Staff Assessment Report

26 February 2020

Advice to the Decision-making Committee to determine the new organism status of microbial pathogens

Application code: APP203966

Application type and sub-type: Determination

Applicant: South Pacific Sera Limited

Date application received: 31 January 2020

Purpose of the document: Information to support the consideration of the determination of Lactococcus garvieae, Tenacibaculum maritimum and New Zealand Rickettsia-like organisms (NZ-RLOs) 1 and 2.

Executive Summary

Application APP203966 submitted by South Pacific Sera Limited seeks a determination on the new organism status of Lactococcus garvieae, Tenacibaculum maritimum and New Zealand Rickettsia-like organisms (NZ-RLOs) 1 and 2 in New Zealand.

The applicant provided evidence that the microbial species have been isolated from many different locations in New Zealand and based on international evidence, are ubiquitous in the natural environment.

After reviewing the information provided by the applicant and information found in scientific literature, EPA staff recommend that Lactococcus garvieae, Tenacibaculum maritimum and NZ-RLOs 1 and 2 are not new organisms for the purpose of the Hazardous Substances and New Organisms Act 1996 (the Act).

1 Table of content

Introduction ...... 3

Microbial ubiquity ...... 3

Organism descriptions ...... 4

Lactococcus garvieae...... 4

Tenacibaculum maritimum ...... 5

New Zealand Rickettsia-like Organisms 1 and 2 ...... 6

Evidence regarding presence in New Zealand ...... 7

Historical Background ...... 7

Evidence for the presence of the proposed organisms in New Zealand ...... 7

Comments from Agencies ...... 8

Effect on New Zealand’s international obligations ...... 9

Recommendation ...... 9

References ...... 10

Appendix 1: Revised s26 pathway ...... 13

Introduction

1. On 31 January 2020, South Pacific Sera Limited applied to the EPA under section 26 of the HSNO Act seeking a determination on the new organism status of Lactococcus garvieae, Tenacibaculum maritimum and New Zealand Rickettsia-like organisms (NZ-RLOs) 1 and 2.

2. Section 2A(1) of the HSNO Act prescribes that a new organism includes an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998. It is against that criterion that we evaluated the evidence available for the organisms in the application.

Organism descriptions

Lactococcus garvieae Table 1: Taxonomic description of Lactococcus garvieae.

Taxonomic Unit Classification

Order Lactobacillales

Family Streptococcaceae

Genus Lactococcus

Species garvieae Collins et al. 1984, Schleifer et al. 1986

3. Lactococcus garvieae is a facultatively anaerobic, non-motile, non-spore forming, Gram-positive ovoid coccus, occurring in pairs and short chains and it produces a-haemolysis on blood agar. It grows at 4–45ºC in media containing 6.5% sodium chloride at pH 9.6 with 40% bile and in 0.1% methylene blue-milk. Its optimal growth temperature is 37ºC for 24 hours while at 4ºC, it needs between 12 and 15 days (Kusuda et al. 1991; Eldar et al. 1996). It also grows rapidly in rich media such as brain-heart infusion agar, trypticase-soy agar, blood agar, trypticase-soy broth and bile- esculin agar (Toranzo et al. 1994). 4. Lactococcus garvieae is typically associated with aquatic species such as fish; however, it may also infect humans with 14 reported cases of human infection (Wilbring, 2011). This species has also been isolated from subclinical intramammary infections in cows, subclinical mastitis in water buffalos, poultry meat, raw cow's milk, meat products, porcine blood from industrial abattoirs and from cat and dog tonsils (Zuily et al. 2011). 5. Historically, L. garvieae was previously described as Streptococcus garvieae and was isolated in the United Kingdom from a mastitic udder (Collins et al. 1983). In 1991, the taxonomic name changed to Enterococcus seriolicida in order to bring together a number of Gram-positive isolates recovered from Streptococcus outbreaks in Japanese yellowtail (Seriola quinqueradiata) over the preceding 20 years. Lactococcosis and relevance to L. garvieae

6. Lactococcosis is a kind of Streptococcosis caused by L. garvieae. The first known outbreak of Lactococcosis in rainbow trout from Spanish farms occurred in 1988 with the causal agent being L. garvieae (Palacios et al. 1993; Prieta et al. 1993).

