Environment Risk Assessment Manual

Version 1.0

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© Australian Pesticides and Veterinary Medicines Authority 2018

ISSN XXXXXX (electronic)ISBN XXXXXX (electronic)

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Contents1 ENVIRONMENTAL RISK ASSESSMENT 41.1 Step 1 – Problem formulation 4

1.2 Step 2 – Environmental hazard assessment 4

1.3 Step 2 – Environmental exposure assessment 4

1.4 Step 3 – Environmental risk characterisation 5

1.5 Refining the risk assessment 5

2 REGULATORY FRAMEWORK 6

3 INFORMATION ON THE PRODUCT AND ITS USES 7

4 FATE AND BEHAVIOUR 84.1 The environment 8

4.1.1 Assessment approach 84.1.2 References 8

4.2 Fate and behaviour in soil 8

4.3 Fate and behaviour in water 9

4.4 Fate and behaviour in air 9

5 EFFECTS AND ASSOCIATED RISKS TO NON-TARGET SPECIES 105.1 Terrestrial vertebrates 11

5.1.1 Assessment approach 115.1.2 Calculation approaches 125.1.3 Conclusions 135.1.4 References 13

5.2 Aquatic species 145.2.1 Assessment approach 145.2.2 Calculation approaches 145.2.3 Conclusions 145.2.4 References 15

5.3 Bees 155.3.1 Assessment approach 155.3.2 Calculation approaches 155.3.3 Conclusions 165.3.4 References 16

5.4 Other non-target arthropods 165.4.1 Assessment approach 165.4.2 High level calculation approaches 175.4.3 Conclusions 175.4.4 References 17

5.5 Soil organisms 17

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5.5.1 Assessment approach 185.5.2 Calculation approaches 185.5.3 Conclusions 195.5.4 References 19

5.6 Non-target terrestrial plants 195.6.1 Assessment approach 195.6.2 Calculation approaches 205.6.3 References 20

5.7 Spray drift 20

5.8 Runoff modelling 215.8.1 Tier 1 runoff assessment 235.8.2 Tier 2 runoff assessment 23

5.9 Sediment runoff 25

5.10 Sediment of a pond 25

5.11 Groundwater 25

6 EFFECTS AND ASSOCIATED RISKS OF COMBINATION PRODUCT TO NON-TARGET SPECIES 26

7 OVERALL CONCLUSIONS 27

8 LABELLING RECOMMENDATIONS 28

9 REFERENCES 29

10 ABBREVIATIONS 30

11 GLOSSARY 32

1 APPENDIX A – TERRESTRIAL VERTEBRATES 341.1 Introduction 34

1.2 Toxicity figures 34

1.3 Risk assessment 351.3.1 Home garden uses 361.3.2 Seed treatments and solid formulations 371.3.3 Rodenticides 391.3.4 Avicides 40

1.4 Combination toxicity 41

1.5 Risk assessment tables 41

1.6 Risk mitigation 47

1.7 References 48

1 APPENDIX B – OTHER NON-TARGET ARTHROPODS 501.1 Introduction 50

1.2 Toxicity values 50

1.3 Risk assessment 512

1.4 Combination toxicity 52

1.5 Risk assessment tables 52

1.6 Risk mitigation 55

1.7 References 55

1 APPENDIX C – SOIL ORGANISMS 561.1 Introduction 56

1.2 Toxicity figures 57

1.3 Risk assessment 571.3.1 Screening level assessment 581.3.2 Refined assessment 59

1.4 Combination toxicity 60

1.5 Risk assessment tables 60

1.6 Risk mitigation 60

1.7 References 60

1 APPENDIX D – NON-TARGET TERRESTRIAL PLANTS 601.1 Introduction 60

1.2 Toxicity figures 60

1.3 Risk assessment 60

1.4 Combination toxicity 60

1.5 Risk assessment tables 60

1.6 References 60

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ENVIRONMENTAL RISK ASSESSMENT

1 ENVIRONMENTAL RISK ASSESSMENTThe assessment of risk to the environment, like the assessment of risk to human health, is a three-step process. A Hazard Assessment determines how toxic a chemical is to non-target animals and plants an Exposure Assessment involves understanding what happens to a chemical once it enters the environment, and Risk Characterisation uses information from the first two steps combines to produce a single value that sums up the overall level of risk.

1.1 Step 1 – Problem formulationPrior to the risk assessment, risk assessors and managers from APVMA engage in a planning dialogue to consider and clarify the goals of the assessment. After planning agreements are reached, the problem formulation phase, which is the foundation for the risk assessment, begins. In this process, risk hypotheses or assumptions are generated about why ecological effects may have occurred.

1.2 Step 2 – Environmental hazard assessmentSome chemicals are more toxic than others. The purpose of the environmental hazard assessment is to determine the hazard to non-target plants and animals of a chemical, based on its toxicity.

Toxicity is generally established in controlled laboratory settings. Lab studies determine the effects of short and long-term exposure to particular chemicals on small numbers of selected animal and plant species, including birds, insects, earthworms and water-based plants and animals such as fish and aquatic invertebrates.

Regulatory bodies around the world assess toxicity tests using the same general approach. Because of this common approach, scientists from Australia, Europe, United States, Canada and many other countries are able to share the results of their studies, reducing the overall amount of testing required.

When determining the toxicity of a particular chemical, scientists are not only interested in determining the lethal level of exposure, many studies also examine the longer-term impacts on growth and reproduction. Some more complex studies investigate the impact on the composition of a species, on an ecological community and on an entire ecosystem.

The final product of an environmental hazard assessment is an ecotoxicity value, which is an estimate of the lowest amount of a chemical that may cause harmful effects in an ecosystem. This value provides the other part of the information needed to establish the Risk Characterisation.

1.3 Step 2 – Environmental exposure assessmentOnce a chemical enters the environment a lot of things can happen to it. It can be moved around by air or water or come to rest in soil. It can be broken down by sunlight, water or microorganisms. It can also be taken up by plants and animals, where it can either be metabolised (broken down by an organism) or bioaccumulate (stored in an organism’s tissues). Scientists take all these factors into account when conducting studies to determine the behaviour, or fate, of a chemical in the environment.

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A chemical’s fate also depends upon how it is used. For example, a chemical delivered through a spray mechanism will behave differently from one added directly to soil or to one fed to an animal. When conducting environmental exposure assessment scientists consider factors such as the method of application, the target crops or animals, what time of the year it is usually applied and the geographic area in which it will be used.

The final product of an environmental exposure assessment is the calculation of a Predicted Environmental Concentration (PEC). A PEC is an estimated value of how much of a chemical (and its break-down components) is likely to be found in a particular part of the environment, such as water or soil or sediment, as a result of normal use. This value provides one part of the information needed to establish the overall level of risk, or Risk Characterisation.

1.4 Step 3 – Environmental risk characterisationRisk characterisation is the final step in the risk assessment process. In this step, the results of the first two steps are combined to produce an estimate of the overall risk to the environment of a particular chemical.

There are a number of different methods available to determine the overall level of risk. The most common is the deterministic approach, so-called because it determines a single numeric value known as a Risk Quotient, or RQ, which sets the safe limit for the chemical in the environment. The RQ is calculated by dividing the PEC) (derived in Step 1) by the ecotoxicity value (derived in Step 2).

An RQ determinant should also include detailed information about how the final value was established, as well as discussion about the uncertainties, assumptions, strengths and limitations of the studies used. This allows regulators to take all available information into consideration when determining the rules for how a particular chemical should be used, if at all.

Some chemicals have the potential to not only be highly toxic, but to also persist in the environment for a very long time. Particular care is required when assessing persistent, bioaccumulative and toxic (PBT) chemicals, whose effects on the environment are often apparent only after a prolonged period of time. Australia has international obligations when assessing chemicals, including the Stockholm Convention on Persistent Organic Pollutants (POPs)1. The APVMA takes these obligations very seriously and assesses each agvet chemical with respect to its persistence in the environment, the ability of the chemical to bioaccumulate and its toxicity to environmental organisms.

1.5 Refining the risk assessmentThe APVMA can require additional studies to be conducted on a product. Additional studies are aimed at developing a more accurate understanding of the risks to the environment from a particular chemical product, which in turn allows regulators to establish more effective rules for its use. For example, a field study may be requested to determine whether or not a chemical behaves the same way ‘in nature’ as it does in a laboratory. Or an ecotoxicology test may be requested to ascertain if the impact of a chemical one or two species in the laboratory is applicable to the impacts that might be seen on a whole ecosystem.

1 www.pops.int/Home/tabid/2121/Default.aspx5

ENVIRONMENTAL RISK ASSESSMENT

2 REGULATORY FRAMEWORKThe Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled in the Agricultural and Veterinary Chemicals Code Act 1994 (the Act), provides the basis for using risk analysis to regulate activities with agricultural and veterinary chemicals (agvet chemicals) in Australia.

The objective of the Code is for the evaluation, approval, and control of the supply, of active constituents for proposed or existing agricultural chemical products or veterinary chemical products; and the evaluation, registration, and control of the manufacture and supply, of agricultural chemical products and veterinary chemical products.

The decision on whether to approve an active constituent or an agvet product is made by the Australian Pesticides and Veterinary Medicines Authority (the APVMA), an independent statutory office holder established by the Act.

The Act mandates that APVMA implement the Code in a manner that reflects ‘established best-practice principles for the assessment and management of risk, based on science’. To do this, APVMA’s regulatory scientists must balance regulatory effort and regulatory burden with the risk that agvet chemical use will present to the health and safety of human beings, animals and the environment.

The APVMA must be satisfied under s14 of the Agricultural and Veterinary Chemicals Code Act 1994 that:

The proposed use of the product meets the safety criteria with respect to s5A(1)(c); and

The proposed label meets the labelling criteria under s5D(1), with respect to environmental considerations, provided that the labelling recommendation in this report are adopted.

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3 INFORMATION ON THE PRODUCT AND ITS USESOverview information is reviewed that includes:

location and description of industry

where is the product to be used

distribution of crop

change over time of crop (decrease/increase areas)

application method and use pattern

This may include information as to whether it is a new active, new application or new combination of actives that requires assessment to be undertaken.

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4 FATE AND BEHAVIOUR4.1 The environment4.1.1 Assessment approach

Fate and behaviour may consider:

hydrolysis

photolysis – aqueous photolysis, soil photolysis

biodegradation – aerobic soil metabolism, anaerobic soil metabolism, aerobic aqueous metabolism, field dissipation, mobility, bioconcentration

Assessment will be made regarding:

the environmental concentrations of the active

short term risks to non-target species – combined vs single active

determining whether there has already been assessment of the active

determination of end points

4.1.2 Referenceshttps://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_efsa_degt50.pdf https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_wd-env-sft-eval-mbca.pdf https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_metabolites-groundwtr.pdf https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_soil-persistance.pdf http://esdac.jrc.ec.europa.eu/projects/focus-dg-sante https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_evidence_identify-pop-pbt-vpvb-props.pdf http://archives.eppo.int/EPPOStandards/era.htm

4.2 Fate and behaviour in soilThe European Draft Assessment Report (DARs) Volume 1 Level 2 section 2.5.2 is used for guidance on the type of detail and approach used.

In addition to the Risk Assessment Manual (RAM, EPHC 2009), relevant guidance documents include:

http://ec.europa.eu/food/plant/protection/evaluation/guidance/wrkdoc11_en.pdf http://archives.eppo.int/EPPOStandards/PP3_ERA/pp3-03(2).pdf https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_terrestrial.pdf

4.3 Fate and behaviour in water

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The European Draft Assessment Report (DARs) Volume 1 Level 2 section 2.5.3 is used for guidance on the type of detail and approach used.

In addition to the RAM, relevant guidance documents include:

http://archives.eppo.int/EPPOStandards/PP3_ERA/pp3-04(2).pdf http://archives.eppo.int/EPPOStandards/PP3_ERA/pp3-05(2).pdf

4.4 Fate and behaviour in airThe European Draft Assessment Report (DARs) Volume 1 Level 2 section 2.5.4 is used for guidance on the type of detail and approach used.

In addition to the RAM, relevant guidance documents include:

http://archives.eppo.int/EPPOStandards/PP3_ERA/pp3-12(1).pdf

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5 EFFECTS AND ASSOCIATED RISKS TO NON-TARGET SPECIES

Assessment is undertaken based on:

the taxonomic group

key indicator species

exposure, endpoint

assessment factors

RAL.

Assessment also examines the potential impact of the active component as singular compounds but also the potential impact of the combination of actives and other chemicals that may be in the formulation.

The environmental risk assessment integrates the environmental exposure and ecotoxicity information to estimate the potential for adverse effects on non-target species. This integration is achieved by comparing predicted exposure concentrations (PECs) with concentrations at which adverse effects occur. PECs are estimated using standard models which take into consideration the application rate(s), chemical and environmental fate properties, including the dissipation of the pesticide between applications.

Ecotoxicity information includes acute and chronic toxicity data for various organisms or groups of organisms from both terrestrial and aquatic habitats including invertebrates, vertebrates and plants. Toxicity endpoints used in the risk assessments are adjusted to determine regulatory acceptable concentrations (RACs) to account for potential differences in species sensitivity as well as varying protection goals (ie, protection at the community, population, or individual level).

The worst case should identify the sensitive environmental components most at risk from exposure to the active component.

Table 1: Sample table used for Environmental toxicity and regulatory acceptable levels (RALs) for Active Component

Taxonomicgroup

Key indicatorspecies

Exposure Endpoint Assessment

factor

RAL

Birds Serinus canaria Acute LD50 >2000 mg ac/kg bw 10 >200 mg ac/kg bw

Reproduction NOEC 142 mg ac/kg bw/d 1 142 mg ac/kg bw/d

Mammals Rattus norvegicus Acute LD50 5000 mg ac/kg bw 10 500 mg ac/kg bw

Reproduction NOEC 104 mg ac/kg bw/d 1 104 mg ac/kg bw/d

Fish Cyprinus carpio Acute LC50 0.62 mg ac/L 10 0.062 mg ac/L

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Taxonomicgroup

Key indicatorspecies

Exposure Endpoint Assessment

factor

RAL

Fathead minnow Chronic NOEC 0.17 mg ac/L 1 0.17 mg ac/L

Aquaticinvertebrates

Mysidopsis bahia Acute LD50 1.5 mg ac/L 10 0.15 mg ac/L

Daphnia magna Chronic NOEC 0.75 mg ac/L 1 0.75 mg ac/L

Algae Pseudokirchneriella subcapitata

Chronic EC50 2.8 mg ac/L 10 0.28 mg ac/L

Aquatic plants Lemna gibba Chronic EC50 2.7 mg ac/L 10 0.27 mg ac/L

Bees Apis mellifera Acute oral LD50 >4.2 µg ac/bee 2.5 >1.7 µg ac/bee

Acute contact

LD50 >98 µg ac/bee 2.5 >39 µg ac/bee

Predatoryarthropods

Typhlodromus pyri Lab (glass plate)

LR50 >160 g ac/ha 0.5 >320 g ac/ha

Parasiticarthropods

Aphidius rhopalosiphi

Lab(glass plate)

LR50 12 g ac/ha 0.5 24 g ac/ha

Aleochara bilineata Extended lab (soil)

ER50 >113 g ac/ha(>150 mg ac/kg dry soil)

1 >113 g ac/ha(>150 mg ac/kg dry

soil)

Earthworms Eisenia fetida Acute LC50corr >500 mg ac/kg dry soil

10 >50 mg ac/kg dry soil

Chronic NOECcorr 2.0 mg ac/kg dry soil

1 2.0 mg ac/kg dry soil

Soil micro-organisms

N and C mineralisation

Chronic NOEC 1.0 mg ac/kg dry soil

1 1.0 mg ac/kg dry soil

Non-targetterrestrial plants

10 species tested pre-emergent ER25 >100 g ac/ha 2 >50 g ac/ha

RAL = regulatory acceptable level = endpoint/assessment factor

5.1 Terrestrial vertebrates Further information on the risk assessment for terrestrial vertebrates is provided in Appendix A.

