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Guidance on the Assessment of Exposure for Operators, Workers, 3 Residents and Bystanders in Risk Assessment for Plant Protection 1 4 Products

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Guidance on the Assessment of Exposure for Operators, Workers, 3 Residents and Bystanders in Risk Assessment for Plant Protection 1 4 Products EFSA Journal 20YY;volume(issue):NNNN 1 GUIDANCE OF EFSA 2 Guidance on the Assessment of Exposure for Operators, Workers, 3 Residents and Bystanders in Risk Assessment for Plant Protection 1 4 Products 5 European Food Safety Authority2, 3 6 European Food Safety Authority (EFSA), Parma, Italy 7 8 ABSTRACT 9 Regulation (EC) No 1107/2009 has the purpose to ensure that the residues of the plant protection products, 10 consequent to application consistent with good plant protection practice and having regard to realistic conditions 11 of use, shall not have any harmful effects on human health. In 2010, the EFSA Panel on Plant Protection 12 Products and their Residues (PPR) prepared a Scientific Opinion on Preparation of a Guidance Document on 13 Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents (EFSA Journal 14 2010;8(2):1501), which highlighted some inconsistencies between the approaches adopted by regulatory 15 authorities. Therefore, the PPR Panel proposed a number of changes to practice in use (e.g. routine risk 16 assessment for individual PPPs should continue to use deterministic methods, and that a tiered approach to 17 exposure assessment remains appropriate; need of introducing an acute risk assessment for operators, workers 18 and bystanders, where PPPs are acutely toxic; for acute risk assessments, exposure estimates should normally be 19 based on 95th centiles of relevant data sets, whereas for longer term risk assessments, the starting point should 20 be a 75th centile). To prepare a Guidance Document an ad hoc working group was established to revise all the 21 available data and procedures to perform the operator, worker, bystander and resident risk assessment. In 22 addition to what reported in the PPR opinion, further data were made available to the working group which were 23 analysed and considered. The opinion also identifies those scenarios for which exposure estimates are least 24 satisfactory, and makes recommendations for further research that would reduce current uncertainties. A 25 calculator reflecting the content of the guidance is annexed to it, to support stakeholders in performing the 26 assessment of exposure and risk. 27 28 29 © European Food Safety Authority, 2014 30 31 KEY WORDS 32 exposure, operator, worker, bystander, resident, estimation, guidance, calculator 33 34 1 On request from European Commission, Question No EFSA-Q-2011-01062, approved on DD Month YYYY. 2 Correspondence: [email protected] 3 [If applicable] Acknowledgement: EFSA wishes to thank [the members of the Working Group on name of the WG]: name surname, name surname and name surname] [or] [the name of the WG/Network/EFSA Unit, etc.] for the preparatory work on this scientific output [and, if appropriate] [the hearing experts: name surname, name surname and name surname,] [and/or if appropriate] [EFSA staff: name surname and name surname] for the support provided to this scientific output. Suggested citation: European Food Safety Authority, 2014. Guidance on the Assessment of Exposure for Operators, Workers, Residents and Bystanders in Risk Assessment for Plant Protection Products. EFSA Journal 20YY;volume(issue):NNNN, 59 pp., doi:10.2903/j.efsa.20YY.NNNN Available online: www.efsa.europa.eu/efsajournal © European Food Safety Authority, 2014 Guidance on Pesticides Exposure Assessment of Operators, Workers, Residents and Bystanders 35 SUMMARY 36 37 (To be inserted) EFSA Journal 20YY;volume(issue):NNNN 2 Guidance on Pesticides Exposure Assessment of Operators, Workers, Residents and Bystanders 38 TABLE OF CONTENTS 39 Abstract .................................................................................................................................................... 1 40 Summary .................................................................................................................................................. 2 41 Table of contents ...................................................................................................................................... 3 42 Background as provided by the Commission ........................................................................................... 4 43 Terms of reference.................................................................................................................................... 4 44 Assessment ............................................................................................................................................... 5 45 1. Introduction ..................................................................................................................................... 5 46 2. Background Data ............................................................................................................................. 6 47 3. Definitions of exposed groups ....................................................................................................... 11 48 4. Overall approach ............................................................................................................................ 12 49 5. Default values proposed for the assessment .................................................................................. 14 50 5.1. Body weights ........................................................................................................................ 14 51 5.2. Breathing rates ...................................................................................................................... 14 52 5.3. Average air concentrations ................................................................................................... 15 53 5.4. Hectares treated per day ........................................................................................................ 15 54 5.5. Exposure durations ................................................................................................................ 16 55 5.6. Absorption values ................................................................................................................. 16 56 5.7. Default surface area of body parts ........................................................................................ 17 57 6. Methods for first tier exposure assessment .................................................................................... 17 58 6.1. Operator exposure ................................................................................................................. 17 59 6.2. Worker exposure ................................................................................................................... 23 60 6.2.1. Dermal exposure of workers ............................................................................................. 24 61 6.2.2. Dislodgeable Foliar Residue (DFR) ................................................................................. 25 62 6.2.3. Multiple Application Factor (MAF) ................................................................................. 25 63 6.2.4. Transfer Coefficient (TC) ................................................................................................. 25 64 6.2.5. Inhalation exposure of workers ........................................................................................ 27 65 7. Resident and bystander exposure................................................................................................... 28 66 7.1. Resident exposure ................................................................................................................. 30 67 7.1.1. Spray drift ......................................................................................................................... 30 68 7.1.2. Vapour .............................................................................................................................. 32 69 7.1.3. Surface deposits ................................................................................................................ 32 70 7.1.4. Entry into treated crops ..................................................................................................... 34 71 7.2. Bystander exposure ............................................................................................................... 35 72 7.2.1. Spray drift ......................................................................................................................... 35 73 7.2.2. Vapour .............................................................................................................................. 36 74 7.2.3. Surface deposits ................................................................................................................ 36 75 7.2.4. Entry into treated crops ..................................................................................................... 37 76 Conclusions ............................................................................................................................................ 39 77 Recommendations .................................................................................................................................. 39 78 References .............................................................................................................................................. 40 79 Appendices ............................................................................................................................................. 43 80 A. Cipac formulation codes ...............................................................................................................
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