(a) General. All live fish, fertilized eggs, and gametes of SVC-susceptible species that are imported from any region of the world must be accompanied by a health certificate issued by a full-time salaried veterinarian of the national government of the exporting region, 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 fish, fertilized eggs, or gametes must state that:

(1) The live fish, fertilized eggs, or gametes 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 SVC; and

(2) The live fish, fertilized eggs, or gametes covered by the health certificate meet the requirements of this section.

(b) Surveillance. The live fish, fertilized eggs, or gametes must meet the following conditions to be eligible for importation into the United States:

(1) The live fish, fertilized eggs, or gametes must originate in a region or establishment which conducts a surveillance program for SVC under the supervision of the competent authority.

(2) The region or establishment must demonstrate freedom from SVC through a minimum of 2-years' continuous health history, supported by laboratory testing by a pathogen detection facility approved for SVC viral assays by the competent authority.

(3) SVC-susceptible fish populations in the region or establishment must be tested at least twice annually, with at least 3 months between the tests and at times or under environmental conditions that would facilitate the detection of SVCV if it were present. Sampling procedures must utilize an assumed pathogen prevalence of 2 percent, with a corresponding confidence level of 95 percent. Samples must be collected and submitted by a certifying official or veterinarian recognized by the competent authority. The standard screening method for SVC must include isolation of SVCV in cell culture, using either the epithelioma papulosum cyprini (EPC) or fathead minnow (FHM) cell lines. However, the Administrator may authorize other assays for SVCV detection in lieu of virus isolation through cell culture, if the Administrator determines that such assays provide equivalent assurance of the SVC status of an exporting region or establishment. All viral testing results must be negative.

(c) Shipping containers. All live fish, fertilized eggs, and gametes must be shipped to the United States in new containers or in used containers that have been cleaned and disinfected in accordance with this section.

(1) Cleaning and disinfection of shipping containers must take place under the supervision of the veterinarian or certifying official who issues the health certificate.

(2) Cleaning and disinfection must be sufficient to neutralize any SVC virus to which shipping containers may have been exposed. Acceptable disinfection procedures include individual or combination treatments with: Solutions having a pH of 12 or higher or 3 or lower with a contact time of at least 10 minutes; heat at or above 56 °C for at least 15 minutes; chlorine solutions having a concentration of at least 500 ppm with a contact time of at least 10 minutes; iodine solutions having a concentration of at least 100 ppm with a contact time of at least 10 minutes; ultraviolet exposure (254 nm; min exposure of 10,000 microwatt seconds/cm2); or other disinfectants such as Virkon used according to the manufacturer's directions. The Administrator may authorize other procedures if the Administrator determines they are adequate to neutralize the SVC virus.

(3) Cleaning and disinfection protocols 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 0579-0301)