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Plant Protection Products & their Residues (PPR)

Panel

Presentation to the EFSA Management Board, Lisbon

13th December 2007

Tony Hardy , Central Science Laboratory, UK, Chair of PPR Panel

Mandate How the Panel functions Types of work/activities Examples Issues Future work load

Outline

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PPR Panel mandate Art. 22.6 EFSA Regulation 178/2000

Provides independent scientific opinions and guidance for the Community’s legislation in the field of plant protection products (Directive 91/414/EEC).

Deals with scientific questions relating to the risk assessment of plant protection products in relation to the user/worker, the consumer of treated products and the environment.

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The 2 fields of scientific activities

Providing scientific opinions, on generic issues on pesticide risk assessment or on specific active substances on the basis of questions from the European Commission, EFSA’s PRAPeR unit (self-tasking), the European Parliament or from Member States

Updating existing and developing new Guidance Documents on pesticide risk assessment : promoting new and harmonized scientific approaches and methodologies

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PPR Panel

• 21 independent scientists – Toxicology (11), Environmental fate (5), Ecotoxicology (5)– BE(2), BU(1), CH(1), CY(1), DE(1), DK(2), ES(1), IT(3), NL(5), UK(4)

• supported by ad hoc experts (appointed for their relevant expertise) in specific areas in Working Groups which deal with related questions

• A rapporteur (Panel member) co-ordinates the work of the opinion in a relevant Working Group

• PPR Unit (8 staff) overall co-ordination of the work on the opinion and technical support

• 6/8 Plenary meetings/year, 38 WGs in 2006, 50 in 2007 • Adoption of an opinion in 6 months average (quorum of 2/3

members of the Panel) at a plenary meeting or by written procedure (circulation and agreement in 10 working days)

• The Panel members adopt the opinion, the ad hoc experts are acknowledged in the opinion

• Published on the internet, may include public consultation

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PPR panel and WGs

4 standing Working Groups and one variable one for Guidance Documents

PPR Panel21 experts

Working GroupToxicology

Working GroupsGuidance Documents

Birds and Mammals,Persistence in soil

Working Group Residues

Working Group Fate and behaviour

Supported by the EFSA Secretariat (PPR Unit)

Working Group Ecotoxicology

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SCIENCE

Risk Assessment

Food Additives & Packaging (AFC)

Biological Hazards (BIOHAZ)

Contaminants (CONTAM)

Animal Health & Welfare (AHAW)

Feed Additives (FEEDAP)

Genetically Modified Organisms (GMO)

Nutrition (NDA)

Plant Protection Products (PPR)

Scientific Cooperation & Assistance

Assessment Methodology

Zoonoses (Data Collection)

Data Collection Exposure

Scientific Cooperation

Emerging Risks

AssessmentPeer Review

(PRAPeR)

Plant Health(PLH)

Pesticide Risk

•Scientific staff (5)Muriel DUNIER-THOMANN (Head of Unit)Christine FUELL (Ecotoxicology)Karin NIENSTEDT (Ecotoxicology)Mark EGMOSE (Fate and behaviour)Istvan SEBESTYEN (Toxicology)•Administrative support (3)Giorgia BOSCHETTOCinzia PERCIVALDIIsabelle RHIHANI

PPR Unit within EFSA

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)

33 opinions adopted since 2003 by the PPR Panel in the areas, 3 more on 11th December:

• Toxicology (10+2)• Ecotoxicology (9)• Fate and behaviour (7+1)• Residues of pesticides (5)• Analytical methods (1)• Physico-chemical properties (1)

Published PPR Opinions

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Questions to the Panel 2006-2007

• Self tasking (EFSA PRAPeR unit, PPR Panel)

On a specific active substance or regulation (Questions from the Commission)• Acute reference dose for imazalil• MRL for dieldrin• Acute dietary exposure of pesticides residues in fruit and vegetables IESTI• Toxicological relevance of a metabolite of tritosulfuron• Revision of the Annexes II and III of Dir. 91/414: Toxicology• Revision of the Annexes II and III of Dir. 91/414: Ecotoxicology• Revision of the Annexes II and III of Dir. 91/414: Fate• In 2006, adopted Annexes II and III on Residues, Analytical methods and

Physico-Chemical propertiesOn generic issues and on EU guidance documents (GD) (Self-tasking questions from within EFSA)• FOCUS landscape and mitigation GD• FOCUS air GD• Birds and mammals GD (revision)• Cumulative risk assessment of pesticides in human health• Q10 default value for transformation rates of pesticides in soil• Genotoxic and carcinogenic potential of buprofezin

