Staff Presentation GF-2687 APP202336 Hearing: 17 December 2015 2 - - PowerPoint PPT Presentation

Staff Presentation – GF-2687

APP202336 Hearing: 17 December 2015

Outline

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Introduction to application Submissions Classifications, Risks, Controls Benefits Recommendations Questions from applicant

Introduction

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Herbicide – weed control in cereals Wettable granule 2 new active ingredients halauxifen-methyl and florasulam Both active ingredients registered in Canada and Australia

Proposed use pattern

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Ground boom and aerial spraying Applied at rates of 25 g product/hectare (g/ha) equivalent to 5 g a.i./ha of both active ingredients Frequency of 2 applications of per year with a minimum of 14 day interval

Submissions

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Submissions

7 submissions were received:

3 in support of approval

• Federated Farmers Arable Industry Group
• Rural Contractors New Zealand
• PGG Wrightson

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Key issues raised by submitters

Benefits of having new modes of action to reduce the risk of resistance developing Lower risk than existing alternatives Wettable granules lower operator exposure

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Submissions

Reihana Robinson

• Opposed to approval

Te Rūnanga o Ngāi Tahu

• Neutral but opposed to approval for aerial application

Ngāpuhi HSNO Komiti

• Opposed to approval for aerial application

Ngāti Whātua Ōrākei (NWŌ)

• Use of herbicides against values but did not directly oppose the

application

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Key issues raised by submitters

Concerns about spray drift from aerial application Concerns about runoff Risks to native species Risks to Māori culture - traditional food gathering Risks from non active ingredient components and impurities

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Staff response (1)

Native species assessment

EPA staff consider that the uncertainty factors used in

• ur environmental risk assessment are adequate

Mahinga kai

EPA acknowledge that this is an issue of potential concern EPA are working on an approach to consider how to address this issue

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Staff response (2)

EPA staff have reviewed the entire composition

• f the substance and have used this for the

hazard classification and risk assessment EPA are proposing to set impurity limits for florasulam No impurities of concern for halauxifen-methyl

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Classifications and Risks

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Classifications

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Hazard Endpoint EPA classification Contact Sensitisation 6.5B Target organ systemic toxicity 6.9B (Oral) Aquatic ecotoxicity 9.1A Soil ecotoxicity 9.2A

• Error in the EPA staff report which proposed applying

a respiratory sensitiser (6.5A) classification – this should not apply due to the physical form of the substance

Risks to human health

For the proposed use patterns risks to human health were less than the level of concern

Operators (specific PPE required) Re-entry workers Bystanders

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Risks to the environment

Risks were less than the level of concern for

Ground water Sediment dwelling organisms Earthworms Birds Bees Non target arthropods Risks to surface water from runoff (concerns from submitters)

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Risks to the environment

Consistent with the concerns from submitters there were non negligible risks from spraydrift to

aquatic plants (both threatened and non threatened) non target terrestrial plants (both threatened and non threatened)

Controls proposed to manage these risks

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Key Controls

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Additional controls

Approved handlers only Maximum application rate = 25 g product per hectare (5 g of both a.i.) / ha proposed Maximum number of applications = 2 in any year with a minimum of a 14 day interval

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Protection of aquatic environment

Not onto/into water Label statement requiring coarse droplet size Ground based application

2 m mandatory buffer zone for downwind waterbodies

Aerial application

65 m mandatory buffer zone for downwind waterbodies

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Protection of non target plants

Requires a different approach from protection of the aquatic environment Definition of “non target plant” difficult for compliance and enforcement

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Protection of non target plants

Performance based control requiring that applicators do not cause damage to plants

• utside of the property boundary

Information must be provided on the product label to outline how this is done

Advisory buffer zones on product label

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Protection of non target plants

Application method Downwind buffer zone – non-target plants Downwind buffer zone - threatened non-target plants Ground based 5 m 10 m Aerial 25 m 220 m

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NZS8409:2004 users should check if there are indigenous vegetation habitat areas and reserves close to the application area before spraying

Relationship of Māori to the Environment

With the proposed controls, we consider that any potential impact to the relationship of Māori to the environment will be adequately managed Approval of substance is not likely to be inconsistent with the principles of the Treaty of Waitangi

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Benefits

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Benefits

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New modes of action to existing herbicides used in cereals

Reduces the risk of weeds developing herbicide resistance

Lower risk profile than existing products

Recommendation

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EPA staff propose that the import or manufacture of GF -2687 is approved, subject to the proposed controls

Applicant questions

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Endpoint for risk assessment

Halauxifen-methyl Myriophyllum endpoint, ErC50 = 0.393 μg a.i./L was used for risk assessment rather than the formulation endpoint for Myriophyllum

Lowest endpoint available used for risk assessment For risk assessment we need to know information about the half life in the environment and physicochemical properties

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Waterbody and terrestrial deposition width

50 m wide water body Terrestrial deposition (point estimate)

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Version of AGDRIFT and AGDISP

AgDrift: Ground based

Use deposition curves from the APVMA website

AGDISP: Aerial

Currently using v 8.15 Moving to v 8.28

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Evaporation rate

For this assessment we used the default evaporation rate in AGDISP is 84.76 μm2/deg C/sec Aware of the discussion internationally about changing this value, but we will await decisions by other regulators before considering changing this value

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Application rate questions

Water rate, active fraction and non volatile fraction used for modelling For aerial application the EPA do not carry out individual AGDISP modelling for each use scenario EPA have a series of representative use scenarios

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Application rate questions

12 representative use scenarios

Similar to the standard aerial spray drift risk assessment scenarios on the APVMA website Developed with the assistance of applicators

For this application we used our “Agricultural herbicide coarse droplets scenario”

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Application rate questions

For each representative use scenario we have a deposition curve (fraction of the application rate) Correct for the application rate to estimate spray drift in terms of g/m2

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Agricultural herbicide coarse droplet scenario

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0.0001 0.001 0.01 0.1 1 100 200 300 400 500 600 700 800 900

Distance from application area (m) Fraction of application rate

Questions

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