3DUW$±&RUH

$VVHVVPHQW 5HJLVWUDWLRQ5HSRUW

3DJHRI

The toxicity of GIBER GOBBI 20 to non-target arthropods has been investigated by carrying out a Tier I
test on Aphidius rhopalosiphi and on Typhlodromus pyri. These two species are tested, in accordance
with ESCORT 2, as representative non-target arthropods since they have been found to be particularly
sensitive species, and therefore can be considered as indicators of potential effects to the most sensitive
arthropods in the field. For convenience, the results of these studies are summarised in Table 10.5-2.
Study summaries are provided below (IIIA 10.5.2).

Table 10.5-2: GIBER GOBBI 20 - Toxicity to non-target arthropods

Test Exposed life LR50
Species Study type Reference
substance stage (g product/ha)
Aphidius Laboratory KIIIA1 10.5.1/01, Mr. S.
Adult 1108
rhopalosiphi Conditions Kimmel, 2013
GIBER
Protonymphs
GOBBI 20 Typhlodromus Laboratory KIIIA1 10.5.1/02, Mr. S.
not older 765
pyri Conditions Kimmel, 2013
than 24 h

Exposure
In-field
Non-target arthropods living in the crop can be exposed to residues from GIBER GOBBI 10 by direct
contact either as a result of overspray or through contact with residues on plants and soil or in food items.

The in-field exposure (predicted environmental residue, PER) is calculated according to ESCORT 2 using
the following equation:

PER infield Applicatio n rate (g ai/ha) u MAF

The MAF is a generic multiple application factor, which is used to take into account the potential build-
up of applied substances between applications based on the application interval, DT50 value and number
of applications. Default foliar and soil MAF values following are given in the ESCORT 2 Guidance
Document.

As recommended, the risk envelope approach will be used for the calculation of the PECs according to
the guidance document SANCO/11244/2011 rev. 5.

Rationale for crop groupings

Assuming the worst-case scenario of 100% crop interception, the key parameters in this area are the
individual application rate, the number of application and interval days between them.
The crop grouping covering the worst case scenario is presented in the table 10.5-3.

$SSOLFDQW'RFXPHQW,' B)G55*,%%(5*2%%, (YDOXG'DWH

$SSOLFDQW$XWKRU).KDOLOL
3DUW$±&RUH
5HJLVWUDWLRQ5HSRUW
$VVHVVPHQW

3DJHRI

Table 10.5-3: Summary of crop grouping for the risk envelope approach
Maximum application rate Maximum number Interval
Crop group Crops included
(g formulation/ha) of applications (days)
Pear, Orange,
lemon,
Orchards Clementine, 200 1 -
mandarin and
Cherry
Grape Grape 300 2 5
Tomato, eggplant
Vegetables 200 3 15
and artichoke

The maximum predicted environmental residues (PER) occurring within the field after application of
GIBER GOBBI 10 at the maximum application rate are presented in Table 10.5-4.

Table 10.5-4: In-field PER values for application of GIBER GOBBI 10

Substance Crop group Application rate MAF PER (foliar)
(g formulation/ha)
Orchards 200 - 200
GIBER GOBBI
Grape 300 1.7 510
10
Vegetables 200 2.3 460
In bold, the worst case value used in the calculation of HQ

Off-field
Risk assessment of areas immediately surrounding the crop is considered important since these areas
represent a natural reservoir for immigration, emigration and reproduction of arthropod populations and
provide increased species diversity. Exposure of non-target arthropods living in off-field areas to GIBER
GOBBI 10 will mainly be due to spray drift from field applications. Off-field areas are assumed to be
densely vegetated and thus spray drift is unlikely to reach bare ground. Therefore, evaluation of exposure
via soil residues in off-field areas was not considered. Off-field foliar PER values were calculated from
in-field foliar PERs in conjunction with drift values published by the BBA (2000)12 as shown in the
following equation:

Maximum in - field foliar PER x (% drift/100)

Off - field foliar PER
vegetation distributi on factor

Vegetation distribution factor: The model used to estimate spray drift was developed for drift onto a two-
dimensional water surface and, as such, does not account for interception and dilution by three-
dimensional vegetation in off-crop areas.Therefore, a vegetation distribution or dilution factor is
incorporated into the equation when calculating PERs to be used in conjunction with toxicity endpoints
derived from two-dimensional (glass plate or leaf disc) studies. A dilution factor of 10 is recommended
by ESCORT 2. For 3-dimensional studies, i.e. where spray treatment is applied onto whole plants, the
dilution factor of 10 is not used, as any dilution over the 3-dimensional vegetation surface is accounted
for in the study design.

