Staff Presentation – GF-2687 APP202336 Hearing: 17 December 2015
2 Outline Introduction to application Submissions Classifications, Risks, Controls Benefits Recommendations Questions from applicant
3 Introduction Herbicide – weed control in cereals Wettable granule 2 new active ingredients halauxifen-methyl and florasulam Both active ingredients registered in Canada and Australia
4 Proposed use pattern 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
5 Submissions
6 Submissions 7 submissions were received: 3 in support of approval • Federated Farmers Arable Industry Group • Rural Contractors New Zealand • PGG Wrightson
7 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
8 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
9 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
10 Staff response (1) Native species assessment EPA staff consider that the uncertainty factors used in our 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
11 Staff response (2) EPA staff have reviewed the entire composition of 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
12 Classifications and Risks
13 Classifications 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
14 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
15 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)
16 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
17 Key Controls
18 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
19 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
20 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
21 Protection of non target plants Performance based control requiring that applicators do not cause damage to plants outside of the property boundary Information must be provided on the product label to outline how this is done Advisory buffer zones on product label
22 Protection of non target plants Application Downwind buffer zone Downwind buffer zone - – non-target plants method threatened non-target plants Ground based 5 m 10 m Aerial 25 m 220 m 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 23 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
24 Benefits
25 Benefits New modes of action to existing herbicides used in cereals Reduces the risk of weeds developing herbicide resistance Lower risk profile than existing products
26 Recommendation EPA staff propose that the import or manufacture of GF -2687 is approved, subject to the proposed controls
27 Applicant questions
28 Endpoint for risk assessment Halauxifen-methyl Myriophyllum endpoint, E r C 50 = 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
29 Waterbody and terrestrial deposition width 50 m wide water body Terrestrial deposition (point estimate)
30 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
31 Evaporation rate For this assessment we used the default evaporation rate in AGDISP is 84.76 μm 2 /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
32 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
33 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 h erbicide coarse droplets scenario”
34 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/m 2
35 Agricultural herbicide coarse droplet scenario Distance from application area (m) 1 Fraction of application rate 0 100 200 300 400 500 600 700 800 900 0.1 0.01 0.001 0.0001
36 Questions
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