EFSA Guidance document on operator and worker

exposure assessment Manuela TIRAMANI

Pesticides Unit

EFSA

2

OUTLINE

EFSA OpEx GD

Background Why a GD on operator and worker exposure? Different approaches all over EU (justified?) Available data satisfactory? EU harmonisation vs zonal approach Easy exercise? What the challenges? (challenges for evaluation) Data availability Statistical issues Selection of scenarios based on what? Driven by scenarios of concern or data availability? Public consultation Main comments Data gaps? Perspectives (who can do what)? (challenges for research and prevention)

3

EFSA OpEx GD

4

WHY A GD ON OPERATOR AND WORKER EXPOSURE?

EFSA OpEx GD

Pesticide risk assessments must be carried out for all scenarios of non dietary exposure Different approaches all over EU (justified?) Available data satisfactory? EU harmonisation vs zonal approach So far, models established over 20 years ago have been the standards to assess exposure of agricultural operators to PPPs, but they do not reflect current application techniques ( AOEM!) EFSA was asked by COM to proceed with the preparation of a Guidance Document Working group

The GD had to include:

•A quality assessment of the available databases •The derivation of regulatory percentiles from the most appropriate datasets

•The preparation of an operator exposure calculator spreadsheet

The WG basic idea was to establish a first tier exposure assessment

5

PREPARATORY WORK

EFSA OpEx GD

2007 EFSA “Project to assess current approaches and knowledge with a view to develop a Guidance Document for pesticide exposure assessment for workers, operators, bystanders and residents”) http://www.efsa.europa.eu/en/scdocs/doc/26e.pdf 2010 EFSA Scientific Opinion on preparation of a guidance document on pesticide exposure assessment for workers, operators, bystanders and residents. EFSA Journal 2010;8(2):1501 2011 Request from European Commission (A working group of risk managers was set up and a meeting took place in Brussels on 11 May 2011 to discuss about the specific questions raised by EFSA opinion) 2013 First draft of the GD circulated to MSs for commenting 2013 Finalisation of a new model developed by BfR (AOEM) 2013-2014 Revision of the first draft (inclusion of new data) 2014 (April-May) Public consultation 2014 (October) PUBLICATION

6

CHALLENGES - 1

EFSA OpEx GD

Easy exercise? No What the challenges? (challenges for evaluation) Data availability/representativeness/selection Statistical issues Due to the complexity Tier approach:

•Standardised first tier exposure assessment is available (most scenarios) •Scenarios not covered by standardised methods: the most appropriate ad hoc approach can always be proposed

( development of new data?) •Where a non-standardised higher tier exposure assessment is adopted, the justification should be clearly documented

7

CHALLENGES - 2

EFSA OpEx GD

What the challenges? Data availability ± representativeness ± selection +

Exposed category Database/model

Operator (field) German model

Operator (field) UK POEM

Operator (field) Agricultural operator exposure model

(AOEM)

Operator (field) EUROPOEM II

Operator (field) PHED

Operator (field) TNsG Biocides

Amateur ConsExpo

Amateur French data

Operator (greenhouse) Industrieverband Agrar (IVA)—Germany

Operator (greenhouse) Southern Europe

Operator (greenhouse) Dutch

Operator (seed treatment) SeedTropex

Worker EUROPOEM II

Worker German

Worker (fork lift driver, sowing) SeedTropex

Worker Transfer coefficient

Residents and bystanders EUROPOEM II

Residents and bystanders BREAM (Resident and Bystander Exposure

Assessment Model)

Residents and bystanders ConsExpo

Residents and bystanders Lloyd and Bell 1983 and 1987 (spray drift values)

Residents and bystanders CRD 2008

Residents and bystanders California EPA

Residents and bystanders Ganzelmeier spray drift data

Residents and bystanders BfR 2008

•Amount and quality of data? •Availability of data? •Selection of scenarios based on? •Driven by scenarios of concern or data availability?

8

CHALLENGES - 3

EFSA OpEx GD

Acute exposures derived as the higher of: (a) the 95th percentile of the distribution of measurements in the sample (the level of exposure an individual in the population can experience over a single day); or (b) a statistical estimate of the 95th percentile for the theoretical population of measurements from which the sample was derived, under the assumption that this population has a log-normal distribution Longer term exposures, derived as the higher of: (a) the 75th percentile of the distribution of measurements in the sample (the level of exposure an individual in the population can experience repeatedly each day over a season); or (b) a statistical estimate of the 75th percentile for the theoretical population of measurements from which the sample was derived, under the assumption that this population has a log-normal distribution Reasonable to depart from this default method if, for example, there were good evidence that the assumption of an underlying log-normal distribution was inappropriate Where only a small sample of relevant exposure measurements is available a decision must be made whether or not the dataset is adequate to support a valid risk assessment. The deterministic methods is still suggested in routine risk assessment for individual PPPs, because of the limitations of the currently available data

What the challenges? Statistical issues

9

CHALLENGES: 4

EFSA OpEx GD

Exposed group

PPPs with no potential for acute systemic toxicity

PPPs with potential for acute systemic toxicity

Operators L A, L

Workers L A (a), L Residents L L (A covered by bystander)

Bystanders L (covered by residents) A

Risk assessments that may be required

(a): An acute assessment is in principle needed but in the current Guidance insufficient data are available to perform it.

