Public Hearing for APP An application to import DuPont Zorvec Enicade Fungicide Dr Ivy Robinson Applications Advisor Hazardous Substances Team Staff Presentation

Background on APP DuPont Zorvec Enicade Fungicide is an oil dispersion formulation intended to be used to control downy mildew in onions DuPont Zorvec Enicade Fungicide contains an active new to New Zealand, oxathiapiprolin

Lifecycle information DuPont Zorvec Enicade Fungicide will be imported in 1– 5L containers The applicant intends that DuPont Zorvec Enicade Fungicide will be transported by sea, rail and road, and stored in accordance with NZS 8409:2004 Management of Agrichemicals. The applicant intends that DuPont Zorvec Enicade Fungicide be disposed of by use as a fungicide, and recommends that waste containers be recycled using the Agrecovery scheme DuPont Zorvec Enicade Fungicide is intended to be used by commercial growers and contractors familiar with safe practices for storing and handling pesticides. The applicant intends that there would not be domestic or home use of DuPont Zorvec Enicade Fungicide by untrained users DuPont Zorvec Enicade Fungicide is intended to be diluted in 200– 500 L/ha of water and applied at a rate of 35 g of the active oxathiapiprolin per hectare Application is intended to be by foliar boom spray.

Submissions Five submissions were received Three submitters opposed the application: Ngati Huarere ki Whangapoua Trust Te Rūnanga o Ngāi Tahu – requested to be heard at a hearing Ngāpuhi HSNO Komiti – requested to be heard at a hearing, but subsequently decided not to attend the hearing Two submitters neither opposed nor supported the application: Ngāti Whātua Ōrākei Whai Maia Limited noted that they did not oppose the application provided that the issues raised in their submission are given adequate consideration Beef + Lamb New Zealand Ltd did not support or oppose the application

Key issues from submissions Submission from Beef + Lamb New Zealand Ltd Beef and Lamb noted that agrichemicals are applied to crops that are fed to food producing animals, and that residues in the resulting animal products could provide a risk to human health. Trade markets could also be impacted if those markets do not accept the animal products due to residues Submission from Ngati Huarere ki Whangapoua Trust Ngati Huarere ki Whangapoua have concerns about the impacts of chemicals where risks are not fully known and understood. They also had concerns about human safety and aquatic ecotoxicity if field testing has not been undertaken As a result, they recommend a precautionary approach until monitoring of use is undertaken in other countries

Submission from Ngāti Whātua Ōrākei Whai Maia Limited Ngāti Whātua Ōrākei advocate for an approach to mildew eradication that does not involve harmful chemicals and do not support any use of fungicides in their rohe They consider that use of DuPont Zorvec Enicade Fungicide will result in depletion and degradation of native biodiversity and ecological systems, and that this would adversely impact on their values Submission from Ngāpuhi HSNO Komiti Ngāpuhi recommended further investigation on the toxicity of DuPont Zorvec Enicade Fungicide to aquatic species, and New Zealand native flora and fauna

Submission from Ngāpuhi HSNO Komiti (continued) Ngāpuhi are concerned about poor management of chemical sprays with chronic toxicity, and their impact on the well being of the whenua and food sourced from aquatic environments (kai roto, kai awa) Ngāpuhi consider that improvements can be made by parties involved in regulating and using hazardous substances to mitigate risks and ensure compliance with controls and regulations Ngāpuhi consider that hazardous substance applications fail to recognise non-target, endangered, or native species. They consider that practises and beliefs of cultural significance, and Te Tiriti o Waitangi are not taken into account Ngāpuhi consider that appropriate consultation was not undertaken, and consider that the application should be withdrawn until further evidence is provided that risks to Māori have been fully investigated and mitigated

Submission from Te Rūnanga o Ngāi Tahu Ngāi Tahu criticised the application for not including a draft label for DuPont Zorvec Enicade Fungicide in the publicly available material Ngāi Tahu criticised the application for not discussing tank mixing of DuPont Zorvec Enicade Fungicide with other fungicides prior to application. They consider that the application should have included a risk, cost and benefit analysis of use of DuPont Zorvec Enicade Fungicide in tank mixes Ngāi Tahu criticised the section of the application on Māori culture and the relationship of Māori to the environment as comprising of toxicology and ecotoxicology data rather than assessing risks, costs and benefits to Māori Ngāi Tahu are concerned that because the formulation has low solubility in water it has aquatic ecotoxicity properties that are difficult to assess Ngāi Tahu consider that the application should be declined, but, if not declined, that conservative buffer zones should be applied to manage risks from aquatic ecotoxicity

