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HArmonised environmental Indicators for pesticide Risk

Occupational indicators
Operator, worker and bystander
















SSPE-CT-2003-501997
Alterra
Wageningen
The Netherlands

Biologische Bundesanstalt
Kleinmachnow
Germany

Central Science Laboratory
Sand Hutton
United Kingdom
Central Service for Plant
Protection and Soil
Conservation
Hungary

Cranfield University,
Silsoe,
United Kingdom

Helmholtz - Centre for
Environmental Research
Leipzig-Halle
Germany

Forschungsinstitut fr
biologischen Landbau , Frick
Switzerland

International Centre for
Pesticides and Health Risk
Prevention, Milan, Italy

Institute for Environment and
Sustainability
Ispra, Italy

Istituto Mario Negri
Milan
Italy

Joint Research Centre,
European Commission,
Ispra, Italy

Laboratory of Crop
Protection Chemistry
Gent
Belgium

National Environmental
Research Institute
Silkeborg
Denmark

National Institute for Public
Health and the Environment
Bilthoven
The Netherlands

Norwegian Institute for
Agricultural and
Environmental Research
s, Norway

Universit Cattolica
del Sacro Cuore
Piacenza
Italia

Universit catholique
de Louvain
Louvain-la-Neuve
Belgium
University of York
York
United Kingdom

Veterinary and Agrochemical
Research Centre
Tervuren
Belgium





This publication was funded by the EU sixth Framework Programme, within the
project HArmonised environmental Indicators for pesticides Risks, HAIR, contract
number SSPE-CT-2003-501997. The report does not represent the views of the
Commission or its services

Occupational indicators - Operator, worker and bystander




Authors:

Ir. Floortje Garreyn
1
,
Ir. Bndicte Vagenende
1
,
Prof. Dr. Ir. Walter Steurbaut
1


1 = Ghent University, Belgium







Contact persons for report on occupational indicators:
Ir. Floortje Garreyn E-mail: Floortje.Garreyn@UGent.be
Prof. Dr. Ir. Walter Steurbaut E-mail: Walter. Steurbaut@UGent.be

Contact person for the HAIR project:
Robert Luttik E-mail: Robert.Luttik@RIVM.NL


















Acknowledgements

This work has been funded by the European Union within the 6th framework (FP6, STREP:
Harmonized Environmental Indicators for Pesticide Risk, SSPE-CT-2003-501997).

Our thanks goes out to the project partners and the numerous experts that were willing to give
advice, in particular: Dr. ir. C. Vleminckx (Scientific Institute of Public Health), Prof. Dr. J.
Willems (Superior Health Council Belgium; Ghent University, Department of Public Health,
Faculty of Medicine and Health Sciences), Dr. F. Mettruzio and Dr. S. Visentin (International
Centre for Pesticides and Health Risk Prevention, Luigi Sacco Hospital and University (ICPS)),
Prof. Dr. M. Trevisan (Universit Cattolica del Sacro Cuore, Piacenza, Italy), M. Calliera
(University of Milano Bicocca), Prof. Dr. G. Matthews (IPARC, Imperial College, Silwood
Park), Dr. P.G. Pontal (Rhone Poulenc Agro), Prof. Dr. T. Arcury (Department of Family and
Community Medicine, Wake Forest University School of Medicine, Winston-Salem), Dr. R.
Brown (PSD), Dr. J.J. van Hemmen (TNO Chemistry, Zeist, The Netherlands), Dr. M. Thomas
(CSL), Dr. V. Flari (CSL), Dr. R. Glass (CSL), A. De Jong (Alterra Green World Research), Dr.
R. Kruijne (Alterra Green World Research), Dr. J. Deneer (Alterra Green World Research), Dr.
D.R. Johnson (ARTF), Dr. G. Herndon (U.S. EPA), Dr. C. Eiden (U.S. EPA), Dr. S.Tayadon
(U.S. EPA), Dr. D. Miller (U.S. EPA), Dr. P. Price (the LifeLine Group), Dr. R. Luttik (RIVM),
P. van Vlaardinghen (RIVM), J. Pineros (FOD Volksgezondheid, Veiligheid van de
Voedselketen en Leefmilieu), V. Van Bol (FOD Volksgezondheid, Veiligheid van de
Voedselketen en Leefmilieu), L. Pussemier (VAR), B. Vagenende (Ghent University), S.
Vergucht (Ghent University) and W. Steurbaut (Ghent University).



Contents
I. INTRODUCTION....................................................................................................................................... 1
II. ACUTE INDICATORS............................................................................................................................... 6
1. PESTICIDE OPERATOR ................................................................................................................................ 6
Introduction ................................................................................................................................................................ 6
Proposed Pesticide Operator Indicator ....................................................................................................................... 7
Exposure ............................................................................................................................................ 7
Toxicity............................................................................................................................................. 12
Risk Index......................................................................................................................................... 14
2. RE-ENTRY WORKER................................................................................................................................. 15
Introduction .............................................................................................................................................................. 15
Proposed Re-Entry Worker Indicator ....................................................................................................................... 15
Exposure .......................................................................................................................................... 15
Toxicity............................................................................................................................................. 28
Risk Index......................................................................................................................................... 28
3. GREENHOUSE WORKER............................................................................................................................ 29
Proposed Greenhouse Worker Indicator................................................................................................................... 29
Exposure .......................................................................................................................................... 29
Toxicity............................................................................................................................................. 32
Risk Index......................................................................................................................................... 33
4. BYSTANDER............................................................................................................................................. 34
Introduction .............................................................................................................................................................. 34
Proposed Bystander Indicator................................................................................................................................... 36
Exposure .......................................................................................................................................... 36
Toxicity............................................................................................................................................. 45
Risk Index......................................................................................................................................... 45
5. SENSITIVE POPULATION GROUPS.............................................................................................................. 47
Children................................................................................................................................................................... 47
Factors determining the unique vulnerability of children......................................................................................... 47
Exposure routes ........................................................................................................................................................ 48
Proposed algorithms for assessing childrens exposure to pesticides ....................................................................... 49
Exposure .......................................................................................................................................... 49
Toxicity............................................................................................................................................. 53
Risk Index......................................................................................................................................... 54
Pregnant women..................................................................................................................................................... 55
Factors determining the vulnerability of pregnant women ....................................................................................... 55
Uncertainty factor..................................................................................................................................................... 55
Default values........................................................................................................................................................... 56
III. PROPOSED CHRONIC INDICATORS............................................................................................ 57
1. PESTICIDE OPERATOR .............................................................................................................................. 57
Proposed Pesticide Operator Indicator ..................................................................................................................... 57
Exposure .......................................................................................................................................... 57
Toxicity............................................................................................................................................. 58
Risk Index......................................................................................................................................... 58
2. RE-ENTRY WORKER................................................................................................................................. 59
Proposed Re-Entry Worker Indicator ....................................................................................................................... 59
Exposure .......................................................................................................................................... 59
Toxicity............................................................................................................................................. 63
Risk Index......................................................................................................................................... 63
3. GREENHOUSE WORKER............................................................................................................................ 64
Proposed Greenhouse Worker Indicator................................................................................................................... 64
Exposure .......................................................................................................................................... 64
Toxicity............................................................................................................................................. 65
Risk Index......................................................................................................................................... 65
4. RESIDENT ................................................................................................................................................ 66
Introduction .............................................................................................................................................................. 66
Proposed Resident Indicator..................................................................................................................................... 68
Exposure .......................................................................................................................................... 68
Toxicity............................................................................................................................................. 71
Risk Index......................................................................................................................................... 72
IV. AGGREGATE AND CUMULATIVE RISK ASSESSMENT.......................................................... 73
Introduction .............................................................................................................................................................. 73
Overview of approaches to handle cumulative assessments..................................................................................... 75
Proposed Methodology to handle cumulative assessments....................................................................................... 78
Overview of methodologies to handle aggregate assessments.................................................................................. 81
Proposed methodology to handle aggregate assessments ......................................................................................... 83
V. OVERALL OCCUPATIONAL AND HUMAN HEALTH RISK INDEX........................................... 84
1. OVERALL OCCUPATIONAL RISK INDEX................................................................................................... 84
2. OVERALL HUMAN HEALTH RISK INDEX.................................................................................................. 84
3. WEIGHTING FACTORS.............................................................................................................................. 85
VI. CALCULATION OF THE ACUTE & CHRONIC INDICATORS................................................. 86
1. PESTICIDE OPERATOR .............................................................................................................................. 86
Case I........................................................................................................................................................................ 86
Case II ...................................................................................................................................................................... 87
Case III ..................................................................................................................................................................... 90
2. RE-ENTRY WORKER................................................................................................................................. 99
3. BYSTANDER/RESIDENT.......................................................................................................................... 107
VII. PRIORITISATION OF ACTIONS FOR REDUCING PESTICIDE IMPACT ........................... 114
1. PESTICIDE OPERATOR ............................................................................................................................ 115
Introduction ............................................................................................................................................................ 115
Factors influencing exposure.................................................................................................................................. 115
Specific exposure mitigation measures................................................................................................................... 116
2. RE-ENTRY WORKER............................................................................................................................... 121
3. BYSTANDER/RESIDENT.......................................................................................................................... 123
Introduction ............................................................................................................................................................ 123
Factors influencing exposure.................................................................................................................................. 123
Specific exposure mitigation measures................................................................................................................... 128
4. QUANTITATIVE ASSESSMENT OF MITIGATION MEASURES ...................................................................... 132
VIII. VALIDATION.................................................................................................................................... 134
1. PESTICIDE OPERATOR ............................................................................................................................ 137
2. RE-ENTRY WORKER............................................................................................................................... 138
Validation through biological monitoring .............................................................................................................. 138
Evaluation of indicator assumptions....................................................................................................................... 140
3. BYSTANDER/RESIDENT.......................................................................................................................... 143
Validation through biological monitoring .............................................................................................................. 143
Evaluation of indicator assumptions....................................................................................................................... 143
IX. CITED LITERATURE...................................................................................................................... 156
X. ANNEXES......................................................................................................................................................
Annex I: EUROPOEM.................................................................................................................................................
Annex II: Grouping of formulation types into categories.............................................................................................
Annex III: Linking crops and application methods & categorizing them.....................................................................
Annex IV: Exposure mitigation efficiency...................................................................................................................
Annex V: Dermal absorption........................................................................................................................................
Annex VI: Inhalation absorption ..................................................................................................................................
Annex VII: Agricultural Default Transfer Coefficients................................................................................................
Annex VIII: Foliar half life times.................................................................................................................................
Annex IX: Estimated number of workdays a year ........................................................................................................
Annex X: Spraying schemes used for validation and prioritisation..............................................................................




1
I. Introduction

Annex VI of the European Council Directive 91/414EEC of 15 July 1991 provides detailed
rules (Uniform Principles) for the evaluation of information submitted by applicants and for
the authorization of plant protection products by individual member states. One of the general
principles of the evaluation process (1(b)) under Annex VI is that member states shall
identify the hazards arising, assess their significance and make a judgement as to the likely
risks to humans, animals or the environment (EUROPOEM II, 2002).

One of the specific principles of the evaluation process under Annex VI relates to the
assessment of the impact on human health. The assessment requires that Member States shall
evaluate the operator exposure to active substances and/or to toxicologically relevant
compounds in the plant protection product likely to occur under the proposed conditions of
use (including in particular: dose, application method and climatic conditions). Realistic data
on exposure should be used and, if such data are not available, one should apply a suitable,
validated calculation model. The assessment also requires that Member States shall evaluate
the possibility of exposure of other humans (bystanders or workers exposed after the
application of the plant protection product) or animals to the active substance and/or to other
toxicologically relevant compounds in the plant protection product under the proposed
conditions of use (EUROPOEM II, 2002).

For many plant protection products and use patterns field studies of operator exposure have
not been generated. Therefore, in many cases predictive models are used to estimate likely
levels of operator exposure. It was determined that such models should be able to provide
initial estimates of likely total potential exposure, for use at the first tier stage of a tiered
approach to assessing operator exposure and risk. Within the EU various national authorities
use three predictive models in their authorization processes. These models are the UK-POEM
(JMP, 1986; Martin, 1990; POEM, 1992), the German model (Lundehn et al., 1992) and the
Dutch model (van Hemmen, 1992; van Golstein Brouwers et al., 1996; Snippe et al., 2002)
which were developed in isolation. Two comprehensive comparisons of the various predictive
models have been published (van Hemmen, 1993; Kangas & Sihvonen, 1996). These reviews
describe the features of the models and analyse how the differences between them affect the
outputs. Comparison of the exposure estimates for five different pesticide formulations
highlighted the need for model harmonization in Europe. In addition predictive models were
needed for assessing the exposure of re-entry workers and bystanders. Within this context,
the EUROPOEM project was established. The EUROPOEM Working Group gathered as
many high-quality, well documented exposure studies as possible in one unique and readily
available source. As a result of this the EUROPOEM database was developed. This database
was extended in the EUROPOEM II project. Recently a new predictive database for human
exposure has been developed, namely the AHED database (Agricultural Handlers Exposure
Database), which has a European version as well as an American one. The reviewing of
EUROPOEM II data as well as a number of industry studies including some new studies
conducted by the ECPA (European Crop Protection Agency) for inclusion in the European
version of AHED has been finalised (about 115 studies in total) (pers. comm. Pontal, 2006).
AHED is ready for use but the EU authorities have not yet reached a decision concerning the
acceptance of AHED (pers. comm. Pontal, 2006; pers. comm. van Hemmen, 2006).
2
AHED is a harmonised model underpinned by high quality generic databases of field studies
relevant to European and American exposure conditions and incorporates the best features of
all the available models. The AHETF (Agricultural Handlers Exposure Task Force), in
cooperation with the European Crop Protection Association (ECPA) developed the database
software, accessible via a web-based server, for handling the data entry, calculations and data
analysis. A common database software tool will be used for risk assessments both in North
America and Europe. However, the data generated in Europe will be uploaded to the
European version and the AHETF data will be uploaded to the North American (AHETF)
version. Thus, the software for both the European and the American version is the same, but
only the data that are applicable to each continent are uploaded in the respective databases.
The Agricultural Handlers Exposure Database will only contain data that regulators have
deemed appropriate for use in a generic database (www.exposuretf.com). The AHED
database is a management system running under a Microsoft SQL server and will be able to
handle probabilistic assessments (in the future, not at the moment due to lack of data, pers.
comm. Pontal, 2006). The database will be able to provide percentiles, means and
distributions of exposure. AHED might rectify the deficiencies of EUROPOEM. Ideally this
database could have been used in the HAIR project if a decision concerning the use of AHED
had already been taken. In order to keep the database up-to-date field studies should be
conducted in the future to fill in the data gaps and to gather data for new techniques and
formulation types. These studies should be designed in such a way that the results can easily
be incorporated in the database. Therefore a harmonized protocol for the conduct of field
studies of operator exposure to plant protection products should be established.
Outside Europe the US Pesticide Handlers Exposure Database (PHED) is currently used,
awaiting the approval of AHED. This predictive model is based on the generic PHED
database of published and unpublished studies carried out by industry and other scientists.
The initial version 1.1 (PHED, 1992) was revised in order to include studies from other
countries. A further update has been abandoned. The American version of AHED was
developed by an industry task force AHETF
1
, with US EPA and Health Canadas Pesticide
Management Regulatory Agency (PMRA) participation and oversight to replace the PHED.
The defficiences of the current PHED were taken into consideration while developing AHED
and were rectified as much as possible. It has to be mentioned that the information from the
AHETF database may only be used for regulatory decisions for those members who have
sponsored the research. The American version of the proprietary exposure database will be
used by USEPA, California Department of Pesticide Regulation (CDPR), and Canada's Pest
Management Regulatory Agency (PMRA) to evaluate member companies' products
(www.exposuretf.com).

Within the framework of the HAIR project, Ghent University developed acute as well as
chronic indicators in order to assess the occupational risk to pesticides. Moreover special
attention was paid to sensitive population groups such as children and pregnant women. The
risk for applicators, workers in agriculture and bystanders/residents is assessed by the use of
risk indices. A risk index (RI) is the quotient of the estimated human exposure and a
toxicological reference dose (AOEL, Acceptable Operator Exposure Level). The global

1
The AHETF is a consortium of 18 agricultural chemical companies that formed a limited-liability company
(L.L.C.) task force. These companies are pooling their technical and financial resources to satisfy regulatory
requirements for data on exposure of agricultural workers who mix, load and/or apply pesticides.

3
process of the assessment of risks to humans exposed to pesticides is represented in diagram
form (Fig. I.1.1).

Figure I.1.1 Risk evaluation of pesticides: principle for computing the worker indicators

According to the decisions taken in the most recent HAIR project meetings (22
nd
-24
th
May
2004, the Netherlands, 22
nd
23
rd
September 2004, Belgium, 14
th
15
th
16
th
March 2005,
UK, 22
nd
23
rd
September 2005, Hungary and 13
th
14
th
15
th
March 2006, Italy, 13
th
14
th

November, 2003, Bonn) the following steps will be followed to calculate the acute and
chronic risk indicators for the occupational human health compartment:

FIRST STEP: CALCULATION OF THE BASIC RISK INDICATOR
This basic risk indicator corresponds closely to the first tier regulatory procedures approved
by the European Union. The output of the Risk indices is expected to comply with the
endpoints set in Annex VI of the European Union Directive 91/414 and the most recent
Guidance document from the European Commission. The risk indicators are expressed as risk
indices. This complies with the decisions made by the HAIR consortium at the Steering
Committees held so far. The occupational indicator work package consists of three different
indicators: the operator, the re-entry worker and the bystander/resident indicator.
Moreover, special attention was paid to sensitive population groups such as children and
pregnant women. Below a short description on the principles of the indicators is presented.

Operator Exposure Risk Assessment for different application scenarios

Tier 1: The human exposure for applicators is estimated using the human exposure model
EUROPOEM. The EUROPOEM database is a generic database of monitored operator
exposure studies relevant to plant protection products in European agriculture. Experimental
exposure studies of the applicator during mixing/loading and application of pesticides are
compiled in one database. Annex I gives additional information on the EUROPOEM (I & II)
model. We opted for this model since the EUROPOEM model is currently being revised
within the framework of AHED. It is very important that a decision concerning AHED
follows in the near future. It would be best if the European version of AHED could be used in
the HAIR Operator Indicator. We contacted Dr. Pierre Gerard Pontal, who reviewed
EUROPOEM II data as well as a number of industry studies including some new studies
conducted by ECPA (about 115 studies in total) to incorporate them into the AHED database.
This process has been finalized, but the agreement of the EU authorities is essential for
acceptance of AHED in the EU. This topic has not yet been discussed in a meeting with
experts. The UK-POEM model and the German model were not chosen since we opted for a
harmonised European Model. The German model is based on published and non published
hazard identification
data set
exposure assessment
estimation of the human exposure dose (ED)
effect assessment
toxicological reference dose (TRD)
risk characterisation
RI = ED/TRD
4
studies conducted by the German phytopfarmaceutical companies. Since only German studies
were taken up in the database, this database does not seem relevant for use in risk assessment
on the European level. The UK-POEM model was also not selected for use in the HAIR
operator indicator since this model has not been updated, expecting EUROPOEM to be
accepted in Europe by the European Commission (van Hemmen et al., 2005).

Tier 2: Generation of specific/customised higher tier scenarios is only possible when relevant
data from product specific exposure studies and dermal penetration studies are available. Also
the actual mitigation provided by PPE can be incorporated at the higher tier level.

Worker Exposure Risk Assessment for different re-entry scenarios

Tier 1 & 2: The worker risk assessment is based on the generic assumption on initial
Dislodgeable Foliar Residues (DFR) and a database for transfer factors to give single
conservative point estimates (surrogate values) for total potential exposure, fully exploiting
the capacity of the database which is applicable to a range of re-entry scenarios common to
European conditions. If the estimated re-entry exposure is within the AOEL no further action
is required. Exposure mitigation factors (i.e. exposure reduction coefficients for PPE pertinent
to the case) are taken into account at Tier 2. Taking into account this supplementary use
specific information is a refinement of the exposure estimation and thus reduces uncertainty.

Tier 3 & 4: Generation of specific/customised higher tier scenarios is possible when relevant
additional data on dislodgeable foliar residue studies and their dissipation curves from foliar
dislodgeable residue studies under actual conditions are available. Also data on product-
specific percutaneous absorption can be taken into account when available (Tier 3). At the
highest tier (Tier 4) product specific data from biological monitoring studies or re-entry
exposure studies on the active substance under consideration and the actual re-entry
conditions should be used. This provides absolute exposure data and places the greatest
demands upon the quality and the relevance of the data required. Re-entry restrictions have to
be developed when the AOEL is exceeded. Regulatory authorities of the different Member
States have already established retricted re-entry intervals for several actives applied in
various crops.

Bystander Exposure Risk Assessment

The Bystander Working Group agreed to adopt a two tiered approach to exposure estimation.

Tier 1: A first tier bystander exposure value is estimated according to the likely level of
particle drift likely to directly contaminate bystanders who are located within the range of
spray drift fallout. A series of working values for this level was generated from available
published measurements of bystander contamination by spray drift (i.e. from UK CSL studies
in EUROPOEM I). Corresponding simultaneously measured levels of spray drift fallout were
available for direct comparison.

Tier 2: Second tier estimates of likely bystander exposure are to be based upon measurements
made in the field, according to the needs for specific data. Such measurements should be
based upon study of realistic situations representative for specific cases. Measured values may
be gathered using a suitable methodology, which ideally should allow correlation with
measurements of ambient environmental contamination (e.g. spray drift deposition, airborne
vapour concentrations) in the relevant situation, in order to aid interpretation of results and
5
allow controlled comparison with other similar data as far as possible. Specific/customised
higher tier scenarios take into account the presence of buffer strips and the use of low drift
nozzles amongst others.

Currently no such data are available for use in predictive modelling for the purpose of general
risk evaluation. Therefore individual field studies should be conducted in order to perform a
more exact evaluation of the levels of bystander exposure to specific pesticides used under
particular conditions. Due to the possibly greater variability of bystander exposure opposed to
that of workers and operators, individual studies should be conducted following standard
procedures taking into account current and new application technologies and risk mitigation
measures.

SECOND STEP: CALCULATION OF THE ADVANCED RISK INDICATOR
In this second step refined tier information, when available, is incorporated to calculate the
advanced risk indicators. This refined tier information includes new exposure estimates in
relation to results from field trials incorporating field data for other regions in Europe, dermal
absorption studies, data on the effectiveness of personal protective equipment (PPE),
refinement of the default transfer factors used to calculate re-entry worker exposure, etc.
According to decisions made at the Steering Committee Meeting held on the 16
th
of March
2005, the absence of refined tier information does not lead to re-estimated exposure values.
The risk indices will automatically adjust to the trigger values corresponding to the approved
status of the plant protection products by the regulatory authorities. Other refined tier
information, as there are label precautions or restrictions for use, is also expected to be
incorporated. Due to the different approaches of regulatory authorities in the different member
states, these refined indicators may differ. Moreover an extra level of uncertainty may be
incorporated due to lack of information regarding the degree of compliance of farmers with
label precautions and/or mitigation procedures (Good Agricultural Practices). This uncertainty
can only be quantified if farmer practises are regularly monitored. Moreover the uncertainties
concerning the missing link regarding the key effects in the field have to be highlighted (Flari
& Hart, 2006).

THIRD STEP: WEIGHTING THE RISK INDICES
By applying weight factors the actual/local parameters which may affect the likelihood of
exposure of the population, of susceptible subjects or subgroups will be taken into account.
The risk for certain regions can be weighed according to the population density in particular
regions. The risk for the applicators and workers can be weighed according to the number of
applicators/workers in particular regions. This weighting of the risk indices and its relation to
the actual usage data of plant protection products constitute a suggestion for aggregating the
risk that they pose onto workers in the field or greenhouses. The risk for sensitive population
groups contributes, as a default, for 5% to the total risk (pers. comm. van Hemmen, 2006). An
overall human health risk index can be calculated by attributing weight factors to the
consumer and applicator indicators according to the composition of the population. These
weight factors should be based on national or regional statistics, which should be available in
all the Member States.

In the first part of this report, the acute worker risk indicators are described, followed by an
outline of the chronic risk indicators. In a third phase the different worker indicators are
calculated for several case-studies.

6
II. Acute Indicators

For the calculation of the acute worker indicators, the formulas of the POCER (Pesticide
Occupational and Environmental Risk Indicator) are used (Vercruysse et al., 2002; Maraite et
al., 2005). The POCER indicator is based on the acceptance criteria formulated in Annex VI
of the European Council Directive 91/414/EC. In Annex VI, the Uniform Principles for the
evaluation and acceptance of plant protection products are set. Dependent on the availability
of specific data on the use of PPE, the area treated, the indicator can be adapted to the real
situations of each country. When no data are available, default values will be used to calculate
the worker indicators.

The acute indicators are outlined in detail below.

1. Pesticide operator

Introduction

Pesticide handlers or operators are persons who mix, load and apply the pesticides. They are
usually considered to receive the greatest exposure because of the nature of their work, and
are therefore at highest risk for acute intoxications. The potential for development of long-
term adverse health effects depends on several factors: types of pesticides handled, frequency
of application (times per season) and exposure duration (years of application) are the most
important ones (Fenske et al., 2005). This worker population has been the subject of
significant regulatory scrutiny, and exposure databases have been developed both in North
America and Europe to better understand the extent and variability of exposure.

Exposure also depends on the type of task performed by an individual, and it is therefore
important to collect data for each. Different tasks that can be identified are mixing/loading,
application, mixing/loading/application, flagging and other activities (cleaning of equipment,
soil incorporation of an herbicide immediately after application,). The exposure during
specific handling events can be modified by several important factors, as follows: type of
equipment used, formulation, packaging, environmental conditions, protective clothing and
personal protective equipment, hygienic behaviour, dual activities and duration of activity.
These parameters are described in detail in Fenske et al. (2005).

7
Proposed Pesticide Operator Indicator

The risk index for pesticide operators (RI
operator
) is calculated by dividing the internal exposure
(IE
operator
) by the acceptable operator exposure level (AOEL). Both the IE
operator
and the AOEL
are expressed in mg/kg body weight/day.

EXPOSURE

We propose to use the following formulas to calculate the acute exposure of operators in
conformity with the POCER indicator (Vercruysse et al., 2002; Maraite et al., 2005).

treated n applicatio load mix operator
Area
BW
AR
IE IE IE + = ) (
/


| |
/
( ) ( * * )
mix load I I I hand hand DE
IE L PPE Ab L PPE Ab = +

( ) ( * * ) ( )
application I I I hand hand DE body body DE
IE L PPE Ab L PPE Ab L PPE Ab ( = + +



With:
L
I
, L
hand
, L
body
(mg a.s./kg a.s.): surrogate or field data on exposure, depending on
data availability;
PPE
I
, PPE
hand
, PPE
body
: personal protective equipment coefficients (-);
Ab
I
, Ab
DE
: respectively inhalation and dermal absorption factors (%);
AR: application rate (kg/ha);
Area treated (ha/d);
BW: body weight (kg);
IE
mix/load
: internal exposure during mixing and loading (mg a.s./kg a.s.);
IE
application
: internal exposure during application (mg a.s./kg a.s.);
IE
operator
: internal exposure of the pesticide operator (mg a.s./kg bw/d).

Below, the different parameters are explained more into detail:

L
I
, L
hand
, L
body
(mg a.s./kg a.s.): surrogate or field data on exposure, depending on
data availability

1. If field data on exposure are available for the different routes of exposure,
these values should be used to calculate the internal exposure. These field data
should be expressed as mg a.s./kg a.s. and should be used to calculate the
indicator for real situations at particular locations (at higher tier).
2. If field data on exposure are not available for a given crop and a given active
substance, surrogate exposure values from the EUROPOEM database are
used. The computer program should select the appropriate surrogate exposure
values for mixing/loading and application according to the application
equipment used and the formulation type applied. It is important to mention
that it is necessary to establish a link between the active substances applied and
the formulation types of the products. This link was established by WP 5.

8
Annex I gives an overview of the surrogate exposure values used in the EUROPOEM
(I & II) model. Annexes II & III present tables in which the formulation types and
application methods are linked to the crops. Using these look-up tables the correct
surrogate exposure value can be selected. Seed treatment, application of granules,
dipping into a pesticide solution or pouring a pesticide solution onto plants are other
ways of pesticide application for which operator exposure is normally not assessed by
the human exposure models. In these cases the following assumptions are made. When
treated seed is used no exposure of the operator is expected, since seeding is mostly
done mechanically. Operator exposure during application of granules is only expected
during mixing and loading, it will be estimated by assuming exposure during mixing
and loading of a water dispersible granule (WG) formulation. Operator exposure
during the use of a pesticide solution for dipping or pouring is estimated by assuming
exposure during mixing and loading of a certain formulation (WG, WP (wettable
powder) or liquid). When water soluble bags are used, no exposure during
mixing/loading is assumed. For the application phase the surrogate exposure values of
liquid applications are chosen.
PPE
I
, PPE
hand
, PPE
body
: personal protective equipment coefficients (-)
The default factors used in EUROPOEM should be applied. These factors are given in
the table below (Table II.1.1). (see Annex IV for additional information concerning
new developments in the research topic on the reductive effect of personal protective
equipment).

Table II.1.1: Default values for the personal protective equipment reduction coefficients
Phase Inhalation (mask) Hands (gloves) Body (overall)
Mixing/Loading 0.1 0.1 -
Application 0.1 0.1 0.2

Remarks:
When a tractor with closed cabin and carbon filter is used, the highest level of
PPE is chosen.
When normal clothing is worn a reduction factor of 0.5 is used.
The user should have the possibility to introduce other PPE factors associated
with new types of Personal Protective Equipment.

On regional and national scale, the use of PPE can be taken into account as follows:

) % 1 ( %
,
PPE RI PPE RI RI
noPPE k k PPE applicator
+ =
RI
applicator
: applicator risk index taking into account the use of PPE on
regional/national level;
RI
PPE,k
: applicator risk index for a specific type of PPE;
% PPE
k
: percentage of the applicators wearing a specific type of PPE;
RI
noPPE
: applicator risk index not considering the use of PPE;
% PPE: percentage of the applicators not wearing any PPE.

Usually there are no data available concerning the compliance with which different
types of PPE are worn.Therefore the operator indicator is calculated assuming that the
PPE is worn by all the individuals living or working in a particular region or country.

9
The influence of wearing a particular type of PPE on the risk for applicators is in this
way assessed. Within the framework of the Belgian Science Policy Project
Agriculteurs et pesticides, connaissances, attitudes et pratiques: Rsultats dune
enqute mene en fruitculture, marachage et grandes culture (2002-2003), a survey
was conducted among the Belgian farmers concerning the sustainable use of
pesticides. One of the aspects that were studied was the use of personal protective
equipment. Half of the farmers do not wear any protective accessories when they
handle pesticides. Of those farmers who do use protective equipment, most of them
wear gloves (49%) as the minimum. Some also wear a mask (20%), boots (6%),
goggles (10%) or a coverall (17%). Of those who use gloves, only 12% replaces them
regularly (five utilisations maximum). After pesticide application, 13% of the farmers
do not wash their hands and about 80% do not wash their bodies (Marot et al., 2006).
By comparison, only 13% of the fruits growers and 11% of the vegetables growers do
not wear any protective equipment while respectively a quarter and half of these
reported that they felt unwell after spraying. Table II.1.2 gives an overview of the
survey results concerning the use of PPE.

Table II.1.2: The use of personal protective equipment during mixing, loading and application
activities (Marot et al., 2003)
% farmers
PPE
Fruit growing Vegetable growing Field crops
none 13 11 50
boots 36 77 6
coverall 22 37 17
gloves 75 68 49
mask 57 37 20
goggles 14 4 10

Although most of the farmers read the label before using a new pesticide, they do not
really follow the security advices of this label (Marot et al., 2003; Maraite et al.,
2004).
Ab
I
, Ab
DE
: respectively inhalation and dermal absorption factors
If there are data available regarding the dermal absorption of a specific active
substance, these data should be used. For a great deal of active substances European
endpoints are available regarding dermal absorption. If not, the Guidance Document
on dermal absorption should be followed (see Annex V). For the inhalation absorption
factor a default value of 100% is assumed (see Annex VI).

AR: application rate (kg/ha)
These data are supplied by the means of surveys (see WP5).


10
Area treated (ha/d)
For the area treated per day default values are listed in Table II.1.3 below for The
Netherlands, Germany, Belgium and the United Kingdom. By means of surveys each
member state can determine the average treated area per day.

