DECISION 14 January 2016 1. Summary Substance MYCOTAL WG Application code APP202247 Application type To import or manufacture for release any hazardous substance under Section 28 of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Applicant New Zealand Gourmet Limited Purpose of the application To seek approval to import MYCOTAL WG, a microbial pest control agent containing the spores of the entomopathogenic fungus Lecanicillium muscarium 19-79 strain, for the control of whitefly in greenhouse crops Date application received 13 April 2015 Consideration date 15 December 2015 Further information was requested from the applicant during the evaluation and review of the application in accordance with sections 52 and 58 of the Act and consequently the consideration was postponed in accordance with section 59 of the Act Considered by The Chief Executive1 of the Environmental Protection Authority (“the EPA”) Decision Approved with controls Approval code HSR101089 Hazard classifications 6.5A, 6.5B, 9.1D 1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act. www.epa.govt.nz Page 2 of 121 Decision on application for approval to import or manufacture Mycotal WG for release (APP202247) 2. Background 2.1. MYCOTAL WG is intended for use as a microbial pest control agent (MPCA) to control whitefly in greenhouse crops. It is a water dispersible granule (WDG) formulation containing spores of the fungus Lecanicillium muscarium 19-79 strain. 2.2. The applicant intends to import MYCOTAL WG into New Zealand fully formulated, packed and labelled in 500 g and 1 kg polyethylene bags in fibreboard containers. 2.3. MYCOTAL WG will be mixed with water at a rate of up to 1 g of MYCOTAL WG per litre of water and applied at application rates of up to 3 kg of MYCOTAL WG per hectare. 2.4. It is intended that the substance should be used completely i.e. until the container is emptied, to avoid a requirement for disposal. 3. Process, consultation and reasons for non-notification 3.1. The application was lodged pursuant to section 28 of the Act. 3.2. WorkSafe New Zealand, the Ministry for Primary Industries (ACVM group), and the Ministry for the Environment were advised of the application and invited to comment. No comments were received. 3.3. The applicant requested that the application be considered as an application for rapid assessment under section 28A of the Act. 3.4. Lecanicillium muscarium is not a new organism and therefore not regulated under the New Organisms provisions of the Act. However, the 19-79 strain of L. muscarium has not been used as a pesticide active ingredient in New Zealand previously. Other strains of L. muscarium already exist in New Zealand and similar substances containing other strains of this fungus have been approved for use as microbial pest control agents. It was considered that this substance should be evaluated by a full assessment and determined under section 29 of the Act, rather than by rapid assessment, in order to evaluate the risks of this new pesticide active ingredient. 3.5. It was considered that the application would not be of significant public interest as other strains of L. muscarium already exist in New Zealand, and similar substances containing other strains of this fungus have previously been approved for use as microbial pest control agents. Therefore the application was not publicly notified in accordance with section 53(2) of the Act. 4. Hazardous properties 4.1. The staff determined the hazard classification of MYCOTAL WG based on the information provided by the applicant and other available information as documented in Appendix B. 4.2. The classifications determined by the staff are different to those submitted by the applicant (Table 1). The classification determined by the applicant was based on advice provided to the applicant by the staff prior to this application; however, the formulation of MYCOTAL WG has changed since that advice was provided. The hazard classifications of the active ingredient have been reviewed based on December 2015 Page 3 of 121 Decision on application for approval to import or manufacture Mycotal WG for release (APP202247) the data submitted in this application, and as a result the staff determined that classification for respiratory sensitisation is appropriate for MYCOTAL WG. Table 1 Hazard classifications of MYCOTAL WG as proposed by the applicant and the staff Hazard Endpoint Applicant classification EPA classification Respiratory sensitisation - 6.5A Contact sensitisation 6.5B 6.5B Aquatic ecotoxicity 9.1D (from biocidal use) 9.1D (from biocidal use) 5. Assessment of risks, costs and benefits Human health risk assessment 5.1. The currently available exposure models for pesticides are not appropriate for microorganisms, because the quality of the technical grade active ingredient is not related to the concentration or quantity of material that may be present for exposure assessment. This is due to the ability of microbial substances to reproduce very rapidly under favourable conditions. Additionally, L. muscarium 19-79 does not elicit any signs of toxicity, infectivity, or pathogenicity. As a result, a quantitative risk assessment of operator, worker and bystander exposure was not performed. 