Bee guidance documents: An end users view. Mark Miles Research & Development Environmental Safety Ecotoxicology Bees

Transcription

1 Bee guidance documents: An end users view Mark Miles Research & Development Environmental Safety Ecotoxicology Bees

2 Agenda 1. Guidance documents: expectations, uses and users (3 slides) 2. What does the new guidance bring? (5 slides) 3. So what is the potential impact of the new guidance? (9 slides) 4. What does the new guidance mean to me? (2 slides) 5. Recommendations (1 slide)

3 Who uses guidance documents? Regulated industry Meet requirements of pesticide legislation Decide on product development Screen for new ( safer ) substances Plan testing and research programmes for substances and products Prepare dossiers and risk assessment for submission Product submission Guidance document on bees Regulatory authorities and Commission Check substances conform to uniform principles Ensure data requirements are met Perform a peer review of the submitters dossier Risk assessment Approval of products and placement on the market Implementation of risk management NGOs Pressure groups Special interest groups Public Public commenting EFSA Coordinate the peer review Write guidance

4 Guidance documents can impact product development timelines

5 12 Expectations of a Guidance Document (GD) Build on previous guidance to solve and fix problems (ICPPR, EPPO, SANCO) Be generated as part of a clear process with concept paper to define the framework, scale of revision and time scales Expert input based on scientific excellence, not affiliation Separate from an opinion translate an opinion into a workable regulatory process Needs to be designed to be used Each GD should have a tiered approach with reasonably spaced tiers to screen out substances of low concern All methodology should have been tested or validated in collaborative trials or have a guideline published by a reputable organization, in which such testing and validation has been undertaken, e.g. OECD Be subject to a testing and validation phase before implementation to demonstrate that the GD is fit for purpose Have a sensible and practical implementation phase that is appropriate for the new GD to be met Clear and concise, save time Useable by appropriately qualified persons Resolve uncertainties not just list them Applicable to the available risk assessment framework and toolbox

6 What does the new guidance bring? More species for risk assessment Honey bees (Apis mellifera) Bumble bees (Bombus terrestris) Solitary bees (Osmia spp.) As in all areas of regulatory ecotox they are a sentinel species

7 New laboratory data requirements: Honey bees Honey bee Methods Acute oral adult OECD 213 Acute contract adult OECD 214 Chronic 10 day adult None (poss. dev based on OCED 213) Chronic 28 day larval development None (7 day OECD 237) Hyphopharyngeal gland (HPG) development None (questioned relevance to risk assessment) Only two of the methods are existing and validated Chronic test needs development and validation Larval test available does not meet GD aspirations Histopath endpoint for an invertebrate species at the screening tier?

8 New laboratory data requirements Bumble bees Acute oral adult Acute contract adult Chronic 10 day adult Chronic larval development Solitary bees Bumble and solitary bees Almost none are available Acute oral adult Acute contract adult Methods None (possible dev based on HB test) ICPPR group working on acute contact/oral Bumble bee Chronic larval development None (possible dev based on HB test) None (possible dev based on HB test) To have such methods validated, ring tested and published is Questionable larvae cannot be handled many years work Need to prioritize methods Methods Which will bring the most to the risk assessment? None (limited experience) None (limited experience) Technical challenges will a test work? Is it feasible? (e.g. Chronic 10 day adult None (limited experience) solitary bee development lasts 1 year) Univoltine species (test >1 year)

9 Protection goals SPG (specific protection goals) based on ecosystem services were defined according to using EFSA methodology Magnitude of effects cannot exceed 7% reduction in colony size Forager mortality cannot be increased compared to the control 1.5x for six days or 2 for three days or 3 for two days Honey production excluded Level of protection (includes an exposure assessment goal) of 90 th percentile exposure So that 90% of all colonies at the edge of a treated field in one regulatory zone should be exposed to a lower quantity than in the risk assessment Does not fit with uniform principles and decision making Realistic worse case exposure under normal conditions of use (the unless clause of the uniform principles)

10 SO WHAT IS THE POTENTIAL IMPACT OF THE NEW GUIDANCE? Where are the pinch points? Is the new guidance realistic Do I have the tools? How useable is it? Are the extra safety factors reasonable? Let s take a look with data from 150 substances and 163 uses for spray uses

11 Acute risk assessment to honey bees % number of uses passing the screening RA for foliar applications Use HQ contact (<50) HQ contact (<42 or 85) HQ oral (<50) ETR oral (<0.2) Herbicides Fungicides Insecticides Others All Previous HQ values checked against field data: Smart & Stevenson (1982): Bee World, 63, Mineau et al. (2008): Environ. Entomol. 37(2): (2008) Confirmed by EFSA mathematically (42 and 85 similar to 50)

