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Draft Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents

ECPA – IBMA- EFSA Workshop Parma, 26th April 2012

Committed since 2002 to ensuring that Europe’s food is safe

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Background

• In 2006 EFSA ran an investigation among MSs to ask the priorities of Guidance Documents

• One of the claims was the development of a new GD on operator exposure assessment

• Prioritised by EFSA

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Background

• 2007: Call to outsource the information gathering and evaluation of the existing models/activities (Art. 36. of Regulation 178/2002)

• 2008: Report from outsourced work carried out jointly by the UK Pesticides Safety Directorate (PSD) and the University of Ghent (UG).

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Scientific Opinion

• 2009: Public consultation on the draft scientific opinion on Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents, containing the draft GD (as an annex).

• In response to the comments received, various clarifications and amendments were made.

Public Consultation

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Table 2: Comments received on the draft opinion and GD per organizations and countries

Organization Country Number ECPA BEL 20 IPH BEL 8 Health Canada - Pest Management Regulatory Agency CAN 14 National Institute of Public Health CZE 1 Federal Environmental Agency DEU 1 Federal Institute of Risk Assessment Berlin DEU 17 Danish EPA DNK 1 INSHT/MTIN ESP 2 Finnish Institute of Occupational Health FIN 14 AFSSA (Agence Française de Sécurité Sanitaire des Aliments) FRA 22

BCPC GBR 1 Nufarm UK Ltd GBR 11 Health and Safety Executive GBR 1 Silsoe Spray Application Unit, The Arable Group GBR 10 JSC International Limited GBR 6 Toxicology Unit, PCS, Department of Agriculture, Fisheries & Food IRL 9

The Netherlands NLD 37 Swedish Chemicals Agency (KemI) SWE 9 US Environmental Protection Agency, Office of Pesticide Programs USA 2

Total number of comments 186

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Scientific Opinion

• 2010: Scientific Opinion on Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents, containing the draft GD (as an annex), adopted by the PPR Panel on 27 January 2010.

Available online: www.efsa.europa.eu/en/efsajournal/pub/1501.htm

• 2010: Outcome of the Public Consultation on the Draft Scientific Opinion on Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents

Available online: www.efsa.europa.eu/en/efsajournal/pub/1517.htm

Introduction • The starting point for this opinion was an outsourced project

carried out jointly by the UK Pesticides Safety Directorate (PSD) and the University of Ghent (UG).

• Relevant new data could be expected from several sources over the next five years. The PPR Panel concluded that it would be worth developing the Guidance Document for immediate use.

• This could then be revised, as and when new data emerged. • During drafting, the Panel aimed for a level of precaution

similar to, or somewhat higher than, that which is currently applied, but changing the level of precaution if necessary, can be performed without major restructuring of the text.

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Main contents • The opinion starts by defining the scope of the Guidance

Document (Section 2). • It then reviews the legal requirements that underpin the

relevant components of risk assessment for plant protection products (Section 3).

• It describes the methods of risk assessment that are currently used (Section 4), and considers their adequacy and limitations (Sections 5 and 6).

• Next it proposes a revised approach to exposure and risk assessment for operators, workers, residents and bystanders, and gives the underlying rationale (Section 7).

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Main contents • Section 8 then builds on the PSD/UG review, setting out

proposals for standard models and data sets that should be used as a default when estimating exposures for different scenarios, and giving reasons for choices where more than one option is available.

• Section 9 provides a link to the draft Guidance Document, which is set out in Appendix 1. Finally, there is a brief summary of conclusions and recommendations.

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Scope

• The Guidance Document is intended for use in relation to chemical PPPs

• It does not apply to biocides, which are the subject of separate legislation (Directive 98/8/EC), or to biological pesticides.

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Scope • Definitions of exposed groups Compatible with the draft Guidance Document on AOELs

that is currently in use. • The main focus of the opinion is risk assessment for systemic

toxicity it does not cover all the aspects of exposure that could be

relevant to localised toxicity such as respiratory irritation, and

it does not provide guidance on the quantification of dermal absorption.

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New approaches Proposed percentiles

• A particular challenge in exposure estimation is the wide variability (often over several orders of magnitude), between individual measurements of exposure associated with the same exposure scenario.

• One implication of the substantial variability of pesticide exposures for a given scenario is that the 50th or 75th centile from a set of measured exposures might importantly underestimate some individual exposures on a single day.

