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ASSESSMENT OF PROPOSAL FOR AMENDMENT
Application proposed to be amended APP203321
Approval holder The New Zealand Institute for Plant and Food Research Limited Purpose of the approval To genetically modify bacterial, fungal and plant species to
analyse the virulence of plant-pathogenic fungi.
Date of approval 16 July 2018
Amendment number APP203742
Purpose of the amendment To allow the approval holder to undertake research on one additional fungal pathogen and five additional plant species (whole plant)
Amendment applicant The New Zealand Institute for Plant and Food Research Limited
Date of advice 20 August 2019
Summary
1. This memo provides the EPA staff assessment and recommendation regarding the proposed amendment to the approval of application APP203321.
Introduction
2. The New Zealand Institute for Plant and Food Research Limited (PFR; the approval holder and the applicant) was granted approval APP203321 in July 2018, by the decision of the Decision Making Committee. The approval allows PFR to develop (through genetic modification) the microorganisms and plant host species (listed in Appendix one of the original decision) to analyse the virulence of plant-pathogenic fungi.
3. The controls proposed for APP203321 mitigate the risk of the Genetically Modified Organisms (GMOs) escaping from containment. The controls are outcome-based, specifying outcomes that must be achieved rather than prescribing a set method by which the outcome must be
achieved.
4. The approval holder is seeking to amend this approval to allow the development of 6 additional species, one fungal pathogen and five plant species (whole plant), in accordance with the existing approval.
5. The original decision was made by an Environmental Protection Authority (EPA) Decision Making Committee, under section 40(1) of the Hazardous Substances and New Organisms
(HSNO) Act 1996, taking into account matters relevant to the purpose of the Act, as specified under Part 2 of the Act and the HSNO (Methodology) Order 1998.
6. This proposal will be determined by an EPA Decision Making Committee in accordance with powers delegated by the Authority under section 19(2)(b) of the Act.
Legislative criteria and EPA guidance
7. Any approval may be amended under section 67A of the HSNO Act, provided the change is minor in effect or corrects a minor or technical error.
8. A “minor error” is likely to be an error (a mistake) that is thought to be comparatively unimportant or insignificant. A “technical error” may include typographical or drafting errors related to a technical aspect of the approval and are not restricted to “minor” technical errors.
Changes that are “minor in effect” may include alterations that do not significantly increase risks, especially those risks that are associated with the organism, and on the parties involved.
9. This amendment proposed is minor in effect and the amended decision will allow for the development of the additional species to be carried out under the proposed controls.
The proposed amendments and staff analysis
The proposed amendment
10. The approval currently allows the development of a variety of bacterial, fungal and plant species under outcome-based controls. The applicant wishes to add five plant species (Vitis vinifera L., Vitis rotundifolia Michx., Vitis rupestris Scheele, Vitis riparia Michx., and Vitis champini Planch) and one fungal species (Botrytis cinerea) to the approval to be developed under this approval.
11. Vitis vinifera L. is the predominant species in the New Zealand wine industry and includes all major grape varieties, such as Sauvignon blanc, Pinot noir, Chardonnay, Pinot gris, and Merlot.
12. Vitis rotundifolia Michx., V. rupestris Scheele, V. riparia Michx., and V. champini Planch are primarily used as rootstocks.
13. All Vitis species proposed in the amendment proposal are listed in the Plant Biosecurity Index1, MPI.
14. Out of the five Vitis species, only Vitis vinifera has been subject to development under the HSNO Act.
15. Botrytis cinerea Pers. Fr. (teleomorph Botryotinia fuckeliana (de Bary) Whetzel) is an airborne plant pathogen causing grey mould infecting over 200 crops worldwide including flowers, fruits,
1 The Plants Biosecurity Index contains a list of plant species that are legally allowed to be imported into New Zealand, subject to the relevant Import Health Standard (IHS) under the Biosecurity Act. The Ministry for Primary Industries (MPI) oversees this list, and undertakes an assessment of biosecurity risks for a plant before it is assigned to an IHS. Plant species listed on the PBI are not new organisms
(https://www.epa.govt.nz/industry-areas/new-organisms/about-new-organisms/).
leaves, shoots and soil storage organs. Several major crops are affected by this fungus, including tomato, kiwifruit, roses, strawberry, table grapes and wine grapes (Williamson et al.