5.1.1 Assessment approach

The procedures of risk characterisation are described according to the present state of knowledge. In this tiered assessment framework, potential risk for birds and mammals is identified on the basis of responses of individual organisms observed in controlled laboratory experiments, noting that the abundance and

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persistence of populations of organisms are potentially more relevant as endpoints for assessment than are responses of individual organisms. The proposed approach is justified on the ground that too little is known about the responses of populations to chemical exposure to support regulatory decisions on that basis. Extrapolation tools aiming at bridging the gap between individual level and population level by means of population modelling techniques are not yet satisfactory. Risk assessors have to consider, at least qualitatively, that if only a small fraction of a population is exposed (spatial scale) risks associated with the use of the pesticide product may be small even if some individuals would be affected. That does not preclude, that appreciable mortality without population level consequences may be judged unacceptable.

The standard risk assessment is based on the field scale and not landscape scale, ie the risk to non-target birds and mammals frequenting the treated field is assessed. No consideration is made of the risk from applications of the same pesticide to neighbouring fields. If concern is raised (ie RQ >1.0) then the risk can be refined appropriately. When refining the risk it may be appropriate to consider such issues as suitability of the standard scenarios, scale of use and potential impact on populations. However, no deviations from worst case assumption are made unless they are justified.

Uses that may not require assessment includes those products that are used indoors or in enclosed structures, or other situations where the exposure or risk is considered negligible (due to the type of product such as disinfectants, preservatives, slimicides or antifouling products).

The risks of the product is based on intensity of use (gram per ac/ha) and what will be the crop grouping and likely vertebrate groups that may be exposed (eg effect on birds, effect on mammals). Similar product/active/studies will be reviewed and determined if valid for the current assessment. If these studies are not considered suitable, than a full assessment will be undertaken by the APVMA.

Predicted concentration is made based on maximum application rate, frequency of application, direct or indirect application and assumptions of dietary contribution of potential affected food material.

The risks to birds are assessed based on single and maximum seasonal application rates. The dietary end points are determined in terms of acute and chronic risk assessments.

Estimated residues are based on Kenaga nomogram which relates food item residues and pesticide application rate (Pfleeger et al., 1996). Dietary intakes are calculated based on standard assumptions of diet from US EPA 1993.

5.1.2 Calculation approaches

Risk assessments are tabulated to include:

which effects endpoints were used and associated assessment factors

the parent and metabolites levels

derivation of RAC (LD50/10, NOEC/1)

how exposure estimates were determined (including assumptions)

resulting risk quotients (acceptable chronic RQ ≤1.0, acute RQ≤0.1. ).

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The risk assessment assess the major potential routes of exposure of terrestrial vertebrates feeding on food items directly contaminated from spray applications. Assessment first calculates a regulatory acceptable dose (RAD) for acute and chronic exposure scenarios. If required, a Tier 1 assessment according to EFSA (2009) guidance will considers more specific exposure scenarios.

Tier 2 assessment considers the animal’s daily diet is obtained beyond that which are treated with the product, or the diet is not just the particular type of affected food.

Detailed assessments may be required for the following:

Home garden uses

Seed treatments and solid formulations

o Granular products

o Seed treatments

o Slug pellets

o Forage area of concern

o Forage time to concern

o Other refinement options

Rodenticides

o Primary poisoning

o Secondary poisoning

o Exposure scenarios

Avicides

Combination toxicity

5.1.3 Conclusions

The overall conclusions on risk are described. Determination is made on any hazard or risk mitigation labelling.

5.1.4 ReferencesRelevant guidance documents for risk assessment:http://ec.europa.eu/food/plant/protection/evaluation/guidance/wrkdoc19_en.pdfhttp://archives.eppo.int/EPPOStandards/PP3_ERA/pp3-11(2).pdf http://www.efsa.europa.eu/en/scdocs/doc/1438.pdf http://www.efsa.europa.eu/en/efsajournal/pub/1438 https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_ra_birds-mammals-jwg.pdf http://archives.eppo.int/EPPOStandards/era.htm https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_ra_birds-mammals.pdf

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5.2 Aquatic species5.2.1 Assessment approach

Determination is made whether an assessment is required based on potential impacts to fish, aquatic invertebrates, effects on algae and sediment dwelling organisations. If assessment is not required, there must be valid reasons why (usually due to negligible exposure expected based on use pattern and/or fate and behaviour properties, no toxicity/effects at limit doses, or covered by a previous assessment or product).

The Risk Assessment Manual (RAM, EPHC 2009) applies a quotient approach (Urban and Cook, 1986) to predict environmental risk for aquatic organisms.

A risk assessment is tabulated which demonstrates which effects endpoints were used and associated assessment factors, derivation of RAC (LC50/10, NOEC/1), how exposure estimates were determined (including footnotes to describe the assumptions), and resulting risk quotients (acceptable RQ ≤1.0). Based on this, assessment is made on the overall conclusions on risk and whether hazard or risk mitigation labelling is required.

5.2.2 Calculation approaches

Standard assumptions are applied. A screening level assessment is undertaken considering 15cm water depth, runoff assessment for risks of produce to aquatic invertebrates and sediment dwellers.

Testing of sediment dwellers is not required when the lowest Daphnia magna acute EC50 value is >1 mg ac/L and chronic NOEC value is > 0.1 mg ac/L (SANCO/3268/2001 Section 2.3.4.2)

The movement rate to sediment is based on the testing that has been undertaken and provided to APVMA. Chronic risk may need to be considered in both water and sediment systems for species.

The predicted environmental concentration is calculated based on ac applications in a 3 m wide × 15 cm deep body of water. The calculation will be assessed against the chronic toxicity endpoint (28 d NOEC) for sediment dwelling organisms from water spiked sediment tests to determine if the risk to sediment dwelling organism is unacceptable.

Calculations may also be made in relation to spray drift and runoff. Assessment will be made against the most sensitive aquatic RAL and corresponding risk quotient.

The maximum PEC at the edge of field is calculated based on the application rate and method. Determination of the chronic risks to sediment dwelling organisms based on RQ<1.

5.2.3 Conclusions

The overall conclusions on risk are described. Determination is made on any hazard or risk mitigation labelling.

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5.2.4 Referenceshttp://ec.europa.eu/food/plant/protection/evaluation/guidance/wrkdoc10_en.pdfhttp://www.scew.gov.au/system/files/resources/bffdc9e9-7004-4de9-b94f-b758140dbc8c/files/cmgt-nchem-eragm-agricultural-and-veterinary-chemicals-200902.pdf https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_aquatic.pdf https://www.efsa.europa.eu/en/efsajournal/pub/3290 http://archives.eppo.int/EPPOStandards/era.htm

5.3 BeesFurther information on the risk assessment for terrestrial vertebrates is provided in the APVMA framework ‘Roadmap for insect pollinator risk assessment’ in Australia.

5.3.1 Assessment approach

Assessment is undertaken through the following approach:

The application is assessed through understanding whether the active component presents a risk to non-target species based on use, chemistry, fate and transport based on standard calculations.

Examine the screening assessment that has been undertaken, particularly looking at where is the data referenced.

Determination of the potential exposure pathway to bees is assessed and whether exposure is during the flowering stage of the plant. The APVMA framework ‘Roadmap for insect pollinator risk assessment’ in Australia (APVMA, 205) is used for the assessment of the risk to bees from the proposed use of the product.

If data is not provided or clear statements that other non-target arthropods are not at risk, then an assessment will need to be undertaken.

Tabulated risk assessment demonstrates which effects endpoints were used and associated assessment factors, derivation of RAC (LD50/2.5, NOEC/1), how exposure estimates were determined (may require footnotes to describe the assumptions), and resulting risk quotients (acceptable RQ ≤1.0). What are overall conclusions on risk? Is hazard or risk mitigation labelling required?

5.3.2 Calculation approaches

Adult bee contact exposure

PEC(contact) = AR × 2.4 µg ac/bee

Where: AR = application rate (normalised to 1 kg ac/ha)

The risk quotient is calculated by comparing the PEC(contact) with the adult contact LD50:

RQ = PEC(contact)/LD50(contact)

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The RQ is then compared to the level of concern (LOC) for interpretation. Currently Australia uses a standard LOC of 1.0 for the honey bee contact and oral risk assessment (EPHC, 2009).

Adult bee oral exposure

PEC(oral) = AR ×(98μg acg ) × 0.292g

day

For acute oral risk assessment the PEC(oral) is compared to the adult acute oral LD50:

RQ = PEC(oral)/LD50(oral)

The RQ is then compared to the level of concern (LOC) for interpretation. Currently, Australia uses a standard LOC of 1.0 for the honey bee oral risk assessment (EPHC, 2009).

5.3.3 Conclusions

The overall conclusions on risk are described. Including any requirement for hazard and risk mitigation labelling.

5.3.4 References

Relevant guidance documents for risk assessment:

https://apvma.gov.au/node/18536 http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2338.2010.02419.x/epdf http://www2.epa.gov/sites/production/files/2014-06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf http://www.oecd.org/chemicalsafety/pesticides-biocides/work-related-beespollinators.htm https://www.epa.gov/pollinator-protection/pollinator-risk-assessment-guidance http://archives.eppo.int/EPPOStandards/era.htm https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_terrestrial.pdf

5.4 Other non-target arthropodsFurther information on the risk assessment for terrestrial vertebrates provided in Appendix B.

5.4.1 Assessment approach

Products that are used as prescribed should not cause unacceptable effects on populations of non-target arthropods both in- and off-field. The approach determines whether the application and active component present a risk to non-target species based on use, chemistry, fate and transport and standard calculations.

If data is not provided or clear statements that other non-target arthropods are not at risk, then an assessment will need to be undertaken. Indoor uses are generally considered to have negligible exposure to natural populations. A tiered approach is undertaken.

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Tier 1 laboratory test is a dose–response test assessing lethal effects of the active substance on the test species. This tier has a screening character and is required for all representative formulations where exposure of non-target arthropods can occur. Generally the LR50 in g/ha for sensitive arthropods (eg Aphidius rhopalosiphi, Aleochara bilineata, Typhlodromus pyri) is compared to the expected maximum rate of exposure. Exposure will be determined through the application and lifecycle of the application (such as whether an ingestation pathway, or spray exposure).

Tier 2 may comprise extended laboratory tests (eg on natural substrates), semi-field bioassays and field experiments.

Tier 3 consists of field trials based on effects on populations rather than on individuals.

If the risk is acceptable in field it will be acceptable off-field so no further assessment will be required.

If reference products are provided for comparison, then risks are assessed whether they are higher or lower than the reference products.

5.4.2 High level calculation approaches

The EU approach is used in considering risk to non-target arthropods.

In-field Hazard Quotient (HQ) where HQ = in-field exposure/LR50 for the standard (glass plate) tests (EC, 2002).

The in-field exposure is calculated through the application rate × MAF (Multiple Application Factor).

The default MAF value = 2.7 (dissipation on foliage for 4 applications) is used in the absence of provided DT50 (foliage) values.

If the in-field HQ is <2 for the two standard species tested [parasitic wasps (Aphidius rhopalosiphi) and predatory mite (Typhlodromus pyri)], then no further testing/assessment is required based on guidance in ESCORT 2 (Candolfi et al, 2001).

5.4.3 Conclusions

The overall conclusions on risk are described. Determination is made on any hazard or risk mitigation labelling.

5.4.4 References

Relevant guidance documents for risk assessment:

http://archives.eppo.int/EPPOStandards/era.htm https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_terrestrial.pdf

5.5 Soil organismsFurther information on the risk assessment for terrestrial vertebrates is provided in Appendix C.

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5.5.1 Assessment approach

The general protection goal is to protect biodiversity and ecosystems. EFSA (2017) has proposed specific protection goals for soil organisms being key drivers for relevant ecosystem services in agricultural landscapes such as nutrient cycling, soil structure, pest control and biodiversity. Considering the time-scales and biological processes related to the dispersal of the majority of soil organisms, risk assessment are made at in- and off-field scale considering field boundary levels.

Soil micro-organisms could be directly exposed to the active and combined residues in soil. Consideration is made on whether there is additive toxicity of any combinations. The screening level approach is based on contact exposure to residues within the treatment area immediately after application.

The results of provided trials are examined to determine the effect on soil micro-organisms of the parent and potential metabolites. Assessment against PECsoil is used to determine potential impacts on microbial respiration and nitrification. Risk assessments are tabulated that include the endpoints and associated assessment factors, derivation of RAC (tier1 LR50/0.5, tier2 ER50/1 or LR50/1), how exposure estimates were determined (which may require footnotes to describe the assumptions), and resulting risk quotients (acceptable RQ ≤1.0).

Assessment is based on the most sensitive chronic NOEC values for the parent and its metabolite. The accumulation potential in soils is also determined based on DT5D (field and soil studies), and what is the potential accumulation in soils after one year. Combined residues in soils will also be examined.

5.5.2 Calculation approachesAssumptions

Assumptions are applied:

Soil concentrations are considered in the top 5 cm.

Soil density is based on SCEW, 2009. Assumption of 1500 kg/m3

PECsoil is based on the application rate.

Ci = [A · (1−fI) · 106]/ l · 104 · d

in which:Ci = initial concentration in soil (mg kg−1 soil)A = application rate (kg ha−1)fI = fraction intercepted by the crop (dimensionless)l = thickness of soil layer (m) (default 0.05 m)d = bulk density of soil (kg m−3) (default 1500 kg m−3).