Table II.1.3: Default values for treated area per day for a few member states of the EU
Country
Crop
UK Germany The Netherlands Belgium
Field crops 50* 20* 10* 9**
Orchards 15* 8* 6* 6**
Handheld
applications
1* 1* 1* 1**
* Source: EUROPOEM I (2000)
** Source: NIS (2000)

Data on farm size structures can be used to aid the selection of daily work rates.
Many countries collect this type of data. In England, an annual survey of agricultural
and horticultural holdings has been collected since 1866 (MAFF, 2000). Full censuses
are also required at intervals within the European Community to provide farm
structure information that is used to develop and monitor policies, and to assist in
planning of future agricultural activity (Hamey, 2001). Such data can be used in
various ways to estimate a typical daily work rate for a product applied in a particular
crop. A first estimate could be based on the average holding size. For field crops, the
average arable farm size would obviously be a better, more appropriate estimate. A
further refinement would be to use data on holdings where a particular crop, e.g.
cereals is cultivated as not all the area of arable holdings will be down to cereals.
There can be clear regional differences. Moreover the distribution of holding size is
clearly skewed, like farm size. These regional and size differences may be associated
with different use patterns, equipment and application techniques which may be
relevant for exposure assessment. For example, regional climate difference may affect
pesticide use, and smaller farms may use small tractor mounted sprayers, while large
farms may be more likely to use self-propelled machines. These equipment differences
may be associated with different unit exposures, as the larger equipment may have
more technical measures to reduce exposure. Another consideration is that growers on
larger farms are more likely to use reduced doses (Thomas, 1999), and they may also
use lower spray volumes. It can be concluded that the overall mean area can be used if
this is considered appropriate to represent the typical use. If regional variation is
considered important, then the mean area from the main growing regions should be
used. Having established representative crop areas estimates of maximum areas likely
to be treated in a day can be made by reference to typical work rates for different
equipment types. For example work rates can be estimated from the following formula
(Baltin, 1959):
11

4
1 2
10 ( )
w L
f s f f
T T q aq C
t
Q V S S L V Qf V F

= + + + +



Where:
t: work time per hectare (s/ha);
T
L
: time for loading (s);
q: application rate (l or kg/m);
Q
f
: quantity loaded per fill (l or kg);
V
s
: speed when spraying (m/s);
V
f
: speed when travelling between fill site and application site (m/s);
S:swath wide (m);
T
w
: time for one turn at the end of one spray run (s);
L: average length of field (m);
C: average distance between fields (m);
F: average size of fields (m);
A: average distance of fill site to fields (m).

Alternatively, some farm management manuals and other advisory literature give
typical work rate examples for selected pesticide application equipment. For example,
the Farm Management Handbook 1994/95 (Anon, 1994) gives typical work rates. In
the Netherlands the Kwantitative Informatie Reports give similar data
(www.ppo.wur.nl/NL). By comparing likely work rates and holding sizes, daily work
rates can be estimated. A possible further refinement of the estimated area to be
treated in a workday could be to take into account information on the percentage of the
crop treated (Hamey, 2001).

However it has to be mentioned that a major limitation of the usefulness of UK
pesticide usage surveys for elucidating users exposure patterns is that they cannot be
used to inform on use patterns of commercial contractors who apply pesticides on
more than one holding (Hamey, 2001). Studies should be performed to obtain insight
in the exposure use patterns of custom applicators.

To define representative scales and patterns of use to ensure appropriate exposure
assessments, information relating to the use patterns of individual operators is
required. This information should allow the assessment of: the scale of use in terms of
the amount of pesticide used in a day, the duration of use, the frequency of use, the
type of application equipment used, and the application techniques employed. These
data should be collected in routine surveys or surveys conducted to support specific
exposure assessments. Information must support both use by individual growers and
commercial contract spray operators.The existing EUROSTAT and OECD guidelines
should be used as the basic guidance with sampling of the users at the farm level. A
separate survey should be conducted to include commercial contract pesticide
applicators where identified as relevant. As an alternative to a completely
representative survey, the use of widely used products/active substances could be
sampled to give a realistic worst case. Sampling strategy and validation of data are
issues that need to be resolved as well as the specific information required (Hamey,
2001).
12
The following information should be collected (Hamey, 2001):
Data on the crop and area grown;
Product applied;
Date of application;
Application rate;
Area treated;
Application method;
Application equipment;
Handling practice;
Use of PPE;
Spraying machinery filling and washing practices.

BW: body weight (kg)
The default body weight is set to 70 kg.

TOXICITY

Most of the chemicals do not cause toxic or adverse effects until a certain dose has been
given. These are called threshold chemicals. The lowest dose level at which no adverse effects
are observed in the test animals is called the No Observed Adverse Effect Level (NOAEL).
The NOAEL is the starting point for the calculation of the toxicological reference dose. For
the latter the terminology used may differ among regulatory agencies, but the applied
concepts are similar. In North America the term margin of safety or exposure (MOE) is used,
whereas in Europe an Acceptable Operator Exposure Level (AOEL) is applied (Franklin et
al., 2005). An AOEL is a health-based exposure limit and is established on the basis of the
toxicological properties of an active substance. The term "AOEL" under Directive
91/414/EEC implies particular reference to operators which are represented by
mixers/loaders and applicators and re-entry workers. However, according to Directive
97/57/EC, the AOELs established should also be used to evaluate the possible exposure of
non-occupationally exposed groups (bystanders). Therefore, based on the current Community
legislation, the AOELs set for operators and workers should be established in such a way that
they are also applicable for bystanders (EC, 2001).

The default AOEL represents the internal (absorbed) dose available for systemic distribution
from any route of absorption and is expressed as an internal level (mg/kg bw/d). It is set on
the basis of oral studies provided that no major route-specific differences are anticipated.
According to Directive 91/414/EEC, the AOEL is based on the highest level at which no
adverse effect is observed in tests in the most sensitive relevant animal species or, if
appropriate data are available, in humans. As a default, only one AOEL is established for an
exposure period appropriate to the frequency and duration of exposure of operators (including
contractors) and re-entry workers. This is typically short-term exposure, e.g. repeated
exposure during a total of up to 3 months per year. Hence, the default AOEL will be a
systemic AOEL based on the NOAEL from an oral short-term toxicity study provided that the
critical endpoints of the substance (including reproductive/developmental toxicity and
carcinogenicity) are covered and an adequate margin of safety (MOS) for irreversible effects
is given (MOS >1000). Since targets, critical effects and NOAELs for an active substance
may differ depending on the exposure period, more than one AOEL might in principle be
established to allow for more flexibility in the risk assessment. Although the use of oral
studies for AOEL setting is preferred if there are indications that type and extent of effects of
the substance is independent of the route of exposure making route-to-route extrapolation
13
possible, it might be better to use appropriate route-specific studies as a basis for AOEL
setting where there are indications that toxicity is dependent on the route of exposure. For
instance, the majority of orally absorbed substances pass directly into the liver where they can
be inactivated or excreted in the bile before they reach the systemic circulation and/or the
target organs (first pass effect). When administered dermally or by inhalation, these
substances may be distributed in an unmetabolised state and metabolic activation/inactivation
may therefore be more gradual than following oral absorption. In practice, route-specific
studies can only be considered for AOEL setting if: 1) the number and type of parameters
studied are considered adequate; 2) the number of animals examined and the animal species is
adequate; and 3) the route-specific study covers all the critical effects of the substance. For
some substances, certain toxic effects, for example on the lung, only occur during inhalation
exposure. In these cases (i.e. where effects are air-concentration- rather than dose-related), an
internal AOEL value cannot be established. The risk management for such substances may be
best addressed by establishing occupational exposure limit values. If a substance is mutagenic
and/or carcinogenic and a threshold dose does not exist (this applies for some types of effects
such as direct interaction with DNA), it will generally not be possible to set an AOEL (EC,
2001).

In establishing an AOEL the choice of the NOAEL is very important. The NOAEL for an
effect which is relevant to humans and for which the duration, frequency and route of
exposure in the test animals are relevant to human exposure should be chosen (Franklin et al.,
2005). Selection of the most appropriate NOAEL needs to be assessed on a case-by-case
basis, and requires expert judgement. The AOEL is calculated by dividing the suitable
NOAEL by the uncertainty factors appropriate for the pesticide under review. A 100-fold
uncertainty factor (10 for interspecies variability x 10 for intra-individual variability) is
generally used when considering risk for the general population, but this factor can range
upwards and downwards depending on the nature of the data and the completeness of the
database. It was recommended that the current procedure of applying 10-fold uncertainty
factors for interspecies differences and human variability be refined (IPCS, 1994).
Subdivision of each 10-fold factor into toxicokinetic and toxicodynamic components for both
extrapolation from animals to humans (2.5 and 4.0 respectively) and for intra-human
variability (3.16 and 3.16 respectively) would allow part of the default to be replaced by
relevant, chemical-related, specific data when these were available (IPCS, 1999). However,
the extent to which the uncertainty factor could be reduced under such circumstances has yet
to be determined. Although establishment of an AOEL relies heavily on expert judgement, its
derivation needs to be reported as transparently as possible. Any agreed AOEL may need to
be reassessed in the light of new data (EC, 2001).

Within the framework of HAIR, the systemic AOEL will be used as the toxicological
reference dose against which the estimated human exposure will be compared in order to
obtain an idea of the risk associated with a particular active substance. For the calculation of
the acute indicators, short-term AOEL values will be applied since these AOEL values are
available in the UGent database. Acute AOELs may be applied in order to cover effects that
may arise from a single exposure or repeated (isolated) single exposures (i.e. at intervals that
enable clearance of the active substance from the body). These AOELs can be set in line with
the procedures proposed for setting an Acute Reference Dose for consumers (European
Commission, 2001; Doc. 7199/VI/99). However, since according to the current knowledge
there are no active substances with only acute exposures, the setting of acute AOELs may
only be considered on a case-by-case basis (EC, 2001). Therefore, AOELs based on short-
term toxicity studies will be applied. AOELs based on long-term toxicity studies should be
14
used in the chronic risk assessments. This applies for these cases where operators or re-entry
workers are exposed for more than three months per year.

Concerning the availability of the AOEL values it has to be mentioned that only systemic
AOEL values are available. The department of Crop Protection from Ghent University
compiled a database of AOEL values, but since a lot of data were delivered by the industry,
the issue of confidentiality plays a role. In 2008 these data will be made public. Until then
UGent adjusted their database and replaced the confidential data by public available data. It
has to be mentioned that the confidential database is much more liable than the database
supplied for HAIR.

If the AOEL value for a particular active substance is not available in the supplied database,
the geometric mean of the AOEL values of the substances having a similar mode of action
(thus belonging to the same chemical family) will be taken (IRAC mode of action
classification version 5.1, September 2005, HRAC classification January 2005 & FRAC
classification December 2005).

RISK INDEX

The risk index for pesticide operators (RI
operator
) is calculated by dividing the internal exposure
(IE
operator
) by the acceptable operator exposure level (AOEL). Both the IE
operator
and the AOEL
are expressed in mg/kg body weight/day.

,
,
operator acute
operator acute
IE
RI
AOEL
=

With:
RI
operator, acute
: acute risk index for the pesticide operator (-);
IE
operator, acute
: acute internal exposure of the pesticide operator (mg a.s./kg bw/d);
AOEL: Acceptable Operator Exposure Level (mg a.s./kg bw/d).


15
2. Re-entry worker
Introduction

Workers are defined as persons who are exposed to pesticides during their working activities,
but are not actively involved in the actual application process. Agricultural workers are
potentially exposed to pesticide residues when they enter pesticide-treated fields to perform a
variety of hand-labour tasks, such as pruning, thinning, scouting, harvesting, bending and
tying up of the crop required for the commercial production of agricultural crops. These
exposures can occur in different crops, throughout the growing season and can be of similar
magnitude to exposures of operators of pesticides (Worgan and Rozario, 1995). In the case of
ornamentals, vegetables and fruits re-entry exposure is likely.

The routes of exposure during post-application activities are the same as in operator exposure,
i.e. dermal and inhalation. However the sources are different: foliage, surfaces, soil and also
dust may contribute. As a result from dermal exposure, oral exposure may occur as well. For
workers this route is generally considered less important than inhalation and dermal exposure.
Since no oral data on exposure are available, this route is not considered. Only by including
data obtained from biological monitoring techniques can this route be taken into account.
Inhalation exposure is very low compared to the dermal exposure.
Proposed Re-Entry Worker Indicator

EXPOSURE

The developed indicator assumes that during application, the foliage of a crop is covered with
pesticide residues. These residues may or may not disappear in time due to various reasons,
such as uptake in the foliage or hydrolysis. What remains on the foliage (i.e. dislodgeable
foliar residue) may be transferred to clothing and skin of the worker, when activities involving
contact with the crop, such as harvesting, are carried out. Important factors in the indicator are
the application rate, the foliage density, the time of activities after application, the transfer of
residues from foliage to worker and the duration of the work. The type of activity/task also
determines the exposure.

The main activities which may lead to contact between crop and worker in the outdoor
environment are harvesting, pruning, thinning, and also inspection. Differentiation was made
between crops that need to be harvested regularly or from time to time (e.g. apples, pears,
grapes, olives, etc.), and in crops that need not to be harvested (at all or hardly at all). For
vegetables and ornamentals grown outdoors, conditions with respect to dermal exposure are
largely comparable to the same crops growing indoors. Therefore no further consideration is
necessary. Exposure to pesticides with field crops is highly mechanised, therefore the re-entry
worker exposure will not attain a high level. This applies to crops such as cereals, maize or
sugar beet (EUROPOEM II, 2002).

In the indoor environment ornamentals and vegetables grown in greenhouses can be
distinguished. Higher crops from which the ornamentals or fruits are picked or cut and for
which there is extensive physical contact with the foliage of the crop, are the most important
with regard to exposure. Roses and carnations and some pot-ornamentals are important flower
types, important vegetables are tomatoes, cucumbers and sweet peppers (EUROPOEM II,
2002).
16
Table II.2.4 lists various post-application/re-entry scenarios. Exposure due to sorting and
packing was considered to be most comparable to the harvesting scenario by the
EUROPOEM Re-entry Working Group (EUROPOEM II, 2002).

a. Dermal Exposure

Dermal exposure is considered to be by far the most important exposure route during re-entry
activities. The amount of the resulting exposure for a particular activity depends on the
amount of residue on foliage and on the intensity of the contact with the foliage in case of
different activities. Time of contact is also an important issue. Droplet size spectra of spray
applications also play an important role with respect to re-entry worker exposure.

The dermal exposure of the re-entry worker is estimated by a multiplication of DFR
(dislodgeable foliar residue), TF (transfer factor) and T (duration of the work/re-entry). The
algorithm proposed by the Re-Entry Working Group is outlined below (EUROPOEM II,
2002):

0.001 DE DFR TF T P =
0.01
AR
DE TF T P
LAI
=
With:
DE: dermal exposure (mg/d);
0.001/0.01: conversion factor for the units;
DFR: dislodgeable foliar residue (g/cm);
AR: application rate (kg a.s./ha);
LAI: Leaf Area Index (m leaf area/ m ground area);
TF: transfer factor (cm/person/hr);
T: duration of re-entry (hr);
P: factor for PPE (-).

Below, the different parameters are explained more into detail:

DFR: dislodgeable foliar residue (g/cm) and LAI: Leaf Area Index (m leaf area/
m ground area)

In this formula the dissipation factor of the active substance on the foliage is not
taken into account. The dissipation factors is set to one as a default sine the
dissipation function is frequently unknown. The dissipation of residues on crop
foliage over time depends on the physical and chemical properties of the applied
active substance as well as on environmental conditions. Mostly the exact nature
of dissipation over time is not known, in this case DFR
0
, i.e. the residue available
directly after application (when dry) is used for calculations. The initial DFR data
are defined as the DFR samples taken between 0 and 24 hours after application.
Thus, the most conservative approach is to assume no dissipation at all. The
EUROPOEM II Re-entry Working Group made an overview of the data on initial
foliar residues. This review showed a large variation in DFR
0
, even when
standardized for application rate. There are certain factors that may potentially
17
lead to variability in DFR levels. These include (1) crosswinds that may result in
higher residues on the downwind side of the field than on the upwind side of the
field, (2) hotspots where the applicator has turned at the end of the field to start
application to a new row, (3) variability due to overlap of application between
rows. Such spatial heterogeneity may affect the observed variability of the entire
set of DFR and worker exposure measurements (Whitmyre et al., 2005). All else
being equal, a person working in an are of the field containing the high end of the
range of DFR levels has a greater probability of receiving a higher exposure per
unit time than a person working in a part of the field with lower DFR levels.

The declination of pesticide residues with time may be accounted for by using a
dissipation function to describe the DFR at a given time t after application. Often it
has been assumed that the residue levels on the foliage will follow a monotonically
decreasing decay curve which is exponential, namely (Whitmyre et al., 2005):

( ) t
t
DFR e

=
With:
DFR
t
: dislodgeable foliar residue at any given time t after
application (g/cm);
, : fitted constants;
t: time after application (d);
DFR
0
: the day-zero dislodgeable foliar residue;


( )
0
DFR e

= if R > 0.85

1/ 2
(log0.5)
( )
T

: half-life time (d) (see Annex VIII).



Sometimes, one encounters cases where the first order degradation equation does
not give a good yield. An alternative form that is sometimes seen is a log-log
relationship where several compartments exist (e.g. surface of leaf, interior of leaf,
etc.) which are each associated with different half lives.

| | log( ) log( )
t
DFR t =

Climatic factors such as humidity and temperature, as well as the physico-
chemical properties of the active ingredient, affect the rates at which the DFRs
decline for a given crop. Furthermore losses due to drift may occur outdoors,
especially for low-volume and ultra-low volume spraying techniques), and losses
to soil are also likely to occur (van Hemmen et al., 1995).

AR: application rate (kg a.s./ha)
LAI: Leaf Area Index (m leaf area/ m ground area)

In the absence of experimentally determined DFR (Dislodgeable Foliar Residue)
data, the application rate (kg a.s./ha) divided by the leaf area index (m/m) of the
crop (which is the one-sided surface area of the total foliage of a crop divided by
the ground surface area on which the crop is growing) provides a crude estimate of
the initial foliar residue on the crop, assuming uniform distribution of residues
18
across the crop (Bates, 1990). But one should be careful since such an approach
assumes that the coverage of the foliage is homogeneous. An LAI of 2 can be used
as a possible default in a first tier approach (Hamey, 2003) when no data are
available. So far there has been no report available in which a correlation between
DFR
0
and LAI has been scientifically established. Therefore, the following
theoretical considerations have to be taken into account: in early growth stages,
where the leaf canopy does not cover the ground completely, or in high crops
where the leaf canopy is not yet closed, a corresponding part of the product will
not reach the plant surface but will reach the soil or will be lost by drift. For one
sided applications, a default value of 1 can be assumed and if both sides of the
leaves are treated, the theoretical LAI (m/m) may be increased up to 2. With
progressing plant growth the LAI increases and the default LAI value may be up to
about 2 for one sided treatment and about twice the chosen LAI for two sided
treatment. If specific DFR data exist, the term (AR (kg/ha) /LAI) should be
replaced by the DFR values, since only a portion of the total initial residue
estimated using the LAI approach is actually dislodgeable to workers. Thus, DFRs
calculated using the LAI approach, probably overestimate actual starting DFR
levels obtained by monitoring. The EUROPOEM II Working Group compiled all
the available information on leaf area index. In the report of the Re-entry working
group Post-application exposure of workers to pesticides in agriculture
(EUROPOEM II, 2002) a review was made of the available leaf area index data.
The re-entry working group carried out a literature evaluation on leaf area index
data within the framework of the EUROPOEM II project. Additionally non-
published data on LAI measurements were also included. Several databases
(EMBASE, ESBIOBASE, Agricola,) were consulted. Only data with regard to
agricultural and horticultural crops were considered, hereby giving preference to
data generated in crops grown in European countries.

For exposure determinations one should always use the DFR values that are in the
contact zone of the foliage with the workers. A conservative Default Value of
3g/cm per kg applied/ha can be used if no data are available for a highly
conservative assessment of the initial DFR
0
in a first tier assessment. This value
corresponds with the 90
th
percentile of the distribution. This value was obtained by
the EUROPOEM II Re-entry Working Group after conducting an extensive
analysis of the available literature on initial dislodgeable foliar residue data. The
number of records per crop type was not large enough to assess a DFR
0
value
based on a specific crop type and application rate. Due to the small number of
records and the variety in application rates and crop types the database is useful to
indicate an approximate relationship between DFR
0
values and application rate,
leaving the crop type aside.

For each task performed by a re-entry worker a different DFR should be available
if one wants to conduct refined exposure assessments. At the moment such data
are not available. If data on DFR, TF and duration of task are available for each
task performed, than the total dermal exposure can be calculated by summing the
task individual dermal exposures.


19
TF: transfer factor (cm/person/hr)
The transfer factor depends on the nature of the contact and the degree of contact
between body and foliage, and the duration of the work. The transfer of residues
from the crop foliage to the clothes or skin of the worker can be regarded as more
or less independent of the kind of product applied. Several studies regarding re-
entry scenarios have been conducted over the last two decades, primarily in the
United States.

Zweig et al. (1985) and Nigg et al. (1984) proposed the empirical factor of 5000
cm/person/hr as a generic default for the TF for estimating dermal exposure,
based on one-sided DFR values. However this single default value does not
adequately reflect the potentially wide range of TF values across different crops
and across different work activities. Krieger et al. (1990, 1992) have presented
TFs varying from about 1000 cm/hr to as high as 400.000 cm/hr for various
worker re-entry activities involving different crops. An example listing of these TF
values are given in Table II.2.1. The data, presented in this table are based on field
studies conducted by the Worker Health and Safety Branch, California Department
of Pesticide Regulation. Several transfer factors for more specific re-entry
scenarios under American conditions are presented here (Worgan & Rozario,
1995).
Table II.2.1: Transfer factors for various re-entry worker activities (adapted from Krieger et
al. (1990))
TF (cm/hr)
Crop type Work task
Standard
clothing
Plus PPE
Active
21000 12000 (new nylon gloves)
- 17000 (used nylon gloves) Pole tomatoes Harvesting
- 7000 (rubber latex gloves)
Chlorotalonil
Hand harvesting 9000 -
Bush tomatoes
Mechanical harvesting 1000 -
Chlorotalonil
Cutting - 13000 (rubber latex gloves)
Lettuce
Packing - 6000 (rubber latex gloves)
Folpet
- 6000 (rubber latex gloves) Captan
- 500 (rubber latex gloves) Malathion
- 2000 (rubber latex gloves) Dicofol
Strawberry Harvesting
- 1000 (rubber latex gloves) Naled
54000 - Azinphosmethyl
Peach Harvesting
24000 - Phosmet
Nectarine Harvesting 7000 - Azinphosmethyl
Plum Thinning 390000 - Captan
Apples Harvesting - 6000 Azinphosmethyl
Cane-cutting 17000 -
Grapes
Harvesting 18000 -
Captan

van Hemmen et al. (1995) attempted to group TFs by activity type and contact
type, based on Krieger et al. (1990, 1992) (see Table II.2.2)

Table II.2.2: Range for Transfer factors for particular activities
Activity Details TF (cm/hr)
Sort & select
Hand exposure only, e.g.
mechanical harvest
50-800
Reach & pick
Hand and arm exposure e.g.
tomato & strawberry
500-8000
Search, reach & pick
Hand/upper body exposure
e.g. tree fruit
4000-30000
Expose, search, reach & pick
Whole body contact (wine
grapes)
20000-140000
20
A literature evaluation was carried out by the Re-entry Woking Group on TFs. The
TFs were calculated by dividing the dermal exposure to hands or body by the
dislodgeable foliar residue sample the same day. From the relatively small
databases, indicative surrogate transfer coefficients were deduced. The rounded
90
th
percentile was taken for the smaller databases, while the rounded 75
th

percentile was taken for the larger databases. A small database may not be typical
for a given scenario and therefore the 90
th
percentile was taken as surrogate
exposure value. Large databases contain more representative data and therefore the
75
th
percentile is taken.

When no field data are available the following indicative TF values are proposed
for four different harvesting scenarios with bare hands:

Fruit, Vegetables and Ornamentals in greenhouses: 5000 cm/person/hr
(Schipper et al., 1999, Brouwer et al., 1992);
Vegetables in open air: 5800 cm/person/hr (EUROPOEM II, 2002);
Ornamentals in open air: 5000 cm/person/hr (EUROPOEM II, 2002);
Fruit in open air (high crops): 30000 cm/person/hr (Krieger et al., 1990);
20000 cm/person/hr (EUROPOEM II, 2002);
Strawberries: 3000 cm/person/hr (EUROPOEM II, 2002).

The TFs proposed here are based on potential exposure data (except for
strawberries and ornamentals). Therefore a generic clothing permeation factor P is
used to estimate the actual dermal exposure. The number and quality of studies
which are available for inclusion in a database to predict re-entry exposure for all
relevant crop/work activity is generally poor. There is a clear need for more
studies and data need to be generated under typical EU conditions. The collection
of data on TFs is of extreme importance and further research in this field is highly
relevant and necessary. In the Belgian registration procedure for pesticides, other
TFs are currently applied. For respectively field crops and high crops a TF of 5000
cm/person/hr and 30000 cm/person/hr is used.

In the United States the Agricultural Re-entry task Force, which is a joint data
development task force formed under FIFRA, developed a database of generic
agricultural re-entry transfer coefficients that are applicable to all crop/activity
scenarios for use by its members for assessment of exposure and risk in any post-
application agricultural worker re-entry scenario. This database of generic
agricultural transfer coefficients is being used by the EPA (Environmental
Protection Agency), California Department of Pesticide Regulation (CDPR) and
Canadas Pest management Regulatory Agency (PMRA) to evaluate member
companies chemicals and enables the regulators to estimate post-application
exposure of workers. These data may however only be used to make regulatory
decisions by the members who have sponsored the research
(http://www.exposuretf.com). The approach followed by the ARTF can be applied
to the European situation.
21
If monitoring data on both, exposure and DFRs are available then the following
equation is applied to obtain a TF, normalized per hour of task duration.

Exp
TF
DFR
=
With:
TF: transfer factor (cm/hr);
Exp: exposure (g/hr);
DFR: dislodgeable foliar residue (g/cm).

In this way chemical and activity specific transfer coefficients are obtained. When
monitoring data are not available, which usually is the case, surrogate transfer
coefficients are used. These are listed above and in Table II.2.4. It is very
important to mention that a harmonized approach in determining data for
dislodgeable foliar residues should be established. The Agricultural Re-entry
Exposure Task Force (ARTF) developed a protocol for a standardized assessment
of dislodgeable foliar residues.

T: duration of re-entry (h); (default: 8 hours a day)
Exposure duration may be up to 6 hours on a normal day of harvesting, sorting and
bundling and occasionally even longer. The exposure may be over several days a
week in view of the continued presence of pesticides on the crop depending on the
stability of a particular pesticide or a mixture of pesticides. This parameter should
be established for each re-entry task. Currently such data are not available.

P: factor for PPE (no PPE: 1; with PPE: 0.1)
In fruit orchards (apples and pears) the harvesting activities and the thinning are
done with bare hands. For pruning, occasionally, gloves are worn not to protect
against pesticide exposure but against skin damage. Depending on the weather and
on the region in Europe, the clothing might vary for the same activities. When
performing activities in hops, gloves are worn as a rule in order to prevent injury
since the bines have small hooked hairs with needle points. There is potential
exposure during harvesting, particularly when collecting bines for transport to
static picking machines. Harvesting and pruning in vineyards is usually done with
bare hands and under conditions that light clothing is required. The degree of
exposure largely depends on the structure of the vine. In cultures of ornamentals
all activities are done with bare hands, with possible exceptions for roses with
thorns and crop activities, which lead to greenish hands. The use of gloves is fairly
common with all work tasks in tomatoes.

Special case:
The case of possible dermal exposure to soil containing pesticide residues is based on the
concept of dermal adherence. The contribution of soil residues to the total exposure is
usually expected to be less important than that of DFR. A study conducted in Florida
(Stamper et al., 1987) indicated that if soil residues were to make an equal contribution to
dermal exposure as DFRs, 170 g of soil on the hands would be required.

Relevant scenarios, where exposure due to soil borne residues occurs in the absence of
contact with the treated foliage, are for example the use of compost treated with an
insecticide or the manual harvesting of root crops. Data on soil residue levels, either
22
estimated or measured, can be used with soil dermal adherence data to estimate potential
human exposure with the actual exposure being estimated on the fraction absorbed.

The algorithm specified below is used to estimate exposure (EUROPOEM II, 2002):

soil
Sk S C S S
T SA DA Conc
D

/

=

A
f D AD =
With:
D: dermal exposure (mg/d);
Conc
S
: soil concentration of the active substance (mg/m);
The soil concentration of the active substance can be determined by applying
the same approach as the terrestrial work package (WP 6);
DA
S
: Dermal adherence of soil (mg/cm);
Field studies investigating dermal exposure to soil by direct gravimetric
measurements (Kissel et al., 1996) suggest that an appropriate hand soil
loading for a worker would be 0.44 mg/cm (geometric mean peak value for
farmers involved in hand weeding, default). A laboratory study to determine
the extent of soil adherence to hands when totally immersed in a range of dry
soil samples (Driver et al., 1996) concluded that the mean hand loading for un-
sieved soil was 0.58 mg/cm of skin surface. Data for sieved samples suggested
that hand loading increased when soil particle size was reduced;
SA
C
: Skin area contaminated (cm);
A default value of 820 cm is to be used;

soil
: soil bulk density (g/cm);
T
S/Sk
:Transfer of the active substance from soil to skin (-);
Data on the transfer of active substance from soil to skin are usually not
available at the moment;
AD: absorbed dose (mg/d);
f
A
: fraction absorbed (%).

As a preliminary approach it is assumed that all of the chemical in a layer of soil is bio-
available to skin. Conservative assumptions like these have to be used when no specific
information is available. More research should be performed in order to make more
reliable exposure estimations for this route of exposure.
b. Inhalation Exposure

Inhalation exposure may occur to residual vapour and airborne aerosols during a relatively
short period after application. In case of outdoor crops, exposure will occur during the time
the spray is drying; in case of greenhouse crops, exposure will occur within a few hours after
application. Outdoors, there generally is a rapid dissipation of vapour and aerosols, leading to
much lower inhalation potential than in greenhouses. Furthermore, the majority of the applied
pesticides are non-volatile which implicates a low potential inhalation exposure. Thus,
inhalation exposure is in many cases less important for risk assessment than dermal exposure
especially for outdoor scenarios, with of course exceptions for aerosols and volatile pesticides
of concern.
23
The EUROPOEM Re-entry Working Group developed an algorithm for a few re-entry
scenarios (EUROPOEM II, 2002). There is no generic model for inhalation exposure
available. Here, only a preliminary approach for indoor inhalation exposure is presented (see
Table II.2.3). The identified representative crop/activity re-entry scenarios relevant to Europe
that may result in post-application exposure of workers to plant protection residues are listed
in Table II.2.4. Thus, this estimation procedure for inhalation exposure is only applied for
greenhouse workers. For field workers, the inhalation exposure is considered negligible
because of the dilution in free air.

The algorithm proposed to estimate inhalation exposure to vapours is outlined below

T TSF AR I =
Where:
I: potential inhalation exposure (mg a.s./d inhaled);
AR: application rate (kg a.s./ha);
TSF: Task Specific Factor;
These factors can be used in the first tier exposure and risk assessment and have
been estimated for a small set of exposure data on harvesting of ornamentals and
re-entry of greenhouses about 8-16 hours after specific applications. The indicative
Task Specific Factor values for specific indoor glasshouse scenarios are given in
Table II.2.3;
T: hours working per day (hr/d);
Table II.2.3: Estimated values for indicative Task Specific Factors
Post-application scenario Re-entry time Task Specific Factor
Cutting ornamentals - 0.1
Sorting and bundling ornamentals - 0.01
Re-entering greenhouses after
low volume mist application
8 0.03
Re-entering greenhouses after
roof fogging
16 0.15

A preliminary approach to estimate inhalation exposure to dusts whenever considered
relevant is presented hereafter. This inhalation exposure will generally be relatively low
compared to other exposures.

Inhalation exposure can be approximated by using field data on individual exposure levels to
soil dust during relevant operations. Data from California (Nieuwenhuijsen et al., 1998) on a
dry-climate situation likely to give a conservative value, show a worst case total inhalation
dust exposure when cultivating using a vehicle with no cab of 98,6 mg/m. The exposure to
respirable dust was 0.58 mg/m under the same conditions. A Polish study indicated personal
dust levels during plant harvesting within the range of 3.3 to 19.3 mg/m (Molocznik &
Zagorsky, 2000).

For a chemical homogeneously distributed in soil at the rate equivalent of 1 kg/ha to a 5 cm
depth assuming the worst case exposure of 98,6 mg/m, over an 8 hour day a 60 kg person
breathing 29 litres per minute would be exposed 30 ng/(kg b.w. d). This amount is very low
indicating that the potential inhalation risk from residues in soil is typically very low.
Therefore this route of exposure will not be taken into account in this exposure assessment but
can be included when relevant and if suitable data are available.

