APP203254 RFC 397 (New Formulation) · and a combination of three fungicide actives: boscalid, pyraclostrobin, and tebuconazole, plus other components. 1.3. RFC 397 (New Formulation)

www.epa.govt.nz

SCIENCE MEMO

APP203254 – RFC 397 (New Formulation)

August 2019

2

Science memo for application to import or manufacture RFC 397 (New Formulation) for release (APP203254)

August 2019

Executive Summary

RFC 397 (New Formulation) is a soluble concentrate containing an insecticide pyriproxyfen, and three

fungicides boscalid, pyraclostrobin, tebuconazole as the active ingredients, plus other components. It is

intended for use as a plant protection product for control and prevention of harm from the insect pests and

fungi in roses and other ornamentals in both home and small commercial settings.

All four actives are individually approved for use in New Zealand and internationally in Australia, Canada,

Europe, and the USA. However, the combination of all the actives in one formulation is new.

For home-use applications on roses and ornamentals minimal human health risks are predicted as operator

exposures to the actives are below the Acceptable Operator Exposure Level (AOEL) even without the use of

personal protective equipment (PPE).

For commercial applications the predicted human health risks from operator exposures are above the AOEL

and would require full PPE during mixing, loading and application (excluding respirator) to mitigate health

risk. Unacceptable re-entry risks can be mitigated with use of gloves and a 7-day re-entry interval. Estimated

bystander exposure to toddlers from spray drift was below the AOEL and deemed to be low risk even in the

absence of an 8 m buffer zone.

In regard to environmental fate, boscalid is considered persistent in soil under laboratory as well as under

field conditions (DT50(lab) = 367 days and DT50(field) = 151 days). The substance is expected not to be mobile in

soil based on the column leaching test. Pyraclostrobin is considered persistent in soil and slightly mobile. In

soil, tebuconazole was persistent in laboratory studies but not under field conditions (DT50(lab) = 137 days,

DT50(field) = 34 days). It is expected to exhibit medium to high mobility in soil. Pyriproxyfen is not persistent in

soil. No information regarding mobility in soil is available for pyriproxyfen.

In regard to ecotoxicity, pyraclostrobin and pyriproxyfen are considered bioaccumulative (based on a fish

bioconcentration factor of 675 and log Kow of 5.37, respectively), boscalid and tebuconazole are not

bioaccumulative (with fish bioconcentration factors of 70 and 78, respectively).

The substance RFC 397 (New Formulation) is very ecotoxic in the aquatic environment. To manage this risk,

we propose applying controls to reduce spray-drift, including label statements requiring the substance to be

sprayed as coarse droplets and in wind speeds likely to minimise the risks of spray drift.

Chronic risks were identified for birds. Given the limited proposed use pattern (spot treatment of roses and

ornamentals using a handheld or backpack sprayer) it is considered that birds are likely to obtain sufficient

uncontaminated food. No risks from secondary poisoning were identified.

No acute risks for bees were identified, however, no information regarding larval toxicity or chronic toxicity

are available. The applicant provided additional information and a bee risk assessment. The EPA still has

concerns that the proposed use of pyriproxyfen might cause adverse effects on the health of a hive in

general and development of larvae and pupae in particular. In theory, it is considered that the proposed

controls mitigate these risks. It is uncertain whether these controls are enforceable however, given that the

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August 2019

substance is a home-use product for application to roses and other ornamentals, which are very attractive to

bees.

We consider the risks to the evaluated environment to be non-negligible but low based on the available

information. However, significant data gaps were identified.

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August 2019

Table of Contents

Executive Summary ............................................................................................................................... 2

Table of Contents .................................................................................................................................. 4

1. Introduction/Background ........................................................................................................... 7

Regulatory status........................................................................................................................... 7

2. Hazardous properties ................................................................................................................. 7

3. Risk assessment context ........................................................................................................... 8

4. Human health risk assessment .................................................................................................. 9

5. Environmental risk assessment ................................................................................................ 9

6. Proposed controls ..................................................................................................................... 11

Appendix A: Proposed controls ......................................................................................................... 12

Exposure thresholds .................................................................................................................... 12

Ecotoxicity controls ...................................................................................................................... 12

Maximum application rate ........................................................................................................... 12

Other ecotoxicity controls ............................................................................................................ 12

Mixture hazard classification calculations for identification controls ........................................... 13

Appendix B: Identity of the active ingredients, use pattern and mode of action ......................... 14

Identity of the active ingredient and metabolites ......................................................................... 14

Regulatory status......................................................................................................................... 14

Use pattern and mode of action .................................................................................................. 14

Appendix C: Hazard classification of RFC 397 (New Formulation) ................................................ 17

Appendix D: Physico-chemical properties of RFC 397 (New Formulation) ................................... 20

Appendix E: Environmental fate ........................................................................................................ 21

Executive summaries and list of endpoints ................................................................................. 21

Residues relevant to the environment ......................................................................................... 21

Degradation and fate of the active ingredients in the aquatic environment ................................ 22

Degradation and fate of the metabolite in the aquatic environment ............................................ 22

Degradation and fate of the active ingredients in soil ................................................................. 23

Degradation and fate of the metabolite in soil ............................................................................. 24

Information on the degradation and fate of the major metabolite of tebuconazole in the soil

environment is summarised in Table 16. .................................................................................... 24

General conclusion about environmental fate ............................................................................. 24

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August 2019

Appendix F: Mammalian toxicology .................................................................................................. 26

General conclusion about mammalian toxicology of the active ingredients and formulated substance

..................................................................................................................................................... 26

Appendix G: List of ecotoxicity endpoints ....................................................................................... 27

Executive summaries and list of endpoints ................................................................................. 27

Aquatic toxicity ............................................................................................................................. 27

Soil toxicity ................................................................................................................................... 31

Terrestrial vertebrate toxicity ....................................................................................................... 33

Ecotoxicity to bees and other terrestrial invertebrates ................................................................ 34

General conclusion about ecotoxicity to bees and terrestrial invertebrate toxicity ..................... 35

Appendix H: Human health risk assessment methodology ............................................................ 36

Introduction .................................................................................................................................. 36

Operator exposure and risk ......................................................................................................... 36

Re-entry worker exposure and risk ............................................................................................. 38

Bystander exposure and risk ....................................................................................................... 41

Equations used for exposure assessment .................................................................................. 44

Appendix I: Human health risk assessment ..................................................................................... 47

Quantitative risk assessment ...................................................................................................... 47

Appendix J: Environmental risk assessment methodology ........................................................... 55

Methodologies ............................................................................................................................. 55

Consideration of threatened native species ................................................................................ 56

Terrestrial risk assessment ......................................................................................................... 56

Earthworm and soil organism risk assessment ........................................................................... 57

Non-target plant risk assessment ................................................................................................ 58

Bird risk assessment ................................................................................................................... 59

Food chain from earthworm to earthworm-eating birds .................................................... 61

Bee risk assessment ................................................................................................................... 62

Non-target arthropod risk assessment ........................................................................................ 64

Appendix K: Environmental risk assessment .................................................................................. 65

Toxicity of the formulation ........................................................................................................... 65

Aquatic risk assessment .............................................................................................................. 65

Environmental mobility and persistence ........................................................................... 65

Aquatic toxicity .................................................................................................................. 65

Conclusion of the aquatic risk assessment ....................................................................... 66

Terrestrial risk assessment ......................................................................................................... 66

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August 2019

Non-target plant risk assessment ................................................................................................ 70

Bird risk assessment ................................................................................................................... 70

Secondary poisoning ......................................................................................................... 72

Pollinator risk assessment ........................................................................................................... 72

Non-target arthropod risk assessment ........................................................................................ 74

Conclusions of the ecological risk assessment ........................................................................... 75

Appendix L: Standard terms and abbreviations .............................................................................. 78

Appendix M: References ..................................................................................................................... 81

Appendix N: Confidential Composition ............................................................................................. 84

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August 2019

1. Introduction/Background

1.1. This application, APP203254, is for RFC 397 (New Formulation).

1.2. RFC 397 (New Formulation) is a soluble concentrate containing the insecticide active pyriproxyfen,

and a combination of three fungicide actives: boscalid, pyraclostrobin, and tebuconazole, plus other

components.

1.3. RFC 397 (New Formulation) is intended to be used in both home and small commercial settings as a

plant protection product for control and prevention of harm from the insect pests and fungi in roses

and other ornamentals.

1.4. It is intended to be applied with backpack or hand-held sprayers.

1.5. All four actives are individually approved for use in New Zealand and internationally in Australia,

Canada, Europe, and the USA. However, the combination of all four actives in one formulation is new

to New Zealand and anywhere else as far as the EPA is aware.

1.6. We have assessed the risks to people and the environment of New Zealand under the Hazardous

Substances and New Organisms (HSNO) Act.

1.7. We have accepted the conclusions of the overseas reviews and have not assessed in detail the test

endpoints presented in the foreign regulatory review documents.

1.8. We have assessed the risks to people and the environment in New Zealand from the use of the

substance using the endpoint data available and the standard risk assessment methodologies used by

the EPA. Full details of the risk assessment can be found in Appendices I and K.

Regulatory status

Table 1: Mixture regulatory status in New Zealand and overseas

Mixture name Regulatory history in New Zealand International regulatory history

(Australia, Canada, Europe, Japan, USA)

RFC 397 (New Formulation) New substance Not approved

2. Hazardous properties

2.1. The hazard classifications we propose for the substance are outlined in Table 2.

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August 2019

Table 2: Proposed classification for RFC 397 (New Formulation)

Hazard endpoint RFC 397 (New Formulation)

Reproductive/ developmental

toxicity 6.8B

Target organ toxicity (oral) 6.9B

Aquatic ecotoxicity 9.1A

Terrestrial invertebrate ecotoxicity 9.4B

2.2. Based on mixture rules, RFC 397 (New Formulation) is of relatively low acute toxicity in mammals and

is not classified for acute oral, dermal or inhalation toxicity. The substance is not classified as a skin or

eye irritant. RFC 397 (New Formulation) is classified as a reproductive toxicant (6.8B) and requires

6.9B classification for target organ toxicity following oral exposure.

2.3. The formulated substance is very ecotoxic to the aquatic organisms (9.1A) and ecotoxic to terrestrial

invertebrates (9.4B). For soil toxicity and terrestrial vertebrates information on several components is

insufficient to classify RFC 397 (New Formulation).

2.4. The applicant proposed the same hazard classifications as those we identified, with the exception of

not proposing a classification for reproductive/developmental toxicity (6.8B) and proposing the

formulation to be classified for skin (6.3B) and eye irritation (6.4A). The most likely explanation for the

differences are that the applicant incorrectly used the mixture rules for their irritancy classifications and

they overlooked the classification of tebuconazole as a potential reproductive/developmental toxicant.

3. Risk assessment context

3.1. We consider there is potential for significant exposure to people and/or the environment during the use

phase of the lifecycle. We have, therefore, undertaken quantitative risk assessments to understand

the likely exposures to the substance under the use conditions proposed by the applicant.

3.2. During the importation, manufacture, transportation, storage and disposal of this substance we believe

that the proposed controls and other legislative requirements will sufficiently mitigate risks to a

negligible level. This assessment takes into account the existing HSNO requirements around

packaging, identification and disposal of hazardous substances. In addition, the Land Transport Rule

45001, Civil Aviation Act 1990, Maritime Transport Act 1994 and New Zealand’s health and safety at

work requirements all have provisions for the safe management of hazardous substances.

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August 2019

4. Human health risk assessment

4.1. We consider the risks from the use of active, as a proxy for substance on users and operators of the

substance, re-entry workers and bystanders.

4.2. For home use on roses and ornamentals the predicted operator exposure to the actives are below the

Acceptable Operator Exposure Level (AOEL). This is even without the use of personal protective

equipment (PPE). Therefore, operator exposures for home use are not expected to result in adverse

health effects.

4.3. Although the ‘no PPE’ exposure model leads to an acceptable level of risk, we consider it is

appropriate to retain requirements for PPE triggered by the hazard classifications of substance since

the use of PPE when handling agrichemicals as this is good practice.

4.4. For commercial use on roses and ornamentals the predicted operator exposures are above the AOEL

even with the use of gloves during mixing, loading, and application and would require full PPE

(excluding respirator) to mitigate the risk. The difference between the home use and commercial use

relates to the comparative work rates (0.01 ha and 0.5 hours for home use compared to 1 ha and 8

hours for commercial backpack application) and consequently the amount of product handled and

duration of exposure.

4.5. Predicted exposures to actives for workers re-entering and working in areas where substance has

been applied are above the AOEL without use of gloves. These risks were considered to be mitigated

with use of gloves and a 7-day re-entry interval.

4.6. Estimated bystander exposure to toddlers from spray drift was below the AOEL and deemed to be low

risk.

4.7. The APVMA has set a maximum impurity level for dimethyl sulphate in pyraclostrobin as follows and

this should apply to RFC 397 (New Formulation):

dimethyl sulphate: 3 mg/kg (of pyraclostrobin active ingredient).

4.8. We consider the risks to human health to be minimal from home use of RFC 397 (New Formulation).

4.9. We consider the risks to human health to be significant from the use of RFC 397 (New Formulation)

for commercial applications unless appropriate PPE is worn during mixing, loading, and application.

5. Environmental risk assessment

5.1. The risks to a range of environmental receptors were considered, from the use of actives as a proxy

for the risks from substance.

5.2. The substance RFC 397 (New Formulation) is very ecotoxic in the aquatic environment. To manage

this risk, we propose applying controls to reduce spray-drift, including label statements requiring the

substance to be sprayed as coarse droplets and in wind speeds likely to minimise the risks of spray

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August 2019

drift. The following control is proposed: DO NOT apply when the garden is adjacent a water body.

With these controls we consider the risks to aquatic organisms to be negligible.

5.3. Predicted exposures to earthworms and other soil organisms were less than the level of concern from

acute exposure. The chronic risks to threatened species are above the level of concern in-field.

However, it is considered highly unlikely that threatened earthworm species would be present in

agricultural fields (Conservation status of New Zealand earthworms, 2014, Department of

Conservation). As such, the risk to threatened earthworm species is considered low since there is no

exposure pathway. Insufficient information is available to determine the risks to soil organisms from

application of boscalid, pyraclostrobin and pyriproxyfen.

5.4. No information was available for plants, however, the substance is designed to be applied to a wide

range of plants and a non-target effect is considered unlikely. As such, the risk is considered low.

5.5. Predicted exposures to birds were less than the level of concern from acute exposure. Chronic risks

were identified. Given the limited proposed use pattern (spot treatment of roses and other ornamentals

using a handheld or backpack sprayer), it is considered that birds are likely to obtain sufficient

uncontaminated food. No risks from secondary poisoning were identified.

5.6. No acute risks for bees were identified, however, no information regarding larval toxicity as well as

chronic toxicity are available. The applicant provided additional information and a risk assessment.

Looking at all this information, the EPA still has concerns that the proposed use of pyriproxyfen might

cause adverse effects on the health of a hive in general and development of larvae and pupae in

particular. In theory, it is considered that the proposed controls mitigate these risks. It is uncertain

whether these controls are enforceable however, given that the substance is a home-use product for

application to roses and other ornamentals, which are very attractive to bees.

5.7. For non-target arthropods only a partial assessment could be performed for pyraclostrobin which

indicated that those risks are below the level of concern. For this non-target group not all risks could

be evaluated. Therefore, a warning statement is proposed to inform that compatibility with integrated

pest management (IPM) has not been demonstrated.

5.8. Pyraclostrobin, tebuconazole and pyriproxyfen are not considered to be highly persistent in the aquatic

environment (with aerobic aquatic whole system DT50 values of 27, 38.7 and 28.1 days, respectively),

for boscalid no information regarding whole system degradation was available.

5.9. Pyraclostrobin and pyriproxyfen are considered bioaccumulative (based on a fish bioconcentration

factor of 675 and log Kow of 5.37, respectively), boscalid and tebuconazole are not bioaccumulative

(with fish bioconcentration factors of 70 and 78, respectively).

