APP204132 EPA Staff Advice Report.Pdf

Staff Advice Report

13 October 2020

Application code: APP204132

Application type and sub-type: Statutory determination

Applicant: Functional and Integrative Medicine Limited

Date application received: 22 September 2020

Purpose of the Application: Information to support the consideration of the determination of Bacillus clausii and Bacillus indicus

Purpose of this document

1. This document has been prepared by the EPA staff to advise the Committee of our assessment of application APP204132 submitted under the Hazardous Substances and New Organisms Act 1996 (the Act). This document discusses information provided in the application and other sources. 2. The decision path for this application can be found in Appendix 1.

The application

3. With the fast expansion of the probiotic market, which is expected to reach $57.4 billion by 2022, the interest around the antimicrobial and immunomodulatory activities of Bacillus strains is quickly growing (Oyeniran 2019). The pharmaceutical industry is looking to develop probiotic supplements for animal feeds, as well as dietary supplements and registered medicines for humans (Hong et al. 2005; Cutting 2011; Patel 2011). 4. According to the applicant, probiotic products containing B. clausii and B. indicus have been imported into New Zealand for more than five years by consumers and practitioners. Functional and Integrative Medicine Limited (Fxmed) began to distribute a product containing the two bacteria two years ago. They only became aware of the restrictions around the import of new organisms in September 2020 when one of their shipments was held at the border by MPI.

5. On 22 September 2020, Fxmed applied to the EPA under section 26 of the HSNO Act seeking a determination on the new organism status of Bacillus clausii and B. indicus bacteria species. 6. The applicant provided evidence that B. clausii naturally occurs in soil samples from various countries, including New Zealand, to show its ubiquitous global distribution. Fxmed considered this bacterium to have been present in New Zealand since before the HSNO Act came into force and therefore it is not a new organism. 7. The bacterium B. indicus has been found in many parts of Asia in arsenic-contaminated sand, water samples from oceans, marine sediment, seafood, human faeces and soil. All of these environments are also present in New Zealand and considering the movement of people and goods, the applicant considers that this bacterium to be present here and not new for the purpose of the Act.

8. Our assessment includes information contained within the application and any other relevant information found in the scientific literature or elsewhere.

Organism description

9. Species in the genus Bacillus are ubiquitous in the environment. They are commonly associated with soil, water, dust and air (Sanders et al. 2003).

Bacillus clausii

10. Bacillus clausii (Table 1) is a Gram-positive, aerobic, endospore-forming, rod-shaped bacterium (0.5-0.7 µm wide and 2.0-4.0 µm long). Colonies of B. clausii form white filamentous margins (Cenci et al. 2006). The optimum pH is 8 but cells can grow well at pH values exceeding pH 9 or pH 7. The organism can be found in terrestrial and marine soils (Nielsen et al. 1995; Kumar et al. 2004)

Taxonomic Unit Classification

Order Bacillales

Family Bacillaceae

Genus Bacillus

Species Bacillus clausii Nielsen et al. 1995

Table 1: Taxonomic description of Bacillus clausii

11. According to some studies, the alkaliphilic nature of B. clausii helps maintaining the intestinal microbial balance and is used to prevent and treat various gastrointestinal disorders (Senesi et al. 2001; Patel 2011; Sharma et al. 2020).

Bacillus indicus

12. Bacillus indicus (Table 2) is a Gram-positive, aerobic, endospore-forming, non-motile rod-shaped bacterium (0.9–1.2 µm wide and 3.3–5.3 µm long). Cells form orange-yellowish circular colonies between 3 and 4 mm in diameter (Suresh et al. 2004) which can grow in high salinity conditions. The bacterium B. cibi is a synonym of B. indicus and Metabacillus indicus is a basonym (Stropko et al. 2014).

13. Bacillus indicus produces high levels of natural antioxidant (carotenoids) which are easily bio- accessible and could protect against adverse oxidation reactions in the stomach (Sy et al. 2013).

