Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment of plant protection products

Abstract

This guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of regulatory risk assessment for plant protection products (PPPs). It is based on the Scientific Opinion on 'Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders' developed by the EFSA Panel on Plant Protection Products and their Residue (PPR) in 2010. Highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e. use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments). In the first version of the guidance, issued in 2014, several scenarios for outdoor uses were included, with an annexed calculator, as well as recommendations for further research. The guidance has been updated in 2021 with the inclusion of additional scenarios and revision of default values, on the basis of the evaluation of additional evidence. To support users in performing the assessment of exposure and risk, an online calculator, reflecting the guidance content, has been further developed.

Keywords: bystander; calculator; exposure; operator; plant protection products; resident; worker.

Figure A.1

Overview of the study characteristics and different scenarios in the greenhouse database (BfR, 2020)

Figure A.2

Distribution of the area treated and the total amount of active substance applied on one day in the old greenhouse studies (red columns) and in both old and new greenhouse studies (green columns) (BfR, 2020)

Figure C.1

Acceptance criteria used for the BROWSE transfer coefficient database (BROWSE, 2016)

Figure D.1

Reported and calculated DT₅₀ values, and differences as regards reliability

Figure D.2

Distribution of DT₅₀ values as regards reliability of data points

Figure D.3

Histogram of DT₅₀ values as regards reliability of data points

Figure D.4

Histogram of DT₅₀ values as regards reliability of data points

Figure F.1

Overview of data considered by the US EPA, showing individual log₁₀ TC values for total dermal exposure (TDE, cm²/h) and the EPA crop activity clusters (codes are given in Table F.1)

1. Cluster group prefixes are: C = cotton; D = turf; G = greenhouse; H = hairy field crops; O = orchard crops; S = smooth field crops; T = trellis crops; and W = waxy field crops. Each group is shown separately in more detail below. The dashed red line is the current EFSA grapes TC, the dashed orange line = EFSA tree fruits TC and the dashed green line is the EFSA general TC. These EFSA TCs, and other values discussed below, assume workwear and bare hands so are analogous to the EPA approach.

Figure F.2

EPA Orchard and Trellis crop activity clusters, showing individual log₁₀ TC values for total dermal exposure (TDE, cm²/h)

1. The orchard Clusters are: OH = hand harvest; OHn = mechanical harvest nuts; OP = hand pruning, scouting, & similar; OT = thinning; and OW = weeding and similar. Trellis clusters are: THb = hand harvest cane berries; THjg = hand harvest juice/wine grapes; THrg = hand harvest raisin grapes; Tp = hand pruning, scouting and similar; and Tx = intense contact (cane turning). The dashed red line = EFSA grapes TC; dashed orange line = EFSA Tree fruits TC, and the dashed green line = EFSA General TC.

Figure F.3

EPA Greenhouse crops activity clusters, showing individual log₁₀ TC values for total dermal exposure (TDE, cm²/h)

1. The three clusters are: GHf = Floriculture hand harvesting; GHv = vegetables hand harvesting and similar; and GN = greenhouse & nursery all activities. For the greenhouse crops, the EFSA TCs are dashed red line = Ornamentals, dashed orange line = Strawberries and dashed green line = Vegetables.

Figure F.4

EPA Field crop activity clusters, showing individual log₁₀ TC values for total dermal exposure (TDE, cm²/h)

1. Hairy leaf clusters: HH = hand harvest; HHt = tobacco hand harvest, canopy management; and HS = scouting and similar. Smooth leaf clusters: SH = hand harvest & tying; SSr = row conditions scouting; SSs = solid stand scouting; SW = weeding, thinning and similar; and Sx = intense contact (e.g. hand harvest sweet corn). Waxy leaf clusters: WIH = low height hand harvest and similar; WIS = low height scouting; and Wm = medium height all activities, full foliage weeding. Dashed lines are: red = EFSA Tree fruit TC, orange = EFSA Vegetables TC and green = EFSA General TC.

Figure F.5

EPA Turf activity clusters, showing individual log₁₀ TC values for total dermal exposure (TDE, cm²/h)

1. DH = sod harvesting, scouting, transplanting and hand weeding DM = golf course maintenance. The comparisons are red line = EFSA Tree fruit TC, orange line = EFSA Golf course (Vegetables) TC, and green line = EFSA General TC.

Figure F.6

EPA Cotton mechanical harvesting activity clusters, showing individual log₁₀ TC values for total dermal exposure (TDE, cm²/h) The activities are: CHm = module builder operator; CHp = picker operator & raker; and CHt = tramper. Here the red line = EFSA Tree fruit TC, orange line = EFSA Vegetables TC, and green line = EFSA General TC. Although, again it should be noted that the cotton TCs are derived from boll residue not DFRs.

Figure F.7

EPA Irrigation activity cluster, showing individual log₁₀ TC values for total dermal exposure (TDE, cm²/h)


1. The red line = EFSA Tree fruit TC, orange line = EFSA Vegetables TC and green line = EFSA General TC.

Figure G.1

Relative distribution of exposure based on 75th percentile of the measured exposure of workers removing bolting beets. (hands = handwash + gloves)

Figure G.2

Determination of the decline rate for DFR on leaves of sugar beets. The chequered rectangle represents the AUC without dissipation of residue. With dissipation, only the area of the rectangle below the blue regression curve should be considered. The ratio between both areas was used as correction factor