5.10. Boscalid is considered persistent in soil under laboratory as well as under field conditions (DT50(lab) =

367 days and DT50(field) = 151 days). The substance is expected not to be mobile in soil based on the

column leaching test. Pyraclostrobin is considered persistent in soil and slightly mobile. In soil,

tebuconazole was persistent in laboratory studies but not under field conditions (DT50(lab) = 137 days,

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August 2019

DT50(field) = 34 days). It is expected to exhibit medium to high mobility in soil. Pyriproxyfen is not

persistent in soil. No information regarding mobility in soil is available for pyriproxyfen.

5.11. No impurities of ecotoxicological concern were identified.

5.12. We consider the risks to the evaluated environment to be non-negligible but low based on the

available information. However, significant data gaps were identified.

6. Proposed controls

6.1. We consider that the proposed controls will manage most of the risks to humans and the environment.

However, we recommend that the additional controls are added under Section 77 and Section 77A of

the HSNO Act to adequately manage the risks to human health and the environment:

The substance must not be applied at rates exceeding 10 L of formulated product/ha per

application (equivalent to 64 g pyraclostrobin/ha, 126 g boscalid/ha, 215 g tebuconazole/ha

and 50 g pyriproxyfen/ha); and the substance must not be applied to the same area more than

9 times, with a minimum interval of 14 days in any 365-day period.

Only ground based methods (hand-held or backpack sprayers) are approved.

DO NOT apply when the garden is adjacent to a waterbody.

DO NOT apply when bees are actively foraging (e.g. apply in the evening after flight).

DO NOT apply on beehives or bee nests.

DO NOT apply to plants in flower or close to flower.

The following controls concerning the information presented on the label are required:

- Label statement stating “DO NOT apply using spray equipment when wind speeds are less than 3

km/hr or more than 20 km/hr as measured at the application site”.

- Label statement stating the approved application methods.

- Label statement stating the approved application rates, frequencies and intervals between

applications.

- Label statement stating the controls to protect aquatic organisms.

- Label statement stating the controls to protect pollinators

- Label statement indicating “WARNING” the substance is not compatible with Integrated Pest

Management (IPM)

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Appendix A: Proposed controls

Exposure thresholds

Exposure thresholds for Acceptable Daily Exposure (ADE) and Potential Daily Exposure (PDE) values are

not required as RFC 397 (New Formulation) is not used on edible crops.

Ecotoxicity controls

Maximum application rate

A maximum application rate is proposed to be set for RFC 397 (New Formulation), as shown in Table 3.

Table 3: Active ingredient(s) maximum application rates

Active component

Pyraclostrobin 64 g/ha, maximum nine applications/year with a minimum interval between

applications of 14 days

Boscalid 126 g/ha, maximum nine applications/year with a minimum interval between


Tebuconazole 215 g/ha, maximum nine applications/year with a minimum interval between


Pyriproxyfen 50 g/ha, maximum nine applications/year with a minimum interval between


Other ecotoxicity controls

It should be noted that not all risks can be managed by the following controls and that not all risks could be

quantified. Therefore, these controls do not manage all the risks.

The substance must not be applied at rates exceeding 10 L of formulated product/ha per application

(equivalent to 64 g pyraclostrobin/ha, 126 g boscalid/ha, 215 g tebuconazole/ha and 50 g

pyriproxyfen/ha); and the substance must not be applied to the same area more than nine times,

with a minimum interval of 14 days in any 365-day period.

Only ground based methods (hand held or backpack sprayers) of application are approved.

DO NOT apply where wind speed is less than 3 kilometres per hour or greater than 20 kilometres

per hour.

DO NOT apply when the garden is adjacent to a waterbody.

DO NOT apply when bees are actively foraging (e.g. apply in the evening after flight).

DO NOT apply on beehives or bee nests.


The following controls concerning the information presented on the label are required:

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August 2019

o Label statement stating “DO NOT apply using spray equipment when wind speeds are less

than 3 km/hr or more than 20 km/hr as measured at the application site”.

o Label statement stating the approved application methods.

o Label statement stating the approved application rates, frequencies and intervals between

applications.

o Label statement stating the controls to protect aquatic organisms.

o Label statement stating the controls to protect pollinators.

o Label statement indicating “WARNING” the substance is not compatible with Integrated Pest

Management (IPM)

Mixture hazard classification calculations for identification controls

Table 4: Cut-off values triggering HSNO classification and requiring identification controls on the label and/or SDS

HSNO Classification Cut-off for label (% w/w) Cut-off for SDS (% w/w)

6.1A, B, C, D Any % of component that would independently

of any other component cause the product to

classify

Any % that causes the product to

classify

6.1E aspiration

(required on the basis of S77a)

Any % of component that would independently

of any other component cause the product to

classify

Any % of component that would

independently of any other

component cause the product to

classify

8.2, 8.3 Any % that causes the product to classify as

8.2 and/or 8.3

Any % that causes the product to

classify

6.5A, 6.5B, 6.6A, 6.7A 0.1 0.1

6.6B 1 1

6.7B 1 0.1

6.8A, 6.8C 0.3 0.1

6.8B 3 0.1

6.9A, 6.9B 10 1

Table 5: List of components requiring identification

Label SDS

Tebuconazole (6.1D, 6.8B, 6.9B)

Pyraclostrobin (6.1B)

Tebuconazole (6.1D, 6.8B, 6.9B)

Pyraclostrobin (6.9B)

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Appendix B: Identity of the active ingredients, use pattern and mode of action

Identity of the active ingredient and metabolites

This is the first full application under Part 5 of the Hazardous Substances and New Organisms (HSNO) Act

1996 considered for this combination of four active ingredients.

Regulatory status

The regulatory history of boscalid, pyraclostrobin, tebuconazole and pyriproxyfen is summarised in Table 6

below.

Table 6 Active ingredient(s) regulatory status

Active ingredient name Regulatory history in New

Zealand

International regulatory history

(Australia, Canada, Europe,

Japan, USA)

Pristine® (boscalid and

pyraclostrobin) Approved (HSR007853)

Approved in Australia, Canada,

and USA

Boscalid Approved (HSR007669) Approved in Australia, Canada,

Europe, and USA

Pyraclostrobin Approved (HSR000652) Approved in Australia, Canada,

Europe, and USA

Tebuconazole Approved (HSR002879) Approved in Australia, Canada,

Europe, and USA

Pyriproxyfen Approved (HSR003297) Approved in Australia, Canada,

Europe, and USA

Use pattern and mode of action

Use pattern

This product is a combination of four active ingredients, three are fungicides and one insecticide. The

proposed use pattern is to control fungal diseases and pest insects in roses and ornamental plants for home

garden and small commercial uses.

The applicant seeks to have the substance approved for ground based application using spot spraying using

handheld and backpack sprayers.

Application will be at the rate of 10 litres of product per hectare (L/ha) which is equivalent to 64 g

pyraclostrobin/ha, 126 g boscalid/ha, 215 g tebuconazole/ha and 50 g pyriproxyfen/ha, with a maximum

frequency of nine applications per year with a minimum of 14 days apart. More details on the intended uses

for RFC 397 (New Formulation) are given in Table 7.

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Mode of action

Boscalid (fungicide) is a succinate dehydrogenase (SDH) inhibitor; it targets the complex II enzyme in the

mitochondrial respiration chain. It inhibits spore germination and germ tube elongation, and by doing so

inhibits the growth of the fungi.

Pyraclostrobin (fungicide) is part of the strobilurin family, which are systemic fungicides that block electron

transport in the mitochondrial chain by binding to the ubihydroquinone oxidation centre of the mitochondrial

bc1 complex (complex III). This prevents the energy production of the fungus, which if this state persists

leads to death.

Tebuconazole (fungicide) belongs to the triazole group of fungicides that inhibit the 14-alpha-demethylase

enzyme which result on a disruption of the permeability of the fungal cell membrane. Accumulation of

lanosterol and other methylated sterols and a decrease in sterols, especially the ergosterol concentrations,

which results in decreased fungal growth and finally death. Tebuconazole does not prevent spore

germination and some species of fungi can still produce infective structures.

Pyriproxyfen (insecticide) belongs to the class of juvenile hormone mimics, other examples of this class are

fenoxycarb and methoprene. The mode of action is suppression of embryogenesis, and inhibition of

metamorphosis and reproduction. By overloading the hormonal system of the target insect, the substance

ultimately affects egg production, brood care and other social interactions.

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Table 7: List of intended uses for RFC 397 (New Formulation)

Crop

and/or

situation

(a)

Use

pattern

(b)

Pests or

group of

pests

controlled

(c)

Mixture Application Application rate per treatment

Remarks

(l) Type

(d-f)

Conc of a.i.

(g)

Method

and kind

(h-i)

Growth

stage &

season

(j)

Number

Min max

(k)

Interval

between

applications

– days

(minimum)

kg a.i./hL

min max

water

L/ha

min

max

kg a.i./ha

max

Roses and

ornamental F and G

Plant pest

insects

and fungal

diseases

SC

6.4 g/L

pyraclostrobin,

12.6 g/L

boscalid,

21.5 g/L

tebuconazole,

5 g/L

pyriproxyfen

Hand

held and

backpack

sprayer

Any time

(when

bees are

unlikely

to visit)

1-9 14-30

0.64 kg/hL

pyraclostrobin,

1.26 kg/hL

boscalid,

2.15 kg/hL

tebuconazole,

0.5 kg

pyriproxyfen/hL

1000

0.064 kg/ha

pyraclostrobin,

0.126 kg/ha

boscalid,

0.215 kg/ha

tebuconazole,

0.05

pyriproxyfen

Spot

spraying –

not wide

dispersive.

1:100

dilution

a Where relevant, the use situation should be described (e.g. fumigation of soil) b Outdoor or field use (F), glasshouse application (G) or indoor application (I). c e.g. biting and sucking insects, soil borne insects, foliar fungi, weeds d e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) e CropLife international, 2008. Technical Monograph no 2, 6th edition. Catalogue of pesticide formulation types and international coding system f All abbreviations used must be explained g g/kg or g/l or others h Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench, aerial, etc , i Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant - type of equipment used must be indicated. If spraying include droplet size spectrum j growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell (ISBN 3-8263-3152-4) , including where relevant, information on season at time of application k Indicate the minimum and maximum number of application possible under practical conditions of use l Remarks may include: Extent of use/economic importance/restrictions

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Appendix C: Hazard classification of RFC 397 (New Formulation)

The hazard classifications of RFC 397 (New Formulation) are listed in Table 8.

Table 8: Applicant and EPA Staff classifications of RFC 397 (New Formulation)

Hazard Class/Subclass

Mixture classification

by:

Method of

classification

Remarks

Applicant EPA

Staff

Mix

ture

da

ta

Re

ad

ac

ros

s

Mix

ture

ru

les

Class 1 Explosiveness No NA Aqueous formulation

Class 2, 3 & 4 Flammability No No

Class 5 Oxidisers/Organic

Peroxides No ND

No data on several

components

Subclass 8.1 Metallic

corrosiveness No ND

No data on several

components

Subclass 6.1 Acute toxicity (oral) No No

Subclass 6.1Acute toxicity

(dermal) No ND

Dermal toxicity is anticipated

to be minimal based on the

low acute oral toxicity

potential.

Subclass 6.1 Acute toxicity

(inhalation) No ND

Subclass 6.1 Aspiration hazard No ND

This hazard is unlikely as the

material is an aqueous

formulation.

Subclass 6.3/8.2 Skin

irritancy/corrosion 6.3B No

Subclass 6.4/8.3 Eye

irritancy/corrosion 6.4A No

Subclass 6.5A Respiratory

sensitisation No ND

This hazard is unlikely based

on the large percentage of

components not classified as

sensitisers and the structure

activity potential of the few

components with ND.

Subclass 6.5B Contact

sensitisation No ND

This hazard is unlikely based

on the large percentage of

components not classified as

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August 2019

Hazard Class/Subclass

Mixture classification

by:

Method of

classification

Remarks

Applicant EPA

Staff

Mix

ture

da

ta

Re

ad

ac

ros

s

Mix

ture

ru

les

sensitisers and the structure

activity potential of the few

components with ND.

Subclass 6.6 Mutagenicity No ND

None of the actives are

genotoxic, no data on

several non-active

components.

Subclass 6.7 Carcinogenicity No ND

No data on several

components. None of the

actives are genotoxic.

Subclass 6.8 Reproductive/

developmental toxicity No 6.8B

Triggering component:

tebuconazole

Subclass 6.8 Reproductive/

developmental toxicity (via

lactation)

No ND

Subclass 6.9 Target organ

systemic toxicity (oral) 6.9B 6.9B

Triggering component:

tebuconazole and

pyraclostrobin


systemic toxicity (dermal) ND


systemic toxicity (inhalation) ND

Subclass 9.1 Aquatic ecotoxicity 9.1A 9.1A Component A, A1, A2, A4,

A9(4), D, E1, E2, G, H

Subclass 9.2 Soil ecotoxicity No ND Not sufficient information on

several of the components

Subclass 9.3 Terrestrial

vertebrate ecotoxicity No ND

Not sufficient information on

several of the components

Subclass 9.4 Terrestrial

invertebrate ecotoxicity 9.4B 9.4B Component H

NA: Not Applicable. For instance, testing for a specific endpoint may be omitted if it is technically not possible to conduct

the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances

cannot be used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the

substance required in certain studies may not be possible.

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August 2019

ND: No Data or poor quality data (according to Klimisch criteria1). There is a lack of data for one or more components.

No: Not classified based on actual relevant data available for the substance or all of its components. The data are

conclusive and indicate the threshold for classification is not triggered.

1 Klimisch., H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997)

20


August 2019

Appendix D: Physico-chemical properties of RFC 397 (New Formulation)

The physico-chemical properties of RFC 397 (New Formulation) are listed in Table 9.

Table 9: Physical and chemical properties of RFC 397 (New Formulation)

Property Reference

Colour tawny Application form

pH 5.5

Density 1.000 – 1.100 kg/L

Physical state Slightly viscous liquid

Water Solubility (20°C) Soluble

21


August 2019

Appendix E: Environmental fate

Executive summaries and list of endpoints

Information on the active ingredients were sourced from the EPAs internal resources (e.g. internal database

and previous applications). For boscalid and pyraclostrobin most information was provided in HSR07051, for

boscalid additional information was found in HSR06045. It is likely that more information has become

available after this application. For tebuconazole a recent evaluation of the available data was performed in

APP203305. For pyriproxyfen information was sourced from the EPAs internal database.

Residues relevant to the environment

The relevant metabolites (>10%) for the four active ingredients are listed in Table 10.

Table 10: Metabolites of the active ingredients

Metabolite code Properties

Boscalid M510F64 9.4% in water

Pyraclostrobin BF 500-3 Maximum 67.7% aquatic (mainly sediment)

Tebuconazole 1,2,4-triazole Maximum 32.1% in soil, 14% in aquatic

HWG 1608-pentanoic acid Maximum 40.2% aquatic

HWG 1608-lactone Maximum 21% aquatic

Pyriproxyfen Pypac Not available

4-OH-Pyr Not available

For boscalid, the internal database only contained information on one metabolite in water, which was not

considered a major metabolite, no metabolites were identified in soil.

For pyraclostrobin, the internal database only contained information on one major metabolite in water

(67.7%), no metabolites were identified in soil. Insufficient information was available to determine the

relevance of this metabolite for the environmental risk assessment.

For tebuconazole, the metabolite 1,2,4-triazole accounted for up to 31.2% of applied radioactivity in soil

under aerobic conditions. No other information was provided indicating any other soil metabolites exceeding

10% applied. In aqueous systems, 1,2,4-triazole was found up to 14%. Two additional major water

metabolites were identified: HWG 1608-pentanoic acid (maximum 40.2% AR) and HWG 1608-lactone

22


August 2019

(maximum 21.0% AR). Based on other environmental data it was determined that the environmental risk

assessment for the parent compound would cover the potential risks of the metabolites.

For pyriproxyfen, the internal database only contained information of two major metabolites in

water/sediment systems, Pypac and 4-OH-Pyr. Insufficient information was available to determine the

relevance of these metabolites for the environmental risk assessment.

Degradation and fate of the active ingredients in the aquatic environment

Information on the degradation and fate of the active ingredients in the aquatic environment is summarised in

Table 11. Information on bioaccumulation potential is listed in Table 12.

