Staff Assessment Report APP203045: To determine the new organism status of Lactobacillus sanfranciscensis, Lactobacillus rossiae, Lactobacillus crustorum, Lactobacillus curvatus, Lactobacillus pontis, Lactobacillus hilgardii, Lactobacillus paralimentarius, Leuconostoc lactis, Pediococcus parvulus and Pediococcus acidilactici 19 April 2017 Purpose To determine if Lactobacillus sanfranciscensis, Lactobacillus rossiae, Lactobacillus crustorum, Lactobacillus curvatus, Lactobacillus pontis, Lactobacillus hilgardii, Lactobacillus paralimentarius, Leuconostoc lactis, Pediococcus parvulus and Pediococcus acidilactici are new organisms under Section 26 of the HSNO Act Application number APP203045 Application type Statutory Determination Applicant The New Zealand Institute for Plant & Food Research Date formally received 22 November 2016 EPA Staff Assessment Report: Application APP203045 Executive Summary and Recommendation The New Zealand Institute for Plant & Food Research has submitted an application in order to seek a determination on the new organism status of Lactobacillus sanfranciscensis, L. rossiae, L. crustorum, L. curvatus, L. pontis, L. hilgardii, L. paralimentarius, Leuconostoc lactis, Pediococcus parvulus and P. acidilactici. After reviewing the information provided by the applicant, we recommend that the Hazardous Substances and New Organisms (HSNO) Decision-making Committee determines that Lactobacillus sanfranciscensis, L. rossiae, L. crustorum, L. curvatus, L. pontis, L. hilgardii, L. paralimentarius, Leuconostoc lactis, Pediococcus acidilactici and P. parvulus are not new organisms for the purpose of the HSNO Act. 2 EPA Staff Assessment Report: Application APP203045 Table of Contents Executive Summary and Recommendation ........................................................................................ 2 Table of Contents .................................................................................................................................. 3 1. Introduction .................................................................................................................................. 4 Purpose of this document .............................................................................................................. 4 The application .............................................................................................................................. 4 2. Summary of information ............................................................................................................. 5 Ubiquity of microorganisms ........................................................................................................... 9 3. Evaluation against legislative criteria ..................................................................................... 10 4. Comments from government agencies ................................................................................... 10 5. Overall findings and conclusion .............................................................................................. 11 6. References ................................................................................................................................. 12 Appendix 1: Decision path for section 26 determination ................................................................ 14 Context ........................................................................................................................................ 14 Introduction .................................................................................................................................. 14 Figure 1 Flowchart: Decision path for applications under Section 26 for determination as to whether an organism is a new organism ........................................................................................................ 15 Figure 1 Explanatory Notes ......................................................................................................... 16 3 EPA Staff Assessment Report: Application APP203045 1. Introduction Purpose of this document This document has been prepared by Environmental Protection Authority (EPA) staff to advise the Hazardous Substances and New Organisms (HSNO) Decision-making Committee (the Committee) of our assessment of application APP203045 submitted under the HSNO Act (the Act). This document discusses information provided in the application and other sources. The decision path for this application can be found in Appendix One of this memo. The application The application, from New Zealand Institute for Plant & Food Research, was submitted under section 26 of the Act to determine whether the organisms listed below are new organisms for the purpose of the Act: - Lactobacillus