Post on 01-Apr-2018
EPPO Workshop Mutual recognition of Minor Uses
EC funded Extrapolation project
David RichardsonPesticides Safety Directorate
York
ContentContent
• Background and rationale for the project• The Efficacy Extrapolation project• What next?• What more can be done?
• Apologies……..
• Background and rationale for the project• The Efficacy Extrapolation project• What next?• What more can be done?
• Apologies……..
Background and rationaleBackground and rationale
• Loss of actives• High cost of minor use registrations• Is the investment justified • Problems of insufficient control options
– Resistance/crop losses/• Slow uptake of Mutual Recognition
• Loss of actives• High cost of minor use registrations• Is the investment justified • Problems of insufficient control options
– Resistance/crop losses/• Slow uptake of Mutual Recognition
EU extrapolation projectsEU extrapolation projects
• 2 desk based projects awarded to PSD– residues – efficacy
• Objective: to explore the scope to broaden existing extrapolations without compromise to safety and efficacy
• Benefits: improve scientific integrity and uniformity of decisions between MS whilst minimising data required
• 2 desk based projects awarded to PSD– residues – efficacy
• Objective: to explore the scope to broaden existing extrapolations without compromise to safety and efficacy
• Benefits: improve scientific integrity and uniformity of decisions between MS whilst minimising data required
Efficacy extrapolation projectEfficacy extrapolation project• Desk study• Look at existing extrapolations in MS• Consider ‘ground rules’ for extrapolations• Develop list of extrapolations• Explore scope for and propose new extrapolations• Draft guidance produced and wide consultation• Discarded some extrapolations• ‘Proposal for extending and harmonising efficacy and
crop safety requirements’.• End date : October 2005
• Desk study• Look at existing extrapolations in MS• Consider ‘ground rules’ for extrapolations• Develop list of extrapolations• Explore scope for and propose new extrapolations• Draft guidance produced and wide consultation• Discarded some extrapolations• ‘Proposal for extending and harmonising efficacy and
crop safety requirements’.• End date : October 2005
Proposal StructureProposal Structure
• Fungicides• Insecticides• Herbicides• Crop safety
– Insecticides and fungicides– Herbicides
• Extrapolations removed post consultation
• Fungicides• Insecticides• Herbicides• Crop safety
– Insecticides and fungicides– Herbicides
• Extrapolations removed post consultation
Key pointsKey points
• Apply expert judgement• Extrapolation applies to same product,
dose, and timing.• Use to support extrapolation to minor
crops• May allow some reduction in data for a
use on a major crop• Apply expert judgement
• Apply expert judgement• Extrapolation applies to same product,
dose, and timing.• Use to support extrapolation to minor
crops• May allow some reduction in data for a
use on a major crop• Apply expert judgement
InsecticidesInsecticides
• Important factors relating to suitability for extrapolation– Crop (morphology, growth habit, family)– Pest (taxonomic relationship, life cycle,
behaviour)– Product (Mode of action, timing)– Agronomic (protected v outdoor, soil type)
• Important factors relating to suitability for extrapolation– Crop (morphology, growth habit, family)– Pest (taxonomic relationship, life cycle,
behaviour)– Product (Mode of action, timing)– Agronomic (protected v outdoor, soil type)
Major insect target on major crop
Further evidencerequired
Differencesin pest?
Differences in crop?
Extrapolate to:-
same pest ondifferent crop
different pest ondifferent crop
different pest on same crop
ExtrapolateyesNo
Extrapolations insecticidesExtrapolations insecticidesTarget Insect Target Crop FRUIT (AND
NUT) GROWING CROPS
From To From To
Aphids Cryptomyzus ribis Redcurrant blister
Not possible Redcurrant Blackcurrant, white currant, gooseberry
Rhodobium porosum or Aphis gossypii
Chaetosiphon fragaefolii, Aphis gossypii, A. fabae, … Myzus ascalonicus
Strawberry (protected)
Strawberry (outdoor)
Psyllids (not virus vectors)