Table 11: Degradation and fate in aquatic environments of the active ingredients

Test type Boscalid Pyraclostrobin Tebuconazole Pyriproxyfen

Ready biodegradation No No No No

Aqueous photolysis half-life

(DT50) (days)

Stable 0.06 590 6.23

Degradation in aerobic

water/sediment (DT50) (days)

Not available 27 38.7 23.1

Degradation in aerobic water

(DT50) (days)

21 Not available Not available Not available

Degradation in aerobic

sediment (DT50) (days)

66 33 Not available Not available

Water solubility at 20°C [mg/L] 4.64 1.9 32 0.367

Hydrolysis half-life (DT50) Stable Stable Stable Stable

Table 12: Bioaccumulation potential of the active ingredient


Partition coefficient

octanol/water [Log Kow]

2.96 3.99 3.7 5.37

Fish bioconcentration (whole

fish)

70 675 78 Not available

Degradation and fate of the metabolite in the aquatic environment

Information on the degradation and fate of the relevant metabolites of pyraclostrobin and pyriproxyfen is

summarised in Table 13

23


August 2019

Table 13: Degradation and fate in aquatic environments of the relevant metabolite BF 500-3 (pyraclostrobin) and PYPAC and 4-OH-Pyr (pyriproxyfen)

Test type BF-500-3 PYPAC 4-OH-Pyr

Ready biodegradation Not available Not available Not available

Aqueous photolysis half-life (DT50) whole

system

55 days 15.8 days 0.69 days

Degradation in aerobic water/sediment

(DT50)

Not available Not available Not available

Degradation in aerobic water (DT50) Not available Not available Not available

Degradation in aerobic sediment (DT50) Not available Not available Not available

Water solubility at 20°C [mg/L] Not available Not available Not available

Hydrolysis half-life (DT50) Not available Not available Not available

Table 14: Bioaccumulation potential of the relevant metabolite BF 500-3 (Pyraclostrobin) and PYPAC and 4-OH-Pyr (pyriproxyfen)

Test type BF-500-3 PYPAC 4-OH-Pyr

Partition coefficient octanol/water [Log Kow] Not available Not available Not available

Fish bioconcentration (whole fish) Not available Not available Not available

Degradation and fate of the active ingredients in soil

Information on the degradation and fate of the active ingredients in the soil environment is summarised in

Table 15.

Table 15: Degradation and fate in soil of the active ingredient


Aerobic half-life in soil

(DT50lab) (days)

3671 137 4 770 12.4

Anaerobic degradation in soil

(DT50lab) (days)

345 Not available Not available Not available


(DT50field) (days)

1512 346 57.55 3.5 up to 16.5

Soil photolysis half-life (DT50) 135 days Not available Not available 6.8 up to 8.5

Sorption to soil (Kd / Koc) Kd: 3.28 L/kg 3

Koc: 655 L/kg 3

Kd: not available

Koc: 6000 L/kg

Kd: 16.39 L/kg 3

Koc: 910.4 L/kg 3

Not available

Column leaching Not mobile under

test conditions

Not available Not available Not available

24


August 2019

1: Upper 80% of 108, 322, 384, 376, 133 days at 20°C

2: Upper 80% 90, 49, 28, 208, 175, 147, 144, 27, 78 days normalised to 20°C

3: Lowest value non-sandy soil used for risk assessment

4: Worst-case of a range upper 80% could not be calculated

5: Upper 80th percentile of 57.5, 28.9, 29.5, 65.3, 25.8 and 48.4 days

6 Upper 80th percentile of 31, 37, 25, 26 days

Degradation and fate of the metabolite in soil

Information on the degradation and fate of the major metabolite of tebuconazole in the soil environment is

summarised in Table 16.

Table 16: Degradation and fate in soil of the relevant metabolite 1,2,4-triazole (tebuconazole)

Test type


(DT50lab) Not available


(DT50field) 92.8 days1

Sorption to soil (Kd / Koc)2 Koc = 43 L/kg (clay loam); Kd = 0.722 L/kg (silty clay loam)

Max % of AR 32.1%

1: Upper 80th percentile of slow phase DT50 of 70.7, 59.8, 25.1 and 126 days

2: Lowest values non-sandy soils

General conclusion about environmental fate

Boscalid

Insufficient information is available to determine the persistence of boscalid in the aquatic system as a

whole. Boscalid is considered persistent in soil under laboratory as well as under field conditions (DT50field =

151 days). The substance is expected not to be mobile in soil based on the column leaching test. The

substance is considered not bioaccumulative in organisms.

Pyraclostrobin

For pyraclostrobin one major metabolite was identified (BF 500-3, 67.7% in the aquatic environment).

Insufficient information was available to determine the significance of this metabolite. Pyraclostrobin is

considered persistent in the aquatic and soil environment. Furthermore, pyraclostrobin is considered

bioaccumulative (BCF 675). Pyraclostrobin is considered slightly mobile in soil based on the Koc (6000 L/kg).

Tebuconazole

Tebuconazole is persistent in water and sediment. The substance is considered not bioaccumulative in

organisms. In soil, tebuconazole was persistent in laboratory studies but not under field conditions (DT50field =

25


August 2019

57.5 days). It is expected to exhibit medium to high mobility in soil. The only soil metabolite considered in this

assessment was 1,2,4-triazole, formed up to 32.1%. No information is available for persistence of this

metabolite in soil in a controlled environment, however the metabolite is considered slightly degradable in

field studies. The metabolite may be considered highly mobile in the soil environment based on standard soil

adsorption/desorption data (Koc = 43 L/kg).

Pyriproxyfen

Pyriproxyfen is considered persistent in the aquatic environment (DT50 = 23.1 days) and potentially

bioaccumulative based on the Log Kow of 5.37. The substance is not persistent in soil (DT50 = 12.4 days).

No information is available regarding the mobility in soil. For pyriproxyfen two major metabolites were

identified in the aquatic environment. Insufficient information was available to determine the significance of

these metabolites.

26


August 2019

Appendix F: Mammalian toxicology

No new mammalian toxicity data on the actives or the substance were submitted by the applicant. All

mammalian toxicity conclusions were based on information in EPA internal databases and mixture rules.

General conclusion about mammalian toxicology of the active ingredients and formulated substance

Acute toxicity, irritation and sensitisation

The actives boscalid, tebuconazole, and pyriproxyfen are of relatively low acute toxicity in mammals and are

not skin or eye irritants, or contact sensitisers. However, pyraclostrobin is classified as 6.1B for inhalation

toxicity and dermal irritation and similarly is not classified for eye irritation or sensitisation. Based on mixture

rules the formulated substance is not classified for any 6.1 hazards.

Mutagenicity

None of the actives are classified for mutagenicity. Based on mixture rules the mutagenicity of the substance

was not determined due to an absence of data on some of the other components.

Carcinogenicity

None of the actives are classified for carcinogenicity. Based on mixture rules the carcinogenicity of the

substance was not determined due to an absence of data on some of the inert components.

Reproductive and developmental toxicity

The active tebuconazole is classified as a reproductive toxicant (6.8B) and is present at a concentration that

requires classification of the substance to also be 6.8B.

Target organ toxicity

The actives pyraclostrobin and tebuconazole possess target organ toxicity via the oral route (6.9A and 6.9B

respectively) and the overall classification of the substance is 6.9B based on mixture rules.

Toxicokinetics and dermal absorption

No dermal absorption data for the substance were submitted so default values were used in exposure

modelling.

27


August 2019

Appendix G: List of ecotoxicity endpoints

Executive summaries and list of endpoints

Information on the active ingredients were sourced from the EPAs internal resources (e.g. internal database

and previous applications). For boscalid and pyraclostrobin most information was provided in HSR07051, for

boscalid additional information was found in HSR06045. It is likely that more information has become

available after this application. For tebuconazole a recent evaluation of the available data was performed in

APP203305. For pyriproxyfen information was sourced from the EPA’s internal database. Only endpoints

relevant for the risk assessment have been included.

Aquatic toxicity

Table 17 contains the acute and chronic aquatic toxicity test results for the active ingredients. Table 18

contains the aquatic toxicity test results for the metabolites of tebuconazole. No information is available on

the toxicity of the major metabolites of pyraclostrobin and pyriproxyfen.

28


August 2019

Table 17: Summary of aquatic toxicity data for the active ingredients

Test species Test type and

duration

Active ingredient

Boscalid Pyraclostrobin Tebuconazole Pyriproxyfen

Fish Acute

Rainbow trout.

Oncorhynchus mykiss

96 hr LC50

2.7 mg/L 0.00616 mg/L 4.4 mg/L Not available

Bluegill sunfish, Lepomis

macrochirus > 4 mg/L Not available Not available Not available

Carp, Cyprinus carpio Not available Not available Not available 0.45 mg/L

Chronic

Rainbow trout.

Oncorhynchus mykiss ELS, NOEC 0.125 mg/L 0.00235 mg/L 0.012 mg/L

0.0067 mg/L

(ELS 35 days)

0.0043 mg/L (95 days)

Invertebrates Acute

Daphnia magna 48 hr EC50 5.33 mg/L 0.0157 mg/L 2.79 mg/L 0.08 mg/L

(Daphnia carinata)

Chronic

Daphnia magna

21-day

reproduction,

NOEC

1.31 mg/L 0.00342 mg/L 0.010 mg/L 0.00001 mg/L

Chironomus riparius

28-day

emergence

and

NOEC 2 mg/L

(equated to

approx. 3.8 mg/kg

Not available 2.33 mg/L Not available

29


August 2019

development

– spiked water

in sediment by

day 28)

Chironomus riparius

28-day

emergence

and

development

– spiked

sediment

NOEC 23.26

mg/kg Not available

40 mg/kg sediment

dw Not available

Algae and aquatic macrophytes

Green alga,

Pseudokirchneriella

subcapitata

72 hr ErC50 1.34 mg/L > 0.842 mg/L 2.83 mg/L 0.056 mg/L

Duckweed, Lemna gibba 14 day EC50 Not available > 1.72 mg/L 0.144 mg/L >0.18 mg/L

30


August 2019

Table 18: Summary of aquatic toxicity data for tebuconazole metabolites

Test species Test type and

duration

Tebuconazole metabolites

Metabolite Value

Rainbow trout, Oncorhynchus mykiss 96 h LC50

HWG 1608-pentanoic acid >10 mg/L

HWG 1608-lactone >10 mg/L

Daphnia magna 48 h EC50

1,2,4-triazole >100 mg/L



Green alga, Pseudokirchneriella subcapitata 72 h EC50

1,2,4-triazole >31 mg/L



Chironomus riparius 28 d EC15 HWG 1608-lactone 51.2 mg/L

31


August 2019

General conclusion about aquatic toxicity

The hazard classifications for the active ingredients boscalid, pyraclostrobin, tebuconazole and pyriproxyfen

are 9.1B, 9.1A, 9.1A, and 9.1A, respectively.

The applicant did not provide formulation data for RFC 397 (New Formulation)and therefore classifications

are based on mixture rules. The hazard classification for the substance was determined to be 9.1A.

Soil toxicity

Table 19 contains the acute and chronic soil toxicity test results for the active ingredients.

Table 20 contains the acute and chronic soil toxicity test results for tebuconazole metabolite 1,2,4-triazole.

32


August 2019

Table 19: Summary of soil toxicity data for the active ingredients

Test species Test type and duration active ingredient


Earthworm, Eisenia fetida Acute, 14-day LC50 > 1000 mg/kg 567 mg/kg 1381 mg/kg soil dw >1000 mg/kg soil dw

Reproduction, NOEC Not available Not available 10 mg/kg soil dw Not available

Springtail, Folsomia candida Reproduction 28-day,

NOEC

Not available Not available 250 mg/kg soil dw Not available

Terrestrial plants

Six dicot and four monocot

crop species

Vegetative vigour, 21 days

Foliar application to

seedling plants

Not available Not available Not available Not available

Seedling emergence, 21

days

Application to soil surface


Soil microbial function

Soil microflora Nitrogen mineralisation, 28

days

Not available Not available <25% effects at 8.23

mg/kg soil dw

Not available

Carbon mineralisation, 28

days

Not available Not available <25% effects at 8.23

mg/kg soil dw

Not available

33


August 2019

Table 20: Summary of soil toxicity data for tebuconazole major metabolite 1,2,4-triazole

Test species Test type and duration Test substance Result

Soil macro fauna

Earthworm, Eisenia fetida Acute, 14-day LC50 1,2,4-triazole LC50 >1000 mg/kg soil dw

Reproduction, 1,2,4-triazole NOEC = 1.0 mg/kg soil dw

Springtail, Folsomia candida Reproduction 28-day 1,2,4-triazole NOEC = 1.8 mg/kg soil dw

General conclusion about soil toxicity

All active ingredients do not trigger a hazard classification for soil toxicity.

The applicant did not provide formulation data for RFC 397 (New Formulation)and therefore classifications

are based on mixture rules. Insufficient information was available on several components of RFC 397 (New

Formulation) to determine the classification.

Terrestrial vertebrate toxicity

For effects on terrestrial vertebrates other than birds, refer to the mammalian toxicity section.

Table 21 contains the acute and chronic avian toxicity test results for the active ingredients.

Table 21: Summary of terrestrial vertebrate toxicity data for the active ingredients

Test species

Test type

and

duration


Bobwhite quail,

Colinus

virginianus

Acute oral

LD50

> 2000 mg/ kg

bw > 2000 mg/kg bw 1555 mg/kg bw >2000 mg/kg bw

5-day dietary

LC50

> 5000 ppm

diet

> 1176 mg/kg

bw/d

>703 mg/kg bw

bw/d (>5000

mg/kg diet)

> 520 mg/kg bw

(>5200 ppm)

Reproductive

1 generation,

21 weeks

NOEC

300 ppm (30

mg/kg bw/d) 105 mg/kg bw/d

5.8 mg/kg bw/d

(73.5 mg/kg diet) Not available

Mallard duck,

Anas

platyrhynchos

Acute oral

LD50 Not available Not available

Not available >2000 mg/kg bw

8-day dietary

LC50

> 5000 ppm

diet

> 1320 mg/kg

bw/d

>4816 mg/kg diet > 520 mg/kg bw

(>5200 ppm)

34


August 2019

Test species

Test type

and

duration


Reproductive

1 generation,

21 weeks

NOEC

Not available Not available

170 mg/kg diet

(17.7 mg/kg bw/d) Not available

General conclusion about ecotoxicity to terrestrial vertebrates

The LD50 to bobwhite quail for tebuconazole triggers a HSNO classification of 9.3C for that active ingredient.

Boscalid, pyraclostrobin and pyriproxyfen do not trigger a HSNO classification for terrestrial vertebrate

toxicity.

The applicant did not provide formulation data for RFC 397 (New Formulation) and therefore classifications

are based on mixture rules. Insufficient information was available on several components of RFC 397 (New

Formulation) to determine the classification.

Ecotoxicity to bees and other terrestrial invertebrates

Table 22 contains the toxicity test results for the active ingredients on terrestrial invertebrates.

Table 22: Summary of terrestrial invertebrate toxicity data for the active ingredients

Test species

Test type

and

duration


Pollinators

Honeybee, Apis

mellifera

Acute oral,

48 hr LD50 >165.96 µg/bee > 73.1 µg/bee >83.05 µg/bee >100 µg/bee

Acute

contact LD50 >200 µg/bee > 100 µg/bee >100 µg/bee Not available

Larval

toxicity test

LD50


Chronic

toxicity Not available Not available Not available Not available

Other beneficial arthropods

Parasitic wasp,

Aphidius

rhopalosiphi

48 hr LR50

laboratory

glass plate

Not available NOEC (foliar)

320 g/ha Not available Not available

35


August 2019

Test species

Test type

and

duration


Predatory mite,

Typhlodromus

pyri

48 hr LR50

laboratory

glass plate



Green lacewing,

Chrysoperla

carnea

48 hr LR50

laboratory

glass plate



Ladybirds Not available NOEC (foliar)


Beetles Not available NOEC (foliar)


Wolf spider Not available NOEC (foliar)


Cockroach Not available Not available Not available Not available LD50 = 0.1

µg/nymph

General conclusion about ecotoxicity to bees and terrestrial invertebrate

toxicity

Based on the acute dermal and oral toxicity three active ingredients do not trigger a HSNO hazard

classification for toxicity to bees and other terrestrial invertebrates. Pyriproxyfen is very ecotoxic to bees and

other terrestrial invertebrates and triggers a 9.4A hazard classification based on its toxicity to cockroaches.