10

In particular for: •Body weights •Breathing rates •Average air concentrations •Hectares treated per day •Exposure durations •Absorption values •Default surface area of body parts

CHALLENGES: 5

EFSA OpEx GD

A further challenge was the analysis and harmonisation of default values to be used in the calculator

11

Finally, everything had to be included in a user-friendly calculator!

CHALLENGES: 5

EFSA OpEx GD

12

An issue that was raised by the PPR Panel, discussed in

the Working Group and rediscussed after te public

consultation is related to the appropriateness of health-

based reference values to be considered for the risk

assessment (AOEL vs AAOEL)

CHALLENGES: 6

EFSA OpEx GD

13

PUBLIC CONSULTATION - 1

EFSA OpEx GD

Comments received on the draft GD per stakeholder category

Stakeholder category Number of Comments

Authority 96 Academia/research 226

Agrochemical industry / ECPA 88 Consultancy 22

Farmers 3 NGOs

Others

27

3

TOTAL 465

14

PUBLIC CONSULTATION - 2

EFSA OpEx GD

Public consultation Main comments

Sections of the draft GD Number of Comments

General comments

Abstract 8

Summary

Table of contents

Background as provided by the Commission 9

Terms of reference 8

Assessment 18

1. Introduction 10

2. Background Data 13

3. Definitions of exposed groups 13

4. Overall approach 32

5. Default values proposed for the assessment 10

5.1. Body weights 10

5.2. Breathing rates 6

5.3. Average air concentrations 7

5.4. Hectares treated per day 17

5.5. Exposure durations 10

5.6. Absorption values -

5.7. Default surface area of body parts 1

6. Methods for first tier exposure assessment 4

6.1. Operator exposure 27

6.2. Worker exposure 16

6.2.1. Dermal exposure of workers 9

6.2.2. Dislodgeable Foliar Residue (DFR) 9

6.2.3. Multiple Application Factor (MAF) 15

6.2.4. Transfer Coefficient (TC) 27

6.2.5. Inhalation exposure of workers 12

7. Resident and bystander exposure 21

7.1. Resident exposure 12

7.1.1. Spray drift 29

7.1.2. Vapour 14

7.1.3. Surface deposits 14

7.1.4. Entry into treated crops 11

7.2. Bystander exposure 8

7.2.1. Spray drift 16

7.2.2. Vapour 9

7.2.3. Surface deposits 10

7.2.4. Entry into treated crops 10

Conclusions

154

115

15

EFSA OpEx GD

16

PERSPECTIVES - 1

EFSA OpEx GD

Data gaps The WoG highlights the following specific data gaps: •Operator: Seed treatment exposure scenarios, greenhouse exposure scenarios, home and allotment garden exposure scenarios and other minor scenarios are not covered by the Guidance. Water-soluble bags: the exposure deriving from ML activities is assumed to be 10 % of the corresponding formulation; however further data are needed. Less experienced operators: no data are available to model these cases (but operators and workers have to be trained) •Use of PPE A lot still needs to be done for an appropriate application of the proposed factors at the post-marketing level. •Workers Available data are not reliable enough to proceed with the acute exposure assessment (in particular with regard to the TC and DFR values); further collection/production of data on specific TC and DFR values is needed to produce more realistic exposure assessments.

17

PERSPECTIVES - 2

EFSA OpEx GD

Challenges for research and prevention EU Projects: e.g. BROWSE (close to finalisation) EU organisations: EFSA (e.g. surveys to define representative scenarios, literature search for relevant published papers) MSs: national initiatives to address specific scenarios (on exposure, on te use of PPE, etc…) Industry: field studies to address specific scenarios, to refine the current ones Academia: field studies integrating exposure and healt data (see EFSA activity on epidemiology)

18

ACKOWLEDGMENTS

EFSA OpEx GD

Members of the EFSA working group

•Claudia Grosskopf (BfR, Germany)

•Paul Y Hamey (CRD, UK)

•Kyriaki Machera (BPI, Greece)

•Sabine Martin (BfR, Germany)

•Walter Steurbaut (University of Ghent, Belgium)

•Jane Richardson (EFSA)

•Manuela Tiramani (EFSA)

• Text

Thank you Manuela TIRAMANI European Food Safety Authority Manuela.TIRAMANI@efsa.europa.eu