1. Public Hearing for APP202774
An application for the modified reassessment of DuPont Exirel Insecticide
Staff Presentation
Dr Anna Ramarosandratana
Advisor, Hazardous Substances

2. DuPont Exirel® Insecticide (“Exirel”)
Exirel contains 100 g/L cyantraniliprole as the active ingredient and is formulated as a suspo-emulsion.
Exirel is an insecticide which is used in New Zealand to control pests such as cabbage white butterfly, diamond back moth, soybean looper, European leaf miner and grey cabbage aphid in fodder brassica crops.

3. History of Exirel
An application for Exirel was first submitted by DuPont (New Zealand) Limited in January 2012.
This application was processed as a Category C application and assessed cyantraniliprole as a new active ingredient for use in New Zealand.
Two substances were part of this initial application: Exirel® Insecticide and Benevia® Insecticide. Benevia is a different formulation of the active ingredient intended for use on onions, potatoes and field tomatoes.
Both Exirel and Benevia were approved for release in June 2013.

4. History of Exirel, continued
Additional controls were applied to Exirel, including:
This substance shall not be applied onto or into water.
A maximum application rate was set of 50 g a.i./ha ground based application, maximum three applications per year and a minimum interval of seven days.
The following must be stated on the label:
Use of Exirel must be by ground based methods.
Spray Exirel in flowering crops only after daily honeybee flights, unless spraying after daily honeybee flights is not possible
Ensure flowering weeds are removed before spraying Exirel to avoid potential exposure of honeybees.
The maximum application rate was based on the intended use pattern for Benevia, but was also applied to Exirel.

5. APP202774: Modified Reassessment
In 2015, DuPont (NZ) Ltd sought Grounds for Reassessment to allow aerial application of Exirel.
Grounds for reassessment were granted on the basis that information showing a significant change of use had become available.
The purpose of this modified reassessment (APP202774) is to determine whether the restriction to ground-based application methods can be removed.
The applicant has indicated that for aerial application, the proposed application rate is:
15 g a.i./ha, maximum three applications per year and a minimum interval of 14 days,
and that this is adequate to protect against chewing insects on fodder brassica crops.

6. Submissions Four submissions were received from:
Apiculture NZ Technical Focus Group
Te Runanga o Ngāi Tahu
Ngāpuhi HSNO Komiti
The Honeybee Society of NZ Inc.
Where appropriate, information from these submissions has been used to inform our assessment, proposed controls and recommendation.

7. Hazard classifications of Exirel
The hazard classifications of Exirel are:
These were determined in the original risk assessment for Exirel.
No new information was available for Exirel or the active ingredient cyantraniliprole at the time of reassessment.
Hazard
Classification
Skin irritant
6.3A
Contact sensitisation
6.5B
Target organ or system toxicity
6.9B
Aquatic ecotoxicity
9.1A
Terrestrial invertebrate ecotoxicity
9.4B

8. Evaluation of new use pattern
To identify and evaluate the risks associated with changing the use pattern of Exirel we conducted a quantitative risk assessment based on the parameters of both ground-based and aerial application
Key parameters of this assessment were:
Ground-based application:
Application rate: 50 g a.i./ha, applied 3 times per year with a minimum interval of 7 days
Aerial application
Application rate: 15 g a.i./ha, applied 3 times per year with a minimum interval of 14 days

9. Human health risk assessment
Risks to operators, re-entry workers and bystanders were evaluated
Our assessment determined that the following risks were below the Acceptable Operator Exposure Level (AOEL):
risks to operators mixing, loading and applying Exirel
risks to re-entry workers from residues that may be present on treated crops
risks to bystanders (toddlers) who may be exposed to spray drift during application
Note: the operator exposure assessment was based on ground-based application; operator exposure for aerial application is predicted to be lower due to the lower application rate

10. Human health risk assessment (cont.)
We note that the the hazard classifications of Exirel trigger default controls including a requirement for Personal Protective Equipment (PPE) when handling the substance.
PPE will protect against adverse effects which may arise from the contact sensitisation and skin irritant classifications of the substance.
Given the PPE requirement and the results of the assessment, we consider that the risks to human health are negligible for both ground-based and aerial application of Exirel.