7. Lactococcus garvieae is considered to have a ubiquitous global distribution where outbreaks of Lactococcosis affecting rainbow trout, yellowtail, grey mullet and freshwater prawn have been reported in several countries such as Australia, South Africa, Japan, Taiwan, England and the Mediterranean region (Ghittino & Prearo, 1992; Vendrell et al. 2006; Carson et al. 1993) and the Black Sea region in Turkey (Ozturk et al. 2013). Isolations of L. garvieae have also occurred in saltwater fish in the Far East specifically in European rainbow trout (Onchorynchus mykiss) (Wilbring, 2011).

Tenacibaculum maritimum Table 2: Taxonomic description of Tenacibaculum maritimum.

Taxonomic Unit Classification

Order Flavobacteriales

Family Flavobacteriaceae

Genus Tenacibaculum

Species maritimum Hikida et al. 1979, Yoon et al. 2005

8. Tenacibaculum maritimum, formerly known as Flexibacter maritimus, is a Gram-negative and filamentous bacterium that has a broad host range and a global distribution (Perez-Pascual et al. 2017). It has been described as the etiological agent of tenacibaculosis in marine fish. The pathology of the disease caused by the organism has been associated with characteristic body lesions such as ulcers, necrosis and frayed fins (McVicar & White, 1979; Campbell & Buswell, 1982).

9. Tenacibaculosis is responsible for considerable economic losses in all major areas of marine finfish aquaculture worldwide (i.e. Japan, Europe including the Atlantic, Channel and Mediterranean coasts, North America and the Red Sea) (Perez-Pascual et al. 2017). Tenacibaculum maritimum has also been isolated in Norway from diseased farmed sea lice cleaner fish Cyclopterus lumpus (Smage et al. 2016) and is suspected to be responsible for fish mortalities in Chile (Bernardet, 1998).

10. It has been isolated from farmed Atlantic salmon in Australia. This species is difficult to culture under laboratory conditions and diagnosis is therefore primarily based on the appearance of clinical signs such as lesions (MPI, 2017). Under experimental conditions, peak mortality occurs within one to two weeks of exposure and can range anywhere from 10% to 98% depending on the virulence of the strain as well as other environmental conditions (MPI, 2017). 11. Tenacibaculum maritimum grows optimally in water temperatures ranging from 15ºC to 35ºC. Mortality rates in susceptible fish species increase with higher water temperatures and lower water salinities, which favour pathogen replication. This species is only found in the marine environment (MPI, 2017).

Table 3: The geographical distribution of T. maritimum in wild and fish farmed fish (Avendano-Herrera et al. 2006):

New Zealand Rickettsia-like Organisms 1 and 2

12. Rickettsia-like organisms (RLOs) are very small bacteria that live inside the cells of fish some of which are harmless, while others may cause disease and death (MPI, 2017). 13. New Zealand Rickettsia-like organisms 1 and 2 (NZ-RLO) are closely related to Piscirickettsia salmonis which has been linked to disease outbreaks in Marlborough Sounds, New Zealand (Brosnahan et al. 2019). 14. These organisms are fastidious, obligate intracellular, coccobacilli and difficult to culture in vitro, making it difficult to classify using phenotypic characterisation. In vivo growth research showed NZ-RLO2 was able to grow in Chinook salmon embryo cell line (CHSE-214) and Epithelioma papulosum cyprini cell line (EPC).

15. New Zealand Rickettsia-like organism 1 appears to be part of an Australasian grouping sharing high similarity with the Tasmanian RLO and NZ-RLO2 was shown to be the same as an Irish strain based on two genes (Brosnahan et al. 2019). Rickettsiosis and relevance to RLOs

16. The globally ubiquitous marine disease Rickettsiosis is due to the causative agents of unidentified species of RLOs. Rickettsiosis has been recognised in disease outbreaks of farmed salmon in Canada, United States, United Kingdom, Norway, Chile and Australia (Rozas & Enriquez, 2014) since 1992. 17. Rickettsiosis affects a plethora of marine species from oysters, scallops, cockles and many fish species such as snapper (Diggles et al. 2002).

