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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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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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• 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.