24
Table II.2.4: Re-entry/post application scenarios relevant to Europe (Distinction is made between crops grown indoors and outdoors and subdivision is realised
according to the comparability of work patterns (way of cultivation and related activities))
Crop group Crops Post-application activities LAI TF
potebtial
(cm/hr) TF
actual
(cm/hr)
Common Wheat
Durum Wheat
Rye
Barley (Spring & Winter)
Oats
Grain Maize
Rice
Cereals
Other cereals (Corn, Spelt, Triticale)
Inspecting/Scouting, Irrigation
Weeding
Pulses Fodder Peas
Pulses
Pulses Fodder Field Beans
Harvesting, Inspecting, Scouting
Weeding,& Irrigation
Potatoes
Early Potatoes, Storage Potatoes, Seed
Potatoes
Harvesting, Irrigation, Scouting, Planting &
Weeding
Sugar beet Sugar beet Harvesting, Scouting, Irrigation & Weeding
1**(early)
2**(late)
NA
A
: highly
mechanised harvest
1000* (Weeding)*
1000* (Scouting)*
NA
A
: highly
mechanised harvest
(pers. comm.
Vleminckx, 2006)
Tobacco
Harvesting, stripping, training, thinning,
topping, irrigation, scouting & Planting
NA
A
(Vl. p.c.)
Hops
Training the shoots, removing superfluous
ground shoots (manually/mechanically),
defoliation of the bottom 2 metres
(manually/chemically), tilling
(mechanically), stripping, thinning, topping,
irrigation, scouting and harvesting
(mechanically/manually)
NA
A
(Vl. p.c.)
Cotton/Flax
Nursing/Scouting, Harvesting, Irrigation &
Weeding
1000* (early); 4000*
(late) for scouting
Oil seed or fibre plants (Rape, Turnip,
Sunflower, Soya, Chicory (Ordinary &
Coffee), other))
Scouting, Irrigation & Weeding NA
A
(Vl. p.c.)
Aromatic, Medicinal and Culinary Plants
(Herbs: Basil, Mint)
Scouting NA
A
(Vl. p.c.)
Industrial plants
Other industrial plants Several activities
1**(early)
2**(late)
NA
A
(Vl. p.c.)
NA
A
(Vl. p.c.)
Fodder Fodder Roots and Brassicas Several activities
1**(early)
2**(late)
NA
A
(Vl. p.c.) NA
A
(Vl. p.c.)
25
Table II.2.4: Re-entry/post application scenarios relevant to Europe (Distinction is made between crops grown indoors and outdoors and subdivision is realised
according to the comparability of work patterns (way of cultivation and related activities))
Crop group Crops Post-application activities LAI TF
potential
(cm/hr) TF
actual
(cm/hr)
Fresh vegetables (Alfalfa, Artichokes,
Asparagus, Broccoli, Brussels Sprouts,
Cabbage, Canola, Carrot, Cauliflower,
Celery, Chinese Leaves, Chervil, Chives,
Clover, Cucumber, Fennel, Garlic, Gherkin,
Kale, Lettuce, Leek, Ley, Onion, Parsley,
Radish, Rhubarb, Scorzonera, Shallot,
Sorrel, Spinach, Tomato)
Pruning, harvesting, weeding,
planting, (cabbage & lettuce) sorting
& packing
1** (early)
2** (late)
5800** 2500**
Melons Harvesting, thinning,
Outdoor (open field &
market gardening): Fresh
Vegetables, Melons &
Strawberries
Strawberries, Blackberries, Dewberries,
Currants, Gooseberries, Raspberries
Harvesting, hand pruning, pinching,
training and thinning and leaf pulling
(blueberries (high bush))
1** (early)
2** (late)
- 3000**
Fresh Vegetables (Aubergine, Been, Beet,
Cauliflower, Celery, Courgette, Cucumber,
Currant, Cutbeet, Endive, Gherkin, Lettuce,
Pepper, Seed, Sweet Pepper, Tomato &
Watercress)
5800** 2500**
Melons
Strawberries, Blackberries, Dewberries,
Currants, Gooseberries, Raspberries
Training, thinning (one or several
weeks), pruning, harvesting (2-3 day
interval), sorting & packing
1** (early)
2** (late)
- 3000**
Flowers and Ornamental Plants
Pruning, harvesting, sorting,
bundling, packing, picking and
planting of cuttings, thinning, pulling
up grids, training of plants, visual
control for diseases, making bundles
of flowers and bagging ornamentals
1** (early)
2** (late)
14000** 5000**
Greenhouse crops
(Vegetables, flowers and
permanent crops)
Permanent Crops Under Glass (Grapes)
Handling of soil containing
pesticides, handling of cuttings and
inoculation activities, pruning, weed
control, mechanical removal of the
tree and the pulling from the soil,
sorting and bundling activities of
smaller trees and cuttings & planting
and potting activities
2** (early)
4** (late)
20000** 4500**
26
Table II.2.4: Re-entry/post application scenarios relevant to Europe (Distinction is made between crops grown indoors and outdoors and subdivision is realised
according to the comparability of work patterns (way of cultivation and related activities))
Crop group Crops Post-application activities LAI
TF
pot

(cm/hr)
TF
act

(cm/hr)
Outdoor flowers and
ornamental plants
Flowers and Ornamental Plants Pruning, harvesting, sorting & packing 1** 14000** 5000**
Nurseries
Handling of soil containing pesticides,
handling of cuttings and inoculation
activities, pruning, weed control,
mechanical removal of the tree and the
pulling from the soil, sorting and bundling
activities of smaller trees and cuttings &
planting and potting activities
Vineyards (raisins, table grapes, other wines,
other wines, quality wine)
Pruning (minor activity), foliage work,
harvesting & packing
Olive plantations (oil production, table olives)
Harvesting, pruning, thinning, irrigation,
scouting, sorting, packing, handling after
post-harvest treatment
Citrus plantation (oranges)
Harvesting, sorting, packing, handling after
post-harvest treatment, tying, pollination,
training, pruning, irrigation, scouting &
weeding
Fruit (temperate climate, subtropical climate)
(Apple, Cherry, Kiwi, Pear, Peach, Plum) and
Nuts
Pruning, harvesting, thinning, tying, sorting,
handling & packing
Permanent crops
Other permanent crops Several activities
4
(late growth
stages)

2
(early growth
stages)
20000** 4500**
Rough grazings Permanent grassland and
meadows Pasture and meadows
No activities NA
A
NA
A
NA
A

Temporary grass
Other green fodder (green maize, leguminous
plants)
Forage plants
Other
Harvesting, Scouting, Irrigating & Weeding NA
A
NA
A
NA
A

Other Other No activities NA
A
NA
A
NA
A

NA
A
: Not applicable
Vl. p.c.: pers. comm. Vleminckx, 2006
*: Source: Policy Science Advisory Council for Exposure (May 7
th
, 1998). Agricultural Default Transfer Coefficients (See Annex VII).
**: Source: EUROPOEM II Re-entry Working Group
27
Remarks:
The harvest of cereals, sugar beet and maize is highly mechanised and therefore the
exposure will be considerably less than for the other scenarios. Within the framework of
this project the exposure for these crops is considered negligible. But further consideration
should be given to the inspection of crops and diseases, possibly hoeing activities. But
currently no data concerning this scenario are available. One could use a default TF factor
for potential exposure of 1000 cm/hr for hoeing and weeding activities as proposed by the
Science Advisory Council for Exposure (1998);
If the harvest and planting of potatoes or tubers and onions is done by hand, then a default
transfer coefficient of 10.000 cm/hr can be applied. A default TF of 2500 cm/hr for
sorting and packing activities of tubers can also be applied. These default values were
proposed by the Science Advisory Council for Exposure (1998);
There is a relative low potential for dermal exposure regarding activities concerning
berries since after blossoming pesticides are generally not applied;
Lawns, greens and playgrounds are considered not relevant with respect to the level of re-
entry exposure. Possible exceptions may be children playing and sporting activities having
much contact between body and grass. For this scenario data should be gathered by the
means of field experiments;
The higher crops from which the ornamentals or fruits are picked or cut and for which
there is extensive physical contact with the foliage of the crop are most important. Roses
and carnations are important flower types and tomatoes, cucumbers and sweet peppers are
important vegetables in this respect;
Thinning activities are considered to involve lower or similarly intensive contact with
foliage in comparison with pruning. In addition the same body parts of the worker will be
exposed to the foliage during both types of activities. Exposure assessments for pruning
will also cover the worst case exposure assumptions for thinning;
Dermal exposure during post-application activities results primarily from sorting and
packaging (bundling). In case of sorting, workers have to handle the harvested commodity
with their hands, most often in a similar way as during harvesting but without any contact
with the foliage. Therefore, these post-harvest exposures can be considered as the most
comparable to exposure during harvesting;
Further research is required with respect to dermal exposure resulting from particular
post-harvest activities.
c. Total Internal Exposure
The total internal exposure is calculated as the sum of the dermal exposure (DE; mg/person/
d) multiplied by the dermal absorption factor (Ab
DE
; %) and the inhalation exposure (I;
mg/person/d) multiplied by the inhalation absorption factor (Ab
I
; %), divided by the body
weight (BW, default: 70 kg) of the worker (Vercruysse et al., 2002).

_ ker
DE I
re entry wor
DE Ab I Ab
IE
BW

+
=
Where:
DE: dermal exposure (mg/person/d);
Ab
DE
: dermal absorption factor (%/100);
I: greenhouse inhalation exposure (mg/person/d);
Ab
I
: inhalation absorption factor (%/100) (default: 100%);
BW : body weight (kg) (default: 70);
IE
re-entry worker
: internal exposure (mg/kg bw/d).
28
TOXICITY

Since for most if not all of the active substances only the systemic AOEL is available, these
values are used for risk evaluation. If re-entry workers are exposed less than three months a
year, the estimated exposure should be compared with the short-term AOEL. If not, the
estimated exposure should be compared to the long-term AOEL. As mentioned before the
choice of an appropriate toxicological benchmark is very important. With respect to the
intermittent exposure of pesticide workers it is recognized that both information on the
anticipated exposure scenario as well as knowledge on the effect of intermittent exposure on
the toxicity are needed. From a toxicological point of view, the setting of more than one
AOEL, covering effects that may arise after different periods of exposure, as well as the
development of more robust acute and short-term studies are strongly recommended.

RISK INDEX

For risk assessment the internal exposure is compared with the systemic AOEL according to
the European approvals process. It is assumed that the AOEL can be used as a reference dose
against which re-entry worker exposure is assessed. Thus the risk index for re-entry workers
is calculated as follows:

_ ker,
_ ker,
re entry wor acute
re entry wor acute
IE
RI
AOEL

=
With:
RI
re-entry_worker, acute
: acute risk index for the re-entry worker (-);
IE
re-entry_worker, acute
: internal exposure of the re-entry worker (mg a.s./kg bw/d);
AOEL: Acceptable Operator Exposure Level (mg a.s./kg bw/d).

Remarks:
Agricultural re-entry exposure studies should be conducted to provide data that can
ultimately be based to predict worker exposure during specific re-entry activities, and
indirectly can be used to estimate transfer factors associated with a given work activity.
It is clear that in general more field data on post-application (re-entry) scenarios from
which relevant data for predictive modelling can be extracted, are needed.

29
3. Greenhouse worker
Proposed Greenhouse Worker Indicator

EXPOSURE
a. Dermal Exposure
The dermal exposure for the greenhouse worker is estimated in the same way as for the re-
entry worker.
b. Inhalation Exposure
Previously the approach proposed by the Re-Entry Working Group of EUROPOEM
(EUROPOEM II, 2002) to estimate the inhalation exposure of greenhouse workers was
outlined. For information, another approach is mentioned here. The inhalation exposure for
the greenhouse worker is assessed making use of the formulas proposed in the improved
computer model USES (an integral risk-decision system used by the Dutch authorities). This
model was developed to assess internal greenhouse concentrations and aerial pesticide
concentrations near greenhouses (Mensink, 2004).

The following formulas are proposed to estimate the gas-phase pesticide concentrations in
greenhouses:
gh
t gh
H
AR C
1
10
5
0 ,
=
=

With:
C
gh,t=0
: the nominal gas-phase concentration inside the greenhouse immediately
after application. It is dependent on dosage and greenhouse volume. And it is
assumed that the applied amount is instantaneously and homogeneously distributed
over the whole greenhouse volume (g/m);
10
5
: a conversion factor for the units (kg to g);
AR: application rate (kg/ha);
H
gh
: height of the greenhouse (m).

The assumption that the whole amount of sprayed, fogged, smoked or otherwise applied
pesticides contributes to the gas-phase concentration is worst case, and less realistic in
particular for treatments with relatively larger droplets (e.g. high- and low volume
applications). Therefore a correction factor is introduced varying from 0.02-0.71. This
factor is based on initially actually recovered amounts of pesticides in experiments. The
experimental evidence, however, is limited as only a few experimentally based figures are
available. Prospective experiments may reveal more realistic and suitable input values. Table
II.3.1 gives an overview of the default values for different scenarios used in the Netherlands.
A first-order decrease of the pesticide concentration in the greenhouse during the first hours
after application (until re-opening) is assumed based on the combined effect of volatilisation,
ventilation and deposition. Deposition in the greenhouse may occur after volatilisation.
Ventilation is mainly based on convection through chinks and cracks of the greenhouse
construction. Ventilation through open windows is not taken into account.

The following formula is proposed for estimating a more realistic pesticide concentration in
greenhouses (Mensink, 2004):
30
| | | |
) (
1
, ,
) * (
0 ,
,
dep gh vent gh
x T
t gh
T gh
k k T
e C
C
+

=

=


With:
C
gh,T
(g/m): the estimated actual gas-phase concentration after T seconds inside
the greenhouse;
C
gh,t=0
(g/m): the nominal gas-phase concentration inside the greenhouse
immediately after application;
(-): empirical recovery fraction at t=0;
k
gh
,
dep
: deposition rate constant inside greenhouse (s
-1
) This parameter was
experimentally derived as an average for several active ingredients in different
greenhouses with different application techniques. The deposition rate constant
can also be determined using the following formula:

gh gh gh
dep gh
W H L
ISA
k

=
4
,
10 5 , 5
With:
ISA (m): Inner greenhouse surface area, including roof and floor, perpendicular
on the wind direction;
L
gh
(m): greenhouse length;
H
gh
(m): greenhouse height;
W
gh
(m): greenhouse width.

k
gh
,
vent
: ventilation rate constant inside greenhouse (s
-1
). This parameter is derived
by assuming a flow rate constant directly proportional to the wind speed;
x =
dep gh vent gh
k k
, ,
+ (s
-1
);
T (s): time over which the concentration is integrated.

The proposed calculation scheme is supposedly realistic worst-case taking into account that
the calculations have been based on processes (volatilisation, deposition and ventilation) and
on experimental values (ventilation and deposition rate constants, values). However, the
assumptions in the calculation scheme cannot be sufficiently tested yet as actual
concentrations inside the greenhouse are very scarce or lacking. Comparison with measured
concentrations revealed that the scheme may be realistic for volatile pesticides, but probably
not for less volatile pesticides. This is however based on only a few measurements. The
likelihood of underestimating exposure seems small, whereas overestimating exposure to less
volatile pesticides may still occur. To restrict the overestimation of exposure, a limit is set for
the pesticide concentrations in greenhouses, namely the saturated vapour concentration. In
this way the approach used is more realistic for less volatile and moderately volatile
pesticides. This concentration is calculated as follows:
T R
f MW P
C
vap
s


=
With:
C
s
: saturated concentration of an active substance in the atmosphere
(g a.s./ m air);
P
vap
: Vapour pressure (Pa);
MW: Molecular Weight (g/mol);
f: 10
6
, conversion factor g to g;
R: gas constant (8,314 J/molK);
T: Temperature (K).
31
When the calculated concentration C
gh
(g/m) exceeds C
s
(g/m), the value for C
s
(g/m) is
used to calculate the internal inhalation exposure I (mg/person/d).
Table II.3.1: Proposed default values
Parameter Value Unit
L
gh
100 m
H
gh
4,5 m
W
gh
100 m
ISA 450 m
k
gh
,
dep
2,66E(-4) s
-1

k
gh
,
vent
1,67E(-4) s
-1

(highly volatile, application type, not relevant) 0.51 -
(moderately volatile, space treatment) 0.71 -
(moderately volatile, high-volume application) 0.02 -
(moderately volatile, low-volume application) 0.04 -
(slightly volatile, application type, not relevant) 0.1 -
Three volatility classes are distinguished: highly volatile (>10 mPa), moderately volatile (0.01-10 mPa)
and slightly volatile (<0.01mPa)
The acute inhalation exposure for the greenhouse worker is then estimated using the formula
below:
3
10

= WR IR C I
gh


I : greenhouse worker inhalation exposure (mg/person/d);
C
gh
: concentration of an active substance in the greenhouse atmosphere (g a.s./
m air);
IR: inhalation rate (m air/ hr);
A default value of 1,25 m/hr can be assumed for an adult. Table II.3.2 presents
alternative values for the inhalation rate recommended by the EPA Exposure
Factors Handbook 1997. The PSD applies an IR of 0.82 m/hr;

Table II.3.2: Default values for the inhalation rate for adults
Time-scale Activity/Population Value Average Value Unit Source
Rest 0.4*
Sedentary activities 0.5*
Light activities 1.0*
Moderate activities 1.6*
Acute
Heavy activities 1.9*
0.55
(=13,3/24)
m/hr
Females 11.3**
Chronic
Males 15.2**
13.3 m/d
Exposure Factors
Handbook (U.S.
EPA, 1997b,
page 5-24)
* These values should be used to assess short-term scenarios of a few hours in duration, such as
post-application inhalation exposures following lawn treatment, foggers and crack and crevice
treatments (depending on chemical specific data, such as air measurements, vapour pressure, and
persistence).
** These values should be used to assess short-term scenarios of a few days in duration, such as
post-application inhalation exposures following crack and crevice treatments, and termiticide
treatments (depending on chemical specific data, such as air measurements, vapour pressure, and
persistence).

WR: work rate (hr/d);
As a default value it is assumed that a greenhouse worker is exposed for the
duration of 8 hours a day;
10
-3
: correction factor for the units.
32
c. Total Internal Exposure
The total internal exposure is calculated as the sum of the dermal exposure (DE; mg/person/
/d) multiplied by the dermal absorption factor (Ab
DE
; %) and the inhalation exposure (I;
mg/person/d) multiplied by the inhalation absorption factor (Ab
I
; %), divided by the body
weight (BW, default: 70 kg) of the worker (Vercruysse et al., 2002).

*
DE I
greenhouse
DE Ab I Ab
IE
BW
+
=

Where:
DE: dermal exposure (mg/person/d);
Ab
DE
: dermal absorption factor (%/100);
I: greenhouse inhalation exposure (mg/person/d);
Ab
I
: inhalation absorption factor (%/100) (default: 100%);
BW : body weight (kg) (default: 70);
IE
greenhouse
: internal exposure (mg/kg bw/d).

TOXICITY

The estimated exposure is compared to the AOEL of the considered active substance.

According to Directive 94/79/EEC, " for volatile substances (vapour pressure > 10-
2
Pascal), expert judgement is required to decide whether the short-term studies have to be
performed by oral or inhalation exposure". In the case of gaseous substances, only inhalation
studies are technically feasible. Therefore, the toxicokinetic, metabolism and toxicity studies
that are required under Annexes II and III of Directive 91/414/EEC will be performed via the
route of inhalation. For converting an inhalation NOAEL (expressed as mg/l) to an internal
dose (mg/kg bw/d), the respiration rate of the test species, the duration of daily inhalation
exposure in the study and the extent of respiratory absorption have to be taken into account.
The extent to which the size distribution of droplets/particles in an inhalation toxicity study is
relevant to human inhalation exposure to the active substance (as product concentrate or in-
use dilution) should be considered. To calculate the NOAEL in mg/kg bw/d for a rat study
with daily inhalation exposure of 6 hours, the following assumption should be used (Lundehn
et al., 1992): NOAEL (mg/kg bw/d) = NOAEL (mg/l) x 45 l/kg bw/hr (rat respiration rate) x
6 h (daily inhalation exposure) x 1 (default respiratory absorption: 100 %) (EC, 2001).

For some substances, certain toxic effects, for example on the lung, only occur during
inhalation exposure. In these cases (i.e. where effects are air-concentration- rather than dose-
related), an internal AOEL value cannot be established. The risk management for such
substances may be best addressed by establishing occupational exposure limit values (EC,
2001).
33
RISK INDEX

For risk assessment of greenhouse workers, the internal exposure has to be compared with the
systemic AOEL. The total internal exposure and the risk index are calculated with the
following formulas (Vercruysse et al., 2002).

,
greenhouse
greenhouse acute
IE
RI
AOEL
=
Where:
RI
greenhouse, acute
: acute risk index for the greenhouse re-entry worker (-);
IE
greenhouse
: internal exposure for the greenhouse re-entry worker (mg/kg bw/d);
AOEL: Acceptable Operator Exposure Level (mg/kg bw/d).

Remark
Concerning greenhouse scenarios there is an urgent need for more predictive modelling.
Appropriate realistic data need to be generated.

34
4. Bystander

Introduction

The term bystander is not formally defined under national rules and in the European
Directive 91/414 EEC on the authorization of plant protection products. In the latter it is
indicated that applicants seeking approval must submit exposure assessments for bystanders.
Member States are instructed to evaluate the exposure of bystanders or workers exposed after
the application under the proposed conditions of use. In addition, it is required that waiting
and re-entry intervals are such that the exposure of bystanders or workers exposed after the
application must not exceed the AOEL.

Through the evaluation of active substances at the European level a working understanding of
what is meant by bystander has been developed. This has been taken up by the
EUROPOEM Group of regulatory and industry scientists who proposed the following
definition of bystanders:

Bystanders are people who are located within or directly adjacent to the area where pesticide
application or treatment is in process or has taken place; people whose presence is quite incidental
and unrelated to work involving pesticides but whose position may put them at risk of exposure;
people who take no action to avoid or control exposure; people for whom it is assumed that no
protective clothing is worn and perhaps little ordinary clothing; and for whom exposure can
potentially occur during the process of application (including the preparation for application) and
after the application (Anon, 1997).

In the UK the issue of bystander exposure was considered in the early 1980s when the
Central Science Laboratorys Application Hazards Group started making measurements of
bystanders exposure to tracers during pesticide applications (Table II.4.1). Tracer studies are
acceptable since most pesticides are non-volatile so that potential exposure will mainly occur
due to drifting spray droplets. The studies conducted involved collecting airborne tracer in the
breathing zone and tracer that would impinge on the clothing and uncovered skin of a
bystander positioned at 8 metres directly downwind from the sprayer. This distance was
chosen to reflect the fact that there usually would be some distance, containing at least the
field margin and any boundary structure, between the bystander and the application
equipment.

Table II.4.1: Data for bystander exposure (EUROPOEM II, 2002 Report of the Bystander Working
Group) (estimates of bystander surface contamination by applied spray for range of application methods)
Application method
Bystander contamination per single swath only (AHU 8m
data 90
th
percentile; percentages of the application rate per
square meter)
0.83 % (hydraulic nozzles)
Arable spraying
0.97% (rotary atomizers)
Orchards early 5.5 %
Orchards late 0.91%

UK bystander exposure assessments for pesticides use the average levels from these studies.
The following remarks can be noted. The potential dermal exposure might be three times as
high if the sprayer is applied in sequential upwind swaths and if the bystander remains in the
same position downwind of a sprayer. But, no significant increase in airborne levels would be
expected. No reduction by clothing of the potential dermal exposure is assumed.
35
Although Directive 91/414/EEC requires all Member States to address exposure of
bystanders, there appear to be few bystander data apart from the CSL (Central Science
Laboratory) data adequate for use in such assessments. Therefore other Member States follow
various approaches. Often bystander exposure is considered in a semi-quantitative manner by
considering that bystander exposure will be less than the predicted operator exposure when
they are not wearing any PPE during spraying. A qualitative adjustment is often made as
operator exposure is based on an entire working day in close proximity to the spray and
includes exposure from direct handling of spraying equipment. Whereas bystanders will not
touch the spraying equipment and their exposure to spray drift will occur at a distance outside
of the treated area.

Within the framework of the first Concerted Action (AIR3 CT93-1370) the Expert Group
identified a series of reports available from the UK Central Science Laboratories and based on
preliminary research of these studies the Expert Group was able to establish a guidance
document for the collection of bystander exposure data, including definitions concerning the
nature of bystanders and the likely type and duration of exposure. A likely worst case
scenario was developed for the assessment of bystander exposure. However the complexities
inherent in assessing bystander exposure warranted greater attention to this topic. Thus, a
generic database of bystander exposure studies was developed, a number of generic bystander
exposure scenarios were defined and the tiered approach to exposure estimation was adopted
within the framework of the EUROPOEM II project. Nevertheless, an official model
implemented on Community level is not yet available. Also on national level, models for
assessing bystander exposure are lacking (EFSA, 2006).

The 22
nd
September 2005, the Royal Commission on Environmental Pollution (RCEP)
published its report on Crop spraying and the health of residents and bystanders (Blundell,
2005). The main focus of the RCEP report is the risk assessment that is performed for
bystander exposure to pesticides. The Advisory Committee on Pesticides (ACP) commented
on this report last December (2005). The RCEP concluded that a statutory 5 m buffer zone
should be introduced alongside residential properties and other buildings such as schools,
hospitals and retirement homes where people may be adversely affected as the result of crop
spraying. This conclusion contrasts with that reached previously by the ACP. The ACP
concluded that on the basis of experimental data available to them, the risk assessment
performed for bystanders provided adequate protection. Though, it was indicated that further
consideration was needed for dithianon, trifluralin and soil fumigants. Thus further
confirmative work is still needed. Research involving the collection of air monitoring and bio-
monitoring data for bystanders should be undertaken and the practicality of defining standards
or limits for airborne concentrations of volatile pesticides should be considered. However,
some months after the above advice had been agreed and delivered three ACP members
indicated their reservations about the confidence that could be placed that the current risk
assessment provided adequate protection for bystanders. In that retrospect, one of these three
felt that he should have registered disagreement when the earlier advice was given.

One of the critical areas of uncertainty identified by the RCEP relevant to mention is the
assessment of the potential exposure for bystanders. The RCEP report highlights several
potential determinants of exposure that are not accounted for in the model currently used to
estimate exposures from spray drift (e.g. use of reduced spray volumes, differences in boom
height, local air turbulence, topographical features, the height of the person exposed,) and
expresses concern that the model does not incorporate other possible sources of exposure,
such as dermal contact with contaminated surfaces by spray drift (including any subsequent
36
hand to mouth transfer in infants leading to ingestion and inhalation of vapour (Blundell,
2005). The ACP commented on this aspect after reviewing data collected by the PSD
(Pesticide Science Directorate) on potential sources of bystanders exposure other than
directly from spray drift. Based on these data it was concluded that spray drift indeed was the
main determinant of maximum possible exposure for bystanders as well as for residents. The
ACP agrees that the current model does not include all the variables that might have an
impact on potential bystander exposure. Thus research is necessary to consider the extent to
which the model might underestimate exposure and the implications of any such
underestimation for risks to health. Underestimation is particularly possible for bystanders
who were very close to a spray boom as it passed. Research revealed that exposures at 1 meter
distance from a spray boom might sometimes be up to seven times higher than the average at
8 metres (the distance taken in the regulatory approach). Taking this into account, together
with potentially relevant variables such as those identified by the RCEP, and also the potential
for exposure from sources other than direct contact with spray drift, the ACP assessed that the
current model is extremely unlikely to underestimate the maximum 24 hr exposure of any
bystander by as much of a factor 10, and that exposure above this, if it occurs at all, will be
rare. Apart from that it would also be very rare for a bystander to stand within one meter of a
spraying boom. Most people would stand back and most farmers do not spray right next to a
member of the public. On days when a bystander is not immediately next to the field that is
being sprayed, the potential for exposure above the one estimated by the current model is
even more reliable.

These matters indicate that more research is necessary regarding bystander and resident
exposure. But overall, while there is a need for further empirical data to confirm the adequacy
of the current approach to risk assessment, there is no indication of a problem from the data
that are currently available (ACP, 2005). The ACP agrees with the RCEP that pesticide risk
assessment should be backed up by epidemiological monitoring and health surveillance.
However, how this can be achieved most effectively and efficiently is a difficult question.

In the near future, Member States and the Commission will reconsider the definition of
bystanders proposed by the EUROPOEM group, along with the groups evaluation of the
available data from CSL. It was proposed that the 90
th
percentile values for bystanders at 8
metres should be used in the harmonised European approach.

Proposed Bystander Indicator

EXPOSURE

Currently, there are no generally accepted models for estimating bystander exposure. There is
no harmonised approach under EU rules and in fact very few appropriate data exist which can
be used for conducting bystander exposure assessments. Human health risk assessments for
bystanders are routinely performed using exposure data from tracer studies where bystanders
were monitored at 8 m distance from the application equipment. Several Member States use
drift deposition data as surrogate data and do not include any potential inhalation exposure.
Therefore the exposure estimations are based on the recommendations made by the
EUROPOEM II bystander working group (EUROPOEM II Bystander Working Group,
December 2002).
37
In general, it is assumed that exposure of bystanders mainly occurs when spray drift impinges
on persons next to fields being sprayed. Bystanders, walking alongside a field which is being
treated, are exposed only for a short period of time when the sprayer moves along the person.
Repeated exposure is unlikely, since the sprayer is considered to only pass along the edge of a
field for each spraying swathe. Bystander exposure can occur during the process of
application (incl. preparation) of pesticides and during the period of treatment following the
application itself. For applications where the operator is present in the treated area (e.g. hand
held spraying) the process of application means that working period. For other applications
(e.g. space treatments) where pesticides are released into an enclosed container zone, and no
operator is present, the deposition phase of the pesticides (i.e. the operators own exclusion
period from first release until completion zone of the ventilation process to remove excess
pesticide from the zone) should be regarded as the application process. Following completion
of the pesticide application process, but during the period of the pesticide action when the
treatment is underway direct exposure would be regarded as re-entry exposure, but indirect
bystander exposure could occur due to movement of pesticide (e.g. vapour) away from the
treatment area (EUROPOEM II, 2002).

It is assumed that only ordinary clothing is worn and the total uncovered skin area amounts to
0.4225 m (= head, back & front of neck, forearms, upper arms and hands) (pers. comm.
Vleminckx, 2006). Bystanders are assumed to be located at a certain distance downwind from
the centre of the treated field (assuming that this region will contain the highest concentration
of ambient pesticide contamination). The wind direction is from the treated field straight
towards the bystander subject, which is worst case in respect of exposure to drifting spray
particles. The likely access and proximity of bystander subjects to the source of potential
exposure is considered to be the main factor determining risk.

In the Guidance Document for bystander exposure data gathering (2002) several scenarios
were identified. A bystander may be located (1) within an area directly adjacent to the area
being treated with pesticides or where pesticide treatment is taking place (e.g. on a footpath
next to a field), the likely worst case with little scope for assured preventive control measures;
(2) within the area being treated with pesticides or where pesticide treatment is taking place
(e.g. in the same field or glasshouse). Bystanders in this situation should come under the
control of the safety regime in force for pesticide applications; (3) in some locations indirectly
connected to the area being treated with pesticides, but with a clear scope for potential
exposure (e.g. sharing a common access). Scenario (1) is considered the most relevant one.

Bystanders participating in the work involving pesticides and thus brought into a position of
potential exposure may be expected to be managed as a part of the operational workforce and
should be considered as potentially exposed workers, thus would be protected by PPE,
engineering or operational controls.

The exposure is estimated both for the dermal and inhalation route.
a. Dermal exposure

It can be postulated that the dermal exposure is directly correlated to the amount of active
substance applied per area, the area of the uncovered body surface contaminated and the drift
distance. Drift data are of crucial importance to the estimation of potential dermal exposure of
bystanders in the current European registration procedures. The likely amount of spray drift
depends on several factors, each of which may vary within a wide range within the bounds of
38
associated good agricultural practices for spray application (e.g. the strength of the wind, the
application method, sprayed volume rate, applied form of spray quality, the forwards speed of
the vehicle and calibrated swath wide). The formula outlined below is applied to assess the
potential dermal exposure (pers. comm. Vleminckx, 2006). Hereby it is assumed that 100% of
the drift arrives on the body of the bystander.

The following algorithm is used to calculate dermal exposure (EUROPOEM II, 2002):
EA Drift AR DE =
Where:
DE: theoretical potential dermal exposure (mg/person/d);
AR: application rate (active substance)(mg a.s./m);
Drift: downwind pesticide ground deposits at 8m distance from the field
(Ganzelmeier tables) (%/100);
EA: exposed area (m/person/d) (default: 0.4225) (total uncovered area: head, back
& front of neck, forearms, upper arms and hands).

The spray drift is calculated for the outdoor scenarios on the basis of drift tables published by
the BBA (BBA 2004; Rautmann & Streloke, 2001). Indoor operation e.g. with hand-held
sprayers, mist blowers or fog generators, should exclude bystanders as part of the safe
management of the work. Other persons possibly present should be regarded in the same way
as re-entry workers for risk assessment. These tables describe the percentage of applied
pesticide moving beyond the borders of a treated field depending on crop type (arable crops,
fruits, grapes, hops and vegetables), the crop stage (early, late) and on the distance from the
last nozzle of the spraying equipment to the edge of the field.