2007). Botrytis cinerea is found throughout New Zealand and is an ongoing concern for many New Zealand horticultural industries, including wine grapes (Plant & Food Research. 2015) where it causes grey mould, and kiwifruit (Michailides & Elmer 2000), where it causes post- harvest rots.
16. Botrytis cinerea survives on the soil in the form of resting spores called sclerotia, on a saprophytic2 interaction with plant debris, or as a latent infection in plant tissues. Sclerotia germinate at temperatures between 3 and 27ºC to produce mycelium3. Conidiphores4 produced directly from the hyphae form conidia5, are dispersed by wind, water splash and irrigation.
Conidia germinate on plant tissues in cool and humid weather, with temperature around 1- 30 ºC (optimum 18). Conidia directly penetrate through wounded tissues. Infection occurs in the presence of free water or relative humidity higher than 90% for several hours, and is optimal at 15-25 ºC resulting in signs of mould. Repeated cycles of disease will occur while there is a possible host in the field. Under adverse environmental conditions (ie, high temperatures and low humidity), the fungus will produce new sclerotia overwinter (Bugwood Wiki 2019).
17. In 2012, non-statutory advice (PNZ1000111) advised that Botrytis cinerea is present in New Zealand, and this non-statutory advice superseded a previous approval (NOC99015) which required importation into containment of Botrytis cinerea. Under APP201258, the existing approval (NOC99015) was amended to remove Botrytis cinerea (along with three other organisms).
Assessment of the proposal
18. All the proposed new species are Category 2 host organisms as they are clearly identifiable and classifiable according to genus, species, and strain or other sub-specific category as
appropriate; and
are whole plants with a reproductive structure and that are (or are not) kept in a closed container, or without a reproductive structure and that are not kept in a closed container (Vitis species), or
are microorganisms of risk group 1 or risk group 2 (see paragraph 19), and are or contain an infectious agent pathogenic to humans, animals, plants, or fungi; or produce desiccation- resistant structures, such as spores or cysts, that may normally be disseminated in the air (Botrytis cinerea).
2 Obtaining food by absorbing dissolved organic material
3 the mass branched, tubular filaments (hyphae) of fungi
4 A specialised hyphal branch of some fungi that produces conidia
5 An asexual spore formed by abstraction at the top of a hyphal branch.
19. According to AS/NZ 2243.3:2002, risk group 1 microorganisms are unlikely to cause human, plant or animal disease; and risk group 2 microorganisms are pathogens that can cause human, plant or animal disease, but are unlikely to be a serious hazard to laboratory workers, the community, livestock, or the environment; laboratory exposures may cause infection, but effective treatment and preventive measures are available, and the risk of spread is limited.
20. None of the species proposed to be added to the original approval are listed as prohibited organisms by the HSNO Act (Schedule 2, Prohibited new organisms, HSNO Act).
21. None of the species proposed to be added to the approval are listed as unwanted organisms (Unwanted Organisms 2019).
22. APP203321 (the original approval) has outcome-based controls which means that we do not prescribe containment controls, rather the EPA proposes outcomes that the applicant then achieves according to the best practice. However, the proposed containment regime of the applicant is adequate to contain all these proposed new host species. The applicant has proposed that all intended experiments with new species are already outlined in the existing approval, and no further controls are required.
23. The applicant has stated in their amendment application that a specific containment regime to contain Botrytis cinerea spores will be in place. As the applicant stated “all manipulations of Botrytis cinerea spores will be carried out in liquid suspensions to prevent any airborne release.
There will be no spraying of spore suspensions, and all inoculations of host tissue will be done using directly applied droplets rather than spraying. If living host plants that cannot be kept in secondary containment are to be inoculated, or spray inoculations are required, this work will be carried out under an enhanced6 level of containment”.
24. In the original application, there was one airborne fungus (Podosphaera leucotricha) whereby a special containment regime was imposed. A similar containment regime is proposed for Botrytis cinerea, one of the additional host organisms that has been proposed to be added to the original application.
25. EPA staff are satisfied that the containment regime in the original approval is adequate to contain the proposed additional organisms.
