Environmental risks - Bees

Table of contents
Introduction Australia Canada China EU USA Can the legislative criteria be applied in other countries?	Legislation Groundwater risks Surface water risks Risks for bees Risks for soil organisms Terminology reference

Table of contents

Introduction

The protection goal for bees* include protection of bee biodiversity (species richness and abundance), pollination services (population size and stability) and production of hive products (quantity and quality of hive products). Generally the risk assessment frameworks rely on data specific to honey bees and are used as a surrogate for other Apis and non-Apis bees. It is recognised that the science in this field continues to evolve.

* Apis bees such as honey bees and bumble bees and non-Apis bees including native bees and solitary bees

What this page contains

This table summarises the principles applied to the first tier screening level assessment of risks to honeybees. The screening level assessment identifies those pesticides that are not a risk to bees and where no further testing or analysis is required. Some guidance documents also describe risk assessments directed at bumblebees and solitary bees. As the methodology is not in common use, is not described here.

Links are provided to available guidance on risk assessment where a refined assessment is necessary.

Summary analysis

Risk assessment approaches in relation to bees and other pollinators are well described by the various regulators. Guidelines and policy documents are comprehensive and have been updated or developed relatively recently.Risk assessment approaches in relation to bees and other pollinators are well described by the various regulators. Guidelines and policy documents are comprehensive and have been updated or developed relatively recently.

Australia

Aspect	Description
Links to risk assessment guidelines, manuals and science policy documents	APVMA risk assessment manual Environment, April 2019 Appendix C, Bees, April 2019
Hazard assessment and end-point selection	The following endpoints are derived from the hazard assessment: Adults for acute contact exposure the relevant LD50 for acute oral exposure the relevant LD50 for chronic oral exposure the relevant NOEL Larvae for chronic oral exposure the relevant NOEL for acute contact exposure the relevant LD50
Setting of toxicological reference values and the use of assessment factors	The RAD is calculated for acute and chronic exposure scenarios using the following parameters: Adults for the acute contact exposure LD50 an assessment factor of 2.5 is applied for the acute oral exposure LD50 an assessment factor of 2.5 is applied for the chronic oral exposure NOEL an assessment factor of 1 is applied Larvae for the acute contact exposure LD50 an assessment factor of 2.5 is applied for the chronic oral exposure NOEL an assessment factor of 1 is applied
Exposure assessment	A screening level risk assessment assuming the worst case scenario of a direct overspray of blooming plants that are frequented by bees. For systemic products, exposure considerations and calculations are based on the active constituent present in the respective parts (eg nectar, pollen) to which honeybees could be exposed. Exposure expressed as the predict-ed total dose is calculated using US EPA BeeRex tool. If risks to bees are not acceptable in the screening level assessment and a refined assessment is necessary, the attractiveness of the crop plant to honeybees may be considered based on guidance developed by EFSA 2013 and US DA 2017. Further details are provided in the document: Roadmap for insect pollinator risk assessment in Australia, September 2017
Risk assessment and acceptability criteria	RQs are calculated by comparing the predicted total dose to the RAD. Risk are considered to be acceptable where the RQ<1. The magnitude of effects on colonies should not exceed 7% reduction in colony size. Foragers’ mortality should not be increased com-pared with controls by a factor of 1.5 for six days or a factor of 2 for three days or a factor for 3 for two days.

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Canada

Aspect	Description
Links to risk assessment guidelines, manuals and science policy documents	Guidance for Assessing Pesticide Risks to Bees, July 2014 Pollinator Protection information can be found at: Pollinator Protection information
Hazard assessment and end-point selection	Canada’s risk assessment frame-work for bees was developed in cooperation with the US EPA and the California Department of Pesticide Regulation. The following endpoints are derived from the hazard assessment: Adults: for acute contact toxicity the relevant LD50 for acute oral toxicity the relevant LD50 for chronic oral toxicity the NOAEL (effects to survival or longevity) Larvae for chronic oral NOAEL (effects to adult emergence, survival)
Setting of toxicological reference values and the use of assessment factors	n.a.
Exposure assessment	EECs for contact and oral routes of exposure in adults and larvae are calculated using the exposure values outlined in the Guidance for Assessing Pesticide Risk to Bees (July 2014), and are the same as those used by the US EPA in their Bee-REX model. The values described in the Bee-Rex model is a screening level tool that is intended for use in a screening level risk assessment to assess exposure of bees to pesticides and to calculate risk quotients. If risks to bees are not acceptable in the screening level assessment additional refinements in exposure and/or effects estimates and/or mitigation measures may be required.
Risk assessment and acceptability criteria	RQs are calculated using the EECs derived from the BeeREX model and the endpoint derived from laboratory studies. For the screening level assessment the LOC are defined as: for acute exposure the LOC is 0.4 for chronic exposure the LOC is 1 If RQ values are below their respective LOCs, it is presumed that risks to bees are minimal.

