APP204012 Application.Pdf

Home , Paenibacillus, Paenibacillus macerans

APPLICATION FORM Section 26 Determination

To obtain a determination of whether an organism is a new organism under the Hazardous Substances and New Organisms Act 1996 Send to Environmental Protection Authority preferably by email ([email protected]) or alternatively by post (Private Bag 63002, Wellington 6140) Payment must accompany final application; see our fees and charges schedule for details.

Application Number

Date

www.epa.govt.nz 2

Application Form To obtain a determination of whether an organism is a new organism

Completing this application form

1. This form is used when you wish to apply for a statutory determination under section 26 of the Hazardous Substances and New Organisms (HSNO) Act 1996 as to whether or not an organism is a new organism (i.e. whether the organism is regulated under the HSNO Act or not). 2. If you wish to make an application for approval of for use of a new organism, a different form will have to be used. All forms are available on our website. 3. It is recommended that you contact an Advisor at the Environmental Protection Authority (EPA) as early in the application process as possible. An Advisor can assist you with any questions you have during the preparation of your application. 4. Unless otherwise indicated, all sections of this form must be completed for the application to be formally received and assessed. If a section is not relevant to your application, please provide a comprehensive explanation why this does not apply. If you choose not to provide the specific information, you will need to apply for a waiver under section 59(3)(a)(ii) of the HSNO Act. This can be done by completing the section on the last page of this form. 5. Any extra material that does not fit in the application form must be clearly labelled and cross- referenced, and included with the application form when it is submitted. 6. Please add extra rows/tables where needed. 7. You must sign the final form (the EPA will accept electronically signed forms) and pay the application fee (including GST) unless you are already an approved EPA customer. To be recognised by the EPA as an “approved customer”, you must have submitted more than one application per month over the preceding six months, and have no history of delay in making payments, at the time of presenting an application. 8. Information about application fees is available on the EPA website. 9. All application communications from the EPA will be provided electronically, unless you specifically request otherwise. Commercially sensitive information

10. Commercially sensitive information must be included in an appendix to this form and be identified as confidential. If you consider any information to be commercially sensitive, please show this in the relevant section of this form and cross reference to where that information is located in the confidential appendix. 11. Any information you supply to the EPA prior to formal lodgement of your application will not be publicly released. Following formal lodgement of your application any information in the body of this application form and any non-confidential appendices will become publicly available. 12. Once you have formally lodged your application with the EPA, any information you have supplied to the EPA about your application is subject to the Official Information Act 1982 (OIA). If a request is made for the release of information that you consider to be confidential, your view will be considered in a manner consistent with the OIA and with section 57 of the HSNO Act. You may be required to provide further justification for your claim of confidentiality.

December 2013 EPA0327 3

Application Form To obtain a determination of whether an organism is a new organism

Definitions

Any organism in which any of the genes or other genetic material:  Have been modified by in vitro techniques, or Genetically Modified  Are inherited or otherwise derived, through any number of replications, from Organism (GMO) any genes or other genetic material which has been modified by in vitro techniques

A new organism is an organism that is any of the following:  An organism belonging to a species that was not present in New Zealand immediately before 29 July 1998;  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;  An organism for which a containment approval has been given under the HSNO Act;  An organism for which a conditional release approval has been given under the HSNO Act; New Organism  A qualifying organism approved for release with controls under the HSNO Act;  A genetically modified organism;  An organism belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been eradicated from New Zealand;  An organism present in New Zealand before 29 July 1998 in contravention of the Animals Act 1967 or the Plants Act 1970. This does not apply to the organism known as rabbit haemorrhagic disease virus, or rabbit calicivirus A new organism does not cease to be a new organism because:  It is subject to a conditional release approval; or  It is a qualifying organism approved for release with controls; or  It is an incidentally imported new organism

December 2013 EPA0327 4

Application Form To obtain a determination of whether an organism is a new organism