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New approaches Acute risk assessment

• In the current practice operator and other non-dietary pesticide

exposure assessments consider repeated exposure often geometric/arithmetic mean, 75th centile, 90/95th

centile exposure values occasional higher exposures not assessed

• The underestimation of exposure could be more important

where toxic effects could result from acute exposure on a single day.

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New approaches Acute risk assessment

• For PPPs which might cause toxicity through exposures on a

single day, a separate acute risk assessment should be carried out

• The acute risk assessment for operators, workers and bystanders will require the specification of a separate toxicological reference value, an “acute AOEL∗” (“AAOEL”), derived from a relevant study or studies.

• This should not require any additional use of experimental animals.

• The AAOEL should be used as a reference for realistic upper estimates of exposure in a single day for operators, workers and bystanders.

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New approaches Statistical variability

• Estimates of exposure derived from empirical data sets are subject to statistical uncertainty.

• This could lead to substantial underestimation of potential exposures

• To address this problem, in addition to the relevant centile of the empirical data set, a parametric estimate should be made of the corresponding centile in the theoretical population from which this sample of measurements was derived with the assumption that the population has a log-normal distribution.

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New approaches Proposed percentiles

• For risk assessments in relation to acute exposures (i.e. those that could occur in a single day), exposure estimates should as a default be derived as the higher of: a) the 95th centile of the distribution of measurements in the

sample; and b) a statistical estimate of the 95th centile for the theoretical

population of measurements from which the sample was derived, under the assumption that this population has a log-normal distribution.

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• For risk assessments in relation to longer term exposures, exposures should as a default be derived as the higher of: a) the 75th centile of the distribution of measurements in the

sample; and b) a statistical estimate of the 75th centile for the theoretical

population of measurements from which the sample was derived, under the assumption that this population has a log-normal distribution.

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New approaches Proposed percentiles

OPERATOR EXPOSURE • In current practice multiple models are used Pooling data? Data quality issues (EUROPOEM)

Professional judgement to select most “robust” individual data sets

• Typical (main) scenarios identified • Scenario exposure data sets taken from EUROPOEM, German

model, PHED and interpreted according to GD • Several scenarios without data, and protective surrogates

proposed

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Harmonisation Proposed methods and standard data sets

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Choices of standard models and underpinning data sets for first tier estimation of exposures in operators when mixing and loading

Scenario Formulation Sources of data

Dermal exposure Inhalation exposure

SOLIDS

1 a (i) Large scale (e.g. tractor-mounted) equipment

WP, SP German model (PDE)

[German model has most robust dataset]

PHED

[PHED has larger and more robust data set than EUROPOEM and German model]

(ii) GR, FG PHED (ADE)

[PHED has larger and more robust data set than EUROPOEM]

[Data for exposure to body not log-normal, use parametric estimate for 95th centile]

PHED

[PHED has larger and more robust data set than EUROPOEM]

[Data not log-normal, use parametric estimate for 95th centile]

Harmonisation Proposed methods and standard data sets

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Specific exposures during mixing/loading (potential exposures except where indicated otherwise)

Scenario Formulation Standard 75th and 95th Specific Exposure Centiles (mg exposure/kg a.s. mixed/loaded, excepted where stated otherwise)

Dermal exposure Inhalation exposure

SOLIDS 75th Centile 95th Centile 75th Centile

95th Centile

1 a (i) Large scale (e.g. Tractor mounted) equipment

WP, SP Hands 13.5

Hands 48.0

0.248

0.973

(ii) GR, FG Hands under protective gloves

0.00145 Body under coverall

0.00198

Hands under protective glove 0.00688 Body under coverall 0.036

0.0146

0.0784

(iii) WG, SG Hands 3.52 Hands 9.20 0.0332 0.140

1 b (i) Medium scale (e.g. Professional hand-held) equipment

WP, SP Hands under protective gloves 10.7

mg in-use preparation/min

Hands under protective gloves 39.4

mg in-use preparation/min

1.53 4.06

Harmonisation Proposed methods and standard data sets

WORKER EXPOSURE • EUROPOEM DFR & TC approach Potential dermal exposure (PDE) µg/day = DFR µg/cm2 x TC cm2/h x T h/day

DFR dissipation no data default t/2 = 30 days TC values

i) Total potential exposures ii) Arms, body and legs covered

• Inhalation exposure in greenhouses Potential inhalation exposure (mg a.s./hr inhaled) = Application rate (kg/a.s./ha) x

Task Specific Factor (ha/hr x 10-3)

• Residues in soil/compost 21

Harmonisation Proposed methods and standard data sets

RESIDENTS (i) • Spray drift Arable crop single pass 8m distant, dermal data 10x

adjustment Commission: level of precaution?

