1. Industry View on EFSA Environmental Guidance Document Development and Recent Experiences with Opinions & Guidance Dr Peter Campbell

2. Review of Existing Guidance Experience with recent EFSA Guidance
Presentation Outline
Purpose of Guidance
Review of Existing Guidance
Experience with recent EFSA Guidance
Protected Crops, Birds & Mammals, Aquatic Organisms & Bees
EFSA Plans for New Guidance & Opinions
Potential future problematic areas – NT Plants & NT Arthropods
General lessons learned
Conclusions & Recommendations

3. Purpose of Guidance Documents
Provide a Risk Assessment Framework
Science Based
Fit for purpose
Robust
Protective
Harmonized
Risk Assessment Outcome should be:
Predictable - along the development and regulatory timelines
Practicable
Consistent

4. Env PPP Guidance Prior to SANCO/EFSA
SETAC Guidance e.g.:
EPPO Scheme for the environmental risk assessment of plant protection products

5. Existing EC PPP Env Guidance
FATE and BEHAVIOUR in the ENVIRONMENT:
SANCO/9188/VI/98-rev 8, "Guidance Document on Persistence in Soil", 2000
SANCO/4802/2001-rev.1 “FOCUS Surface Water Scenarios in the EU Evaluation Process under 91/414/EEC”, 2002
SANCO/321/2000 rev.2, “FOCUS Groundwater Scenarios in the EU Review of Active Substances”
Generic guidance for FOCUS Groundwater Scenarios version:1.1, 2002
SANCO/221/2000-rev 10, "Guidance Document on Relevant Metabolites in Groundwater", Feb. 2003
Ecotoxicology:
SANCO/10329/2002-rev 2 final, "Guidance Document on Terrestrial Ecotoxicology", 2002
SANCO/4145/2000, "Guidance Document on Risk Assessment for Birds and Mammals",
SANCO/3268/2001-rev 4 final, "Guidance Document on Aquatic Ecotoxicology", 2002

6. Recent EFSA Environmental Guidance Documents for PPPs
EFSA GD Risk Assessment for Birds and Mammals
EFSA GD on Tiered Risk Assessment for Aquatic Organisms at edge of field
EFSA GD on Emissions from Protected Crops
EFSA GD on Risk Assessment for Bees – not adopted yet

7. Recent Experience EFSA Guidance Document on Birds & Mammals
Only guidance document on which we have real experience
Positive Aspects
Guidance built on SANCO 4145/2002
Aligned with 91/414/EEC and 1107/2009
Working group involved risk assessors and industry
Led by an experienced Risk Assessor Expert
Difficult Aspects
Complex
High failure rate
Particularly for chronic risks to mammals (even for low toxicity products)

8. Recent Experience EFSA Guidance Document on Aquatic Organisms in edge-of-field surface waters
Notified in 2014 – first impressions
Positive Aspects
Guidance built on existing SANCO Aquatic Ecotox Guidance and additional guidance on high tier studies (ie SETAC eLink & Mesocosm GDs)
Aligned with 1107/2009 and Uniform Principles:
Working group led by a very experienced aquatic risk assessment expert
Overall practicable and should not lead to unexpected conclusions
Tricky Aspects
Acceptability of Time Weighted Concentrations for assessing Chronic Risk
Use of Mesocosm data and safety factors applied
Acceptance of Recovery in Protection Goal
Regulatory Acceptable Concentration: Recovery
Regulatory Acceptable Concentration: NOEC

9. Recent Experience EFSA Guidance Document on Protected Crops
Noted at the January Standing Committee
But many uncertainties!!
“Protected crops” do not appear in Regulation 1107/2009 – how does guidance link with “greenhouses” in 1107/2009?
Sample scenarios provided but not complete and representative. Why not agree scenarios before application?
Soil risk assessment for greenhouse linked to EFSA Guidance on Soil Risk Assessment (which is not scheduled until 2017/18!)
Report indicates that an important model used in the guidance does not pass a validation test. Why was it adopted?
And documentation necessary to run the model are not publically available.