RQ = PECsoil/NOEC (earthworms)

RQ = PECsoil/RAL

Lower plateau concentrations, upper plateau concentration is calculated.

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ENVIRONMENTAL RISK ASSESSMENT

If RQ<1 acceptable risk

For a combined toxicity LC50 – assessment factor of 10 is applied to determine the RAC. If PECsoil<RAC then risk of combination product is acceptable.

RQ=PECsoil/acute 14dLC50

If it is necessary to refine the assessment for any particular taxonomic group or process, crop interception should be considered as a first step. Ideally, the crop and its growth stage at the time of application should be specified. If such data is not available, data for similar crops may be adequate. Crop interception factors presented for surface water in EFSA (2014) are preferred.

If further assessment is necessary, higher tier studies can be considered. Higher-tier tests may take the form of limited community/population studies (eg terrestrial model ecosystems, soil mesocosms) or field studies (including, if appropriate, litter-bag studies). Other groups (eg earthworms, microbial functions) may also be tested in the same study. It is important that the timing, levels and routes of exposure reflect, as far as possible, those of the proposed use of the product.

5.5.3 Conclusions

The overall conclusions on risk are described. Determination is made on any hazard or risk mitigation labelling. Other species and studies may be assessed to support or not support the findings.

5.5.4 Referenceshttp://archives.eppo.int/EPPOStandards/PP3_ERA/pp3-09(2).pdf (based on ESCORT 2/3) put in link to the detailed guidance manualshttp://archives.eppo.int/EPPOStandards/era.htm https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_terrestrial.pdf

5.6 Non-target terrestrial plantsFurther information on the risk assessment for terrestrial vertebrates provided in Appendix D.

5.6.1 Assessment approach

The assessment is to determine what are the adverse effects on plant species based on application rates and the exposure potential for non-target terrestrial plants.

The screening level approach is based on pre- and post-emergent exposure to direct overspray. Only one application is assessed for post-emergent exposure risk assessment (cumulative application is not considered). It is assumed that the biodiversity is maintained when the plant populations will not be affected by the use of pesticide product.

5.6.2 Calculation approaches

Environmental hazard from acute exposure is calculated for the Environmental Risk Quotient (RQ = PEC/LC50 or EC50, Urban and Cook, 1986). Assessment is based on a tiered approach to determine the potential phytotoxic properties.

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Tier 1 consists of assessing single dose phytotoxicity screening data for terrestrial non-target plants at or above the maximum application rate based on at least six species.

Tier 2 is undertaken if there is a >50% effect observed in the Tier 1 testing. Dose- response relationships for at least six species representing families for which significant herbicidal action has been found are assessed.

Tier 3 is required where the risks based on the tier 2 assessment cannot be mitigated through management measures and involves field or semi-field studies using realistic applications.

For the aquatic risk scenarios, the initial worst-case situation of direct overspray at the maximum label rate is considered. If this scenario is greater than 0.5 (RQ>0.5) than more likely practical situations are assessed.

RQ > 0.5: risk is unacceptable

≤ RQ ≤ 0.5: risk may be able to be mitigated by some form of risk management, such as label restraints for a specific use and an identified risk arising from that use

RQ < 0.1: risk is considered low (and may or may not require some form of risk management, such as general label restraints).

The risk assessment is tabulated to be able to demonstrate which effects endpoints were used and associated assessment factors, derivation of RAC (NOEC/1), how exposure estimates were determined (may require footnotes to describe the assumptions), and resulting risk quotients (acceptable RQ ≤1.0).

5.6.3 ReferencesRelevant guidance documents:http://ec.europa.eu/food/plant/protection/evaluation/guidance/wrkdoc09_en.pdfhttp://archives.eppo.int/EPPOStandards/PP3_ERA/pp3-07(2).pdf https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_terrestrial.pdf http://archives.eppo.int/EPPOStandards/era.htm

5.7 Spray driftSpray drift is assessed to determine the length of buffer necessary (ie “downwind no-spray zone”), to protect aquatic organisms under the proposed use according to APVMA policy for spray drift risk assessment (APVMA 2008a,b,c and 2010a,b).

Concentrations arising in a 3 m wide × 15 cm deep body of water at various distances downwind of the sprayed area are modelled, consistent with EPHC (2009).

For ground applications, AgDRIFT® model (Version 2.0.09) is used based on the settings for the appropriate APVMA scenario (2008b).

The APVMA lists a range of Broadacre Ground Boom application to be used for risk assessment (APVMA 2008b). The most relevant application is determined based on the application scenario. The application approach will be assessed based on the Application and Use Pattern and draft label.

The cumulative application rate is determined based on ac/ha, frequency of application and DT50 values.

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ENVIRONMENTAL RISK ASSESSMENT

5.8 Runoff modellingScreening level runoff exposure estimates are calculated using an in house model as described in the APVMA Agricultural Manual of Requirements and Guidelines – AgMORAG, Volume 3, Part 7 – Environment APVMA AgMORAG).

The physio-chemical properties used for runoff calculations include:

crop situation and critical application characteristics.

maximum application rate (ACg/ha)

water solubility

koc

field dissipation

common carp 96 h LC50

daphnia magna 21 day NOEC

The model allows the concentration of pesticide in the ‘edge of field’ runoff water to be calculated for a worst case scenario. The model considers rainfall and run-off water, topography of the land (slope), degradation of the pesticide, mobility of the pesticide, and buffer zones. Consideration is also given to the heterogeneity of fields, interception and retention of the pesticide by crops following foliar applications and transport of the pesticide by suspended sedimentary particles. The proportion of the applied pesticide that is contained in the ‘edge of field’ runoff water is calculated according to Equation 1 (Table 8). The concentration of pesticide in the worst case “edge of field” run-off water is calculated by considering the volume of run-off water and the amount of pesticide contained in the runoff water on a per-hectare basis. The model assumes that the volume of runoff water from a 1 ha field is 200,000 litres.

The risk to aquatic organisms is determined by comparing the toxicity endpoints for the most sensitive aquatic organisms with the predicted concentration of pesticide in the ‘edge of field’ runoff water. A tiered approach is used to assess the risk to aquatic organisms from run-off. Initially, the ‘edge of field’ concentration is calculated by considering application specific factors in Tier 1. If risk is shown to aquatic organisms then pesticide specific factors are taken into account in tier 2 (Equation 3). If risks are identified in tier 2 then consideration is given to the field size of the crop and to the dilution of the ‘edge of field’ runoff water in a standard water body (tier 3).

The equations used for runoff calculations are presented in Table 2 whilst the values for the parameters in Equation 1 are presented in Table 3.

Table 2 - Equations for the Calculation of Pesticide Runoff

L%runoff = (R/P) × Crsoil_surface × f1slope × f2bufferzone × f3foliar_application × heterogeneity_factor × 100 + suspended_pesticide; (Equation 1).

f1slope = 0.02153 × slope + 0.001423 × slope2; where slope is expressed as % (Equation 2).

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ENVIRONMENTAL RISK ASSESSMENT

Crsoil_surface = e(-3 ln2/DT50) × (1/(1+Kd)); for three days of degradation (Equation 3).

f3foliar_application = (1 - Fret); (Equation 4) where Fret is fraction of pesticide retained by crop and is assumed to be 50% of the fraction intercepted by the crop (F int).

Table 3 - Values for the Parameters in Equation 1

Parameter Value

R (The daily quantity of runoff water) 20 mm (default value)

P (The daily precipitation) 100 mm (default value)

Crsoil_surface (Concentration reduction factor based on the environmental fate of the pesticide in soil)

For Tier 1, Crsoil_surface = 1

Calculated value for Tier 2 & Tier 3 (Equation

3)

f1slope for steep slopes > 12.5% - < 20% (>7° - <11°) 1

f1slope for ordinary slopes > 4% - ≤ 12.5% (> 2° - ≤ 7°) 0.5 (default value)

f1slope for gentle slopes ≤ 4% (≤ 2°) 0.1

f2bufferzone (Represents the reduction of pesticide in runoff water due to buffer zones) 1 (default value)

f3foliar_application (The amount of foliar applied pesticide available for runoff.) Calculated (Equation 4)

f3foliar_application (When pesticide is applied to bare soil or weeds no foliar interception occurs; Fint = 0) 1

Heterogeneity factor 0.5 (default value)

Suspended pesticide 0 (default value)

Volume of water in the edge of field runoff 200,000 L/ha

Volume of water in a standard water body for Tier 3 calculations on a 1 ha field 1500 m3 (Tier 3)

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ENVIRONMENTAL RISK ASSESSMENT

5.8.1 Tier 1 runoff assessment

The runoff concentration and associated risk quotients are determined for a ‘worst case’ scenario (Table 4). Calculations are made based on factors that may be applicable to the potential of the ac migrating to the soil. Factors to be considered are presented in Table 6. Foliar interception may be considered depending on the application method and growth period. This will remove residues of the product from the foliage and carry it into the soil. Therefore the foliar interception value (fint) will be determined. The default value of 1 is used for Crsoil_surface at Tier I level.

Table 4 - Tier 1 Runoff Calculations

Parameter Value

L%runoff (Percent of applied ac in runoff water) 4.25%

Volume of pesticide contaminated runoff water (per hectare) 200,000 L

Edge of field concentration ac µg ac/L (single application) ac µg ac/L (multiple applications)

Risk to Common carp (acute)RQ = 25.50 µg/L ÷ 22.9 µg/L = 1.114

RQ=edge of field concentration (single application)/LC50 Carp

RQ >> 0.1

Risk to Daphnia magna (chronic)RQ = 62.7 µg/L ÷ 19.7 µg/L = 3.18

RQ=Edge of field calculation (multiple applications)/ 21 day NOEC Daphnia magna/

RQ >> 1

The tier 1 calculations predict an edge of field concentration of the active component. The acute and chronic risks are determined. If RQ>>0.1 (acute) or RQ>>1 (chronic) then tier 2 assessment is required.

5.8.2 Tier 2 runoff assessment

Runoff concentrations and associated risk quotients are determined for tier 2 assessments. The tier 2 assessment takes into account pesticide specific factors (Equation 3) including the half life of the ac in soil (DT50) and the mobility of the pesticide in soil (Koc).

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ENVIRONMENTAL RISK ASSESSMENT

Table 5 - Tier 2 Runoff Calculations

Parameter Value

DT50 soil d

Koc

L%runoff (Percent of applied ac in runoff water) %

Volume of pesticide contaminated runoff water (per hectare) 200,000 L

Edge of field concentration xx µg amisulbrom/L for single application (xx µg amisulbrom/L for multiple applications)

Risk to Common carp (acute)RQ=tier 2 edge of field concentration (single application)/LC50 Carp

RQ < 0.1

Risk to Daphnia magna (chronic)RQ=Edge of field calculation (multiple applications)/ 21 day NOEC Daphnia magna/

RQ < 1

The tier 2 calculation predict the edge of field concentrations for single application (µg ac/L based on g ac/ha) and multiple applications (µg ac/L for x applications with x d intervals including the DT50 (soil) based on g ac/ha). If DT50 is greater than the application frequency, it will be assumed that there is a potential for the ac to accumulate in the soil. Worst case scenarios are considered (based on DT50 and Koc). Assessment is determined on whether acute and chronic risks to are acceptable for worst case scenarios with RQ <0.1 and RQ <1 respectively. Tier 3 calculations are used were tier 2 risks are considered unacceptable.

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ENVIRONMENTAL RISK ASSESSMENT

5.9 Sediment runoffThe water solubility of the AC and its level of adsorption to soils may lead to a significant proportion of the applied AC being removed via sediment runoff.

Calculations are based on worst case scenarios. The calculations for sediment runoff assume that, in a worst case scenario, 400 kg/ha or 0.3% of top soil is eroded and is deposited into a 1 ha pond [Afyuni et al. (1997), Mensink et al. (1996)].

5.10 Sediment of a pondThe sediment loading of a pond will be determined by how much of the ac is adsorbed to soils based on water solubility (ie if <1mg/L) and level of sediment runoff.

The amount of sediment runoff into a pond is calculated based on 0.3% of top soil or 400kg/ha into a 1 ha pond.

Total amount of sediment that may come from a treated area multiplied by the cumulative application rate. Calculation is made of the sediment depth of the EU pond model (1cm) x bulk density (1400kg/m3) – This is to calculate the additional sediment coming from the treated area containing AC. The total ac in the whole sediment body is used to derive a concentration of the ac ug ac/kg sediment).

Based on the calculations, the risk to sediment dwellers is assessed to be acceptable or not.

5.11 GroundwaterAssessment will be made on how mobile the ac is through soils (leachability) that may lead to contamination of groundwater.

Groundwater risk assessment will examine the potential depth to groundwater, mobility of the ac, the longevity of the ac, and potential for the ac to be transported and accumulate in the groundwater.

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ENVIRONMENTAL RISK ASSESSMENT

6 EFFECTS AND ASSOCIATED RISKS OF COMBINATION PRODUCT TO NON-TARGET SPECIES

Similar to the independent active component consideration, the potential risk of combination products to non target species are assessed.

Short-term risks to non-target species are assessed following direct exposure to combined residues immediately after application. Endpoints for formulation toxicity are obtained from trials provided.

In the absence of formulation toxicity data, combination toxicity is estimated assuming additive toxicity for organisms. Predicted formulation toxicity values can also be calculated to compare with the toxicity studies provided as to provide validation of the predicted values.

EFSA (2013) provides rationale for checking the plausibility of the measured formulation toxicity against the calculated mixture toxicity. This is defined as the model deviation ratio (MDR) where the ratio of the calculated value divided by that of the measured value. In interpreting the MDR, if the value falls between 0.2 and 5, CA is assumed to hold for the mixture. Where the MDR is >5, the mixture is considered more toxic than additive, and where the MDR is <0.2, the mixture is considered less toxic than additive.

The impact of combination product is applied to each of the subject matter areas:

terrestrial animals

aquatic

bees

beneficial insects

soil organisms

non-target plants.

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ENVIRONMENTAL RISK ASSESSMENT

7 OVERALL CONCLUSIONSOverall conclusion statements for each of the potential environmental impacts are presented. This includes:

fate and transport considerations

terrestrial animals

aquatic

bees

beneficial insects

soil organisms

non-target plants.

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ENVIRONMENTAL RISK ASSESSMENT

8 LABELLING RECOMMENDATIONSRecommendations for labelling will be based on the outcomes of the risk assessments, reference product labels and current labelling standards.