Taxonomic Unit Classification

Order Bacillales

Family Bacillaceae

Genus Bacillus

Species Bacillus indicus Suresh et al. 2004 emend. Stropko et al. 2014

Synonym Bacillus cibi Yoon et al. 2005

Basonym Metabacillus indicus (Suresh et al. 2004) Patel and Gupta 2020

Table 2: Taxonomic description of Bacillus indicus

Distribution of the bacteria

14. The applicant provided supporting evidence of the ubiquity distribution of B. clausii and B. indicus which was complemented with information found in the scientific literature.

15. Where there is no direct evidence for these organisms being in New Zealand before 1998 or in the present day, international literature is used to validate applicant claims that they are not new organisms. The key information from these reviews is where these organisms have been isolated. On the basis of probability, if the bacteria have been isolated on different continents, it is considered that there is a strong case for arguing microbial ubiquity, even though no literature shows they were present in New Zealand before 1998.

Evidence regarding the globally ubiquitous distribution of B. clausii

16. The bacterium B. clausii was isolated in New Zealand in July and September 2014 and in January 2015 from dairy effluents in three different Waikato farms (Gupta & Brightwell 2017).

17. As summarised in Table 3, B. clausii has also been isolated in the Americas (USA, Brazil), Asia (Japan, Turkey, South Korea), and Europe (Denmark, Germany, England, Scotland, Sweden) from common environmental samples (garden soil, compost, faecal material from organic chicken farms, seafloor).

18. The strain SC109 of the bacterium has been recognized as safe to be used as a food ingredient and probiotic. According to the Generally Recognized As Safe (GRAS) document, the strain B. clausii SC109 was isolated from human faeces, however the origin of the samples is not mentioned (Cutting et al. 2018). 19. Due to its global distribution in habitats also represented in New Zealand, and its presence in the country, we considered that the bacterium is highly likely to have been present in New Zealand before the 29 July 1998 when the Act came into force.

Country Sample Year Reference

Denmark Soil sample from a garden (NCIMB 1967 (Nielsen et al. 1995) 10309)

Germany Clay sample from a meadow 1967 (Nielsen et al. 1995) (MCIMB 10317) and soil sample from a wood (NCIMB 10281)

Japan Soil (DSM 2515) 1982 (Kobayashi et al. 1995; Nielsen et al. 1995)

Brazil Soil 1995 (Nielsen et al. 1995)

USA Soil 2006 (Outtrup et al. 2006)

Turkey Compost 2003 (Denizci et al. 2004)

England Faecal material from organic 2004 (Barbosa et al. 2005) chicken farms

Scotland Garden soil 2002 (CCUG ND)

Sweden Industry 2002 and (CCUG ND) 2007

South Korea Soil from Yellow Sea 2004 (Kumar et al. 2004)

New Zealand Farm dairy effluents 2017 (Gupta & Brightwell 2017)

Table 3: Samples containing Bacillus clausii around the world.

Evidence regarding the globally ubiquitous distribution of B. indicus

20. The bacterium B. indicus was more recently identified (2004) than B. clausii which was discovered in 1995. It has not yet been identified in New Zealand samples but has been found all across Asia (India, Pakistan, South Korea, China, Vietnam, Thailand), from the far north (Svalbard and Jan Mayen, Norway) to the bottom east (Greece) of Europe and in South America (Brazil). 21. As summarised in Table 4, B. indicus was isolated from human faeces, marine samples (water, sediment, plankton, mangroves), the Korean seafood dish Jeotgal, and various soil samples from a plethora of environments e.g. arsenic-contaminated sand, hot spring, salt pan, mangroves and oily sludge. All of these environments favourable for the growth of this bacterium can be found in New Zealand. Arsenic contaminated sites are found in Barewood goldfield in Central Otago (from mine tailings generated from historic gold mining activities) and Lake Ohakuri from geothermal effluent (Anderson & Cook 2004), salt pans are naturally found in Central Otago, hot springs are spread across the country, mangroves are present in the North Island (Northland, Auckland, Bay of Plenty and Waikato) and oily sludge is produced by petrochemical companies

22. The strain HU36 of the bacterium isolated from human faeces has been recognized as safe to be used as a food ingredient and probiotic (Cutting et al. 2013). 23. Considering the broad distribution of B. indicus and the presence of similar environments in New Zealand, we consider that the bacterium is highly likely to be present here.

