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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). 2 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. 3 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. 4 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.
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