16
Tetraniliprole (200 g/L formulation; Vayego) Consideration of aspects of the New Zealand EPA Environmental Assessment Report Submitted To: Richard Mohan Bayer New Zealand Limited 3 Argus Place Glenfield, Auckland, 0627 New Zealand 15 October 2019 Prepared by: Chris Lee-Steere Australian Environment Agency Pty Ltd Unit 14/16 National Cct BARTON ACT 2600 Tel: 02 6273 7777 e-mail: [email protected] website: www.aeapl.com.au

EPA - Tetraniliprole (200 g/L formulation; Vayego) Consideration of aspects … · 2019. 10. 21. · large degree of conservatism associated with the EPA assessment use of the EC10

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

  • Tetraniliprole (200 g/L formulation; Vayego)

    Consideration of aspects of the New Zealand EPA

    Environmental Assessment

    Report Submitted To:

    Richard Mohan

    Bayer New Zealand Limited

    3 Argus Place

    Glenfield, Auckland, 0627

    New Zealand

    15 October 2019

    Prepared by:

    Chris Lee-Steere

    Australian Environment Agency Pty Ltd

    Unit 14/16 National Cct

    BARTON ACT 2600

    Tel: 02 6273 7777

    e-mail: [email protected]

    website: www.aeapl.com.au

    mailto:[email protected]://www.aeapl.com.au/

  • 2

    Table of Contents

    1 INTRODUCTION .......................................................................................................................... 3

    2 ECO-TOXICITY END-POINT ..................................................................................................... 3

    3 RUNOFF ASSESSMENT .............................................................................................................. 6

    4 SPRAY DRIFT ASSESSMENT .................................................................................................... 9 4.1 Water/sediment kinetics ........................................................................................................ 9 4.2 NZ EPA calculated spray drift buffer zone ......................................................................... 11 4.3 Averaging period applied in spray drift assessment ............................................................ 11 4.4 Refinement of spray drift risk assessment outcomes ........................................................... 12

    5 REFERENCES ............................................................................................................................. 13

    APPENDIX 1: XLFIT SUMMARY STATISTICS REPORT, CHIRONOMUS 28 D, EMERGENCE

    .............................................................................................................................................................. 14

    APPENDIX 2: XLFIT SUMMARY STATISTICS REPORT, CHIRONOMUS 28 D, DEVELOPMENT

    .............................................................................................................................................................. 15

    APPENDIX 3: POINT AND AVERAGE DEPOSITION AT DOWNWIND DISTANCES, ORCHARD

    APPLICATION, ‘BASIC DRIFT VALUES’. ...................................................................................... 16

  • 3

    1 Introduction

    Bayer New Zealand Limited submitted an application to import for release Vayego into New Zealand.

    Vayego contains the new active constituent, tetraniliprole, at 200 g/L and use is intended in pome fruit,

    stone fruit, grapes and kiwifruit. The New Zealand EPA has undertaken an assessment for this product

    and active constituent and derived environmental controls as reported in their Science Memo,

    APP203605 – Vayego, September 2019.

    Bayer have requested consideration of the EPA assessment and considering additional arguments with

    respect to the environmental assessment report. Specifically, the issues to be considered included the

    critical ecotoxicity study (28 day spiked water test with Chironomus riparius); confirming the outcomes

    of the EPA’s runoff methodology; and refined modelling for spray drift using the appropriate drift

    deposition curves and dissipation of tetraniliprole in water bodies between applications. The proposed use pattern for Vayego for Pomefruit has also changed from 3 applications to 2 applications so the risks

    from this revised use pattern have also been assessed.

    2 Eco-toxicity end-point

    The specific request from Bayer related to reviewing the eco-toxicity end-point applied in the EPA

    assessment and determine whether any additional refinement could be applied. The toxicity end-point

    that drives the risk assessment outcome is the chronic 28 day No Observed Effect Concentration

    (NOEC) to Chironomus riparius of 0.0008 mg/L. Given the importance of this value, it is worth

    considering its relevance. The following thoughts are offered:

    1) The NOEC is based on initial nominal concentrations, but these were measured at the start of the test. The initial measured concentration corresponding to the NOEC is 0.00087 mg/L, which

    will help the risk assessment outcomes;

    2) The NOEC is based on emergence, and a statistically significant effect on emergence at the next highest test concentration, initial measured 0.00176 mg/L. At this level there was a 13.3%

    reduction in emergence compared to controls.

