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Risk assessment: the bees (including a personal point of view from a private beekeeper)

J. Pistorius (JKI)

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I. Risk assessment of plant protection products/bees

II. Examination center for bee poisoning incidents

III. Research on risks of pesticides to bees

Bees in the Institute for Plant Protection

in Field Crops and Grassland

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Beekeepers point of view:

statements in this talk represent

my personal point of view

and do not necessarily reflect the point

of view of Bee keeping organisations

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• Authorities, risk assessors and risk managers

• Individual Beekeepers,

• Bee keeping organisations

• Pesticide producers

• Testing facilities

• Agriculture

• Environmental organisations, NGO

• Science

• Public

• Politics

Who wants a share of say in the risk assement of

pesticides and bees?

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Bees are of special interest!

• Many reasons for Beekeeping:

– Fascination of Social insects and complex

superorganism

– Fascination, love and affection of bee colonies

and joy of beekeeping

– Profit and living for professional beekeepers

– Additional income and/or hobby, leisure

– Pollination & envrionmental service

• Affection also for other Pollinating bees

– Pollination services

– Protection of the environment (sentinel?)

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No effects on wellbeing of bees,

Quantity and Quality of hive products:

• Honey

• Pollen

• Wax

• Royal jelly

• Propolis

• Bee venom

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Individual bees and the whole colony may be

influenced by pesticides

Numerous aspects make out of a number of bees a highly complex

superorganism with many factors that influence the wellbeing of bees

and the „success“ of a bee colony, e.g. (but not limited to: )

• Mortality, fitness and longevity of bees, Functionality of all „casts“

• Development of bee brood, Egg laying rate, queen fecundity

• ability for complex interactions in the hive and colony,e.g.

thermoregulation, communication in the hive to maintain colony

wellbeing, brood care, etc….

• Communication of forage (waggle dance), orientation

• Capability to resist stressors e.g. diseases

No specific tests for a number of important aspects available!

Need for updating risk assessment schemes and methodology used!

Need for higher tier testing with bee colonies for substances of concern

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A beekeeper´s needs:

Strong and healthy colonies

Following pesticide use:

• No effects on individual bees and bee colony

• No effects on production of hive products- quantity and

quality

• No residues in hive products

– Residues in hive products: as necessary for risk assessment

– Residues in principle not a risk assessment issue, thus excluded

from further considerations here and in this talk!

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• Varr

From G. Liebig, modified

Bee biology – possible impact of stressors in

different seasons

Winterbees

Bees

Varroa-mites Brood

Winterbee-

brood

Spring Summer Autumn Winter

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Overwintering

Surviving temperatures up to-60° C!

In the broodnest: always 35 °C

In areas/times with no brood: 20 °C

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Concern- interactions with pesticides

• Incidents

• Weakening of colonies

• Overwintering capacity

• Fitness and disease resistance

• Both short-term and long-term

But what is done in a Risk assessment procedure to

cover concerns on bee health, bee mortality, colony

and brood development, sublethal and lethal effects

(etc…) ?

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Risk assessors needs

• Reliable and suitable methods for assessment of

effects

• Reproducible results

• Meaningful tests

• Useful endpoints

• A suitable risk assessment scheme to incorporate the

tests

• A suitable risk assessment scheme to distinguish

substances of low concern from those of potential

concern

• Flexibility to adress additional concerns

• Feedback from practical use in realistic conditions

(Monitoring, Incident monitoring)

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Risk assessment- legal framework (EU) Legal framework:

Directives:

• Directive 91/414/EEC (Annex II point 8.3.1.1, Annex III point 10.4)

Where there is a possibility of honeybees being exposed, 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.

• Directive 91/414/EEC (Annex VI point 2.5.3.2)

Guidance documents:

• Sanco 10329/2002 rev 2 chapter 4

• New Sanco guidance document in preparation for seed treatments

• EFSA Guidance document

Guidelines:

• Test guidelines OECD (213: acute, 214: contact, 237: acute tox larvae, 75 brood

development),

• EPPO PP 170 (4) (especially semi-field and field set-up)

• EPPO 170 risk assessment scheme - also „only“ published or additional,

established protocols have been requested by authorities

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Registration procedures and RA process

• Different Registration procedures: EU-level (active substance),

zonal Level, national Level, mutual recognition

• Application of regulations 283/2013 and 284/2013 :

– Active substances:

• For renewal of approval of active substances whose approval

expires on 1 January 2016 or later, regulations apply as of entry

into force.