11. Environmental risk assessment: approach
The potential impacts of both ground-based and aerial application of Exirel were evaluated.
The assessment evaluated risks to:
the aquatic environment
the soil environment
terrestrial plants, vertebrates and invertebrates.
The potential for Exirel to cause adverse effects to threatened species was taken into account in our assessment.
This approach recognises that any adverse effects to organisms may have more severe impacts on the population of a threatened species and therefore requires a more conservative approach when setting controls to mitigate risks.

12. Environmental risk assessment: key points
Exirel poses risks to both threatened and non-threatened aquatic invertebrates, and to sediment dwelling organisms.
Exirel does not pose risks to earthworms, but does pose temporal risks to some other organisms (e.g. springtails) within the application area. Outside this area, these risks are limited to threatened species.
Exirel poses risks to bees, particularly through oral exposure.
There are risks to some species of non-target arthropods, which may include threatened species.
The risks for all other organisms are considered to be negligible.

13. Risks to the aquatic environment
Both aerial and ground-based application of Exirel pose risks to aquatic environments (aquatic invertebrates, sediment-dwelling organisms)
We propose that buffer zones can be set to mitigate these risks, as these will reduce the amount of spray drift onto water bodies to a safe level.
Spray drift modelling was used to determine the size of buffer zones that would be required.
This assumed that Exirel is applied with a medium/fine spray.
Based on this modelling, we consider that the following buffer zones will sufficiently reduce exposure of aquatic organisms to Exirel:
Ground-based application methods: 2 metres
Aerial application methods: 10 metres

14. Risks to soil organisms
Exirel does not pose risks to earthworms that are present either within or outside the application area.
There are risks to other soil-dwelling organisms within the application area, as indicated by the sensitivity of springtails to Exirel. Outside the application area, these risks are limited to threatened species.
We note that there is evidence to suggest that effects on populations of springtails will be transitory, and that populations of these organisms are abundant.
We consider that while Exirel poses risks to some soil-dwelling organisms, the effects of this will be temporal.
The risks to soil organisms are posed by Exirel irrespective of the application method.

15. Risks to bees
Our assessment identified that Exirel is likely to cause adverse effects to bees if dietary exposure occurs.
As part of the assessment, we evaluated studies on the effect of cyantraniliprole on colony strength and brood development. No adverse effects were observed.
Study data also indicated that pre-flowering application of Exirel does not present a risk to bees.

16. Mitigation of risks to bees
Exirel is intended to be applied to fodder brassica crops during leaf development, and the crops will be grazed before reaching the flowering stage.
This use pattern reduces the potential exposure of bees to Exirel.
However, as adverse effects on bees are highly undesirable, we have proposed a series of label statements to inform user behaviour in a way that will mitigate the risks to bees.

17. Risks to non-target arthropods
Parasitic wasps and predatory mites were used as representative organisms to evaluate the effects of Exirel on other non-target arthropods.
This assessment, and review of studies on Green lacewing and ladybird beetle identified that these organisms display varied susceptibility to Exirel.
Exirel therefore poses risks to some non-target arthropods, which may include threatened species.

18. Risks posed by aerial application of Exirel
We evaluated risks to the environment posed by both aerial and ground-based application of Exirel.
This evaluation was for application rates of:
Ground-based: 50 g a.i./ha, three times per year with minimum interval of 7 days
Aerial: 15 g a.i./ha, three times per year with minimum interval of 14 days
Under these use conditions, the risks posed by aerial application are largely the same as those posed by ground- based application.
While aerial application has greater potential for spray drift, we consider that a larger buffer zone for downwind water bodies can be imposed to mitigate this higher risk.

19. Benefits of aerial application of Exirel
In evaluating the proposed benefits, we recognise that fodder brassica production in New Zealand is a valuable industry as it contributes to provision of a consistent food supply for stock
In comparison to ground-based application, aerial application of Exirel is expected to:
Reduce the likelihood of harm to vehicle operators
Preserve soil quality, as use of heavy equipment on wet soil or pugged pasture will be decreased
Ensure Exirel can always be applied to crops, allowing recommended application frequencies to be adhered to and minimising the development of pest pressure

20. Benefits of aerial application of Exirel
Allowing aerial application of Exirel may also:
Assist farmers to produce greater quantities of health fodder brassica crops for stock, facilitating good animal husbandry
Increase the economic benefits for those growing or working with fodder brassica crops, by allowing better utilisation of land and increased production of crops.
Due to a lack of information, we have not been able to quantitatively assess the significance of these benefits.