    3) A regression derived EC10 (the concentration that effects 10 % of the test species) is a more scientifically robust and preferable value to use in this situation. Use of an EC10 value is

    allowed in the guidance from the European Foods Safety Authority (EFSA) and the New

    Zealand EPA use EC10 values for risk assessment using Chironomus species when assessing

    the risks through spiked sediment (EFSA, 2013 and EPA NZ 2018). Further, it is standard

    methodology in the EFSA (2013) guidance to apply an EC10 for a chronic surface water

    regulatory acceptable concentration at Tier 1 (p 17, EFSA (2013)). In this instance given the

    large degree of conservatism associated with the EPA assessment use of the EC10 is

    appropriate.

    4) The study authors derived an EC10 of 0.00071 mg/L by probit analysis, but noted their calculation was invalid1 so it should not be relied on. They did not attempt any other way of

    calculating the EC10;

    5) Using a standard dose/response with a sigmoidal dose/response model (Gadakar & Call 2014, citing Hill 1910)2. The equation applied is a 4-parameter logistic model as follows:

    1 See Appendix D of test report, p 88. 2 Gadakar S and Call G, 2015. Computational tools for fitting the Hill equation to dose-response curves. Journal

    of Phamacological and Toxicological Methods. Vol 71 pp 68-76.

  • 4

    % 𝑖𝑛ℎ𝑖𝑏𝑖𝑡𝑖𝑜𝑛 = 𝐴 +𝐵 − 𝐴

    [1 + (𝐶𝑥)

    𝐷

    ]

    6) The parameters “A” and “B” are set at 100 and 0 respectively. “x” = concentration (µg/L). Parameters “C” and “D” depend on the dose/response and these are provided in the following

    assessments. “C” is the dosage at which 50% effects occur and “D” is the slope at the steepest

    part of the curve. The EC10 is 0.0021 mg/L and the dose/response curve is well defined (see

    Figure 1 below).

    The study ECx values were calculated using probit analysis. The EC10 for emergence was calculated

    to be lower than the study NOEC despite only 2.7% inhibition on emergence at this rate (0.8 µg/L

    nominal). The probit analysis performed in the study for emergence used probit analysis using linear

    maximum likelihood regression. No other methods for calculating ECx values were tried and the results

    obtained by the study authors are stated in their test report to not be valid. There was a poor goodness

    of fit (Chi2 62.7) and no meaningful concentration/response. This is puzzling given a dose/response

    seems apparent. Nonetheless, the EC10 derived through the study authors probit analysis of 0.71 µg/L

    should be rejected and it should not have been reported in the body of the report without noting its

    unreliability. Other valid methods for calculating an EC10 value, which could be applied in the risk

    assessment instead of the NOEC, are available. The emergence data used for assessing this is as

    follows:

    Table 1: Effects of tetraniliprole on emergence of Chironomus riparius in a 28 day spiked water

    study

    Treatment (initial

    measured

    concentration)

    Number

    introduced

    Number

    emerged

    % emergence % reduction in

    emergence compared

    to controls

    0 (pooled controls) 160 150 93.75

    0.216 80 71 88.75 5.33

    0.432 80 67 83.75 10.67

    0.872 80 73 91.25 2.67

    1.76 80 65 81.25 13.33

    3.58 80 48 60 36.0

    7.3 80 6 7.5 92.0

    Using the quantal emergence data (number introduced/number emerged), probit analysis has been

    carried out with the probit sigmoid curve and the logit sigmoid curve. The data were shown to be

    satisfactory for analysis. Using the probit curve, the EC50 (the concentration that effects 50 % of the

    test species), EC10 and Chi2 were 3.67 µg/L, 2.10 µg/L and 6.23 µg/L respectively. The 95%

    Confidence Interval (CI) for the EC10 was 1.55-2.51 µg/L. Using the logit model the EC50, EC10 and

    Chi2 were 3.68 µg/L, 2.12 µg/L and 5.63 µg/L respectively. The 95% CI for the EC10 was 1.56-2.53

    µg/L. These results have been obtained with StatsDirect Statistical Software, v 3.2.8 (16/09/2019) and

    are in terms of initial measured concentrations.

