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

Transcription

1 Risk assessment: the bees (including a personal point of view from a private beekeeper) J. Pistorius (JKI)

2 Bees in the Institute for Plant Protection in Field Crops and Grassland I. Risk assessment of plant protection products/bees II. III. Examination center for bee poisoning incidents Research on risks of pesticides to bees

3 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

4 Who wants a share of say in the risk assement of pesticides and bees? Authorities, risk assessors and risk managers Individual Beekeepers, Bee keeping organisations Pesticide producers Testing facilities Agriculture Environmental organisations, NGO Science Public Politics

5 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?)

6 No effects on wellbeing of bees, Quantity and Quality of hive products: Honey Pollen Wax Royal jelly Propolis Bee venom

7 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

8 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!

9 Bee biology possible impact of stressors in different seasons Varr Brood Varroa-mites Bees Winterbeebrood Winterbees From G. Liebig, modified Spring Summer Autumn Winter

10 Overwintering Surviving temperatures up to-60 C! In the broodnest: always 35 C In areas/times with no brood: 20 C

11 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 )?

12 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)

13 Risk assessment- legal framework (EU) Legal framework: Directives: Directive 91/414/EEC (Annex II point , 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 ) 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

14 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

15 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

16 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...

17 Laboratory Semi-field Field Exposure data, effects data Possibility to take into account complexity of impacts on colonies Control of test conditions Data evaluation, Risk assessment & Risk mitigation Registration Monitoring

18 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 may not be used: on flowering plants, on other plants visited by bees - this also applies to weeds and also applies to honeydew. may only be used with the permission of the beekeeper: within 60 m of an apiary (during the bee flight period)

19 Monitoring T T Active monitoring pre-selected bee colonies are regularly surveyed for their health in relation to defined influencing factors Passive monitoring (or incident reporting) bee mortalities or other incidents are recorded and analyzed wherever they are reported Bee health/multifactorial monitorings Pesticides: Postregistration monitoring e.g. WIIS (UK), Untersuchungsstelle Bienenvergiftungen (JKI),...

20 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

21 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

22 Risk assessment Incident investigation Risk mitigation Risk management

23 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?

24 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!

25 Statistics and feasibility: higher tier tests

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28 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?

29 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.

30 Thank you!