18. A New Zealand study by Brosnahan et al (2019) observed that NZ-RLO1 is almost identical to an RLO from Tasmania, Australia.

19. Brosnahan et al. (2019) noted that the detection of NZ-RLOs in five fish that were not showing visible signs of disease suggests that the bacteria can infect fish without causing clinical signs of disease.

Evidence regarding presence in New Zealand

Historical Background

20. Information in New Zealand such as isolations on the proposed microbial organisms is limited and predominantly in the 21st century. While information in New Zealand is scarce, the global information relating to these species shows that they are known to be causal agents for diseases primarily in aquatic species such as fish.

21. The ubiquitous distribution of these diseases suggests that these microbial organisms that are the causal agents by default have a ubiquitous distribution.

Evidence for the presence of the proposed organisms in New Zealand

Lactococcus garvieae Collins et al. 1984, Schleifer et al. 1986

22. There is no available evidence or reports of L. garvieae isolations in New Zealand.

23. However, based on scientific literature which states this microbe has been isolated from porcine blood, fish farms, human blood and urine, cow’s milk, water buffaloes, meat products, poultry, abattoirs and cat and dog tonsils, it is highly probable that this organism is present in New Zealand and has been prior to when the HSNO Act came into effect. 24. The geographical range of these L. garvieae isolations spans Australia, South Africa, Japan, England, Mediterranean countries such as Spain and Italy, Israel and the United States (Eldar et al. 1999; Zuily et al. 2011). Tenacibaculum maritimum Hikida et al. 1979, Yoon et al. 2005

25. Tenacibaculum maritimum is currently present in Marlborough Sounds (see Table 4 below), Canterbury and Stewart Island (Brosnahan et al. 2019). It is ubiquitous in the New Zealand marine environment and affects a broad range of marine fish species (Diggles et al. 2002).

26. Juveniles and adults of virtually all species of marine fish can be affected by flavobacterial diseases of which, Flexibacter maritimum, now known as T. maritimum is a causative agent (Diggles et al. 2002). 27. Outbreaks of flavobacterial diseases are problematic for snapper (Pagrus auratus) in Japan during winter and this may correspond to the apparent disposition of snapper in New Zealand (Diggles et al. 2002). New Zealand Rickettsia-like organisms (NZ-RLOs) 1 and 2

28. New Zealand Rickettsia-like organisms 1 and 2 have been isolated from disease outbreaks of farmed salmon situated in the Marlborough Sounds since 2012 (Brosnahan et al. 2016).

29. Testing of tissue samples from dead fish from the disease outbreaks in Marlborough Sounds between 2012-2015 using a suite of improved scientific techniques revealed that RLOs were

present then, is likely to have been present in New Zealand for some years and may be widespread in our marine environment (MPI, 2017). Table 4: Positive (+) and negative (-) detections of NZ-RLOs and T. maritimum at tested marine farms in Marlborough Sounds between 2012 – 2015 (MPI, 2017).

30. Mortalities of scallops (Pecten novaezelandiae) in New Zealand are associated with gill infections sometimes occurring at high prevalence (up to 100%) in apparently healthy scallops caused by unidentified RLOs (Diggles et al. 2002). As 23-39% of New Zealand wild scallops may experience mortalities each year (Bull, 1976), these mortalities may be associated with RLO infection.

Comments from Agencies

31. In accordance with section 58(1) of the Act, and clauses 2(2)(e) and 5 of the Methodology, the Department of Conservation (DOC) and the Ministry for Primary Industries (MPI) were notified and provided with the opportunity to provide further information on the application.