    Non-linear regression without log transforming exposure concentrations results has also been applied

    and results in very different values. Using a 4 parameter model logistic dose/response model (0-100%

    inhibition), an EC50 and EC10 of 4.06 and 2.11 µg/L (95% CI 1.0-3.2 µg/L), respectively were

    calculated. This value is in excellent agreement with the other probit analysis results provided above.

    The software used was XLfit v 5.4.0.8. The output report with fit parameters and statistics is provided

    in Appendix 1.

  • 5

    Figure 1: Dose/Response with EC10 intercept, emergence data, Chironomus riparius.

    In addition, the results for development rate have also been considered further. Using nominal

    concentrations, the study authors calculated an EC10 of 1.0 µg/L (95% CI 0.09-1.83 µg/L. The

    following mean replicate data were used:

    Table 2: Effects of tetraniliprole on development rate of Chironomus riparius in a 28 day spiked

    water study Treatment (initial

    measured

    concentration)

    Mean

    development

    rate (/d)

    % reduction in

    development rate

    compared to controls

    0 (pooled controls) 0.065 -

    0.216 0.067 -3.08

    0.432 0.064 1.54

    0.872 0.066 -1.54

    1.76 0.051 21.5

    3.58 0.042 35.4

    7.3 0.038 41.5

    These percent reduction values are slightly different to those used by the study author but are likely due

    to rounding in mean development rate values. Probit analysis is not really appropriate for non-quantal

    data such as growth rates. However, the author’s probit analysis result is confirmed through non-linear

    regression modelling. In undertaking the modelling, individual replicate data were used to obtain higher

    statistical power and confidence in the results. The individual replicate results are reported in the

    summary output for this model in Appendix 2.

    Figure 2: Dose/Response with EC10 intercept, development rate data, Chironomus riparius.

    The EC10 from this dose/response relationship is 1.15 µg/L (95% CI 0.67-1.63 µg/L) based on initial

    measured concentrations (1.0 µg/L based on nominal concentrations). The software used was XLfit v

    5.4.0.8. The output report with fit parameters and statistics is provided at Appendix 2.

  • 6

    Recommendation: Revise the final toxicity value from the nominal concentration NOEC to

    the initial measured concentration EC10. The EC10 based on development rate is lower than

    that for emergence and should be applied in the risk assessment. The appropriate value for risk

    assessment is 1.15 µg/L.

    3 Runoff assessment

    In their Microsoft Excel spreadsheet, the EPA has a variable “Averaging time for concentration in

    waterbody (default is 3)”. The EPA appears to have misunderstood this variable in the context of the

    REXTOX model. This is supposed to be the time between application and a rainfall event and it is used

    to calculate the Crsoil_surface value, that is, it considers degradation between the time of application

    and runoff event. It is not related to the receiving water or residence time in it. The formula used is

    therefore wrong but the difference in outcome does not end up being significant.

    The model as applied by the EPA results in a receiving water body concentration from runoff in the

    dissolved phase. A Multiple Application Factor (MAF) is applied. The runoff is assumed then to occur

    at 3 days after the final application. Tetraniliprole is relatively persistent in soil with the EPA half-life

    of 131.4 days, so with three applications and a 21 day spray interval, the MAF is 2.70 and the application

    rate assessed for runoff is 60*2.7 = 162 g/ha with a 65% crop interception value3.