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9 REFERENCESEFSA, 2013. Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters. EFSA Journal 2013;11(7):3290

SCEW, 2009. Environmental Risk Assessment Guidance Manual for agricultural and veterinary chemicals. (Formerly) Standing Council on Environment and Water, February 2009. (available from: http://www.scew.gov.au/sites/www.scew.gov.au/files/resources/bffdc9e9-7004-4de9-b94f-b758140dbc8c/files/cmgt-nchem-eragm-agricultural-and-veterinary-chemicals-200902.pdf

Aquatic organismshttps://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_aquatic.pdf https://www.efsa.europa.eu/en/efsajournal/pub/3290 http://archives.eppo.int/EPPOStandards/era.htm

Crop-specifichttps://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_crop_rice.pdf https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_efsa_protected-crops.pdf

Product-type specifichttps://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_doss_semiochemicals-201605.pdf https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_doss_botanicals-rev-8.pdf https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents https://echa.europa.eu/documents/10162/23036412/bpr_guidance_ir_part_vol_iv_part_a_en.pdf/e5ffe222-c4ae-40c7-8306-83645e52aca2 https://echa.europa.eu/documents/10162/23036412/bpr_guidance_ra_vol_iv_part_b-c_en.pdf/e2622aea-0b93-493f-85a3-f9cb42be16ae http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1879/pdf

Veterinary productshttp://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/environmental-safety.html https://www.efsa.europa.eu/en/efsajournal/pub/842 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001511.jsp&mid= http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001634.jsp&mid=WC0b01ac058002ddc5 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001506.jsp&mid=WC0b01ac058002dd37 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001507.jsp&mid=WC0b01ac058002dd37 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001508.jsp&mid=WC0b01ac058002dd37 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001503.jsp&mid=WC0b01ac058002dd37

Generalhttps://www.efsa.europa.eu/en/efsajournal/pub/4970 https://www.efsa.europa.eu/en/efsajournal/pub/4971

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10 ABBREVIATIONSADI Acceptable daily intake

ADWG Australian Drinking Water Guidelines

AERP Adverse Experience Reporting Program

ALARA As low as reasonably achievable

APVMA Australian Pesticides and Veterinary Medicines Authority

DAWR Department of Agriculture and Water Resources

DDD Daily dietary dose

DDSD Daily dry soil dose

DEE Department of the Environment and Energy

DEFRA UK Department of Environment, Food and Rural Affairs

DGD Daily granule dose

EFSA European Food Safety Authority

EPA Environment Protection Agency

EPHC Environment Protection and Heritage Council

EPPO European and Mediterranean Plant Protection Organization

EUBEES European Union Biocides Environmental Exposure Scenario working group

FAISD First aid instructions and safety directions

FAO Food and Agriculture Organisation

FIR Food Intake Rates

FSANZ Food Standards Australia New Zealand

GHS Globally Harmonised System of Classification and Labelling of Chemicals

GLP Good laboratory practice

GMP Good manufacturing practices

HBGV Health Based Guidance Values

IPM Integrated Pest Management

LOC Level of Concern

LOEC Lowest observed effect concentration

MAF Multiple Application Factor

MDR Model deviation ratio

MLS Manufacturers Licensing Scheme

MOE Margin of exposure

MRL Maximum residue limit

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ENVIRONMENTAL RISK ASSESSMENT

NAR Nominal (loading) application rate

NOAEL No-observed-adverse-effect level

NOEC No-observed-effect concentration

NOEL No-observed-adverse level

NRS National Residue Survey

OCS Office of Chemical Safety

OECD Organisation for Economic Co-operation and Development

OGTR Office of the Gene Technology Regulator

PAA Pre-application Assistance

PBT Persistent, bioaccumulative and toxic

PEC Predicted environmental concentration

POP Persistent organic pollutants

RAC Regulatory acceptable concentrations

RAD Regulatory acceptable dose

RAL Regulatory acceptable levels

RAM Risk Assessment Manual (EPHC 2009)

RAR Regulatory acceptable rates

RCP An RCP may be declared if special knowledge, skills, training and equipment are needed to be able to obtain, handle or use the product. This is based on the risks posed by the product to human health, animals, plants or the environment.

REI Re-entry interval

SUSMP Standard for the Uniform Scheduling of Medicines and Poisons

USEPA USA Environmental Protection Authority

VICH International Cooperation on Harmonization of Technical Requirements of Veterinary Medicinal Products

WHO World Health Organization

WHP Withholding period

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11 GLOSSARYActive constituent

The component of an agricultural or veterinary chemical product responsible for its physiological or pharmacological action

Acute toxicity

Immediate toxic effects shortly after exposure

Agvet chemicals

This covers agricultural chemical products and veterinary chemical products, as defined in the Agricultural and Veterinary Chemicals Code (Agvet Code). It encompasses all chemicals regulated by the APVMA

As Low as Reasonably Achievable (ALARA)

Means making every reasonable effort to minimise exposure to agvet chemicals, and reduce the use to the minimum necessary to achieve the required effect

Benthic

Relating to the bottom of a sea, lake or river, or resident organisms

Ecotoxicity

Toxic effects on plants and animals, both terrestrial and aquatic

FAISD Handbook

The Handbook of First Aid Instructions, Safety Directions, Warning Statements and General Safety Precautions for Agricultural and Veterinary Chemicals updated each quarter

Genotoxicity

The propensity to damage cellular DNA and chromosomes, resulting in mutations

Health Based Guidance Values (HBGV)

Health Based Guidance Values used in dietary risk assessments

Maximum Residue Limit (MRL)

Maximum permitted concentration of a residue, resulting from the registered use of an agricultural or veterinary chemical, usually expressed in units of mg/kg or μg/kg on a fresh weight basis

Occupational exposure

Exposure to a chemical during use by workers

Organophosphorus (OP)

A group of phosphorus-containing insecticides which act to inhibit acetylcholinesterase, an enzyme which is essential to nerve function in insects, animals and humans.

Restricted chemical product (RCP)

An RCP may be declared if special knowledge, skills, training and equipment are needed to be able to obtain, handle or use the product. This is based on the risks posed by the product to human health, animals, plants or the environment.

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ENVIRONMENTAL RISK ASSESSMENT

Safe threshold

The dose of a chemical that a person could have without suffering any measurable harm

Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

The Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories

Uncertainty factor

The factor by which an observed or estimated NOAEL is divided to generate a standard considered safe or without appreciable risk

VICH

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

VICH program

A trilateral EU-Japan-USA program aimed at harmonising technical requirements for veterinary product registration

Withholding Period (WHP)

The minimum time that must elapse between treating a crop or animal and availability of crop or animal product for safe human consumption

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APPENDIX C – SOIL ORGANISMS

1 APPENDIX A – TERRESTRIAL VERTEBRATES1.1 IntroductionThe procedures of risk characterisation are described according to the present state of knowledge. In this tiered assessment framework, potential risk for birds and mammals is identified on the basis of responses of individual organisms observed in controlled laboratory experiments, noting that the abundance and persistence of populations of organisms are potentially more relevant as endpoints for assessment than are responses of individual organisms. The proposed approach is justified on the ground that too little is known about the responses of populations to chemical exposure to support regulatory decisions on that basis. Extrapolation tools aiming at bridging the gap between individual level and population level by means of population modelling techniques are not yet satisfactory. Risk assessors have to consider, at least qualitatively, that if only a small fraction of a population is exposed (spatial scale) risks associated with the use of the pesticide product may be small even if some individuals would be affected. That does not preclude, that appreciable mortality without population level consequences may be judged unacceptable.

The standard risk assessment is based on the field scale and not landscape scale, ie the risk to non-target birds and mammals frequenting the treated field is assessed. No consideration is made of the risk from applications of the same pesticide to neighbouring fields. If concern is raised (ie RQ >1.0) then the risk can be refined appropriately. When refining the risk it may be appropriate to consider such issues as suitability of the standard scenarios, scale of use and potential impact on populations. However, no deviations from worst case assumption should be made unless they are justified.

1.2 Toxicity figuresAcute: Birds: LD50 from acute oral test

Mammals: LD50 from acute oral test

Chronic: Birds: NOEL from avian reproduction study

Mammals: NOEL based on most sensitive endpoint of relevance for survival rate, reproduction rate and development of individuals, for example results from multi-generation studies or teratology studies on mammals.

In each category the toxicity of the most sensitive test species is used.

With regard to chronic exposure in mammals, the assessment is conducted with a dose level that represents the no observed adverse effect level from a toxicological point of view. If the resulting RQ exceeds 1.0 then the ecological relevance of endpoints should be re-evaluated.

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APPENDIX C – SOIL ORGANISMS

1.3 Risk assessmentThe major potential routes of exposure of terrestrial vertebrates are considered to be feeding on food items (eg vegetation and invertebrates) directly contaminated from spray application of the product. The acute and reproductive risks for terrestrial vertebrates following dietary exposure to contaminated food items are assessed using a tiered approach which is in line with current EFSA (2009) guidance. The Australian assessment, however, first calculates a regulatory acceptable dose (RAD) for acute and chronic exposure scenarios as indicated in Table 6. A risk quotient is then calculated that compares the daily dietary dose for a ‘worst case scenario’ with the RAD.

For multiple applications, a default foliar DT50 of 10 days is assumed. Foliar dissipation data can be used to refine the assessment if it is shown that the dissipation of the active constituent is faster than assumed.

If it is necessary to refine the assessment, a Tier 1 assessment according to EFSA (2009) guidance is conducted which considers more specific exposure scenarios for generic focal mammal species relevant to the crop and timing of application (Table 7).

To further refine the assessment, a Tier 2 assessment considers that not all of the animal’s daily diet is obtained in habitat treated with the pesticide (PT = fraction of diet obtained within the treatment area) or that not all of the animal’s dietary items are available within the treatment area (PD = fraction of a particular food type in the diet). As a worst-case assumption at the screening and Tier 1 levels of assessment, animals are assumed to find all of their food (PT = 1) and dietary items (PD = 1) within the treatment area. The Tier 2 assessment considers more realistic estimates of PT or PD. Available sources of PT or PD data include:

Aargard (2014) provides guidance on risk assessments for birds and mammals, based on the European Northern zone focal species relevant for the crop type and its growth stage. Biological background information on crop stage specific relevant focal species and available refinement options are presented.

Buxton et al. (1998) provides information on birds that occur in the agricultural environment in the UK and in particular their diet and breeding period. This publication can be used to help refine PD as outlined in EC (2002).

Crocker et al. (1998a) provides information on the behaviour of birds in UK orchards. In particular, it provides useful information on the time that birds spend in orchards and hence can be used to refine PT as outlined in EC (2002).

Finch et al. (2006) demonstrates how the proportion of diet obtained in treated areas by birds can be estimated from the recorded radio tracked ‘active time’ data and discussed the most appropriate percentile value for regulatory use in the current deterministic non-target bird risk assessment for pesticides.

Gurney et al. (1998) provides information on mammals that occur in the UK agricultural environment and in particular on their diet. This publication can be used to help refine PD as outlined in EC (2002).

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Prosser (2010) contains listing of all the PT data from UK FERA’s previous projects in a single document. Modelled PT distributions have been fitted to these data to give more accurately calculated 90th, 95th or other percentile points from the distributions.

For higher levels of assessment, it may be necessary to identify focal species for the specific crop(s) of concern. There are no Australian-specific focal species identified to date; however, there are some European publications available that could be used to identify surrogate focal species for the same crops. Crocker and Irving (1999) highlights the type of work required to determine appropriate focal species, it also proposes several focal species for certain crops. Crocker et al. (1998b) summarises the influence of pesticide use, other aspects of husbandry and environmental factors on bird populations in orchards. Pascual et al. (1998) presents information on the occurrence of birds and mammals on arable fields in the UK.

For other refinement options:

Crocker et al. (2002) can be used to determine for appropriate food intake rates (FIRs).

Hart (2002) evaluated the feasibility of carrying probabilistic risk assessment. The report summarises several case studies and concludes that probabilistic risk assessment can be accommodated and could provide a significantly better basis for decision-making, if they are used appropriately.

Any additional refinements are likely to need additional data, either specific data on the product to be assessed or generic data. Some information may be available already in the dossier or can be produced by literature searches, other data have to be generated by new studies. As it is desirable to minimise animal testing other options for refinement should be explored first, where possible. In any case the assumptions and input data in the refinement steps should be fully justified. It should be noted that refinement reduces the uncertainty and produces a more precise characterisation of the risk, but additional data do not necessarily result in a risk level which is lower than previously expected.

1.3.1 Home garden uses

Hart (1999) provides information on the occurrence and subsequent use of non-target organisms in the home garden and should be consulted when the risk from a home garden is assessed as it highlights key species as well as issues associated with residues.

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1.3.2 Seed treatments and solid formulationsGranular products

If granules are based on an organic carrier having a nutritional value then they may be taken by birds or mammals as food. In such cases exposure could be assessed in a similar way as for baits or treated seeds. Granules with an inorganic base could be ingested either incidentally as birds and mammals inevitably incorporate a certain amount of soil when gathering food or intentionally when birds search for grit. The tier 1 assessment followed the EFSA (2009) methodology considers the following scenarios:

Birds ingesting granules with/as grit (Table 9).

Birds ingesting granules when seeking seeds as food (Table 10).

Mammals and birds ingesting granules when eating soil-contaminated food (Table 11).

Seed treatments

The Tier 1 assessment according to EFSA (2009) assumes that granivorous mammals and birds feed entirely on readily available, freshly treated seeds (100% of diet) assuming no incorporation into the soil (Table X). Herbivorous and insectivorous mammals and birds are not considered to be attracted to fields immediately after treated seed has been drilled.

In general, granivorous mammals and birds prefer a certain type of seed for their diet. Not all birds are attracted to all sizes and shapes of seeds. Therefore, in a Tier 1 assessment, small granivorous birds that feed on small seeds and larger medium-sized birds that feed on large seeds (such as maize, sugar beets and beans) are considered separately. A small omnivorous mammal is the indicator species for mammals, regardless of the seed size.

Slug pellets

Slug pellets are based on organic material and thus have a nutritional value for mammals and birds. It is known that small rodents like wood mice as well as granivorous birds ingest slug pellets if available (birds may take them as feed or as grit). As a starting point it could be assumed that animals feed exclusively on pellets. Suitable indicator species are the granivorous bird and the granivorous mammal from the standard scenarios. If a risk is indicated then palatability studies would be the most logical way to proceed because experience has shown that the attractivity of the pellets usually is limited. The pellets are coloured, and that feature among others may deter birds to a certain degree (EC 2002). Palatability studies should be conducted with the formulated product.

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Foraged area of concern

USEPA (2016) provides guidance to refine the assessment based on the ‘forage area of concern’. The ‘foraged area of concern’ represents the amount of area the target species would have to cover to consume enough pesticide to exceed the RAC. This area is based on the minimum number of seeds that would trigger a risk concern, the seeding rate and the fraction of seeds incorporated in planting. This area that a species would have to cover to consume sufficient pesticide to trigger a risk concern is then compared to the home range of the species. If the area of concern is larger than the home range, then the likelihood that the animal is able to consume enough seeds to trigger a risk concern is low. If the area is within the home range of the animal, then there is a potential for exceeding the RAC.

