normativa n o 19/2002) de Santa Catarina serão testados para brucelose pela técnica de AAT (Rosa Bengala) e as amostras reagentes serão submetidas å Fixação de Complemento. Brazil meets all requirements established by OIE concerning to communication of disease occurrence. Besides immediate, six-monthly and annual communications sent to OIE, Brazil sends to OIE, EU and other countries, on a monthly basis, an International Monthly Report on the occurrence of the OIE listed diseases. Information on the communication of the classical swine fever outbreaks in the municipalities of Afua and Chaves, located on Marajo s Archipelago, was made available to the mission team during the visit to Santa Catarina State. The following documents were handed to the mission team: Informação DSA Nº 03/2009, de 16 de outubro de 2009; Nota Técnica DSA Nº 56/09, de 16 de julho de 2009; Ofício DSA Nº 588/09, de 27 de julho de 2009 and Ofício DSA Nº 724/09 de 08 de setembro de 2009. The information was updated to OIE by means of the follow-up report number 4 (November 18 th, 2009). Regarding the observation that the Official Veterinary or Technical Person in Charge cannot guarantee that pigs will remain a minimum period of 90 days at the finishing farms, we reported that the pigs to be slaughtered for that market will come from dedicated farms that will join the traceability program in accordance with specific legislation to be published by this Ministry and implemented by the states involved. This program is outlined in the proposal submitted in response Page: 4
to the DG SANCO Mission Report 2009-8360 (Public Health), containing a proposal for specific procedures for verification by the Official Service and for internal traceability in the slaughter and processing plants. Thus, with the controls provided, we believe there is no possibility of lack of control regarding the period of permanence of the animals or any other required guarantees. As regards the declaration of cleaning and disinfection of vehicles transporting animals, contained in the Health Bulletin, we reported that such statement will be adjusted so that the declaration signed by the Veterinarian or Technical Person in Charge on cleaning and disinfection will be based on the cleaning certificate issued by the slaughterhouse, which is responsible for the procedure in all vehicles. Finally, on the topic that addresses certification guarantees, we reported that although much of the information is provided by staff who are not under official veterinary supervision, this information is checked by the Official Veterinarian upon signing of the Certification, and is subject to periodic supervision and auditing. Nevertheless, any supporting information for certification requested in compliance with specific laws that is untrue, unclear or conflicting, entails immediate disqualification of the products for the intended market or even disqualification of the establishment. Page: 5