5.2. The staff have advised me that the level of risk from the use of MYCOTAL WG is expected to be negligible, for the following reasons: MYCOTAL WG exhibits a lack of toxicity, infectivity, and pathogenicity associated with L. muscarium 19-79. Risks associated with sensitisation, through respiratory or contact routes, are considered to be negligible provided requirements imposed by the default HSNO controls are complied with. The default controls are discussed in section 6 below. 5.3. A qualitative assessment of the risks associated with the sensitisation hazards of MYCOTAL WG is set out in Table 2. Environmental risk assessment 5.4. As Mycotal WG contains a new active ingredient, L. muscarium 19-79, a full quantitative assessment of the ecotoxicological risks from the use of MYCOTAL WG was carried out. This quantitative risk assessment is detailed in Appendix F. 5.5. The staff identified several data gaps during the environmental risk assessment for Mycotal WG. No studies were provided with Mycotal WG. Studies were provided for a different formulation. In the reports provided by the applicant, information regarding the strain used, the formulation, and the test conditions were not able to be fully determined. There was insufficient information to conduct a thorough quantitative risk assessment of use the substance, in particular an assessment of December 2015 Page 4 of 121 Decision on application for approval to import or manufacture Mycotal WG for release (APP202247) environmental fate and behaviour, and effects to non-target species were not able to be quantitatively assessed. 5.6. The staff determined that for permanently covered structures, the risks to the environment are below the level of concern. However, for non-enclosed structures or structures that could be partly open during the application of Mycotal WG high risks were identified for birds. 5.7. The risks to non-target arthropods could not be fully assessed due to the lack of data and information. 5.8. Based on a qualitative assessment of the risks to the environment from the non-use phases of the lifecycle of MYCOTAL WG (import/manufacture, transport, storage, and disposal) the staff have advised me that risks during these lifecycle phases would be negligible due to the low hazard profile, and the very low likelihood of a significant environmental exposure. Relationship of Māori to the environment 5.9. The potential effects of MYCOTAL WG on the relationship of Māori to the environment have been assessed in accordance with sections 5(b), 6(d), and 8 of the Act. Under these sections all persons exercising functions, power and duties under this Act shall recognise and provide for the maintenance and enhancement of people and communities to provide for their cultural wellbeing; and take into account their culture and traditions with their ancestral lands, water, taonga and the principles of the Treaty of Waitangi (Te Tiriti o Waitangi). 5.10. The staff have advised me that MYCOTAL WG triggers a number of hazardous properties giving rise to the potential for cultural risk e.g. contact and respiratory sensitisation, and use as a biocide. Cultural risk includes the deterioration of the mauri of taonga flora and fauna species, the environment and the general health and well-being of individuals and the community. 5.11. In general, the introduction and use of hazardous substances has the potential to inhibit the ability of Māori to fulfil their role as kaitiaki. This is particularly in relation to the guardianship of waterways, given the ecotoxic nature of some substances to aquatic species, and potential risks to the mauri ora of human health under prolonged exposure to some substances. 5.12. The main concerns relating to this application for Māori are likely to be in relation to dangers to birds, as a result of the quantitative risk assessment showing the potential for non-negligible risks to birds. Maori traditional mātauranga systems value New Zealand’s native birds as taonga. Māori attribute cultural and spiritual values to birds, including their importance in folklore, art, ornamentation and textiles, in addition to some birds being considered traditionally cherished cuisine. Therefore there is the potential for cultural risk arising from harm to birds. 5.13. There is also uncertainty regarding the effects of Mycotal WG due to the data gaps in the information available for the ecotoxicological assessment, and therefore some potential for cultural risk arising from harm to species not fully assessed. 5.14. If MYCOTAL WG is applied in the prescribed manner, it is considered that it is not likely to breach the principles of the Treaty of Waitangi, in particular the principle of active protection.