    The runoff concentration is provided as a peak value and this is then compared to the aquatic NOEC of

    0.0008 mg/L. The following result is obtained and is provided here to demonstrate the PERAMNZ

    output assesses to EPA methodology:

    3 Note that the assessment below has been carried out to assess the impacts of 3 applications to validate the

    EPA’s runoff assessment. Only 2 applications of Vayego are now being proposed, which reduces the risks.

  • 7

    Figure 3 Output from the PERAMNZ model according to the EPA assessment methodology

    The downslope buffer zone of 23 m is as calculated by the EPA in their Science Memo.

    The EPA Rextox approach essentially calculates an edge of field concentration and then calculates a

    buffer zone required for that edge of field concentration to be reduced to an acceptable level. This

    assumes that the edge of field runoff constitutes the whole water body and does not actually account for

    dilution of the runoff water into a standing body of water. This has been the EPA’s long standing

    approach, however, possible further refinement is provided below.

    In their methodology document (EPA, 2018), the EPA states this OECD model to be validated by the

    work of Probst et al, 2005. This is incorrect. The version of Rextox, developed by an OECD work

    group, used by the EPA was adapted by the Australian Department of Environment back in 2009 to

    adopt a standard 20 mm runoff from 100 mm rainfall. This is not a scientifically justified approach and

    deviates from the OECD work. The Australian Pesticides and Veterinary Medicines Authority

    (APVMA) has since rejected this approach. Probst et al (2005) considered an in-stream extension and

    applied the curve numbers from the OECD work, not those adopted by Australia for fixing

    runoff/rainfall. The model used by the Australian regulator uses the modified Rextox model to predict

    the edge of field, then distributes this to a standard water body assuming runoff from a 10 ha catchment

    to a 1 ha pond with initial water depth of 15 cm. The New Zealand methodology stops at the edge of

    field concentration and does not distribute into a receiving water body.

  • 8

    The PERAMNZ software has output standardised to NZ EPA requirements but can also include output

    to consider the impact of changes to NZ methodology and the potential refinement through considering

    runoff from a catchment to a standard water body is one option.

    If runoff from the above scenario is assumed to occur from 10 ha to a 1 ha pond, the water volume of

    the pond is 3 ML prior to rainfall and an extra 2 ML will run into the pond from 20 mm runoff over 10

    ha. The following refined outcomes are calculated where the ecotoxicity end-point based on the

    Chironomus riparius development rate of 1.15 µg/L is applied. Three scenarios are modelled and the

    results shown below:

    Table 3: Refined scenario 1; Application to vines, 1 application, 5% slope; 60% interception

    Table 4: Refined scenario 1; Application to stone fruit, 2 applications, 14 day spray interval, 5%

    slope; 65% interception

  • 9

    Table 5: Refined scenario 1; Application to pome fruit, 2 applications, 21 day spray interval, 5%

    slope; 65% interception

    Following the NZ EPA’s standard methodology for calculating an edge of field concentration, but

    applying a refinement in consideration of runoff from a catchment to a water body, applying a shallower

    slope to account for the fact that tree crops in New Zealand are very unlikely to be grown on steep

    slopes and refining the ecotoxicity end-point, runoff buffer zones could be reduced to between 5 and 8

    m depending on the application scenario being considered.

    It should be pointed out that although grapes could potentially be grown on slopes, the vast majority

    are expected to be grown on relatively flat land. The area of New Zealand where grapes are most likely

    to be grown on slopes is Central Otago, however, this represent only 3 % of New Zealand’s total wine

    by tonnage (New Zealand Wine, 2019)

    4 Spray drift assessment

    4.1 Water/sediment kinetics

    The New Zealand EPA considers multiple applications in their spray drift assessment. In doing this, the

    EPA methodology applies a whole system half-life, then considers removal from that system through a

    series of fate processes including sorption to suspended matter, sorption to sediment and degradation.

    This method is suitable for a screening approach and chemicals that pass this level of assessment

    without the need for additional controls require no further assessment. This was not the case for

    tetraniliprole. Results for two systems were available with very different whole system half lives

    (DT50s), and the most conservative value was adopted.