Based on mixture rules the formulation triggers a 9.4B hazard classification.

It should be noted that no chronic information from a GLP-environment is available for the active ingredients.

For boscalid and pyraclostrobin there are indications that chronic effects can impact honey bee health

however this information is not obtained in a GLP setting (raw data not available to the EPA staff) and

therefore quality of the study cannot be verified.

Pyriproxyfen is an insect growth regulator and is known to inhibit adult emergence of several insects (flies,

mosquitos) and disrupts the normal development of insects. Therefore, the EPA staff has concerns regarding

chronic effects on terrestrial invertebrates.

36


Appendix H: Human health risk assessment methodology

Introduction

Our pesticide exposure assessment methodology has been developed to estimate exposure to

pesticides used for commercial agricultural purposes. It calculates risk quotients and the control

measures necessary to reduce bystander, operator and re-entry worker exposure to acceptable

levels. In addition, it estimates the buffer zones required to protect aquatic organisms in a still water

body from pesticide spray drift. The purpose of this appendix is to explain the approach, so that

stakeholders can understand how the exposure and risk assessments are carried out.

Data input

The exposure assessment modelling approach requires the following variables as a minimum

Formulation type (liquid, powder, granule, powder)

Application rate for ground boom, airblast or aerial application (g.a.i./ha) as applicable

Acceptable Operator Exposure Level (AOEL) (mg/kg bw/day)

Dermal absorption of the active ingredient.

In addition, there are many variables that can be varied to refine an assessment or default values can

be used. The following sections describe these variables and how they are used in the risk

assessment process.

Operator exposure and risk

An operator’s exposure is estimated using the UK Chemicals Regulation Directorate (CRD) version of

the BBA (German Federal Biological Institute) operator exposure model (Chemicals Regulation

Directorate, 2016c). Home use exposure was assessed through the UK POEM model which includes

a home use scenario for outdoor sprayers and low level targets, which staff used as the most

appropriate scenario to assess the use of RFC 397 (New Formulation) for home use.

To estimate operator exposure the following information is required:

application rate

application type

formulation type.

Information about the following variables can also be used (or if they are not available default values

are used).

Dermal absorption from spray

Dermal absorption from product

Work rate.

37


The European Food Safety Authority (EFSA) has published guidance on the assessment of dermal

absorption of pesticides which can be used to inform the interpretation of dermal absorption studies

(EFSA, 2012). The EFSA guidance also includes details of procedures to follow when reading across

dermal absorption information between formulations and for the extrapolation of dermal absorption

data on an active ingredient to a formulated product.

When substance specific dermal absorption data are not available, default values can be used in the

assessment. We have adopted the default values proposed by Aggarwal et al. which are based on a

review of studies on over 150 active ingredients, rather than the default values listed in the EFSA

guidance (Aggarwal et al. 2015). The default values used are 6% for liquid concentrates, 2% for solid

concentrates and 30% for spray dilutions. The EFSA guidance includes options to further refine

dermal absorption values based on physical chemical properties or data on oral absorption. Guidance

from the OECD can also be used to inform decisions on the appropriate dermal absorption value to

be used (OECD 2011).

Information on the work rate (or area treated per day) should ideally come from the applicant or from feedback from users. If no information is provided then the default values in the EFSA exposure assessment model, listed in

Table 23, can be used. These values are consistent with feedback that the EPA received during the

Organophosphate and Carbamate reassessment (APP201045). For handheld application it can be

assumed that 1 hectare would be treated per day.

Table 23: Area treated per day by boom (EFSA, 2014)

Crop Area treated per day (ha)

Ornamentals 10

The UK CRD version of the BBA operator exposure model calculates exposure using the results of

actual measurements carried out in the field (Chemicals Regulation Directorate, 2016c). These values

represent the geometric mean values of these studies and hence may not be as conservative as

some other operator exposure models which are based on the 75th percentile of exposure datasets.

The impact of wearing different forms of PPE is estimated using exposure reduction factors which

have also been empirically derived. These protection factors are based on the 2014 EFSA operator,

worker, resident and bystander exposure model and are outlined below in Table 24 (EFSA, 2014).

Table 24: PPE and RPE exposure reduction factors used

PPE Exposure reduction coefficients

Dermal Component Inhalation

Gloves (liquid) 0.1 Hands NA

Certified protective

coverall

0.05 Body NA

Hood and visor 0.05 Head NA

38


PPE Exposure reduction coefficients

Dermal Component Inhalation

FP1, P1 and similar 0.8 Head 0.25

FP2, P2 and similar 0.8 Head 0.1

Gloves (solids mixing

and loading)

0.05 NA NA

Risk is estimated by comparing exposure to the Acceptable Operator Exposure Level (AOEL). The

AOEL is a health based exposure guidance value against which non-dietary exposures to pesticides

are currently assessed. It is intended to define a level of daily exposure throughout a spraying

season, year on year, below which no adverse systemic health effects would be expected (EFSA,

2014). The AOEL is normally derived by applying an assessment factor (most often 100) to a No

Observed Adverse Effect Level (NOAEL) (corrected if appropriate for incomplete absorption) from a

toxicological study in which animals were dosed daily for 90 days or longer. Less often, the critical

NOAEL comes from a study with a shorter dosing period (e.g. a developmental study) or a longer

dosing period (e.g. a chronic toxicity/carcinogenicity study). The AOEL represents the internal

(absorbed) dose available for systemic distribution from any route of exposure and is expressed as an

internal level (in milligrams/kilogram body weight/day).

Exposure and risk are estimated under the following Personal Protective Equipment (PPE) scenarios:

No PPE during mixing, loading and application;

Gloves only during mixing and loading;

Gloves only during application;

Full PPE during mixing, loading and application (excluding respirator);

Full PPE during mixing, loading and application (including FP1, P1 and similar respirator

achieving 75 % inhalation exposure reduction)

Full PPE during mixing, loading and application (including FP2, P2 and similar respirator

achieving 90 % inhalation exposure reduction

The level of PPE that is required is determined based on which scenario reduces exposure to an

acceptable level.

Re-entry worker exposure and risk

The re-entry worker exposure is based on dermal exposure through contact with foliar residues only;

inhalation exposure or exposure to other contaminated surfaces (e.g. soil) is not accounted for. If

required it is possible to estimate exposure via these routes using the approaches outlined in the

EFSA model (EFSA, 2014). Re-entry exposure is calculated using the formula below which was

developed by other regulators (Chemicals Regulation Directorate, 2016b, EUROPOEM, 2002).

Re-entry worker exposure = DFR x TC x WR x AR x DA

39


BW

These parameters, with default values where they exist, are:

DFR is the Dislodgeable Foliar Residue (3 µg/cm2 per kg a.i./ha)

TC is the Transfer coefficient for the anticipated activity being performed (cm2/hr,

defaults in Table K3)

WR is the work rate per day (default is 8 hrs/day; note that it is possible to change this

value if it is deemed necessary)

AR is the Application rate (kg/ha)

BW is the Body weight (70 kg)

DA is the dermal absorption, expressed as a proportion. The appropriate dermal

absorption value for exposure to dried dispersed residue should be the higher of the

values for the concentrate and the spray dilution (EFSA, 2012).

Transfer coefficients

Transfer coefficients refer to the amount of contact between a re-entry worker and foliage. These are

regarded as independent of the active ingredient/product used and depend on the crop type and the

activity that the re-entry worker is carrying out (EUROPOEM, 2002). In the absence of data, we will

use the values in Table 25 obtained from overseas regulators.

Table 25: Default transfer coefficients used for the re-entry worker risk assessment

Crop Activity Transfer coefficient

(cm2/hr)

Source of transfer

coefficient

Ornamentals Cut/Sort/Bundle/Carry 5000 (EUROPOEM, 2002)

These transfer coefficients all assume that re-entry workers are wearing long trousers and long

sleeved shirts and are not wearing gloves. If there is a substance for which the crop or activity is

unknown, a default reasonable worst case of 5200 cm2/hr should be used unless judgement indicates

that an alternative value may be more appropriate.

Impact of wearing PPE

The impact of wearing gloves on worker exposure can be considered using the transfer coefficient

values outlined in the EFSA operator, worker, resident and bystander model (EFSA 2014). However,

the impact of wearing gloves cannot be calculated for some crops/activities because TC attributable

to hands only are not available.

Table 26: Impact of gloves on re-entry worker transfer coefficients (EFSA, 2014)

Crop Transfer coefficients for workers not

wearing gloves (cm2/hr)

Transfer coefficients for re-entry

workers wearing gloves (cm2/hr)

Ornamentals 5000 1400

40


Multiple applications

The effect of multiple applications on re-entry worker exposure is considered in the assessment. The

DFR is the only parameter that is altered by multiple applications.

The DFR immediately following the nth application (DFRn(a)) is estimated by assuming first order

dissipation and using the following equation derived from the FOCUS guidance (FOCUS, 1997):

DFRn(a) = DFRsingle-application x (1-e-nki)/(1-e-ki)

where

n is the number of applications

k is the rate constant for foliar dissipation

i is the interval between applications (days).

If k is unknown, the FOCUS default of 0.0693, corresponding to a half-life foliar of 10 days, is used

(FOCUS Working Group on Surface Water Scenarios, 2003).

The reduction in DFRn(a) over time after last application is then given by:

DFRn(a)+t = DFRn(a) x e-kt

where

t is days since last application.

Risks to re-entry workers immediately after application

Risk to re-entry workers immediately after the final treatment is estimated using the following

approach, which compares the predicted exposure to the AOEL.

The absorbed dose is calculated by:

DFRn(a) x C x D

where

C = TC x WR x AR/BW

D = Dermal absorption.

Therefore the risk to re-entry workers immediately after the final application is given by the following equation:

RQ = DFRn(a) x C x D/AOEL

41


Calculation of Restricted Entry Intervals (REI)

The REI is determined as being the day when the exposure multiplied by the dermal absorption

equals the AOEL, i.e.

DFRn(a)+t x C x D = AOEL

Substituting DFRn(a) x e-kt for DFRn(a)+t, setting t as the REI (R) and rearranging the equation, gives:

DFRn(a) x e-kR x C x D = AOEL

e-kR = AOEL/DFRn(a) x C x D

ekR = DFRn(a) x C x D/AOEL

R = ln(DFRn(a) x C x D/AOEL)/k

Bystander exposure and risk

Default exposure parameters

The following exposure parameters can be changed by the user or, if they are not, default values

obtained from overseas regulators (outlined here in brackets) will be used:

Distance from the edge of the application area at which a toddler’s exposure will be

estimated (8 m)

Turf transferable residue grass (0.05) (EFSA, 2014)

Turf transferable residue object (0.2) (EFSA, 2014)

Transfer coefficients (2600 cm2/hr) (EFSA, 2014)

Exposure duration (2 hrs) (EFSA, 2014)

Toddler body weight (15 kg) (Chemicals Regulation Directorate, 2016a)

Saliva extraction factor (0.5) (EFSA, 2014)

Surface area of hands (20 cm2) (EFSA, 2014)

Frequency of hand to mouth events (9.5 events)/hour ( EFSA, 2014)

Ingestion rate grass (25 cm2/day) (EFSA, 2014)

Ingestion rate soil (100 mg/day) (Chemicals Regulation Directorate, 2016a)

Fraction of residue remaining in the soil (1) (USEPA, 2007b)

Soil density factor (6.7 x 10-4cm3/mg) (USEPA, 2007b).

Exposure calculations

The approach used estimates the exposure to contaminated residues of a toddler 8 m (default) away

from the edge of the area to which the substance was applied (i.e. exposure is to surfaces on which

spray has deposited; not through direct contact with the spray).

Exposure is estimated using the equations from the European Food Safety Authority (EFSA) which

account for dermal exposure, hand-to-mouth exposure and object-to-mouth exposure (EFSA, 2014).

42


In addition, incidental ingestion of soil is taken into account using a modified exposure equation from

the United States Environmental Protection Agency (USEPA) (USEPA, 2007b). These equations are

all listed below.

Dermal absorption is also factored into the dermal exposure assessment. In this case the dermal

absorption value used is the value for the diluted spray. The same approach is used as for the

operator exposure assessment in terms of using a default value (30 %) when specific data are not

available and refining these based on physical chemical properties or data on oral absorption.

Spray drift is estimated using models specific to the type of application equipment. For pesticides

applied by ground boom or airblast sprayer, the AgDrift model is used. The model is based on data

from a series of field trials carried out in the United States (APVMA, 2009b) in which the percentage

of the application rate deposited is plotted against distance from the area of application. These

deposition curves were taken from the Australian Pesticides and Veterinary Medicines Authority

(APVMA) website (APVMA, 2010). For ground boom applications there are deposition data for the

following scenarios which represent the 90th percentile of the spray drift data collected:

High boom (1.27 m above the ground) fine droplets

High boom (1.27 m above the ground) coarse droplets

Low boom (0.5 m above the ground) fine droplets

Low boom (0.5 m above the ground) coarse droplets

For ground based applications the most appropriate value should be used. If there is any uncertainty

the most conservative value should be used. If the applicant is able to produce an alternative spray

drift deposition dataset which has been collected using international best practice and is considered to

be acceptable, these data could be used for the exposure assessment.

Bystander risk assessment

Risks to bystanders are estimated by comparing predicted exposure to the Acceptable Operator

Exposure Level (AOEL). Although it could be argued that it is more appropriate to compare bystander

exposures with an acute reference dose, it is possible that a bystander who resides adjacent to a

treated area or who regularly walks around areas treated with plant protection products could receive

repeated exposures. There is also the potential for bystanders to be ‘residents’ and have a longer-

term exposure. Therefore, the use of the default AOEL based on studies up to 90 days duration is

considered to also be an appropriate health based exposure guidance value to be protective of

bystanders (European Commission, 2006).

In the event of a substance being identified as posing a high risk through aerial application then more

detailed spray drift modelling may be possible. The results of this additional modelling (spray drift

deposition data) can then be used for the exposure assessment.

43


Buffer zone required to reduce the bystander exposure to the AOEL

Buffer zones to protect bystanders are estimated based on the distance required to reduce bystander

exposure to the AOEL, in a two-step process:

the percentage of the application rate that would deliver an exposure equal to the AOEL

is calculated, and

the distance at which this percentage is deposited is calculated.

Multiple applications and bystander exposure

If it is known that multiple applications are intended the exposure is estimated immediately after the

final application.

The following equation is used to calculate the concentration of the pesticide in soil and in grass after

multiple applications. This equation which assumes first order degradation is used to estimate the

cumulative concentration in soil (FOCUS, 1997):

PECfinal = PECone application x (1- e-nki) / (1-e –ki)

where

PEC = predicted environmental concentration

n = number of applications

k= ln2/ DT 50 (days) where DT50 = foliar half life (days) for dermal, hand to mouth and object to

mouth systemic exposure and DT50 = soil half life (days) for the oral dose from soil on the day of

application

i= interval between two consecutive applications (days)

e = constant= 2.718

The user needs to input information on ‘n’, ‘k’, ‘i’ and DT50 (foliage). Foliar half life will frequently not be

available. In such cases an assumption will be made that the foliar half is 10 days, which is the default

value assumed in the European FOCUS (FOrum for Co-ordination of pesticide fate models and their

Use) suite of environmental exposure models (FOCUS Working Group on Surface Water Scenarios,

2003).

Toddler exposure to a treated surface (recreational exposure)

The EPA estimate the direct exposure of a toddler to a surface (for example, a lawn or sports field)

that has been treated with pesticides, referred to as recreational exposure. This uses the same

approach as the bystander exposure assessment; apart from the fact that the spray drift variable is

not considered.

As in the exposure of bystanders to spray drift residues, when calculating the risks for bystanders

exposed directly to a treated area, a Risk Quotient (RQ) is estimated by dividing the predicted

exposure by the AOEL.