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Fate and behaviour WG

• (FOrum for the Coordination of Exposure Models and their Use) FOCUS air report (DG SANCO): models for exposure assessment in air

• Q10 value used to describe the temperature effect on transformation rates of pesticides in soil

• Starting to update the GD on persistence of pesticides in soil

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Ecotoxicology WG

• Aquatic risk assessment of cyprodinil (a fungicide) and the use of mesocosm studies

• Choice of endpoints to assess the long term risks to mammals in the field

• Revision of guidance document on risk assessment for birds and mammals

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Risk Assessment for aquatic organisms

• Relevance of tests with case-specific design intended to simulate more realistic exposure scenarios?

• Reduction of the uncertainty in the RA by provision of additional data

• Concept of Ecotoxicologically Relevant Concentration & comparison of the concentration over time in the ecotoxicity study & the predicted environmental concentration (PEC).

•Opinion on the request on the risks associated with an increase of the MRL for dieldrin on courgettes (question from the Commission)

•Opinion on how to evaluate the suitability of existing methodologies and the identification of new approaches to assess cumulative and synergistic risks from pesticides to human health with a view to set MRLs for those pesticides in the frame of regulation (EC) No. 336/2005(self-tasking question from EFSA)

Consumer exposureResidues WG

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The IESTI opinion

-The European Commission asked EFSA (PPR Panel) for an opinion on the acute dietary intake assessment of pesticide residues in fruit and vegetables with a view « to deciding about the use of the IESTI equation (International Estimate of Short Term Intake) to be used for future fixing of MRLs for pesticide residues»

-The opinion was adopted on 19 April 2007 and was part of the discussion for the EU position at the Codex Alimentarius and subsequent discussions with the Member States.

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Toxicology WG

Opinion on genotoxic and carcinogenic potential of buprofezin (an insecticide) in the context of the human risk assessment (self-tasking from EFSA PRAPeR Unit)

Opinion on the toxicological relevance of the soil and ground water metabolite TBSA of tritosulfuron in the context of the human risk assessment (question from the Commission)

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Guidance Documents

• EFSA’s new mandate transferred from the Commission to update/develop EU Guidance Documents for the risk assessment of pesticides

• Priority list was established by Member States (summer 2006)

• EFSA proposes to accelerate the procedure in externalizing part of the work where possible

• Stakeholder consultations – at beginning, and at the end of updating or developing new GDs

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Exposure to pesticides in food, wildlife

food intake per day (wet wt)

concentration on food type

fraction of food type in diet

fraction of diet obtained in

treated areas exposure(mg/kg bw/day)

initial concentration

LD50(mg/kg bw)

%Mortality

daily energy expenditure

body weight

gross energy content of food

moisture content of food

assimilation efficiency

application rate

residue per unit dose

slope ofdose- response

0 0.2 0.4 0.6 0.8 10

1

2

3

4

5

6

7

Fre

quen

cy

0 0.2 0.4 0.6 0.8 10

5

10

15

20

25

30

PT

Probability D

ensity

0 0.2 0.4 0.6 0.8 10

0.5

1

1.5

2

2.5

3

Fre

qu

en

cy

0 0.2 0.4 0.6 0.8 10

0.5

1

1.5

2

2.5

3

3.5

PD Insect - May

Pro

ba

bility D

en

sity

dose- response for skylark

0.0001 0.01 1 100 100000 0

20%

40%

60%

80%

100%

Dose [mg / kg BW / d]

% o

f sp

eci

es

0.0001 0.01 1 100 100000 0

20%

40%

60%

80%

100%

Dose [mg / kg BW / d]

% o

f sp

eci

es

LD50Median95% Confidence Interval

108 108 106 106

Mallard Duck

Bobwhite Quail

Mallard Duck

Bobwhite Quail

10-4

10-2

100

102

104

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Benzonitrile herbicideChlorinated cy clodiene insecticide