Various regression functions have been derived from these drift tables (OECD, 2000;
FOCUS, 2002). The regression functions that were developed in the FOCUS group (FOCUS,
2002) have been suggested for use in the aquatic indicator. For the bystander indicator these
functions can be simplified as risk is defined at a single distance from the edge of the treated
area rather than within a water body of defined width.

The exposure via drift for a bystander will be calculated at a particular distance from the edge
of the treated area. As proposed by the terrestrial work package, it would be prudent to retain
the functionality of the drift calculator. In this way exposure can be calculated also for other
distances. The location of the bystander relative to the pesticide related activity should always
be assessed and reported, together, if possible with the underlying reason for their being in
that position. Bystander subjects should ideally be placed at key locations, e.g. as near to the
known source of pesticide contamination as foreseeable circumstances would allow in normal
practice, or no nearer to the source of contamination than assured control measures could
allow. Bystander movement patterns or activities at their static location should be described.
The following standard locations were identified by the EUROPOEM II Bystander Working
Group (Table II.4.2).
Table II.4.2: Standard bystander scenarios
Application Method Standard bystander location
Hand-held equipment (e.g. lever operated
knapsack sprayers)
2 m downwind from the downwind edge of the swath,
midway along the length of the swath.
Vehicle mounted equipment (e.g. tractor drawn
boom sprayers)
8 m downwind from the downwind edge of the swath,
midway along the length of the swath.
Static equipment (e.g. dipping)
As close to the source of pesticide contamination as it
would normally be possible for a bystander to gain access.
39
According to the regression functions the mean drift deposition is calculated by a simple
potential function for the crop types of arable crops, vines and vegetables. A power function is
suitable as equation function, indicating a linear run of the curve when represented with
logarithmic scales on both axes. Seed and granular treatments will always have drift of 0 %
for all treatments and aerial drift loadings have been set to 33.2% for all applications. This
latter value has been calculated using the AgDrift model (SDTF, 1999) and corresponds to a
distance of 3 m from the edge of the treated field.

The general functional equation for arable crops is:

B
r
Drift A x f =

Other crop types (fruit crops and hops) are represented by two sequential power functions
connected at the hinge distance (H):

B
r
Drift A x f = (for x=0 to H)
D
r
Drift C x f = (for x > H)

Where:

Drift: percentage of application rate lost by drift (%) or the mean percentage drift
loading at a distance x from the edge of the treated field;
A, B, C, D: previously defined regression factors (-);
x: distance from the edge of the treated field to the point of assessment (bystanders
are located at 8 metres from the treated field). (m);
H: hinge point, distance limit for each regression (m);
f
r
: reduction factor which considers improved spraying equipment (f
r
= 0.5 in case
of 50% reduction, f
r
= 0.1 in case of 90% reduction).

Table II.4.3 gives an overview of the classification of crops according to crop grouping,
growth stage and application equipment.

Table II.4.3: Overview of the classification of crops according to crop grouping, growth stage and
application equipment (Source: FOCUS (2002))
Crop Crop grouping Growth stage Application
Cereals spring and
winter, rape, cotton,
maize, tobacco, soy bean
Arable crops - Boom sprayer
Vegetables, grass,
potatoes, sugar beets
Vegetables - Boom sprayer
Hops Hops - Air blast
Pome/stone fruit early
applications
Fruit crops Early Air blast
Pome/Stone fruit late
applications, Citrus,
Olives
Fruit crops Late Air blast
Vines early application Vines Early Air blast
Vines late application Vines Late Air blast
40
The values for all the parameters listed above are presented in Table II.4.4. Further details can
be found in the FOCUS Report Chapter 5.4 and Appendix B (2002).

Table II.4.4: Model parameters (A, B, C and D) and hinge distance (H) (Source: FOCUS (2002))
Crop grouping Growth stage Percentile A B C D H
Arable crops - - -
Vegetables <
0.5 m
- 90 2.7593 -0.9778 - - -
Vegetables >
0.5 m
- 90 44.769 -1.5643 - - -
Hops - 90 58.247 -1.0042 8654.9 -2.8345 15.3
Early 90 15.793 -1.6080 - - -
Vines
Late 90 44.769 -1.5643 - - -
Early 90 66.702 -0.7520 3867.9 -2.4183 11.4
Fruits
Late 90 60.396 -1.2249 210.70 -1.7599 10.3
Aerial
application
- 90 50.470 -0.3819 281.1 -0.9989 16.2

The use of the 90
th
percentile is in accordance with proposals made on the EU-level by the
FOCUS-group. Otherwise to gain an estimate of a probable realistic level of spray deposition
from a single application, mean values for drift fallout measured at 7 meters downwind
distance from a single application are 0.14% for arable crops, 8.2% for orchards sprayed in
early season and 2.6% for orchards sprayed late (with full foliage).

Intermezzo on drift-reducing equipment

All classified sprayers are listed in the list of drift-reducing equipment (www.bba.de). There
are more than 160 entries in this list. It includes field crop sprayers and air-assisted sprayers
for orchards, hops and vineyards. Some sprayers for asparagus and red/blackcurrant are also
listed. Application rules on pesticide labels refer to this list and prescribe buffer zones
depending on the drift reduction class (Rautmann, 2001).

Field crops
Field crop sprayers can easily be equipped with air induction nozzles to reach the
requirements for the drift reduction classes. Dependent on the nozzle size and the spraying
pressure, a drift reduction of 50% up to 90% is possible. Sprayers with air-assistance achieve
drift reductions of 50% in crops with a minimum height of 30 cm and 75% in crops with a
minimum height of 50 cm. Band sprayers, which are used for weed control in sugar beet or
maize, are listed in the 90% drift reduction class.

Orchards
In air blast sprayers air induction nozzles lead to drift reduction. However further steps are
necessary to reach the mentioned drift reduction classes. In orchards the air-assistance
towards the field edge must be turned off in the first five rows. This can be achieved with a
cover shield on the fan outlet or a redirection metal sheet (Rautmann, 2001). The use of these
sprayers does not result in additional difficulties in comparison to standard sprayers. In
contrary to tunnel sprayers there is no restriction for the use on slopes. Some sprayers are
equipped with green detectors. They will shut of the nozzles when no leaves are in sight. Even
with hollow cone nozzles which produce fine droplets the drift reduction is at least 50%.
Another possibility is to spray beneath a hail net. Depending on the nozzle, drift reduction is
at least 50%, sometimes 75%. When using orchard sprayers with small axial fans (air flow
41
reduced to 20.000 m/hr) and air induction nozzles are used, a drift reduction of 75% has been
found. Some sprayers with a cross-flow fan have been tested and could be classified in the
75% and 90% reduction class. Tests with a tunnel sprayer with air induction nozzles in
orchards resulted in a drift reduction of 99%.

Vineyards
In vineyards there is a growing number of sprayers registered in the 75% and 90% reduction
classes. The first sprayer has been the tunnel sprayer, but nowadays air-assisted sprayers of
different types equipped with air induction nozzles achieve the same drift reduction, if the
outermost row is sprayed inwards only. Further tests are necessary to find solutions for
existing sprayers to improve the possibilities for drift reduction.

Hops
Drift reduction in hops is quite easy. Sprayers need a shield on one side of the fan outlet and
air induction nozzles to spray the outermost part of the hop garden. For the inner part the
shield must be removed. This leads to a drift reduction of 90%. Nearly all sprayers can be
adapted in this way.

b. Inhalation Exposure
Generally, in open fields inhalation exposure is negligible due to the extreme small volume of
spray in droplets small enough to be inhaled into the lungs. Nevertheless, there is concern
about downwind spray drift, which may be deposited on bystanders. However tests have
shown that, in general, the exposure of unprotected bystanders is only a fraction compared
with the spray operator (Gilbert & Bell, 1988). On p 52 an algorithm is outlined for assessing
bystanders inhalation exposure to volatile pesticides. Specific data should be gathered to
assess bystanders exposure to volatile chemicals by means of monitoring.

Case 1: water rate value is known

The potential bystander inhalation exposure is calculated using the formula outlined below in
case the water rate value is known.

T Drift IR C I
spray
=
Where:
I: potential inhalation exposure (mg/person/d);
C
spray
: active substance concentration in the spray mist (mg/m);
3
10 =
WRV
AR
C
spray

Where:
AR: application rate (kg a.s./ha);
WRV: water rate value (l/ha);
10
3
: correction factor for the units.
IR: inhalation rate (m/hr) (default value adults = 1,25 m/hr);
Drift: percentage of application rate lost by drift (%);
T: exposure time (hr) (default: 1 min = 1/60 hr; pers. comm. Vleminckx,
2006).
42
Case 2: concentration of active substance in the spraying solution is known

The potential bystander inhalation exposure is calculated using the formula outlined below in
case the concentration of the active substance(s) in the spraying solution is known.

T IR C I
spray
=
Where:
I: potential inhalation exposure (mg/person/d);
IR: inhalation rate (m/hr) (default value adults = 1,25 m/hr);
T: exposure time (hr) (default: 1 min = 1/60 hr; pers. comm. Vleminckx,
2006);
C
spray
: active substance concentration in the spray mist (mg/m).

.) . %( s a Default C
spray
=
Where:
% (a.s.): active substance concentration in the
pesticide formulation (mg/ml);
Default: - arable sprayers = 0.03 ml spray /m (90
th
)
breathed air (or per hour of spraying);
- orchard sprayers = 0.06 ml spray /m
(90
th
) breathed air (or per hour of
spraying).

Source: EUROPOEM II Report of the Bystander Working Group. Inevitably, under field
conditions with variations in wind speed and direction, there will be some variability in
measurements. The adoption of a mean value has been criticised with the suggestion that
more account should be taken of the probability of more exposure under some conditions.

Bystander inhalation exposure is calculated in this case on the basis of the data collected in
the series of AHU/CSL trials listed in the EUROPOEM II Report of the Bystander Working
Group. Inhalation sampling was done by volunteers wearing respirators modified to simulate
the mechanics of nasal breathing, containing multiple layers of absorbent gauze material. The
reported results were normalised to provide potential inhalation exposure levels in terms of ml
spray per m of breathed air (equivalent to 1 hour of breathing). The source of spray was the
airborne drift arising from the sprayed swath closest to the location of the bystander. The
results have not been correlated with respect to sprayer output volume or dose rate, because it
is impossible to determine that fraction of the applied spray which would have been capable
of reaching the bystanders breathing zone. Therefore the data should be regarded as realistic
worst case, as some sprayed swaths were close to the bystanders and others were further
away. It is also reasonable to assume that the whole of a sprayed field would present a lower
potential inhalation rate than that measured for the nearest swathe. It is proposed that potential
bystander exposure via the inhalation route is estimated at the 90
th
percentile level, i.e. 0.03
ml spray per m of air breathed (or per hour of spraying) for arable operations and 0.06 ml
spray per m of air breathed (or per hour of spraying) for orchard sprayers. The exposure
predicted using these data are often orders of magnitude lower than the AOEL (EUROPOEM
II, 2002).

43
The effectiveness of bystanders own clothing at preventing actual dermal exposure resulting
from the potential exposure level (i.e. surface contamination rate) has not been factored into
these recommended values. The likelihood of bystanders wearing clothing on different parts
of their body may alter depending on the season of the year, the location and the activities
being performed. The most reasonable conservative estimate is to assume that bystanders are
wearing little clothing. But when wearing little clothing, it is more likely that the feeling of
drifting spray droplets depositing on the exposed skin will be perceived and consequently one
will move away from the spray drift. When wearing full clothing bystanders will not be
quickly aware of spray drift contamination and will thus not move away as easily. On the
other hand the clothing can absorb the contaminants and can in this way reduce the actual
dermal exposure (EUROPOEM, 2002).

Case 3: based on the operator inhalation exposure

The inhalation exposure is calculated as for the operator (only considering inhalation
exposure) but the exposure time is only 1 minute (pers. comm. Vleminckx, 2006) instead of
the total exposure time of the applicator, which can be set to 6 hours a day. The exposure time
can also be augmented to 5 or 10 min.

a treated
treated
I Area AR DED
I
Area ST

=


Where:
I: bystander inhalation exposure (mg/person/d);
I
a
: applicator inhalation exposure (mg/kg a.s.);
Area
treated
: area treated per day work rate expressed in ha per day (ha/d);
AR: application rate (kg a.s./ha);
DED: daily exposure duration (min/d);
ST: spraying time (min/ha).

Case 4: bystanders living nearby greenhouses

For assessment of the acute residential and bystander inhalation exposure due to the
application of pesticides in greenhouses, the approach suggested for implementation in the
USES 5.0 model (a computerised and integral risk-decision system used by the Dutch
authorities) is proposed. Such calculations will be increasingly important for example in the
Netherlands, as more inhabitants will be living nearby greenhouses in the future.

The model allows exposure of nearby residents to be calculated up to a distance of 20 meter.
Expectations are that the module adaptations will improve the aerial pesticide calculations,
particularly within the first few hours after the application. The module uses a process-
oriented approach rather than emission factors. Relevant processes that are considered are
volatilisation and deposition inside the greenhouse and outdoor ventilation of remaining
residues. The ventilation mainly occurs primarily via convection of inside air to outside
through chinks and cracks in the glass construction. Comparison with measured
concentrations inside the greenhouse were made and cautiously concluded these comparisons
reveal that the scheme may be realistic for volatile pesticides, but probably not for less
volatile substances. This is however based on only a few measurements. More experimental
research is needed. This module for calculating the exposure of nearby residents is based on a
44
calculation scheme developed by Alterra in consultation with the National Institute for Public
Health and the Environment and Applied Plant Research Horticulture (Naaldwijk).

The algorithms for assessing the pesticide concentration inside a greenhouse are outlined in
this report (page 2931). To obtain the outdoor pesticide concentration, the formula below can
be applied (Mensink, 2004):

,
, ,
, ,
, ,
,
gh vent
gh inair T
gh
gh vent gh dep
gh outair T
gh gh faade
k
C V
k k
C
T K A u
(
(

(

+
(

=


With:
C
gh,outair,T
(g/m): the estimated actual gas-phase concentration over T seconds
outside the greenhouse in the lee side eddy up to 20 metres;
C
gh,inair,T
(g/m): the estimated actual gas-phase concentration over T seconds
inside the greenhouse;
k
gh
,
dep
: deposition rate constant inside greenhouse (s
-1
) This parameter was
experimentally derived as an average for several active ingredients in different
greenhouses with different application techniques. The deposition rate constant
can also be determined using the following formula:

gh gh gh
dep gh
W H L
ISA
k

=
4
,
10 5 , 5
With:
ISA (m): Inner greenhouse surface area, including roof and floor, perpendicular
on the wind direction;
L
gh
(m): greenhouse length;
H
gh
(m): greenhouse height;
W
gh
(m): greenhouse width.

k
gh
,
vent
: ventilation rate constant inside greenhouse (s
-1
). This parameter is derived
by assuming a flow rate constant directly proportional to the wind speed;
K
gh
: greenhouse construction coefficient referring also to the wind direction (-)
(default: 0.5, experimentally determined average realistic value);
A
gh, faade
: surface area of the faade (m) (default: 450 m ( = 100*4.5);
V
gh
: volume of the greenhouse (m) (default: 45000 m);
u: wind velocity just above the greenhouse (m/s) (default: 3 m/s; this value
corresponds with a wind speed between light air and light breeze. This value is
arbitrary and it does not represent a worst-case approach. Calm air (i.e. no wind at
all) is more likely to increase the exposure in the immediate vicinity of
greenhouses.);
T (s): time over which the concentration is integrated.

The outdoor concentration is thus calculated by dividing the source strength for air emission
by the wind speed, the construction factor K and the surface area of the faade perpendicular
on the wind speed. The inhalation exposure is then calculated by multiplying the outdoor
concentration with the inhalation rate and the daily exposure duration.

45
c. Total Internal Exposure
The estimated exposure for bystanders is calculated with the following formulas:


tan
* *
DE I
bys der
DE Ab I Ab
IE
BW
+
=
Where:
DE: dermal exposure (mg/person/d);
Ab
DE
: dermal absorption factor (%) (default: 10; POCER II);
I: bystander inhalation exposure (mg/person/d);
Ab
I
: inhalation absorption factor (%) (default: 100);
BW: body weight (kg) (default: 70).


TOXICITY

The human health risk assessments involve comparing the routes, levels and frequency of
exposure with some indicator of toxicity. For bystanders the estimated exposure is compared
with an AOEL. Operators, particularly spray contractors, may use a pesticide repeatedly over
a period of several months. Since bystanders usually are exposed less frequently, this
approach may be more protective for bystanders. However the aim is to protect in the worst
case, and therefore we favour its continued use.

Currently, a proposal is made to develop a Guidance Document on Community Level in
which the relevant toxicological end point(s) will be established for bystanders for
comparison with the exposure, resulting from the respective exposure assessment. When more
refined mathematical procedures for exposure assessments for bystanders will have been
developed, it should be clarified if the already existing end points may serve as reference
values. New toxicological end points may possibly be required as a result (EFSA, 2006). The
Scientific Community on Plants has already recommended to the Commission to reconsider
the adequacy of applying the AOEL to this subpopulation (Howard, 2004). Since no specific
toxicological parameter for bystanders is available, we make use of the systemic AOEL.

RISK INDEX

The risk index for the bystander is obtained by dividing the internal exposure of the bystander
by the AOEL:
tan
tan er
bys der
bys d
IE
RI
AOEL
=
Where:
RI
bystander
: acute risk index for the bystander (-);
IE
bystander
: internal exposure (mg/kg bw/d);
AOEL: Acceptable Operator Exposure Level (mg/kg bw/d).
46
Remarks:

Because of the lack of useful data for tier 2 assessments it is recognized that individual field
studies will remain necessary to be performed in order to evaluate more exactly the level of
bystander exposure to specific pesticides applied under certain conditions. Research regarding
measurements of actual levels of bystander exposure arising from applications that follow
standard procedures based upon current and new application technologies and risk mitigation
measures would provide useful data.

It is essential to validate the proposed approach for assessing bystander exposure against
empirical data. In case of bystanders, exposure may occur by several routes, the best method
of measuring will often be biomonitoring, provided that there is a suitable analyte. Data
regarding bystander exposure are few in most if not all European countries. Recognizing this
gap in data, biomonitoring studies should be undertaken. Such research is going on in the UK
as recommended by the ACP.

Other routes of exposure, besides drift should be taken into account. Possible exposure to
pesticides as vapour or as particulates which are remobilized following completion of spray
application has not been possible to evaluate as no useful data were found. Individual studies
are required if such routes are considered to be relevant for specific products.
47
5. Sensitive population groups

High-risk population groups can be defined as groups which are either more highly exposed
to an environmental agent or more susceptible to its effects (Ashford et al., 1990). Children of
agricultural producers and re-entry workers appear to meet both of these criteria as well as
pregnant women living in agricultural areas. First of all children are discussed, followed by
pregnant women.

CHILDREN

Factors determining the unique vulnerability of children

Several factors determine the unique vulnerability of toddlers, infants and children to
pesticides. Because of the differences in physiology and behaviour, exposures among children
are expected to be different than exposures among adults.

First of all there are the physiologic characteristics. These characteristics influence exposure
by affecting a childs rate of contact with exposure media or by altering the exposure-uptake
relationship that governs the internal dose resulting from exposure. Children have a larger
surface-area to body weight ratio than adults. This ratio decreases by approximately one-third
within the first year of life and remains constant until approximately 17 years of age, when it
decreases to the adult value. In addition to providing more area for dermal absorption, the
larger relative surface area implies that body heat will be lost more rapidly to the
environment, requiring a higher rate of metabolism to maintain the body temperature and
additional energy requirements to sustain growth and development. The higher metabolic rate
and energy requirements imply that oxygen, water and food requirements are greater per unit
of body weight than for an adult. The higher breathing rate and food consumption rate
required to meet these physiologic needs for children will result in higher relative exposures
to environmental contaminants in air and food (Hubal et al., 2000). On a body-weight basis,
the volume of air passing through the lungs of a resting infant is twice that of a resting adult
under the same conditions, and therefore, twice as much of any chemical in the atmosphere
could reach the lungs of an infant (U.S. EPA, 2002a). Another important physiological
difference between children and adults is the permeability of the skin, which is highest at birth
and decreases in the first year such that the permeability of the skin of a 1-year-old child is
similar to that of an adult (Bearer, 1995). In terms of risk, children may also be more
vulnerable to environmental pollutants because of differences in absorption, excretion and
metabolism (U.S. EPA, 2002a). The cellular immaturity of children and the ongoing growth
processes account for the elevated risk. Compared with adults, absorption and retention of
environmental chemicals is greater in early life: metabolic pathways responsible for
detoxification may differ with age so that foetuses and children may have a lower ability to
detoxify exogenous agents and to repair damage. Cell proliferation in tissues of children is
higher whereas immunological surveillance is less efficient (Perera, 1997). Moreover
childrens increased sensitivity of cholinergic receptors to pesticides can be mentioned
(Faustman et al., 2000). Although in some cases children can cope better with environmental
toxicants than adults. They are for example unable to metabolise toxicants to their active form
(Landrigan et al., 1999). Because children have more future years of life ahead of them
compared to adults, chronic diseases that may be initiated by early exposures have the
opportunity to develop over many decades.
48
Secondly behavioural characteristics and physical activities play a role. Childrens
behaviour and the way that children interact with their environment may have a profound
effect on the magnitude of their exposures to contaminants. For example, children crawl
around on the floor where toxic chemicals adsorbed to dust and other particulate materials
tend to reside. Factors such as hand-mouth behaviour and play patterns can be mentioned.
Exposure to pesticides is also a function of the specific physical activities in which a child is
engaged, the location of these activities (outdoors, indoors, etc.) and the childs activity level
when so engaged. Differences in duration and frequency of periods spent in particular
locations result in different exposures and risks to children that vary with age and
developmental stage. Other influencing factors are diet and eating habits, gender, socio-
economic status and race.

Exposure routes

Children can be exposed to pesticides from multiple sources and through multiple pathways.
In addition to the standard pathways of diet, drinking water and residential pesticide use,
children in agricultural communities can be exposed to pesticides used in agricultural
production (Fenske et al., 2000). Children living in agricultural areas may experience higher
exposure to pesticides than do other children, since concentrated formulations of pesticides
are stored and/or mixed, although not used in high concentrations near the home. The
difference in metabolite concentrations of pesticides between children from agricultural and
reference families was about a four-to fivefold. These concentrations decreased with
increasing distance from farmland (Lu et al., 2000). In addition these children can play in
nearby fields or be exposed via consumption of contaminated breast milk from their
farmworker mother (Eskenazi et al., 1999). Children younger than 6 months of age may
receive their greatest exposures through breast milk ingestion or inhalation, whereas dermal
absorption and ingestion may be the major pathway of exposure when children begin
crawling and placing their hands on dusty surfaces and increasing their hand-to-mouth
behaviour. The level of exposure may continue to increase given that the normal tendency of
young children to explore their environment orally increases up to 2 years of age (Eskenazi et
al., 1999). Sources of exposure can be materials carried into the home via various take home
pathways or pesticide residues that have been transferred from treated surfaces to the hands or
objects that are mouthed such as toys. Dust and tracked in soil accumulate most effectively in
carpets where young children spend a significant amount of time (Lewis et al., 1999). Several
studies have also shown that agricultural workers bring contaminated clothing into the home
(Chiao-Cheng et al., 1988; Clifford & Nies, 1989). Poor hygienic practices such as these
among pesticide formulators have been associated with measurable blood levels of pesticides
(chordecone or kepone) in family members (Cannon et al., 1978). Classic organo-
phosphorous pesticide exposure symptoms in spouses and children of greenhouse workers
have been reported (Richter et al., 1992). Another route of exposure is the soil ingestion
pathway. Children are more likely to ingest soil than do adults as a result of behavioural
patterns during childhood.

49
Proposed algorithms for assessing childrens exposure to pesticides

EXPOSURE

The following algorithms assess the level of exposure likely to result when children playing in
the garden are exposed through dermal, hand-to-mouth and object-to-mouth routes.

a. Dermal exposure

Dermal exposure resulting from direct contact with spray drift
Exposure due to direct contact with spray drift is assessed in the same way as for bystanders
(see earlier). However, different default values are assumed for several parameters. Table
II.5.1 gives an overview of the proposed default values for infants, toddlers and children.
Default values for short-term as well as for long-term exposures are proposed.

When the duration of activity and the activity pattern for children are not specified, the default
values for infants are to be applied, since infants have the highest daily inhalation rate among
all children groups when body weight is considered. The proposed default value equals 0.52
m/kg bw/d, assuming an inhalation rate of 4.5 m/d and a body weight of 8.7 kg. This
inhalation rate is based on the research performed by Layton (1993) and the body weight of
an infant proposed by The Pesticide Safety Directorate (1999). When specific information is
available regarding age and activity level, the values summarized in Table II.5.1 can be
applied.
Table II.5.1: Default parameters needed to calculate childrens exposure
Time-
scale
Parameter Population (years) Value Default Unit Source
Rest 0.3*
Sedentary activities 0.4*
Light activities 1.0*
Moderate activities 1.2*
Acute Inhalation rate
Infants, toddlers and
children (<1 18)
Heavy activities 1.9*
0.36
(=8,7/24)
m/hr
Infants < 1 4.5**
Children (1-2) 6.8**
Children (3-5) 8.3**
Children (6-8)
males/females
10**
males 14**
Children (9-11)
females 13**
males 15**
Children (12-14)
females 12**
males 17**
Chronic Inhalation rate
Children (15-18)
females 12**
8.7 m/d
Child-specific
Exposure
Factors
Handbook
(U.S.EPA,
2002a)
Infants 8.7
Toddlers 14.5
Acute and
Chronic
Body Weight
Children
males/females
43.3
15 kg PSD (1999)
Infants 0.158
Toddlers 0.263
Acute and
Chronic
Exposed Area
(three times
larger surface
area on a body
weight basis) Children 0.784
0.2 m/d
pers. comm.
Vleminckx, 2006
* These values should be used to assess short-term scenarios of a few hours in duration, such as post-application inhalation
exposures following lawn treatment, foggers and crack and crevice treatments (depending on chemical-specific data such as air
measurements, vapour pressure, persistence).

** These values should be used to assess short-term scenarios of a few days in duration, such as post-application inhalation
exposures following crack and crevice treatments, and termiticide treatments (depending on chemical specific data, such as air
measurements, vapour pressure, and persistence).
50
Dermal exposure resulting from contact with a lawn contaminated by spray drift
A childs exposure to pesticides resulting from dermal contact with a lawn contaminated by
spray drift is calculated as follows:

DED TF TTR Drift AR DE
drift spray
=
_


Where:
DE
spray_drift
: Potential dermal exposure due to contact with a lawn contaminated
with spray drift when children are playing in the garden (g/person/d);
AR: application rate (g a.s./cm);
Drift: percentage of application rate lost by drift (%/100);
Estimates of fallout from spray drift are calculated using the same algorithms as
for the bystander indicator. The distance between the edge of the field and the
location of a neighbouring garden should be filled in by the user of the HAIR
software. As a default the distance is set to 8 m;
TTR: turf transferable residue value (%/100) (default: 5%, standard EPA value for
wet hands based on data by Clothier (2000)). Clothier (2000) measured percent
transfer efficiency means of 0.156% 0.138%, 2.72% 1.12%, 4.18% 1.53%
for the pesticides chlorpyrifos, chlorothalonil, and cyfluthrin respectively. The
results are based on single hand presses of volunteers hands (wetted with their
own saliva) onto St. Augustine turf treated with the above mentioned pesticides.
These types of transfer efficiency data are needed to assess the hand-to-mouth
exposure pathway when using hand-to-mouth frequency data based on videotapes
or other observational data. The wet values were two to three times higher than
similar hand presses performed by volunteers whose hands were dry;
TF: transfer factor (cm/hr) (default: 5200 cm/hr, standard EPA value for this
situation);
DED: daily exposure duration (hr/d) (default: 2 hr/d; standard EPA value based on
the 75
th
percentile for children playing on grass for ages 1-4 years and ages 5-11
years). The latter value was obtained from Tsang & Klepeis (1996) as cited on
page 15-79 of the Exposure Factors Handbook (U.S. EPA, 1997b). 23% of
children aged 1-4 years played on grass more than 2 hours per day (U.S. EPA,
1997b page 15-78). In comparison, the 95
th
percentile for playing outdoors is 3,5
hours, the 95
th
percentile for time spent at home in the yard or other areas outside
the home is 5,75 hours for children ages 1-4 years (U.S. EPA, 1997b page 15-96,
15-124 and 15-136).

EPA assesses dermal exposure due to spray drift only on occasion depending on the chemical
or use pattern, for the purpose of implementing a buffer zone.

51
Dermal exposure resulting from ingestion of turf residues (hand-mouthing activity)
Additional exposure resulting from ingestion of turf residues transferred from contaminated
hands to the mouth is calculated as follows:

DED N EA SE TTR Drift AR DE
events mouth hand
=
_


Where:
DE
hand_mouth
: Potential dermal exposure via the hand-to-mouth route (g/person/d);
AR: application rate (g a.s./cm);
Drift: percentage of application rate lost by drift (%/100);
Estimates of fallout from spray drift are calculated using the same algorithms as
for the bystander indicator. The distance between the edge of the field and the
location of a neighbouring garden should be filled in by the user of the HAIR
software. As a default the distance is set to 8 m;
TTR: turf transferable residue value (%/100) (default: 5%);
SE: saliva extraction factor (default: 50%, standard EPA default value);
Camann et al. (1995) investigated the use of surgical sponges wetted with human
saliva to remove residues from hands to volunteers. Removal efficiency of 50% by
saliva was reported for the pesticides chlorpyrifos, piperonyl butoxide and
pyrethrins. Thus, for screening purposes, the value of 50% is recommended. A
saliva extraction factor of 50% allows us to more realistically model the transfer
processes from a contaminated hand in the mouth;
EA: exposed area, i.e. surface area of the hands in contact with the mouth (default:
20 cm/event, which represents the palmar surface of three fingers). The 1999
Scientific Advisory Panel (SAP) suggested that each hand-to-mouth event consists
of the insertion of 1 to 3 fingers. The same SAP also suggested the use of a palmar
surface (both hands) of 114 cm. The problem of assigning surface area values to
the palms and palmar surface of the fingers was solved by Gurunathan (1998) who
simply divided the palmar surface of the hands by 2, with each half representing
the palms and palmar surface of the fingers. Since the hand-to-mouth has been
defined by the SAP as 1 to 3 fingers (5,7 to 17,1 cm) a screening level of 20 cm
was selected based on the assumption that each hand-to-mouth event equals 3
fingers. A criticism of hand-to-mouth frequency data based on video tapes is that it
is not clear if the counting of hand-to-mouth events is based on finger insertions or
if the hands were simply located near the mouth (Kissel et al., 1998);
N
events
: Number of hand-to-mouth exposure events per hour (default: 20 events per
hour, which is the 90
th
percentile of observations ranging from 0 to 70 events per
hour). Reed et al. (1999) reported hourly frequencies of hand-to-mouth events in
pre-school children aged 2 to 5 years based on observations using video tapes. The
data consist of 20 children at daycare centers and 10 children at home. A range of
0 to 70 events per hour were reported. The 1999 Scientific Advisory Panel (SAP)
recommended the use of the 90
th
percentile value of 20 events. A mean of 9,5
events was also reported by Reed et al. (1999) which is similar to the mean
reported by Zartarian et al. (1997) using similar video tape techniques while
observing four farmworker children (2-4 years old);
DED: daily exposure duration (hr/d) (default: 2 hr/d; standard EPA value based on
the 75
th
percentile for children playing on grass for ages 1-4 years and ages 5-11
years).
52
Dermal exposure resulting from ingestion of turf residues (object-to-mouth exposure)
Additional exposure resulting from ingestion of turf residues transferred from contaminated
objects to the mouth is calculated as follows:

IgR TTR Drift AR DE
mouth object
=
_


Where:
DE
object_mouth
: Potential dermal exposure via the object-to-mouth route
(g/person/d);
AR: application rate (g a.s./cm);
Drift: percentage of application rate lost by drift (%/100);
Estimates of fallout from spray drift are calculated using the same algorithms as
for the bystander indicator. The distance between the edge of the field and the
location of a neighbouring garden should be filled in by the user of the HAIR
software. As a default the distance is set to 8 m;
TTR: turf transferable residue value (%/100) (default: 20%, standard EPA value
for object-to-mouth assessments). On the day of application, it may be assumed
that 20% of the application rate is available to be ingested. 20% dislodgeability is
based on the large body of dislodgeable foliar residue data available for
agricultural crops;
IgR: ingestion rate for mouthing (default: 25 cm grass per day, standard EPA
value). The default value is the assumed ingestion rate for grass for toddlers (age 3
years) and is intended to represent the approximate area from which a child may
grasp a handful of grass.

b. Inhalation exposure
Inhalation exposure of children exposed as bystanders is assessed in the way outlined for
bystanders.