26. Kaupapa Kura Taiao (KKT) had no major concerns from a Māori point of view and were satisfied that the organisms would be adequately contained and not adversely affect Māori interests. However, KKT suggested that the applicant receive comments from Ngāti Whātua Orākei’s on the proposal, as the containment facility is located in their rohe (tribal territory).
Also, KKT states that the inclusion of five plant species from the Vitis genus may be of interest to Māori-owned viticulture and wine making operations, for example, Kono Beverages which
6 As the applicant stated in their original application, they have designed an enhanced containment facility, referred to as a PC3 laboratory (section 4.2 of the original application).
owns Tohu Wines and Aronui Wines. KKT included the contact details for Kono beverages for the applicant to contact them.
Māori consultation
27. Despite the efforts of the applicant to obtain the requested Māori advice, they were not successful. Therefore, KKT agreed that we move forward to formally receive the amendment application without further Māori engagement.
Assessment conclusion
28. In assessing whether the proposed amendment meets the criteria required for an amendment under s67A of the HSNO Act, we conclude that the amendment is minor in effect, as there is no change in the risk posed by the organisms, and the controls provide for suitable containment of the organisms.
29. Therefore, we recommend that it is appropriate to amend this approval under section 67A of the HSNO Act as the amendment is minor in effect.
30. The proposed amendment may be achieved by adding the additional organisms to Table 1 of the draft amended decision document, as well as to the table in Appendix 1 of the decision document. We have provided a tracked changes version of the document to highlight the required changes, should you approve the amendment.
Matters in Part 2 of the Act
31. The proposed amendment relates to an approval for a GM development in containment application. The change proposed by the amendment is minor in effect and will not alter the risks of this research. As such, I do not think that the purpose, principles or matters to be considered (sections 4-8 of the HSNO Act) would be adversely affected by the proposed amendment.
Consultation
32. The Ministry for Primary Industries (MPI) and the Department of Conservation (DOC) were consulted regarding the proposed amendment. DOC had no objection to this amendment. MPI did not respond.
Recommendation
33. I recommend that you approve the amendment of the Decision document for application APP203321 under section 67A of the HSNO Act, as the proposed amendment is to add five plant and one fungal species that all occur in New Zealand.
Date Advisor, New Organisms
Hazardous Substances and New Organisms
References
Bugwood Wiki, 2019. Botrytis cinerea. Retrieved 25 February 2019.
https://wiki.bugwood.org/Botrytis_cinerea
Michailides TJ, Elmer PAG 2000. Botrytis Gray Mold of Kiwifruit Caused by Botrytis cinerea in the United States and New Zealand. Plant Dis 84(3): 208-223.
Plant & Food Research., 2015. Controlling botrytis in New Zealand
https://www.plantandfood.co.nz/growingfutures/case-studies/controlling-botrytis-nz-vineyards Unwanted Organisms, Ministry of Primary Industries, 2019. Unwanted Organisms search. Retrieved 7
February 2019. https://www1.maf.govt.nz/uor/searchframe.htm
Williamson B, Tudzynski B, Tudzynski P, van Kan JA 2007. Botrytis cinerea: the cause of grey mould disease. Mol Plant Pathol 8(5): 561-80.
Michailides TJ, Elmer PAG 2000. Botrytis Gray Mold of Kiwifruit Caused by Botrytis cinerea in the United States and New Zealand. Plant Dis 84(3): 208-223.
Oliveira. M. S, Bugwood Wiki,. , 2019. Botrytis cinerea. Retrieved 25 February 2019.
https://wiki.bugwood.org/Botrytis_cinerea
Plant & Food Research., 2015. Controlling botrytis in New Zealand
https://www.plantandfood.co.nz/growingfutures/case-studies/controlling-botrytis-nz-vineyards Unwanted Organisms, Ministry of Primary Industries, 2019. Unwanted Organisms search. Retrieved 7
February 2019. https://www1.maf.govt.nz/uor/searchframe.htm
Williamson B, Tudzynski B, Tudzynski P, van Kan JA 2007. Botrytis cinerea: the cause of grey mould disease. Mol Plant Pathol 8(5): 561-80.