12
90th percentile drift according to BBA (2000): Bundesanzeiger Jg. 52 (Official Gazette), Nr 100, S. 9879-9880
(25.05.2000) Bekanntmachung über die Abtrifteckwerte, die bei der Prüfung und Zulassung von
Pflanzenschutzmitteln herangezogen werden
$SSOLFDQW'RFXPHQW,' B)G55*,%%(5*2%%, (YDOXDWRU
$SSOLFDQW$XWKRU).KDOLOL
3DUW$±&RUH
$VVHVVPHQW 5HJLVWUDWLRQ5HSRUW

3DJHRI

As recommended, the risk envelope approach will be used for the calculation of the PECs according to
the guidance document SANCO/11244/2011 rev. 5.

Rationale for crop groupings

The key parameters in this area the individual application rate, the number of application and interval
days between them and the drift value related to the crops.
The crop grouping covering the worst case scenario is presented in the table 10.5-5.

Table 10.5-5: Summary of crop grouping for the risk envelope approach
Maximum
Crops Maximum number Interval Drift value
Crop group application rate
included of applications (days) (%)
(g formulation/ha)
Pear, Orange,
lemon,
Orchards Clementine, 200 1 - 15.72
mandarin and
Cherry
Grape Grape 300 2 5 8.03 7.23
Tomato,
Vegetables eggplant and 200 3 15 2.76 6.90
artichoke

The drift value at 1 m distance is 2.76% of the application rate (90th percentile drift) for vegetables. The
drift factor (% drift/100) is therefore 2.77/100 = 0.0277.

The drift value at 3 m distance is 15.72% of the application rate (90th percentile drift) for orchards. The
drift factor (% drift/100) is therefore 15.72/100 = 0.1572.

The drift value at 3 m distance is 8.03% of the application rate (90th percentile drift) for grapes. The drift
factor (% drift/100) is therefore 8.03/100 = 0.0803.

The resulting PERoff-field values are shown in Table 10.5-4.

Table 10.5-6: Off-field foliar Predicted Environmental Rates (PER)

Crop group Maximum in-field foliar drift factor Vegetation Off-field foliar PER
PER a (% drift/100) distribution factor (g formulation/ha)
(g formulation/ha)
Orchards 200 0.1572 3.14
Grape 510 0.0803 10 4.1
Vegetables 460 0.0277 1.3
a
See Table 10.5-4
In bold, the worst case value used in the calculation of HQ

$SSOLFDQW'RFXPHQW,' B)G55*,%%(5*2%%, (YDOXG'DWH

$SSOLFDQW$XWKRU).KDOLOL
3DUW$±&RUH
$VVHVVPHQW 5HJLVWUDWLRQ5HSRUW

3DJHRI

Risk assessment
The risk to non-target arthropods is assessed using the approach recommended in the published ESCORT
2 document (Candolfi et al. 2001)13 and the EC Guidance Document on Terrestrial Ecotoxicology 14.
In-field
The potential risk of GIBER GOBBI 10 to in-field non-target arthropods was assessed by calculation of
the hazard quotient (HQ = exposure/toxicity) with the predicted environmental rate (PER) and the lowest
lethal rate (LR50) values according to the following formula:

In - field PER
In field HQ
LR 50

The HQ trigger for Tier I laboratory and Tier II extended laboratory studies is 2 and 1, respectively. The
resulting HQin-field values are presented, quoted to 2 significant figures, in Table 10.5-5.

