Annex

Source freedom of Spring viraemia of carp virus (SVCV) and Aeromonas salmonicida for goldfish (other than goldfish ulcer disease strains)

1. The certification of (2) ‘The goldfish originate from a country, zone or export premises determined to be free from spring viraemia of carp virus (SVCV) and Aeromonas salmonicida (other than goldfish ulcer disease strains) based on a) the absence of clinical, laboratory or epidemiological evidence of these disease agents in the source fish population in the previous two years; and b) a system of monitoring and surveillance for the previous two years acceptable to the Competent Authority and consistent with the Department of Agriculture and Water Resources Import Conditions Additional health certification criteria and procedures for goldfish’ must be based on active targeted surveillance in the country, zone or compartment described under Sections 1.1 to 1.8 below.
   

   1.1. Surveillance must demonstrate the absence of SVCV and A. salmonicida and suspected clinical signs in the source population during a two (2) year period of surveillance. To certify source freedom, the active targeted surveillance program must include a minimum of two rounds of sampling and testing for SVCV and A. salmonicida in the source population of fish to be exported to Australia. Chapter 1.4 Aquatic Animal Health Surveillance of the OIE Aquatic Animal Health Code (OIE Code) should be referred to when designing a surveillance program for health certification purposes.
   

   1.2. The Competent Authority may recognise the country, a zone or compartment as free of SVCV and A. salmonicida based on negative test results using internationally recognised diagnostic protocols referred to under Section 1.4 and 1.5 below. The testing regimens apply in addition to the requirement for an absence of suspected clinical signs associated with SVCV and A. salmonicida, and that basic biosecurity conditions, as defined in the OIE Code and stated under Section 1.7 below, must have been continuously met during the two year surveillance period.
   

   Sample size for source freedom
   

   1.3. The sample size within a source population should be calculated using the guidelines in Chapter 1.4 Aquatic Animal Health Surveillance of the OIE Code. The sampling design of active targeted surveillance for demonstrating SVCV-free and A. salmonicida-free status for a country, zone or compartment must require a minimum level of sampling appropriate for a 5 % assumed prevalence with a 95% confidence level of SVCV and A. salmonicida detection in a source population. The population size is defined as the number of fish of the same species that share a common water supply and originate from the same broodstock. Examples of sample sizes for various combinations of design prevalence, test sensitivity and specificity values are provided in Table 1 below.
   

   Diagnostic tests
   

   1.4. SVCV: The appropriate test methods for the purpose of demonstrating freedom of SVCV are those capable of detecting subclinical carriers of the virus, as described in the OIE Manual of Diagnostic Tests for Aquatic Animals (OIE Manual) or equivalent published peer reviewed reference material.
   

   1.5 A. salmonicida: The appropriate diagnostic test methods for the purpose of demonstrating freedom of A. salmonicida are those capable of detecting subclinical carriers of the bacteria, such as those described in the AQUAVETPLAN Disease Strategy Manual: Furunculosis Version 2 (2009) or from equivalent published peer reviewed reference material.
   

   Ongoing surveillance
   

   1.6. Ongoing surveillance to demonstrate SVCV and A. salmonicida freedom should involve twice yearly sampling and testing at a level appropriate for a 10 % assumed prevalence with a 95% confidence level of detecting SVCV and A. salmonicida in a source population. The conditions for ongoing surveillance to demonstrate pathogen freedom will only be recognised following two (2) years of continuous active targeted surveillance with no positive detections of SVCV or A. salmonicida, an absence of suspected clinical signs and demonstration that basic biosecurity conditions (see OIE Code and section 1.7 below) were continuously met for the period.
   

   1.7.Basic biosecurity conditions are defined in the OIE Code as a set of conditions applying to a particular disease, and a particular compartment, zone or country, required to ensure adequate disease security, such as:
   

1.7.1. the disease, including suspicion of the disease, is compulsorily notifiable to the Competent Authority; and

1.7.2. an early detection system is in place within the compartment, zone or country; and

1.7.3. import requirements to prevent the introduction of disease into the compartment, zone or country, as outlined in the OIE Code, are in place.

Health certification

1.8. Exporting countries are required to provide health certification attesting to freedom from SVCV and A. salmonicida for all fish destined for export to Australia. This includes attestations of disease freedom for fish that may have been sourced from a different country to the final export country. Attestations of disease freedom in these circumstances must be based on satisfactory certification arrangements between the original source country and the final exporting country’s Competent Authority.