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China

Aspect	Description
Links to risk assessment guidelines, manuals and science policy documents	Guidance on environmental risk assessment for pesticide registration- Part 4: Honeybee NY/T 2882.4-2016 (in Chinese)
Hazard assessment and end-point selection	n.a.
Setting of toxicological reference values and the use of assessment factors	For sprayed pesticides, the PNEC is not calculated in the 1st tier risk assessment. For systemic soil applied or seed treatment pesticides, the PNEC is calculated using endpoints from ecotoxicological studies and uncertainty factors (10).
Exposure assessment	For sprayed pesticides, the PEC is not calculated in the 1st tier risk assessment. For systemic soil applied or seed treatment pesticides, the PEC of honey bees to a pesticide in pollen or nectar is a function of the estimated or measured residue level in pollen/nectar and the amount of pollen and/or nectar consumed.
Risk assessment and acceptability criteria	Acceptability criterion is based on the calculation of a risk quotient For sprayed pesticides, RQ=application rate/(LD50*50). Where the RQ>1, a honeybee semi-field study is required. For systemic soil applied or seed treatment pesticides, RQ=PEC/PNEC. If RQ>1 risk is not acceptable.

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EU

Aspect	Description
Links to risk assessment guidelines, manuals and science policy documents	EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus app. and solitary bees), July 2013 (this guideline is currently under revision)
Hazard assessment and end-point selection	The following endpoints are derived from the hazard assessment: Adults for acute contact toxicity the relevant LD50 for acute oral toxicity the relevant LD50 for chronic oral toxicity the 10-day LC50 for sublethal effects on hypopharygeal glands the NOEL Larvae NOEL for larvae (toxicity expressed as microgram/larvae per development period)
Setting of toxicological reference values and the use of assessment factors	n.a.
Exposure assessment	The screening level risk assessment for acute contact exposure for adult bees uses the application rate as the exposure value. Shortcut values are used in the risk assessed for the oral route of exposure (acute and chronic as well has chronic and sublethal exposure of larvae). The shortcut values are derived from feed (nectar and pollen) consumption and worst case residue levels. Different sets of shortcut values are used for downwards and for upwards/sideways sprays application. If a trigger value is reached, a first tier risk assessment is conducted. Higher tier risk assessment will consider risk mitigation measures, refined exposure assessments and/or higher tier effects studies. EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus app. and solitary bees), July 2013
Risk assessment and acceptability criteria	For acute contact exposure for adult bees a hazard quotient (HQ) = application rate/endpoint) is calculated. For acute and oral chronic exposure for adult bees and chronic and sublethal exposure for larvae an ETR is calculated. The following trigger values are used for a screening risk assessment: acute oral exposure adult bees: ETR>0.2 acute contact toxicity adult bees: HQ (downwards spray>42; HQ (upwards and sideways spray)>85 chronic oral exposure adult bees: ETR>0.03 chronic oral exposure larvae: ETR> 0.2 sublethal development of hypo-pharyngeal glands: ETR>1 Risks to bees are considered acceptable (that is, the protection goal is met) if the calculated HQ and ETR is lower than the trigger value.

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USA

Aspect	Description
Links to risk assessment guidelines, manuals and science policy documents	Pollinator Risk Assessment Guidance (US EPA) Guidance for Assessing Pesticide Risks to Bees, July 2014
Hazard assessment and end-point selection	The US EPA risk assessment framework for bees was developed in cooperation with the California Department of Pesticide Regulation and Canada’s PMRA. The following endpoints are derived from the hazard assessment: Adults: for acute contact toxicity the relevant LD50 for acute oral toxicity the relevant LD50 for chronic oral toxicity the NOAEL (effects to survival or longevity) Larvae for chronic oral NOAEL (effects to adult emergence, survival)
Setting of toxicological reference values and the use of assessment factors	n.a.
Exposure assessment	The first step determines whether a reasonable potential exists for exposure of bees to the pesticide of concern. Information on the pesticide use characteristics, chemical properties and potential exposure routes are evaluated. EECs for contact and oral routes of exposure in adults and larvae are calculated using the Bee-REX model. The Bee-Rex model is a screening level took that is intended for use in a screening level risk assessment to assess exposure of bees to pesticides and to calculate risk quotients. If risks to bees are not acceptable in the screening level assessment additional refinements in exposure and/or effects estimates and/or mitigation measures may be required.
Risk assessment and acceptability criteria	RQs are calculated using the EECs derived from the BeeREX model and the endpoint derived from laboratory studies. For the screening level assessment the LOC are defined as: for acute exposure the LOC is 0.4 for chronic exposure the LOC is 1 If RQ values are below their respective LOCs, it is presumed that risks to bees are minimal.

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Can the legislative criteria be applied in other countries?

The principles and policies followed in the hazard assessment and end-point selection for bees is similar across regulatory frameworks and can be applied in any country.

Some regulatory framework set a toxicological reference values for bees. In this case the risk assessment compares the exposure value with the toxicological reference value. Other regulatory frameworks the risk assessment compares the exposure value with the hazard end-points. Country or regional policy should determine whether or not to set toxicological reference values for bees and what approach to use for the risk assessment.

Screening level exposure assessments based on worst-case scenarios may be suitable for application in other countries. For higher tier risk assessments is important that the regulator understands the scope and limitations of models they intend to use. Higher tier risk assessment methods and models used focus on site and agriculture-practice specific scenarios. Country/region specific models based on site-specific scenarios may not readily be applied in other countries.

Different regulatory frameworks apply different criteria for acceptable risk and therefore country or regional policy should determine the trigger value/level of concern to be applied.