Country Sample Year Reference

India Arsenic-contaminated aquifer 2001 (Suresh et al. 2004) (DSM 15820) (Zaed et al. 2017) 2016 Water sample from Indian Ocean (DSMZ ND) 2012 Marine sediment (DSM 28032)

South Korea Seafood dish jeotgal (DSM 2001 (Yoon et al. 2005) 16189)

Vietnam Human faeces 2006 (Duc et al. 2006; Hong et al. 2008)

Pakistan Soil (Thal desert) 2020 (Chaudhri et al. 2020)

Greece Marine plankton 2013 (MGnify 2019a)

China Material sample 2012 (European Nucleotide Archive 2019a)

France Marine sediment 2000 (MGnify 2019b) (Mediterranean Sea)

Svalbard and Jan Material sample 2016 (European Nucleotide Archive Mayen (Norway) 2019b)

Thailand Hot spring and salt pan ND (AmiBase ND-b) sediments (AmiBase ND-a) After a flood and mangrove sediments

Brazil Petrochemical oily sludge 2011 (Cerqueira et al. 2011)

Table 4: Samples containing Bacillus indicus around the world.

Evaluation against legislative criteria

24. For an organism to be determined as “not new” under section 26 of the Act, the organism must be shown to lie outside the definition of a new organism as defined in section 2A(1) of the Act:

25. A new organism is- a. an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998: b. an organism belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar prescribed as a risk species, where that organism was not present in New Zealand at the time of promulgation of the relevant regulation: c. an organism for which a containment approval has been given under this Act: d. an organism for which a conditional release has been given: e. a qualifying organism approved for release with controls: f. a genetically modified organism: g. an organism that belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been eradicated from New Zealand.

26. The decision pathway for a section 26 determination is outlined in Appendix 1. 27. Section 2A(1)(a) of the Act states that a new organism must belong to “a species that was not present in New Zealand immediately before 29 July 1998”. We have evaluated the information regarding B. clausii and B. indicus against this criterion. 28. Regarding other criteria listed in section 2A of the Act B. clausii and B. indicus: 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)).

Comments from Agencies

29. In accordance with section 58(1) of the Act, and 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. 30. DOC noted that the applicant did not state explicitly that the two bacteria were not new organisms and despite being widespread, they considered that no evidence has been presented to establish that B. clausii and B. indicus are not new organisms (Appendix 2).

31. MPI made no comments on the application.

Effect on New Zealand’s international obligations

32. It is not considered that any international obligations that may be affected by this determination.

Recommendation

33. Based on the information available, the two bacteria appear to be globally ubiquitous and commonly identified in environments that are also found in New Zealand (soil, human faeces, marine sediment, water, seafood dish, etc.). 34. There is sufficient weight of evidence for the Committee to agree that B. clausii and B. indicus were present in New Zealand prior to 29 July 1998 and continuously after that, and therefore are not new for the purpose of the Act.