32. DOC stated that this application provides absolutely no evidence that any of these organisms were present in New Zealand prior to 29 July 1998. 33. DOC stated that the inference is that since L. garvieae and T. maritimum are very widespread globally they are likely to have long been present here but this hypothesis is not stated or supported by evidence or argument. For Rickettsia-like organisms 1 and 2, even less evidence is presented beyond a statement that Rickettsia-like organism 1 belongs to an Australasian group. 34. MPI stated that based on the information provided by the applicant, MPI is of the view that this information does not provide sufficient information to determine that these organisms were present in New Zealand immediately prior to 29 July 1998. 35. For L. garvieae, MPI stated that this species was detected by MPI’s Animal Health Laboratory (AHL) for the first time in December 2017 from a wild trout skin lesion amongst mixed growth. Further investigation revealed that L. garvieae was isolated from a soil sample in the North Island by Landcare Research in 2015. In January 2019, MPI isolated L. garvieae from fish experiencing mortalities at a freshwater salmon farm by culture, histology, PCR and nucleotide sequencing. Genetic analysis is currently being undertaken at AHL to understand the relationship between the soil isolates and the two isolates recovered from fish. 36. For T. maritimum, the Diggles (2002) paper referred to by the applicant does not make any reference to T. maritimum. This paper refers to flavobacterial diseases and the causative agents of the Flexibacter/Flavobacterium/Cytophaga group in general including F. maritimus and Flavobacterium sp., but provides no conclusive evidence of the presence of the organism prior to 29 July 1998. 37. MPI stated that Rickettsia spp. are considered to be unwanted organisms under the Biosecurity Act 1993. MPI noted that the paper by Brosnahan et al (2019), indicates that the NZ-RLOs have a limited distribution and are restricted to particular regions, the NZ-RLOs are not genetically identical to any other RLOs worldwide but show a strong similarity to strains from Ireland and Chile. 38. In addition, MPI stated that the rRNA genetic diversity of the NZ-RLO strains suggests that NZ- RLOs could have existed in New Zealand for some time, but this is inconclusive. MPI is of the view that no evidence has been supplied by the applicant to indicate that these organisms were present in New Zealand prior to 29 July 1998.

Effect on New Zealand’s international obligations

39. EPA staff are not aware of any international obligations that may be affected by this determination.

Recommendation

40. After completing our assessment of the information that was submitted by the applicant, as well as our own findings, we consider that on the balance of probabilities Lactococcus garvieae, Tenacibaculum maritimum and NZ-RLOs 1 and 2 were present in New Zealand immediately before 29 July 1998, have had an ongoing presence in New Zealand and are ubiquitous in the natural environment.

41. A new organism is defined in section 2A of the HSNO Act, and includes: (a) An organism belonging to a species that was not present in New Zealand immediately before 29 July 1998:

42. The following HSNO Act criteria were not applicable to these determinations as the species under consideration in this application; o have not been prescribed as a risk species (section 2A(1)(b)); o have not been approved to be held in containment or released with controls (sections 2A(1)(c), (ca) and (cb)); o are not genetically modified organisms (section 2A(1)(d)); and o have not been eradicated from New Zealand (section 2A(1)(e)). 43. Therefore, we recommend that the microbial pathogens Lactococcus garvieae, Tenacibaculum maritimum and New Zealand Rickettsia-like organisms 1 and 2 should be determined to be not new organisms for the purpose of the HSNO Act.