The ‘foraged area of concern’ analysis relies on the following assumptions: 1) birds/mammals have a spatial limit to the area over which they can feed; 2) there is a finite limit of available seed in a given unit area; 3) there is a limit to the ability of a bird/mammal to glean bioavailable seed from a given unit area; and 4) the foraged area cannot exceed the home range of an individual animal (ie, if an animal must exceed its home range to acquire a lethal dose, the likelihood of that event is considered remote).

Forage time to concern

The ‘forage time to concern’ is the length of time that an individual animal would need to spend eating treated seeds to receive the daily dose of pesticide that would equal the RAC. For birds, this time is principally determined by the seed consumption rate (ie, the number of seeds that can be consumed in a given length of time). The ‘forage time to concern’ is compared to the total time of daylight within a day to determine if consuming that number of seeds within one day is feasible.

There is limited information on the individual seed consumption rate with the majority of the data focusing on mass of seed consumed rather than number of seeds. USEPA (2016) lists species specific seed handling times for five surrogate sparrows and finches based on the data from Benkman and Pulliam (1988). The analysis considers only species that can potentially consume treated seed of a particular size. The indicator species identified by USEPA (2016) are used as surrogate species for Australian birds of a similar size and feeding habits.

Other refinement options

Fryday et al. (1999) and (2001) provide useful information on the design of avoidance studies. These two reports should be consulted if an applicant is considering carrying out an avoidance study, or is assessing the risk to birds or mammals from a solid formulation.

In the case of seed eating birds and mammals dehusking may reduce exposure. Regardless, whether seed treatment is the intended use of the product or weed seeds are contaminated during spraying, the substance will be mainly on the husk and therefore dehusking can remove the majority of the residue. This reduction can be as high as 85 % (EC 2002). Small birds are more likely to dehusk seeds than large birds, but it depends on the kind of seed, and even when dehusking occurs, only a proportion of seeds are dehusked. Prosser (1999) provides useful information on what seed is consumed by what bird.

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1.3.3 Rodenticides

Rodenticides are inevitably toxic to mammals and birds, thus the risk assessment usually is a challenging task (EC 2002). Most rodenticides are anticoagulants which are far more toxic if consumed repeatedly over several days compared to a single dosing making a short-term assessment more relevant than the acute assessment. Especially for mammals it may be necessary to take into account other toxicity figures than in the standard assessment, eg a five-day LD50 which often is carried out for such substances.

Primary poisoning

Rodenticidal baits consist of cereals, grease or wax; therefore direct exposure is relevant mainly for rodents and seed eating birds. As rodenticides inevitably are toxic to non-target species an exposure assessment that is based on exclusive feeding on the bait will always come to the conclusion of potential risk. Two refinement steps are obvious:

Consider accessibility of baits. Accessibility might be reduced by requiring appropriate use instructions to be put on the label.

o Baits placed in rooms or other enclosed spaces usually are inaccessible

o Baits placed in bait stations or are covered in some other way are fairly inaccessible to non-target species; occasionally small birds might have access to the bait if the quality of the cover is poor.

o Baits placed sub-surface (burrow-baiting) are inaccessible to almost all non-target animals. The burrows of common voles or water voles are usually not used by other rodents.

o Baits spread on surface are accessible to many non-target species depending on factors such as kind and height of vegetation.

Consider attractivity: Rodenticidal baits are designed to be attractive for rodents, so avoidance should not be expected. Often a bitter agent is added which repels children and carnivores but is unable to deter non-target rodents and birds. Nevertheless, the bait could be unattractive to birds to a certain degree due to colour, consistency and other factors, but that has to be tested before avoidance can be considered in the exposure estimate. Such tests could be conducted with a dummy formulation (which contains no active substance but is equal in all other features).

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Secondary poisoning

Indirect exposure (secondary poisoning) can only be ruled out completely when the rodenticide is used in fully enclosed spaces so that rodents cannot move to outdoor areas. For other situations a risk assessment for avian and mammalian predators and scavengers is necessary. In order to estimate the exposure quantitatively a model calculation could be conducted based on a nominal concentration of the active substance in/on bait, bait uptake rate of target rodent, and estimated time to death of target rodent. However, such an estimate usually is unrealistically high as no elimination is assumed. Fortunately, in nearly all cases measured residues in rodents are available from different sources (special laboratory studies, secondary poisoning studies, monitoring of rodent control operations). For the purpose of exposure assessment whole body residues are relevant (not liver residues). If a risk is indicated the following options for refinement are possible:

Evaluate secondary poisoning studies which are already available for current rodenticides (Joermann 1998, EPPO 1995).

Improve estimate of proportion of target rodent in the diet of predators; suitable information might already be available from literature on feeding ecology; otherwise data could be generated using a marker in the bait.

Field studies, monitoring.

Exposure scenarios

In addition to primary and secondary poisoning, EUBEES (2003a) has developed environmental exposure scenarios for the following situations:

sewer systems

in and around buildings

open areas

waste dumps

1.3.4 Avicides

Non-target vertebrates are exposed to avicides primarily through consumption of treated food and secondarily from consumption of poisoned birds. EUBEES (2003b) has developed exposure scenarios with respect to uptake by non-target vertebrates.

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1.4 Combination toxicityTerrestrial vertebrates could be directly exposed to combined residues if oversprayed food sources are consumed immediately after application. Short-term risks are determined following direct exposure to combined residues immediately after application. In the absence of formulation toxicity data, combination toxicity is estimated assuming additive toxicity for organisms which are sensitive to at least two of the constituents in the mixture. If one active substance drives the overall toxicity (≥ 90%), then it is concluded that the toxicity is driven by the active constituent and additive toxicity is not considered further.

If formulation toxicity data are available, the observed toxicity of the mixture is compared to the predicted toxicity based on active substance data which can be done for any ratio of active substances by calculation of the Model Deviation Ratio (MDR) (Table 14). If the MDR is within the range of 0.2 to 5, the mixture toxicity is assumed to be additive. If the MDR is <0.2, the mixture toxicity is considered to be less than additive (antagonistic) and if the MDR is >5, the mixture toxicity is considered to be more than additive (synergistic).

1.5 Risk assessment tablesTable 6 - Regulatory acceptable doses for terrestrial vertebrates

Taxonomic group Exposure Endpoint Assessment factor

RAD

Birds Acute LD50 XX mg ac/kg bw/d 10 XX mg ac/kg bw/d

Chronic NOEL XX mg ac/kg bw/d 1 XX mg ac/kg bw/d

Mammals Acute LD50 XX mg ac/kg bw/d 10 XX mg ac/kg bw/d

Chronic NOEL XX mg ac/kg bw/d 1 XX mg ac/kg bw/d

RAC = regulatory acceptable level = endpoint/assessment factor

Table 7 - EFSA (2009) shortcut values for screening level assessment of terrestrial vertebrates

Taxonomicgroup

Crop group Indicator species Shortcut value

Acute Chronic

Bird Bare soils and hops Small granivorous bird 25.3 11.4

Grassland Large herbivorous bird 30.5 16.2

Bush and cane fruit small frugivorous bird 52.2 23

Orchards and ornamentals/nursery Small insectivorous bird 46.8 18.2

Vineyards Small omnivorous bird 95.3 38.9

Bulbs and onion like crops, cereals, fruiting vegetables, leafy vegetables, legume forage, maize, oilseed rape, potatoes, pulses, root and stem vegetables, strawberries, sugar beet, and sunflower

Small omnivorous bird 158.8 64.8

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Taxonomicgroup

Crop group Indicator species Shortcut value

Acute Chronic

Cotton Small omnivorous bird 160.3 65.4

Mammal Bare soil Small granivorous mammal

14.4 6.6

Bush and cane fruit Small herbivorous mammal

81.9 43.4

Bulbs and onion like crops, cereals, oilseed rape, potatoes, root and stem vegetables, strawberries, sugar beet, and sunflower

Small herbivorous mammal

118.4 48.3

Cotton, fruiting vegetables, grassland, leafy vegetables, legume forage, maize, orchards, ornamentals/nursery, pulses, and vineyard

Small herbivorous mammal

136.4 72.3

Table 8 - Screening level assessment of risks to terrestrial vertebrates (crop group: orchards)

Group Indicator species Exposure Shortcut value Application rate(kg ac/ha)

DDD(mg ac/kg bw)

RAD(mg ac/kg bw)

RQ

mammal Small herbivorous mammal

Acute 136.4

Chronic 72.3

bird Small insectivorousbird

Acute 46.8

Chronic 18.2

Shortcut value from Table XAcute DDD = daily dietary dose (mg/kg bw/d) = shortcut value * rate (kg ac/ha)Chronic DDD = daily dietary dose (mg/kg bw/d) = shortcut value * rate (kg ac/ha) * time-weighted average factor 0.53RAD = regulatory acceptable dose (from Table X)RQ = risk quotient = DDD/RAD, where acceptable RQ ≤1

Table 9 - Screening level assessment of risks to birds directly ingesting granules

Application rate (kg granules/ha)

Active constituent content (mg acs/kg granules)

Granular density (granules/kg)

Gsurface (number of granules/m2)

Gloading (mg acs/granule)

Indicator species Small granivorous bird Large granivorous birdGranular size preference 0.75 to 2 mm 2 to 6 mm

BW (kg) 0.025 0.30Exposure Acute Chronic Acute Chronic

RAD (mg ac/kg bw/d)

Birds ingesting granules with as/gritDGritD (mg ac/kg bw/d)

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RQ

Birds ingesting granules when seeking seeds as foodDGD (mg ac/kg bw/d) n/a n/a

RQ n/a n/aAssessment method according to EFSA (2009)Gsurface = number of granules on soil surface per m2 = application rate (kg granules/ha) / granular density (granules/kg) /10000 Gloading = active constituent content (mg acs/kg granules) / granular density (granules/kg) BW = body weight (default values)RAD = regulatory acceptable dose (from Table X)Small bird acute DGritD = daily grit dose (mg ac/kg bw/d) = 651/BW * (Gsurface / (15200 + Gsurface)) * Gloading Large bird acute DGritD = daily grit dose (mg ac/kg bw/d) = 2453/BW * (Gsurface / (71 + Gsurface)) * Gloading Small bird chronic DGritD = daily grit dose (mg ac/kg bw/d) = 386 * (Gsurface / (15200 + Gsurface)) * Gloading * time-weighted average factor 0.53Large bird chronic DGritD = daily grit dose (mg ac/kg bw/d) = 1306 * (Gsurface / (71 + Gsurface)) * Gloading * time-weighted average factor 0.53Acute DGD = daily granule dose (mg ac/kg bw/d) = 620 * (Gsurface / (100 + Gsurface)) * Gloading Chronic DGD = daily granule dose (mg ac/kg bw/d) = 620 * (Gsurface / (100 + Gsurface)) * Gloading * time-weighted average factor 0.53RQ = risk quotient = DGritD/RAC where acceptable RQ ≤1

Table 10 - Screening level assessment of risks to terrestrial vertebrates ingesting granules when eating soil-contaminated food

Application rate (kg ac/ha)

Taxonomic group Mammal BirdExposure Acute Chronic Acute Chronic

Application rate (kg ac/ha)

RAD (mg ac/kg bw/d)

DGD (mg ac/kg bw/d)

RQAssessment method according to EFSA (2009)RAD = regulatory acceptable dose (from Table X)Mammal acute DDSD = daily dry soil dose (mg ac/kg bw/d) = 0.097 * application rate (kg ac/ha)Bird acute DDSD = daily dry soil dose (mg ac/kg bw/d) = 0.283 * application rate (kg ac/ha)Mammal acute DDSD = daily dry soil dose (mg ac/kg bw/d) = 0.005 * application rate (kg ac/ha) * time-weighted average factor 0.53Bird chronic DDSD = daily dry soil dose (mg ac/kg bw/d) = 0.025 * application rate (kg ac/ha) * time-weighted average factor 0.53RQ = risk quotient = DGD/RAC where acceptable RQ ≤1

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Table 11 - Screening level assessment of risks to terrestrial vertebrates feeding on freshly drilled seeds

NAR (mg acs/kg seed)Indicator species Small omnivorous

mammalSmall granivorous

birdLarge granivorous

bird2

Type of seeds Any Small seeds(not maize, beans or

peas)

Large seeds(maize, beans or peas)

FIR/bw (kg seed/kg bw)

0.24 0.30 0.10

Exposure Acute Chronic Acute Chronic Acute ChronicRAD (mg acs/kg bw)

RQFIR/bw = food ingestion rate per body weight (from EFSA 2009)NAR = nominal (loading) application rate of active constituent per kg seedRAD = regulatory acceptable dose (from Table X)Acute RQ = risk quotient = NAR* (FIR/bw) / RAC, where acceptable RQ<1Chronic RQ = risk quotient = NAR* (FIR/bw) * time-weighted average factor 0.53 / RAC, where acceptable RQ<1

Table 12 - Foraged area of concern for mammals and birds

Indicator species Mammal BirdSize Small Medium Large Small Medium Large

Body weight (kg) 0.015 0.035 1.0 0.020 0.10 1.0CE (unitless) 1.0 1.0 1.0 1.0 1.0 1.0IR (unitless)

SR (seeds/ha)Seed loading (mg

acs/seed)

Exposure3

RAD (mg acs/kg bw)Seedconcern (number of

seeds)Foraged area of concern

(ha)Home range (ha) 0.15 0.38 16 1.4 8.7 114

Assessment method according to USEPA (2016)CE = consumption efficiency expressed as the fraction of seed gleaned from a unit area = default of 1.0 unless other data are availableIR = fraction of incorporationSR = seed rate RAD = regulatory acceptable dose (from Table X)Seedconcern = minimum number of seeds required to trigger risk concern = body weight (kg) * RAD (mg acs/kg bw) / Seed loading (mg acs/seed)2 This group also encompasses medium-sized birds for the purpose of refinement if necessary3 Acute or chronic; add an additional column if both time scales are of concern

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Foraged area of concern = Seedconcern/[SR*(1-IR)*CE]

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Table 13 - Forage time to concern for birds according to USEPA 2016

Bird size Small MediumSurrogate species Chipping

sparrowAmerican goldfinch

Dark-eyed junco

House finch Evening grosbeak

Body weight (kg) 0.013 0.013 0.020 0.021 0.055Max seed size for bird (mg) 4.0 60 1.5 70 120

Seed size (mg)Seed loading (mg

acs/seed)Exposure

RAD (mg acs/kg bw)Seedconcern (number of

seeds)X (unitless) -1.18 1.13 -0.49 1.41 1.54Y (unitless) 3.26 0.12 1.60 0.03 0.01