References AmiBase, ND-a. ASEAN Microbial Database. Strain in culture collections. Scientific name: Bacillus cibi. Retrieved 17 September. Page last https://www.amibase.org/detail_data.php?page=strain&country=Thailand&collection=BCC&insti tute=BCC&scientific_name=Bacillus_cibi AmiBase, ND-b. ASEAN Microbial Database. Strain in culture collections. Scientific name: Bacillus indicus. Retrieved 17 September. Page last https://www.amibase.org/detail_data.php?page=strain&country=Thailand&collection=BCC&insti tute=BCC&scientific_name=Bacillus_indicus Anderson CR, Cook GM 2004. Isolation and characterization of arsenate-reducing bacteria from arsenic-contaminated sites in New Zealand. Current microbiology 48(5): 341-347. Barbosa TM, Serra CR, La Ragione RM, Woodward MJ, Henriques AO 2005. Screening for Bacillus isolates in the broiler gastrointestinal tract. Applied and environmental microbiology 71(2): 968- 978. CCUG, ND. Culture Collection University of Cothenburg. Retrieved 14 September. Page last https://www.ccug.se/collections/search?t=+Bacillus+clausii+&collection=entire Cenci G, Trotta F, Caldini G 2006. Tolerance to challenges miming gastrointestinal transit by spores and vegetative cells of Bacillus clausii. Journal of applied microbiology 101(6): 1208-1215. Cerqueira VS, Hollenbach EB, Maboni F, Vainstein MH, Camargo FA, Maria do Carmo RP, Bento FM 2011. Biodegradation potential of oily sludge by pure and mixed bacterial cultures. Bioresource technology 102(23): 11003-11010. Chaudhri AA, Nadeem M, ur Rahman A, Alam T, Sajjad W, Hasan F, Badshah M, Khan S, Rehman F, Shah AA 2020. Antioxidative and Radioprotective Properties of Glycosylated Flavonoid, Xanthorhamnin from Radio-Resistant Bacterium Bacillus indicus Strain TMC-6. Current Microbiology: 1-9. Cutting SM 2011. Bacillus probiotics. Food microbiology 28(2): 214-220. Cutting SM, Heimbach JT, Soni MG 2013. Determination of the Generally Recognized As Safe (GRAS) status of Bacillus indicus HU36. Synergia Life Sciences Pvt. Ltd. Cutting SM, Martin RL, Soni MG 2018. Conclusion of the Generally Recognized As Safe (GRAS) status of Bacillus clausii SC109 as a food ingredient. Synergia Life Sciences Pvt. Ltd. Denizci A, Kazan D, Abeln E, Erarslan A 2004. Newly isolated Bacillus clausii GMBAE 42: an alkaline protease producer capable to grow under higly alkaline conditions. Journal of Applied Microbiology 96(2): 320-327. DSMZ, ND. Leibniz Institute DSMZ - German Collection of Microorganisms and Cell Cultures (Deutsche Sammlung von Mikroorganismen und Zellkulturen). Retrieved 15 September. Page last https://www.dsmz.de/collection/catalogue/details/culture/ Duc LH, Fraser PD, Tam NK, Cutting SM 2006. Carotenoids present in halotolerant Bacillus spore formers. FEMS microbiology letters 255(2): 215-224. European Nucleotide Archive, 2019a. (EMBL-EBI). Geographically tagged INSDC sequences. Occurrence dataset https://doi.org/10.15468/cndomv. Retrieved 17 September. Page last https://www.gbif.org/occurrence/2308655131 European Nucleotide Archive, 2019b. (EMBL-EBI) Geographically tagged INSDC sequences. Occurrence dataset https://doi.org/10.15468/cndomv. Retrieved 17 September. Page last https://www.gbif.org/occurrence/2308953956 Gupta TB, Brightwell G 2017. Farm level survey of spore‐forming bacteria on four dairy farms in the Waikato region of New Zealand. Microbiologyopen 6(4): e00457. Hong HA, Duc LH, Cutting SM 2005. The use of bacterial spore formers as probiotics. FEMS microbiology reviews 29(4): 813-835. Hong HA, Huang JM, Khaneja R, Hiep L, Urdaci M, Cutting S 2008. The safety of Bacillus subtilis and Bacillus indicus as food probiotics. Journal of applied microbiology 105(2): 510-520.