12 Acute risk assessment to non-apis bees % number of uses passing the screening RA for foliar applications Use Bumble bee Solitary bee HQ contact (<0.7/1.4) HQ oral (<0.0036) HQ oral (<0.8/1.6) ETR oral (<0.004) Herbicides Fungicides Insecticides Others All No validation vs. field data: Mathematical calculations by EFSA Compared to honey bee all uses 82% (contact) and 74% (oral) Majority of substances would be triggered into higher tier testing

13 Chronic risk assessment to adult honey, bumble and solitary bees % number of uses passing the ETR chronic adult risk assessment Use HB (<0.03) BB (< ) SB (< ) Herbicides Fungicides Insecticides Others All % - 100% of all uses require higher tier refinement Assumes chronic oral 10 day LD50 = 0.1x acute LD50 Industry (end users) are scaremongering!!!

14 Revised chronic risk assessment to adult honey, bumble and solitary bees Use % number of uses passing the ETR chronic adult risk assessment Honey bee (<0.03) Bumble bee (< ) Solitary bee (< ) Endpoint (acute LD50) 0.1x 0.2x 1x 0.1x 0.2x 1x 0.1x 0.2x 1x Herbicides Fungicides Insecticides Others All Using more liberal estimates for chronic endpoints improvement For honey bees but still 82 to 66% of all uses require higher tier

15 Why does the risk assessment not discriminate low from high toxicity products? SPG: 90 th percentile exposure, so that 90 th of colonies at the edge of field experience lower exposure 90 th %ile residues (or max of 5 field tests), 90 th %ile consumption, safety factors SPG: Magnitude of effects < 7% reduction in colony size Trigger values built on lowest observed mortality X safety factors Exposure range + Uncertainty factors / outliers + Uncertainty factors / outliers Effect range Low risk range certain Risk range: overlap of uncertainties Built up on uncertainties, and the resulting level of protection is >>> 90 th or 7% effect

16 How can I pass the chronic risk assessment? Back calculations to find what chronic LD50 is necessary to pass using the honey bee as the test species Triggers for BB and SB are 5-6x lower Different SV for each type of bee Additional safety factor of 10x when using HB endpoints Example for a product applied at 200 g as/ha in arable crops Bee Dose (µg/bee/day) Concentration µg/ml in 10% sugar a.s. as % of bw consumed in 10 days Factor of spray solution conc.(200l/ga) Honey bee % 2.5x Bumble bee % 277x Solitary bee % 137x In practical terms doses cannot be administered due to solubility and repellence issues even for non-toxic substances

17 Refinement of exposure Field trials 5x exposure field trials per regulatory zone (take the highest? Mean? Value?) Extreme levels of refinement E.g. for a substance applied at 200 g as/ha, LD µg as/bee Level of exposure refinement necessary to pass risk assessment (200 g as/ha) Bee HQc ETRoral ETRchronic ETRlarvae Honey bee None None 5.0x None Bumble bee 2.9x 6.2x 467x None Solitary bee 2.5x 2.8x 169x None None = no refinement necessary passes risk assessment Refinement of x are unlikely unless exposure estimates in GD are extreme Refinement levels 10x higher for 2000 g as/ha applications

18 Effect refinement Semi-field and Field tests Must meet exposure goal (easy in tunnel) Must meet statistical effects goal (to able to detect 7% difference from control) Field tests require colonies per study Bumble bee field tests very difficult Low fidelity with crop (30% of OSR pollen when at edge of field) Solitary bee field tests Unknown area of regulatory research Commercially available v wild populations If goal is so necessary why it is impossible to achieve? Proposal: Use well conducted field and semi-field tests under realistic worse case exposure under normal conditions of use

19 Example: field study to meet exposure goal and statistical needs (Honey bees) 16 km 28 Fields 4 km apart 186 colonies (7 colonies/field) 28 km 2 Km 2 Ha

20 WHAT DOES THE NEW GUIDANCE MEAN FOR ME? Lots of reading Questions from my boss Changes to workload Changes to testing Changes to the risk assessment Increased cost of development Delays in product registration Possible loss of products

21 End user view worried Highly conservative risk assessment Lack of validated test methods Most substances will require higher tier risk assessment Exposure refinement unlikely to be successful Effects refinement in field trials are practically impossible We need a solution

22 Recommendations Guidance document in its current form is not ready for implementation Too complex, not discriminatory, leads to risk assessment cul de sac (dead end) BUT Lot of valuable work Eventually could be developed into a workable document Further work on exposure Reduce no. scenarios to those most relevant Development appropriate tests Calibrate risk assessment Involvement of all key stakeholders to produce workable GD E.g. Industry, ICPPR, OECD, member states