1. Applicant details

1.1. Applicant

Company Name: (if applicable) Ecotabs Nz Ltd

Contact Name: Christopher Smith

Job Title: Director

Physical Address: 3 Glenwarrick Court, Rototuna , Hamilton 3210

Postal Address (provide only if not the same as the physical):

Phone (office and/or mobile): 0274139924

Fax: 07 8535513

Email: [email protected]

1.2. New Zealand agent or consultant (if applicable)

Company Name:

Contact Name:

Job Title:

Physical Address:

Postal Address (provide only if not the same as the physical):

Phone (office and/or mobile):

Fax:

Email:

December 2013 EPA0327 5

Application Form To obtain a determination of whether an organism is a new organism

2. Information about the organism

2.1. Name of organism Identify the organism as fully as possible

Organism name: Paenibacillus macerans Briefly describe the biological characteristics of the organism: Paenibacillus macerans is a diazotroph bacterium found in soil and plants capable of nitrogen fixation and fermentation. These bacteria was originally discovered in 1905 by an Austrian biologist named Schardinger and thought to be a bacillus.

2.2. Regulatory status of the organism

Is the organism that is the subject of this application also the subject of:

An innovative medicine application as defined in section 23A of the Medicines Act 1981?

☐ Yes ☒ No

An innovative agricultural compound application as defined in Part 6 of the Agricultural Compounds and Veterinary Medicines Act 1997?

☐ Yes ☒ No

3. Evidence regarding whether the organism meets the definition of a new organism

Does the organism meet the definition of a new organism under the HSNO Act?

For example, does it belong to a species that was not present in New Zealand before July 29 1998? Is it a genetically modified organism? etc.

Describe the evidence you have to support this view, providing supporting materials in an appendix as appropriate. The Ecotab product range is used extensively in the USA, Europe, Africa and Australia. There has already been a permit issued for supply of the product in NZ and this has been in place for the past 8 years.

Note 1: Wakelin PhD A PhD by S.A Wakelin was completed in 2001 which clearly identifies the presence of P.Macerans in soil found in the Canterbury area. A thesis typically takes 3-5 years to complete and although Wakelin finished his MSc in 1998 and his PhD in 2001 we could not confirm that the organism was isolated before July 1998. According to Wakelin

December 2013 EPA0327 6

Application Form To obtain a determination of whether an organism is a new organism

(personal correspondence - email below), the bacterium identified as P. macerans used in his thesis was isolated before 1998 (ref of Wakelin article in Note 1 appendix). He noted that while the method used to identify the bacterium (API 50 CHB microtubule system) would not been seen as particularly authoritative by today’s standards, it is remarkably accurate.

Email extract is in the Appendix – Note 1

A copy of an email response from Barry Wards (MPI) that this organism was present in NZ prior to 1998 in his opinion is below. There are multiple references to P. Macerans throughout this thesis identifying its presence. Extract ;

19.02.20 Hi Chris

I’ve had a chance to look through Wakelin’s thesis and see where the organisms were sourced from, and when. I’ve also done another extensive search to see if I can find references to “macerans” being isolated or reported elsewhere in NZ.

Wakelin reports that P. macerans (PT1) was sourced from pea fields in Canterbury as an unidentified isolate, which he subsequently identified and used in further studies. Since the thesis is published in 2001, I imagine that the isolate would likely have been collected several years previously (noting that a doctorate takes several years at least).

I’ve been unsuccessful in finding any further references to “macerans’ being isolated or reported elsewhere in NZ.

Based on the above, I think the evidence of Wakelin would be strong enough to support a successful application to the EPA to determine that P. macerans was present in NZ immediately prior to 29 July 1998. MPI cannot make that decision because it’s a statutory process managed by the EPA under the HSNO Act.

Regards

Note 2: Ghazalibiglar PhD This is another PhD titled - Discovery of a Paenibacillus isolate for biocontrol of black rot in brassicas which again mentions and identifies P.Macerans as being present in N.Z. Although this thesis was completed in 2014 it provides foundation that that Wakelin thesis post 2001 clearly identified the same bacteria. This would provide evidence that anecdotally the bacteria have been in NZ for a number of years.