Forage time to concern (seconds)

Assessment method according to USEPA (2016)RAD = regulatory acceptable dose (from Table X)Seedconcern = minimum number of seeds required to trigger risk concern = body weight (kg) * RAD (mg acs/kg bw) / Seed loading (mg acs/seed) X and Y are species-specific parameters for seed handling time according to USEPA 2016Forage time to concern (seconds) = Seedconcern* ln (X + Y * (treated seed size in mg))

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Table 14 - Combination toxicity to terrestrial vertebrates

Active 1 Active 2 Combination4 5 6

Fraction in combination 0.XX 0.XX 1.00

Acute toxicity to mammals LD50 XX mg ac/kg bw Test itemTest speciesReference

LD50 XX mg ac/kg bw Test itemTest speciesReference

Measured:LD50 XX mg ac/kg bw Test itemTest speciesReference

Predicted:LD50 XX mg ac/kg bw

Relative toxicity contributions:X% + X%

MDR X

4 Predicted values calculated assuming additive toxicity of active constituents in a the specified ratio (p1:p2) using most sensitive endpoints reported for that organism group where:

ECxCA=( 1

∑i−1

n PiECxi )

Where:ECxCA is the predicted additive toxic effect of the active constituent in combinationPi = is the fraction of individual active constituent in the productECxi is the effect concentration of the individual active constituent

5 %relative¿=

piEC xi

∑i=1

n p iEC x i

×100

6 MDR = model deviation ratio (unitless) = measured LD50 / predicted LD50

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APPENDIX C – SOIL ORGANISMS

Active 1 Active 2 Combination

Fraction in combination 0.XX 0.XX 1.00

Acute toxicity to birds LD50 XX mg ac/kg bw Test itemTest speciesReference

LD50 XX mg ac/kg bw Test itemTest speciesReference

Measured:LD50 XX mg ac/kg bw Test itemTest speciesReference

Predicted:LD50 XX mg ac/kg bw

Relative toxicity contributions:X% + X%

MDR X

1.6 Risk mitigationRisk management options generally aim at a reduction of exposure. The possibilities of risk management very much depend on the type of product, the intended use, and specific conditions of the treatment area. Usually this is the final step in the assessment, but often it may be useful to envisage risk mitigation measures before all possibilities of refinement are exhausted. Whatever risk management option is chosen, the practicality should be assessed fully to ensure that it does not reduce the effectiveness and usefulness of the product.

Risk from spray application

If a risk to birds and mammals has been indicated from the use of a spray, then the risk may be reduced by decreasing application rate and/or application frequency, however this may significantly affect the efficacy of the product. Alternatively spot or row treatment may be appropriate depending upon the pest or disease being treated. Changing the method of application from spray to a more target approach, eg bait or paste/paint may reduce the risk to birds and mammals, however the success of this approach will depend upon the disease or pest being treated. If a reproductive risk to birds or mammals has been highlighted, then it may be appropriate to restrict the time of application when birds or mammals are not breeding, or to limit the number of applications and hence reduce exposure.

Risk from seed treatments

If a high risk from a seed treatment is predicted a label instruction should require to remove spills immediately. Furthermore, it may be appropriate to consider that the seed be drilled or incorporated immediately after application. If seed is incorporated availability to birds and mammals will be reduced and hence if an acute risk has been highlighted then this will be reduced as birds and mammals will take longer to find and consume treated seed. It has to be assessed, of course, whether consumption is reduced enough to conclude that the risk is acceptable.

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Risk from granules

If a high risk from granules has been highlighted, again removal of spills should be required and the feasibility of incorporating them at the time of application be considered in order to reduce the availability to birds. As for seed treatment, agronomic implications should be considered when assessing this as a risk management option.

Risk from rodenticides

The availability of bait to non-target birds and mammals can be reduced by prescribing burrow-baiting or the use of bait stations. When surface spreading is necessary then application should be on vegetation rather than on bare soil. As far as rodent control in and around buildings and similar premises is concerned, removal of dead and moribund rodents and removal of bait remains after completion of the control operation should be regarded as routine safety measures.

1.7 ReferencesAagard A, 2014, Pesticide risk assessment for birds and mammals: Selection of relevant species and development of standard scenarios for higher tier risk assessment in the Northern Zone in accordance with Regulation EC 1107/2009, version 1.1.

Benkman CW, Pulliam HR, 1988, Comparative feeding ecology of North American sparrows and finches, Ecology 69: 1195-1199

Buxton JM, Crocker DR, Pascual JA, 1998, Birds and farming: information for risk assessment, 1998 update contract PN0919 Milestone Report FERA project no. M37. Available online: http://www.hse.gov.uk/pesticides/resources/B/Birdbible.pdf

Crocker DR, Irving PV, 1999, Milestone report 02/01 Variation of bird numbers on arable crops, Contract PN0915 – Improving estimates of exposure to pesticides in arable crops. Available online: http://www.hse.gov.uk/pesticides/resources/R/Research_PN0915.pdf

Crocker DR, Prosser P, Tarrant DA, Irving PV, Watola G, Chandler-Morris S, Hart J, Hart ADM, 1998a, Contract PN0903: Improving the assessment of pesticide risks to birds in orchards, Objective 1: Use of radiotelemetry to monitor birds’ use of orchards, FERA Report No. EH18/02, Available online: http://www.hse.gov.uk/pesticides/resources/P/PN090320Orchard20radio-tracking.pdf

Crocker DR, Irving PV, Watola G, Tarrant KA, Hart ADM, 1998, Contract PN0903: Improving the assessment of pesticide risks to birds in orchards, Objective 2: Relative importance of pesticides and other factors influencing birds in orchards, FERA Report No. EH18/01, Available online: http://www.hse.gov.uk/pesticides/resources/P/PN090320Orchard20bird20censuses.pdf

Crocker DR, Hart ADM, Gurney J, McCoy C, 2002, Project PN0908: Methods for estimating daily food intake rate of wild birds and mammals: Final report FERA. Available online: http://www.hse.gov.uk/pesticides/resources/R/Research_PN0908.pdf

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EC (European Commission), 2002, Guidance document on risk assessment for birds and mammals under Council Directive 91/414/EEC, SANCO/4145/2000 final, Brussels, BE. Available online: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_ra_birds-mammals.pdf

EFSA (European Food Safety Authority), 2009, Guidance document on risk assessment for birds & mammals on request from EFSA, EFSA Journal 2009; 7(12) 1438, doi: 10.2903/j.efsa.2009.1438. Available online: www.efsa.europa.eu

EPPO (European and Mediterranean Plant Protection Protection Organization), 1995, Guideline for the evaluation of side-effects of plant protection products – Non-target effects of rodenticides, EPPO Bull 25, 553-574.

EUBEES (European Union Biocides Environmental Exposure Scenario working group), 2003a, Emission scenario document for biocides used as rodenticides (Product type 14). Available online: https://echa.europa.eu/documents/10162/16908203/pt14_rodenticides_en.pdf/159a8bb4-69bb-4bc4-9267-0b3221d16d09

EUBEES (European Union Biocides Environmental Exposure Scenario working group), 2003b, Emission scenario document for biocides used as avicides (Product type 15), Available online: https://echa.europa.eu/documents/10162/16908203/pt15_avicides_en.pdf/6e9dca51-905d-4122-a040-51e859eb0a93

Fryday SL, Chandler-Morris SA, Tarrant KA, Hart ADM, 1999, Contract PN0914: Validation of methods for testing the avoidance of treated seeds by birds, Final report April 1999, FERA Report no. FL6400, Available online: http://www.hse.gov.uk/pesticides/resources/P/PN091420Validation20of20avoidance20methods.pdf

Fryday SL, Chandler-Morris SA, Hart ADM, 2001, Contract PN0909: Robust tests for the acceptance of bait and treated seed by birds, November 2001, FERA Report No. FL3900. Available online: http://www.hse.gov.uk/pesticides/resources/P/PN090920Robust20tests20of20avoidance.pdf

Gurney JE, Perrett J, Crocker DR, Pascual JA, 1998, Mammals and farming: information for risk assessment, 1998 Update Contract PN0919 Milestone Report FERA Project No. M37. Available online: http://www.hse.gov.uk/pesticides/resources/M/MammBible.pdf

Hart ADM, 1999, Exposure of non-target organisms to pesticides in gardens, Final Report of PN0916. Available online: http://www.hse.gov.uk/pesticides/resources/P/PN0916.pdf

Hart ADM, 2002, Project PN0920: UK case studies on quantitative risk assessment: Final report 1. Available online: http://www.hse.gov.uk/pesticides/resources/P/PN0920_final_report.pdf

Joermann G,1998, A review of secondary poisoning studies with rodenticides. EPPO Bull 28: 157-176.

Pascual J, Crocker DR, Hart ADM, 1998, Project PN0919: Improving estimates of the exposure of non-target wildlife to pesticides in arable crops – a review of existing data – Discussion document for meeting on 15

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May 1998, Contract PN0910/PN0919 Milestone report, Available online: http://www.hse.gov.uk/pesticides/resources/P/PN091920Arable20Literature20Review.pdf

Prosser P, 1999, Project PN0907: Potential exposure of birds to treated seed, Final milestone report FERA. Available online: http://www.hse.gov.uk/pesticides/resources/R/Research_PN0907.pdf

Prosser P, 2010, Consolidation of bird and mammal PT data for use in risk assessment, UK DEFRA, Food and Environment Research Agency (FERA).

USEPA (United States Environmental Protection Agency), 2016, Refinements for risk assessment of pesticide treated seeds – interim guidance, USEPA Office of Pesticide Programs, Environmental Fate and Effects Division, Washington DC.

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1 APPENDIX B – OTHER NON-TARGET ARTHROPODS

1.1 IntroductionNon-target arthropods play a vital role in the ecosystem and therefore pesticide products that are used as prescribed should not cause unacceptable effects on populations of non-target arthropods both in- and off-field. Many species of non-target arthropods are natural enemies of pests. Their presence and healthy activity keeps primary and secondary pests in check. The objective of the assessment is therefore to ensure that any risk to non-target arthropod populations, both within and off the cropping field, are highlighted and to assess the nature of the risk so that adequate risk reduction measures can be taken.

1.2 Toxicity valuesTier 1 testing

The Tier 1 laboratory test is a dose–response test assessing lethal effects of the active substance on the test species. This tier has a screening character and is required for all representative formulations where exposure of non-target arthropods can occur. At this tier, detailed information is not considered, eg about sublethal effects or about the effects of specific formulations. A representative formulation should be used for this test instead of the active substance as relevant experimental exposure of non-target arthropods to the pure active substance is impractical. Testing guidelines indicated in Candolfi et al. 2000) should be used for dose–response tests. The study should include different application rates of the test compound and should allow calculation of a dose–response regression curve. The report should include regression analysis and calculation of the required LR50 to be expressed in g ac/ha. In certain conditions, eg when the toxicity is very low compared with maximum field rates or in other cases where experimental assessment of a reliable LR50 value is not reasonably possible, a limit test at the maximum seasonal rate may be sufficient.

Standard species are Aphidius rhopalosiphi (a parasitoid hymenopteran insect) and Typhlodromus pyri (a predatory phytoseiid mite). These standard indicator species have been shown to be relatively sensitive and representative of non-target arthropods in a comparative study of arthropods of nine families exposed to 95 plant protection products (Candolfi et al. 1999) and are therefore suitable as indicator species for this group of terrestrial non-target arthropods.

Tier 2 testing

Higher-tier tests may comprise extended laboratory tests (eg on natural substrates), semi-field bioassays and field experiments. They are not necessarily executed in this order but depending on the question that needs to be answered one may choose, for instance, to skip extended laboratory tests and move directly to semi-field or field experiments.

If one or both indicator species are affected in tier 1 testing, the affected species should be tested further in higher-tier studies. Moreover, additional species should be included in higher-tier tests. The choice of additional species, including criteria for the choice and testing methodology, is discussed in Candolfi et al. 2001. IGRs should be tested in these higher tiers on susceptible, immature life stages.

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Tier 3 testing

In field trials, effects on populations rather than on individuals should be the testing endpoint. The effect on the population of a species including time to recolonization/recovery should be analysed by comparison with control plots. There is no fixed threshold (trigger) value for acceptability of effects, because the consequence/impact of treatments and potential for recovery can be markedly different for different organisms and circumstances. Factors such as mobility of a species, reproduction time and developmental stage at risk can influence the severity of product effects on a population.

1.3 Risk assessmentOther beneficial (predatory and parasitic) arthropods could be directly exposed to the active constituent within the crop during treatment or as a result of spray drift. Risks to beneficial arthropods are assessed using a tiered approach which is in line with EPPO (2003) guidance.

For multiple applications, a default foliar DT50 of 10 days is assumed. Foliar dissipation data can be used to refine the assessment if it is shown that the dissipation of the active constituent is faster than assumed:

Cumulative rate = Single rate · (1-EXP(-N*ln2/DT50*interval))/(1-EXP(-ln2/DT50*interval))

in which:Cumulative rate = accumulated application rate immediately after the last application (g ac/ha)Single rate = single application rate (g ac/ha)N = number of applicationsDT50 = foliar half-life (default 10 d)Interval = time between application (d)

Tier 1 assessment

A screening level risk assessment utilises Tier 1 toxicity data and assumes the non-target arthropods are exposed to fresh-dried residues within the treatment area immediately after application (Table 16).

Tier 2 assessment

If it is necessary to refine the assessment, a Tier 2 assessment is conducted which considers higher-tier tests conducted under progressively more natural, realistic conditions.

Tier 3 assessment

The tier 3 assessment considers the results of field trials. Relevance to the Australian situation must be considered. Acceptability has to be assessed on a case-by-case basis for each arthropod taxon or group under investigation. Expert judgement is required to interpret field study results. In some cases, in particular with insecticides, a certain level of adverse impact on in-field arthropods is likely and almost unavoidable. The final criterion for acceptable risk in-field is that non-target arthropods affected by pesticide products should be able to recover to levels of corresponding control fields within, at most, 1 year after treatment(s).

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1.4 Combination toxicityOther beneficial (predatory and parasitic) arthropods could be directly exposed to combined residues on treated plants during treatment. Risks are determined following direct exposure to combined residues immediately after application. In the absence of formulation toxicity data, combination toxicity is estimated assuming additive toxicity for organisms which are sensitive to at least two of the constituents in the mixture. The estimation method for combination toxicity is provided in Table X. If one active substance drives the overall toxicity (≥ 90%), then it is concluded that the toxicity is driven by the active constituent and additive toxicity is not considered further.

