An overview of honeybee risk assessment for pesticides

Helen M Thompson, The Food and Environment Research Agency, Sand Hutton, York, YO41 1LZ, UK

 Honeybees have been subject of regulatory data requirements at national level within the EU for more than 50 years Initial assessment only on toxicity data (hazard) - shown not to be good indicator of effects in the field Led to development of Hazard Quotient (HQ= (g ai/ha)/LD50) for sprayed pesticides, i.e. A measure of risk Move from laboratory to increasing levels of realism based on HQ (sequential testing)

ICPBR
International Commission for Plant-Bee Relationships
Bee Protection Group European expert forum addressing risks of pesticides to bees Representing academia, regulators and industry Provides technical input to EPPO 170 and associated risk assessment schemes (EPPO, EU) 10th meeting in Bucharest 80 delegates from 15 countries

Wildlife Incident Investigation Scheme

60 50 40

Number of incidents

30

20

10

0 1994 1996 1998 2000 2002 2004 2006 2008

Year
Incidents investigated Pesticide incidents

WIIS Review Bee poisonings

Compound Incidents 1994-98 16 7 6 5 20 Incidents 1999-03 3 1 0 1 18 Incidents 2004-08 1 0 0 0 9

dimethoate pirimiphos-methyl chlorpyrifos fenitrothion bendiocarb

Compound groups in bee pesticide poisoning incidents, 1994-2008

carbamates 37%

organophosphates 37%

organochlorines other 6% 5%

pyrethroids 15%

n=136

Risk Assessment based on HQ Hazard Quotient

Application rate (g ai/ha)/LD50 (ug/bee) no authorization shall be granted if the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product according to the proposed conditions of use

 If the hazard quotient is <50, there are no indications of major sublethal effects and the active substance in the product is not an insect growth regulator no need for further consideration. If any of the 3 criteria are not met then a) it is a condition of approval that the product is not used on the flowering crop.
or

b) the risk must be assessed further which will require higher tier data

Higher Tier Studies

Cage/Tunnel studies Outdoor studies. Small hives of bees can forage freely within the cage (approx 10m x 5m). Easy for mortality and behaviour to be assessed and observations made of hive health in the short term Outdoor studies. Hives of bees can Field studies. forage naturally. Losses of bees, structure and development of the population and hive health in the long term can be observed. Behaviour can also be observed, residues of pesticides assessed in bees, food and plants. These studies encompass individual factors e.g. behaviour, development. Subject of EPPO guidelines

 The difference between hazard (toxicity)and risk is key. Use targetted studies to recognized protocols and GLP. Sublethal effects seen under artificial conditions (lab) may not be relevant to real life. Higher tier studies encompass sublethal as well as acute effects and realistic exposure. Data are evaluated by the regulatory authority. In the UK independent expert advice from the Advisory Committee on Pesticides and the Environmental Panel.

ICPBR Bees and Pesticides Group:

Non-sprayed products such as seed dressings not covered by the current schemes proposals to EPPO Also submitting to EFSA for consideration in revision of the Terrestrial Ecotoxicology Guidance Document

PROPOSED RISK ASSESSMENT SCHEME HONEYBEES AND USE OF PLANT PROTECTION PRODUCTS THROUGH SEED COATING AND SOIL APPLICATIONS

 PPPs through seed coatings and soil applications (bare soil) are intended to concentrate the product in/on plant parts to be protected or where pests most abundant Exposure of most non-targets reduced compared to spray applications but if product has systemic properties then growing plants may contain residues Exposure of bees may arise if significant amounts of residues reach nectar and/or pollen

 No EU/EPPO technical guidance available on how to assess risks to bees posed by substances with systemic properties (each country developed own system) Proposals based on analysis of conditions for exposure of bees to residues A stepwise approach Start with simple calculations based on existing data in dossiers Higher tier field studies Scheme tested with data packages of high and low risk PPPs

PROPOSED RISK ASSESSMENT

 Plant attractive to bees (plants in rotation for persistent compounds) Potential for systemic transfer to pollen/nectar For larvae based on mode of action and any observed effect on growth/development or other data in the dossier

Residues in plants, nectar and pollen

Very little published data for systemic pesticides in pollen and nectar Residues are generated for parts of plants intended for consumption Dossier data were compiled (leaves, fruit, green part, inflorescence, whole plant, grain) from as close to flowering as possible