Dithiocarbamate f ungicideTriazine herbicide

Urea herbicideSy nthetic py rethroid

Phosphate insecticideQuaternary ammonium herbicide

Phosphorothioate insecticidePhosphorodithioate insecticide

Phosphorothioate insecticidePhosphonodithioate insecticide

Coumarin anticoagulant rodenticideDinitrophenol herbicide

Coumarin anticoagulant rodenticideIndandione anticoagulant rodenticide

Phosphoramidothioate insecticideMethy l-carbamate insecticide

Triazole f ungicideMethy l-carbamate insecticide

Pheny lpy razole insecticidePhosphonothioate insecticide

Triazole f ungicidePhosphorothioate insecticide

Oxime carbamateInorganic cy anide compound

Phosphinic acid herbicidePhosphorothioate insecticide

Chlorinated cy clodiene insecticide

Cum

ulat

ive

Pro

babi

lity

0 0.2 0.4 0.6 0.8 10

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

2

Fre

quen

cy

0 0.2 0.4 0.6 0.8 10

0.5

1

1.5

2

2.5

3

3.5

4

AE Plants

Probability D

ensity

25 30 35 40 45 50 55 600

0.02

0.04

0.06

0.08

0.1

Probab

ility De

nsity

25 30 35 40 45 50 55 600

0.02

0.04

0.06

0.08

0.1

Probab

ility De

nsity

BW [g]

Male BW

Female BW

1.2 1.4 1.6 1.8 21.6

1.8

2

2.2

2.4

2.6

log10

BW [g]

log 1

0 D

EE

[kJ

/ g]

Best Fit95% Prediction IntervalData

18 20 22 24 26 28 300

0.05

0.1

0.15

0.2

0.25

0.3

0.35

Fre

quen

cy

18 20 22 24 26 28 30Gross Energy Insects [kJ / g]

0 0.2 0.4 0.6 0.8 10

1

2

3

4

5

6

Fre

qu

en

cy

0 0.2 0.4 0.6 0.8 10

0.5

1

1.5

2

2.5

3

3.5

Moisture Content Insects

Pro

ba

bility D

en

sity

10 20 100 2000

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

Pro

babi

lity

Den

sity

RUD Insects

0 1 2 3 4 50%

20%

40%

60%

80%

100%

% o

f sky

lark

s

Immature Seeds

FIR / BW

0 1 2 3 4 50%

20%

40%

60%

80%

100%

% o

f sky

lark

s

FIR / BW

Sin

gle

Foo

d Ite

m

0 1 2 3 4 50%

20%

40%

60%

80%

100%

% o

f sky

lark

s

Mature Seeds

FIR / BW

0 1 2 3 4 50%

20%

40%

60%

80%

100%

% o

f sky

lark

s

FIR / BW

Mul

tiple

Foo

d Ite

ms

95% Confidence IntervalMedian

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Guidance Document on Bird & Mammal Risk Assessment

• Original SANCO document (2002)• Risk assessment mandate but good GD is wider• Protection goals, triggers, risk management decisions • Initial public consultation• Workshop & consultation with stakeholders (MS as

regulators and industry as practitioners)• Public consultation on draft final guidance - current• Status of Guidance Document

– EFSA opinion– endorsement/adoption by SCFCAH & MSs ?

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Possible ‘short circuit’ Article 36 proposals • Panel has heavy workload

• Tendered “Project to assess current approaches and knowledge with a view to develop a new Guidance Document for pesticide exposure assessment for workers, operators, bystanders and residents”

• A 9-month grant restricted to the list adopted by EFSA Management Board according to Article 36 of European Parliament and Council Regulation (EC) No 178/2002 [deadline 07/09/2007, contract under signature], a project to help the Toxicology WG to start its work.

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Article 36 Issues

• Need for clear specification of the tender (Panel involvement, conflicting interest)

• Independence of the successful contractor• Project must be managed to deliver the contract• The outcome must be usable/acceptable to the

PPR Panel • Time delays before the Panel picks up the issue -

(9 months preparation until signature, 9 month contract to deliver)

• Attractive but not perfect solution. The timeline is not necessarily reduced

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Communication of opinions

• The PPR opinions are published on the EFSA website as EFSA Journal (summary translated in 3 languages FR, DE, IT) : www.efsa.europa.eu

• Press releases and web story on the opinions raise accessibility to wider public and stakeholder community

• Regular information to Member State competent authorities, stakeholders and the European Commission

• Regular presentations (and posters) in scientific fora, symposia and Workshops

• Peer-reviewed scientific publications

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•Review dossiers

•Risk assessment Guidance Document revisions

•Cumulative Risk assessment of pesticides

•Uncertainty evaluation and quantification of risks

•Dialogue (stakeholders, MS)

•Expansion and communication with MS

•Maintenance of expertise

•Smarter working, remuneration of experts

Future Workload and Issues

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Thank you for your attention