If formulation toxicity data are available, the observed toxicity of the mixture is compared to the predicted toxicity based on active substance data which can be done for any ratio of active substances by calculation of the Model Deviation Ratio (MDR). If the MDR is within the range of 0.2 to 5, the mixture toxicity is assumed to be additive. If the MRD is <0.2, the mixture toxicity is considered to be less than additive (antagonistic) and if the MDR is >5, the mixture toxicity is considered to be more than additive (synergistic).

1.5 Risk assessment tablesTable 15 - Regulatory acceptable rates for other non-target arthropods

Taxonomic group Indicator species Endpoint Assessment factor* RAR

Tier 1 toxicity testing

Predatory arthropods Typhlodromus pyri LR50 XX g ac/ha 0.5 XX g ac/ha

Parasitic arthropods Aphidius rhopalosiphi LR50 XX g ac/ha 0.5 XX g ac/ha

Tier 2 toxicity testing

Predatory arthropods Typhlodromus pyri LR50 or ER50 XX g ac/ha 1 XX g ac/ha

Coccinella septempunctata LR50 or ER50 XX g ac/ha 1 XX g ac/ha

Parasitic arthropods Aphidius rhopalosiphi LR50 or ER50 XX g ac/ha 1 XX g ac/ha

Aleochara bilineata LR50 or ER50 XX g ac/ha 1 XX g ac/haRAR = regulatory acceptable rate = endpoint/assessment factor*Tier 1 assessment factor for predatory and parasitic arthropods as per trigger value specified in EPPO (2003) at the tier 1 level of assessment for the indicator species. Other species and higher tiers (extended laboratory, semi-field and field studies) have an assessment factor of 1.

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Table 16 - Assessment of risks to other non-target arthropods

Taxonomic group Indicator species Application rate(g ac/ha)

RAR(g ac/ha)

RQ

Tier 1 assessment

Predatory arthropods Typhlodromus pyri

Parasitic arthropods Aphidius rhopalosiphi

Tier 2 assessment

Predatory arthropods Typhlodromus pyri

Coccinella septempunctata

Parasitic arthropods Aphidius rhopalosiphi

Aleochara bilineata

Application rate is cumulative rate of 3× 150 g ac/ha, 7-day interval between applications and default foliar DT50 10 daysRAR = regulatory acceptable rate (from Table X)RQ = application rate / RAR, where acceptable RQ ≤1.0

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Table 17 - Combination toxicity to other non-target arthropods

Active 1 Active 2 Combination7 8 9

Fraction in combination 0.XX 0.XX 1.00

Toxicity to predatory arthropods

LR50 XX g ac/ha Test itemTest typeTest speciesReference

LR50 XX g ac/ha Test itemTest typeTest speciesReference

Measured:LR50 XX g acs/haTest itemTest duration + mediumTest speciesReference

Predicted:LR50 XX g acs/ha

Relative toxicity contributions:X% + X%

MDR X

7 Predicted values calculated assuming additive toxicity of active constituents in a the specified ratio (p1:p2) using most sensitive endpoints reported for that organism group where:

ECxCA=( 1

∑i−1

n PiECxi )

Where:ECxCA is the predicted additive toxic effect of the active constituent in combinationPi = is the fraction of individual active constituent in the productECxi is the effect concentration of the individual active constituent

8 %relative¿=

piEC xi

∑i=1

n p iEC x i

×100

9 MDR = model deviation ratio (unitless) = measured LR50 / predicted LR50

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Active 1 Active 2 Combination

Fraction in combination 0.XX 0.XX 1.00

Toxicity to parasitic arthropods

LR50 XX g ac/ha Test itemTest typeTest speciesReference

LR50 XX g ac/ha Test itemTest typeTest speciesReference

Measured:LR50 XX g acs/haTest itemTest duration + mediumTest speciesReference

Predicted:LR50 XX g acs/ha

Relative toxicity contributions:X% + X%

MDR X

1.6 Risk mitigationRisk management should be done separately for the in-field and off-field situations. ‘In-field’ is the land intended for agricultural production activities (including horticulture and forestry). The field includes a cropped area and field margins. A cropped area is that part of the field intended to grow the crop. It extends half a row distance beyond the centre of the last crop row. A field margin is the outer part of the field, between the cropped area and the off-field area. The field margin includes the parts of land used for agricultural purposes such as roads and fences, wind breaks, and vegetation planted for reduction of drift (catch crop) and run-off. ‘Off-field’ is all area surrounding the field. The off-field area includes natural and semi-natural habitats, in particular hedgerows and woodland. The edge of the field is the boundary line between the field margin and the off-field area.

In-field risks

If acceptable risk cannot be determined within the treatment area and compatibility with IPM is desired, then restraints on the application rate, application frequency or intervals, or timing of application (early and late crop stages, presence of concerned populations of non-target arthropods) can be considered. Otherwise, the product is not considered to be compatible with IPM.

Off-field risks

Currently the APVMA does not required mandatory no-spray zones for the protection of non-target arthropods, and therefore does not conduct a spray drift assessment. In the interim, advisory text is required to minimise spray drift to non-crop areas when in-field risks are identified.

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1.7 ReferencesCandolfi MP, Bakker F, Cañez V, Miles M, Neumann C, Pilling E, Primiani M, Romijn K, Schmuck R, Storck-Weyhermüller S, Ufer A, Waltersdorfer A (1999) Sensitivity of non-target arthropods to plant protection products: Could Typhlodromus pyri and Aphidius spp. be used as indicator species? Chemosphere 39: 1357–1370

Candolfi MP, Blümel S, Forster R, Bakker F, Grimm C, Hassan SA, Heimbach U, Mead-Briggs MA, Reber B, Schumuck R, Vogt H, 2000, Guidelines to evaluate side-effects of plant protection products on non-target arthropods, IOBC/BART/EPPO Joint Initiative, IOBC/OILB WPRS/SROP, Ghent, BE.

Candolfi MP, Barrett KL, Campbell P, Forster R, Grandy N, Huet M-C, Lewis G, Oomen PA, Schmuck R, Vogt H, 2001, Guidance document on regulatory testing and risk assessment procedures for plant protection products with non-target arthropods. In SETAC/ESCORT2 Workshop Report, 21–23 March 2000, Wageningen, NL.

EPPO (European and Mediterranean Plant Protection Organization), 2003, Environmental risk assessment scheme for plant protection products: Chapter 9: Non-target terrestrial arthropods, PP3/9(2)

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APPENDIX C – SOIL ORGANISMS

1 APPENDIX C – SOIL ORGANISMS1.1 IntroductionThe assessment of the effects and risks of chemicals for the terrestrial environment is a complex matter. This complexity comes, among others, from factors such as the need for sharing of the available landscape among urban/industrial activities, agricultural production in the form of agro-systems, and supporting terrestrial ecosystems. In addition, terrestrial systems are not associated with a single compartment, but with the interface between soil and the atmosphere.

General adverse effects on the soil organisms include effects on soil functions and on organisms (invertebrates, micro-organisms) important for proper soil function and nutrient cycle conservation. There is a common understanding that the ecological risk assessment aims not at individuals but at the protection of populations. In general the continuance of populations of non-target organisms should be ensured. Structural and functional endpoints should be regarded of equal importance.

Soil organisms are species that dwell primarily in the soil and soil litter. Soil organisms are exposed to active constituents from contact and oral uptake routes of exposure in the surrounding soil compartment. A ‘healthy’ soil supports a range of ecosystem functions or services (such as nutrient cycling) that are essential for supporting the growth of crops as well as the organisms that depend on those crops. Soil communities of invertebrates and microorganisms are the most diverse part inhabiting agricultural landscapes.

The general protection goal is to protect biodiversity and ecosystems. EFSA (2017) has proposed specific protection goals for soil organisms being key drivers for relevant ecosystem services in agricultural landscapes such as nutrient cycling, soil structure, pest control and biodiversity. Considering the time-scales and biological processes related to the dispersal of the majority of soil organisms, risk assessment are made at in- and off-field scale considering field boundary levels.

For outdoor situations, the following applications are considered to have negligible soil exposure:

when precautions are taken to prevent contact with the soil (eg, when pots/containers are placed on plastic sheets)

when crop is not cultured in soil, but on other substrates

wound healing with pastes

use under glass

use on timber or felled trees

use of baitboxes against rodents with their subsequent removal.

Soil sterilants and similar products are, in most cases, designed to have broad-spectrum activity against the soil microflora, and so will evidently show strong activity when tested according to the subscheme. The environmental risk posed by such products should be judged on other criteria, particularly on the basis of persistence, mobility, and effects on other non-target organisms.

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1.2 Toxicity figuresIn general, toxicity testing should be conducted using the technical grade active constituent. However, certain study types may be conducted with a formulated product instead of the active substance. This may be applicable to, for example, the earthworm reproduction test and the soil micro-flora test.

If testing with formulated product, it should be representative of the formulation proposed for registration. Refer to EC (2002) for guidance on when testing of soil metabolites are required.

Acute: Eisenia fetida: LC50 (OECD guideline 207)

Chronic: Eisenia fetida: NOEC (OECD guideline 222)10

Folsomia candida: NOEC (OECD guideline 232)11

Hypoaspis aculeifer: NOEC (OECD guideline 226)2

Soil nitrification: NOEC (OECD 216)Carbon mineralisation: NOEC (OECD 217)Litter bag test: NOEC (2004 draft OECD guideline)12

The availability of lipophilic products in soil and therefore their toxicity to soil macro-organisms depends on the organic matter content of the soil (EPPO 2003). For chemicals with log Kow >2, sorption is expected to be linearly related to soil organic matter content. A factor of 2 (division of all toxicity end-points) is used to correct the toxicity data from macro-organism studies conducted in artificial soil with 10% peat content. Typical agricultural soil has not more than 5% organic matter. Soils with extreme characteristics, such as very sandy or peaty soils, are not taken into account as they are not normally used for agricultural purposes. The use of this correction factor depends upon the compound (EPPO 2003). For some compounds, it can be shown that this factor does not apply since sorption and exposure is not dependent on soil organic matter. However, this has to be adequately demonstrated.

1.3 Risk assessmentDirect exposure of soil means exposure at the time of the application, either because soil itself is treated or as a result of crop treatment with incomplete interception of the product by the crop. Exposure is also possible when a treated substrate for growing crops or manure from treated animals is disposed on land. A third route of exposure involves plant material, treated with pesticide prior to planting (eg stored potatoes or dipped bulbs).

10 Not required when DT90f <100d and <3 applications11 Required when DT90f >100 days and risks to other non-target arthropods (Typhlodromus pyri and Aphidius

rhopalosiphi) are not acceptable at the screening level12 Refer to EC (2002) for when this test is required

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1.3.1 Screening level assessment

The acute and chronic risks to soil organisms are assessed using a tiered approach which is in line with current EC (2002), EPHC (2009), and EPPO (2003) guidance. A screening level risk assessment assumes the worst-case scenario of a direct overspray of soil without interception in order to identify those substances and associated uses that do not pose a risk to soil organisms.

The Australian assessment first calculates a regulatory acceptable concentration (RAC) for acute and chronic exposure scenarios for the most sensitive species in each taxonomic group as indicated in Table 18.

Estimation of initial soil concentrations Ci is based on the assumption of instantaneous, homogeneous distribution of the product in a layer of soil with a certain depth (default 5 cm) and of a certain bulk density (default 1500 kg/m3). The following formula is used calculate PECsoil at the maximum single application rate, which is compared with acute effects:

Ci = [A · (1−fI) · 106]/ l · 104 · d

in which:Ci = initial concentration in soil (mg kg−1 soil)A = application rate (kg ha−1)fI = fraction intercepted by the crop (dimensionless)l = thickness of soil layer (m) (default 0.05 m)d = bulk density of soil (kg m−3) (default 1500 kg m−3).

The concentration Ct represents the concentration in the plough layer at time t after each application. It can be estimated from the transformation rates in laboratory soils or from field dissipation studies.

Ct = Ci · exp−(ln 2 /DT50) · t

in which:Ct = concentration in soil at time t (mg kg−1 soil)Ci = initial concentration in soil (mg kg−1 soil).

In situations where multiple applications are made (constant application rate, constant interval between applications, linear first-order transformation), the system eventually reaches a steady state where concentrations fluctuate between a maximum level, when an application has just been made (the upper plateau concentration), and a minimum level just before the next application is made (the lower plateau concentration). This lower plateau concentration can be calculated by the following equation (Hill et al. 1955), which is compared with chronic effects.

Rlow = [A · X · (1-Xn)] / [1 – X]

in which:Rlow = the lower plateau concentration, ie the residue at the end of the nth applicationX = the proportion of the applied dose remaining after the first application (Ct)A = the amount applied at each application

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n = the number of applications.

For persistence substances13, the upper plateau concentration is compared with chronic effects:

Rhigh = [A · (1-Xn)] / [1 – X]

Risk quotients compare the appropriate PECsoil values with the corresponding RAC (Table 19): PECsoil based on Ci is compared to acute RAC PECsoil based on Rlow is compared to chronic RAC PECsoil based on Rhigh is compared to chronic RAC for persistent substances

Litter bag studies

If the difference in litter mass loss is ≤10% at 12 months, the risk is considered to be low. If the difference is > 10% at 1 year, or it is clear that decomposition rates are still diverging, a refined or higher-tier risk assessment should be performed. This may involve extending the existing study (eg by burying new bags) or conducting a new study under more realistic conditions. Alternatively the risk can be considered high and regulatory action taken, or risk reduction options may be considered. Risk/benefit analysis should be done in any case if the difference is > 25% after 12 months, as the risk is considered to be unacceptable under these conditions.

1.3.2 Refined assessment

If it is necessary to refine the assessment for any particular taxonomic group or process, crop interception should be considered as a first step. Ideally, the crop and its growth stage at the time of application should be specified. If such data is not available, data for similar crops may be adequate. Crop interception factors presented for surface water in EFSA (2014) are preferred.

If further assessment is necessary, higher tier studies can be considered. Higher-tier tests may take the form of limited community/population studies (eg terrestrial model ecosystems, soil mesocosms) or field studies (including, if appropriate, litter-bag studies). Other groups (eg earthworms, microbial functions) may also be tested in the same study. It is important that the timing, levels and routes of exposure reflect, as far as possible, those of the proposed use of the product. Key effect end-points include: changes in community and population structure; species diversity; number and biomass of key species/groups, if appropriate, organic matter breakdown. An ‘effect’ can be defined as a statistically significant deviation from the control for any key parameters at any time. This relies on the validity of the study and the level of significance which can be achieved. A reference product helps to determine validity. An effect at a single time may point to a short-term impact, but the potential for recovery should also be considered. ‘Recovery’ is indicated if significant effects compared with the control are no longer observed within one season or 1 year (whichever is most ecologically relevant). Expert judgement should be used to evaluate higher-tier studies and to determine ecological relevance.