One additional algorithm for assessing exposure to vapour is outlined here. This assessment
makes use of a surrogate value for residues in the air adjacent to treated crops, derived from
Californian Environmental Protection Agency studies (California EPA, 1998). In these studies
a 24 ha orange orchard was treated with chlorpyrifos using broadcast air-assisted sprayers.
During application, wind speeds ranged from 2 to 20 km/hr and the maximum temperature
was 42 C. Chlorpyrifos residues in air adjacent to the orchard were monitored over 72 hours.
The highest 24 hour time-weighted average residue in air was 15 g/m.

The algorithm applied for assessing a childs exposure to volatile pesticides is outlined below.

DED IR C I
air
=

Where:
I: Potential inhalation exposure (g/person/d);
C
air
: surrogate value for residues in air adjacent to treated crops (g/m), which
equals 15 g/m (the highest 24 hour time-weighted average residue in air);
IR: inhalation rate (m/hr) (see Table II.5.1);
DED: daily exposure duration (hr/d) (default: 2 hr/d).
53
c. Total Internal Exposure
The estimated total systemic exposure for children is calculated with the following formula:

BW
Ab I Ab DE
IE
I DE
child
+
=

Where:
IE
child
: internal exposure of a child (mg/kg bw/d);
DE: dermal exposure (mg/person/d) (conversion from g to mg has to be done);
The total dermal exposure is calculated by summing up the different types of
dermal exposure (spray drift, hand-to-mouth and object-to-mouth);
Ab
DE
: dermal absorption factor (%);
I: Inhalation exposure (mg/person/d) (conversion from g to mg has to be done);
Ab
I
: inhalation absorption factor (%) (default: 100);
BW: body weight (kg) (default: 15);

TOXICITY

Within the Food Quality Protection Act (1996), the U.S. EPA was instructed to incorporate an
additional ten-fold uncertainty factor into pesticide risk assessments in case of threshold
effects. The introduction of the ten-fold uncertainty factor was promoted to account for the
possible inadequacies of the existing toxicological databases to provide all of the information
related to infant safety (Landrigan et al., 1999). A different margin of safety could be
incorporated only if reliable toxicological data were available. Thus, only if there is no
indication of increased sensitivity in the young to the effects of the pesticide, the extra
uncertainty factor can be removed. Such factors have sometimes been incorporated by the
World Health Organisation for ADIs on a case by case basis. The addition of the ten fold
uncertainty factor to the ADIs was recently proposed for evaluating acceptable pesticide
residues in infant foods, with case by case adjustments where adequate toxicological data
were available. A report of the Dutch Health Council of the Netherlands (Report N
GZB/VVB-993063, 7
th
June 2004) notes that in young animals in some circumstances even
single exposures to some pesticides can be enough to produce an effect. The report
acknowledges that children take in pesticides from multiple sources and recommends that an
additional uncertainty factor ranging from 3 to 10 be considered to protect health during the
developmental period, pending a period of further research (Howard, 2004). The EPA
recently failed to apply the ten fold uncertainty factor (Agrow publications, 2003). The reason
is that if a 10-fold uncertainty factor were to be applied to the current EPA reference doses,
virtually all children with detectable metabolites would exceed this level (Fenske et al., 2000).
We contacted toxicologists and asked them if an additional uncertainty factor should be
applied to assess the risk to pesticides for children. In general, it is considered that children
and pregnant women are covered by the assessment factors which are applied. It is assumed
that the assessment factors relevant to the whole population should be used when setting
toxicological reference values (e.g. pregnant women could be operators, children could be
exposed as bystanders) (pers. comm. Brown, 2006). Thus, no additional uncertainty factor is
introduced and the systemic AOEL is applied as the toxicological reference parameter.
54
RISK INDEX

The risk index for a child bystander is obtained by dividing the internal exposure of the
bystander by the AOEL:

AOEL
IE
RI
child
child
=

Where:
RI
child
: acute risk index for children (-);
IE
child
: internal exposure of a child (mg/kg bw/d);
AOEL: Acceptable Operator Exposure Level (mg/kg bw/d).



55
PREGNANT WOMEN

For assessing systemic exposure for pregnant women, the bystander formulas are applied.
Factors determining the vulnerability of pregnant women
The toxicity of pesticides on human reproduction is largely unknown, particularly how
mixtures of pesticide products may affect foetal toxicity. Research by Arbuckle et al. (2001)
showed moderate increases in risk of early abortions for preconception exposures to phenoxy-
acetic acid herbicides, triazines and other herbicides. For late abortions, preconception
exposure to glyphosate, thiocarbamates, and the miscellaneous class of pesticides was
associated with elevated risks. Post-conception exposures were generally associated with late
spontaneous abortions. Post-conception exposures to specific pesticides also tend to damage
the foetus or foetal placenta (Arbuckle et al., 2001). Rather than cause chromosomal
anomalies.

In addition to the nature of the chemical and its target, the consequences of exposure to
chemical agents depend on the timing of exposure relative to critical windows in the
development of the foetus or reproductive system. Time is as important as dose. A
reproductive hazard could cause one or more health effects, depending on when the woman is
exposed. For example, exposure to harmful substances during the first three months of
pregnancy might cause a birth defect or a miscarriage. During the last six months of
pregnancy, exposure to reproductive hazards could slow the growth of the foetus, affect the
development of its brain, or cause premature labour. Reproductive hazards may not affect
every pregnancy. Whether a woman or her baby is harmed depends on how much of the
hazard they are exposed to, when they are exposed, how long they are exposed, and how they
are exposed. Only a few substances are known to cause reproductive health problems. For
most pesticides examined, preconception exposure contributed more to the risk of a
spontaneous abortion than exposures during the first trimester (Arbuckle et al., 2001).

The following problems may be caused by workplace exposures: menstrual cycle effects,
infertility and sub-fertility and miscarriage, stillbirths, birth defects, low birth weight and
premature birth, developmental disorders and childhood cancer (NIOSH, 1999). Residential
use of pesticides increases the risk of paediatric brain tumours and birth defects.

Uncertainty factor
We contacted toxicologists and asked them if an additional uncertainty factor should be
applied to assess the risk to pesticides for pregnant women. The introduction of an additional
uncertainty factor should be considered on a case by case basis and depends upon the
completeness of the toxicological database of the concerning pesticide (Willems, pers.
omm.., 2006). The effects of active ingredients on pregnant animals are generally tested in
the regulatory guideline studies through the developmental and reproduction studies routinely
required for all active ingredients. When warranted neurotoxicity studies are also used. If a
statistically significant effect on the pregnant animals or their fetuses or offspring is observed
in one or more of these studies, it is regulated on that effect to protect the developing young
and the pregnant female. When setting an AOEL, the most appropriate NOAEL is chosen.
The NOAELs for the teratogenicity studies have to be compared to the NOAELs applied for
assessing the other toxicological endpoints. In case that reproductive toxicity is the most
sensitive endpoint, the AOEL is derived from this endpoint. In case of acute exposure the
AOEL should be derived from a short-term study and it should be evaluated whether this
56
AOEL will prevent teratogenic effects. Moreover, considering that bystander exposure is
much lower (at least one order of magnitude) than the operators exposure, no additional
uncertainty factor is required for pregnant women.
Default values
For pregnant women the same default values as for adults are assumed.


57
III. Proposed Chronic Indicators

The chronic indicators are based on the same formulas as proposed for the acute worker
indicators with the respect of a few adjustments to account for the number of treatments and
the exposure duration.

1. Pesticide operator
Proposed Pesticide Operator Indicator

EXPOSURE

The chronic exposure for pesticide operators (IE
operator,chronic
) is calculated by multiplying the
acute internal exposure (IE
operator
) with the frequency of application (FA) and dividing the
obtained value by 365 to obtain the annual exposure estimate. The factor FA is a
multiplication factor which expresses the number of treatments that were performed in one
year on a given treated area. Annual exposure will be calculated as the sum of all daily
exposure amortized over 365 days. The averaging time can be adjusted according to the
duration of exposure. Lifetime exposure estimates will be calculated as the sum of all annual
ecposures amortized over 75 years (DPR, 2001). In case of intermediate-term exposure
characterized by periods of frequent exposure lasting more than 7 days but substantially less
than one year, whether exposure is constant or intermittent during the period, it is assumed
that the average daily exposure is received on every day of an intermediate-term period.
However if the exposure is intermittent or sporadic, the exposure may be amortized over the
total period.

We propose to use the following formulas to calculate the chronic exposure of operators.

365
) (
/ ,
FA
Area
BW
AR
IE IE IE
treated n applicatio load mix chronic operator
+ =

| |
/
( ) ( * * )
mix load I I I hand hand DE
IE L PPE Ab L PPE Ab = +

( ) ( * * ) ( )
application I I I hand hand DE body body DE
IE L PPE Ab L PPE Ab L PPE Ab ( = + +



With:
L
I
, L
hand
, L
body
(mg a.s./kg a.s.): data on exposure (see p.6);
PPE
I
, PPE
hand
, PPE
body
: personal protective equipment coefficients (-);
Ab
I
, Ab
DE
: respectively inhalation and dermal absorption factors (-);
AR: application rate (kg/ha);
Area treated (ha/d);
FA: frequency of application (number of applications per year) (1/yr);
IE
mix/load
: internal exposure during mixing and loading (mg a.s./kg a.s.);
IE
application
: internal exposure during application (mg a.s./kg a.s.);
IE
operator
: internal exposure of the pesticide operator (mg a.s./kg bw/d);
BW: body weight (kg);
AOEL: Acceptable Operator Exposure Level (mg a.s./kg b.w./d).
58
Below, some more information on the FA is given. The values for the frequency of
application should be available by means of surveys. The Central Science Laboratory
performed a detailed survey in which the FA for various active substances and various crops
was determined. One can estimate the frequency of application (FA) by dividing the Pesticide
Usage Data (kg a.s./yr) with the Application rate (kg a.s./ha). To obtain a realistic value for
the frequency of application one should apply the average application rate. Within the
framework of this project the data gathered by the CSL will be used. In America, the Canada-
United States Trade Agreement (CUSTA) Working Group established a position paper on the
typical workdays for various crops. In this document default values were proposed for the
estimated average number of annual workdays for a grower or an employee of a custom
applicator who apply pesticides to a specific crop. Estimates of the annual frequency of a
wokday exposure were derived from pesticide use patterns submitted by the registrant,
government surveys, farm advisors and grower associations. The same procedure should be
followed in Europe.

TOXICITY

An AOEL based on a long-term NOAEL should be used as toxicological reference parameter.
If there are indications that effects may occur after exposure has ceased, but did no come
apperent during short-term exposure, the NOAEL for these effects in the long-term study
should be used for AOEL setting. In cases where exposure duration is more than three months
per year, the NOAEL from a long-term study should be considered for AOEL setting in order
to cover effects arising from chronic exposure. Generally, this approach for setting an AOEL
uses the same starting point as the ADI. Although an AOEL is routinely based on the relevant
NOAEL from a particular set of short-term toxicity studies, it may sometimes be more
appropriate to use a higher NOAEL, especially when a chronic study may indicate a higher
NOAEL than a short-term toxicity study because differences in dose level selection.

RISK INDEX

The risk index for pesticide operators (RI
operator, chronic
) is calculated by dividing the chronic
internal exposure (IE
operator, chronic
) by the acceptable operator exposure level (AOEL). Both the
IE
operator,chronic
and the AOEL are expressed in mg/kg body weight/day.

AOEL
IE
RI
chronic operator
chronic operator
,
,
=

With:
RI
operator, chronic
: chronic risk index for the pesticide operator (-);
IE
operator, chronic
: internal exposure of the pesticide operator (mg a.s./kg bw/d);
AOEL: Acceptable Operator Exposure Level (mg a.s./kg bw/d).

59
2. Re-entry worker

Proposed Re-Entry Worker Indicator

EXPOSURE

Workers who come into contact with the crop will be contaminated by contact with pesticides
that are still available on the crop after application. Exposure during re-entry tasks, such as
harvesting, bending and tying up of the crop is likely in the case of ornamentals, vegetables
and fruits. Inhalation exposure is very low compared to the dermal exposure. For outdoor re-
entry scenarios inhalation exposure is neglected. Though for greenhouse scenarios the
inhalation exposure will be taken into account.

The routes of exposure during post-application activities are the same as in operator exposure,
i.e. dermal and inhalation routes. However the sources are different: foliage, surfaces, soil and
also dust may contribute.
a. Dermal Exposure
The chronic annual dermal exposure of the re-entry worker is estimated as follows:
0.001
365
cum
WD
DE DFR TF T P =
0.01
365
AR WD
DE FA TF T P
LAI
=
With:
DE: dermal exposure (mg/d);
0.001, 0.01: conversion factors for the units;
DFR
cum
: cumulative dislodgeable foliar residue (g/cm);
AR: application rate (kg a.s./ha);
LAI: leaf area index (m/m);
Here, I refer to page 15 till 28 for extended information;
FA: frequency of application (-);
TF: transfer factor (cm/person/hr);
T: duration of re-entry (hr/d); As a default it is assumed that a re-entry worker works
8 hours a day;
P: factor for PPE (no PPE: 1; with PPE: 0.1);
WD: the estimated number of workdays a year (d/yr).

As mentioned before the time-window of exposure can be adjusted according to the query
made by the user of the HAIR software.


60
Below the different parameters are explained more into detail:

DFR
cum
: cumulative dislodgeable foliar residue (g/cm)

If specific DFR data are available, the DFR after consecutive applications can be
calculated as follows:

Case 1: There is no information on the decline rate
When there are no data concerning the decline rate of active substances on the
foliage, no degradation is assumed, then

0 cum
DFR FA DFR =
Where:
DFR
cum
: cumulative dislodgeable foliar residue (g/cm);
FA: frequency of application (-);
DFR
0
: initial dislodgeable foliar residue (g/cm).

It is clear that this case represents a worst case scenario.

Case 2: Degradation on the foliage is taken into account
Taking the degradation process and the multiple applications into account and
assuming that the dissipation function which describes the DFR at a given time t
after application follows a monotonically decreasing exponential decay curve, the
following formula can be applied to determine the cumulative DFR after consecutive
applications:
1
0
1
( )
n
kt n
cum
i
DFR DFR e

=
| |
=
|
\ .


Where:
DFR
0
: initial dislodgeable foliar residue (g/cm);
n: number of applications (= FA) (-);
k: degradation factor (d
-1
);
The degradation factor k is the pesticide out-flux, depending on diffusion,
growth, absorption, transport, run-off, volatilisation, photo-degradation and
chemical breakdown. A literature review conducted by Seuntjes et al. (2006)
has shown that the impact of most processes is very important in the first
hours after pesticide application. In frame of the impact of dislodgeable foliar
residues, it can be concluded that the most important factor for long-term
decline is the biochemical degradation;
1/ 2
ln(2)
k
T
=
Where: T
1/2
: foliar half life (d); a lumped parameter describing the loss rate
of pesticides on the plant canopy.

Foliar half-life times were obtained from the SWAT pesticide default
database (http://www.brc.tamus.edu/swat/manual2000/pestdb/pestdflt.html).
The sources for the foliar half-life times were Willis et al. (1980) and Willis
& Mc.Dowell (1987). About 450 DT
50
values (81 chemicals) for a broad
spectrum of vegetative plant materials (grass, cereals, forage crops, cotton,
vegetables, tobacco, foliage of fruit trees) are presented in these papers. The
61
authors expect that many of the half-lives may be overestimates due to the
time schedule of sampling in the original studies. For most pesticides, the
foliar half-life is much less than the soil half-life due to enhanced
photodecomposition and volatilization. In the SWAT database values for
foliar half-life were available for some pesticides, but the majority of the
foliar half-life values were calculated using the following rules:

1. Foliar half-life was assumed to be less than the soil half-life by a
factor 0.5 to 0.25, depending on the vapour pressure and
sensitivity to photo-degradation;
2. Foliar half-life was adjusted downward for pesticides with vapour
pressures less than 10
-5
mm Hg.;
3. The maximum foliar half-life assigned was 30days.

The foliar half-life times for several active substances according to this
database are listed in Annex IX. The EC Guidance Document on Risk
Assessment for birds and mammals Under Council Directive 91/414/EEC
(2000) proposed to use a DT
50
of 10 days as a default for foliar half-life
based on the bias mentioned before and on the fact that the database includes
very stable substances such as organochlorines.

TF: transfer factor (cm/person/hr);
Indicative TF values are listed in Table II.2.4 (see p 24-26) and more specific
information can be found on page 19 till 21 and on page 27 of this document.

If monitoring data on both, exposure and DFRs are available then the following
equation is applied to obtain a TF, normalized per hour of task duration (Franklin et
al., 2005).

Exp
TF
DFR
=
With:
TF: transfer factor (cm/hr);
Exp: exposure (g/hr);
DFR: dislodgeable foliar residue (g/cm).

In this way chemical and activity specific transfer coefficients are obtained.

T: duration of re-entry (hr); As a default it is assumed that a re-entry worker works 8
hours a day;
P: factor for PPE (no PPE: 1; with PPE: 0.1);
WD: the estimated number of workdays a year (d/yr). This value is dependent on the
crop type. The estimated number of workdays must be divided by a factor of 365 to
obtain the annual chronic dermal exposure.
62
Special case: (EUROPOEM Re-Entry Working Group) (EUROPOEM II, 2002)
The case of possible dermal exposure to soil containing pesticide residues is based on the
concept of dermal adherence. The following formula is proposed to estimate the chronic
exposure due to the contribution of soil residues:

The algorithm specified below is used to estimate exposure:

/
365
S S C S Sk
soil
Conc DA SA T WD
D

(
=
(


With:

D: dermal exposure (mg/d);
Conc
S
: soil concentration of the active substance (mg/m);
The soil concentration of the active substance can be determined by applying
the same approach as the terrestrial workpackage;
DA
S
: Dermal adherence of soil (mg/cm);
Field studies investigating dermal exposure to soil by direct gravimetric
measurements (Kissel et al., 1996) suggest that an appropriate hand soil
loading for a worker would be 0.44 mg/cm (geometric mean peak value for
farmers involved in hand weeding, default). A laboratory study to determine
the extent of soil adherence to hands when totally immersed in a range of dry
soil samples (Driver et al., 1996) concluded that the mean hand loading for un-
sieved soil was 0.58 mg/cm of skin surface. Data for sieved samples suggested
that hand loading increased when soil particle size was reduced);
SA
C
: Skin area contaminated (cm);
A default value of 820 cm is to be used;

soil
: soil bulk density (g/cm);
T
S/Sk
:Transfer of the active substance from soil to skin (-);
Data on the transfer of active substance from soil to skin are usually not
available at the moment;
WD: number of workdays a year (d/yr).

As a preliminary approach it is assumed that the complete amount of the chemical in a
layer of soil is bioavailable to skin. Conservative assumptions like these have to be used
when no specific information is available. More research should be performed in order to
perform more reliable exposure estimations for this route of exposure.

b. Inhalation Exposure
Inhalation exposure will only be assessed for greenhouse workers. In all re-entry situations,
low volatility of the active substance (1.35 x 10
-6
Pa at 20C) removes a concern of exposure
to vapour (91/414/EEC, Point 7.1.3 Inhalation) such that an inhalation component need not to
be considered in the exposure assessment.

Inhalation exposure may occur to residual vapour and airborne aerosols during a relatively
short period after application. In case of outdoor crops, exposure will occur during the time
the spray is drying; in case of greenhouse crops, exposure will occur within a few hours after
application. Outdoors, there generally is a rapid dissipation of vapour and aerosols, leading to
much lower inhalation potential than in greenhouses. Furthermore, the majority of the applied
63
pesticides are non-volatile which implicates a low potential inhalation exposure. Thus,
inhalation exposure is in many cases less important for risk assessment than dermal exposure
especially for outdoor scenarios, with of course exceptions for aerosols and volatile pesticides
of concern.
c. Total Internal Exposure
The total internal exposure is calculated as the sum of the dermal exposure (DE; mg/person/d)
multiplied by the dermal absorption factor (Ab
DE
; %) and the inhalation exposure (I;
mg/person/d) multiplied by the inhalation absorption factor (Ab
I
; %), divided by the body
weight (BW, default: 70 kg) of the worker.

_ ker,
DE I
re entry wor chronic
DE Ab I Ab
IE
BW

+
=

With:

IE
re-entry_woker, chronic
: internal exposure of a re-entry worker (mg/kg bw/d);
DE: dermal exposure (mg/person/d);
Ab
DE
: dermal absorption factor (%);
I: Inhalation exposure (mg/person/d);
Ab
I
: inhalation absorption factor (%) (default: 100);
BW: body weight (kg) (default: 15).

TOXICITY

An AOEL based on a long-term NOAEL should be used as toxicological reference parameter.
In cases where exposure duration is more than three months per year, the NOAEL from a
long-term study should be considered for AOEL setting in order to cover effects arising from
chronic exposure.

RISK INDEX

For risk assessment the internal exposure is compared with the systemic AOEL according to
the European approvals process. It is assumed that the AOEL can be used as a reference dose
against which re-entry worker exposure is assessed. Thus the risk index for re-entry workers
is calculated as follows:

_ ker,
_ ker,
re entry wor chronic
re entry wor chronic
IE
RI
AOEL

=

With:
RI
re-entry_worker, chronic
: chronic risk index for the re-entry worker (-);
IE
re-entry_worker, chronic
: internal exposure of the re-entry worker (mg a.s./kg bw/d);
AOEL: Acceptable Operator Exposure Level (mg a.s./kg bw/d).


64
3. Greenhouse worker

Proposed Greenhouse Worker Indicator

EXPOSURE
a. Dermal Exposure

The dermal exposure for the greenhouse worker is estimated in the same way as for the re-
entry worker.
b. Inhalation Exposure

The EUROPOEM Re-entry Working Group developed an algorithm for a few re-entry
scenarios. There is no generic model for inhalation exposure available. Here, only a
preliminary approach for indoor inhalation exposure is presented. The identified
representative crop/activity re-entry scenarios relevant to Europe that may result in post-
application exposure of workers to plant protection residues are listed in Table II.2.4. Thus,
this estimation procedure for inhalation exposure is only applied for greenhouse workers. For
field workers, the inhalation exposure is considered negligible because of the dilution in free
air.

The algorithm proposed to estimate inhalation exposure to vapours is outlined below

YED EF DED TSF AR I =

Where:
I: potential inhalation exposure (mg a.s./d inhaled);
AR: application rate (kg a.s./ha);
TSF: Task Specific Factor;
These factors can be used in the first tier exposure and risk assessment and have
been estimated for a small set of exposure data on harvesting of ornamentals and
re-entry of greenhouses about 8-16 hours after specific applications. The indicative
Task Specific Factor values for specific indoor glasshouse scenarios are given in
Table II.2.3;
DED: daily exposure duration (hr/d); as a default a daily 8 hr exposure is assumed;
EF: number of days exposed in one year divided by 365; exposure frequency (-);
The exposure frequency refers to the fraction of a year over which an exposure
occurs (e.g. 3 months/12 months = 0.25). The number of workdays a year was
estimated for several crops;
YED: yearly exposure duration, number of years exposed divided by 70 years
(average working lifetime expectancy); as a default YED is set to 40/70 (average
working life time/average life-time expectancy).
65
The chronic inhalation exposure for the greenhouse worker is estimated using the formula
below when monitoring data are availble:

YED EF DED IR C I
air
=
3
10
With:
I: re-entry worker inhalation exposure (mg/person/d);
C
air
: mean concentration of the pesticide in the greenhouse air over the period of one
year (g a.s. /m);
IR: chronic inhalation rate (m air/d); a default value of 0.28 m/kg b.w./d can be
assumed for an adult; this equals an IR of 19.6 m/d or 0.82 m/hr.
c. Total Internal Exposure
For risk assessment of greenhouse workers, the internal exposure is calculated in the same
way as for re-entry workers (see p 61).

TOXICITY

An AOEL based on a long-term NOAEL should be used as toxicological reference parameter.
In cases where exposure duration is more than three months per year, the NOAEL from a
long-term study should be considered for AOEL setting in order to cover effects arising from
chronic exposure.

RISK INDEX

For risk assessment the internal exposure is compared with the systemic AOEL according to
the European approvals process. It is assumed that the AOEL can be used as a reference dose
against which greenhouse worker exposure is assessed. Thus the risk index for greenhouse
workers is calculated as follows:

AOEL
IE
RI
chronic greenhouse
chronic greenhouse
,
,
=

With:
RI
greenhouse, chronic
: chronic risk index for the greenhouse re-entry worker (-);
IE
greenhouse, chronic
: internal exposure for the greenhouse re-entry worker (mg a.s./kg
bw/d);
AOEL: Acceptable Operator Exposure Level (mg a.s./kg bw/d).

66
4. Resident
Introduction

The term resident is in this context used for those who live near to sprayed fields (Blundell,
T., 2005). Crops can be sprayed up to the boundary of a field that can be close to
neighbouring property, residents or bystanders. Therefore spray drift (droplets as well as
vapours released at the time of a pesticide application) could lead to the direct exposure of
residents through contact with the skin or by inhalation. Other routes of exposure by which
residents may become exposed to pesticides are from vapours emitted from a treated area post
a pesticide application and from dusts contaminated with pesticide that may be emitted from
treated cropped areas particularly during harvesting operations. The exposure of residents
depends on a wide range of factors and operating conditions including the pesticides used,
wind speed and direction and boom height; the downwind distribution of pesticides both in
the air and on to non-target surfaces as well as the behaviour patterns of people in these
downwind areas relate to the potential exposure of residents and bystanders This means that
the amount of a pesticide to which a resident may be exposed will vary over a wide range
from low to potentially high levels in the worst case. Indoor operations e.g. with hand-held
sprayers, mist blowers or fog generators, should exclude residents as a part of the safe
management of the work. In addition to any spray that may drift into residential properties,
pesticides are also used in homes and gardens, both in rural and urban areas. Apart from
potential direct exposure when using a pesticide, residents can take residues of pesticides into
their homes on clothing (especially agricultural workers) and/or on shoes by walking over
treated surfaces (Matthews, 2006). The take-home of residues of pesticides is clearly a
significant factor in childrens exposure to pesticides in rural areas (Garry, 2004), especially
where the more toxic insecticides are used in agriculture, though the uneducated use of
dispensers in a home is also a crucial source of exposure to pesticides. Lu et al. (2000) also
reported five-fold higher concentrations of pesticide metabolites in children living in
agricultural areas compared to reference children with 0.01 g/ml. The latter scenarios are not
taken into account within the framework of this project since the HAIR project is focussed on
risk due to the application of pesticides in agriculture.

Compared with the occupational exposure of applicators and workers following a pesticide
application in the field, post-application residential exposure to pesticides used in and around
the home is lower in level, but encompasses a wider variety of scenarios, such as age
distribution, activity patterns and product use. Typically, few data are available on residential
exposure, while a large body of data does exist for occupational exposures. In occupational
exposure assessment, a database approach is favoured, while in residential exposure
assessment a mechanistic and statistical modelling approach is dominant (Matoba & Van
Veen, 2005). In the U.S. the Residential Exposure model (REx), developed by the Outdoor
Residential Task Force (ORETF), has recently become available. This model includes data for
professional lawn applicators and non-professional lawn, tree and garden applications. For the
application phase several models are available to predict residential exposures. Though, post-
application residential exposure due to the application of pesticides used in agriculture was
not considered in this model.

Currently, an exposure assessment for residents who are exposed to to the drift of alternating
products several times per year, possibly for several years, is currently carried out neither on
national nor on Community Level (EFSA, 2006).

67
In the U.K. a three-year lasting project concerning bystander and resident exposure recently
started (19
th
July 2006). This project is financed by DEFRA (Department of Environment
Food and Rural Affairs). It sets out to develop a computational model to predict the potential
exposure to pesticides for bystanders and residents in the countryside that can be used as a
tool in risk assessments. The work will be concerned with boom sprayers operating over
arable crops in a range of conditions relevant to the United Kingdom. Model development and
validation will be supported by tests in controlled wind tunnel conditions with the overall
model predictions validated against full-scale field trial results. To estimate the potential
exposure of bystanders and residents, the transport of droplets and vapours during application
will be modelled using three regions, namely:

a region close to the nozzles where the interaction of air, vapour and droplet flows
associated with the operation of the nozzle and air flows arising from the natural
wind and forward motion of the sprayer combine to detrain droplets and vapours
from the spray and so provide the source for drifting spray;
a region around the spraying vehicle where the flows due to the motion of the
vehicle will be considered in the initial phases of the downwind transport of airborne
droplets and vapours;
a larger region away from the spraying vehicle where the drifting cloud of droplets
and vapours may be influenced by features in the terrain such as the presence of
hedges, buildings and slope and where the characteristics of the weather conditions
may also be important.
The construction of the models will be based on approaches identified from the existing
literature together with the results from detailed wind tunnel and field experiments aimed at
quantifying pesticide movements close to the nozzle and spraying vehicle. Where possible
and appropriate, standard modelling packages will be used particularly in the region furthest
from the spraying vehicle. The interfaces between the separate regions in the model will be
defined in terms of vertical airborne spray volume profiles as vapour and droplets with
defined size distributions and air velocity profiles. Losses as vapour from treated areas will be
determined using simplified relationships based mainly on the properties of the sprayed liquid
and the target surface to give a loss rate per unit area over a defined time period of up to 120
hours. The dispersion of this vapour cloud will then be predicted using an established
atmospheric dispersion model. The issue of potential contamination from pesticide
contamination of dusts leaving a cropped area will not be included in the initial model
development. However, it will be included in the literature reviews associated with the project
work so as to obtain an estimate of the extent of this component of potential exposure.
The results from the model will be validated by comparing predictions with measurements
made in full-scale field trials in closely monitored conditions and with active pesticide
formulations together with results in the published literature. The model will also be used to
determine the relative importance of operational factors on the risk of resident and bystander
exposure and to examine the effects of using different application technologies on the risks of
this exposure.
The work will be primarily aimed at predicting the pesticide exposure profiles of residents
and bystanders in the countryside as a tool for the regulatory risk assessment process.
(http://www2.defra.gov.uk/research/project_data/More.asp?I=PS2005&SCOPE=0&M=PSA&
V=NR%3A080).
68
Proposed Resident Indicator

EXPOSURE

Contrary to bystanders, repeated exposure is likely. It is assumed that only ordinary clothing
is worn and that the total uncovered area amounts to 0.4225 m per person (default value
total uncovered area: head, back & front of neck, forearms, upper arms and hands) for
adults. For children the exposed area equals 0.78404 m (b.w.=43.3 kg). Residents are
assumed to be located at 50 m distance downwind from the treated field. The default drift
values are taken from the Ganzelmeier tables. The residents exposure will be estimated for
the dermal as well as for the inhalation route.

a. Dermal Exposure
It can be postulated that the dermal exposure is directly correlated to the amount of active
substance applied per area, the area of the uncovered body surface contaminated and the drift
distance. The number of applications is also taken into account (Franklin et al., 2005).

( * )
365
RD
DE AR Drift FA EA =

DE: dermal exposure (mg/person/d);
AR: application rate (mg a.s./m);
Drift: downwind pesticide ground deposits at 50 m distance from the field for
multiple applications (Ganzelmeier tables). A different distance can be chosen
according to the wishes of the Member States (see Table III.4.2 & Table III.4.3).

In conformity with the FOCUS-group, it was established that a reduced percentile
should be used for multiple uses in order not to exceed the 90
th
percentile
cumulatively. The percentiles for multiple applications, listed in the table below
(Table III.4.1), represent the exposure for one of the multiple applications, leaving
degradation processes aside. Moreover it was established that risk assessment for
multiple uses should at least amount to the Predicted Environmental Concentration
(PEC) required for the calculation of a single use. This regulation ensures in the case
of fast degrading active substances that a multiple use does not lead to a lower risk
than a single use within the assessment.

The following percentiles are used (Table III.4.1):
Table III.4.1: Percentiles used for multiple applications (Maund, 2000)
Number of applications Percentile used
1 90
2 82
3 77
4 74
5 72
6 70
7 69
8 or more 67

EA: exposed area (m/person/d) (default: 0.4225, total uncovered area: head, back &
front of neck, forearms, upper arms and hands);
69
FA: frequency of application;
RD: residence days (d); As a default it is assumed that a resident is exposed at the
same daily level for three months; RD = 90 days. It has to be mentioned that the
averaging time of 365 days can be adjusted according to the query perfomed by the
user of the HAIR software program.