• For other substances: apply from 1 January 2014

– PPP:

• authorisation when application has been submitted by 31 December

2015 and if the PPP contains at least one active substance

approved according to Regulation (EC) No 1107/2009

Synchronisation of the different risk assessment procedures,

EU-wide, zonal and national registration process is needed

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Fundamentals of a risk assessment

• Intended use e.g. treatment of crops, at which

growth stage

• Mode of action

• Active ingredient

• Substance properties etc. acute and oral

Toxicity, Systemicity, Persistence,etc…

• Product & Formulation

• Application rate

• Application method, application timing

• routes of exposure

• Exposure and Effect data

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Which scenarios need to be considered?

Routes of exposure:

– Contact

– Nectar, pollen,

honeydew

– Dust

– Guttation

– Contaminated water,

e.g. Puddles

– ....

Crop scenarios:

Treated crop

Following crops

Weeds

Adjacent crops

Off-field

.....

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Laboratory

Semi-field

Field

Data evaluation, Risk assessment & Risk mitigation

Monitoring

Control of test

conditions

Possibility to take

into account

complexity of

impacts on colonies

Registration

Exposure data, effects data

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Risk management for the honeybee

Protection through the Bee Protection Ordinance of 22 July 1992 (BGBl. I p. 1410)

Label based on studies

B1 - the product is classified as hazardous for bees B2 - the product is classified as hazardous for bees except after the daily bee

flight up to 23:00 B3 - the product is not classified as hazardous for bees due to the intended

uses B4 - the product is not classified as hazardous for bees if the maximum

application rate stipulated at the time of authorisation is not exceeded

According to § 2 BienSchV, PPP which are hazardous for bees

on flowering plants, on other plants visited by bees - this also applies to weeds and also applies

to honeydew.

may not be used:

within 60 m of an apiary (during the bee flight period)

may only be used with the permission of the beekeeper:

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Passive monitoring

(or incident reporting) bee

mortalities or other incidents are

recorded and analyzed wherever

they are reported

e.g. WIIS (UK),

Untersuchungsstelle

Bienenvergiftungen (JKI),

.....

Active monitoring

pre-selected bee colonies are

regularly surveyed for their health

in relation to defined influencing

factors

•Bee health/Multifactorial

monitorings

•Pesticides: Post-

registration monitoring

T

T

Monitoring

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Post-registration Monitoring

• Monitoring studies aim at getting feedback on effects of active

substances

• complement the risk assessment performed in

application of Regulation 1107/2009/EC

• addressing possible uncertainties that may not have been fully

addressed through field studies for time/space scale reasons

• possible effects in the real life when organisms are subject to other

stressors

• If specific questions shall be adressed, special design is necessary

(e.g. dusts, guttation, …)

• Significance of results depend on the set-up

• Feedback into risk assessment

• Feedback for suitable risk mitigation measures

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Incident investigation

• Assessing impact of multiple stressors

• Assess effects of multi-pesticide exposure

• Effects under different forage conditions and nutrition

supply– poor to good nutrition

• To some extent, Long-term effects may be covered

• May help to adress uncertainties of risk assessment

• Covers field realistic situation

• Relies on voluntary reporting of incidents

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Risk assessment

Risk mitigation

Risk management

Incident investigation

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A big Task: updating methodologies and risk

assessment procedures

• risk assessment questions - relevant testing strategies ?

• Development of new methods, Refining, implementation, validation

of test methods and Guideline/Guidance

• assessment endpoints and related measurement endpoints

• Weighing importance of individual bee testing vs bee colony testing.

• Integrating all (relevant) routes of exposure

• Including new test methods, including new species

• Including new aspects into the risk assessment scheme in a tiered

approach

• How to deal with different data gaps in the meantime?

• Which test methods should have the highest priorty?

• How should higher tier test be conducted in the future?

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Fundamentals of risk assessment

• Tier I (screening level), exposure estimates are intended to be

conservative (relatively – reasonably – highly?)

• Which Trigger values to be used? - “reasonably conservative”, “

relatively conservative”, “highly conservative”?

• Conservative tier I approach means that in many cases higher tier

studies are necessary- thus, it is most important that suitable, feasible

guidance is provided for higher tier

• Tier II/Tier III: exposure is based on measured values and more realistic

scenarios with bee colonies

• How to deal with uncertainties?

• Proposed guidance on statistical evaluation of (semi-) field trials is

complicated. No standard requirements on number of fields or colonies

can currently be given. This makes it difficult to evaluate (and perform) a

(semi-) field trial. Clear harmonised guidance on this is necessary.

All the different tiers have some weaknesses but also

strengths!

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Statistics and feasibility:

higher tier tests

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• How many data are needed for a product/substance

of low concern?

• How many data are needed for product/substance of some

concern?

• How many data are needed for product/substance of high

concern?

And how much of these data have to be re-reported?

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Regulatory authorities are confronted with a

considerable number of chemicals and

products that must be assessed in a limited

amount of time.

• Needs to simplify the process and ensure

feasibility while achieving a process which is

sufficiently conservative

• Accept that absolute certainty is impossible.

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Thank you!