Committed since 2002                          to ensuring that Europe’s food is safeDraft Guidance Document on Pesticide E...
Background• In 2006 EFSA ran an  investigation among MSs to  ask the priorities of Guidance  Documents• One of the claims ...
Background• 2007: Call to outsource the information gathering and  evaluation of the existing models/activities (Art. 36. ...
Scientific Opinion• 2009: Public consultation on the draft scientific opinion on  Preparation of a Guidance Document on Pe...
Public Consultation   Table 2:    Comments received on the draft opinion and GD per organizations and countries   Organiza...
Scientific Opinion• 2010: Scientific Opinion on Preparation of a Guidance  Document on Pesticide Exposure Assessment for W...
Introduction• The starting point for this opinion was an outsourced project  carried out jointly by the UK Pesticides Safe...
Main contents• The opinion starts by defining the scope of the Guidance  Document (Section 2).• It then reviews the legal ...
Main contents• Section 8 then builds on the PSD/UG review, setting out  proposals for standard models and data sets that s...
Scope• The Guidance Document is intended for use in relation to  chemical PPPs• It does not apply to biocides, which are t...
Scope• Definitions of exposed groups   Compatible with the draft Guidance Document on AOELs     that is currently in use....
New approachesProposed percentiles• A particular challenge in exposure estimation is the wide  variability (often over sev...
New approachesAcute risk assessment• In the current practice operator and other non-dietary pesticide  exposure assessment...
New approachesAcute risk assessment• For PPPs which might cause toxicity through exposures on a  single day, a separate ac...
New approachesStatistical variability• Estimates of exposure derived from empirical data sets are  subject to statistical ...
New approachesProposed percentiles• For risk assessments in relation to acute exposures (i.e. those  that could occur in a...
New approachesProposed percentiles• For risk assessments in relation to longer term exposures,  exposures should as a defa...
HarmonisationProposed methods and standard data setsOPERATOR EXPOSURE• In current practice multiple models are used   Poo...
HarmonisationProposed methods and standard data sets  Choices of standard models and underpinning data sets for first tier...
HarmonisationProposed methods and standard data sets   Specific exposures during mixing/loading (potential exposures excep...
HarmonisationProposed methods and standard data setsWORKER EXPOSURE• EUROPOEM DFR & TC approach   Potential dermal exposur...
HarmonisationProposed methods and standard data setsRESIDENTS (i)• Spray drift   Arable crop single pass 8m distant, derm...
HarmonisationProposed methods and standard data setsRESIDENTS (ii)• Exposure to surface deposits (fallout in garden)   su...
HarmonisationProposed methods and standard data setsBYSTANDERS• Same 4 pathways as residents    Spray drift pathway      ...
HarmonisationProposed methods and standard data sets• The Panel has also made proposals for default assumptions   Body we...
Draft Guidance Document• Designed to assist risk assessors and notifiers when  quantifying potential non-dietary, systemic...
Draft Guidance Document Overall approachStep one: Identification of risk assessments that are required                    ...
Draft Guidance DocumentOverall approach• Step two: Use standardised first tier methods of exposure  assessment where avail...
Recommendations• The PPR Panel recommends that a new guidance document  on exposure assessment for operators, workers, res...
Recommendations• Once the exact format of the guidance document has been  agreed by risk managers, it should be published ...
Current Mandate of EFSA• Consultation of risk managers in the European  Commission took place in May 2011- Risk management...
Current Mandate of EFSA• Preparation of an EXCEL calculator sheet facilitating the  use of the methodologies presented in ...
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Istvan Sebestyen - Workers operators bystanders and residents

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Istvan Sebestyen - Workers operators bystanders and residents

  1. 1. Committed since 2002 to ensuring that Europe’s food is safeDraft Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents ECPA – IBMA- EFSA Workshop 1 Parma, 26th April 2012
  2. 2. 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 2
  3. 3. 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). 3
  4. 4. 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. 4
  5. 5. Public Consultation 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 FRA 22 Aliments) 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, IRL 9 Fisheries & Food The Netherlands NLD 37 Swedish Chemicals Agency (KemI) SWE 9 US Environmental Protection Agency, Office of USA 2 Pesticide Programs Total number of comments 186 5
  6. 6. 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 6
  7. 7. 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. 7
  8. 8. 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). 8
  9. 9. 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. 9
  10. 10. 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. 10
  11. 11. 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. 11
  12. 12. New approachesProposed 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. 12
  13. 13. New approachesAcute 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. 13
  14. 14. New approachesAcute 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. 14
  15. 15. New approachesStatistical 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.   ( ) exp  x + t n −1,a * S * 1 + 1  n  15
  16. 16. New approachesProposed 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. 16
  17. 17. New approachesProposed percentiles• 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. 17
  18. 18. HarmonisationProposed methods and standard data setsOPERATOR 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 18
  19. 19. HarmonisationProposed methods and standard data sets 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 SOLIDS1 a (i) Large scale (e.g. tractor- WP, SP German model (PDE) PHED mounted) equipment [German model has most robust dataset] [PHED has larger and more robust data set than EUROPOEM and German model] (ii) GR, FG PHED (ADE) PHED [PHED has larger and more robust data set than [PHED has larger and more robust data EUROPOEM] set than EUROPOEM] [Data for exposure to body not log-normal, use [Data not log-normal, use parametric parametric estimate for 95th centile] estimate for 95th centile] 19
  20. 20. HarmonisationProposed methods and standard data sets 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 95th Centile Centile 1 a (i) Large scale (e.g. Tractor WP, SP Hands 13.5 Hands 48.0 0.248 0.973 mounted) equipment (ii) GR, FG Hands under Hands under 0.0146 0.0784 protective gloves protective glove 0.00145 0.00688 Body under coverall Body under coverall 0.00198 0.036 (iii) WG, SG Hands 3.52 Hands 9.20 0.0332 0.140 1 b (i) Medium scale (e.g. WP, SP Hands under Hands under 1.53 4.06 Professional hand-held) protective gloves 10.7 protective gloves 39.4 equipment mg in-use mg in-use preparation/min preparation/min 20
  21. 21. HarmonisationProposed methods and standard data setsWORKER 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
  22. 22. HarmonisationProposed methods and standard data setsRESIDENTS (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 22
  23. 23. HarmonisationProposed methods and standard data setsRESIDENTS (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? 23
  24. 24. HarmonisationProposed methods and standard data setsBYSTANDERS• 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 24
  25. 25. HarmonisationProposed 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 25
  26. 26. Draft Guidance Document• 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. 26
  27. 27. Draft Guidance Document Overall approachStep one: Identification of risk assessments that are required Risk assessments that may be required(a) PPPs with no significant potential PPPs with significant potential for Exposure group for toxicity from exposure in a toxicity from exposure in a single single day day Operators L AL Workers L AL Residents L L Bystanders A(a): A = acute, L = longer term International Fresenius Conference for the Agrochemical Industry Operator and Resident Exposure and Risk Assessment 27 Mainz, 13-14 December 2010
  28. 28. Draft Guidance DocumentOverall approach• 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. 28
  29. 29. Recommendations• 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. 29
  30. 30. Recommendations• 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. 30
  31. 31. Current Mandate of EFSA• 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. 31
  32. 32. Current Mandate of EFSA• 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. 32

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