References

Alsina, M. & Blanch, A.R. 1993. First isolation of Flexibacter maritimus from cultivated turbot (Scophthalmus maximus). Bulletin of the European Association of Fish Pathologists. 13: 157- 160. Avedano-Herrera, R., Toranzo, A.E. and Magarinos, B. 2006. Tenacibaculosis infection in marine fish caused by Tenacibaculum maritimum: a review. Diseases of Aquatic Organisms. 71: 255-266. Avedano-Herrera, R., Magarinos, B., Lopez-Romalde, S. Romalde, J.L. and Toranzo, A.E. 2004b. Phenotypic characterisation and description of two major O-serotypes in Tenacibaculum maritimum strains from marine fish. Diseases of Aquatic Organisms. 58: 1-8. Avedano-Herrera, R., Magarinos, B., Morinigo, M.A. and Toranzo, A.E. 2005b. A novel O-serotype in Tenacibaculum maritimum strains isolated from cultured sole (Solea solea). Bulletin of the European Association of Fish Pathologists. 25: 70-74. Baxa, D.V., Kawai, K. and Kusuda, R. 1986. Characteristics of gliding bacteria isolated from diseased cultured flounder, Paralichthys olivaceous. Fish Pathology. 21: 251-258. Baxa, D.V., Kawai, K. and Kusuda, R. 1988b. In vitro and in vivo activities of Flexibacter maritimus toxins. Usa Marine Biological Institute, Kochi University. 10: 1-8. Baxa, D.V., Kawai, K. and Kusuda, R. 1988c. Chemotherapy of Flexibacter maritimus infection. Usa Marine Biological Institute, Kochi University. 10: 9-14. Bernardet, J.F. 1998. Cytophaga, Flavobacterium, Flexibacter and Chryseobacterium infections in cultured marine fish. Fish Pathology. 33: 229-238. Bernardet, J.F., Campbell, A.C. and Buswell, J.A. 1990. Flexibacter maritimus is the agent of ‘black patch necrosis’ in Dover sole in Scotland. Diseases of Aquatic Organisms. 8: 233-237. Bernardet, J.F., Kerouault, B. and Michel, C. 1994. Comparative study on Flexibacter maritimus strains isolated from farmed sea bass (Dicentrarchus labrax) in France. Fish Pathology. 29: 105-111. Brosnahan, C.L., Ha, H.J., Booth, K., McFadden, A.M.J. and Jones, J.B. 2016. First report of a rickettsia-like organism from farmed Chinook salmon, Oncorhynchus tshawytscha (Walbaum), in New Zealand. New Zealand Journal of Marine and Freshwater Research. 51(3): 1-14. Brosnahan, C.L., Munday, J.S., Ha, H.J., Preece, M. and Jones, J.B. 2019. New Zealand rickettsia- like organism (NZ-RLO) and Tenacibaculum maritimum: Distribution and phylogeny in farmed Chinook salmon (Oncorhynchus tshawytscha). Journal of Fish Diseases. 42: 85-95. Bull, M.F. 1976. Aspects of the biology of the New Zealand scallop, Pecten novaezelandiae Reeve 1853, in the Marlborough Sounds. Unpublished PhD thesis, Victoria University of Wellington. 175. Campbell, A.C. & Buswell, J.A. 1982. An investigation into the bacterial aetiology of ‘black patch necrosis’ in Dover sole, Solea solea L. Journal of Fish Diseases. 5: 495-508. Carson, J., Gudkovs, N. and Austin, B. 1993. Characteristics of an Enterococcus-like bacterium from Australia and South Africa, pathogenic for rainbow trout (Oncorhynchus mykiss Walbaum). Journal of Fish Diseases. 6: 381-388. Cepeda, C. & Santos, Y. 2002. First isolation of Flexibacter maritimus from farmed Senegalese sole (Sole senegalensis, Kaup) in Spain. Bulletin of the European Association of Fish Pathologists. 22: 388-392. Chen, M.F., Henry-Ford, D. and Groff, J.M. 1995. Isolation and characterisation of Flexibacter maritimus from marine fishes of California. Journal of Aquatic Animal Health. 7: 318-326. Collins, M.D., Farrow, J.A., Phillips, B.A. and Kandler, O. 1983. Streptococcus garvieae sp. nov. and Streptococcus plantarum sp. nov. Journal of General and Applied Microbiology. 129: 3427- 3431.