Residue data collated by AFSSA, France

2.5 Levels of residues (mg a.s./kg)

95th percentile

1.5

0.5

0 0 10 20 30 40 50 60 70 Cumulated values of residues levels

 Majority of samples less than 1 mg ai/kg active substance (95th percentile 0.55 mg ai/kg n=62) Similar data for metabolites Data for pollen and nectar less than 0.1 mg ai/kg each Translocation of pesticides to fruiting structures measurably less effective than to other plant parts

Are specific effects to larvae expected? No Tier 1 Risk assessment to adults Oral adult toxicity test LD50 Residues in aerial plant parts (90th percentile) or 1 mg/kg Yes Tier 1 Risk assessment to brood Brood test NOEL Residues in aerial plant parts (90th percentile) or 1 mg/kg

TER = LD50/exposure TER > 10 TER < 10 Tier 2 Risk assessment to adults 10-day toxicity test with adult NOEL Residues in pollen and nectar

TER = NOEL/exposure TER < 1 Tier 2 Risk assessment to larvae based on residues in pollen and nectar

TER > 1

TER = NOEL/exposure TER < 1

TER < 1

Higher tier risk assessment to the colony Tunnel test Significant effects Field test Significant effects Acceptable risk Envisage risk mitigation measures or conclude on non-acceptable risk Acceptable risk Non significant effects

TER > 1

Tier 1 Risk assessment to adults Oral adult toxicity test LD50 Residues in aerial plant parts (90th percentile) or 1 mg/kg

TER = LD50/exposure TER > 10 TER < 10 Tier 2 Risk assessment to adults 10-day toxicity test with adult NOEL Residues in plants or in pollen and nectar (50th percentile)

TER = NOEL/exposure TER < 1

Higher tier risk assessment to the colony Tunnel test Significant effects Field test Significant effects Acceptable risk Envisage risk mitigation measures or conclude on non-acceptable risk Non significant effects Acceptable risk

TER > 1

Tier 1 Risk assessment to brood Brood test NOEL Residues in aerial plant parts (90th percentile) or 1 mg/kg

TER = NOEL/exposure TER < 1 Tier 2 Risk assessment to larvae based on residues in pollen and nectar

TER > 1

TER < 1

Higher tier risk assessment to the colony Tunnel test Significant effects Field test Significant effects Envisage risk mitigation measures or conclude on non-acceptable risk Acceptable risk Non significant effects

 The ability of the risk assessment scheme to discriminate between products that may need a refined assessment from those of low concern was assessed Tier 1 and 2 calculations performed for adults for all Annex 1 listed Worst case estimate of exposure of 1mg ai/kg matrix used (converted to ingestion rate for foraging bee 128 mg nectar/bee/day)

Percentage of active substances that do Mode not pass at the first Tiers of the risk action assessment (TER < trigger value, n = 171) TER Tier 1 (trigger value: 10) 15.2 %

of

24 insecticides 1 fungicide 1 nematicide

Summary
Stepwise approach developed which discriminates between substance requiring further assessment and those of low concern This approach fits with other risk assessment schemes within EPPO and EU Based on evidence of exposure and uses existing data first to avoid routine requirement for field studies Update to current EPPO guidance document with special emphasis on seed/soil treatments Confirm/adjust triggers and study protocols for higher tiers to provide data on which to base further EPPO guidance

 Publication of papers presented at meeting including discussion of risks posed by dusts Proposals for EPPO guideline revisions
http://www.jki.bund.de

Dusts from treated seed

Recipe for disaster High rate of application of an insecticide which is highly toxic to bees Insufficient sticker Poor machinery/planting technique Windy conditions Adjacent crops in flower Foraging bees

The Solution
ICPBR working group. France and Germany are in the forefront. Control the amount of dust from the treated seed. Maximum of 4 g/Kg seed. Planting machinery in which outflow fans directed towards soil + defectors which redirect dust to soil. Use of both measures can reduce dust output by 99%

Conditions to be taken into account by Member States. the seed coating shall only be performed in professional seed treatment facilities. These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded; the use of adequate equipment ensuring a high degree of incorporation in soil and minimisation of spillage during application monitoring of exposure of bees to systemic neonicotinoid seed treatments under real use