44


Equations used for exposure assessment

Children’s dermal exposure

Systemic exposures via the dermal route will be calculated using the following equation (EFSA,

2014):

SE (d) = AR x DF x TTR x TC x H x DA

BW

where:

SE(d) = systemic exposure via the dermal route

AR = field application rate

DF = spray drift value

TTR = turf transferable residues – the US EPA default value of 5 % will be used

TC = transfer coefficient – a value of 2600 cm2/h will be used for the estimate, this is to be

consistent with the EFSA (2014) model

H = exposure duration for a typical day (hours) – this will be assumed to be 2 hours which

matches the 75th percentile for toddlers playing on grass in the US EPA Exposure

Factors Handbook

DA = percent dermal absorption (product specific or default value)

BW = body weight – 15 kg which is the average of UK 1995-7 Health Surveys for England

values for males and females of 2 and 3 yrs.

Children’s hand-to-mouth exposure

Hand-to-mouth exposures will be calculated using the following equation (EFSA, 2014):

SE(h) = AR x DF x TTR x SE x SA x Freq x H x OA

BW

where:

SE(h) = systemic exposure via the hand-to-mouth route

TTR = turf transferable residues – the US EPA default value of 5% derived from

transferability studies with wet hands will be used

SE = saliva extraction factor – the default value of 50% will be used

45


SA = surface area of the hands – the assumption used will be that 20 cm2 of skin area is

contacted each time a child puts a hand in his or her mouth (this is equivalent to the

palmer surface of three figures and is also related to the next parameter (Freq))

Freq = frequency of hand to mouth events/hour – for medium to long term exposures a value

of 9.5 is used as per the EFSA (2014) model

H = exposure duration (hours) – this will be assumed to be 2 hours (as above)

OA = oral absorption (% enter as a fraction).

Children’s object-to-mouth exposure

Object to mouth exposures will be calculated using the following equation (EFSA, 2014):

SE(o) = AR x DF x TTR x IgR x OA

BW

where:

SE(o) = systemic exposure via mouthing activity

TTR = turf transferable residues; the default value of 20% transferability from object to mouth

assessments will be used. This is based on guidance from EFSA who used the same

value as the USEPA (EFSA, 2014).

IgR = ingestion rate for mouthing grass/day – this will be assumed to be equivalent to

25cm2 of grass/day (EFSA, 2014)

OA = oral absorption (% enter as a fraction).

Children’s incidental ingestion of soil

The approach that will used to calculate doses attributable to soil ingestion is (US EPA, 1997):

ADOD = AR (μg/cm2) x DF x F (cm) x IgR (mg/day) x SDF (cm3/mg) x OA

BW (kg)

where:

ADOD = oral dose on day of application (μg/kg/day)

F = fraction or residue retained on uppermost 1 cm of soil (%) (Note: this is an adjustment

from surface area to volume)

SDF = soil density factor - volume of soil (cm3) per milligram of soil

46


IgR = ingestion rate of soil (mg/day)

OA = oral absorption (% enter as a fraction)

BW = body weight (kg)

Assumptions (all come from the USEPA, 2007b):

F = fraction or residue retained on uppermost 1 cm of soil is 100 percent based on soil incorporation

into top 1 cm of soil after application (1.0/cm)

IgR = ingestion rate of soil is 100 mg/day

SDF = soil density factor - volume of soil (cm3) per gram of soil; to weight 6.7 x 10-4 cm3/mg soil).

Total exposure

Total exposure will be calculated as the sum of the above equations:

∑ Exposure = SE (d) + SE (h) + SE (o) + ADOD.

47


Appendix I: Human health risk assessment

Quantitative risk assessment

The operator exposure assessment is based on a modification of the approach used by European

regulators, taking into account New Zealand specific factors. The model is based on the results of

actual measurements carried out in the field and has an established history of providing reliable and

reproducible results.

The re-entry worker exposure assessment is based on a modification of the approach used by

European regulators and the US EPA. The parameters for the modelling are based on empirical data

relating to measurements of dermal exposure of workers from contact with residues on foliage for

various activities and the amount of foliar residues that are dislodgeable.

The bystander exposure assessment is based on a modification of the approaches used by European

regulators and the US EPA. Spray drift deposition from ground-based application is estimated using

the AgDrift model using the curves produced by the Australian Pesticides and Veterinary Medicines

Authority (APVMA2). The parameters are based on empirical data.

Full details of the methodology can be found in Appendix H.

To assess risks, the predicted systemic exposures to the active ingredients are compared with an

acceptable operator exposure limit (AOEL) for the active ingredient and a risk quotient (RQ) is

calculated. RQ values greater than one indicate that predicted exposures are greater than the AOEL

and potentially of concern. RQ values below one indicate that predicted exposures are less than the

AOEL and are not expected to result in adverse effects.

Input values for the human health risk assessment

Reference doses for the four active ingredients established by internationally reputable regulatory

authorities are summarised in Table 27.

Table 27: Reference doses established by overseas regulators

Available

international

Reference

doses

Key systemic

effect

NOAEL

(LOAEL)

mg/kg

bw/day

Uncertainty

factors

AOEL

mg/kg

bw/day

Staff’s

modifications Remarks

EFSA

boscalid

Systemic toxicity

(changes in

clinical

chemistry,

increased liver

weights and

thyroid glands

weights)

22 100 0.1 None

Corrected

for 44 %

oral

absorption

2 http://archive.apvma.gov.au/archive/spray_drift/scenarios.php

http://archive.apvma.gov.au/archive/spray_drift/scenarios.php

48


Available

international

Reference

doses

Key systemic

effect

NOAEL

(LOAEL)

mg/kg

bw/day

Uncertainty

factors

AOEL

mg/kg

bw/day

Staff’s

modifications Remarks

EFSA

pyraclostrobin

Maternal toxicity

in

developmental

toxicity study

(rabbits)

3.0 100 0.015 None

Corrected

for 50%

oral

absorption

EFSA

tebuconazole

Hypertrophy in

the zona

fasciculate

(adrenal) in 90

day dog study

3.0 100 0.03 None

Assuming

100%

absorption

was used

EFSA

Pyriproxyfen

No consistent

findings were

noted at the

highest dose

administered

10.0 100 0.04 None

Corrected

for 40%

oral

absorption

No dermal absorption data were provided for RFC 397 (New Formulation) so default values have

been used in the risk assessment. For pesticides, we have adopted default dermal absorption values

proposed by Aggarwal et al (2015), which are based on a review of a robust data set of 295 in vitro

human dermal absorption studies with over 150 agrochemical active ingredients. These default values

are 6% for liquid concentrates and 30% for spray dilutions.

Table 28: Input values for human exposure modelling

Active Physical

form

Concentration

of each active

(g/L)

Maximum

application rate

(for each active,

for each method of

application)

g a.i./ha

Dermal absorption (%) AOEL

mg/kg

bw/day

Concentrate Spray

boscalid

Liquid

12.6 126

6 30

0.1

pyraclostrobin 6.4 64 0.015

tebuconazole 21.5 215 0.03

pyriproxyfen 5.0 50 0.04

49


Operator exposure assessment for home use exposure

In order to assess the operator exposures for home use, staff used the UK POEM model. The model

includes a home use scenario for an outdoor sprayer for both low-level targets and high-level targets

to assess the applicant’s proposed end-use on roses and ornamentals.

Input parameters (home use)

The operator body weight = 60 kg

The model was run assuming no use of personal protective equipment (PPE) by the home

user.

The concentration is the concentration of each individual active utilized in the formulation.

The application rate is 10 L product /ha (GAP table)

The product is diluted 1/100 before spraying (1000 L/ha) (GAP table).

The UK POEM model gives 0.01 ha and 0.5 hr of work time as the default area and time for a

home garden sprayer.

The model was ran under two different exposure scenarios:

o ground level scenarios (ornamentals): home garden sprayer (5 litre tank), outdoor,

low level target

o higher target (ornamentals/shrubs): hand-held rotary atomiser equipment (2.5L tank),

outdoor, high level target

The modelled container was a “home garden, separate measure”.

The daily work exposure duration was 30 min/day for all home-related end-uses.

The results of the operator exposure assessments for home use are shown in Table 29 and Table 30.

Table 29: Estimated exposures and risk quotients for the home use operator (output of operator mixing, loading and application exposure assessment – Low level target

Exposure Scenario

Home Sprayer with no PPE

Estimated operator

exposure (mg/kg

bw/day)

Risk

Quotient

Home garden sprayer (5L tank)

Boscalid 0.013 0.13

Pyraclostrobin 0.006 0.22

Tebuconazole 0.022 0.72

Pyriproxyfen 0.006 0.15

50


Table 30: Estimated exposures and risk quotients for the home use operator (output of

operator mixing, loading and application exposure assessment – High level target

Exposure Scenario

Home Sprayer with no PPE

Estimated operator

exposure (mg/kg

bw/day)

Risk

Quotient

Hand-held rotary atomiser equipment (2.5L tank)

Boscalid 0.009 0.09

Pyraclostrobin 0.005 0.15

Tebuconazole 0.015 0.51

Pyriproxyfen 0.004 0.09

The results of the exposure estimates for home use applications indicate risk are minimal for the

operator even if no PPE is worn. Although the no PPE exposure model for home use leads to an

acceptable level of risk, it is appropriate to retain requirements for PPE since the use of PPE when

handling agrichemicals is good practice.

Operator exposure assessment for commercial use exposure

In order to assess the operator exposures for commercial use, staff used the UK Chemicals

Regulation Directorate (CRD) version of the BBA (German Federal Biological Institute) operator

exposure model (Chemicals Regulation Directorate, 2016c).

Input parameters (commercial use)

The operator body weight = 70 kg

The concentration is the concentration of each individual active utilized in the formulation.

The application rate is 10 L product /ha (GAP table)

The product is diluted 1/100 before spraying (1000 L/ha) (GAP table).

The results of the commercial operator exposure assessments for use of RFC 397 (New Formulation)

in commercial end uses using back-pack sprayers are shown in Table 31 to 34.

Table 31: Output of operator mixing, loading and application exposure assessment for

boscalid in commercial end uses – Ornamentals

Exposure Scenario

Estimated operator

exposure (mg/kg

bw/day)

Risk

Quotient

Backpack - High Level Target

No PPE during mixing, loading and application 0.045 0.45

Gloves only during mixing and loading 0.025 0.25

51


Gloves only during application 0.039 0.39

Full PPE during mixing, loading and application (excluding

respirator)

0.004 0.04

Full PPE during mixing, loading and application (including FP1, P1

and similar respirator achieving 75 % inhalation exposure

reduction)

0.004 0.04



reduction)

0.004 0.04


pyraclostrobin in commercial end uses - Ornamentals

Exposure Scenario

Estimated operator

exposure (mg/kg

bw/day)

Risk

Quotient






respirator)

0.002 0.14



reduction)

0.002 0.13



reduction)

0.002 0.12


tebuconazole in commercial end uses - Ornamentals

Exposure Scenario

Estimated operator

exposure (mg/kg

bw/day)

Risk

Quotient






respirator)

0.007 0.24

52




reduction)

0.006 0.21



reduction)

0.006 0.21


pyriproxyfen in commercial end uses - Ornamentals

Exposure Scenario

Estimated operator

exposure (mg/kg

bw/day)

Risk

Quotient






respirator)

0.002 0.04



reduction)

0.001 0.04



reduction)

0.001 0.04

Predicted operator exposures during mixing, loading and application of RFC 397 (New Formulation)

for potential end uses in commercial operations are above the AOEL for pyraclostrobin and

tebuconazole in the absence of PPE. However, risk quotients can be reduced to acceptable levels

(<1) with the use of full PPE (excluding a respirator). The difference between the home use and

commercial use relates to the comparative work rates (0.01 ha and 0.5 hours for home use compared

to 1 ha and 8 hours for commercial backpack application) and consequently the amount of product

handled and duration of exposure.

Re-entry worker exposure assessment

The results of the re-entry worker exposure assessment are summarised in Table 35.

53


Table 35: Output of the re-entry worker exposure assessment for boscalid, pyraclostrobin, tebuconazole and pyriproxyfen

Active

ingredient Crop/activity

Internal (absorbed)

dose available for

systemic

distribution

(mg/kg bw/8 hours)

AOEL

(mg/kg

bw/day)

Risk Quotient

immediately after

application

Re-entry

interval

WITHOUT

gloves

(days)

boscalid Ornamentals -

Cut/sort/bundle/carry

0.10 0.1 1.04 1

pyraclostrobin 0.05 0.015 3.53 18

tebuconazole 0.18 0.03 5.93 26

pyriproxyfen .04 0.04 1.03 1

Table 36: Output of the re-entry worker exposure assessment for boscalid, pyraclostrobin, tebuconazole and pyriproxyfen

Active

ingredient Crop/activity

Internal (absorbed)

dose available for

systemic

distribution

(mg/kg bw/8 hours)

AOEL

(mg/kg

bw/day)

Risk Quotient

immediately after

application

Re-entry

interval

WITH

gloves

(days)

boscalid Ornamentals -

Cut/sort/bundle/carry

0.03 0.1 0.29 0

pyraclostrobin 0.01 0.015 0.99 0

tebuconazole 0.05 0.03 1.66 7

pyriproxyfen 0.01 0.04 0.29 0

Predicted exposures to pyraclostrobin and tebuconazole for workers re-entering and working in areas

where RFC 397 (New Formulation) has been applied are above the AOEL in the absence of gloves.

The exposure assessment indicates that a 7 day restricted entry interval (REI) control is needed for a

worker wearing gloves to ensure worker exposure is below the AOEL. The exposure assessment

indicates that, in the absence of gloves, there could be a restricted re-entry interval (REI) control of up

to 26 days to ensure worker exposure is below the AOEL.

Quantitative bystander risk assessment

We consider that the main potential source of exposure to the general public for this substance is via

spray drift to surface surrounding its intended use (roses and ornamentals). In terms of bystander

exposure, toddlers are regarded as the most sensitive sub-population and are regarded as having the

greatest exposures. For these reasons, the risk of bystander exposure is assessed in this sub-

population and the exposure modelling assessed the risk with no buffer zone as a child could be

exposed directly to an immediately sprayed lawn or park. We use the AOEL calculated for the

operator and re-entry worker exposure assessments for the bystander assessment, as the use of an

oral chronic reference dose (CRfD) is usually likely to be over precautionary. There is no modelling

54


available to assess bystander exposure for spot spraying with hand-held or back-pack sprayers. Data

from low boom sprayers was used in assessing this risk and represents a conservative estimate. The

only results presented are those for tebuconazole as it is the active with the highest risk potential.

The results of the bystander exposure assessment are summarised in Table 37.

Table 37 Output of the bystander exposure assessment for tebuconazole

Exposure Scenario

Estimated exposure of 15

kg toddler exposed

through contact to

surfaces 8 m from an

application area

(µg/kg bw/day)

Risk Quotient

Buffer zone needed to

reduce toddler

exposure to the AOEL

Boom

Low boom, fine droplets 21.84 0.73 0

Low boom, coarse droplets 21.53 0.72 0

Estimated bystander exposure to all four actives is below the AOEL and no buffer zone is needed.

Conclusions of the human health risk assessment

Home use

The estimated risk to a home operator or child bystander from the use of RFC 397 (New Formulation)

for fungal control on roses and ornamentals was deemed minimal and acceptable. This risk was

under the assumption that no PPE would be utilized during the mixing, loading, and application of

RFC 397 (New Formulation) using backpack or hand held sprayers for 0.5 hours with a coverage of

100 m2.

Commercial use

The estimated risk to a commercial operator applying RFC 397 (New Formulation) with a hand-held or

backpack sprayer for fungus control on roses and ornamentals was deemed unacceptable in the

absence of full PPE (excluding respirator). Predicted exposures to the actives for workers re-entering

and working in areas where RFC 397 (New Formulation) has been applied are above the AOEL for

harvesting ornamentals without gloves, but are anticipated to be mitigated with gloves and a 7-day re-

entry interval.

55


Appendix J: Environmental risk assessment methodology

Methodologies

Methods used to assess environmental exposure and risk differ between environmental

compartments are summarised in Table 38.