A copy email 15.04.2020 is below from Hoda Ghazalibiglar -

Hi Chris,

December 2013 EPA0327 7

Application Form To obtain a determination of whether an organism is a new organism

Thanks for your email and such a nice surprise to see my PhD thesis after a while 

The sample culture P8 = LU1219 should be at Lincoln University Collections held by the Bio- Protection Research Centre, Lincoln University, Canterbury, NZ.

The isolates listed on my thesis were isolated from NZ produced vegetables as a part of ‘Smart Seeds’ project, before I start my PhD at the centre (2009). I am not sure exactly when.

I cced Prof. John Hampton in this email, my PhD supervisor and also the project leader, who has more information about the background of the project.

Please don’t hesitate to contact me if I can be of any further assistance.

Good luck with your search. Kind regards, Hoda

Note 3: Wikipedia Ecology P. macerans is usually found in soil and plant materials but has also been identified in blood cultures of infants with infection.[7] The bacterium is not normally pathogenic in humans but could cause allergies as a result of its histamine producing properties.

Note 4: Biosafety Clearing-House (BCH) The role of the BCH is a mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on Living Modified Organisms (LMOs) and assist the Parties to better comply with their obligations under the Protocol. Global access to a variety of scientific, technical, environmental, legal and capacity building information is provided in the six official languages of the UN. According to the BCH website, the geographical distribution of P. macerans is described as ‘usually found in soil and plant materials but has also been identified in blood cultures of infants with infection’.

Note 5: NZ Gazette Oct 2007 The NZ Gazette is the official newspaper from the NZ Government. On pages 38 and 41 respectively the Enzyme – “Cyclodextrin glucanotransferase (CGTase)” is derived from the source P. Macerans. (formerly Bacillus Macerans) – which is a starch binding domain - (*Ref Note 3 in the reference area at the end of this application). Therefore, this enzyme was known to be present in NZ prior to this date.

There is also an edition Notice number 2000-gs9376 which lists Food Authority Amendment No. 53 to the Food Standards Code in Australia and New Zealand. The variations set forth in the Schedule below are variations to the Food Standards Code (hereinafter called 'the Code') which was published by the National Health and Medical Research Council in the Commonwealth of Australia Gazette, No. P 27, on 27 August 1987, and which has been varied from time to time. The Schedule contains variations adopted by the Australia New Zealand Food Standards Council in November and December 2000. There is mention of Bacillus macerans being the former name for Paenibacillus macerans.

December 2013 EPA0327 8

Application Form To obtain a determination of whether an organism is a new organism

4. Checklist This checklist is to be completed by the applicant

Application Comments/justifications

All sections of the application form completed ☒ Yes ☐ No or you have requested an information waiver (If No, please discuss with an under section 59 of the HSNO Act Advisor to enable your application to be further processed)

Confidential data as part of a separate, ☐ Yes ☒ No identified appendix

Supplementary optional information attached:

 Copies of additional references ☒ Yes ☐ No

 Relevant correspondence ☒ Yes ☐ No

Administration Are you an approved EPA customer? ☐ Yes ☒ No If Yes are you an: Applicant: ☐ Agent: ☐

If you are not an approved customer, payment of fee will be by:  Direct credit made to the EPA bank ☐ Yes ☐ No account (preferred method of payment) ☒ Payment to follow Date of direct credit:

 Cheque for application fee enclosed ☐ Yes ☐ No ☐ Payment to follow

Electronic, signed copy of application e- ☒ Yes mailed to the EPA

December 2013 EPA0327 9

Application Form To obtain a determination of whether an organism is a new organism

Signature of applicant or person authorised to sign on behalf of applicant

☐ I am making this application, or am authorised to sign on behalf of the applicant or applicant organisation.

☒ I have completed this application to the best of my ability and, as far as I am aware, the information I have provided in this application form is correct.