Table III.4.2: Basic Drift values for multiple applications (Ground sediment in % of the application rate)
at a distance of 50 m downwind from the edge of the sprayed area)
Drift (%) according to the percentile Crop grouping Growth
stage
82 77 74 72 70 69 67
Arable Crops - 0.05 0.04 0.04 0.04 0.03 0.03 0.03
Vegetables
Ornamentals &
Small Fruits < 50 cm
- 0.05 0.04 0.04 0.04 0.03 0.03 0.022
Vegetables
Ornamentals &
Small Fruits > 50 cm
- 0.08 0.08 0.08 0.08 0.07 0.07 0.04
Early 0.22 0.19 0.17 0.17 0.16 0.16 0.15
Fruit crops
Late 0.15 0.13 0.13 0.13 0.11 0.11 0.11
Early 0.02 0.02 0.02 0.02 0.02 0.02 0.009
Vines
Late 0.08 0.08 0.08 0.08 0.07 0.07 0.04
Hops - 0.09 0.08 0.08 0.07 0.07 0.06 0.02

Table III.4.3: Basic Drift values for multiple applications (Ground Sediment in % of the application rate
at a distance of 7 m downwind from the edge of the sprayed area)
Drift (%) according to the percentile Crop grouping Growth
stage
82 77 74 72 70 69 67
Arable Crops - 0.34 0.29 0.27 0.26 0.24 0.24 0.23
Vegetables
Ornamentals &
Small Fruits < 50 cm
- 0.34 0.29 0.27 0.26 0.24 0.24 0.23
Vegetables
Ornamentals &
Small Fruits > 50 cm
- 1.89 1.80 1.75 1.72 1.67 1.65 1.63
Early 12.84 11.99 11.65 11.35 10.95 10.73 10.43
Fruit crops
Late 4.66 4.06 3.79 3.67 3.55 3.49 3.39
Early 0.62 0.59 0.57 0.56 0.55 0.53 0.52
Vines
Late 1.89 1.80 1.75 1.72 1.67 1.65 1.63
Hops - 6.41 5.70 5.48 5.25 5.08 4.94 4.70
Source: EUROPOEM II: Bystander Working Group Report (2002)

b. Inhalation Exposure
Droplets that remain airborne are generally larger than 100 m in size, and unless the liquid is
non-volatile they will become smaller in flight. Briand et al. (2002) evaluated spray drift from
an orchard. Compared to earlier studies, the relative high concentrations that were detected in
the gas phase indicated that evaporation in the high temperatures from small droplets allowed
them to drift. Thus, temperature and relative humidity as well as the physical properties of the
pesticide will influence the vapour and particle distribution, making it important to
differentiate between drift and post-application transfer from deposits.

In Germany, the time-weighted air concentration of pesticides downwind of a barley field due
to spray drift was highest during the first two hours after application, and then decreased.
70
Over 21 hours, up to 0.58 g/m was detected at ten metres downwind. Volatile insecticides
were detected at up to 200 metres in the first two hours, but this was below the limit of
quantification (Siebers et al., 2003).

In all the Member States, there is generally a lack of data on long-term air levels of pesticides
and hence estimates of bystander exposure. Few studies have sampled air in the U.K. for
pesticides, but where these have been done (Turnbull, 1995) the highest quantities observed
over 24 or 48 hours were in samples taken near to field applications. One sample was just
over 2000 pg/m, which is 42.000 times less than the air concentration measured at the
bystander position 8m from the boom. Mean values of pesticides in air were generally less
than 400 pg/m. Similar air quality studies elsewhere have generally detected the most volatile
pesticides, such as methyl bromide, which was used to fumigate soil (Lee et al., 2002).
Several studies conducted in California provide useful data on long-term air levels of
pesticides. These data suggest that in the 72 hours after following application maximum peak
air levels of most pesticides are very low (i.e. below 1 g/m or less). At this level daily
exposure would be about 0.0003 mg/kg bw/d), which indicates that exposures of most
pesticides would be well within acceptable levels.

Case 1: monitoring data on ambient pesticide levels are available

The inhalation exposure for each active substance can then be estimated as follows:

YED EF DED IR C I
air
=
3
10
With:
I: resident inhalation exposure (mg/person/d);
C
air
: mean concentration of the pesticide in the air over the period of one year
(g a.s./m);
IR: chronic inhalation rate (m air/d); a default value of 0.28 m/kg b.w/d can be
assumed for an adult; this equals an IR of 19.6 m/d or 0.82 m/hr;
DED: daily exposure duration (hr/d); as a default a daily 8 hr exposure is assumed;
EF: number of days exposed in one year divided by 365; exposure frequency (-); The
exposure frequency refers to the fraction of a year over which an exposure occurs (e.g.
3 months/12 months = 0.25). It applies only to chronic exposures which are by
definition a year or more. In California estimates of this EF were made for different
active substances based on pesticide use report (PUR) data for the agricultural sections
immediately surrounding each air monitoring site, typically within a 1,5-mile radius.
When no pesticide use was reported within this radius, which was the case for certain
pesticides, the radius was expanded to 3 miles. The exposure frequency can be
described by using triangular distributions when estimates of the minimum, most
likely mean, and maximum points are available (Lee et al., 2002);
YED: yearly exposure duration, number of years exposed divided by 70 years
(average lifetime expectancy); exposure duration (d); as a default YED is set to 1 in
order to be able to calculate the annual average daily concentration.

Air monitoring data on long-term pesticide concentrations are very scarce in Europe and data
on active specific exposure frequencies are also lacking. But the approach suggested here
provides the best option in order to obtain an adequate risk assessment.

71
Case 2: monitoring data on ambient pesticide levels are not available

At the moment no good models are available to predict airborne pesticide concentrations due
to spraying practices. A project financed by DEFRA is currently developing a model as a tool
for the regulatory risk assessment process in the U.K. which should be able to predict the
pesticide exposure profiles of residents and bystanders in the countryside. Within the
framework of HAIR, there was not enough time to develop such a model. Moreover due to
lack of data validation of such a model is not possible without conducting full-scale field trials
in closely monitored conditions and with active pesticide formulations.

For the moment we propose to assume that residents are exposed at the same daily level for
three months (EF = 3 months or 90 days divided by respectively 12 or 365), which is far
greater than those living next door to a treated field would actually experience (Matthews et
al., 2003). The daily inhalation exposure can be estimated in the same way as for bystanders.
The approach making use of the AHU/CSL data can be used to estimate the daily level of
exposure (applying the chronic, not the acute inhalation rate) (1) or one can estimate the daily
level of exposure on the basis of the operators exposure (2) (DED equals (8*60 = ) 480 min
per day).

YED EF DED IR C I
spray
= (1)

YED EF DED
ST WR
AR WR I
I
a


= (2)

For the units and explanation of the parameters: see earlier.
c. Total Internal Exposure
The total internal exposure is calculated as the sum of the dermal exposure (DE; mg/person/d)
multiplied by the dermal absorption factor (Ab
DE
; %) and the inhalation exposure (I;
mg/person/d)) multiplied by the inhalation absorption factor (Ab
I
; %), divided by the body
weight (BW, default: 70 kg) of the resident.

r
*
DE I
esident
DE Ab I Ab
IE
BW
+
=

With:
IE
resident
: internal exposure of a resident (mg/kg bw/d);
DE: dermal exposure (mg/person/d);
Ab
DE
: dermal absorption factor (%);
I: Inhalation exposure (mg/person/d);
Ab
I
: inhalation absorption factor (%) (default: 100);
BW: body weight (kg) (default: 15).

TOXICITY

The long-term AOEL should be used as reference toxicological parameter.
72
RISK INDEX

For risk assessment the internal exposure is compared with the systemic AOEL according to
the European approvals process. It is assumed that the AOEL can be used as a reference dose
against which resident exposure is assessed. Thus the risk index for residents is calculated as
follows:

resident
resident
IE
RI
AOEL
=
With:
RI
resident
: chronic risk index for the resident (-);
IE
resident
: internal exposure for the resident (mg a.s./kg bw/d);
AOEL: Acceptable Operator Exposure Level (mg a.s./kg bw/d).

Resident exposure when spraying greenhouse crops and when applications are performed with
treated seed, granules, dipping a plant in a pesticide solution or pouring a pesticides solution
to a plant is considered negligible. In these cases the RI
resident
equals 1E-12.

Second tier estimates of likely resident exposure are to be based upon measurements made in
the field, according to the needs for such specific data. Measurements should be based upon
study of realistic situations representative of specific cases. Measured values may be gathered
using suitable methodology, which ideally should allow correlation with measurements of
ambient environmental concentrations (e.g. airborne vapour concentrations) in the relevant
situation, in order to aid interpretation of results and allow controlled comparison with other
similar data as far as possible. The Royal Commission on Environmental Pollution has
recommended that the role of monitoring bystander and resident exposure should be part of
the Health Protection Agency under the Department of Health.

73
IV. Aggregate and Cumulative Risk Assessment
Introduction

It has been suggested that risk assessment of pesticides, primarily for food safety, should
include consideration of interactions between different pesticides and this requires some
consideration of the toxicology of mixtures, as well as exposure via other routes than food.
Historically, risk assessments were carried out on single products or active ingredients alone.
However, it has increasingly been realized that this approach may not be sufficiently
protective and not based on sound toxicological principles (WiGRAMP, 2001). Moreover, the
United States Environmental Protection Agency (U.S. EPA) issued guidelines for risk
assessment of chemical mixtures as long ago as 1986 (U.S. EPA, 1986). In the nomenclature
adopted by the US Environmental Protection Agency, cumulative risk assessment is
defined as concurrent exposure to more than one pesticide by the same route, while
aggregate exposure refers to different routes of exposure. Risk assessments carried out
using cumulative and aggregate methods have to be considered under the US Food Quality
Protection Act (Anon, 1996).

In the EU a generally agreed framework/approach for combined risk assessment of pesticides
has not yet been established. However at European and International level there are some
activities ongoing concerning approaches for cumulative risk assessment of pesticides which
have a common mode of action. The EFSA will hold a colloquium the 28
th
and 29
th
of
November 2006 concerning this topic (http://www.efsa.europa.eu/en/science/
colloquium_series/colloquium_7.html). Also for aggregate assessments a harmonised
approach should be established. A lot of research concerning aggregate assessements has been
conducted in the U.S.

Historically, exposure assessors have focused on characterizing the highest levels of exposure
that will occur to an individual or a population over time as the result of the use of pesticides.
One approach that is used to characterize the upper-bound of exposure is to use simple models
of dose rates and a series of conservative model inputs. This approach is applied by many
federal and state agencies. It generally relies on the use of default constants (i.e. the use of a
single value for an unknown or uncertain component of the risk assessment). Each of these
single values is generally selected to fulfil the goal of being health-protective that is selected
to be reasonably certain that risk is not underestimated and to err on the side of overestimating
the risk. This approach has great value for screening out exposures that are of little concern. A
related approach is to back off from one or more of the worst-case assumptions and use a
mixture of conservative and more reasonable estimates (U.S. EPA., 1992a). The approaches,
described above have several shortcomings that can be largely overcome by having good
quality exposure data and using probability distributions and probabilistic techniques. In
contrast to the use of a single default value for a risk parameter, a probability distribution can
reflect the relative likelihood of the different possible values of the parameter. Thus, a
probability distribution can reflect not only the largest and smallest possible values of a
parameter but also the probability of the occurrence of each of the values in its range. If
conservative default constants are used for each of several different parameters in the risk
assessments, then the conservatism in the individual components is compounded when the
components are combined in the risk characterization. Furthermore, the extent of the
overestimation cannot be readily quantified, and thus the magnitude of the overestimation of
the average risk is not identified. Distributional techniques, however, make it possible to more
74
realistically combine exposures from multiple years, subpopulations, exposure pathways and
chemicals without having to assume the worst case for each component. By carrying all of
the information through to the end of the entire risk characterization instead of requiring
interim single-number characterizations at different stages in the risk assessment, probabilistic
techniques help avoiding the compounding of multiple conservatisms (Sielken, 2005). For
example, an individual who receives high levels of exposure from one source will not
necessarily receive high levels of exposure from a second or a third source. In fact, there are
situations in which exposures to high levels from one source will preclude exposure from a
second source. In other words there will be very few, if any, people who will actually
experience the high levels of exposure estimated by simply adding the exposures for each
pathway. Combining point estimates will overstate, sometimes significantly, the potential
exposure that the vast majority of the general population group actually receives. The degree
of overestimation however decreases as the refinement of the individual pathway exposure
estimates improve. The primary advantage of a highly conservative, deterministic approach is
that relatively fewer data, analytical resources and less time to conduct are required. But
exposure assessment approaches that focus on defining individuals who have high levels of
exposure to a single source should not be extended to evaluate exposure from multiple
sources (Price et al., 2000). Moreover, the estimated upper bound for the risk obtained by
combining default constants provides no indication of the relative likelihood or frequency of
that risk or any other risk lower than the exaggerated upper bound. On the other hand, the
characterization of risk obtained by using probability functions and probabilistic techniques
provides a quantitative assessment of the relative likelihood of each of the different possible
values for the risk. Furthermore, default constants and assumptions do not explicitly address
the uncertainty and variability that are an inherent part of human risk. However, probability
distributions can explicitly include both uncertainty and variability. Finally, probability
distribution characterizations can describe the entire population (all of the people in the
exposed population) rather than a single hypothetical person or subpopulation. Individuals are
used as the building blocks for calculating doses and for developing subpopulation and
population characterizations (Sielken, 2005). The methodology for applying probabilistic
approaches for aggregate and cumulative risk assessments exists now, but is continuing to
evolve. In 1998, the ILSI Workshop on Aggregate Exposure Assessment held on February 9-
10 strongly endorsed the use of distributional analysis and probabilistic methods in estimating
and characterizing pesticide exposure and risk from all sources and multiple chemicals (ILSI,
1998).

Over the last 10 years there has been a growing recognition of the need for tools to assess
exposures to multiple chemicals from multiple sources. This need has been driven by
legislative and regulatory actions in the U.S. such as the 1996 Food Quality Protection Act
(FQPA), the residual risk portions of the 1991 Clean Air Act, and the Voluntary Childrens
Chemical Exposure Program (U.S. EPA, 2000b). There has been a general recognition that
computer simulation software is a useful tool for these assessments (ILSI, 1998, 1999; U.S.
EPA, 1999b, 2000a, 2001b). A conceptual framework for the construction of simulation
software for aggregate and cumulative risk assessments has been recently published (Price et
al., 2005).
75
Overview of approaches to handle cumulative assessments

Before outlining the chosen approach to handle cumulative risk assessments, an overview is
given on the different ways in which these assessments can be conducted. First of all, it is
necessary to clarify the terminology of the toxicity of chemical mixtures. The terminology
used in this report is derived from Seed (1995) and Cassee et al. (1998, 1999). The cumulative
effects of more than one toxicant are divided into non-interactive (one toxicant has no effect
on the toxicity of the other component(s) and interactive (one toxicant does affect the
toxicity) of another. The absence of interaction may be represented in two ways additivity of
dose and additivity of effect. Where two or more compounds have the same site and type of
toxic action, the usual starting assumption is that their effective doses will combine additively.
This implies that each element will contribute to the toxicity of the mixture in proportion to its
dose, expressed as a percentage of the dose of that chemical alone which would be required to
produce the given effect of the mixture. Where the components of a mixture have different
sites or different types of toxic action, they may be assumed to act independently of the dose
of the other components. The proportion of the population responding will depend on whether
there is positive, negative or no correlation between the susceptibility of individuals to the
components of the mixture. Interactions can be of two types: if the effect of the mixture is
greater than expected for the chosen additive model, the interaction is known as potentiation;
if less, than interaction is known as antagonism (WiGRAMP 2001). Table IV.1 gives an
overview of the applied terminology in this report.

Table IV.1: Terminology for the toxicity of mixtures (WiGRAMP 2001)
Concept Type of combined Effect Synonyms
Dose Additivity Loewe additivity, Simple similar action, Summation
Non-interactive effects
Effect Additivity Simple dissimilar action, Independent Action
Potentiation Synergism, synergy, supra-additivity
Interactions
Antagonism Sub-additivity

The toxicity of mixtures can be studied in a number of ways. The different approaches will be
outlied below and consequently one approach will be proposed for use within the framework
of HAIR.

Testing mixtures
The simplest approach is to test all the mixtures of interest over the range of doses and
endpoints of interest. Tests normally used to assess the toxicity of the components should be
performed in this case. However, this approach uses a lot of resources, including animals and
would not be practicable on a large scale. The advantage of this approach is that very specific
directly applicable results are obtained (WiGRAMP 2001).

Testing standard mixtures
An alternative approach is to test a smaller set of standard mixtures in which the proportions
of the components vary systematically across the relevant range, and extrapolate the results to
the mixture or mixtures of interest. However, this approach requires subjective decisions to be
made about the similarity of the standard mixtures and the mixture of interest, possibly based
on some response model. This generic approach reduces the testing, but gives less reliable
results (WiGRAMP 2001).

76
The Hazard index approach
There are two main methods used for assessing the toxicity of a mixture when it is reasonable
to assume that doses of its components combine additively. The first method is the Hazard
Index Approach. A hazard quotient is calculated for each component by dividing its dose in
the mixture by its maximum acceptable dose (AOEL in case of occupational exposure) and
adding these components together (Mumtaz et al., 1997). For a mixture (dose A, dose B) of
two components A and B with maximum acceptable doses MAD
A
and MAD
B
respectively,
the hazard index is expressed mathematically as:

B
B
A
A
MAD
Dose
MAD
Dose
HI + = (Adapted from Mumtaz et al., 1997)

The Point of Departure Index and the Margin of Exposure are varieties of this approach.
However, this relationship must be used cautiously. Problems may arise when the maximum
admissible doses are derived from NOAELs observed in different species and particularly
where NOAELs depend on different toxicological endpoints. Furthermore, the magnitude of
the gaps between the LOAELs and NOAELs may skew the relationship. Although this
method is most appropriate where the components act via the same mechanism on the same
organ or organ system and assumes that no interactions occur, it can be modified to take
account of potentiation (Mumtaz & Durkin, 1992). The hazard index approach is widely used
for complex mixtures of the type found in environmental toxicology. This approach is simple
for compounds with a broad database, where the maximum admissible doses already exist.

The Toxic Equivalency Approach
The alternative toxic equivalency approach for assessing the toxicity of a mixture (when it is
reasonable to assume that doses of its components combine additively) was originally
developed to assess the toxicity of mixtures of dibenzo-p-dioxins and dibenzofurans. In this
approach the relative potency of components in a mixture of chemicals is calculated from a
particular test and one compound is usually accorded a toxic equivalency factor of 1. The
compound chosen to have the toxic equivalency of 1 is generally that one that has been
extensively studied. The relative potency of the other compounds is represented by a toxicity
equivalency factor (TEF) (Mumtaz & Hertzberg, 1993; Seed et al., 1995). Decisions are
necessary on which standard endpoint and which study should be used for comparison.
Simple studies can be used, including those in vitro to rank the compounds with a common
mechanism of action. The product of the amount of a compound in a mixture and the TEF is
known as the toxicity equivalent and these, for the components of a mixture, can be added
together. Again, this method is only really appropriate where the components act via the same
mechanism on the same organ or organ system and it assumes that no interactions occur. In
the simple case where the risk for each component is proportional to its dose, the joint risk is
expressed as

=
i i
p d R , where p
i
is the potency of the component I with dose d
i
and the
summation is over all the components in the mixture. More formal statistical methods have
also been used. This method is generally applied in case of mixture of dioxins. Moreover, it is
the most widely used approach in assessing the toxicology of mixtures. However, this
approach immediately raises a number of problems, namely the grouping of chemicals,
identifying the reference compounds and determining standardised assays. The grouping of
chemicals is comparatively easy with groups of common action such as the organophosphates,
but the precise mode of action of many pesticides is unknown. The choice of the reference
compound should be based on a high quality database and should be typical for the group of
77
compounds of interest. Concerning the determination of standardised assays, it has been
suggested that a particular assay, e.g. the 90 day study may be used in calculating the toxic
equivalent factor.

Response Additive Methods
Methods have also been developed that rely on the addition of response rather than dose as in
the Hazard Index and TEF methods. Such methods do not assume that components of a
mixture act by the same mechanism although they may act on the same target and are
frequently used in cancer risk assessment (WiGRAMP 2001).

Mechanistic Models
Attempts have been made to develop mechanistic models for both cancer and non-cancer
endpoints that can be used in risk assessment of chemical mixtures e.g. Kodell et al., 1991
and Clevenger et al., 1991.

Pharmacokinetic Modelling
A further approach is the use of pharmacokinetic modelling of the components of a mixture
itself (Krishnan et al., 1994). However, the latter is impracticable, except for specific mixtures
and cannot be applied generically to a group of compounds. This method can be applied to
humans, provided the data are there. Such data would not normally be supplied in standard
data packages (WiGRAMP 2001).

In the UK the potential for combined action in terms of human health risk assessments for
pesticides has been recently considered by a Working Group of the Committee on Toxicity of
Chemicals in Food, Consumer products and the Environment (http://www.food.gov.uk/
science/ouradvisors/toxicity). The Working Group on Risk Assessment of Mixtures of
Pesticides and Similar Substances (WiGRAMP) that was set up at the request of the Food
Standards Agency (FSA) published a report in September 2002 (COT, 2002). WiGRAMP
recognised that concerning pesticides the toxic effects of different substances in combination
are not routinely addressed. Combinations and interactions are considered under specific
circumstances. The Working Group concluded that, when performing risk assessments, the
default assumptions for cumulative toxicity should be that chemicals with different toxic
actions will work independently (simple additivity of effects) and those with the same
action of toxicity will act with additivity of dose. The recommendations of WiGRAMP are
being taken forward by a combination of research work and policy development. Two of the
key outcomes will be the establishment of a scientifically based systematic framework setting
out when to perform combined risk assessments and the identification of groups of active
substances with common mechanisms of action (http://www.pesticides.gov.uk). Approaches
to identifying common mechanism groups for pesticides are already being established in the
USA, and the International Life Sciences Institute has been developing a framework for
guiding the conduct of cumulative risk assessment, based on five key stages (U.S. EPA,
1999a; ILSI, 1999). Some common mechanism groups have already been proposed by EPA:
the organophosphates (U.S. EPA, 1998), N-methylcarbamates (U.S. EPA, 2001a) and
triazines (U.S. EPA, 2002). The EPA approach to the establishment of common mechanism
groups for organophosphates and N-methylcarbamates has been reviewed for the Science
Group of the Food Standards Agency. The Science Group has also prioritised the triazines and
four additional classes of pesticides/veterinary medicines (avermectins, canazoles, phenoxy-
herbicides, pyrethoids and natural pyrethrins) to be assessed for possible common mechanism
grouping. The IEH (2005) conducted a scoping study to identify the amount of work required
78
to establish common mechanism groups for each of the prioritised classes of pesticides. This
included an evaluation of the amount and quality of data available on each substance
belonging to each class. Also an estimate was made of the resources required to identify and
establish common mechanism groups for the prioritised classes of pesticides. While the
scientific systematic framework setting out when to perform combined risk assessments and
the identification of groups of active substances with common mechanisms of action are being
developed, the current approach of ACP and PSD in evaluating combined toxicity will be
followed within the framework of the HAIR project. In what follows the PSD and ACP
approach to assessing occupational risk of two or more compounds in a pesticide product
(formulation) is outlined.

Proposed Methodology to handle cumulative assessments

Two basic assumptions have been made about how components of a mixture will act together.
These concepts on additive effects in chemical risk assessment of cumulative exposure are
simplistic but as predicted human exposures are at the bottom end of the dose-response curve
(well below the NOAELs in animal studies, making significant interactions unlikely) and
assuming that that the assessment factors address the potential for simple interaction, they are
considered pragmatic and adequately protective. For compounds with similar toxicological
actions, the assumption being used by PSD is that any combined toxicity will follow the rules
of simple dose-additivity. Because compounds having the same mechanism of action act
through the same biochemical pathway, one can cumulate the doses of the individual
compounds in order to estimate the final effect. For compounds with different toxicological
actions and targets it is generally assumed that actions will be independent, with simple
additivity of effects. In circumstances where two compounds cause toxicity to the same
organ but by different mechanisms, the assessment of potential combined toxicity is made on
an ad hoc basis. For some active substances the precise mechanism of mammalian toxicity is
not fully understood and an in depth assessment based on mechanism of action against the
pest, or common target tissues/effects might be appropriate (http://www.pesticides.gov.uk).

a. Formulated Products
Formulated products need to be evaluated on their toxicity, primarily for the acute toxicity,
irritancy and sensitisation classification and labelling, but other aspects of formulation
toxicity also need to be considered (http://www.pesticides.gov.uk).

Products containing a single active substance
A consideration of the combined toxicity of the components needs to be conducted in the light
of re-registration. If data indicate that the toxicity of the formulated product is clearly greater
than predicted, based on simple additivity of the effects of the individual components, an
explanation will be required. The calculation method used to determine the classification of a
product, which is outlined in the Dangerous Preparations Directive (1999/45/EC) and CHIP3
2

regulations, the default position is that the components will act with dose aditivity for acute
toxicity and irritancy, but act independently (i.e. with simple additvity of effects) for other
hazards such as skin sensitisation, carcinogenicity, mutagenicity and reproductive toxicity. If
two co-formulants or a co-formulant and the active substance are known to have the same
toxic mechanism of action or target tissue at low doses the potential for combined action

2
The Chemicals (Hazard Information and Packaging for Supply) Regulations 2002, Statutory Instrument 2002
N 1689.
79
should be addressed. It is accepted that for many co-formulants there is limited information on
the toxicity following repeated exposures. However, when the toxicity is known to be similar
to that of an active substance in the product, consideration should be given to the potential
combined toxicity other than simple additvity of effects. A related issue for co-formulants is
whether they can produce an increased systemic exposure to the active substance e.g. by
increasing absorption relative to values seen with other types of vehicles. Assessments of
dermal absorption routinely consider formulation type and will take into account potential
effects of vehicles (http://www.pesticides.gov.uk).

Products containing two or more active substances
A consideration of the combined toxicity of the active substances needs to be conducted in the
light of re-registration. When a formulated product contains two or more active substances
there is a need to consider the potential for them to act other than by simple additivity of
effects, in a manner that might impact on the consumer and operator/worker/bystander risk
assessments. This concept has been part of the ACP considerations for a number of years. The
initial assessment approach follows the conclusions about the potental for interaction drawn
by WiGRAMP. Most applications considered so far by the committee have been products
including active substances with different modes of action. As such the conclusion has been
reached that there is little potential for additivity of dose. A recent example has highlighted
the need for an agreed methodology to assess applications where there is a potential for
additivity of dose. When formulated products contain two or more active substances it is
necessary to determine if the mechanism of toxicity or the target tissues for the actives are
common. The effects relevant for the cumulative assessments are those that drive the critical
LOAELs/NOAELs used for setting reference doses, or are evident at dose levels in the range
of critical LOAELs/NOAELs. If the target tissue is common even though the mechanism is
different, there should be some case by case consideration of combined action. A tiered
approach was proposed for the assessment of operator risk for products containing multiple
active substances (http://www.pesticides.gov.uk).

At tier 1, the estimated exposure (usually systemic exposure) to each of the active substances
is calculated as a fraction of the AOEL agreed for that substance. If the sum of the fractions is
smaller than one, exposure of the operator is acceptable. This is the case if the proportion of
the respective reference doses taken up by the predictive exposures to each active substance
are only small, e.g. < 50% if there are two components, <33% if there are three components,
etc. Then simple dose additivity can be assumed. The risks would then still be acceptable.
This tier of the assessment can be completed quickly and easily from the information
available fairly readily in evaluation of the active substances and using the standard exposure
assessment approaches. If the sum of the fractions is > 1, a more refined assessment will be
required (http://www.pesticides.gov.uk).

At tier 2, the toxic effect of concern for the combined risk assessment must be identified for
each active substance and exposure scenario. In this case, the exposures to each active
substance represent a high proportion of the respective reference doses (e.g. 60%) and
following risk might not be acceptable if the sum of the individual contributions > 100%. A
more detailed consideration would be needed. Detailed assessments can be performed in
several ways:
80
If the reference doses for the active substances are based on different
toxicological effects, effect specific reference doses should be
determined. The critical NOAEL is derived for each effect and from this
the effect specific reference dose is derived by the use of an appropriate
assessment factor. This effect specific AOEL will always be the
overall AOEL for the active substance. Estimated exposure for each
active substance is then compared to the effect specific AOEL for each
substance and presented as a fraction (or percentage). If the sum of the
fractions is 1; exposure of the operator is acceptable. If the sum of the
factions > 1 exposure is not shown to be acceptable and further specific
data will need to be generated to address the concern. This might include
operator monitoring data, in vitro testing of the combination, or in vivo
testing of the combination. Tier 2 assessments might require some re-
evaluation of relevant studies where the earlier evaluation document does
not enable the derivation of effect specific NOAELs. Again standard
methods of estimating exposure are appropriate;
A scientifically justified case on the potential for interaction can be
presented based on the study of the mechanism of toxicity of the active
substances, molecular structures, target molecules/cells or tissues;
Recommendations for use rates, timings and PPE can be made which
can lead to acceptable exposures taking the additive effects into account
(http://www.pesticides.gov.uk).

Tier 3 assessments will have to be conducted if estimated exposure is not shown to be
acceptable at tier 2. In some cases it might be necessary to perform additional studies to
investigate potential combined effects. This might include operator monitoring data, in vitro
testing of the combination or in vivo testing of the combination. The studies should focus on
the effects driving the risk assessment and use dose levels in the region of the NOAELs
/LOAELs for the individual components. On animal welfare grounds, the feasibility of an in-
vitro approach should be considered in the first instance. If in-vivo studies are required, these
should use the minimum numbers of animals necessary to resolve the issues. If one active
substance is known to be a potent inhibitor of xenobiotics metabolising enzymes (e.g. some
conazoles) the potential impact on the metabolism of other components should be considered
(http://www.pesticides.gov.uk).

Products containing synergists, agonists or herbicide safeners
In addition to the considerations described above, the following should be addressed. The
combined toxicity of the active substances and the synergists, agonists or herbicide safeners
should be evaluated. Synergists, agonists and herbicide safeners are designed to be
biologically active and modify the action of the active substance. In case of synergists and
agonists there is an increased action on the target pest, with herbicide safeners there is a
reduced action on the crop. The default assumption in performing human health risk
assessment in formulated products containing such biologically active compounds is that the
effects induced in the pest or crop could potentially apply to human exposures. The potential
impact on the human health risk assessment of co-exposure of the active substance(s) and the
synergist/agonist/safener should be assessed (http://www.pesticides.gov.uk).
81
b. Tank Mixes
Concerning operator exposure it is important that tank mixes are considered. This
recommendation was reported by the WiGRAMP. Investigations on the patterns of tank
mixing have shown that the majority of tank mixing does not involve active substances with
similar toxic actions. The Medical and Toxicology Panel considered the information and
concluded that the current practices of tank mixing in the UK were not likely to give rise to
significant concerns for combined toxicity based on dose additivity. On the related aspect of
altered dermal penetration the Panel believed there might be an issue due to the potential for
increased systemic exposure when different types of formulations are combined. Operator
exposure estimates include a value for dermal penetration of the active substance from the
formulation and in-use dilution. For some active substances the degree of penetration varies
with the formulation type. It is thus possible that tank mixing two or more different types of
formulation could result in an increase in dermal penetration relative to that from a single
formulation. The greatest concern would relate to a tank mix involving a product giving a low
dermal absorption (e.g. a solid containing active substance and mainly inert components such
as kaolin), with one containing solvents or surfactants that could significantly enhance the
penetration. An increase in dermal absorption by 5 fold could have a greater impact on the
risk assessment than simple dose additivity from two compounds with the same mechanism of
toxicity. PSD has commissioned a research project to investigate the effects of co-formulants
on the dermal penetration of a respective range of active substances. In considering the overall
risks associated with tank mixing, the Medical and Toxicology Panel noted that because tank
mixing reduced the number of application operations performed there could be a reduction in
the overall risks (including physical injury) (http://www.pesticides.gov.uk).

Overview of methodologies to handle aggregate assessments

Until recently most risk assessments focussed on a single pesticide, considered each route
separately, and evaluated each separately. Aggregate assessments consider a single pesticide
but combine multiple routes (ingestion, dermal and inhalation) and multiple sources (e.g.
food, water, residence and occupation) of exposure.