Table 38: Reference documents for environmental exposure and risk assessments

Environmental exposure Risk assessment

Soil organisms,

invertebrates

(macro-

invertebrates)

Soil persistence models and EU

registration. The final report of the work

of the Soil Modelling Work group of

FOCUS (FOrum for the Co-ordination

of pesticide fate models and their USe)

– 29 February 1997

SANCO/10329/2002 rev 2 final. Guidance

Document on terrestrial ecotoxicology under

Council Directive 91/414/EEC- 17 October

2002

Bees

Guidance for assessing pesticide risks to bees. US EPA, Health Canada Pest

Management Regulatory Agency, California Department of Pesticide Regulation, 19

June 2014

Terrestrial

organisms,

invertebrates

(non-target

arthropods)

Guidance document on regulatory testing and risk assessment procedures for plant

protection products with non-target arthropods. From ESCORT 2 Workshop – 21/23

March 2000

Terrestrial

vertebrates (birds)

Guidance of EFSA. Risk assessment to birds and mammals – 17 December 2009.

EFSA calculator tool - 20093

SANCO/4145/2000 final. Guidance Document on risk assessment for birds and

mammals under Council Directive 91/414/EEC- 25 September 2002

Secondary

poisoning and

biomagnification

Technical Guidance Document on risk

assessment in support of Commission

Directive 93/67/EEC on Risk

Assessment for new notified

substances, Commission Regulation

(EC) No 1488/94 on Risk Assessment

for existing substances, Directive

98/8/EC of the European Parliament

and of the Council concerning the

placing of biocidal products on the

market – Part II - 2003

Guidance of EFSA. Risk assessment to

birds and mammals – 17 December 2009

EFSA calculator tool - 2009

SANCO/4145/2000 final. Guidance

Document on risk assessment for birds and

mammals under Council Directive

91/414/EEC- 25 September 2002

3 www.efsa.europa.eu/en/efsajournal/pub/1438.htm

http://www.efsa.europa.eu/en/efsajournal/pub/1438.htm

56


Consideration of threatened native species

No studies are requested to be conducted on native New Zealand species. The risk assessment is

based on studies performed on standard surrogate species from Europe or North America.

Uncertainty factors included in the risk assessment process encompass the possible susceptibility

variations between the surrogate species and the native New Zealand species. However, these

factors are designed to protect populations, not individual organisms. We acknowledge that these

factors may not be protective enough for threatened species for which the survival of the population

could depend on the survival of each and every individual.

Therefore, the US EPA approach for risk assessment of endangered species has been implemented.

Under this approach additional uncertainty factors are included, depending on the type of organism.

The US EPA approach uses higher factors when organisms cannot escape the contaminated area

(for aquatic organisms for instance) than for organisms that can move away, such as birds.

The US EPA has not defined any additional factor for soil organisms except for plants, so we have

applied the same approach as for the aquatic environment, considering that soil invertebrates won’t

be able to escape from the contaminated area.

For the purposes of this risk assessment, the threatened species are those included in the following

categories of the New Zealand Threat Classification System:

‘Threatened’ (Nationally critical, Nationally endangered, Nationally vulnerable)

‘At risk’ (declining, recovering, relict, naturally uncommon).

Terrestrial risk assessment

For terrestrial organisms, Toxicity-Exposure Ratios (TERs) are used for earthworms and birds,

Hazard Quotients (HQ) are used for terrestrial invertebrates and Risk Quotients (RQ) for bees. TERs

are calculated by dividing a toxicity value by the predicted environmental concentrations, whereas

HQs are calculated by dividing the predicted environmental concentration by a toxicity value. This

convention means that TERs are interpreted in a different way to RQs and HQs

The lower the TER the higher the risk

The higher the RQ or HQ the higher the risk

We have adopted the LOCs developed by the European Union to determine whether a substance

poses an environmental risk; these are provided in Table 39.

Table 39: Adopted levels of concern for terrestrial risk assessment

Level of Concern (LOC) Presumption

Earthworm/ Birds

Acute TER < 10 Risks above the LOC

Chronic TER < 5 Risks above the LOC

Threatened Bird species

57




Threatened soil organisms species



Bees

Acute RQ oral/contact > 0.4 Risks above the LOC

Chronic RQ > 1 Risks above the LOC

Terrestrial invertebrates

HQ in-field/off-field ≥2 Risks above the LOC

Non-target plants

Acute RQ/TER

RQ ≥ 1 calculated on the basis of

EC25 or TER ≤ 5 calculated on the

basis of EC50

Risks above the LOC

Threatened non-target plant species

Acute RQ ≥ 1 calculated on the basis of the

NOEC or EC05 Risks above the LOC

Earthworm and soil organism risk assessment

Soil Predicted Environmental Concentration (PEC) determination

Both acute and reproductive earthworm tests are static tests where the test substance is applied to

the system only once at the beginning. Therefore, the nominal dose levels in the test match initial

concentrations in the field and thus it is appropriate to use initial PEC values (no time-weighted

averages) for the acute as well as the long-term TER.

The concentration of active substance in the soil is calculated on the basis of the FOCUS (1997)

document ‘Soil persistence models and EU registration’:

PEC one application (mg/kgsoil) = application rate (gai/ha)

750

The predicted soil concentrations assume the active ingredient is deposited onto bare soil, will mix

into the top 5 cm of soil, and that this soil has a bulk density of 1.5 g/cm3 (or 1500 kg/m3).

In case of multiple applications, the following formula is used:

PEC multiple applications = PEC one application x (1 – e-nki)

(1 – e-ki)

where:

58


n = number of applications

k = ln2/DT50 (day-1)

i = interval between two consecutive applications (days)

DT50 = half-life in soil (days) NB: Use only DT50 values of lab tests done at 10-20 °C and pH

between 5 and 9

e = 2.718 (constant).

When there are DT50 values of several soils available, the GENEEC2 formula are used to determine

the relevant DT50 for modelling purposes.

For the off field risk assessment, we have used the same calculation as for the in field scenario with

an added drift factor. The drift factor is generally taken from the drift models produced by the BBA

model. Details of the values used in the risk assessment can be found in Appendix K.

Calculation of TERs

TERacute = LD50

Predicted Environmental Concentration

TERlong-term = NOEC

Predicted Environmental Concentration

Non-target plant risk assessment

Non-target plants are non-crop plants located outside the treatment area.

Spray drift is considered the key exposure route for terrestrial plants located in the vicinity of the

treated area. The drift models produced by the BBA for the exposure assessment of aquatic

organisms may be used as a surrogate to cover the exposure assessment of terrestrial plants

(Ganzelmeier et al., 1995, recently updated by Rautmann et al., 2001).

It should be noted that these drift data have been generated with regard to intake into surface waters.

In particular, there is no vegetation barrier between the spray boom and the collector plates. In

terrestrial scenarios, however, horizontal and vertical interception by in-crop or off-crop vegetation as

well as patchy distribution is relevant (“three-dimensional-situation“). Thus, when more realistic drift

data become available they should be used.

The initial assessment should be conducted for a distance of 1 m from the field edge for field crops,

vegetables or ground applications such as for herbicides, and 3 m for other crops. Risk mitigation

measures based on buffer zones within the crop area can also be quantified using BBA drift values.

This tier is a quantitative risk assessment following a RQ or TER approach depending on the

available data. Both effects and exposure are expressed in terms of application rate (g /ha). Effects

59


data are represented by ER25 or ER50 values from the toxicity studies, also expressed as g/ha. An RQ

approach is used when an EC25 is available while a TER value is used when an EC50 is available.

The LOCs ascribed to specific RQ/TER values are shown in Table 40. The trigger may be reduced if

information on more species is available.

Bird risk assessment

We use EFSA’s Bird model and Excel© spreadsheets freely available on EFSA’s website to assess

the risks to birds. EFSA provides different spreadsheets to calculate exposure following spray

application, granular application and seed treatment. For bait applications a spreadsheet with Daily

Food Intake of NZ relevant species is available (Crocker et al., 2002).

The methodology calculates TERs where exposure is calculated as the dose that a bird will receive

when feeding in crops that have been sprayed. To avoid doing detailed evaluations for low risk

scenarios, assessments are performed in tiers of increasing complexity.

The steps for the acute assessment are:

Screening assessment

Tier I assessment

Higher tier assessment.

The steps for the reproductive assessment are:


Phase-specific assessment

Higher tier assessment.

Progression to the next tier is only made if the threshold for concern is exceeded at the previous tier.

Screening risk assessment

The principles underlying the exposure assessment are the same for all assessments other than

higher tier assessments in which more specific field exposure data may be used. The dose that a bird

receives (Daily Dietary Dose or DDD) is calculated from the application rate and a so-called ‘Shortcut

value’ for the Residue per Unit Dose (RUD), reflecting the concentration of the active ingredient on

the bird’s food and the quantity of food consumed. Quantities consumed are based on a bird’s energy

requirements, its energy assimilation and the energy content of its food (dry weight). Birds’ energy

requirements are based on an algorithm based on bodyweight and bird type (e.g. passerine/non-

passerine). For further details, refer to the EFSA technical guidance document.

Both screening step assessments (acute and reproduction) select from 6 ‘indicator species’ each

applicable to a particular type of crop. They are not real species, but, by virtue of their size and

feeding habits, their exposure is considered worst-case for birds in a particular crop type. For

example, the representative species for orchards is described as a ‘small insectivorous bird’. It is

assumed that the relevant indicator species feeds only on contaminated food and the concentration of

60


pesticide on the food is not affected by the growth stage of the crop. Thus, the exposure assessment

is expressed as follows depending on the number of applications:

For the acute risk assessment:

DDD one application = application rate (kg/ha) x shortcut value

DDD multiple applications = DDD one application x MAF90

For the reproduction risk assessment:

DDD = application rate (kg/ha) x shortcut value x TWA* x MAFmean

*if the toxic effect is considered to be caused by long-term exposure, use TWA = 0.53 (estimates time-weighted exposure over

21 days assuming a default DT50 of 10 days).

Measures of exposure and toxicity used in the reproduction risk assessment are shown in Table 40.

Table 40: Measures of exposure and toxicity used in the reproduction assessment

Breeding phase Test endpoint used as surrogate Short-term

exposure

Long-term

exposure

Pair formation/ breeding

site selection 0.1 x LD50

1 1 day DDD 21 day TWA DDD

Copulation and egg laying

(5 days pre-laying through

end of laying

NOAEL for the number of eggs laid per

hen 1 day DDD 21 day TWA DDD

NOAEL for mean eggshell thickness 1 day DDD 21 day TWA DDD

Incubation and hatching

0.1 x LD50 1 day DDD 21 day TWA DDD

NOAEL for proportion of viable

eggs/eggs set/hen 1 day DDD 21 day TWA DDD

NOAEL for proportion of

hatchlings/viable eggs/hen 3 day TWA DDD 21 day TWA DDD

Juvenile growth and

survival until fledging

0.1 x LD50 (extrinsic adult) 2 day TWA DDD 21 day TWA DDD

0.1 x LD50 (extrinsic juvenile)

1 day DDD based on

chick shortcut values

of 3.8 and 22.72

21 day TWA DDD

based on chick

shortcut value of 3.8

and 22.72

NOAEL for proportion of 14 day old

juveniles/number of hatchlings/hen 3 day TWA DDD 21 day TWA DDD

Post-fledging survival

0.1 x LD50

1 day DDD based on

chick shortcut values

of 3.8 and 22.72

21 day TWA DDD

based on chick

shortcut value of 3.8

and 22.72

NOAEL for 14 day old juvenile

weights/hen 3 day TWA DDD 21 day TWA DDD

1 from acute study

61


2 The two values are to account for ground and foliar dwelling arthropods with mean residue unit doses of 3.5 and 21 respectively. Assessments are made with both values. If TER are exceeded with either value, then an assessment based on the actual composition of the diet of relevant species should be performed.

Tier 1 risk assessment

Tier 1 uses the same general approach as the screening assessment but requires more specific

exposure scenarios. The first step is to identify all general focal species listed in Table I.1 (Annex I) of

the EFSA’ technical guidance documents that are relevant for the intended use(s).

In the Tier 1 acute and phase-specific reproduction assessments exposure is calculated for generic

focal species, applicable to particular crops. Such assessments refine the screening step

assessments in that:

there are more bird ‘species’ (19) and crop options (21);

the growth stage of the crop is taken into account, affecting the residues on the feed;

more than one bird species may be considered for any one crop;

a bird’s diet can be calculated to include more than one food item.

The larger number of bird species, crop types and growth stages of the crops leads to a total of 138

average residue unit dose (RUD) shortcut options, each with a mean and 90th percentile value.

Secondary poisoning risk assessment

When an active ingredient is bioaccumulative, a risk assessment for secondary poisoning is

necessary for this active ingredient.

Bioconcentration is defined as the net result of the uptake, distribution and elimination of a substance

in an organism due to waterborne exposure, whereas bioaccumulation includes all routes, i.e. air,

water, soil and food (EC, 2003). Bioaccumulation often correlates with lipophilicity, thus, for organic

chemicals, a log Kow ≥ 4 indicates a potential for bioaccumulation. If this condition is met, secondary

poisoning and biomagnification issues should be considered. As bioaccumulation processes often are

slow and substances may be persistent, a long-term assessment is appropriate. Relevant metabolites

must also be considered.

Food chain from earthworm to earthworm-eating birds

The EFSA approach based on dry soil concentration is followed.

Determination of the Predicted environmental concentration of soil (PEC soil). Under heading

‘Earthworm and soil organism risk assessment’ the method to determine the PEC soil is described.

Use the PEC for the in-field situation for the assessment of secondary poisoning.

Determination of the bioconcentration factor for earthworm (BCFearthworm) using the following formula

BCFearthworm = (0.84 + 0.012Kow) / Foc x Koc

Where:

Kow = octanol water partition coefficient

Foc = organic carbon content of soil (0.02 is default value)

62


Koc = organic carbon adsorption coefficient

Determination of PEC earthworm using the following formula

PECearthworm= PEC soil x BCFearthworm

The PECearthworm is converted to daily dose to birds by multiplying with 1.05. Multiplicators are based

on a 100-g bird, eating 104.6 g per day, according to Smit (2005).

Calculate the Toxicity-exposure ratio (TER) by comparing the long term toxicity with the converted

PECearthworm. Compare the TER with the trigger value.

Bee risk assessment

The risk to bees is assessed following the US EPA Guidance for Assessing Pesticide Risks to Bees

(2014).

If a reasonable potential for exposure to the pesticide is identified, a screening-level risk assessment

is conducted. This step involves a comparison of Tier I estimated exposure concentrations (EECs) for

contact and oral routes of exposure to adults and larvae to Tier I acute and chronic levels of effects to

individual bees using laboratory-based studies. The conservatism of the Tier I screening-level risk

quotient (RQ) value results primarily from the model-generated exposure estimates that, while

intended to represent environmentally relevant exposure levels, are nonetheless considered high-end

estimates. The resulting acute and chronic RQ values are then compared to the corresponding level

of concern (LOC) values for acute and chronic risk (i.e., 0.4 and 1.0, respectively). Generally, if RQ

values are below their respective LOCs, a presumption of minimal risk is made, since the Tier I risk

estimation methods are designed to be conservative.

Exposure is estimated as shown in Table 41.

Table 41: Inputs for the bee risk assessment

Measurement

endpoint

Exposure

route

Exposure estimate

(EEC)*

Acute effect

endpoint

Chronic effect

endpoint#

Foliar application

Individual survival

(adults) Contact

Application rate (kg ai/ha)

x 2.4 µg ai/bee

Acute contact

LD50 None

Individual survival

(adults) Diet


x 98 µg ai/g x 0.292

g/day

Acute oral

LD50

Chronic adult oral

NOAEC (effects to

survival or longevity)

Brood size and

success Diet


x 98 µg ai/g x 0.124

g/day

Larval LD50

Chronic larval oral

NOAEC (effects to adult

emergence, survival)

Soil treatment

63


Measurement

endpoint

Exposure

route

Exposure estimate

(EEC)*

Acute effect

endpoint

Chronic effect

endpoint#

Individual survival

(adults) Diet

Briggs EEC x 0.292

g/day

Acute oral

LD50

Chronic adult oral

NOAEC (effects to


Brood size and

success Diet

Briggs EEC x 0.124

g/day Larval LD50

Chronic larval oral



Seed treatment&

Individual survival

(adults) Diet 1 µg ai/g x 0.292 g/day

Acute oral

LD50

Chronic adult oral

NOAEC (effects to


Brood size and

success Diet 1 µg ai/g x 0.124 g/day Larval LD50

Chronic larval oral



Tree trunk application**

Individual survival

(adults) Diet

µg ai applied to tree/g

foliage x 0.292 g/day

Acute oral

LD50

Chronic adult oral

NOAEC (effects to


Brood size and

success Diet

µg ai applied to tree/g

foliage x 0.124 g/day Larval LD50

Chronic larval oral



* Based on food consumption rates for larvae (0.124 g/day) and adult (0.292 g/day) worker bees and concentration in pollen

and nectar.

