Public Hearing for APP202334 An application to import the fungicide - PowerPoint PPT Presentation

Staff Presentation Public Hearing for APP202334 An application to import the fungicide ESTEEM Dr Ivy Robinson Applications Advisor Hazardous Substances Team

Background on APP202334 ESTEEM is a fungicide formulation containing an active new to New Zealand, Polyoxin D zinc salt. ESTEEM is a suspension concentrate formulation intended to be used to control powdery mildew in apples and grapes, and to control gray mold in grapes

Lifecycle information ESTEEM will be imported in 200 – 1000 L bulk containers, then repackaged and relabelled in New Zealand The applicant intends that ESTEEM will be transported by air, sea and road, and stored in accordance with NZS 8409 Management of Agrichemicals. The applicant intends that ESTEEM be disposed of by use as a fungicide, and recommends that waste containers be recycled using the Agrecovery scheme ESTEEM 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 ESTEEM by untrained users ESTEEM is intended to be diluted in 400 – 2000 L/ha of water and applied at a rate of 20 – 50 g of the active Polyoxin D zinc salt per hectare Application is intended to be by low volume spray or high volume broadcast spray to apple trees or grapevines.

Polyoxin D zinc salt Polyoxin D zinc salt is produced by bacterial fermentation Its mode of action is not by directly killing fungal plant pathogens. Instead, it inhibits the growth of the plant pathogens by competitive inhibition of uridine diphosphate-N-acetylglucosamine to fungal chitin synthetase The result is insufficient chitin for normal cell wall growth, and a loss of pathogenicity of the fungus The mode of action is specific to certain susceptible fungi. Yeasts are not affected. Bacteria are also not affected as they do not synthesis chitin

Submissions Four submissions were received Two submitters supported the application: Pipfruit New Zealand Zelam Limited Zelam Limited requested to speak at this hearing, while Pipfruit New Zealand did not request to speak Two submitters opposed the application: Ngāpuhi HSNO Komiti Te Rūnanga o Ngāi Tahu Both of these submitters initially requested to speak at the hearing, but the Ngāpuhi HSNO Komiti are now not speaking at this hearing

Key issues from submissions Submission from Te Rūnanga o Ngāi Tahu Te Rūnanga o Ngāi Tahu consider that the application lacks sufficient information to be assessed Particular concern regarding the identification and assessment of potential risks to Māori culture and values. They consider that this section of the application form made no attempt to identify, quantify or address any of the potential risks to Māori from the use of ESTEEM Consider that the application therefore should not have been formally received

Also consider that the application did not disclose sufficient information to allow submitters to make a full risk assessment of the substance Noted that no data was provided in the application form regarding the aquatic toxicity of the formulation Noted that ESTEEM may present a low-toxicity fungi- specific alternative to some current fungicides

Submission from the Ngāpuhi HSNO Komiti Consider that the benefits of ESTEEM are not significant, given how the substance would be used in their rohe Are concerned about whether contractors applying ESTEEM will be able to comply with any controls on its use Consider that the applicant should be responsible for ensuring that incidents resulting from the use of ESTEEM are prevented Consider that the application process was not one where there was full disclosure of information, and therefore opposed the application

Submission from Pipfruit New Zealand Pipfruit New Zealand noted that there are a limited number of fungicides available for disease control in apples in the preharvest period. They note that ESTEEM is likely to have a short preharvest interval or no preharvest interval, based on overseas registrations, and therefore consider that ESTEEM will be a beneficial new option for use in the preharvest period. Noted that the active is derived from a naturally occurring microorganisms, has a low hazard profile, and has been used for a number of years overseas without reports of adverse effects or the development of disease resistance to the active.

Submission from Zelam Limited Zelam Limited noted that the New Zealand pipfruit industry has developed an Integrated Fruit Production (IFP) programme, an approach to disease control using ecologically safer disease treatment methods. Noted that late season fungal infections can render crops unsaleable, and poor disease control can also affect crop growth in the following season Noted that Polyoxin D zinc salt has a new mode of action that is specific to a narrow range of fungal diseases. They noted that this allows growers to target specific disease problems without interfering with management of other diseases Consider that the low toxicity and ecotoxicity of ESTEEM make it a desirable low risk product. They noted that ESTEEM causes low or nil residues in product from treated crops and is therefore a desirable option for disease treatment in the preharvest period

Staff response to submissions The EPA consider that the application met the requirement for formal receipt in that all aspects of the application form were completed. The staff note that the applicant did not present an assessment of the risks, costs and benefits of ESTEEM with respect to the kaitiaki relationship of Māori and their culture to the environment. However, the staff have made an assessment of the potential risks to Māori culture and values based on information available about the use of the substance and the risks it presents The staff note that the decision-making committee is able to request further information if they consider that they do not have sufficient information to make a decision on this application.

Some of the information that Te Rūnanga o Ngāi Tahu consider should have been released is commercially sensitive information that the EPA has withheld from public release under section 57 of the HSNO Act 1996. This information includes the composition of ESTEEM, as well as data on the physical and toxicological properties of ESTEEM and the active ingredient. The staff note that it is the responsibility of the orchard owner and the person(s) applying the substance for appropriate use of a substance in an orchard. The staff agree with Pipfruit New Zealand and Zelam Limited that ESTEEM has a relatively low hazard profile, and that this makes ESTEEM a desirable alternative to existing fungicides The staff agree that ESTEEM could provide a useful fungal disease treatment option in the pre-harvest period The staff consider that approval of ESTEEM would provide benefits to the apple and grape industries

Hazard classifications The staff classified Polyoxin D zinc salt as 6.4A (eye irritancy), 9.1B (aquatic ecotoxicity). These classifications were based on test data. Based on test data the staff determined that some classifications proposed by the applicant (6.1D inhalation acute toxicity, 6.3B skin irritancy) do not need to be applied to Polyoxin D zinc salt The staff classified ESTEEM as 6.5B (contact sensitisation), 9.1C (aquatic ecotoxicity). The classification of 6.5B is based on test data on ESTEEM Test data also showed that the 6.4A classification applied to Polyoxin D zinc salt does not need to apply to ESTEEM

Human health risk assessment The staff conducted a quantitative risk assessment for ESTEEM This showed that the risks to operators, re-entry workers, and bystanders are below levels of concern, as anticipated exposures are below the acceptable operator exposure level (AOEL) No personal protective equipment is required to reduce risk to an acceptable level, but the staff consider it is appropriate to retain requirements for PPE as this is good practice for handling agrichemicals Risks during the non-use phases of the lifecycle of ESTEEM were qualitatively assessed as negligible

Environmental risk assessment The staff conducted a quantitative assessment of the ecotoxicological risks of ESTEEM Given the proposed use pattern, the risks are below the level of concern for aquatic organisms, earthworms, birds and bees The staff note that no information was provided regarding the potential impact of ESTEEM on non-target plants The staff consider that the risk to non-target plants is likely to be negligible due to the: • Low toxicity to algae • Low application rates • Non-persistence in the environment • Lack of adverse incidents reported overseas

Environmental risk assessment The staff note that the information provided with the application was not sufficient to enable staff to carry out a quantitative risk assessment for non-target arthropods Studies on terrestrial invertebrates carried out using Japanese Ministry of Agriculture, Forestry and Fisheries guidance Results of study could not be used for quantitative risk assessment but all indicated very low toxicity of Polyoxin D zinc salt to non-target arthropods Staff consider that the risk to non-target arthropods is likely to be negligible due to the: • Low toxicity to bees • Low application rates • Non-persistence in the environment • Lack of adverse incidents reported overseas