sanfranciscensis (Weiss & Schillinger 1984) - Lactobacillus rossiae (Corsetti et al. 2005) - Lactobacillus crustorum (Scheirlinck et al. 2007) - Lactobacillus curvatus (Abo-Elnaga and Kandler 1965) - Lactobacillus pontis (Vogel et al. 1994) - Lactobacillus hilgardii (Douglas et al. 1936) - Lactobacillus paralimentarius (Cai et al. 1999) - Leuconostoc lactis (Garvie 1960) - Pediococcus parvulus (Gunther & White 1961) - Pediococcus acidilactici (Lindner 1887) This application was formally received by the EPA on 22 November 2016. The applicant considers that all these species are naturally occurring in the New Zealand environment and were widely used in the food industry prior to the definition of what a new organism is in the HSNO Act. Therefore, the applicant submits that these organisms to be not new. None of these bacteria represent a risk to New Zealand’s environment and are considered to have probiotic1 activity. Our assessment includes information contained within the application and other relevant information found in scientific literature or elsewhere. 1 Probiotics are microorganisms that are believed to provide health benefits when consumed. They are usually found in dairy foods or dietary supplements containing live bacteria that replace or add to the beneficial bacteria normally present in the gastrointestinal tract. 4 EPA Staff Assessment Report: Application APP203045 2. Summary of information Taxonomy of Lactobacillus sanfranciscensis, L. rossiae, L. crustorum, L. curvatus, L. pontis, L. hilgardii, L. paralimentarius, Leuconostoc lactis, Pediococcus parvulus and P. acidilactici: Domain: Bacteria Phylum: Firmicutes Class: Bacilli Order: Lactobacillales Family: Lactobacillaceae and Leuconostocaceae Genus: Lactobacillus or Pediococcus and Leuconostoc The taxonomic order Lactobacillales belongs to the large group of lactic acid bacteria: Gram-positive organisms that produce lactic acid as a by-product of glucose metabolism through fermentation. There are two groups of lactic acid bacteria, based on differences in their ability to ferment sugars: homofermentative species convert sugars mostly into lactic acid, and heterofermentative species convert sugars into lactic acid, acetic acid, ethanol and carbon dioxide (Giraffa et al. 2010). Lactobacillus sanfranciscensis, L. rossiae, L. crustorum, L. curvatus, L. pontis, L. hilgardii, L. paralimentarius, Leuconostoc lactis, Pediococcus parvulus and P. acidilactici can be found in a variety of ecological niches. A recent publication on the history of Lactobacillus species as probiotics states: “They are known constituents of the human gut and also occur widely in dairy, meat, plant and fermented products of commercial value. As a result of their ancient anthropological use in food preservation and their ability to rapidly ferment carbohydrates to lactic acid, they have become industrially important bacteria and are used in a myriad of food and agricultural fermentations worldwide. Their growth causes acidification of food material, preserving the product and imparting unique textures and flavours” (Bull et al. 2013). The ability to colonize such a variety of habitats is a consequence of the metabolic versatility of this group of lactic acid bacteria. Hence, it is not unexpected that Lactobacillales bacteria have been used for decades in food preparation (Giraffa et al. 2010). These bacteria are found in different environments and locations around the world (De Vuyst et al. 2014), and numerous publications attest to their global ubiquity. Table 1 lists, not exhaustively, the types of samples and the locations where each bacterium has been previously isolated. The use of sourdoughs as natural starters in bread making can be traced to the second millennium B.C. (Cappelle et al. 2013). A sourdough starter is created by the fermentation of a mixture of flour (wheat, rye or maize) and water. Almost all the bacteria involved in this process are Lactobacillales (De Vuyst et al. 2014), including Lactobacillus sanfranciscensis, L. rossiae, L. crustorum, 5 EPA Staff Assessment Report: Application APP203045 L. curvatus, L. pontis, L. paralimentarius, Leuconostoc lactis and Pediococcus acidilactici (Table 1 and references within). Lactic acid bacteria are also used around the world to develop aroma and flavour in various dairy products (Vedamuthu 1994). Other examples include cheese making in Azerbaijan using Lactobacillus curvatus (Ahmadova et al. 2013), and in fermented mare milks and products derived from the milks in Mongolia (Yu et al. 2011) and in Italy (Giannino et al. 2009) using Leuconostoc lactis. Lactobacillales are present in alcoholic and non-alcoholic beverages, for example, wine in Spain and Australia (Pediococcus parvulus) (Davis et al. 1986; Pérez-Martín et