Kobayashi T, Hakamada Y, Adachi S, Hitomi J, Yoshimatsu T, Koike K, Kawai S, Ito S 1995. Purification and properties of an alkaline protease from alkalophilic Bacillus sp. KSM-K16. Applied Microbiology and Biotechnology 43(3): 473-481. Kumar CG, Joo H-S, Koo Y-M, Paik SR, Chang C-S 2004. Thermostable alkaline protease from a novel marine haloalkalophilic Bacillus clausii isolate. World Journal of Microbiology and Biotechnology 20(4): 351-357. MGnify, 2019a. Marine plankton Metagenome. Sampling event dataset https://doi.org/10.15468/qin7bq. Retrieved 17 September. Page last https://www.gbif.org/occurrence/2442535110 MGnify, 2019b. Marine sediment Raw sequence reads. Sampling event dataset https://doi.org/10.15468/l7faem. Retrieved 17 September. Page last https://www.gbif.org/occurrence/2441943854 Nielsen P, Fritze D, Priest FG 1995. Phenetic diversity of alkaliphilic Bacillus strains: proposal for nine new species. Microbiology 141(7): 1745-1761. Outtrup H, Pedersen PE, Sørensen MV 2006. Subtilase enzymes. Google Patents. Oyeniran AC 2019. A Modified RCM Medium for the Growth of Lactobacillus bulgaricusthesis, North Carolina Agricultural and Technical State University. Patel A, 2011. MicrobeWiki: Bacillus clausii. Retrieved 15 September. Page last https://microbewiki.kenyon.edu/index.php/Bacillus_clausii Sanders ME, Morelli L, Tompkins T 2003. Sporeformers as human probiotics: Bacillus, Sporolactobacillus, and Brevibacillus. Comprehensive reviews in food science and food safety 2(3): 101-110. Senesi S, Celandroni F, Tavanti A, Ghelardi E 2001. Molecular Characterization and Identification ofBacillus clausii Strains Marketed for Use in Oral Bacteriotherapy. Applied and environmental microbiology 67(2): 834-839. Sharma J, Goyal A, Alam K, Tomar Y 2020. Determination of antimicrobial potential of Bacillus clausii against Candida albicans. Research & Reviews: A Journal of Microbiology and Virology 10(1). Stropko SJ, Pipes SE, Newman JD 2014. Genome-based reclassification of Bacillus cibi as a later heterotypic synonym of Bacillusindicus and emended description of Bacillus indicus. International journal of systematic and evolutionary microbiology 64(11): 3804-3809. Suresh K, Prabagaran S, Sengupta S, Shivaji S 2004. Bacillus indicus sp. nov., an arsenic-resistant bacterium isolated from an aquifer in West Bengal, India. International journal of systematic and evolutionary microbiology 54(4): 1369-1375. Sy C, Caris-Veyrat C, Dufour C, Boutaleb M, Borel P, Dangles O 2013. Inhibition of iron-induced lipid peroxidation by newly identified bacterial carotenoids in model gastric conditions: comparison with common carotenoids. Food & function 4(5): 698-712. Yoon J-H, Lee C-H, Oh T-K 2005. Bacillus cibi sp. nov., isolated from jeotgal, a traditional Korean fermented seafood. International journal of systematic and evolutionary microbiology 55(2): 733- 736. Zaed JAA, Singh P, Charan AA 2017. Study of microbial diversity in Indian Ocean water samples by the use of metagenomics technique. IJCS 5(6): 299-303.

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 pathway A

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

Section 26 pathway B

Item 1 Have the genes or other genetic material been modified by in vitro techniques or inherited from genes or other genetic material that has been modified by in vitro techniques?

If yes, go to item 2.

If no, the organism is not a genetically modified organism. However, you must check whether it meets the other new organism criteria so go to Pathway A item 6 onwards.

Item 2 Does the organism result solely from selection or natural regeneration, hand pollination, or other managed, controlled pollination (Regulation 3(1)(a) of the Regulations)?

Is the organisms solely the result of selection or natural regeneration, hand pollination, or other managed, controlled pollination?