    Where a Double First- Order model (DFOP) model is used, the NZ EPA appear satisfied to use the

    DT50 overall value, so that approach is maintained in this analysis. The whole system half-lives

    between the two systems were significantly different with a DT50 of 11.1 days in the Anglersee system

    (Single First-Order (SFO)) and ~11 times higher in the Wiehltalsperre system with a DT50 of 122 days

    ( DFOP). These differences were due to the behaviour of tetraniliprole in the sediment compartment,

    not the water compartment. This is an important consideration because the risk assessment is driven by

    a water column toxicity end-point. The use of the most conservative whole system DT50 value is taken

    in conjunction with the most conservative soil sorption Koc to consider partitioning in the spray drift

    assessment and these results in tandem lead to overly conservative outcomes which do not reflect what

    would happen in the environment.

    The two water/sediment systems had very different sediment compartments. The Anglersee system had

    a sandy sediment with low organic carbon (0.35%) compared to the Wiehltalsperre systems with a high

    11% OC component. The amount of dry weight sediment in the test systems was also very different

  • 10

    due to the much higher density of the sandy sediment in the Anglersee system and the sediment

    compartment in the Anglersee and Wiehltalsperre systems was 299.8 g dw and 57.6 g dw, respectively.

    In both systems the amount of water was the same. This means that concentrations of active constituent

    in the different sediments will be very different for the same amount of applied radioactively. For

    example, 20% AR in the sediment would equate to a sediment concentration of 0.045 mg/kg dw in the

    Anglersee system compared to 0.18 mg/kg in the Wiehltalsperre. The following table considers

    concentrations of tetraniliprole in the water and sediment compartments and calculating the system Kd

    for each time point:

    Table 6: Concentrations of tetraniliprole in water and sediment, and calculated Kd values for each

    system for different times of measurement. DAT Wiehltalsperre system Anglersee system

    Cw (mg/L) Cs (mg/kg) Kd (L.kg) Cw Cs Kd (L.kg)

    0 0.178 0.130 0.73 0.179 0.031 0.17

    1 0.154 0.169 1.10 0.141 0.045 0.32

    3 0.129 0.266 2.07 0.116 0.045 0.39

    8 0.092 0.381 4.11 0.081 0.050 0.61

    14 0.034 0.579 16.86 0.048 0.033 0.69

    29 0.018 0.533 29.16 0.017 0.017 0.98

    59 0.014 0.462 33.13 0.003 0.005 1.58

    101 0.008 0.431 52.09 0.001 0.001 1.32

    It is clear that partitioning in the Anglersee system is significantly less than that in the Wiehltalsperre

    system. However, metabolism was much faster in the Anglersee system so persistence in the sediment

    compartment was not as long.

    The complexities associated with trying to determine an appropriate Kd/Koc and system half-life for

    modelling decline in surface water concentrations, which is what the EPA does in considering its

    averaging period in the spray drift assessment, can be overcome simply by using the water column half

    life with no additional consideration of partitioning and degradation because these fate processes are

    alread7y accounted for in the water DT50.

    In the water column, tetraniliprole behaved in a similar fashion in both systems with half-lives of 5.3

    and 6.3 days in the Anglersee system and Wiehltalsperre system, respectively, both based on the DFOP

    model. In the Anglersee system, degradation of tetraniliprole was significantly faster in the sediment

    compartment, with conversion primarily to BCS-CL73507-N-methyl-quinazolinone where this

    metabolite reached almost 80% AR in the sediment. Toxicity data (10 day spiked sediment to compare

    to the parent) show this metabolite to be much lower in toxicity than the parent compound with the 10

    day NOEC to Chironomus dilutus being 4.45 mg/kg sediment compared to 0.011 mg/kg sediment for

    tetraniliprole. In the Wiehltalsperre system, this metabolite was formed at much lower levels, and

    formation did not occur in the sediment until later in the incubation period. While it is appropriate to

    maintain a whole system or sediment phase analysis for sediment organisms, the water column exposure

    could be re-assessed through the known dissipation kinetics of tetraniliprole from the overlying water

    given the consistency between the two systems.