Devesa, S., Barja, J.L. and Toranzo, A.E. 1989. Ulcerative skin and fin lesions in reared turbot, Scophthalmus maximus (L). Journal of Fish Diseases. 12: 323-333. Diggles, B.K., Hine, P.M., Handley, S. and Bousted, N.C. 2002. A handbook of disease of importance to aquaculture in New Zealand. NIWA Science and Technology series 49. Ehlers, C. & Lear, G. 2014. The Biogeography of Environmental Microorganisms EPA Contract Reference Number: AAN2014-130. Eldar, A., Ghittino, C., Asanta, L., Bvozzettz, E. and Goria, M. 1996. Enterococcus seriolicida is a junior synonym of Lactococcus garvieae, a causative agent of septicemia and meningoencephalitis in fish. Current Microbiology. 32: 85-88. Eldar, A., Goria, M., Ghittino, C., Zlotkin, A. and Bercovier, H. 1999. Biodiversity of Lactococcus garvieae strains isolated from fish in Europe, Asia and Australia. Applied and Environmental Microbiology. March 1999. 65(3): 1005-1008. Ghittino, C. & Prearo, M. 1992. Report of Streptococcosis in rainbow trout (Oncorhynchus mykiss) in Italy: preliminary note. Boll. Soc. It. Patol. Ittica. 8: 4-11. Handlinger, J., Soltani, M. and Percival, S. 1997. The pathology of Flexibacter maritimus in aquaculture species in Tasmania, Australia. Journal of Fish Diseases. 20: 159-168. Kusuda, K., Kawai, K., Salati, F., Banner, C.R. and Fryer, J.L. 1991. Enterococcus seriolicida sp. nov., a fish pathogen. International Journal of Systematic Bacteriology. 42: 406-409. Masumura, K. & Wakabayashi, H. 1977. An outbreak of gliding bacterial disease in hatchery-born red seabream (Pagrus major) and gilthead (Acanthopagrus schlegeli) fry in Hiroshima. Fish Pathology. 12: 171-177. McVicar, A.H. & White, P.G. 1979. Fin and skin necrosis of cultivated Dover sole, Solea solea (L). Journal of Fish Diseases. 2: 557-562. McVicar, A.H. & White, P.G. 1982. The prevention and cure of an infectious disease in cultivated juvenile Dover sole, Solea solea (L.). Aquaculture. 26: 213-222. MPI, 2017. The Ministry for Primary Industries (MPI) Intelligence Report: NZ-RLO & T. maritimum 2015 response. May 2017. 1-40. Ostland, V.E., LaTrace, C., Morrison, D. and Ferguson, H.W. 1999. Flexibacter maritimus associated with a bacterial stomatitis in Atlantic salmon smolts reared in net-pens in British Columbia. Journal of Aquatic Animal Health. 11: 35-44. Ozturk, T., Bircan, R., Didinen, B., Dogan, G. and Ozer, A. 2013. Lactococcosis in rainbow trout (Oncorhynchus mykiss, Walbaum, 1792) in the middle Black Sea region in Turkey and antimicrobial susceptibility of the aetiological agent, Lactococcus garvieae. Etlik Veteriner Mikrobiyoloji Dergisi. 24(1): 7-12. Palacios, M.A., Zamora, M.J., Vasquez, J., Zamora, E. and Duran, A. 1993. Streptococcosis in rainbow trout (Oncorhynchus mykiss) in Spain. Boll. Soc. It. Patol. Ittica. 13: 11-16. Pazos, F., Santos, Y., Nunes, S. and Toranzo, A.E. 1993. Increasing occurrence of Flexibacter maritimus in the marine aquaculture of Spain. American Fisheries Society (AFS) – Fish Health Section (FHS) Newsletter. 21: 1-2. Pepin, J.F. & Emery, E. 1993. Marine Cytophaga-like bacteria (CLB) isolated from diseased reared sea bass (Dicentrarchus labrax L.) from French Mediterranean coast. Bulletin of the European Association of Fish Pathologists. 13: 165-167. Perez-Pascual, D., Lunazzi, A., Magdelenat, G., Rouy, Z., Roulet, A., Lopez-Roques, C., Larocque, R., Barbeyron, T., Gobet, A., Michel, G., Bernardet, J-F. and Duchaud, E. 2017. The complete genome sequence of the fish pathogen Tenacibaculum maritimum provides insights into virulence mechanisms. Frontiers in Microbiology. 8: 1542.