Cacopsylla pyricola,
C. mali (less common and more susceptible.
Pear Apple
Spider mites (extrapolation between these species is not
Tetranychus urticae
T. urticae in other crops, T. viennensis
Apple Cherry, pear, plum, red black white currant, gooseberry, blackberry, raspberry, vine, strawberry
Allowable} Panonychus ulmi P. ulmi in other crops, Bryobia rubrioculus
Apple Cherry, pear, plum, fruit tree cultures/ rootstocks of apple and pear
Bryobia ribis B. ribis in other crops Apple Black, white currant, gooseberry, blackberry, raspberry
page 21-22
Extrapolations insecticidesExtrapolations insecticidesTarget Insect Target Crop ARABLE From To From To
Aphids (virus transmission)
Myzus persicae Myzus ascalonicus (not vice versa because virus transmission not as effective)
Sugar beet Fodder beet
Aphids – sucking damage
Sitobion avenae, Metopolophium dirhodum, Rhopalosiphum padi
all cereal aphids if data on R padi plus one other species
Major cereals Minor cereals
Extrapolation of pests from major to minor cereals may be possible provided pest biology and pest/crop interaction is comparable. An example where this is not possible is BYDV vectors from winter to spring barley because of significant differences in aphid movement and virus transmission through the crop.
Page 16
Extrapolation matrix - fungicidesExtrapolation matrix - fungicides
Disease
Crop Same Similar Related Different
Major Crop - Evidence No No Same
Minor crop Extrapolate Extrapolate Evidence Evidence
Major crop Reduced data Reduced data No No Similar
Minor crop Extrapolate Extrapolate Evidence Reduced data
Major crop Reduced data No No No Different
Minor crop Evidence Reduced data No No
Reduced data some data on the crop against the targetEvidence evidence on the same or related crops Page 5
Extrapolations: FungicidesExtrapolations: Fungicides
Test organisms Can extrapolate to Notes Test crop Target disease Crop Disease
Pear Scab (Venturia pirina)
Confirmatory data required
Apple Scab (Venturia inaequalis) (Data is required of control on fruit)
Cherry, plum, peach
Scab (Venturia spp)
Confirmatory data required on one other crop.
Cherry or peach
Shot hole disease (Stigmina carpophila)
Plum, peach Shot hole disease (Stigmina carpophila)
Apple or Pear Powdery mildew (Podosphaera leucotricha)
Apple or Pear Powdery mildew (Podosphaera leucotricha)
Confirmatory data required
Page 7
WeedsWeeds
Major weed on major crop
Extrapolate to same weed* in other crop
For the same weed*,some confirmatoryevidence required
Pre emergenceuse
Post emergenceuse
How competitive is the proposed crop?
More or equal Less competitive
*For a different weed, extrapolation unlikely without further data Page 28
Extrapolations between crops for the same target weed
Extrapolations between crops for the same target weed
Test crop: Can extrapolate to: Pre-emergence, pre-sowing or pre-planting application of one crop
Pre-emergence, pre-sowing or pre-planting application of another crop (only if growing conditions are the same).
Any drilled flower, tree nursery or perennial crop.
Planted crop of the same species
Any planted flower, tree nursery or perennial crop.
Drilled crop of the same species
Any non-competitive crop e.g. Orchards, HONS, amenity vegetation, land not intended to bear vegetation.
Any other non-competitive crop, poorly competitive crop e.g. Sugar beet, peas, onions, linseed, horticultural brassicas, or competitive crop e.g. Cereals, grassland, oilseed rape (contact herbicides only)
Any poorly competitive crop e.g. Sugar beet, peas, onions, linseed, horticultural brassicas
Any other poorly competitive crop or competitive crop e.g. Cereals, grassland, oilseed rape (contact herbicides only)
Any competitive crop e.g. cereals, grassland, oilseed rape
Any other competitive crop (contact herbicides only)
Page 29
Extrapolations between different target weeds
Extrapolations between different target weeds
FAMILY Test species (Major species in bold)
Can extrapolate to:
Chenopodiaceae Chenopodium album (Fat hen)
Atriplex patula (Common orache) Chenopodium ficifolium (Fig-leaved goosefoot)
Compositae Cirsium arvensis (Creeping thistle) Matricaria spp 1 (Mayweeds) Senecio vulgaris (Groundsel) Sonchus spp (Sow thistles).
Crepis spp (Hawkweeds) Lapsana communis (Nipplewort) Corrigiola litoralis (Strapwort)
Cruciferae Brassica napus
(volunteer Oilseed rape) Capsella bursa-pastoris (Shepherd’s-purse), Sinapis arvensis (Charlock),
Raphanus raphanistrum (Wild radish) Thlapsi arvense (Field penny-cress) Arabidopsis thaliana (Thale cress) Descurainia sophia (Flixweed) lberis amara (wild candytuft),
Page 30
Crop safetyCrop safety
• Factors making extrapolation between crops more likely to be acceptable;– Good crop safety data on original crops– Knowledge of mode of action (esp herbicides)– Close taxonomic relationship– Similar crop morphology– Similarity of growing conditions– Other data (pot tests, variety screens)– Data on protected crops – but caution
• Factors making extrapolation between crops more likely to be acceptable;– Good crop safety data on original crops– Knowledge of mode of action (esp herbicides)– Close taxonomic relationship– Similar crop morphology– Similarity of growing conditions– Other data (pot tests, variety screens)– Data on protected crops – but caution
Crop safetyCrop safety
• Factors making extrapolation between crops less likely to be acceptable;
– Evidence of damage on some crops– Evidence on a limited range of crops – Non specific or several modes of action– Herbicides!