    The short half-life in water is confirmed from the critical toxicity study (28 day chronic toxicity test

    with water/sediment system, Chironomus riparius). In this study, 6 exposure concentrations were tested

    with water column measurements taken at 0, 4, 8 and 28 days. In all cases, degradation/dissipation

    followed SFO kinetics4 and half-lives in the water ranged from 3.67-4.64 days. The measured water

    concentrations and SFO calculated values (DT50; k) are as follows:

    4 Kinetics analysis performed with CAKE v3.3

  • 11

    Table 7: Measured water concentrations and water column DT50 (day), Chironomus riparius

    spiked water study

    Nominal

    concentration

    (µg/L)

    Measured water concentration SFO results

    Day 0 Day 4 Day 8 Day28 DT50 k

    0.2 0.216 0.104 0.0442 0.012 3.67 0.1889

    0.4 0.432 0.217 0.109 0.012 4.04 0.1716

    0.8 0.872 0.542 0.219 0.012 4.64 0.1494

    1.6 1.76 0.826 0.435 0.0272 3.83 0.1810

    3.2 3.58 1.73 0.969 0.052 4.05 0.1711

    6.4 7.3 3.62 1.96 0.117 4.10 0.1691

    The toxicity end-point that is driving the risk assessment is based on a water column result. Given the

    above analysis and demonstration that tetraniliprole dissipates from water in a similar fashion from

    different water/sediment systems, the following non-EPA derived spray drift buffer zones are based on

    a water dissipation half-life of 6.3 days. However, in considering dissipation during the incubation

    period of the water/sediment studies, the other environmental fate processes of sorption to suspended

    matter and sediment, and degradation are already accounted for so in calculating buffer zones, these

    processes are not included again.

    4.2 NZ EPA calculated spray drift buffer zone

    The buffer zones in the Science Memo have been set based on a dense orchard in Agdrift, which covers

    high volume spraying scenarios such as for citrus and tree nuts. The use pattern for Vayego is not

    represented by this scenario. The EPA only has a choice of “Dense”, “Sparse” or “Vineyard”. However,

    these are all based on AgDrift deposition curves and the previous APVMA spray drift policy (APVMA,

    2008).

    The buffer zones as calculated in the Science Memo are correct based on the EPA current methodology.

    Time between applications is taken into account with a MAF calculated, this is just not shown in Table

    46 of the Science Memo. Importantly though, the MAF is based on the whole system DT50 between

    applications but does not factor in other fate processes of sorption to sediment and suspended

    particulates between application.

    As described above, the whole system half life means the MAF derived (1.89; 2 applications, 21 day

    spray interval, DT50 122 days) will overpredict actual exposure because none of the other removal

    mechanisms from water are considered between applications, only after the final application. Also, the

    use of the longest whole system half-life and lowest sorption value is overly conservative and does not

    reflect the observed removal of the active constituent from water bodies.

    If arguments above are accepted regarding the use of a water dissipation half-life, the spray drift

    assessment can be re-done by using this half-life, but not accounting for additional sorption (Koc set to

    “0” in the model).

    4.3 Averaging period applied in spray drift assessment

    The EPA has applied an averaging period of 28 days in undertaking their spray drift assessment. This

    would be appropriate if the Chironomus toxicity end-point was based on a flow through system, or

    reported in terms of mean measured concentrations. However, the value is reported in terms of the

    initial nominal concentration so the 28 day averaging period should not be factored into the exposure.

    No averaging period will result in longer buffer zones unless the toxicity end-point from the

    Chironomus study is amended to be a 28 day time weighted average (TWA28) value.

    In the following spray drift assessments, no averaging is undertaken given the use of initial

    concentrations. However, the results show the different buffer zones calculated when applying the water

  • 12

    dissipation half-life rather than the whole system half-life, and the effect of using the Chironomus EC10

    based on initial measured concentrations rather than the NOEC based on nominal concentration.

