1. Regulation for Aquaculture Medicines in Japan Mototaka Hiki., D.V.M. Fish and Fishery Products Safety Office, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries (MAFF)

2. Today’s Topics １. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for Aquatic Drugs

3. Aquaculture Market (Million \ ）

4. From Annual Statistics on Fishery Aqua culture Production (MAFF) Order Perciformes account for 79 % of all aquaculture production in Japan Annual Aquaculture Production (2014)

5. Annual Farming Production of Yellowtail and Flounder From Annual Statistics on Fishery and Aquaculture Production (MAFF) Yellowtail Flounder

6. Annual Farming Damage of Yellowtail and Flounder Million \ Yellowtail Flounder From National Statistics (MAFF)

7. Three Major Diseases of Yellowtail and Flounder Species19982003 2009 Diseases Lactococcosis* Damage ratio 53.2%28.0%30.0% Lactococcosis 11.8%20.9%26.9% S. dysgalactiae infection * 10.9%18.6%9.2% 39.4%57.5%50.8% 23.0%8.9%28.1% 9.1%7.6%5.5% Yellowtail 1 st 2 nd 3 rd Flounder 1 st 2 nd 3 rd Diseases Damage ratio Diseases ＼ Years Streptococcosis* Streptococcosis Streptococcosis (Not identified) Nocardiosis Iridovirus infection* Photobacteriosis (Pseudotuberculosis)* Unknown diseases Edwardsiellosis Viral Nervous Necrosis (VNN) Viral hemorrhagic septisemia (VHS) Sea Anemonea stings * Approval years of vaccines ； For Lactococcusis ； 1997 、 Iridovirus ; 1998 、 Photobacteriosis: 2008 、 Streptococcus dysgalactiae : 2010 、 Streptococcosis (S. iniae ;Flounders) 2004. Lactococcosis

8. Today’s Topics １. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for Aquatic Drugs

9. General productsAntimicrobials Vaccines ・ Active element ： 17 kinds ・ Killed Vaccine: 17 kinds 27 products ・ anthelmintic ： 6 ・ antiseptic ： 2 ・ anesthetic ： 1 ・ vitamin etc ※ No. of active elements Kinds of aquatic drugs （ Oct. 2015 ） Aquatic Medicines Aquatic Biologics Drugs for Aquaculture

10. History of Fish Vaccines In Japan 1988 -Development of the first fish vaccine Immersion vaccine against Vibriosis in Ayu and Rainbow Trout 1990’s -Development of an oral vaccine for Lactococcus garviae in Yellowtail, and an injection vaccine against Iridovirus in Red sea bream 2000’s -Development of combined vaccines and oil adjuvant vaccines

11. Fish Vaccines Type of Vaccine: Killed vaccine Administration method : Immersion / Orally / By injection Immersion Orally By injection

12. Major Species of Fish that are Vaccinated Marine Fish Freshwater Fish Seriola fishes （ From Fish Species reference Book,pub.Hokuryu-kan) yellowtail flounder great amberjack amberjack Red sea bream rainbow trout grouper

13. Drugs for aquaculture have been approved as follows: Vaccines Vaccines for aquaculture have been approved according to genus or species. 13 Target Classification of Drugs for Aquaculture General products Antimicrobials Vaccines Aquatic Medicines Aquatic Biologics Target fish ・ Classification by order ・ Classification by Genus or species

14. A case report about the vaccine efficacy Estimated damage cost by Lactoccosis Number of fish vaccinated with Lactoccosis 10thousand Fish Year Fish 10thousand Year \100milion From Oita prefecture reports Amount use of antibiotics (macrolide) Number of fish vaccinated with Lactoccosis ※ Oita PRFE Case in yellowtail

15. Large-scale vaccination of Amberjack ① Capture ② Anesthesia ③ Injection Photo by Dr. Hirae (Kagoshima Pref.) ④ Release

16. Injection machine Large-scale vaccination of Amberjack Photo by Dr. Hirae (Kagoshima Pref.)

17. Today’s Topics １. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for Aquatic Drugs

18. Section of fisheries Fisheries Experimental Station Section of animal pharmaceutical affairs Section of food sanitation Aquaculture farmer Fishery Cooperatives and Federations of Fishery Cooperatives Distributor Aquaculture aquatic animals cooperation Lecture Inspection cooperation Prefectural governments 18 Regulation for Aquatic Drugs pharmaceutical inspector Lecture Inspection

19. Section of animal pharmaceutical affairs Section of food sanitation Aquaculture farmer Fishery Cooperatives and Federations of Fishery Cooperatives Distributor Aquaculture aquatic animals cooperation ① ② ②① ③ Prefectural governments 19 Procedure for Using Aquatic Drugs ④ ⑤ Use drugs ① Consultation, ② Guidance ③ Order drugs ④ Sell drugs Section of fisheries Fisheries Experimental Station

20. Prefectural governments ・ Lecture the way of administration of vaccine and record the condition of the administration ・ Investigate the condition of use & effects/safety of vaccine Distributor ・ Distributor can sell aquatic vaccines only to the aquaculture farmer who has the certification 20 Prefectural governments ・ Check the target fish and lecture how to use the vaccine ・ Issue a certification for use the vaccine Aquaculture farmer submits application form for permission of use aquatic vaccines before use Regulation for Use of Aquatic Vaccines

21. Certification for Use of Aquatic Vaccine 21 ・ Name of aquaculture farmer ・ Date of lecture for administration ・ Number and Date of issue ・ Target fish ・ Target disease ・ Treatment plan (date) ・ Dosage, ・ Target fish ・ Target disease ・ Treatment plan (date) ・ Dosage, ・ Information of issuing institution

22. Thank you for your attention Mototaka Hiki D.V.M Fish and Fishery Products Safety Office, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries (MAFF) e-mail :mototaka_hiki@nm.maff.go.jp