13 Persistence substances are considered to be those with DT 50f >90 days and DT90f >365 days.62

APPENDIX C – SOIL ORGANISMS

1.4 Combination toxicitySoil organisms could be directly exposed to combined residues in over-sprayed soil within the treatment area. Risks are determined following direct exposure to combined residues immediately after application. In the absence of formulation toxicity data, combination toxicity is estimated assuming additive toxicity for organisms which are sensitive to at least two of the constituents in the mixture. The estimation method for combination toxicity is provided in Table X. If one active substance drives the overall toxicity (≥ 90%), then it is concluded that the toxicity is driven by the active constituent and additive toxicity is not considered further.

If formulation toxicity data are available, the observed toxicity of the mixture is compared to the predicted toxicity based on active substance data which can be done for any ratio of active substances by calculation of the Model Deviation Ratio (MDR). If the MDR is within the range of 0.2 to 5, the mixture toxicity is assumed to be additive. If the MRD is <0.2, the mixture toxicity is considered to be less than additive (antagonistic) and if the MDR is >5, the mixture toxicity is considered to be more than additive (synergistic).

1.5 Risk assessment tablesTable 18 - Regulatory acceptable concentrations for soil organisms

Taxonomic group Exposure Endpoint Assessmentfactor

RAC

Macro-organisms Acute LC50 XX mg ac/kg dry soil 10 XX mg ac/kg dry soil

Chronic NOEC XX mg ac/kg dry soil 1 XX mg ac/kg dry soil

Micro-organisms Chronic NOEC XX mg ac/kg dry soil 1 XX mg ac/kg dry soilRAC = regulatory acceptable concentration = endpoint / assessment factor

Table 19 - Screening level assessment of risks to soil organisms

Test organism Exposure Application rate(g ac/ha)

PEC(mg ac/kg dry soil)

RAC(mg ac/kg dry soil)

RQ

Macro-organisms Acute

Chronic

Micro-organisms ChronicRate is cumulative rate of 3× 150 g ac/ha, 7-day interval between applications and DT50 XX daysPEC = predicted environmental concentration in top 5-cm soil (mg ac/kg dry soil) = rate (g ac/ha)/750RAC = regulatory acceptable concentration (from Table X)RQ = risk quotient = PEC / RAC, where acceptable RQ <1

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Table 20 - Combination toxicity to soil organisms

Active 1 Active 2 Combination14 15 16

Fraction in combination 0.XX 0.XX 1.00

Acute toxicity to soil macro-organisms

LC50 XX mg ac/kg dry soil Test itemTest duration + mediumTest speciesReference

LC50 XX mg ac/kg dry soil Test itemTest duration + mediumTest speciesReference

Measured:LC50 XX mg acs/kg dry soil Test itemTest duration + mediumTest speciesReference

Predicted:LC50 o XX mg acs/kg dry soil

Relative toxicity contributions:X% + X%

MDR X

14 Predicted values calculated assuming additive toxicity of active constituents in a the specified ratio (p1:p2) using most sensitive endpoints reported for that organism group where:

ECxCA=( 1

∑i−1

n PiECxi )

Where:ECxCA is the predicted additive toxic effect of the active constituent in combinationPi = is the fraction of individual active constituent in the productECxi is the effect concentration of the individual active constituent

15 %relative¿=

piEC xi

∑i=1

n p iEC x i

×100

16 MDR = model deviation ratio (unitless) = measured LD50 / predicted LD50

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APPENDIX C – SOIL ORGANISMS

Active 1 Active 2 Combination

Fraction in combination 0.XX 0.XX 1.00

Toxicity to soil micro-organisms

NOEC XX mg ac/kg dry soil (indicate % effect at LOEC or <25% effect at limit dose)Test itemSoil processReference

NOEC XX mg ac/kg dry soil(indicate % effect at LOEC or <25% effect at limit dose) Test itemSoil processReference

Measured:NOEC XX mg acs/kg dry soil (indicate % effect at LOEC or <25% effect at limit dose)Test itemSoil processReference

Predicted:NOEC XX mg acs/kg dry soil

Relative toxicity contributions:X% + X%

MDR X

1.6 Risk mitigationRisk mitigation options for soil organisms are limited. There are possibilities to reduce the exposure (reduction of application rate and/or number of applications and/or restriction on glasshouse use only), but these measures must be compatible with the agricultural objectives. The same is true for restrictions concerning the amount of treated area (e.g. band row instead of broadcast application, untreated field margins). If the risk to organic matter decomposition is determined to be sufficiently high and it cannot be adequately managed, then a cost/benefit analysis of the proposed use and/or risk labelling of the product may be considered.

1.7 ReferencesEC (European Commission), 2002, Guidance document on terrestrial ecotoxicology under Council Directive 91/414/EEC, SANCO/10329/2002 rev 2 final. Available online: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_ecotox_terrestrial.pdf

EFSA (European Food Safety Authority), 2014, EFSA guidance document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil, EFSA Journal 12(5):3662, 37 pp. doi:10.2903/j.efsa.2014.3662, Available online: https://www.efsa.europa.eu/en/efsajournal

EFSA (European Food Safety Authority), 2017, Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in-soil organisms, EFSA Journal 15(2):4690, 225 pp. doi:10.2903/j.efsa.2017.4690, Available online: https://www.efsa.europa.eu/en/efsajournal/pub/4690

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EPHC (Environment Protection and Heritage Council), 2009, Environmental risk assessment guidance manual for agricultural and veterinary chemicals, ISBN 978-1-9221173-38-7, available online: http://www.nepc.gov.au/resource/chemical-risk-assessment-guidance-manuals

EPPO (European and Mediterranean Plant Protection Protection Organization), 2003, Environmental risk assessment scheme for plant protection products, Chapter 8: Soil organisms and functions, EPPO Bulletin 33: 147-149.

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APPENDIX D – NON-TARGET TERRESTRIAL PLANTS

1 APPENDIX D – NON-TARGET TERRESTRIAL PLANTS1.1 IntroductionNon-target plants are defined as non-crop plants outside the treatment area. Non-target plants are primary producers supporting organisms at higher trophic levels. These supporting services include primary production, habitat provision and food for other trophic levels. Since it is known that phytotoxic effects may occur for products other than herbicides, some level of testing of all active constituents is necessary, unless it can be shown that exposure will not occur.

The general protection goal is to protect biodiversity and ecosystems. The protection goal for higher terrestrial plants aims to protect both plant species abundance (e.g. numbers and/or cover of individuals for single species) and plant diversity in an agricultural area (EFSA 2014). It is assumed that the biodiversity is maintained when the plant populations will not be affected by the use of pesticide product.

1.2 Toxicity figuresTier 1 testing

Single-dose phytotoxicity screening data for terrestrial non-target plants at or above the maximum application rate on a wide range of species (e.g. at least six but preferably more), is recommended as a first tier to determine whether the active constituent has phytotoxic properties. These data could be supplemented by further information on efficacy, selectivity, phytotoxicity, etc. included in the biological dossier or obtained from the different field assays such as efficacy trials, residue studies, environmental fate and ecotoxicological studies, etc. The initial step is usually skipped for herbicides and plant growth regulators as these inevitably will end up in the second tier.

Tier 2 testing

If >50% effect is observed in Tier 1 testing for one or more species, dose–response relationships for at least six species representing families for which significant herbicidal action has been found are recommended to quantify the level of effect using both soil and foliar exposure scenarios under tier 2. The second tier considers laboratory assays on a selection of plant species. It is recommended to conduct dose-response tests on 6-10 plant species representing as many taxonomic groups as possible. In order to generate data that are useful for probabilistic approaches there should not be a focus exclusively on species assumed to be the most sensitive. If, from the screening data, a specific mode of action is evident, or strong differences in the species sensitivities are identified, this evidence should be used in the selection of the appropriate test species. This may be especially true if non-herbicides reach tier-2 testing. ER25, ER50 and, if possible, HR5 values (on the ER50 data) should be generated.

For foliar applications, the bioassays should be conducted by spraying the product on the plants, reproduce as far as possible the realistic exposure conditions and, in particular, spray drift. Soil application should be chosen if that is more appropriate with regard to the mode of action. The test substance should be the lead formulation (or another formulation) because formulations contain, besides the active substance, all those components and co-adjuvants required for maximising biological activity. For systemic products applied on the ground/soil, the tests should reproduce this application pattern.

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APPENDIX D – NON-TARGET TERRESTRIAL PLANTS

Tier 3 testing

The third tier requires semi-field or field assays, to study the effects observed on non-target plants during realistic applications. Such studies are time-consuming and expensive; before undertaking them it should be checked whether there are options for the refinement of exposure and/or effects. Furthermore, as for all other non-target organisms, field or semi-field studies are not required if the risk based on the tier 2 assessment could be managed by risk mitigation measures (ie, mandatory no-spray zones).

Field or semi-field studies with non-target plants are not standardised. Therefore applicants might wish to discuss the protocol with the APVMA under a Pre-application Assistance (PAA) application. Generally, effects on plant abundance and biomass production at different distances from the crop or at exposure levels representing different distances from the crop should be analysed. These studies are compatible with most semi-field and field studies.

1.3 Risk assessmentNon-target terrestrial adjacent to the treatment area could be directly exposed to spray drift during treatment. Risks to non-target terrestrial plants are assessed using a tiered approach which is in line with current EPHC (2009) guidance. Although non-target plants are defined as non-crop plants located outside the treatment area, screening level risk assessment assumes the worst-case scenario of a direct exposure to the treatment in order to identify those substances and associated uses that do not pose a risk to non-target terrestrial plants (Table X). Both pre-emergent and post-emergent exposure scenarios are considered.

Only the maximum single application rate is considered for post-emergent exposure; however, for pre-emergent exposure, accumulated residues in soil are considered in the case of multiple applications:

Cumulative rate = Single rate · (1-EXP(-N*ln2/DT50*interval))/(1-EXP(-ln2/DT50*interval))

in which:Cumulative rate = accumulated application rate immediately after the last application (g ac/ha)Single rate = single application rate (g ac/ha)N = number of applicationsDT50 = soil half-life Interval = time between application (d)

If the RQ exceeds 1.0 for either exposure scenario, a spray drift assessment is conducted to establish mandatory no-spray zones. Please refer to the following website for details on APVMA standard scenarios for spray drift: https://apvma.gov.au/node/10796

1.4 Combination toxicityNon-target terrestrial plants could be directly exposed to combined residues immediately after application as a result of spray drift. Risks are determined following direct exposure to combined residues immediately after application. In the absence of formulation toxicity data, combination toxicity is estimated assuming additive toxicity for organisms which are sensitive to at least two of the constituents in the mixture. The

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APPENDIX D – NON-TARGET TERRESTRIAL PLANTS

estimation method for combination toxicity is provided in Table X. If one active substance drives the overall toxicity (≥ 90%), then it is concluded that the toxicity is driven by the active constituent and additive toxicity is not considered further.

If formulation toxicity data are available, the observed toxicity of the mixture is compared to the predicted toxicity based on active substance data which can be done for any ratio of active substances by calculation of the Model Deviation Ratio (MDR). If the MDR is within the range of 0.2 to 5, the mixture toxicity is assumed to be additive. If the MRD is <0.2, the mixture toxicity is considered to be less than additive (antagonistic) and if the MDR is >5, the mixture toxicity is considered to be more than additive (synergistic).

1.5 Risk assessment tablesTable 21 - Regulatory acceptable rates for non-target terrestrial plants

Exposure Test Endpoint Assessment factor* RAR

Pre-emergent Seedling emergence ER50 XX g ac/haER25 XX g ac/haHR5 XX g ac/ha

1021

XX g ac/ha

Post-emergent Vegetative vigour ER50 XX g ac/haER25 XX g ac/haHR5 XX g ac/ha

1021

XX g ac/ha

Assessment factor as per EPHC (2009)RAR = regulatory acceptable rate = endpoint/assessment factor

Table 22 - Screening level risk assessment for risks to non-target terrestrial plants

Exposure Test Application rate (g ac/ha) RAR (g ac/ha) RQ

Pre-emergent Seedling emergence

Post-emergent

Vegetative vigour

Assessment factor as per EPHC (2009)RAR = regulatory acceptable rate (from Table X)RQ = risk quotient = rate / RAR, where acceptable RQ <1

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APPENDIX D – NON-TARGET TERRESTRIAL PLANTS

Table 23 - Combination toxicity to non-target terrestrial plants

Active 1 Active 2 Combination17 18 19

Fraction in combination 0.XX 0.XX 1.00

Effects on seedling emergence

ER50 XX g ac/ha Test itemTier of testingTest species (or #species tested if >value)Reference

ER50 XX g ac/ha Test itemTier of testingTest species (or #species tested if >value)Reference

Measured:ER50 XX g ac/ha Test itemTier of testingTest species (or #species tested if >value)Reference

Predicted:ER50 XX mg ac/kg bw

Relative toxicity contributions:X% + X%

MDR X

17 Predicted values calculated assuming additive toxicity of active constituents in a the specified ratio (p1:p2) using most sensitive endpoints reported for that organism group where:

ECxCA=( 1

∑i−1

n PiECxi )

Where:ECxCA is the predicted additive toxic effect of the active constituent in combinationPi = is the fraction of individual active constituent in the productECxi is the effect concentration of the individual active constituent

18 %relative¿=

piEC xi

∑i=1

n p iEC x i

×100

19 MDR = model deviation ratio (unitless) = measured LD50 / predicted LD50

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APPENDIX D – NON-TARGET TERRESTRIAL PLANTS

Active 1 Active 2 Combination

Fraction in combination 0.XX 0.XX 1.00

Effects on vegetative vigour ER50 XX g ac/ha Test itemTier of testingTest species (or #species tested if >value)Reference

ER50 XX g ac/ha Test itemTier of testingTest species (or #species tested if >value)Reference

Measured:ER50 XX g ac/ha Test itemTier of testingTest species (or #species tested if >value)Reference

Predicted:ER50 XX mg ac/kg bw

Relative toxicity contributions:X% + X%

MDR X

1.6 ReferencesEFSA (European Food Safety Authority), 2014, Scientific opinion addressing the state of the science on risk assessment of plant protection products on non-target plants, EFSA Journal 12(7): 3800, 153pp, doi:10.2903/j.efsa2014.3800, available online: www.efsa.europa.eu/efsajournal

EPHC (Environment Protection and Heritage Council), 2009, Environmental risk assessment guidance manual for agricultural and veterinary chemicals, ISBN 978-1-9221173-38-7, available online: http://www.nepc.gov.au/resource/chemical-risk-assessment-guidance-manuals

EPPO (European and Mediterranean Plant Protection Organization), 2003, Environmental risk assessment scheme for plant protection products: Chapter 12: Non-target terrestrial higher plants, PP3/13(1), EPPO Bulletin 33: 239-244.

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