10. First Impressions EFSA Guidance Document for bees
Still not noted (almost 2 years delay)
VERY Problematic and cannot be complied with
GD Working Group not led by Bee Expert / only 1 Risk Assessor
Ignores all previous available guidance (EPPO, SANCO)
Includes new data requirements not in 1107 with no guidelines available
Not consistent with Uniform Principles
Very complex (new species, new methods & multiple exposure routes)
Industry Impact Assessment: – Insecticides will be unregisterable and many herbicides and fungicides will also fail.
Honeybee Protection goal impossible to meet
Very conservative trigger values and safety factors
Field study specification impossible to meet

11. FERA guidance on aged sorption
Timetable for New EFSA Guidance & Scientific Opinions Indicative deadlines for the publication of deliverables according to official EFSA mandates
31 January
30 June
23 April
30 June
30 Sept
31 March
30 June
31 December
2015
2016
2017
2018
Soil PEC
Sediment organisms
FERA guidance on aged sorption
Effect modeling for RA of for aquatic organisms
Non-target Terrestrial Plants
Non Target Arthropods
Non-Target Arthropods
In soil risk assessment
In-soil risk assessment
Amphibians and reptiles
Amphibians and reptiles
Regulatory Use of BEEHAVE
EC10/NOEC Comparison
Guidance Document
Endangered Species in Risk Assessment
Scientific Opinion
Temporal/spatial recovery of NTO in Env RA
Cross Cutting

12. First Impressions EFSA Scientific Opinion on Terrestrial Non-Target Plants
Current major concerns:
Spray drift values potentially increase massively
Reproductive effects now required = additional 35x safety factor
Existing Buffer zones to increase by x10
Protection Goal Proposals:
Negligible effects on populations at the edge-of field
Protect in-crop biodiversity to support food web (i.e. protect in-field weeds!!)
No effect on endangered species ???
How can Herbicides be registerable under Guidance based on this Opinion?

13. First Impressions EFSA Scientific Opinion on Terrestrial Non-Target Arthropods
Current major concerns:
Ignored 10+yrs of Regulatory Guidance from ESCORT 1, 2, 3.
Biodiversity needs to be protected in-field
Direct and indirect effect from multiple pesticide applications
Recovery potential should be based on species with low recovery potential!!!
40 pages on Protection goals options!!!!
How can insecticides be registerable under Guidance based on this Opinion + Bee Guidance??

14. Change in EFSA Process moving from Science Opinion to Guidance Document
EFSA expects Protection Goals to be agreed by Risk Managers within 2 years of publication of the Scientific Opinion:
Process unclear as yet?
Only then will work on the Guidance Document start.
EC also currently reviewing the process for noting Guidance Documents

15. EFSA GDs: Lessons learned
More recent EFSA Expert Groups lack experienced risk assessors
Impractical Guidance
Previous Guidance virtually ignored
Increased Complexity
Unrealistic Protection Goals
Unrealistic level of certainty required
Too many «what if» questions - rather than what is likely
Tiered Risk Assessment approach being undermined
Rejection of Field studies
Requiring studies where no agreed guidelines available
Over conservative assumptions & safety factors
High fail rate
No Impact Assessment

16. EFSA GDs: Lessons learned
Inconsistent Application of Guidance
EFSA Neonicotinoid review
Science Opinion/Draft Guidance was applied
As a result studies were rejected which substantially exceeded established requirements.
Aged Sorption guidance
Draft Guidance was available to EFSA in from UK CRD led Technical Workshop held in (EFSA were present)
EFSA has still not adopted

17. Conclusions Fit for Purpose Guidance Documents need to:
Focus on needs of risk assessors & risk managers
Have clear and workable scientific/agronomic based risk assessment scenarios
Must build on previous experience & guidance
Require guideline availability for new testing
Reduce unnecessary complexity
Derive safety factors and default values which are proportionate and based on data where possible
Have clearly agreed and practical protection goals
Consider impact on availability of crop protection solutions

18. Recommendations for Improvement
Need a clear initial mandate
It should identify and justify the need for a change
Mandates should frame what EFSA have to do and what they don’t have to do
Needs leadership & involvement of experienced ‘users’ in the GD Working Groups
Define appropriate protection goals (and regulatory needs?)
Write practical guidance (based on Scientific Opinion)
Utilises and builds on previous guidance & experience
Includes an impact analysis
Protection goals definition is identified as a crucial step
Should take into consideration the intended agricultural use of the product
Should be set in the wider context of the impact of agricultural per se
Protection goals should include risk/benefit considerations (e.g. availability of crop protection solutions)

19. Recommendations for Improvement in new GD Implementation Steps required for workable implementation:
Testing phase
Allowing feedback and adjustments where necessary
How can Industry contribute to the testing phase?
Define realistic implementation timelines, considering:
Time needed to update risk assessments in New AS and AIR Review Submissions
CRO Testing capacity

20. Thank you!