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‘ground rules’ for extrapolations• Develop list of extrapolations• Explore scope for and propose new extrapolations• Draft guidance produced and wide consultation• Discarded some extrapolations• ‘Proposal for extending and harmonising efficacy and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‘ground rules’ for extrapolations• Develop list of extrapolations• Explore scope for and propose new extrapolations• Draft guidance produced and wide consultation• Discarded some extrapolations• ‘Proposal for extending and harmonising efficacy and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 ……..