Powell, M.D., Carson, J. and van Gelderen, R. 2004. Experimental induction of gill disease in Atlantic salmon Salmo salar smolts with Tenacibaculum maritimum. Diseases of Aquatic Organisms. 61: 179-185. Prieta, J., Domenech, A.M., Fernandez-Garaizabal, J.F., Collins, M.D., Rodrigues, U.M. and Jones, D. 1993. Lactococcosis de la trucha arco iris (Oncorhynchus mykiss). Med Vet. 10: 367-373. Rozas, M. & Enriquez, R. 2014. Piscirickettsiosis and Piscirickettsia salmonis in fish: a review. Journal of Fish Diseases. 37: 163-188. Salati, F., Cubadda, C., Viale, I. and Kusuda, R. 2005. Immune responses of sea bass Dicentrarchus labrax to Tenacibaculum maritimum antigens. Fisheries Science. 71: 563-567. Smage, S.B., Frisch, K., Brevik, O.J., Watanabe, K. and Nylund, A. 2016. First isolation, identification and characterisation of Tenacibaculum maritimum in Norway, isolated from diseased farmed sea lice cleaner fish Cyclopterus lumpus L. Aquaculture. 464: 178-184. Soltani, M. & Burke, C.M. 1994. Responses of fish-pathogenic Cytophaga/Flexibacter-like bacteria (CFLB) to environmental conditions. Bulletin of the European Association of Fish Pathologists. 14: 185-187. Soltani, M., Munday, B.L. and Burke, C.M. 1996. The relative susceptibility of fish to infections by Flexibacter columnaris and Flexibacter maritimus. Aquaculture. 140: 259-264. Toranzo, A.E., Devesa, S., Heinen, P., Riaza, A., Nunez, S. and Barja, J.L. 1994. Streptococcosis in cultured turbot caused by an Enterococcus-like bacterium. Bulletin of the European Association of Fish Pathologists. 14: 19-23. Vendrell, D., Balcazar, J.L., Ruiz-Zarzuela, I., de Blas, I., Girones, O. and Muzquiz, J.L. 2006. Lactococcus garvieae in fish: A review. Comparative Immunology, Microbiology & Infectious Diseases. 29: 177-198. Wakabayashi, H., Hikida, M. and Masumura, K. 1984. Flexibacter infection in cultured marine fish in Japan. Helgolander Meeresunters. 37: 587-593. Wilbring, M. 2011. Lactococcus garvieae causing zoonotic prosthetic valve endocarditis. Clinical Research in Cardiology. 100(6): 545-546. Zuily, S., Mami, S. and Meune, C. 2011. Lactococcus garvieae endocarditis. Archives of Cardiovascular Diseases. 104(2): 138-139.

Appendix 1: Revised s26 pathway

Figure 17: Decision pathway for applications under Section 26 for determination as to whether an organism is a new organism

Context

This decision pathway describes the decision-making process for applications under Section 26 for determination as to whether an organism is a new organism.

Introduction

The purpose of this decision pathway is to provide the HSNO decision maker1 with guidance so that all relevant matters in the Hazardous Substances and New Organisms Act (1996) (the Act) and the Hazardous Substances and New Organisms (Organisms Not Genetically Modified) Regulations (1998) (the Regulations) have been addressed. It does not attempt to direct the weighting that the HSNO decision maker may decide to make on individual aspects of an application.

The decision pathway has two parts –

 Flowchart (a logic diagram showing the process prescribed in the HSNO Act and the Methodology to be followed in making a decision), and  Explanatory notes (a discussion of each step of the process).

Of necessity the words in the boxes in the flowchart are brief, and key words are used to summarise the activity required. The explanatory notes provide a description of each of the numbered items in the flowchart, and describe the processes that should be followed.

For proper interpretation of the decision pathway it is important to work through the flowchart in conjunction with the explanatory notes.

1 The HSNO decision maker refers to either the EPA Board or any committee or persons with delegated authority from the Board.

Figure 17 Explanatory Notes

Section 26

Item 1 Review the content of the application and all relevant information Review the application, staff advice and any relevant information held by other Agencies, and advice from experts.

Item 2 Is further information required? Review the information and determine whether or not there is sufficient information available to make a decision.

Item 3 Seek additional information (Section 52 and Section 58) If the HSNO decision maker considers that further information is required, then this may be sought either from the applicant (if there is an external applicant) or from other sources. If the HSNO decision maker considers that the information may not be complete but that no additional information is currently available, then the HSNO decision maker may proceed to make a determination. If the application is not approved on the basis of lack of information (or if the organism is considered new) and further information becomes available at a later time, then the HSNO decision maker may choose to revisit this determination.

Item 4 Is it an organism (i.e. fits the “organism” definition in Section 2)? An organism

(a) does not include a human being: (ab) includes a human cell: (b) includes a micro-organism: (c) includes a genetic structure, other than a human cell, that is capable of replicating itself, whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity: (d) includes an entity (other than a human being) declared to be an organism for the purposes of the Biosecurity Act 1993: (e) includes a reproductive cell or developmental stage of an organism

If yes, go to item 5. If no, as this is not an organism, it is not regulated under the new organism provisions of the HSNO Act.