21. Risks to the relationship of Māori to the environment
Exirel has several hazardous properties which could lead to cultural risk, such as aquatic ecotoxicity and toxicity to terrestrial invertebrates.
Exirel may harm culturally significant aquatic organisms if it enters into water bodies where these organisms are present.
Māori have concern for taonga species and for species that form part of the food chain for these organisms
The interrelationship of aquatic organisms is significant to Māori
As an insecticide, Exirel poses risks to culturally significant arthropods within Te Aitanga Pepeke (the insect world).
As we identified variatiability in susceptibility of insects to cyantraniliprole, the exact risks are unknown
Such risks are potentially significant due to the role of insects in Māori cosmogeny and environmental lore

22. Risks to the relationship of Māori to the environment
Māori have general concerns about aerial application, due to the potential for impact on culturally significant receptors, particularly through spray drift.
Mitigation of spray drift is critical (e.g. buffer zones)
Māori have responsibility for kaitiakitanga (stewardship/ guardianship) of the environment
Ensure controls are adequate to allow Māori to fulfil this responsibility.
Overall, Exirel poses a number of risks, however the majority of these relate generally to Exirel, and are not specific to the application method.

23. Existing controls The current controls for Exirel state:
A maximum application rate is set for this substance:
50 g a.i./ha ground based application, maximum three applications per year with minimum application interval of seven days.
Additional label information has been specified:
The following must be stated on the label:
Use of Exirel must be by ground-based methods.
We propose removing these controls, to remove the requirement for ground-based application.

24. Proposed controls: application rate and method
We propose that these are replaced with:
Aerial application of this substance is permitted up to a maximum application rate of 150 mL of formulated substance per ha (corresponding to 15 g a.i./ha), with a maximum of three applications per year and a minimum application interval of fourteen days.
Ground-based application of this substance is permitted up to a maximum application rate of 500 mL of formulated substance per ha (corresponding to 50 g a.i./ha), with a maximum of three applications per year and a minimum application interval of seven days.
We note that the restriction to ground-based methods can be removed from the product label; however other labelling requirements will still apply.

25. Proposed controls: risk mitigation
To mitigate the risks associated with the use of Exirel according to the new use pattern, we propose the following controls:
Buffer Zones:
For the protection of aquatic organisms, the following buffer zones must be observed from downwind water bodies:
Ten metres, when the substance is applied by aerial application methods.
Two metres, when the substance is applied by ground-based application methods.
Application methods:
This substance must be applied with a nozzle set to provide a medium quality spray

26. Proposed controls: label statements (1)
The following statements, or words to the same effect, must appear on the product label and documentation supplied with this substance:
Maximum application rates apply to this substance:
Aerial application of this substance is permitted up to a maximum application rate of 150 mL of formulated substance per ha (corresponding to 15 g a.i./ha), with a maximum of three applications per year and a minimum application interval of 14 days.
Ground-based application of this substance is permitted up to a maximum application rate of 500 mL of formulated substance per ha (corresponding to 50 g a.i./ha), with a maximum of three applications per year and a minimum application interval of seven days.
For the protection of honeybees:
DO NOT apply this insecticide to flowering crops.
Take all reasonable steps to ensure that flowering weeds are removed from the application area before spraying Exirel.
Ensure that spray drift into flowering off-crop habitats is avoided during application.
DO NOT apply during bee flight.

27. Proposed controls: label statements (2)
The following statements, or words to the same effect, must appear on the product label and documentation supplied with this substance:
This substance must not be applied into or onto water
For the protection of aquatic organisms, the following buffer zones must be observed from downwind water bodies:
Ten metres, when the substance is applied by aerial application methods.
Two metres, when the substance is applied by ground-based application methods.

28. Overall recommendation
Application of Exirel by both ground-based and aerial methods poses risks to the environment and to Māori culture
We consider that these risks are acceptable and can be mitigated for both aerial and ground-based application methods, noting that aerial application requires a larger buffer zone
The level of risk to society, community and the local economy will be negligible
We note that aerial application of Exirel is likely to have benefits; and that any benefits will outweigh the negligible level of risk
We therefore recommend that the application to allow aerial application of Exirel is approved, with the proposed controls in place.

29. Questions? Thank you