• Factors making extrapolation between crops less likely to be acceptable;
– Evidence of damage on some crops– Evidence on a limited range of crops – Non specific or several modes of action– Herbicides!
Crop safety: Insecticides and fungicides
Crop safety: Insecticides and fungicides
• Low risk of damage• Good database across sensitive crops, then
broad extrapolations possible.• Sensitive example crops identified
– Chinese cabbage, broccoli, cauliflower brassicas
– Fuchsia, Begonia, Ficus, sainpaulia etc potted plants
• Warning on labels in floriculture
• Low risk of damage• Good database across sensitive crops, then
broad extrapolations possible.• Sensitive example crops identified
– Chinese cabbage, broccoli, cauliflower brassicas
– Fuchsia, Begonia, Ficus, sainpaulia etc potted plants
• Warning on labels in floriculture
Crop safety: Seed treatmentsCrop safety: Seed treatments
From: To:
Sugar beet Fodder beet, red beet, spinach beet Maize for silage Sweet corn, kernel maize Leek Seed onion, 1st year onion set, silver skin onion, pickles, seed
shallot, bunched onion, chives, Chinese chives Tomato Egg plant, sweet pepper, Chile pepper Gherkin Cucumber, Courgette, pumpkin, melon, water melon Spinach Lamb's lettuce Heading lettuce all Lactuca species, dandelion salad Whiteloof Chicory, endive, cardoon, sugar loaf and red-leaved chicory Spring carrot Winter carrot, celery, celeriac, blanched celery, fennel, parsley,
caraway, dill and wild carrot
Must have data on a range of varieties of the test crop to extrapolate
Page 37
Crop safety – herbicidesCrop safety – herbicides
• Extensive list of extrapolations• Not exhaustive• Extensive list of extrapolations• Not exhaustive
Additional pointsAdditional points
• Limited information from southern MS– Needs developing in this area
• Limited information on PGR’s• Need to EPPO code the crops and
targets?• Some extrapolations proposed for future
discussion
• Limited information from southern MS– Needs developing in this area
• Limited information on PGR’s• Need to EPPO code the crops and
targets?• Some extrapolations proposed for future
discussion
What next?What next?
• Document available on Europa and PSD website (as a proposal)
• Apply in UK with expert judgement• Proposed that text goes to EPPO to
develop as an efficacy guideline.• Already additional comments from MS
• Document available on Europa and PSD website (as a proposal)
• Apply in UK with expert judgement• Proposed that text goes to EPPO to
develop as an efficacy guideline.• Already additional comments from MS
What next?What next?
• Integrate with other schemes; • E.g.Canada
– For foliar insecticides (based on crop groups)– And subject to four ‘similarity’ requirements
• E.g Australia– Tiered approach based on similarity of pest and crop
• Need to explore/resolve the major/minor crop problem.
• Integrate with other schemes; • E.g.Canada
– For foliar insecticides (based on crop groups)– And subject to four ‘similarity’ requirements
• E.g Australia– Tiered approach based on similarity of pest and crop
• Need to explore/resolve the major/minor crop problem.
BenefitsBenefits• Trust
– Common guidance – same standards
• Speed up Mutual Recognition
• Sustainability– Avoid duplication of effort– Reduce wastage – Crop viability
• Trust– Common guidance – same standards
• Speed up Mutual Recognition
• Sustainability– Avoid duplication of effort– Reduce wastage – Crop viability
What more can be done?What more can be done?
• Is there scope for broader extrapolations?• Reduce efficacy requirements on minor
crops?• Use of indicator species for target pests• Estimates of a.s. deposition (e.g. dose per
unit leaf area) to extrapolate to different crops?
• Is there scope for broader extrapolations?• Reduce efficacy requirements on minor
crops?• Use of indicator species for target pests• Estimates of a.s. deposition (e.g. dose per
unit leaf area) to extrapolate to different crops?
SummarySummary
• Lot of work into developing documents• Documents available via circa• Aim to facilitate minor use approvals• Need to ensure harmonisation of
approach to efficacy to facilitate mutual recognition
• Progress Residues extrapolation
Thank you ……..