Staff response to submissions Residues in animal products Pesticide residues in animal products and their impact on human health and animal products are the regulatory responsibility of ACVM and are outside the scope of HSNO approvals Field testing EPA staff consider that the effects of DuPont Zorvec Enicade Fungicide can be evaluated from the test data available, and quantitative modelling of the expected exposure of the substance to workers, bystanders and re-entry workers We consider that these exposures are below levels that would cause harm and that it is not necessary to undertake field testing and monitoring for human health and environmental impacts prior to approval

Staff response to submissions (2) Aquatic ecotoxicity and native species The staff undertook quantitative modelling of the risks to aquatic organisms and terrestrial flora and fauna This modelling takes into account the potential for native flora and fauna to be more sensitive than organisms used in testing The modelling indicated that exposures to native flora and fauna are expected to be below levels that would cause adverse effects In the assessment, studies on the formulation took the low solubility of the active into account by expressing the toxicity based on measured concentrations Risks to Māori and impacts on mahinga kai The staff consider that adverse effects on mahinga kai (traditional food sources) species are not expected We consider that there will not be any significant impact on culturally important taonga species

Staff response to submissions (3) Information The staff consider that the draft label for the substance can be confidential to the applicant. The staff note that draft labels can be subject to significant revision depending on the outcome of the EPA decision and may contain information that is commercially sensitive at the time of application The staff note the concerns of Ngāi Tahu that the application did not include an assessment of the cultural risks to Māori, with this section of the application form essentially consisting of a detailed discussion of the environmental risks The staff report provides a detailed risk assessment of the human health and environmental risks of DuPont Zorvec Enicade Fungicide. This risk assessment was used to inform an assessment of the risks to the relationship of Māori to the environment The staff note that the applicant provided information to the Te Herenga network prior to formal receipt and public notification of the application

Staff response – tank mixes Tank mixes The staff acknowledge that there may be uncertainty with respect to synergistic or antagonistic effects as a result of tank mixing pesticide formulations The staff note that use of combinations of pesticide actives is standard agricultural practise used to minimise the total number of applications of substances and to aid in management of pest resistance to pesticide actives Pesticide actives are divided into compatibility groups to avoid known issues in tank mixes such as loss of efficacy, physical effects that can cause damage to equipment, actives that are prone to development of cross-resistance or increased toxicity

Staff response – tank mixes (2) The scope of the Act is limited to issuing or not issuing an approval for the substance that is the subject of the application. Hazardous substances used in a tank mix with DuPont Zorvec Enicade Fungicide will be subject to conditions on their own approval under the Act No information is available in the application about potential affects from tank mixing DuPont Zorvec Enicade Fungicide with other pesticide formulations No information is available that indicates that there is a risk to be managed from tank mixing that would not be covered by controls on DuPont Zorvec Enicade Fungicide and the controls on the other substances included in tank mixes The staff note that it may not be feasible to obtain data on all possible combinations of pesticides applied together in tank mixes

Hazard classifications The staff classified oxathiapiprolin as 9.1A (aquatic ecotoxicity). This classification was based on test data on toxicity to Daphnia magna. The staff classified DuPont Zorvec Enicade Fungicide as 6.3A (skin irritant), 6.5B (contact sensitisation), and 9.1D (biocidal action). These classifications were determined from test data on DuPont Zorvec Enicade Fungicide. The biocidal classification is applied because DuPont Zorvec Enicade Fungicide does not have any other ecotoxicity classification (class 9), and it is intended for biocidal use (as a fungicide).

Human health risk assessment The staff conducted a quantitative risk assessment for DuPont Zorvec Enicade Fungicide This showed that the modelled exposures to operators, re-entry workers, and bystanders are below the acceptable operator exposure level (AOEL). No personal protective equipment is required to reduce exposure to less than the AOEL, but the staff consider it is appropriate to retain requirements for PPE as DuPont Zorvec Enicade Fungicide is classified as a skin irritant and contact sensitiser The staff consider that with the controls in place, the risks to workers and bystanders from the use of DuPont Zorvec Enicade Fungicide are negligible Risks during the non-use phases of the lifecycle of DuPont Zorvec Enicade Fungicide were qualitatively assessed as negligible