** Note that concentration estimates for tree applications are specific to the type and age of the crop to which the chemical is

applied.

# To calculate RQs for chronic effects, NOAEC can be used as the effect endpoint to compare with the exposure estimate.

& Assume that pesticide concentration in pollen and nectar of seed treated crops is 1 mg a.i./kg (1 μg a.i./g). No adjustment is

made for application rate (Based on EPPO’s recommended screening value).

Risk quotients are calculated using the following equations.

Acute RQ = EEC

LD50

Chronic RQ = EEC

NOAEC

64


Non-target arthropod risk assessment

Where limit tests are conducted, a low risk to non-target arthropods can be concluded when the

effects at the highest application rate, multiplied by a multiple application factor (MAF) when more

than one application is expected, are below 50% (ESCORT2 workshop, 2000 – p12). This is

assessed by calculating a hazard quotient (HQ) by dividing the application rate (multiplied by the

MAF) by the LR50.

Calculation of HQs

𝐼𝑛 − 𝑓𝑖𝑒𝑙𝑑 𝐻𝑄 = 𝐴𝑝𝑝𝑙𝑖𝑐𝑎𝑡𝑖𝑜𝑛 𝑟𝑎𝑡𝑒 (𝑔 𝑜𝑟mL a.i./ha) × 𝑀𝐴𝐹 ∗

𝐿𝑅50 ∗∗

* application rate and LR50 must not differ in their units, i.e. must be related to either formulation or a.i. rates

** Multiple application factor, refer to Appendix V, p 45 of ESCORT 2 Workshop, 2000. MAF = 1 when there is just one

application.

𝑂𝑓𝑓 − 𝑓𝑖𝑒𝑙𝑑 𝐻𝑄 = 𝑎𝑝𝑝𝑙𝑖𝑐𝑎𝑡𝑖𝑜𝑛 𝑟𝑎𝑡𝑒 × 𝑀𝐴𝐹 × (

𝑑𝑟𝑖𝑓𝑡 𝑓𝑎𝑐𝑡𝑜𝑟 ∗𝑣𝑒𝑔𝑒𝑡𝑎𝑡𝑖𝑜𝑛 𝑑𝑖𝑠𝑡𝑟𝑖𝑏𝑢𝑡𝑖𝑜𝑛 𝑓𝑎𝑐𝑡𝑜𝑟 ∗∗

)

𝐿𝑅50× 𝑐𝑜𝑟𝑟𝑒𝑐𝑡𝑖𝑜𝑛 𝑓𝑎𝑐𝑡𝑜𝑟 ∗∗∗

* Overall 90th percentile drift values are presented in Appendix VI, p 46 of ESCORT 2 Workshop, 2000.

** default value of 10

*** default value of 10

A drift factor for field crops of 2.77% (based on a minimum drift of 1 m) is used for off-field exposure

calculations, based on recommendations made in ESCORT 2 and SANCO/10329/2002 rev 2 final.

65


Appendix K: Environmental risk assessment

Toxicity of the formulation

No ecotoxicity information of the formulation (RFC 397 (New Formulation)) was provided by the

applicant therefore the toxicity of the mixture could not be evaluated. By mixing different active

ingredients the ingredients can interact which can result in different ecotoxicological responses. The

toxicity can be less than expected (less than additive effect), as predicted based on the individual

ingredients (additive effect) or the effects can be magnified (more than additive effect/synergism).

Insufficient information is available to determine the interactions in this formulation.

Aquatic risk assessment

A qualitative approach was used to evaluate the risk to the aquatic environment from use of the

substance RFC 397 (New Formulation). The standard quantitative modelling approach is not

considered applicable for home garden and small commercial uses (spot treatments using handheld

and backpack sprayers) since the quantitative modelling only represents agricultural scenarios.

Environmental mobility and persistence

In regard to potential for environmental mobility, the partition coefficient (Koc) values for boscalid,

pyraclostrobin and tebuconazole are 655, 6000 and 910 mL/g, respectively (see Table 15, Appendix

E). Although no partition coefficient is available for pyriproxyfen, given its low solubility in water (0.367

g/L), pyriproxyfen is expected to be relatively immobile. As such, the four active ingredients have

varying potential for mobility in soil from moderately mobile to immobile.

In relation to environmental persistence in soil, in the laboratory aerobic soil DT50(lab) values for

boscalid, pyraclostrobin, tebuconazole and pyriproxyfen are 367, 137, 770 and 12.4 days,

respectively (see Table 15, Appendix E).

In the field, soil DT50(field) values for boscalid, pyraclostrobin, tebuconazole are 151, 34, and 57.5 days,

respectively (see Table 15, Appendix E). No aerobic soil DT50(field) value was available for

pyriproxyfen. As such, boscalid, pyraclostrobin, tebuconazole are considered to be relatively

persistent in soil. Pyriproxyfen is not considered persistent in soil.

In water/sediment systems, aerobic aquatic whole system DT50 values for pyraclostrobin,

tebuconazole and pyriproxyfen are 27, 38.7 and 28.1 days, respectively (see Table 13, Appendix E).

Whilst no whole system value is available for boscalid, it degrades in an aerobic water system with a

DT50 of 21 days and in aerobic sediment with a DT50 of 66 days. The four active ingredients are

considered relatively persistent in water/sediment systems.

Aquatic toxicity

In regard to acute toxicity in the aquatic environment, for boscalid the lowest acute toxicity value was

obtained for algae (Pseudokirchneriella subcapitata) with an LC50 value of 1.34 mg/L. For

pyraclostrobin the lowest acute toxicity value is an LC50 value of 0.00616 mg/L obtained for fish

66


(Oncorhynchus mykiss). It should also be noted that pyraclostrobin also has low LC50 values of

0.0157 mg/L and >0.842 mg/L for aquatic invertebrates (Daphnia magna) and algae

(Pseudokirchneriella subcapitata), respectively. For tebuconazole and pyriproxyfen the lowest acute

toxicity values were also obtained for algae (Pseudokirchneriella subcapitata) with LC50 values of

0.144 mg/L and 0.056 mg/L, respectively (full list of the ecotoxicity endpoints can be found in

Appendix G). RFC 397 (New Formulation) is considered to be acutely very toxic in the aquatic

environment.

In regard to chronic toxicity in the aquatic environment, the lowest NOEC values for boscalid,

pyraclostrobin, tebuconazole and pyriproxyfen are 0.125 (fish, Oncorhynchus mykiss), 0.0007 (fish,

Oncorhynchus mykiss and crustacea, Daphnia magna), 0.010 (crustacea, Daphnia magna) and

0.00001 mg/L (crustacea, Daphnia magna), respectively (full list of endpoints can be found in

Appendix G). RFC 397 (New Formulation) is considered to be chronically very toxic in the aquatic

environment.

The active ingredients boscalid and tebuconazole are not considered to be bioaccumulative (with fish

bioconcentration factors of 70 and 78, respectively). Pyraclostrobin is considered to be

bioaccumulative (fish bioconcentration factor of 675) and pyriproxyfen is considered to be potentially

bioaccumulative based on the log Kow of 5.37.

Conclusion of the aquatic risk assessment

The substance RFC 397 (New Formulation) triggers a 9.1A hazard classification (very ecotoxic in the

aquatic environment). Since the substance RFC 397 (New Formulation) is intended for home garden

and small commercial uses, spray drift, runoff and/or potential for groundwater contamination is

expected to be limited. As such, acute and chronic risks to fish, crustacea, algae, aquatic plants and

sediment dwelling organisms is also expected to be limited. Despite this, since RFC 397 (New

Formulation) is very ecotoxic in the aquatic environment, the EPA proposes to add the following

control:

DO NOT apply when the garden is adjacent to a waterbody

Terrestrial risk assessment

The terrestrial risk assessment considers the risks to soil organisms, terrestrial plants, birds, bees and

non-target arthropods.

The methodology used to perform the terrestrial risk assessment is described in Appendix J. It should

be noted that although we have retained the quantitative modelling as per the standard risk

assessment approach to assess the risks to the terrestrial environment from use of RFC 397 (New

Formulation), in reality exposure to terrestrial organisms is likely to be limited since RFC 397 (New

Formulation) is intended to be applied only as a spot treatment to individual shrubs using a handheld

or backpack sprayer in home garden and small-scale commercial settings.

67


Soil organisms risk assessment

The soil organism risk assessment is based on a comparison of the PEC with toxicity values for the

substance. The toxicity value is divided by the PEC to give a Toxicity Exposure Ratio (TER). The

different levels of concern assigned to specific TER values are listed in Appendix J.

The results of the acute risk assessment for soil organisms are summarised in Table 42. Results of

the chronic risk assessment are summarised in Table 43. The DT50 values of the field studies were

applied in the risk assessment. The worst-case drift scenario was modelled to determine the off-field

risk. Since, these risks were below the level of concern or could not be determined due to a lack of

data (chronic information boscalid and pyraclostrobin) no further refinement of the drift scenario was

required.

Table 42: Acute TER values for soil organisms

Species LC50

(mg/kg soil)

Drift

(%)

PEC

(mg/kg

soil)

TER acute Conclusion

Boscalid

“in-field”

Earthworm >1000 NA 1.185 844 Below LOC for threatened/non-

threatened species

“off-field”

Earthworm >1000 6.261 0.0742 >13475 Below LOC for threatened/non-

threatened species

Pyraclostrobin

“in-field”

Earthworm 567 NA 0.317 1787 Below LOC for threatened/non-

threatened species

“off-field”

Earthworm 567 6.261 0.020 28540 Below LOC for threatened/non-

threatened species

Tebuconazole

“in-field”

Earthworm 1381 NA 1.442 958 Below LOC for threatened/non-

threatened species

“off-field”


threatened species

1,2,4-triazole (metabolite tebuconazole, formation fraction 0.321)

“in-field”

68


Species LC50

(mg/kg soil)

Drift

(%)

PEC

(mg/kg

soil)


Earthworm >1000 NA 0.001 >1769689 Below LOC for threatened/non-

threatened species

“off-field”


threatened species

Pyriproxyfen

“in-field”

Earthworm >1000 NA 0.123 >8148 Below LOC for threatened/non-threatened species

“off-field”


threatened species

1: BBA drift curve, worst case scenario (ornamentals, height > 50 cm)

Table 43: Chronic TER values for soil organisms

Species NOEC

(mg/kg soil)

Drift

(%)

PEC

(mg/kg

soil)


Boscalid

“in-field”

NA Not

available NA

Not

determined

Not

determined Not determined

“off-field”

NA Not

available NA

Not

determined

Not


Pyraclostrobin

“in-field”

NA Not

available NA

Not

determined

Not


“off-field”

NA Not

available NA

Not

determined

Not


Tebuconazole

“in-field”

69


Species NOEC

(mg/kg soil)

Drift

(%)

PEC

(mg/kg

soil)


Earthworm 10 NA 1.44 6.93

Below LOC for non-threatened

species

Above LOC for threatened

species

“off-field”


threatened species

1,2,4-triazole (metabolite tebuconazole, formation fraction 0.321)

“in-field”

Earthworm 1.0 NA 0.001 1770 Below LOC for threatened/non-

threatened species

“off-field”

Earthworm 1.0 6.261 0.00004 28270 Below LOC for threatened/non-

threatened species

Pyriproxyfen

“in-field”

NA Not

available NA

Not determined

Not determined

Not determined

“off-field”

NA Not

available NA

Not

determined

Not


1: BBA drift curve, worst case scenario (ornamentals, height > 50 cm)

Conclusions of the soil organism risk assessment

Predicted acute exposures to soil organisms of the active ingredients and the major metabolites are

all below the level of concern (LOC).

The chronic risks to threatened species are above the level of concern in-field. It is considered highly

unlikely that threatened earthworm species would be present in areas where ornamentals are being

grown however. As such, the risk to threatened earthworm species is considered low since there is no

exposure pathway.

Insufficient information is available to determine the risks to soil organisms from application of

boscalid, pyraclostrobin and pyriproxyfen.

70


Non-target plant risk assessment

Insufficient information is available to perform this risk assessment, the risk assessment from previous

applications have been performed using formulation data. Since none of the active ingredients in RFC

397 (New Formulation) are herbicides, risks to non-target plants are expected to be low.

Bird risk assessment

The bird risk assessment is based on a comparison of the PEC with toxicity values for the substance.

The toxicity value is divided by the PEC to give a Toxicity Exposure Ratio (TER). The different levels

of concern assigned to specific TER values are listed in Appendix J.

In a previous risk assessment, it was determined that the risks for tebuconazole are significant.

During this assessment the chronic toxicity value for tebuconazole was refined. Since, based on the

application rate it was considered likely that the current substance poses risks, it was decided to start

modelling with this refinement rather than using the lowest endpoint. For tebuconazole the refined

NOEC of 10.1 mg/kg bw/d was used in the screening assessment therefore. This is the geometric

mean of the NOEC from the bobwhite quail and mallard duck.


Predicted exposure to the four active ingredients under the bird acute dietary and reproduction

screening assessments is shown in Table 44.

Table 44: Exposure of birds for acute and reproduction screening assessments

Screening

type1

Indicator

species2

Application

rate

(kg/ha)

Short-

cut

value

(90th%)3

TWA4

MAF

(90th

%)5

No of

applications TER

Boscalid

Acute Small

insectivorous

bird

0.126

46.8 NA 1.4 9 242

Reproduction 18.2 0.53 1.6 9 15.4

Pyraclostrobin

Acute Small

insectivorous

bird

0.064

46.8 NA 1.4 9 477

Reproduction 18.2 0.53 1.6 9 106

Tebuconazole

Acute 0.215 46.8 NA 1.4 9 110

71


Reproduction

Small

insectivorous

bird

18.2 0.53 1.6 9 3.0

Pyriproxyfen

Acute Small

insectivorous

bird

0.050

46.8 NA 1.4 9 611

Reproduction Not determined

1 EFSA, 2009, Table 5 p27 2 EFSA, 2009, Table 6 p28 3 90th %ile short-cut value used for the acute assessment, mean value used for the reproduction assessment. EFSA,

2009, Table 6 p28 4 The exposure assessment of the reproduction assessment uses time-weighted average (TWA) exposure estimates

over 1, 2, 3 or 21 days for different phases of the assessment. 1 day = 1.0; 2 days = 0.93; 3 days = 0.9; 21 days = 0.53. EFSA, 2009, Table 11 p34.

5 90th %ile MAF value used for the acute assessment, mean value used for the reproduction assessment. EFSA, 2009, Table 7 p29

Results of screening assessment

The screening assessment indicated that the acute risks for the substance are below the level of

concern. Chronic risks were identified. Threatened and non-threatened species are at risk according

to the screening assessment (driving active ingredient tebuconazole). For pyriproxyfen no chronic

data was available and no risk assessment was performed.

The refined the first tier risk assessment was performed on tebuconazole focusing on the chronic

risks.

Calculations of TER in first tier risk assessment

TER calculations for the reproductive risk assessment are detailed in Table 45.

Table 45: TER values for tebuconazole reproductive risk assessment (TWA = 0.53; MAF = 1.6, NOEC = 10.1 mg/kg bw/d)

Further refinement bird risk assessment (Tier 1)

The chronic Tier 1 risk assessment indicates risks above the level of concern to both threatened and

non-threatened birds from the use of RFC 397 (New Formulation).