In 1996, the Office of Pesticide Programs (OPP) has taken a number of steps to enhance its
risk assessment to respond to the FQPA mandate to consider aggregate exposure and risk in
making decisions about the safety of tolerances. In 1997, OPP issues HED SOP 97.2 Interim
Guidance for conducting Aggregate Exposure and Risk Assessments (11/26/97) (U.S. EPA,
1997a). Since then the OPP has worked to develop more sophisticated methods of estimating
the combined exposure to pesticides by different routes and pathways (U.S. EPA, 2001a). The
current practices for assessing aggregate exposure and risk in the U.S. typically include a mix
of deterministic or point estimate data and distributional data. US aggregate and cumulative
assessments when sufficient data are available combine the water, diet and non-dietary
pathways (e.g. residential users), but exclude occupational pathways. The latter pathways can
however be included in the aggregate assessments in the same way as the other pathways
(pers. comm. Price, 2006). In 2001 a revised approach suggests an exposure assessment on an
individual basis, culminating in a representative population of interest. In this way, the
individuals temporal (i.e., exposures via all pathways agree in time), spatial (i.e., exposures
via all pathways agree in place/location) and demographic (i.e., exposures via all pathways
agree in age/gender/ethnicity and other demographic characteristics) characteristics are
consistent and reasonable. All linkages of time, space and demographic characteristics
should be made using supporting data. Using this approach, a distribution of total exposure to
(many) individuals in a population of interest can be created. Distributional data analysis is
82
preferred as this tool allows an aggregate exposure assessor to more fully understand the
uncertainty and variability inherent in the data set (U.S. EPA, 2001b)

Data for these probabilistic assessments to aggregate risk can be obtained by applying
different methodologies (Price et al., 2000). In the first instance data on the simultaneous
exposures of individuals from all sources of exposure to a pesticide for each day of the
individuals life can be collected. However, it is difficult to obtain survey results on an
individuals behaviour (either food consumption or activity patterns) for periods longer than
one or two days. Moreover it is difficult to collect sufficient information on a sufficient
number of individuals to allow the evaluation of different subpopulations and as the number
of potential sources increases, the number of behaviours that must be investigated in a survey
increases proportionately. Secondly, biological monitoring data can be used. This approach
proposed by the ILSI (1999) uses the individual as an integrator of exposure. The limitation of
the approach is that it requires the availability of analytical techniques for the pesticides or its
metabolites in blood or urine. It also has the disadvantage that the pesticide must allready be
in use. Thus this approach cannot be applied to new products. The most practical
methodology to handle aggregate assessments is the simulation of the doses received from
multiple sources by individuals in a population (Price et al., 2000). The exposure from each of
the pathways of exposure (e.g. drinking water ingestion, dietary consumption and herbicide
handling by workers,) is described by an equation. Many of the components of these
equations have values that are variable (from individual to individual, from day to day or
season to season, from sample to sample) and/or uncertain. These components of the exposure
equations can be described by probability distribution functions that reflect the relative
frequency of the different values for the variable components and the relative likelihood of the
different possible values for the uncertain components. The outcome of the exposure equation
is a dose. This dose varies because of the variability of the components in the equation. These
chemical-specific doses (mg/kg bw/d) obtained for each exposure pathway and each relevant
route (ingestion, inhalation, dermal) of exposure are summed. The total chemical-specific
dose for each exposure pathway is characterized separately, and then the doses are aggregated
by summing over the multiple exposure pathways. The pathway-specific and aggregate
assessments should be performed separately for each active that is taken into consideration.
Rather than focussing on an average dose in a population, a distribution describes the relative
frequency of each dose value. The variability in the dose from individual to individual within
the population or sub-population is reflected by the distributions. The distributions indicate
the dose that is most likely to occur, the range of doses expected in a population and the
relative likelihood of the different doses in that range. Each of the individual doses in the
distribution is the best estimate of that individual dose and not an upper or lower bound on
that dose. The probability distribution of the dose is generally quite difficult to calculate
analytically but can be fairly readily approximated by using a straightforward technique
known as Monte-Carlo simulation (Mc Kone & Ryan, 1989; Mc Kone & Daniels, 1991).
Such a simulation consists of numerous iterations. In an interation in the simulation, a single
value for each component in the exposure equations is randomly sampled from its
corresponding probability distribution. These component input values are then used in the
exposure equations to calculate the exposure of an individual in the defined population. The
frequency distribution of the calculated values from numerous iterations is the simulated
exposure distribution. The simulated exposure distributions reflect exposure variability but
not the uncertainty about the exposure equations, the distributions of the components and
related assumptions (Sielken et al., 2005). This uncertainty and its quantitative impact on the
simulated exposure distribution are presented in Sielken et al. (1996). In the Monte Carlo
approach, there are no inherent limitations on the complexity of the exposure equation, the
83
number of component variables, or the number of iterations (Morgan & Henrion, 1990).
Another powerful feature of the Monte Carlo approach is that it can reflect dependencies
among the components in an exposure calculation, providing for correlation among variables
and ensuring that the component values (and aggregate estimate) for an individual are
internally consistent. Distributions can be presented not only for a single day but also for
individuals or populations over time. In fact, the dimension of time may play a particularly
important role in aggregate exposure assessments for pesticides (Sielken et al., 2005). It is
important to keep in mind that Monte Carlo simulations are approximations. One way to
determine how much variation there is, is to re-run it several times and see how the
distribution (e.g. mean, median, standard error) varies. To determine how much iterations are
necessary, one needs to decide how precise one wants to approximate the distribution and
how much variation is acceptable. This requires careful consideration on how the distribution
will be used. Sensitivity analyses can be used to identify the parameters that contribute most
to the exposure estimates or to the variance or uncertainty in the estimates. They can be used
to assess the impact of various assumptions that are embedded in the models and, with expert
judgment, to better understand the uncertainties inherent in the models. The results of such
analysis can help in setting priorities in further data collection and refinement efforts. A range
of well-defined statistical methods is available to evaluate variability and to conduct
sensitivity analysis in exposure modelling. The importance of routinely including these kinds
of analyses in aggregate exposure assessments was emphasized. Concerning the data quality
and adequacy, there was a general consensus that whenever possible, when a database is
marginal, it is preferable to collect more data rather than relying on estimates, surrogates or
defaults. However, it was also recognized that there are real constraints on time, cost and
practical feasibility (ILSI, 1998).

Proposed methodology to handle aggregate assessments

Within the framework of the HAIR project it is proposed to use the Hazard Index approach
to aggregate risk for multiple sources and pathways. This method is applied by certain
agencies within the Environmental Protection Agency. The Hazard Index is an aggregation of
individual Hazards Quotients or Risk Indices for each route and pathway of exposure.
Within the framework of the HAIR project, route specific risk indices are not calculated, only
pathway specific reference doses are calculated because of the lack of data. Using the Hazard
Index approach the pathway specific risk indices can be combined into an overall risk index
by summing the individual risk index values. The other ways for aggregating risk follow the
aggregation methodology developd by WP 11. Important to mention is that pathways and
routes are only aggregated when they share a common toxic effect (U.S. EPA, 2001b).



84
V. Overall Occupational and Human Health Risk Index

Below, the aggregation procedure proposed to construct an overall occupational and a global
human health risk index is outlined. The risk indicators will be aggregated using weighting
factors. By applying weights the actual/local parameters which may affect the likelihood of
exposure of the whole population and of susceptible subgroups will be taken into account.
The risk for certain regions can be weighted according to the population density in these
particular regions. The risk for the applicators and workers can be weighted according to the
number of applicators/workers present in these particular regions. Probabilistic ways can also
be used to determine a risk ndex that reflects the average risk of an individual working in
agriculture.

1. Overall Occupational Risk Index

The occupational risk indices (operators, re-entry workers, bystanders, residents and sensitive
population groups) are aggregated in an overall occupational risk index using weighted
averages. The use of weighting is an opportunity that should be taken into consideration since
the impacts on operators, re-entry workers, bystanders, residents and sensitive population
groups are very likely of different significance.

=
=
n
k
k k occ
RI w RI
1


Where:
w
k
: relative importance of indicator k;
RI
k
: risk index value taken by indicator k;
RI
occ
: overall occupational risk index value.

It is the task of the risk managers to identify relevant weighting factors for each of the
indicators. These weighting factors can be determined based on national statistics concerning
the composition of the population. Currently national authorities assume that 5% of the
population can be considered as sensitive or more susceptible. As a default one can assume
that children and pregnant women account for 5% of the total risk. But it has to be mentioned
that the establishment of the weights is a task that needs to be conducted by risk managers.
However, the establishment of the weights is not easy. For example, which weight should be
attributed to the bystander indicator?

2. Overall Human Health Risk Index

An overall human health risk index can be calculated by attributing a weighting factor to the
consumer and to the overall occupational risk indicator according to the composition of the
population. Obviously the consumer indicator will be attributed a weight of one, since
everyone is a consumer. The weight of the overall occupational indicator cannot be easily
established.


85
3. Weighting Factors

The establishment of the weighting factors should be conducted by the risk managers as
mentioned before. They can base their decisions on the composition of the population of a
particular country or region. Regional and national statistics should be available in all the
Member States. After requesting data at several national statistical institutions, it seemed that
data are lacking for this specific purpose. The EUROSTAT surveys were also consulted. But
it seems that data are lacking for this particular purpose. For example the exact number of re-
entry workers is not known. Often farmers cannot be categorized into the group of the
applicators or the group of the re-entry workers. Farmers are generally both. Although
different sources provide a general indication of the number of re-entry workers in different
geographical units, it is virtually impossible to establish the exact size of the re-entry worker
population, particularly when dependents are considered. Knowing the number of re-entry
workers at risk is basic to toxicologic and epidemiologic analyses of pesticide exposure
(Arcury, T. A. et al., 2006). Estimating migrant and seasonal re-entry workers and their non-
re-entry worker household members is an extremely challenging task. Research of Larson
(2000) attempted to examine existing data and developed a reasonable approach for
estimating the number of re-entry workers. Final reports, titled Migrant and Seasonal
Farmworker Enumeration Study Profiles were prepared for ten states of North America. The
enumeration profiles studies of Larson for migrant and seasonal farmworkers, conducted for
several North American States provide estimates of the the following three population
subgroups:

Migrant farmworkers and seasonal farmworkers;
Non-farmworkers present in the same household as migrants farmworkers and
seasonal farmworkers;
Number of people (children and youth) under age 20 in six age groups.

Included in the scope of the study are individuals engaged in field and orchard agriculture;
packing and sorting procedures in food processing, horticultural specialities (including
nursery operations, greenhouse activities and crops grown under cover); and reforestation.
Concerning field agriculture and reforestation, the number of farmworkers was estimated
using a demand for labour process that examines the number of workers needed to perform
temporary agricultural tasks, primarily harvesting. The results estimate full-time equivalent
workers required for the task during the period of peak labor demand. Calculations prepared
for each county, are derived through a formula using four elements:

A H
DFL
W S


Where:
A: Crop acreage (ha);
H: Hours needed to perform a specific task (e.g. harvesting) for one acre of the
crop (hr/ha);
W: Work Hours per farmworker per day during maximum activity (hr/d);
S: Season length for peak work activity (d).

For nurseries/greenhouses, crops under cover and food processing, the number of
farmworkers was estimated based on employment reports. This illustrates a possible approach
for estimating the number of farmworkers. Deterrmng the number of residents and bystanders
is quite a challenge for the future.
86
VI. Calculation of the Acute & Chronic Indicators

The mode of calculating the worker indicators depends upon the data availability concerning
pesticide use and monitoring data. The indicator model should serve both the best as the worst
case of data availability. Three cases of data availability were identified.

1. Pesticide operator

Case I

In the best case of data availability, that will only be reached in a few member states for a
portion of or for the complete agricultural area of the country, monitoring data on exposure
are available on field level. These field data on exposure, expressed in mg a.s. per kg applied,
allow for a calculation of risk taking into account local conditions (meteorological and field
related). Usually these data are not available. Pesticide use data are available as field related
application patterns The application patterns contain all pesticides (products and active
substances) that were used to produce the crop including application time, dose rate,
application technique, formulation type, use of protective equipment for the applicators and
concentration of each active substance in a certain product if only the product dose rate is
given. The application tables can be collected within the framework of a data survey. For each
crop several application strategies exist. A single example of such an application strategy for
apple orchards is presented in Table VI.1.1.

In order to run the indicator on this level all input parameters have to be available for each
field. For a limited number of fields the parameters could be entered by specific user input. In
this case the user must supply the necessary data for each field on the used application
equipment, the product applied, the concentration of active substance in the product, If all
these data are available for all the fields of a farm, the calculated risk potentials can be
aggregated to a single risk potential for that farm. If the field level indicator is used to
calculate the occupational risk for a small region or even a whole country, the extent of input
data is large. Datasets have to be established in order to be able to run the indicator.
According to agricultural statistics a crop will be assigned to each field. Following the
assignment of the crop, an application strategy can be selected randomly from a field based
pesticide use survey in the considered region.

According to the mathematical notation described by WP 11, a basic risk event (for acute
exposure) can be described by the equation below. Crop was added as an additional
aggregation parameter. Between brackets the lowest aggregation level is given.

( , . ., , , _ , )
( , . ., , , _ , )
applicator a i field crop growth period acute
applicator a i field crop growth period acute
Exp
RI
AOEL
=

Where:
RI(): Risk Index (-);
Exp(): Exposure (mg a.s./kg b.w./d);
AOEL: Acceptable Operator Exposure Level (mg a.s./kg b.w./d).
87
Case II

In Case II no field data on exposure are available. Therefore the EUROPOEM surrogate
exposure values will be applied to estimate human exposure. The pesticide use data are
available as a set of crop related application patterns, which are specific for a particular region
but can not be applied to a single field since no data on exposure are available on a field level
basis, only on a regional basis.

The following should also be taken into account:

Within one grid, the area of land on which a particular crop is grown is obtained as
follows. The total agricultural area within one grid can be extracted from the
CORINE geographical datasets on land use with the help of GIS procedures. In
this way values of the total agricultural area specific for every grid are acquired.
When the total agricultural area within one grid is multiplied with the fraction of a
particular crop grown in that grid, the area for a particular crop within one grid is
obtained. The fractions of each crop are supplied by regional agricultural statistics,
which should be available in all the member states. WP 3 already derived these
areas for Europe on 10 km and 25 km.
A range of risk indices can be calculated for each crop and each crop related
application pattern. The mean is calculated to obtain a single risk index value for
each crop within a particular region. If the application method is not known, the
most dominant application method is assumed. Table III.1 links the different crops
to their most dominant application method.

The aggregation possibilities in this case are limited in space. The basic risk event (for acute
exposure) can be described as follows:

( , . ., , , _ , )
( , . ., , , _ , )
applicator a i region crop growth period acute
applicator a i region crop growth period acute
Exp
RI
AOEL
=

A case-study was worked out to illustrate the calculation methodology.

88
CASE-STUDY:
The input data needed in this case are listed in Table VI.1.1. An example listing is given for a spraying scheme for apple orchards. The AOEL
values are also given.

Table VI.1.1: Input data, example of a spraying scheme for apple orchards
Product Formulation as Function
Date of
application
Application
Technique
Aplication Type Indoor/Outdoor
Application
Direction
N of
applications
Dose
(kg as/ha)
Use of PPE
AOEL
Including confidential
values *
Early march
Late Oktober Cuprex 50% WG cupperoxychloride FUNG
Early November
Spraying Mechanical Outdoor Upwards 3 3 NO/YES 0,05
Late March
Dodex L dodine FUNG
Early April
Spraying Mechanical Outdoor Upwards 3 0,9 NO/YES 0,19
Scala L pyrimethanil FUNG Early April Spraying Mechanical Outdoor Upwards 1 0,45 NO/YES 0,6*
Early April
Late April
Early May
Late May
Late July
Captan80 WG captan FUNG
Early August
Spraying Mechanical Outdoor Upwards 8 1,8 NO/YES 0,125
Confidor L imidacloprid INSE Early April Spraying Mechanical Outdoor Upwards 1 0,125 NO/YES 0,15*
Mimic L tebufenozide INSE Late April Spraying Mechanical Outdoor Upwards 1 0,18 NO/YES 0,007
Late April
Early May Geyser L difenoconazool FUNG
Late May
Spraying Mechanical Outdoor Upwards 5 0,038 NO/YES 0,13*
Torque L fenbutatinoxyde INSE Early May Spraying Mechanical Outdoor Upwards 1 0,375 NO/YES 0,03
Early May
Pirimor WG pirimicarb INSE
Late July
Spraying Mechanical Outdoor Upwards 2 0,325 NO/YES 0,14*
Systhane L myclobutanil FUNG Early May Spraying Mechanical Outdoor Upwards 1 0,45 NO/YES 0,03
Insegar WG fenoxycarb INSE Late May Spraying Mechanical Outdoor Upwards 1 0,15 NO/YES 0,4*
Late May
Candit WG kresoxim-methyl FUNG
Early June
Spraying Mechanical Outdoor Upwards 3 0,3 NO/YES 0,9
Dimilin L diflubenzuron INSE Late June Spraying Mechanical Outdoor Upwards 1 0,45 NO/YES 0,02
Delan WG dithianon FUNG
Late June/Early
July
Spraying Mechanical Outdoor Upwards 1 1,05 NO/YES 0,03*
Topaz L penconazool FUNG Early May
Topaz L penconazool FUNG End May
Topaz L penconazool FUNG Late June
Spraying Mechanical Outdoor Upwards 3 0,3 NO/YES 0,7*
Early July
EuparenM WG tolylfluanide FUNG
Early September
Spraying Mechanical Outdoor Upwards 1 1,125 NO/YES 0,3*0,
FUNG: fungicides; INSE: insecticides; *: confidential data
89
The data listed in Table VI.1.1 were used to calculate the operator indicator. The following
assumptions were made:

1. The most widespread method of applying pesticides in apple orchards is by fan
assisted axial sprayers. The applied surrogate exposure values are the ones listed in
Table VI.1.2. No field data on exposure were available. But the computer model
should provide the possibility for users to insert their own data;
Table VI.1.2: Surrogate exposure values from the EUROPOEM database (see Annex I)
Formulation
Type
MixLoadInhal MixLoadDermal ApplicInhal ApplicHand ApplicDermal
WG 0.1 1 0.03 11 63
L 0.005 20 0.03 11 63

2. The average treated area per day was set to 9 ha in accordance with the default
values used in the Belgian registration procedure;
3. When the operator does not wear PPE, PPE
I
and PPE
hand
equal one, while PPE
body

equals 0,5 since normal work clothing is worn;
4. When the operator does wear PPE, PPE
I
and PPE
hand
equal 0.1, while PPE
body

equals 0,1 since (0.5*0.2) equals 0.1;
5. The dermal absorption factor equals 0.1 and the inhalation absorption factor equals
1;
6. The body weight is set to 70 kg.

The results are listed in Table VI.1.3. The output table should present both the RIs when PPE
is used and when no PPE is used.
Table VI.1.3: Risk Indices calculated for a spraying scheme for apple orchards
as Function
N of
applications
IE applicator
AOEL
Including
confidential
values *
RI acute
PPE
RI acute no
PPE
RI chronic
PPE
RI chronic
no PPE
cupperoxychloride FUNG 3 1,73 0,05 5,89 34,56 4,84E-02 2,84E-01
dodine FUNG 2 0,73 0,19 0,57 3,83 3,12E-03 2,10E-02
pyrimethanil FUNG 1 0,36 0,6* 0,091 0,61 2,49E-04 1,67E-03
captan FUNG 8 1,04 0,125 1,41 8,29 3,09E-02 1,82E-01
imidacloprid INSE 1 0,10 0,15* 0,10 0,67 2,74E-04 1,84E-03
tebufenozide INSE 1 0,15 0,007 3,12 20,78 8,55E-03 5,69E-02
difenoconazool FUNG 3 0,03 0,13* 0,035 0,24 2,88E-04 1,97E-03
fenbutatinoxyde INSE 1 0,30 0,03 1,52 10,10 4,16E-03 2,77E-02
pirimicarb INSE 2 0,19 0,14* 0,23 1,34 1,26E-03 7,34E-03
myclobutanil FUNG 1 0,36 0,03 1,82 12,12 4,99E-03 3,32E-02
fenoxycarb INSE 1 0,09 0,4* 0,044 0,22 1,21E-04 6,03E-04
kresoxim-methyl FUNG 3 0,17 0,9 0,033 0,19 2,71E-04 1,56E-03
diflubenzuron INSE 1 0,36 0,02 2,73 18,18 7,48E-03 4,98E-02
dithianon FUNG 1 0,60 0,03* 3,43 20,16 9,40E-03 5,52E-02
penconazool FUNG 3 0,24 0,7* 0,052 0,35 4,27E-04 2,88E-03
tolylfluanide FUNG 2 0,65 0,3* 0,37 2,16 2,03E-03 1,18E-02
FUNG: fungicides; INSE: insecticides
90
Case III

In Case III no field data on exposure are available. Therefore the EUROPOEM surrogate
exposure values will be applied to estimate human exposure. Pesticide use data are not
available in the form of pesticide application patterns. For each crop only a list of active
ingredients is available including the quantity of the active ingredient used for the crop. It is
assumed that the volume of pesticides is applied to the treated area of the corresponding crop.
Information on the total area on which the crop is cultivated and the portion of the area on
which the crop is treated with each active substance can be compiled. Pesticide use data can
be derived from the EUROSTAT surveys (EC-Regulation of the European Parliament and of
the Council of Pesticide Statistics). If this regulation is enforced, pesticide use data will be
available-in this form for all the member states in the near future. When surveys are not
available, data can be derived from sales data as described by WP 5. The dose rate is either a
realistic dose rate (when the treated area of the crop is known) that is calculated by dividing
the applied volume by the treated area of the crop. When there is no information on the
treated area of the crop, the application rate is artificial and is obtained by dividing the applied
volume by the total crop area.

The basic risk event (for acute exposure) is defined as follows:

( , . ., , , , )
( , . ., , , , )
applicator a i country crop year acute
applicator a i country crop year acute
Exp
RI
AOEL
=

Case III will be illustrated below by means of a case study in order to demonstrate the output
of the acute operator indicator.

CASE-STUDY

Structuring the query
Assessing the acute and chronic risk for operators due to the application of the following
active substances: carbendazim, chlorpyriphos, cypermethrin, diuron, lamda-cyhalothrin,
myclobutanil, pirimicarb, tolylfluanid in apple, pear, plum and cherry orchards in the UK
during 2002.

Pesticide usage data
Usage data regarding the application of the above listed active substances were provided by
Miles Thomas (HAIR work package 5). The relevant application events were ordered per
active, area treated and formulation type. Data were provided for the whole of the UK

Toxicological data
The AOEL values and the dermal absorption percentages were taken from the UGent database
and were obtained from the following sources (in order of importance):
1. European Union;
2. CTB The Netherlands (http://www.ctb-wageningen.nl/);
3. Pandoras Box (Linders et al., 1994);
4. The Pesticide Manual (Tomlin, 2004);
5. Extoxnet (http://extoxnet.orst.edu/);
6. Toxnet (http://toxnet.nlm.nih.gov/);
7. Other sources (confidential data; public in 2008).
91
Assumptions taken into account
1. The most widespread method of applying pesticides in orchards in the UK is by fan
assisted axial sprayers. In this way the airflow directly directs the spray droplets onto
the target crop (Blundell, 2005). Thus, the surrogate exposure values for upward
mechanical spraying were applied. These values can be found in Table IX.1.4. The
mixing/loading surrogate exposure values are specific for each formulation type and
are also listed in Table IX.1.4;

2. PPE
I
and PPE
hand
equal one, while PPE
body
equals 0.5 (since normal work clothing
is worn) when no PPE is worn. When PPE is worn PPE
I
and PPE
hand
equal 0.1, while
PPE
body
equals 0.1 since (0.5*0.2) equals 0.1;

3. The average treated area per day was set to 15 ha in accordance with the default
value assumed in EUROPOEM and the body weight is set to 70 kg. The inhalation
absorption factor equals 1.

Input data: Table VI.1.4 lists the input data for the case-study.

Table VI.1.4: Input data for case-study on orchards in the UK
as Function Formulation Crop
Application rate
(kg a.s./ha)
N of
applications
Ab
DE

AOEL
(mg/ kg bw d
Apples 0,287 3,10
L
Pears 0,364 3,07
Apples 0,224 4,73
WG
Pears 0,266 6,86
Apples 0,246 3,04
Carbendazim FUNG
WP
Pears 0,256 2,75
0,01 0,02*
Apples 0,691 1,98
Pears 0,618 1,23 L
Plums 0,584 1,81
Apples 0,636 2,10
Pears 0,579 2,25
Chlorpyriphos INSE
WG
Plums 0,733 2,58
0,01 0,01
Apples 0,031 4,68
Cherries 0,024 1,00
Pears 0,023 1,18
Cypermethrin INSE L
Plums 0,031 4,65
0,42 0,5*
Apples 0,591 1,18
Cherries 0,298 1,00
Pears 0,663 1,14
Diuron HERB L
Plums 0,362 1,25
0,1 0,007*
Lambda-cyhalothrin INSE L Pears 0,011 1,11 0,003 0,0025
Apples 0,057 5,42
Cherries 0,110 1,15
Pears 0,045 4,41
Myclobutanil FUNG L
Plums 0,083 2,98
0,1 0,03
Apples 0,209 1,00
Cherries 0,288 1,49
Pears 0,204 1,00
Pirimicarb INSE WG
Plums 0,258 1,00
0,01 0,14*
Apples 0,628 2,07
Tolylfluanid FUNG WG
Pears 0,713 2,55
0,1 0,3*
FUNG: fungicides; INSE: insecticides; * indicates confidential values

The results are listed in Table VI.1.5. The output table should present both the RIs when PPE
is used and when no PPE is used.


92
Table VI.1.5: Risk Indices calculated for several active substances applied in apple orchards in the UK
as Function Formulation Crop
N of
applications
IE
applicator
PPE
IE applicator no PPE
RI PPE (basic
event) acute
RI no PPE (basic
event) acute
RI PPE (basic
event) chronic
RI no PPE (basic
event) chronic
Frequency of use
RI (no PPE) X F
acute
Apples 3,10 0,098 0,660 0,300 2,033 2,548E-03 1,727E-02 2,102E+03 4,273E+03
L
Pears 3,07 0,098 0,660 0,380 2,574 3,196E-03 2,165E-02 1,868E+02 4,809E+02
Apples 4,73 0,089 0,575 0,213 1,377 2,760E-03 1,784E-02 3,247E+03 4,472E+03
WG
Pears 6,86 0,089 0,575 0,253 1,637 4,755E-03 3,077E-02 7,881E+02 1,290E+03
Apples 3,04 0,277 2,455 0,730 6,468 6,080E-03 5,387E-02 1,749E+03 1,131E+04
Carbendazim FUNG
WP
Pears 2,75 0,277 2,455 0,761 6,742 5,734E-03 5,080E-02 5,053E+02 3,407E+03
Apples 1,98 0,098 0,660 1,444 9,772 7,833E-03 5,301E-02 7,485E+03 7,314E+04
Pears 1,23 0,098 0,660 1,291 8,740 4,350E-03 2,945E-02 7,899E+02 6,904E+03 L
Plums 1,81 0,098 0,660 1,220 8,256 6,050E-03 4,094E-02 5,406E+02 4,463E+03
Apples 2,10 0,089 0,575 1,212 7,831 6,973E-03 4,506E-02 1,437E+03 1,125E+04
Pears 2,25 0,089 0,575 1,104 7,133 6,805E-03 4,397E-02 1,531E+02 1,092E+03
Chlorpyriphos INSE
WG
Plums 2,58 0,089 0,575 1,399 9,037 9,889E-03 6,388E-02 1,640E+02 1,482E+03
Apples 4,68 3,952 26,285 0,053 0,352 6,796E-04 4,513E-03 2,505E+02 8,827E+01
Cherries 1,00 3,952 26,285 0,041 0,273 1,123E-04 7,479E-04 7,172E+01 1,960E+01
Pears 1,18 3,952 26,285 0,040 0,265 1,293E-04 8,567E-04 4,645E+02 1,229E+02
Cypermethrin INSE L
Plums 4,65 3,952 26,285 0,052 0,344 6,625E-04 4,382E-03 7,965E+01 2,740E+01
Apples 1,18 0,944 6,285 17,072 113,722 5,519E-02 3,676E-01 2,415E+03 2,747E+05
Cherries 1,00 0,944 6,285 8,599 57,281 2,356E-02 1,569E-01 3,134E+01 1,795E+03
Pears 1,14 0,944 6,285 19,155 127,600 5,983E-02 3,985E-01 2,295E+02 2,929E+04
Diuron HERB L
Plums 1,25 0,944 6,285 10,449 69,605 3,578E-02 2,384E-01 6,165E+01 4,291E+03
Lambda-cyhalothrin INSE L Pears 1,11 0,032 0,223 0,029 0,206
8,819E-05 6,265E-04
2,552E+02 5,259E+01
Apples 5,42 0,944 6,285 0,382 2,547 5,672E-03 3,782E-02 8,154E+03 2,077E+04
Cherries 1,15 0,944 6,285 0,743 4,948 2,341E-03 1,559E-02 2,813E+02 1,392E+03
Pears 4,41 0,944 6,285 0,302 2,012 3,649E-03 2,431E-02 4,270E+02 8,592E+02
Myclobutanil FUNG L
Plums 2,98 0,944 6,285 0,559 3,721 4,564E-03 3,038E-02 4,541E+02 1,689E+03
Apples 1,00 0,089 0,575 0,028 0,184 7,671E-05 5,041E-04 9,546E+02 1,754E+02
Cherries 1,49 0,089 0,575 0,039 0,253 1,592E-04 1,033E-03 3,244E+02 8,209E+01
Pears 1,00 0,089 0,575 0,028 0,180 7,671E-05 4,932E-04 3,716E+02 6,676E+01
Pirimicarb INSE WG
Plums 1,00 0,089 0,575 0,035 0,227 9,589E-05 6,219E-04 2,893E+02 6,567E+01
Apples 2,07 0,773 4,580 0,347 2,056 1,968E-03 1,166E-02 3,902E+03 8,022E+03
Tolylfluanid FUNG WG
Pears 2,55 0,773 4,580 0,394 2,334 2,753E-03 1,631E-02 8,870E+02 2,070E+03
FUNG: fungicides; INSE: insecticides; HERB: herbicides

The frequency of use for the year 2002 in the UK was calculated as follows:

) _ _ _ _ ( area treated Basic grown area Nat F =

With:
Nat_area_grown: national area grown;
Basic_treated_area: Basic treated area of the area grown for a particular crop.
93
Aggregation
In what follows different possibilities for the display of the results will be shown.

The first tier risk indices can be listed in tables as shown in Table VI.1.5. Such a Table should
list the active substance, the formulation type of the product applied, the pesticide group
category, the number of applications, the number of hectares on which the active was applied
and the RI value. Every application event is characterized by a risk index. This risk index is
either below the trigger value or above the trigger value of 1. The risk below the trigger value
is characterized as risk below screening level; the risk above the trigger value is
characterized as risk above the screening level for which further evaluation is needed.

At any level of aggregation (e.g. by crop, region or overall national level (hectares upon
which the actives are applied), time, actives, application events) these two categories can be
calculated and expressed as a percentage of the combined hectares. These aggregated results
can be presented in several ways. A few examples are given below:

Table showing the frequency in each category

Ex 1: national level (selected actives, orchards, year 2002) (TableVI.1.6)

Table VI.1.6: Table showing the frequency on national level for the two categories: requiring
further assessment and below the screening level (absolute and relative (%))
Category of Risk Frequency %
Risk below the
screening level
3,06E+03 7,84
Risk needing further
evaluation
3,60E+04 92,16
Combined 3,91E+04 100,00

For the actives that need further evaluation, the risk index should be calculated taking
into account the use of personal protective equipment. In this case this applies to the
actives: carbendazim, myclobutanil, tolylfluanid, chlorpyrifos and diuron.

Ex 2: per crop group (selected actives applied in orchards, national level, year 2002)
(Table VI.1.7 & VI.1.8)

Table VI.1.7: Table showing the frequency per crop group for the two categories: requiring further
assessment and below the screening level (absolute)
Crop
Frequency no further
evaluation
Frequency further
evaluation
Apple 1,21E+03 3,05E+04
Pear 1,09E+03 3,97E+03
Plum 3,69E+02 1,22E+03
Cherry 3,96E+02 3,13E+02
94
Risk below the screening level
Risk needing further evaluation
Table VI.1.8: Table showing the frequency on national level for the two categories: requiring
further assessment and below the screening level (relative (%)).
Crop % no further evaluation % further evaluation
Apple 3,09 78,08
Pear 2,79 10,16
Plum 0,94 3,12
Cherry 1,01 0,80

In stead of listing the results along crop type, the results can also be listed along
regions or along years, along pesticide group, depending on the aggregation that is
performed by the user.

Pie or Bar Chart showing the frequency in each category
In stead of presenting the results in Tables, one can also make use of pie charts or bar charts
(Figure VI.1.1 & VI.1.2).














Line plots can also be used to show the time-trend evolution of the risk for applicators. A line
plot showing the evolution in frequency of the risk over the years below the screening level
and a line plot showing the evolution in frequency of the risk over the years requiring further
evaluation can be presented. A stacked line plot showing the total frequency (equals the
number of hectares treated) and a lower line showing the number of hectares below the
screening level also gives a good image of the results. It is also possible to represent the
results in a 3D-plot. In the same plot both categories of risk can be represented. Another
possibility to represent the time-trend risk associated with the use of pesticides for applicators
is by means of bar charts. Each bar consists of two parts. One part reflects the category below
the screenineg level, while the other part reflects the category requiring further evaluation.

