Federal Aquaculture Regulatory Fact Sheet Series UNITED STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE Authority: Animal Health Protection Act (7 USC 8301 – 8322 et. seq.) The AHPA was enacted to prevent, detect, control or eradicate diseases of farmed animals including aquaculture species and promoting species specific best management practices. This law and associated penalties can be found online at http://uscode.house.gov/download/pls/07C109.txt. Virus Serum Toxin Act (21 USC 151-159 et. seq.) The VSTA was enacted to ensure that pure, safe, potent, and effective biologic products are available for sale and distribution in the United States for use in animals. This law and associated penalties can be found online at http://www.aphis.usda.gov/animal_health/vet_biologics/publications/VSTA.pdf. 9 Code of Federal Regulation: Animal and Animal Products – Implementing regulations supporting the AHPA and VSTA can be found at http://www.aphis.usda.gov/regulations. Specific implementing regulations and requirements promulgated under these statues related to aquatic animal health activities: o Domestic Requirements - 9CFR 53.10; 9 CFR 71.2; 9 CFR 71.3 o Export Requirements - 9 CFR 91 o Import Requirements - 9 CFR 93.900-906 o Veterinary Biologics - 9CFR 101-123 o National Veterinary Accreditation Program - 9 CFR 161-162 Regulatory Subject Area: Aquatic Animal Health APHIS provides a wide range of services to the aquaculture community, including laboratory diagnostic and testing capacity, vaccine development, epidemiology and risk assessment expertise, disease surveillance, outbreak response and investigation, import and export assistance and certification. There are several programs within APHIS Veterinary Services that directly address the needs of the aquaculture industry: 1. Aquaculture Program o http://www.aphis.usda.gov/animal_health/animal_dis_spec/aquaculture/ o http://www.focusonfishhealth.org/ o Provides policy and program management - Sets program goals and policy for APHIS related to farmed aquatic animal health. o Policy on Viral Hemorrhagic Septicemia (VHS), Spring Viremia of Carp (SVC), and Infectious Salmon Anemia (ISA): • Imports of APHIS-regulated live fish requiring an import permit (VS Form 17-135). Applications (VS Form 17-129) submitted by fax or email take 7-10 business days to process. APHIS recently announced the availability of online applications which can be processed within 5 business days. • Online instructions for electronic submission of VS Form 17-129 are available at http://www.aphis.usda.gov/animal_health/permits/downloads/vs17-129-inst-onlineepermits.pdf.



Permit processing fees are currently $145.00 and will increase to $150.00 as of October 1, 2012. Permits are valid for 30 days. o Provides training in aquatic animal health for accredited veterinarians under the National Veterinary Accreditation Program. Accredited veterinarians assist APHIS and state officials in controlling disease and facilitating movement of farmed aquatic animals. More information about the NVAP is available online at http://www.aphis.usda.gov/animal_health/vet_accreditation/ o Facilitates international trade of aquatic animals • Endorsement of export health certifications • Additional information is available at http://www.aphis.usda.gov/regulations/vs/iregs/animals/ • NOTE: Export requirements are determined by the importing country. o Provides coordination with other International, Federal, State, and Tribal officials on aquatic animal health issues in the U.S. in accordance with the National Aquatic Animal Health Plan. o Provides official reporting to the OIE for the United States o APHIS Points of Contact • Dr. Janet Whaley, Aquaculture Program Manager, [email protected]; (301) 851-3480 • Dr. Christa Speekmann, Aquaculture Import/Export Specialist, [email protected]; (301) 851-3365 2. National Veterinary Services Lab (NVSL) o http://www.aphis.usda.gov/animal_health/lab_info_services/about_nvsl.shtml o NVSL is the APHIS Reference Laboratory for aquatic animal diseases. o Provides laboratory confirmation services and support of animal disease diagnostics. o Provides review and approval of laboratories to be considered “APHIS – Approved” to conduct aquatic animal pathogen detection assays for export purposes. All federal, state, university and private aquatic laboratories are eligible to apply for approval to become an APHIS-approved laboratory. o APHIS Points of Contact • Dr. Janet Warg, Microbiologist;

[email protected]; (515) 337-7551 3. Center for Veterinary Biologics

o http://www.aphis.usda.gov/animal_health/vet_biologics/ o Provides establishment (manufacturing facilities) licenses and product licenses for o

o

biologics (vaccines) in the United States. Provides permits to sell and distribute biologics manufactured in foreign countries. • No fees are associated with obtaining establishment licenses or product licenses. The only fees associates with obtaining a permit to sell and distribute product manufactured in a foreign country are associated with travel expenses incurred by CVB when inspecting foreign manufacturing facilities. APHIS Point of Contact: • Dr. Melisse Schilling, Senior Staff Veterinarian, [email protected] , (515) 337-6186

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