29thApril 2020

Signature Date

Request for information waiver under section 59 of the HSNO Act

I request for the Authority to waive any legislative information requirements (i.e. concerning ☐ the information that has been supplied in my application) that my application does not meet (tick if applicable).

Please list below which section(s) of this form are relevant to the information waiver request:

Appendices and referenced material (if any) and glossary (if required)

Note 1 Ref: (Email extract from S.A Wakelin 25.04.2020 – Copy to EPA also)

S.A Wakelin wrote: The first publication referring to when P. macerans PT1 was assessed in the laboratory for biological activity was published in August 19981. The reference is attached. This publication does not mention P. macerans PT1, but does reference the experiment that it was part of and gives us a time stamp; it must have been isolated well in advance of this laboratory experiment, the time taken to analyse and report and publish these results. As such, I’m >95% certain that the isolations would have occurred in 1997 (probably mid or early in the year); certainly well before July 1998 (when the Hazardous Substances and New Organisms Act came into force). However, I do not have my laboratory notes from this time to absolutely demonstrate this.

1 Wakelin, S. A., Stewart, T. M. A., & Walter, M. (1998, August). In vitro testing for biological control of Aphanomyces euteiches. In Proceedings of the New Zealand Plant Protection Conference (Vol. 51, pp. 90-95).

December 2013 EPA0327 10

Application Form To obtain a determination of whether an organism is a new organism

As Bevan points out, the taxonomy of this bacterial group has progressed well past when we made the determination that this strain was ‘P macerans’. Furthermore, this identification was based on carbohydrate utilisation profiles (API 50 CHB microtubule system) which wont be considered particularly authoritative in this modern age. Unless Lincoln Uni has an isolate that can be sequence-Identified it will be a hard call to confirm this as the taxon name.

I have sent similar information to the EPA on a separate request from them.

Kind regards everyone Steve

Note 3 Ref: https://en.wikipedia.org/wiki/Paenibacillus_macerans

1. ^ "Paenibacillus macerans - Information on Paenibacillus macerans - Encyclopedia of Life". Encyclopedia of Life. Retrieved 19 December 2014. 2. ^ "Paenibacillus macerans". Interdisciplinary Atlas. Department of Veterinary Disease Biology - University of Copenhagen. 2011. Retrieved 18 August 2016. 3. ^ Jump up to:a b REGNUM PROKARYOTAE. "ABIS Encyclopedia". Tgw1916.net. Retrieved 19 December 2014. 4. ^ Jump up to:a b Gupta, Ashutosh; Murarka, Abhishek; Campbell, Paul; Gonzalez, Ramon (2009). "Anaerobic Fermentation of Glycerol in Paenibacillus macerans: Metabolic Pathways and Environmental Determinants". Applied and Environmental Microbiology. 75 (18): 5871– 83. doi:10.1128/AEM.01246-09. PMC 2747847. PMID 19617389. 5. ^ Rodriguez-Jerez, J.J.; Giaccone, V.; Colavita, G.; Parisi, E. (1994). "Bacillus macerans—a new potent histamine producing micro-organism isolated from Italian cheese". Food Microbiology. 11 (5): 409–15. doi:10.1006/fmic.1994.1046. 6. ^ "Bacillus and related endospore-forming bacteria". Textbookofbacteriology.net. Retrieved 19 December 2014. 7. ^ Noskin, Gary A.; Suriano, Terra; Collins, Susan; Sesler, Stefani; Peterson, Lance R. (2001). "Paenibacillus macerans pseudobacteremia resulting from contaminated blood culture bottles in a neonatal intensive care unit". American Journal of Infection Control. 29 (2): 126– 9. doi:10.1067/mic.2001.111535. PMID 11287883.

Note 4 Ref: https://bch.cbd.int/database/record.shtml?documentid=108888

Note 5 Ref: https://gazette.govt.nz/notice/id/2007-gs7060 (11th Oct 2007) https://gazette.govt.nz/notice/id/2000-gs9376 (20th Dec 2000)

December 2013 EPA0327