Item 5 Is the determination about a potential GMO (Section 2A(1)(d))? If the determination relates to whether an organism is a potential GMO, go to pathway B. If the organism is not a GMO, go to item 6.

Item 6 Does the organism belong to a species that was known to be present in NZ immediately before 29 July 1998 (Section 2A(1)(a))? Determine on the basis of the available information whether on balance of probabilities the organism is known to belong to a species that was present in New Zealand immediately prior to 29 July 1998. For the purposes of making a Section 26 determination an organism is considered to be present in New Zealand if it can be established that the organism was in New Zealand: (a) immediately before 29 July 1998; and

(b) not in contravention of the Animals Act 1967 or the Plants Act 1970 (excluding rabbit haemorrhagic disease virus, or rabbit calicivirus). If yes, go to item 7 to test the organism against the next criterion. If no, go to item 12.

Item 7 Is the organism prescribed as a risk species and was not present in New Zealand at the time of promulgation of the relevant regulation (Section 2A(1)(b))? Determine whether the organism belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been prescribed as a risk species by regulation established under Section 140(1)(h) of the Act. If the organism is prescribed as a risk species, determine whether it was present in New Zealand when it was prescribed. The organism is a new organism if it was not present in New Zealand at the time of the promulgation of the relevant regulation. Note: at this point it may become apparent that the organism is an unwanted organism under the Biosecurity Act. If this is the case, then MPI and DOC may be advised (they may already have been consulted under items 1, 2 and 3). If yes, go 12. If no, go to item 8 to test the organism against the next criterion.

Item 8 Has a containment approval been given for the organism under the Act (Section 2A(1)(c))? For the purposes of making a Section 26 determination, this will also include the following organisms which are “deemed” to be new organisms with containment approvals under the HSNO Act: (a) animals lawfully imported under the Animals Act 1967 before 29 July 1998 pursuant to Section 254 of the HSNO Act; (b) animals lawfully present in New Zealand in a place that was registered as a zoo or circus under the Zoological Garden Regulations 1977 pursuant to Section 255 of the HSNO Act (except where other organisms of the same taxonomic classification were lawfully present outside of a zoo or circus –see section 2A(2)(c)); (c) hamsters lawfully imported under the Hamster Importation and Control Regulations 1972 pursuant to Section 256 of the HSNO Act; or (d) plants lawfully imported under the Plants Act 1970 before 29 July 1998 pursuant to Section 258 of the HSNO Act. If yes, go to item 12. If no, go to item 9 to test the organism against the next criterion.

Item 9 Has a conditional release approval been given for the organism (Section 2A(1)(ca))?

If yes, go to item 12. If no, go to item 10 to test the organism against the next criterion.

Item 10 Has a qualifying organism with controls approval been given for the organism (Section 2A(1)(cb))? A “qualifying organism” is an organism that is or is contained in a “qualifying medicine” or “qualifying veterinary medicine”. These terms are defined in Section 2 of the HSNO Act. If yes, go to item 12. If no, go to item 11 to test the organism against the next criterion.

Item 11 Is the organism known to have been previously eradicated (Section 2A(1)(e))?

Determine whether the organism belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that is known to have been previously eradicated. Eradication does not include extinction by natural means but is considered to be the result of a deliberate act. If yes, go to item 12. If no, then the organism is not a new organism.

Item 12 Has HSNO release approval without controls been given for an organism of the same taxonomic classification under Sections 35, 38 or 38I of the Act or has an organism of the same taxonomic classification been prescribed as a not new organism (Section 2A(2)(a))? If a release approval has been given for an organism of the same taxonomic classification under Section 35 or 38 of the Act then the organism is not a new organism. If a release approval has been given for an organism of the same taxonomic classification under Section 38I of the Act without controls then the organism is not a new organism, however, if this approval has been given with controls then it is a new organism. If an organism of the same taxonomic classification has been prescribed by regulations as not a new organism2 then it is not a new organism. If yes, the organism is not a new organism. If no, the organism is a new organism.

2 http://www.legislation.govt.nz/regulation/public/2009/0143/latest/whole.html#DLM2011201