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

Public Hearing for APP202334

An application to import the fungicide ESTEEM

Dr Ivy Robinson

Applications Advisor Hazardous Substances Team

Staff Presentation

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

• r 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

• pposed 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

• n 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

Risks to the relationship of Māori to the environment

ESTEEM 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 ESTEEM has toxicity to aquatic environments, and therefore could impact on taonga species, in particular species associated with mahinga kai (food resources) Use of ESTEEM could potentially impact on important food species and culturally important species The staff note that based on the environmental risk assessment, ESTEEM is not expected to cause harm to manu (birds), te aitanga pēpeke (insects) or otaota (plants) For the intended use pattern and with the controls recommended by staff, the staff consider that significant harm will not occur in Te Marae o Tangaroa (freshwater and marine ecosystems)

Benefits

The applicant considers that ESTEEM will provide significant benefits associated with:

Improved crop health, and prevention of yield loss Associated financial benefits for growers The new active with a new mode of action will be useful in disease resistance management The reduced hazard classification and negligible risk to human health and the environment makes ESTEEM a suitable alternative to existing fungicides, and provides another pre-harvest treatment option

Staff assessment of benefits

The staff accept that there will be financial benefits to some companies associated with the approval of ESTEEM The staff agree that the approval of ESTEEM provides an additional fungicide active with a different mode of action to existing fungicides, and that as a result, ESTEEM presents a useful option for preharvest disease control and resistance management The staff consider that the reduced hazard compared to existing fungicides is a significant benefit

Controls

Default controls triggered by the classification of the substance are used as the basis for the controls on this substance 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 2 L ESTEEM/ha (equivalent to 100 g Polyoxin D zinc salt/ha), maximum of six applications per 365 days, and a minimum interval between applications of 7 full days Restriction to ground-based application methods only and restriction against application onto or into water Label information control to communicate these requirements to users of the substance

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 ESTEEM be approved