    4.4 Refinement of spray drift risk assessment outcomes

    There is not a suitable AgDRIFT model scenario applicable for the orchard uses of Vayego. In updating

    their spray drift policy, the APVMA recognised there are no validated predictive models currently

    available for vertical sprayers, the ‘basic drift values’ are used as standard deposition curves for the use

    of vertical sprayers. These were generated from field trials conducted in Germany in the 1990s and have

    a long history of effective regulatory use in Germany and other countries, including Canada (APVMA,

    2019). While these drift curves are applied in the APVMA updated spray drift methodology, the

    terminology differs. From the German ‘basic drift values’, Fruit crops – early, Fruit crops – late and

    Grapevine – late are termed “Canopies taller than 2 metres (non-fully foliated)”; “Canopies taller than

    2 metres (fully foliated)”; and “Canopies 2 metres and shorter”, respectively.

    The proposed uses for Vayego are represented by application to fully foliated canopies > 2 m (pome

    fruit and stone fruit) and canopies 2 metres and shorter (grapes and kiwifruit).

    For the following suggested refined buffer zones, the deposition curve from the basic drift values, as

    reported in the APVMA Spray drift risk assessment tool (SDRAT - https://apvma.gov.au/node/10796)

    have been applied, but modified for NZ use. That is, the point source deposition in the SDRAT have

    been averaged over 50 m to account for the standard water body width and a 30 cm water depth is

    included in calculating the drift factor. The deposition profile for the two canopy types assessed here

    are provided in Appendix 3.

    The following table summarises the different calculated spray drift buffer zones based on the refined

    drift deposition profiles, application of the water only half-life with no additional factoring for sorption

    and the refined eco-toxicity end-point:

    Table 8: Refined downwind buffer zones calculated for tetraniliprole for different scenarios (water

    DT50 = 6.3 d, Toxicity end-point = 1.15 µg/L)

    Scenario Canopy Drift fraction1 Buffer zone

    Vines and kiwifruit. 1 application. 2 m, fully

    foliated

    0.00473 14 m

    Pome fruit, 2 applications, 21 day spray interval 0.00523 12 m 1) The drift fraction is based on the EPA threatened species assessment factor (NOEC or EC10/10).

    https://apvma.gov.au/node/10796

  • 13

    5 References

    APVMA, 2008. APVMA Operating Principals in Relation to Spray Drift. Australian Pesticides and Veterinary

    Medicines Authority (APVMA), 15 July 2008.

    APVMA, 2019. Spray Drift Risk Assessment Manual. Australian Pesticides and Veterinary Medicines

    Authority, July 2019. Available at: https://apvma.gov.au/node/51826

    EFSA, 2013. Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-

    field surface waters Available at https://www.efsa.europa.eu/en/efsajournal/pub/3290

    EPA, 2018. Risk Assessment Methodology for Hazardous Substances. How to assess the risk, cost and benefit

    of new hazardous substances for use in New Zealand. Draft for Consultation, May 2018.

    New Zealand Wine, 2019 Vintage Indicators Region 2019 Available at

    https://www.nzwine.com/media/13034/nz-wine-vintage-indicators-2019_regions.pdf

    Probst M. Berenzen N. Lentzen-Godding A. Schulz R., 2005, Scenario-based simulation of runoff-related

    pesticide entries into small streams on a landscape level, Ecotoxicological and Environmental Safety

    62, 145-159

    https://apvma.gov.au/node/51826https://www.efsa.europa.eu/en/efsajournal/pub/3290https://www.nzwine.com/media/13034/nz-wine-vintage-indicators-2019_regions.pdf

  • 14

    Appendix 1: XLfit summary statistics report, Chironomus 28 d, Emergence

  • 15

    Appendix 2: XLfit summary statistics report, Chironomus 28 d, Development

  • 16

    Appendix 3: Point and average deposition at downwind distances,

    orchard application, ‘basic drift values’.

    Downwind

    distance (m)

    Fdeposition, canopy >2 m,

    fully foliated

    Fdeposition, canopy