Crops & BBCH class Generic focal species1 TER Conclusion

Orchards and ornamentals (nursery)

Ornamentals and nursery

Application to plant

Small insectivorous bird “tit” Foliar insects

100% foliar insects 3.0

Above LOC for non-

threatened and threatened

species

Ornamentals and nursery

Application to plant –

exposure to underlying

ground

Small insectivorous/worm feeding species

“thrush” ground invertebrates with interception

100% soil dwelling invertebrates

20.5 Below LOC for non-threatened

and threatened species

72


The maximum safe Daily Dietary Dose (DDD – multiple) of tebuconazole is ~2.0 mg/kg bw/d for non-

threatened species, the current DDD is 3.3 mg/kg bw/d. This means that for non-threatened species

at least 40% of the diet should be sourced outside the treated field. For threatened species this

proportion needs to be higher. Given the limited proposed use pattern (spot treatment of roses and

other ornamentals using a handheld or backpack sprayer), it is considered that birds are likely to

obtain sufficient uncontaminated food.

Secondary poisoning

Pyraclostrobin and pyriproxyfen are bioaccumulative so a risk assessment for secondary poisoning is

necessary for this active ingredient.

The EFSA dry soil approach was followed for earthworms, this resulted in a TER of 321 and 12.8 for

pyraclostrobin and pyriproxyfen respectively. Therefore, no risks for secondary poisoning are

identified.

Pollinator risk assessment

The basis for the pollinator risk assessment is a comparison of the environmental exposure

concentration (EEC) obtained from the BeeRex model (v 1.0) with toxicity endpoints to which safety

factors have been applied. The EEC is divided by the toxicity endpoint to calculate a risk quotient

(RQ) value. The methodology for the pollinator risk assessment, including the level of concern (LOC)

ascribed to specific RQ values, is described in detail in Appendix J. The results of the bee risk

assessment are shown in Table 46.

Table 46: Bee exposure estimates and RQ values

Use scenario Application rate

(kg ai/ha)

EEC (µg

ai/bee)

Toxicity

endpoint

value (µg

ai/bee)

RQ Conclusion

Acute / Adult bees – contact

Boscalid 0.126 0.302 >200 <0.0015 Below LOC

Pyraclostrobin 0.064 0.154 >100 <0.0015 Below LOC

Tebuconazole 0.215 0.516 >100 <0.0052 Below LOC

Pyriproxyfen 0.05 0.120 >100 <0.0012 Below LOC

Acute / Adult bees – oral

Boscalid 0.126 3.61 >165.96 <0.02 Below LOC

Pyraclostrobin 0.064 1.83 >73.10 <0.03 Below LOC

Tebuconazole 0.215 6.15 >83.05 <0.07 Below LOC

Pyriproxyfen 0.05 1.43 Not available Not determined

Acute / Larvae – oral

73


Not available

Chronic / adult and larvae

Not available

It should be noted that no chronic test data on any of the active ingredients are available and acute

oral toxicity to bees for the insecticide pyriproxyfen is also lacking. For boscalid as well as

pyraclostrobin there are indications (peer reviewed literature, non-GLP) that these active ingredients

are considered to have chronic effects on bees and chronic effects on larvae that impact honey bee

health. Considering that the use pattern includes ornamentals the lack of chronic test data is

considered to be a significant data gap.

Conclusions of the pollinator risk assessment

The acute risks to pollinators are below the level of concern. Acute oral risks of pyriproxyfen and

chronic risks could not be evaluated due to a lack of data.

Additional information from the applicant

The applicant provided an overview of all approved active ingredients and stated that the toxicity of

pyriproxyfen is not very ecotoxic to adult bees based on acute contact data only. Also an assessment

using the model BeeRex for pyriproxyfen is provided. The applicant used a value of 74 µg a.i./bee for

acute contact toxicity and 100 µg a.i./bee for acute oral toxicity [reference: Pesticide Properties Data

Base of the UK]. No risks were identified. However, the study reports are not provided to the EPA

therefore, it is not possible to check the validity of these figures.

The applicant provided a bee risk assessment based on information of bees, their behaviour and a

garden situation. To calculate the exposure of a bee, a garden of 100 m2 with 100 rose bushes was

used as an example. The proposed dose rate of pyriproxyfen is 50 g a.i./ha (= 5 mg a.i./m2). It is not

exactly clear how the concentration per rose bush (3.5 mg/kg) is determined as it is stated that a bush

is 2000 g and one bush per m2 is assumed. Consequently, the calculated exposure of a bee to

pyriproxyfen (0.175 µg per bee) is not clear.

The assumed exposure to one bee is stated to be low. This exposure is compared with the acute oral

toxicity of an adult bee, concluding a low risk to bees. Also the applicant argues that such a garden

provides only a small portion of the daily food needs of a bee.

The exposure of a bee for one collection trip is calculated but a bee makes several collection trips a

day however (up to 20 trips/day). Therefore, the exposure is likely to be higher. Furthermore, bees

target rewarding flowers and recruit other bees to visit these areas with good food sources.

Consequently, there is a possibility that the exposure to a hive is higher.

The exposure is compared with the toxicity of an adult bee. The real concern with these IGRs

however, are the potential effects on larvae and pupae. Although no toxicity test data on larvae and

pupae are available, the applicant referred to a publication that showed no adverse effects to larvae

74


pupation, pupal death and adult emergence of 0.1 ppm pyriproxyfen present in larval feed. The next

tested dose rate of 1 ppm caused significant effects on pupal death and adult emergence (Yang et al.

(2010). Effects of sub-lethal dosage of insecticides on honeybee behaviour and physiology).

The EPA sourced another publication of a field test in which pyriproxyfen was applied via the larvae

diet in the concentrations 0.1, 1, 10 and 100 ppm. The toxicity to adult bees, larvae and at colony

level as well as the effects on royal jelly yield were determined. The two highest dose rates (10 and

100 ppm) caused significant mortality during larval stage. The toxicity to adult bees was low. The two

highest dose rates reduced hatching rates, capping rates, eclosion rate (rate of transition from pupal

stage of brood development into adult bees) and increased rate of deformed winged bees.

Significantly more bees with deformed wings were also observed at 1 ppm pyriproxyfen compared to

0.1 ppm and control. The highest dose rate caused a significant reduction in the weight of royal jelly

production. This study indicates that pyriproxyfen can cause significant effects to the development of

honeybee larvae and pupae (Chen et al. 2016. The impact of pyriproxyfen on the development of

honeybee (Apis mellifera) colony in field).

The applicant provided a publication of Agcarm who reports the findings released by MPI regarding

the colony loss survey (Agcarm newsletter May 2017). The survey showed that almost 10% losses

occurred during winter 2016. Starvation, queen problems and wasps were the most important reasons

for the losses. Overall conclusion is that the NZ bee population is thriving.

This article only provides information over the general health of the beehives and no additional data of

effects of pesticides are stated.

Overall conclusion of the pollinator risk assessment

Following review of this information, the EPA still has concerns that the proposed use of pyriproxyfen

may cause adverse effects on the health of a hive in general and development of larvae and pupae in

particular. Therefore, the following controls are proposed:

DO NOT apply when bees are actively foraging, (e.g. apply in the evening after flight)

DO NOT apply on bee hives or bee nests


Non-target arthropod risk assessment

The non-target arthropod risk assessment is a comparison of the predicted environmental

concentration (PEC) obtained from the model calculations (see Appendix J) with toxicity endpoints to

which safety factors have been applied. The PEC is divided by the toxicity endpoint to calculate a

hazard quotient (HQ) value. The methodology for the pollinator risk assessment, including the level of

concern (LOC) ascribed to specific HQ values, is described in detail in Appendix J.

Results of the in-field non-target arthropod risk assessment are shown in Table 47.

75


Table 47: In-field HQ values for non-target arthropods

Species LR50

(g a.i./ha)

Application rate

(g a.i./ha) MAF

Hazard

Quotient Conclusion

Pyraclostrobin

Parasitic wasp >320

64 3.5

0.7 Risk below the

LOC

Predatory mite Not available Not


Green Lacewing Not available Not


Ladybird >320 g/ha

0.7 Risk below the

LOC

Beetle >320 g/ha

0.7 Risk below the

LOC

Wolf Spider >320 g/ha

0.7 Risk below the

LOC

Studies with non-target arthropods are generally performed with the formulation. The applicant did not

provide this information and therefore the assessment is limited to information available for pure

active ingredients. Only data of pyraclostrobin is available, so no risk assessment for the other active

ingredients can be performed.

No off-field risk assessment was performed since identified risks were below the level of concern in-

field.

Conclusion for non-target arthropod risk assessments

The identified risks to non-target arthropods are below the level of concern for both off-field and in-

field. However, no information was available on several species and for three of the active ingredients

no toxicity information was available at all. Therefore, not all risks could be evaluated.

It is suggested that a warning statement to inform that compatibility with integrated pest management

(IPM) has not been demonstrated.

Conclusions of the ecological risk assessment

Identified risks

The missing information regarding the toxicity of boscalid to aquatic plants is considered not to be a

significant data gap. The substance will be used on plants and therefore it is considered unlikely that it

will have a major impact on aquatic plants.

The acute risks to soil dwelling organisms are below the level of concern. Chronic risks for threatened

earthworms were identified in-field. It is considered highly unlikely that threatened earthworm species

76


would be present in agricultural fields however. As such, the risk to threatened earthworm species is

considered low since there is no exposure pathway. The chronic risks of boscalid, pyraclostrobin and

pyriproxyfen could not be determined due to a lack of data.

No information was available for terrestrial plants, however, the substance is designed to be applied

to a wide range of plants and therefore a non-target effect is considered unlikely.

The screening assessment for birds indicated risks above the level of concern. Threatened and non-

threatened species are at risk according to the screening assessment (driving active ingredient

tebuconazole). For pyriproxyfen no chronic data was available and no risk assessment was

performed. Further refinement indicated that at least 40% of the birds diet should be sourced outside

the treated field. This fraction is calculated for non-threatened birds, for threatened birds the

proportion of their diet to be sourced from outside the treated field is higher than 40%. Given the

proposed use pattern (spot treatment of ornamentals in domestic gardens) it is considered that birds

are likely to obtain sufficient uncontaminated food.

No risks for secondary poisoning for earthworm eating birds are identified.

No acute risks for bees were identified. Additional information is considered but the EPA still has

concerns that the proposed use of pyriproxyfen might cause significant adverse effects on the health

of a hive in general and development of larvae and pupae in particular. Therefore, the following

controls are proposed:

DO NOT apply when bees are actively foraging, (e.g. apply in the evening after flight)

DO NOT apply on bee hives or bee nests

DO NOT apply to plants in flower or close to flower

For non-target arthropods only a partial assessment could be performed for pyraclostrobin which

indicated that those risks are below the level of concern. We suggest a warning statement to inform

that compatibility with integrated pest management (IPM) has not been demonstrated.

Uncertainties and significant data gaps

No ecotoxicity information of the formulation (RFC 397 (New Formulation)) was provided by the

applicant therefore the toxicity of the mixture could not be evaluated. By mixing different active

ingredients the ingredients can interact which can result in different ecotoxicological responses. The

toxicity can be less than expected (less than additive effect), as predicted based on the individual

ingredients (additive effect) or the effects can be magnified (more than additive effect/synergism).

Insufficient information is available to determine the interactions in this formulation.

For the sediment dwelling organisms not all risks could be evaluated due to data gaps, for

pyraclostrobin as well as the major metabolite of pyraclostrobin (BF 500-3) and pyriproxyfen

insufficient information to perform this assessment. The metabolite is observed in the sediment at

fractions of the applied radiation above the trigger quantity (>10%). Therefore, the staff considers this

77


a major data gap. However, if the proposed control to protect aquatic species is applied (do not apply

when the garden is adjacent a waterbody) sediment dwelling organisms will be protected as well.

The chronic risks for soil dwelling organisms could not be determined due to a lack of information for

boscalid, pyraclostrobin and pyriproxyfen. Earthworms and other soil organisms are important for soil

health and therefore the staff considers this is significant data gap.

No chronic bird data of pyriproxyfen are available. Although products containing pyriproxyfen are

approved, their use patterns are in greenhouses and no exposure to birds is to be expected from that

use. The proposed use pattern for RFC 397 (New Formulation) is outdoors. This is considered a

significant data gap therefore.

No information is available on the toxicity of the active ingredients to bee larvae and regarding the

potential chronic effects on bees. For boscalid as well as pyraclostrobin there are indications from

non-GLP studies that chronic effects and effects on larvae have been observed. However, these

studies are not performed according to GLP and the quality could not be determined. Furthermore, no

acute oral data of the insecticide pyriproxyfen are available. Considering the use pattern of the

substance, application to ornamentals, exposure is considered likely. Therefore, this is considered a

significant data gap.

For non-target arthropods only information for one of the active ingredients is available. Generally, the

EPA receives formulation specific information and therefore information on the pure active ingredient

is not available. This is considered a significant data gap.

The data gaps and uncertainty regarding the synergistic properties of the active ingredient are

considered significant adding uncertainty to the risk assessment, it should be noted that the proposed

controls do not consider these uncertainties. The applicant could consider providing data to fill these

gaps.

Conclusion

The environmental risks from home garden use are considered non-negligible but given the proposed

use pattern, the use of the product will be limited. In theory, it is considered that with the proposed

controls in place, the overall environmental risks from use of RFC 397 (New Formulation) are low. It is

uncertain whether these controls are enforceable however, given that the substance is a home-use

product for application to roses and other ornamentals, which are very attractive to bees.

It should be noted that not all risks could be evaluated due to a lack of data (see paragraph

uncertainties and significant data gaps).

78


Appendix L: Standard terms and abbreviations

Abbreviation Definition

ai active ingredient

ADE Acceptable Daily Exposure

ADI Acceptable Daily Intake

AOEL Acceptable Operator Exposure Level

BBCH Biologische Bundesanstalt, Bundessortenamt und CHemische Industrie

BCF BioConcentration Factor

Bw body weight

CAS # Chemical Abstract Service Registry Number

cm centimetres

CRfD Chronic Reference Dose

DDD Daily Dietary Dose

DMC Decision-Making Committee

DT50 Dissipation Time (days) for 50% of the initial residue to be lost

dw dry weight

EbC50 EC50 with respect to a reduction of biomass

EC European Commission

EC25 Effective Concentration at which an observable adverse effect is caused in 25 %

of the test organisms

EC50 Effective Concentration at which an observable adverse effect is caused in 50 %

of the test organisms

EEC Estimated Environmental Concentration

EEL Environmental Exposure Limit

EFSA European Food Safety Authority

ErC50 EC50 with respect to a reduction of growth rate (r)

ER50 Effective Residue concentration to 50% of test organisms

g grams

GAP Good Agricultural Practice

GDP Gross Domestic Product

GENEEC Generic Estimated Environmental Concentration

79


ha hectare

HQ Hazard Quotient

Kd partition (distribution) coefficient

Koc organic carbon adsorption coefficient

Kow octanol water partition coefficient

Kg Kilogram

L litres

Lb pounds

LC50 Lethal Concentration that causes 50% mortality

LD50 Lethal Dose that causes 50% mortality

LOAEC Lowest Observable Adverse Effect Concentration

LOAEL Lowest Observable Adverse Effect Level

LOC Level Of Concern

LOD Limit Of Detection

LOEC Lowest Observable Effect Concentration

LOEL Lowest Observable Effect Level

LR50 Lethal Rate that causes 50% mortality

M Molar

m3 cubic metre

MAF Multiple Application Factor

μm micrometre (micron)

mg milligram

μg microgram

mol mole(s)

MSDS Material Safety Data Sheet

NAEL No Adverse Effect Level

ng nanogram

NOAEC No Observed Adverse Effect Concentration

NOAEL No Observed Adverse Effect Level

NOEC No Observed Effect Concentration

NOEL No Observed Effect Level

OECD Organisation for Economic Cooperation and Development

80


PDE Potential Daily Exposure

PEC Predicted Environmental Concentration

PHI Pre-Harvest Interval

pKa Acid dissociation constant (base 10 logarithmic scale)

PNEC Predicted No Effect Concentration

POW Partition coefficient between n-octanol and water

ppb parts per billion (10-9)

PPE Personal Protective Equipment

ppm parts per million (10-6)

REI Restricted Entry Interval

RPE Respiratory Protective Equipment

RQ Risk Quotient

RUD Residue per Unit Dose

81


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https://archive.epa.gov/pesticides/reregistration/web/pdf/carbofuran_red.pdf%20Accessed%2016/03/2016

84


Appendix N: Confidential Composition

The composition of RFC 397 (New Formulation) is confidential.