(a) General. All live VHS-regulated fish that are imported from VHS-regulated regions for other than immediate slaughter or research or laboratory use must be accompanied by a health certificate issued by a full-time salaried veterinarian of the national government of the exporting country, or issued by a certifying official and endorsed by the competent authority of that country. The health certificate must be written in English or contain an English translation. The health certificate will be valid for 30 days from the date of issuance. The health certificate for the live VHS-regulated fish must state that:
(1) The live fish were inspected by the veterinarian or certifying official who issued the certificate within 72 hours prior to shipment, and were found to be free of any clinical signs of disease consistent with VHS; and
(2) The live fish covered by the health certificate originated in a region or facility that has demonstrated freedom from VHS through testing in accordance with paragraphs (b) and (c) of this section.
(b) Testing. A facility can demonstrate freedom from VHS through negative testing results by a pathogen detection laboratory approved for VHS viral assays by the competent authority of that country. Testing must meet the following conditions:
(1) Testing must be conducted with a testing sample size that provides for a 95 percent confidence level of detecting a 2 percent prevalence of infection in the facility.
(i) Facilities with cultured fish of VHS-regulated species which can document a 2-year history of negative testing for VHS virus can conduct testing at a sampling level to provide a 95 percent confidence level of detecting a 5 percent prevalence of infection in the facility. Such testing must be conducted twice a year, with at least 3 months between tests.
(ii) Facilities with cultured fish of VHS-regulated species which can document a 4-year history of negative testing for VHS virus can conduct testing at a sampling level to provide a 95 percent confidence level of detecting a 10 percent prevalence of infection in the facility. Such testing must be conducted twice a year, with at least 3 months between tests.
(iii) Such facilities must be on a secure water source, and document that any VHS-regulated species in the facility that originated in VHS-regulated States or Canadian provinces originate from facilities of the same or higher health status.
(2) Tests must include virus isolation or other assays authorized by the competent authority, using appropriate cell lines to detect VHS virus, if present. All suspect VHS cytopathic effects must be positively identified as VHS through molecular assays and/or genetic sequencing.
(3) Proportional numbers of each VHS-regulated fish species which might be present in a shipment must be used for testing, if applicable.
(4) Testing must be conducted at water temperatures between 50 and 72 [deg]F, or at other times or under environmental conditions when VHS virus is most likely to be detected, if present.
(c) When APHIS adds a new species to the list of VHS-regulated species after a facility has been determined to be free of VHS in accordance with paragraph (b) of this section, the facility must conduct additional testing on fish of the newly listed species, if present in the facility, and the fish must be free of VHS virus for the facility to retain its free status. VHS testing must be conducted on each newly listed species with a sample size that provides for a 95 percent confidence level of detecting a 2 percent prevalence of infection in the fish facility.
(d) Shipping containers. Except as provided in Sec. 93.910(e)-(g), all live fish that are to be shipped to the United States must be shipped in new containers or in containers that have been cleaned and disinfected.
(1) Cleaning and disinfection of shipping containers must be monitored by the veterinarian or certifying official who issues the health certificate.
(2) Cleaning and disinfection must be sufficient to neutralize any VHS virus to which shipping containers may have been exposed.
(3) The cleaning and disinfection protocols used must be referenced in the health certificate or in a separate cleaning and disinfection certificate accompanying the shipment to the U.S. port of entry. (Approved by the Office of Management and Budget under control number 0579-0340)