Table 10.5-5: In-field HQs for non-target arthropods

LR50 In-field foliar
Species Trigger value
(g formulation/ha) (g formulation/ha) HQ
Aphidius rhopalosiphi
Tier I, 2D exposure 1108* 0.46 2
scenario
510
Typhlodromus pyri
Tier I, 2D exposure 765* 0.67 2
scenario
* Toxicity endpoint taken from the studies performed with GIBER GOBBI 20

The in-field HQ values for exposure to maximum residues on leaves for the representative species T. pyri
and A. rhopalosiphi are less than the trigger of 2 for Tier I tests.

The in-field HQ values using the toxicity endpoint taken from the studies performed with GIBER GOBBI
20 indicate that GIBER GOBBI 10 poses low risk to in-field non-target arthropods following application
according to the proposed use patterns.

Off-field
In order to assess the potential risk of GIBER GOBBI 10 to off-field non-target arthropods, the predicted
environmental rate (Table 10.5-3) is compared with the toxicity endpoints according to the following
formula:

PER off field (g/ha)

Off - field HQ u Correction factor
LR 50 (g/ha)

13
Candolfi MP, Barrett KL, Campbell PJ, Forster R, Grandy N, Huet M-C, Lewis G, Oomen PA, Schmuck R, Vogt
H (2000) ‘Guidance Document on regulatory testing procedures for plant protection products with non-target
arthropods’ From the workshop, European Standard Characteristics of Non-target Arthropod Regulatory Testing
(ESCORT 2) 21-23 March 2000.
14
EC Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC, SANCO/10329, 17
October 2002.
$SSOLFDQW'RFXPHQW,' B)G55*,%%(5*2%%, (YDOXG'DWH
$SSOLFDQW$XWKRU).KDOLOL
3DUW$±&RUH
$VVHVVPHQW 5HJLVWUDWLRQ5HSRUW

3DJHRI

The HQ trigger for Tier I laboratory and Tier II extended laboratory studies is 2 and 1, respectively.

Correction factor: ESCORT 2 recommends that a correction factor of 5 be used when assessing Tier II
data, or 10 for Tier I data, to account for extrapolation from testing just 2 representative species, to the
species diversity expected in off-crop areas.

HQoff-field values are given, quoted to 2 significant figures, in Table 10.5-6.

Table 10.5-6: Off-field HQ values for non-target arthropods

Species LR50 Off-field foliar Correction Off-field foliar Trigger
(g product/ha) PER factor HQ value
(g product/ha)
Aphidius
rhopalosiphi
1108* 10 0.04 2
Tier I, 2D exposure
scenario 4.1
Typhlodromus pyri
Tier I, 2D exposure 765* 10 0.05 2
scenario
* Toxicity endpoint taken from the studies performed with GIBER GOBBI 20

The off-field HQ values for T. pyri and A. rhopalosiphi fall below the trigger values, indicating that
GIBER GOBBI 10 does not pose an unacceptable risk to non-target arthropods in off-field areas.

Comments: Tier 1 assessment

IIIA 10.5/01
The toxicity endpoints on the two sensitive indicator species are acceptable, though
sub-lethal effects were not recorded in the two tests.

The toxicity endpoints and resulting HQ values on the two sensitive indicator
species are acceptable. Since toxicity data are generated on a 20% product (GIBER
GOBBI 20) instead of the actual product GIBER GOBBI 10, the toxicity endpoint
should be expressed in μg a.s/bee before used in HQ calculations. The correct risk
assessment is provided below.

LR50 In-field foliar Trigger

Species
(g a.s/ha) (g a.s/ha) HQ value
Aphidius
rhopalosiphi
231.6 0.22 2
Tier I, 2D
exposure scenario
51
Typhlodromus
pyri
159.8 0.32 2
Tier I, 2D
exposure scenario

The HQ values for in-field risk to non-target arthropods do not exceed the trigger
value.

$SSOLFDQW'RFXPHQW,' B)G55*,%%(5*2%%, (YDOXG'DWH

$SSOLFDQW$XWKRU).KDOLOL