Environmental risk assessment The staff conducted a quantitative assessment of the ecotoxicological risks of DuPont Zorvec Enicade Fungicide The staff determined that the acute and chronic exposures to aquatic organisms, earthworms, sediment-dwelling organisms, non- target plants, birds, bees and non-target arthropods are below levels of concern and so the risks are considered negligible There is also not expected to be a risk to ground water

Risks to the relationship of Māori to the environment DuPont Zorvec Enicade Fungicide has hazardous properties that could lead to cultural risk. The staff have determined that the risks to taha hauora (human health) are not likely to be significant given the use pattern and the controls proposed by staff The active ingredient in DuPont Zorvec Enicade Fungicide has toxicity to aquatic environments, and therefore could impact on taonga species, in particular species associated with mahinga kai (food resources) The staff note that based on the environmental risk assessment, DuPont Zorvec Enicade Fungicide is not expected to cause harm to mahinga kai species

Benefits The applicant considers that DuPont Zorvec Enicade Fungicide will provide significant benefits associated with: Improved crop health, and prevention of yield loss Associated financial benefits for growers The new active with an alternative mode of action will be useful in disease resistance management Lower risks to aquatic environments than other existing fungicides

Staff assessment of benefits The staff accept that there will be financial benefits to some companies associated with the approval of DuPont Zorvec Enicade Fungicide The staff agree that the approval of DuPont Zorvec Enicade Fungicide provides an additional fungicide active with a different mode of action to existing fungicides, and that it presents a useful option for resistance management The staff consider that the lower hazard profile compared to existing fungicides and the negligible risks to human health and the environment are significant benefits

ProductActives ConcentrationApplication Rate/ha Typical product hazard classification Zorvec Enicadeoxathiapiprolin100 g/L35 g6.3A, 6.5B, 9.1D (biocide) Acrobat, Cobra and others dimethomorphUp to 500 g/kg90 – 180 g6.9B (oral), 9.1B Ridomil Gold, Helios and others metalaxyl250 g/L160 g3.1C, 6.1D (oral, inh.), 6.3A, 6.4A, 6.5B, 6.8B, 6.9B (oral, inh.), 9.1C, 9.3C Max Cl, Cobra and others chlorothalonilUp to 720 g/L900 g 180 g 6.1B (inh.), 6.3B, 8.3A, 6.5B, 6.7B, 6.9A (oral), 9.1A, 9.2B, 9.3B Nautile, Curfew and others cymoxanil300 g/L or 450 g/kg 111 – 150 g6.1E (oral), 6.3B, 6.4A, 6.5B, 6.9B (oral), 9.1B, 9.2D, 9.3C Amistar, Tazer and others azoxystrobin250 g/L g/kg 125 g250 g/L formulation: 6.1D (oral), 6.3B, 6.4A, 6.9B (oral), 9.1A Acrobat, Nautile and others mancozebvariousUp to 2 kg6.3B, 6.4A, 6.5B, 6.9B (oral), 9.1A Reasonfenamidone500 g/L150 g6.9B (oral), 9.1A, 9.2D Revusmandipropamid250 g/L100 – 150 g6.9B (oral), 9.1D BacStarBacillus subtilis250 g/kg6.5B, 9.1D (biocide) Cusol, Nordox and others Several saltsvariousUp to 5 kg/ha6.1D (oral, inh.), 6.3A, 8.3A, 6.5A, 6.5B, 6.8B, 6.9B (oral, inh.), 9.1A, 9.3B Sources: NZ Novachem Agrichemical Manual 2013, ACVM Register, and EPA

Controls Default controls triggered by the classification of the substance are used as the basis for the controls on this substance Variations proposed to the default controls include the setting of acceptable daily exposure (ADE) and potential daily exposure (PDE) values. A number of additional controls are proposed under section 77A of the HSNO Act 1996 that the staff consider will provide better management of the risks of the substance

Controls Proposed additional controls: A maximum application rate of 350 mL formulated product/ha (equivalent to 35 g oxathiapiprolin/ha), maximum of 2 applications per year, and a minimum interval between applications of 10 full days – based on the intended use pattern described by the applicant Restriction to ground-based application methods only and restriction against application onto or into water A re-entry interval where PPE is required until the spray has dried Label information control to communicate these requirements to users of the substance An impurity control on the level of methanol in the technical grade oxathiapiprolin

Overall recommendation The staff consider that with the proposed controls in place, the level of risk to human health and the environment will be negligible The staff consider that the level of risk to Māori culture, and to society, community and the local economy will be negligible The staff recommend that the application to import or manufacture DuPont Zorvec Enicade Fungicide be approved