Orchard crop whole orchard 8m distant, no adjustment • Vapour drift using the method that has been developed in the

UK (CRD, 2008) and Germany (Martin et al., 2008) 24 h TWA

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Harmonisation Proposed methods and standard data sets

RESIDENTS (ii) • Exposure to surface deposits (fallout in garden) sum of dermal transfer, plus young children hand- and

object- to mouth • Entry into treated crops only dermal exposure, DFR as for workers, 15 minutes

exposure/day on treated lawn drift percentage 100%

• Residues in crops grown adjacent to treated areas - future?

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Harmonisation Proposed methods and standard data sets

BYSTANDERS • Same 4 pathways as residents Spray drift pathway 95th centile exposure spray values

Surface residues Higher TCs Higher hand-to-mouth frequency (20 events /hour)

Vapour drift and entry into treated crops same values as residents

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Harmonisation Proposed methods and standard data sets

• The Panel has also made proposals for default assumptions Body weights Adults & children

Breathing rates Latest EPA approach

Scale of use (work rates) Reflecting equipment used in data

PPE and level of protection TNO Review, similar to biocides

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Harmonisation Proposed methods and standard data sets

• Designed to assist risk assessors and notifiers when quantifying potential non-dietary, systemic exposures as part of regulatory risk assessment for plant protection products (PPPs).

• Risk assessments must be carried out for all scenarios of exposure to operators, workers, residents and bystanders that can be expected to occur as a consequence of the proposed uses of a PPP.

• Most exposure scenarios will fall into a category for which a standardised first tier exposure assessment can be applied as described in this document.

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Draft Guidance Document

Draft Guidance Document Overall approach

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International Fresenius Conference for the Agrochemical Industry Operator and Resident Exposure and Risk Assessment

Mainz, 13-14 December 2010

Risk assessments that may be required(a)

Exposure group PPPs with no significant potential

for toxicity from exposure in a single day

PPPs with significant potential for toxicity from exposure in a single

day Operators L A L Workers L A L Residents L L Bystanders A

(a): A = acute, L = longer term

Step one: Identification of risk assessments that are required

• Step two: Use standardised first tier methods of exposure assessment where available.

Where available, a single, relevant, standard dataset of adequate quality was identified and proposed by the PPR Panel for each exposure scenario. This should then be used to derive the exposure values that will be applied in the risk assessment.

• Step three: Use appropriate ad hoc methods where standardised first tier methods of exposure assessment are not available.

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Draft Guidance Document Overall approach

Recommendations

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• The PPR Panel recommends that a new guidance document on exposure assessment for operators, workers, residents and bystanders should be adopted along the lines of that set out in Appendix A.

• Risk managers in the European Commission wish to vary the level of precaution that is applied, the guidance should be modified accordingly.

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• Once the exact format of the guidance document has been agreed by risk managers, it should be published with a supporting spreadsheet to enable easy application by notifiers and regulatory authorities, and also a separate document detailing the derivation of specified exposure values from underlying datasets.

• The Guidance Document should thereafter be reviewed periodically, as and when relevant new data become available, and if appropriate, be revised.

Recommendations

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• Consultation of risk managers in the European Commission took place in May 2011- Risk management options (e.g. percentiles, default values) included in the draft guidance document were discussed and agreed.

• The outcome of these discussions was communicated to the Standing Committee on the Food Chain and Animal Health and to EFSA in 2011.

• As a consequence EFSA received an external mandate from the Commission, with the preparation of the EFSA Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents.

Current Mandate of EFSA

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• Preparation of an EXCEL calculator sheet facilitating the use of the methodologies presented in the EFSA Guidance

• An EFSA working group is being established to prepare this Guidance Document under the lead of the Pesticide unit.

• Circulating the draft EXCEL calculator to the Commission and stakeholders for a trial phase foreseen at the end of July 2012.

• Expected deadline for finalization of the EFSA Guidance: End of 2012.

Current Mandate of EFSA