For risk managers further analysis of the category Risk requiring further evaluation, will be
necessary. Risk managers should be able to identify which actives are responsible for driving
the results. Therefore, tables should be generated in which the actives together with their
frequency and RI are listed (Table VI.1.9).
Figure VI.1.1: Pie Chart for Cherry
Orchards
Figure VI.1.2: Bar Chart for Cherry
Orchards
0,00E+00
1,00E+02
2,00E+02
3,00E+02
4,00E+02
5,00E+02
6,00E+02
7,00E+02
8,00E+02
Risk below the screening level
Risk needing f urther evaluation
Risk below the screening level
95
Table VI.1.9: List of the actives belonging to the category Risk Requiring further evaluation (listed for
apple orchards only as an example).
Active Formulation Type Frequency RI
Carbendazim WG 3,25E+03 1,377
Carbendazim L 2,10E+03 2,033
Tolylfluanid WG 3,90E+03 2,056
Myclobutanil L 8,15E+03 2,547
Carbendazim WP 1,75E+03 6,468
Chlorpyriphos WG 1,44E+03 7,831
Chlorpyriphos L 7,49E+03 9,772
Diuron L 2,42E+03 113,722

For all the risk events belonging to the category Risk requiring further evaluation, the
influence of the use of personal protective equipment (PPE) should be taken into account.
Risk Indices can be calculated for the different types of PPE and for various combinations of
PPE. Concerning the display of the results, the same options for tables and graphs can be used
as presented above, but instead of two there are three categories of risk, namely risk below
the screening level, risk acceptable based on refined assessment and risk acceptable with
mitigation. A pie chart showing the proportion of the total frequency belonging to each of
these categories can be shown. Other possibilities that can be used are the use of a 3D line
graph or a stacked line graph, with three lines showing the evolution in time for the three
categories.

Table VI.1.10 lists the results for each category of risk.

Table VI.1.10: Table showing the frequency for apple orchards for the three categories (absolute and
relative (%))
Category of risk Frequency %
Risk below the screening level 3,06E+03 7,84
Risk acceptable using PPE 2,27E+04 58,08
Risk needing further evaluation 1,33E+04 34,08
Combined 3,91E+04 100,00

Chlorpyriphos and diuron are the actives that need further evaluation. Figure VI.1.3 shows the
three categories of risk. The category of risk needing further evaluation is split up according
to the degree above which the trigger value is exceeded.

Distribution of risk
0,00E+00
5,00E+03
1,00E+04
1,50E+04
2,00E+04
2,50E+04
3,00E+04
3,50E+04
4,00E+04
4,50E+04
F
r
e
q
u
e
n
c
y
1 order of magnitude
above the trigger value
Above the trigger
value, but same order
of magnitude
Risk acceptable using
PPE
Risk below the
screening level

Figure VI.1.3: Distribution of risk in orchards for the selected actives
96
The frequency in each of these categories can be calculated for several consecutive years. In
this way the time-trend risk can be presented.

Another way to show the results that makes a comparison between pesticide groups and crop
groups possible makes use of the sum (RI x F) values.

Different ways of aggregation are possible. Here, pesticide group aggregation and crop
aggregation is presented. It is assumed that no PPE was worn and the aggregation is only
applied to the acute risk indicators.

1. pesticide group aggregation for orchards (apple, pear, plum and cherry)

The results are presented in Table VI.1.11.
Table VI.1.11: pesticide group aggregation
Pesticide
Group
RI median
RI 95
th

percentile
Sum F Sum RI*F
% of
total Risk
% of total
Frequency
FUNG 2,334 6,468 2,27E+04 6,00E+04 13 58
INSE 9,772 9,772 1,36E+04 9,90E+04 66 21
HERB 1,14E+02 1,28E+02 2,74E+03 3,10E+05 21 7
ALL 2,547 1,14E+02 3,905E+04 4,691E+05 100 100

The high median risk index of the herbicides is due to the low AOEL value of diuron, the
active substance that was selected for analysis.

2. crop group aggregation

The results are presented in Table VI.1.12 & VI.1.13.

Table VI.1.12: Crop group aggregation: Risk for all the studied active substances in apple, pear, plum and
cherry orchards
Crop Group RI median
RI 95
th

percentile
Sum F Sum RI*F
% of total
Risk
% of total
Frequency
Apple 2,55 1,14E+02 3,17E+04 4,08E+05 87 81
Pear 2,33 8,74 5,06E+03 4,56E+04 10 13
Plum 3,72 9,037 1,59E+03 1,20E+04 3 4
Cherry 0,04 4,948 708,70 3,29E+03 1 2
ALL 2,547 1,14E+02 3,91E+04 4,69E+05 100 100

Table VI.1.13: Crop group aggregation: Risk for the studied active substances in orchards (apple, pear,
plum and cherry)
as RI median
RI 95
th

percentile
Sum F Sum RI*F
% of total
Risk
% of total
Frequency
Carbendazim 2,033 6,742 8,58E+03 2,52E+04 5,38 21,97
Chlorpyriphos 9,772 9,772 1,06E+04 9,83E+04 20,96 27,06
Cypermethrin 0,273 0,352 8,66E+02 2,58E+02 0,06 2,22
Diuron 1,14E+02 1,28E+02 2,74E+03 3,10E+05 66,09 7,01
Lambda-
cyhalothrin 0,206 0,206
2,55E+02
5,26E+01 0,01 0,65
Myclobutanil 2,547 3,721 9,32E+03 2,47E+04 5,27 23,86
Pirimicarb 0,184 0,253 1,94E+03 3,90E+02 0,08 4,97
Tolylfluanid 2,056 2,334 4,79E+03 1,01E+04 2,15 12,26
TOTAL 2,547 1,14E+02 3,91E+04 4,69E+05 100 100
97
The following graphs should be presented by the computer program:

Pie charts: Each pie portion represents the proportion of a crop group or a pesticide
group in the total risk (RI x F) for applicators and the total frequency of pesticide
applications. Figures VI.1.4 and VI.1.5 give examples of such graphs.

Contribution of the pesticide groups to the total
frequency
58
21
7
FUNG(58%)
INSE(21%)
HERB (7%)





Boxplots (made by the R-program): These graphs illustrate the characteristics of
the frequency distribution in the various groups, namely the 25
th
, 50
th
, 75
th
and 95
th
percentile as well as the maximum and the minimum.

Histograms (made by the R-program): The risk events are grouped by intervals of
one unity of log 10 of RI. Hence, from one interval to another, the risk increases
10 times. Example: the interval log10=[0;1[ corresponds to an interval from RI=1
to RI=10 (10 not included) and the interval log10=[-1;0[ from 0,1 to 1 (1 not
included). The histogram for the case study is shown below. This graph was made
in Excel, but can be generated using the aggregation program, proposed by WP 11.
The first series of histograms (blue) show the proportion of the applications of the
interval in the total frequency of the crop group and the other (red) their proportion
in the total risk. The purpose of these histograms is that they help to localize the
active substances contributing the most to the total risk. Secondly, they may help
to orientate the choice of pesticide reduction actions. Indeed, in an interval with a
high proportion in the total risk (red) and a low proportion in the total frequency
(blue), the reduction of the risk could be easier because it concerns a low number
of applications. It would be more difficult to decrease the risk in an interval with a
high proportion of the frequency. (Figure VI.1.6)
Figure VI.1.4: Contribution of the
different pesticide groups to the
total risk on an operator
Figure VI.1.5: Contribution of the
different pesticide groups to the
total frequency of use
Contribution of the pesticide groups to the total
risk on applicators
13
66
21
FUNG(13%)
INSE(66%)
HERB (21%)
98
Distribution of frequency and summed risk of all the active
substances taken up in the case-study for the applicator
compartment
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
[-1;0[ [1;0[ [1;2[ [2;3[
log 10 (RI of application)
p
r
o
p
o
r
t
i
o
n



















Sum(F) of interval/Sum(F) total
Sum(RI x F) of interval/Sum(RI x F)

Figure VI.1.6: Histogram: Distribution of frequency and summed risk of all the active substances taken
up in the case-study for the applicator compartment

It should also be possible to graphically represent the time trend risk (Figure VI.1.6).

Riskiest active substances:
The riskiest active substances can be identified by determining those substances that are
above the 95
th
percentile of the total risk. The riskiest active substances can also be given for a
particular crop group or a particular pesticides group.

Table VI.1.14 gives an example output table.

Table VI.1.14: The riskiest active substances (above the 95
th
percentile of the total risk)
a.s. crop crop group Pesticide
group
RI RI x F % total (RI x F)
Diuron pears orchard HERB 127,60 2,93E+04 6,24

HERB: herbicide

99
2. Re-entry worker

Because specific information regarding DFRs is not available, only the most conservative
indicator can be calculated. Thus, the worker risk assessment, based on the generic
assumption on initial DFR and database for TFs, gives single conservative point estimates
(surrogate values) for total potential exposure, fully exploiting the capacity of the database
which is applicable to a broad range of re-entry scenarios common to European conditions.

An example is calculated where the actual and the potential risk for workers is determined.
Table VI.2.1 lists the input parameters that are needed to calculate the re-entry worker
indicator.

CASE-STUDY

Structuring the query
Assessing the acute risk for re-entry workers in orchards (apple, pear, plum and cherry) due to
the application of all the active substances applied in orchards in the UK during 2002.

Pesticide usage data
Usage data regarding the application of the above listed active substances were provided by
Miles Thomas (HAIR work package 5). The relevant application events were ordered per
active and area treated. Data were provided for the whole of the UK

Toxicological data
The AOEL values and the dermal absorption percentages were taken from the UGent database
and were obtained from the following sources (in order of importance):
1. European Union;
2. CTB The Netherlands (http://www.ctb-wageningen.nl/);
3. Pandoras Box (Linders et al., 1994);
4. The Pesticide Manual (Tomlin, 2004);
5. Extoxnet (http://extoxnet.orst.edu/);
6. Toxnet (http://toxnet.nlm.nih.gov/);
7. Other sources (confidential data; public in 2008).

Assumptions taken into account

1. LAI = 4 (fruit orchard) (m/m);
2. T = 8 h (1 workday);
3. P = 1 (without PPE) and P = 1 (with PPE) (because in this case the TF actual is
known; if this is not known, P is set to 0,1);
4. TF potential = 20.000 cm/person/hr; TF actual = 4500 cm/person/hr;
5. The body weight is set to 70 kg.


100
Input data: Table VI.2.1 lists the input data for this case-study.
Table VI.2.1: Input data for case-study on apple orchards in the UK
as Function Formulation Crop
Application rate
(kg a.s./ha)
N of applications Ab
DE
(-)
AOEL
(mg/ kg bw d)
L Apples 0,605 1,09
L Cherries 0,709 1,00
L Pears 0,620 1,22
2,4-D HERB
L Plums 0,835 1,03
0,02 0,15
Amitraz AC L Pears 0,646 1,39 0,1 0,003
L Apples 0,372 1,04
L Cherries 0,788 1,15
L Pears 0,611 1,03
Amitrole HERB
L Plums 1,027 1,78
0,01 0,001
Asulam HERB L Apples 0,231 1,00 0,1 0,45*
L Apples 0,201 3,44
Bupirimate FUNG
L Pears 0,177 6,06
0,1 0,15
WSB Apples 0,118 7,74
WG Apples 0,824 5,06
WG Pears 1,123 4,38
WP Apples 1,103 4,94
Captan FUNG
WP Pears 1,399 4,82
0,1 0,125
L Apples 0,287 3,10
L Pears 0,364 3,07
WG Apples 0,224 4,73
WG Pears 0,266 6,86
WP Apples 0,246 3,04
Carbendazim FUNG
WP Pears 0,256 2,75
0,01 0,02*
Chlorine FUNG L Cherries 0,170 10,24 - -
L Apples 0,691 1,98
L Pears 0,618 1,23
L Plums 0,584 1,81
WG Apples 0,636 2,10
WG Pears 0,579 2,25
Chlorpyrifos INSE
WG Plums 0,733 2,58
0,01 0,01
L Apples 0,189 1,09
L Cherries 0,192 1,00 Clofentezine AC
L Pears 0,192 1,00
0,1 0,02
L Apples 0,097 1,00
L Pears 0,099 1,00 Clopyralid HERB
L Plums 0,180 1,00
0,1 1
L Apples 0,504 1,53
L Cherries 0,997 2,39
L Pears 0,669 1,48
L Plums 0,727 1,05
WP Apples 1,055 2,06
WP Cherries 0,897 2,30
WP Pears 0,326 5,34
Copper oxychloride FUNG
WP Plums 1,497 1,00
0,1 0,05
Copper sulphate FUNG L Apples 27,000 2,00 0,1 0,05
L Apples 0,031 4,68
L Cherries 0,024 1,00
L Pears 0,023 1,18
Cypermethrin INSE
L Plums 0,031 4,65
0,42 0,5*
L Cherries 0,005 1,69
L Pears 0,009 1,00 Deltamethrin INSE
L Plums 0,020 2,00
0,1 0,0075
L Apples 0,028 1,29
L Cherries 0,048 1,00
L Pears 0,026 1,43
Dicamba HERB
L Plums 0,023 1,13
0,01 1,2*
GR Apples 2,596 1,00
Dichlobenil HERB
GR Cherries 0,676 1,00
0,1 0,002
L Apples 0,126 1,44
L Cherries 0,090 1,00
L Pears 0,149 1,28
Dichlorprop-P HERB
L Plums 0,082 1,00
0,1 0,32*
L Apples 0,133 1,46
L Pears 0,141 1,28
L Plums 0,137 1,26
Diflubenzuron INSE
WP Pears 0,072 1,00
0,1 0,02
AC: acaricides; HERB: herbicides; FUNG: fungicides; INSE: insecticides; GR: growth regulators
* indicates confidential values
101
Table VI.2.1: Input data for case-study on apple orchards in the UK
as Function Formulation Crop
Application rate
(kg a.s./ha)
Ab
DE
(-)
AOEL
(mg/ kg bw d)
L Apples 0,246
Dinocap FUNG
L Pears 0,437
0,1 0,001
L Apples 0,112
L Cherries 0,150
L Pears 0,105
Diquat HERB
L Plums 0,104
0,01 0,001
L Apples 0,560
Dithianon FUNG
L Pears 0,682
0,003 0,03*
L Apples 0,591
L Cherries 0,298
L Pears 0,663
Diuron HERB
L Plums 0,362
0,1 0,007*
L Apples 0,750
L Pears 0,777 Dodine FUNG
L Plums 0,433
0,1 0,19
L Apples 0,037
L Cherries 0,059
L Pears 0,044
Fenbuconazole FUNG
L Plums 0,052
0,1 0,03
WG Cherries 0,688
Fenhexamid FUNG
WG Plums 0,620
0,18 0,3
WG Apples 0,070
WG Pears 0,069 Fenoxycarb INSE
WP Pears 0,048
0,15 0,4*
Fenpyroximate AC L Apples 0,039 0,053 0,01*3
L Apples 0,130
Fluroxypyr HERB
L Pears 0,057
0,1 0,8
Fosetyl-aluminium FUNG WG Apples 1,885 0,1 57*
GR Cherries 0,007
GR Pears 0,007
L Apples 0,002
L Cherries 0,001
Gibberellins GR
L Pears 0,002
- -
L Apples 0,257
L Cherries 0,248
L Pears 0,232
Glufosinate-ammonium HERB
L Plums 0,222
0,1 0,008*
L Apples 0,581
L Cherries 0,685
L Pears 0,599
Glyphosate HERB
L Plums 0,574
0,03 0,2
Imidacloprid INSE WG Plums 0,040 0,1 0,15*
L Apples 0,134
L Cherries 0,023 Isoxaben HERB
L Plums 0,014
0,1 0,066
WG Apples 0,083
Kresoxim-methyl FUNG
WG Pears 0,073
0,1 0,9
Lambda-cyhalothrin INSE L Pears 0,011 0,003 0,0025
L Apples 0,604
WG Apples 1,282
WG Pears 1,937
MCPA FUNG
WP Apples 1,076
0,1 0,035
WP Pears 1,717
L Apples 0,380
L Cherries 0,672
L Pears 0,329
Mancozeb FUNG
L Plums 0,295
0,1 0,035
L Apples 0,080
L Cherries 0,113
L Pears 0,088
Mecoprop-P HERB
L Plums 0,059
0,2 0,04
L Apples 0,099
L Cherries 0,162 Methoxyfenozide INSE
L Pears 0,091
0,1 0,1
Metsulfuron-methyl HERB WG Pears 0,002 0,1 0,7
L Apples 0,057
L Cherries 0,110
L Pears 0,045
Myclobutanil FUNG
L Plums 0,083
0,1 0,03
AC: acaricides; HERB: herbicides; FUNG: fungicides; INSE: insecticides; GR: growth regulators; * indicates
confidential values
102
Table VI.2.1: Input data for case-study on apple orchards in the UK
as Function Formulation Crop
Application rate
(kg a.s./ha)
Ab
DE
(-)
AOEL
(mg/kg bw d)
L Apples 0,421
Oxadiazon HERB
L Plums 1,154
0,1 0,004*
L Apples 0,060
L Cherries 0,137
L Pears 0,050
Paclobutrazol GR
L Plums 0,346
0,1 0,1*
L Apples 0,262
L Cherries 0,263
L Pears 0,325
Paraquat HERB
L Plums 0,254
0,005 0,0004
WSB Apples 0,006
L Apples 0,037 Penconazole FUNG
L Pears 0,014
0,035 0,7*
L Apples 0,740
L Cherries 0,930
L Pears 0,940
Pendimethalin HERB
L Plums 0,708
0,1 0,234
WG Apples 0,209
WG Cherries 0,288
WG Pears 0,204
Pirimicarb INSE
WG Plums 0,258
0,01 0,14*
Potassium hydrogen carbonate FUNG WP Apples 1,617 - -
Prohexadione-calcium GR WG Apples 0,080 0,1 0,35
L Apples 0,170
L Cherries 0,190
L Plums 0,488
WP Apples 0,298
WP Cherries 0,312
WP Pears 0,317
Propyzamide HERB
WP Plums 0,288
0,19 0,08
L Apples 0,084
Pyrifenox FUNG
L Pears 0,098
0,1 0,02
L Apples 0,206
Pyrimethanil FUNG
L Pears 0,378
0,2 0,6*
L Apples 0,456
Simazine HERB
L Pears 0,723
0,1 0,006
L Apples 0,121
Thiacloprid INSE
L Pears 0,124
0,01 0,02
WG Apples 0,014
Thifensulfuron-methyl HERB
WG Pears 0,024
0,1 0,07
WG Apples 1,536
Thiram FUNG
WG Pears 0,844
WG Apples 0,628
Tolylfluanid FUNG
WG Pears 0,713
0,1 0,02*
Triadimefon FUNG WP Apples 0,027 0,1 0,03
L Apples 0,064
L Cherries 0,070
L Pears 0,070
Triazamate INSE
L Plums 0,070
0,1 0,004
L Apples 0,333
L Pears 0,274 Triclopyr HERB
L Plums 0,720
0,1 0,05
Trifluralin HERB L Cherries 0,685 0,1 0,026
Vinclozolin FUNG L Apples 0,156 0,02 0,02
AC: acaricides; HERB: herbicides; FUNG: fungicides; INSE: insecticides; GR: growth regulators; * indicates
confidential values

The results are listed in Table VI.2.2 till VI.2.8. The output table should present both the RIs
when PPE is used and when no PPE is used. In Table VI.2.2 the risk is aggregated for
orchards and each subgroup of orchard. The aggregated risk per pesticide group is also listed.
The frequency of use for the year 2002 in the UK was calculated as described above. Only the
acute indicator results are presented.


103
Aggregation:
Different ways of aggregation are possible. Here, pesticide group aggregation and crop
aggregation is presented.

1. pesticide group aggregation for orchards (apple, pear, plum and cherry)

The results are presented in Table VI.2.2.
Table VI.2.2: pesticide group aggregation
Pesticide
Group
RI
median
(no PPE)
RI
median
(PPE)
F
RI*F
(no PPE)
RI*F
(PPE)
% of
total
Risk
% of total
Frequency
N active
substances
AC 5,40 1,22 9,57E+02 5,00E+04 1,13E+04 5,72 0,58 3
GR 0,34 0,08 1,25E+04 1,99E+03 4,48E+02 29,98 45,86 3
FUNG 0,82 0,18 7,59E+04 2,62E+05 5,91E+04 0,23 7,54 23
INSE 0,56 0,13 3,58E+04 7,67E+04 1,73E+04 55,31 24,37 11
HERB 1,80 0,41 4,03E+04 4,84E+05 1,09E+05 8,76 21,65 24
TOTAL 0,76 0,17 1,65E+05 8,76E+05 1,97E+05 100,00 100,00 64

2. crop group aggregation

The results are presented in Table VI.2.3 & VI.2.4.
Table VI.2.3: Crop group aggregation: Risk for all the studied active substances in apple, pear, plum and
cherry orchards
Crop Group
RI median
(no PPE)
RI
median
(PPE)
F
RI*F
(no PPE)
RI*F
(PPE)
% of
total
Risk
% of total
Frequency
Apple 0,70 0,16 1,36E+05 6,60E+05 1,48E+05 75,34 82,38
Pear 0,85 0,19 2,19E+04 1,74E+05 3,92E+04 19,91 13,23
Plum 1,73 0,39 4,46E+03 2,31E+04 5,19E+03 2,64 2,70
Cherry 2,10 0,47 2,79E+03 1,85E+04 4,17E+03 2,12 1,69
TOTAL 0,76 0,17 1,65E+05 8,76E+05 1,97E+05 100,00 100,00

Riskiest active substances:
The riskiest active substances can be identified by determining those substances that are
above the 95
th
percentile of the total risk. The riskiest active substances can also be given for a
particular crop group or a particular pesticides group.

Table VI.2.4 gives an example output table. Only the results for the case assuming no PPE is
worn are presented.

Table VI.2.4: The 10 riskiest active substances (above the 95
th
percentile of the total risk)
a.s. crop Pesticide group
RI
(no PPE)
RI x F
(no PPE)
Oxadiazon Apples HERB 60,19 2,01E+03
Simazine Pears HERB 68,90 4,89E+02
MCPA Cherries HERB 76,77 1,66E+03
Amitraz Pears AC 123,00 1,09E+04
Dinocap Apples FUNG 140,38 1,65E+04
Oxadiazon Plums HERB 164,92 3,33E+02
Dichlobenil Cherries HERB 193,22 2,02E+01
Dinocap Pears FUNG 250,00 1,50E+00
Copper sulphate Apples FUNG 308,57 5,61E+02
Dichlobenil Apples HERB 741,76 4,27E+02
104
Table VI.2.5 and VI.2.6 give additional information. Table VI.2.5 lists the frequency of
pesticide applications belonging to a particular risk category.
Table VI.2.5: Table showing the frequency for orchards for the two categories: requiring further
assessment and below the screening level (absolute and relative (%))
Category of Risk Frequency %
Risk below the
screening level
8,707E+04 55,00
Risk needing further
evaluation
7,13E+04 45,00
Combined 1,58E+05 100,00

To get an idea of the distribution of the RI values, it is useful to represent the results in a
probability density graph (see Figure VI.2.1).

Distribution of the risk for a farm worker in
orchards in the UK in 2002
0,00
0,10
0,20
0,30
0,40
0,50
]-3 -2] ]-2 -1] ]-1 0] ]0 1] ]1 2] ]2 3]
log RI
p
r
o
p
o
r
t
i
o
n

o
f

f
r
e
q
u
e
n
c
y

Figure VI.2.1: Probability density graph in order to show the distribution of the RI values for re-entry
workers in orchards in 2002.

For risk managers further analysis of the category Risk requiring further evaluationwill be
necessary. Risk managers should be able to identify the actives that are responsible for
driving the results. Therefore, a table should be generated in which the actives are listed
together with their frequency and risk index. For the given case-study, part of the list is
presented in Table VI.2.6.

Table VI.2.6: List of active substances belonging to the category Risk Requiring Mitigation
a.s. crop Pesticide group RI Frequency
Carbendazim Pears FUNG 1,04 1,87E+02
Myclobutanil Apples FUNG 1,08 8,15E+03
Fenbuconazole Cherries FUNG 1,13 2,23E+02
Isoxaben Apples HERB 1,16 2,39E+00
Tolylfluanid Apples FUNG 1,20 3,90E+03
Dodine Plums FUNG 1,30 2,19E+00

105
For all the risk events belonging to the category Risk resuiring further evaluation, the
influence of the use of PPE should be taken into account. Table VI.2.7 gives an overview of
the number of hectares (= frequency) belonging to each category of risk when PPE is taken
into account. It is assumed that a re-entry worker wears gloves.

Table VI.2.7: Table showing the frequency for orchards for the three categories of risk: requiring
further assessment and below the screening level (absolute and relative (%))
Category of Risk Frequency %
Risk below the screening level 8,707E+04 55,00
Risk acceptable using PPE 3,961E+04 25,02
Risk acceptable based on
refined evaluation setting of
restricted re-entry intervals
3,16E+04 19,99
Combined 1,58E+05 100,00

Table VI.2.8 lists the actives for which restricted re-entry intervals need to be set.

Table VI.2.8: List of active substances belonging to the category Risk Requiring the setting of re-entry
intervals for apple orchards.
a.s. Formulation Type Crop Pesticide group RI Frequency
Captan WP Apples FUNG 1,1340214 5,10E+03
Clofentezine L Apples AC 1,2155432 1,72E+02
Copper
oxychloride
L Apples FUNG 1,2950674 2,81E+03
Diquat L Apples HERB 1,4374466 3,27E+02
Triazamate L Apples INSE 2,0699136 2,84E+03
Mancozeb L Apples FUNG 2,2173274 1,59E+01
Copper
oxychloride
WP Apples FUNG 2,7130362 6,79E+02
Mancozeb WP Apples FUNG 3,9531918 3,55E+02
Glufosinate-
ammonium
L Apples HERB 4,1288703 1,90E+03
Paraquat L Apples HERB 4,2130586 1,01E+03
Mancozeb WG Apples FUNG 4,7092843 2,05E+02
Amitrole L Apples HERB 4,7766551 1,56E+03
Simazine L Apples HERB 9,7657872 5,60E+01
MCPA L Apples HERB 9,7752296 3,60E+03
Thiram WG Apples FUNG 9,8721443 2,43E+02
Diuron L Apples HERB 10,856529 2,42E+03
Oxadiazon L Apples HERB 13,54208 1,48E+02
Dinocap L Apples FUNG 31,58639 5,22E+02
Copper sulphate L Apples FUNG 69,428571 8,08E+00
Dichlobenil GR Apples HERB 166,89561 2,56E+00

In the UK restricted re-entry intervals are generally product-specific. They would only be set
where required by the nature of the product. Although it is considered to be good practice not
to re-enter the treated area until the applied product has dried (pers. communication J. Smith,
2006). Where a particular product does have specific re-entry requirements, including re-entry
intervals, this information would appear on the label.

106
Figure VI.2.2 shows the distribution of risk for a re-entry worker in orchards. The category of
risk needing further evaluation is split up according to the degree above which the trigger
value is exceeded.

Distribution of risk
0,000E+00
2,000E+04
4,000E+04
6,000E+04
8,000E+04
1,000E+05
1,200E+05
1,400E+05
1,600E+05
1,800E+05
F
r
e
q
u
e
n
c
y
2 orders of magnitude
above the trigger value
1 order of magnitude
above the trigger value
Above the trigger value -
same order of magnitude
Risk acceptable using
PPE
Risk below screening
level

Figure VI.2.2: Distribution of risk for re-entry workers in orchards



107
3. Bystander & Resident

Below, the same case-study as presented for the re-entry worker is worked out for the
bystander and for the resident.

CASE-STUDY

Structuring the query
Assessing the acute risk for bystanders and the chronic risk for residents in orchards (apple,
pear, plum and cherry) due to the application of all the active substances applied in orchards
in the UK during 2002. The same case-study could be worked out for another year(s) and in
this way the time trend risk could be graphically represented. The risk in one year can be
taken as a reference to benchmark the other risks against.

Pesticide usage data
Usage data regarding the application of the above listed active substances were provided by
Miles Thomas (HAIR work package 5). The relevant application events were ordered per
active and area treated. Data were provided for the whole of the UK.

Toxicological data
The AOEL values and the dermal absorption percentages were taken from the UGent database
and were obtained from the following sources (in order of importance):
1. European Union;
2. CTB The Netherlands (http://www.ctb-wageningen.nl/);
3. Pandoras Box (Linders et al., 1994);
4. The Pesticide Manual (Tomlin, 2004);
5. Extoxnet (http://extoxnet.orst.edu/);
6. Toxnet (http://toxnet.nlm.nih.gov/);
7. Other sources (confidential data; public in 2008).

Assumptions taken into account

1. Drift is calculated for the bystander as mentioned before, by applying the
following formula:
B
r
Drift A x f = (for x=0 to H)

The values for the different parameters are listed in Table VI.3.1.
Table VI.3.1: Input parameters for case-study on apple orchards in the UK specifically
for bystanders
Indicator parameter value unit
X 8 m
H (early) 11,4 m
A (early) 66,702 -
B (early) -0,752 -
Bystander
f
r
1 -
90
th
perc. Drift (50 m) early 0,30 %
82
th
perc. Drift (50 m) early 0.22 %
77
th
perc. Drift (50 m) early 0.19 %
74
th
perc. Drift (50 m) early 0.17 %
72
th
perc. Drift (50 m) early 0.17 %
70
th
perc. Drift (50 m) early 0,16 %
69
th
perc. Drift (50 m) early 0,16 %
Resident
67
th
perc. Drift (50 m) early 0,15 %
108
For the resident, drift values are taken from Table VI.3.1 (at 50 meter distance
from the field). The above formula was not used since the values for the
different parameters were not available. Only the output Drift values were
available;

2. EA = 0,4225 m/person/d;
3. WR = 15 ha/d;
4. ST = 24 min/ha;
5. I
a
(mg/kg a.s.) represents the potential inhalation exposure for operators during
application. Default values for this parameter were taken from the German
model. The value in bold was applied in this case-study;

The most widespread method of applying pesticides in apple orchards is by fan
assisted axial sprayers. The applied surrogate exposure values are the ones
listed in Table VI.3.2 (mechanical upwards spraying).
Table VI.3.2: Surrogate exposure values from the German Model
Crop Application technique Inhalation exposure I
a
(mg/kg a.s.)
Mechanical upwards 0,018
High crop
Hand-held 0,3
Field crop Mechanical downwards 0,001

6. The body weight is set to 70 kg.

Input data

Table VI.2.1 lists the input data for this case-study. The same input data were needed as in the
previous case-study worked out for the re-entry workers.

Results

Table VI.3.3 lists the RI values for the bystander and the resident for each active substance
applied in orchards (apple, cherry, pear & plum).


109
Table VI.3.3: Output for the Bystander and Resident case-study
as Function Formulation Crop RI bystander RI resident F
L Apples 0,007 8,27E-05 2,36E+03
L Cherries 0,008 9,30E-05 1,13E+01
L Pears 0,007 8,94E-05 6,17E+02
2,4-D HERB
L Plums 0,009 1,11E-04 6,01E+01
Amitraz AC L Pears 1,816 1,58E-02 3,93E+02
L Apples 0,317 5,71E-03 1,56E+03
L Cherries 0,673 1,25E-02 2,12E+01
L Pears 0,521 9,37E-03 3,64E+01
Amitrole HERB
L Plums 0,877 1,70E-02 3,58E+01
Asulam HERB L Apples 0,004 2,85E-05 1,18E+01
L Apples 0,011 1,45E-04 5,10E+03
Bupirimate FUNG
L Pears 0,010 1,83E-04 6,49E+01
WG Apples 0,056 9,14E-04 4,21E+03
WG Pears 0,076 1,09E-03 8,91E+02
WP Apples 0,074 1,20E-03 5,10E+03
WP Pears 0,094 1,49E-03 9,15E+02
Captan FUNG
WSB Apples 0,008 1,73E-04 1,86E+02
L Apples 0,012 2,80E-04 2,10E+03
L Pears 0,016 3,53E-04 1,87E+02
WG Apples 0,010 2,53E-04 3,25E+03
WG Pears 0,011 3,59E-04 7,88E+02
WP Apples 0,010 2,38E-04 1,75E+03
Carbendazim FUNG
WP Pears 0,011 2,37E-04 5,05E+02
Chlorine FUNG L Cherries - - 1,01E+01
L Apples 0,059 1,19E-03 7,48E+03
L Pears 0,053 1,00E-03 7,90E+02
L Plums 0,050 9,72E-04 5,41E+02
WG Apples 0,054 1,12E-03 1,44E+03
WG Pears 0,049 1,05E-03 1,53E+02
Chlorpyrifos INSE
WG Plums 0,063 1,32E-03 1,64E+02
L Apples 0,080 5,64E-04 1,72E+02
L Cherries 0,081 5,34E-04 2,62E+01 Clofentezine AC
L Pears 0,081 5,34E-04 5,36E+01
L Apples 0,001 5,40E-06 5,88E+00
L Pears 0,001 5,49E-06 2,23E-01 Clopyralid HERB
L Plums 0,002 1,00E-05 2,26E+00
L Apples 0,085 6,13E-04 2,81E+03
L Cherries 0,168 1,77E-03 2,19E+02
L Pears 0,113 1,03E-03 9,06E+02
L Plums 0,123 8,41E-04 7,68E+01
WP Apples 0,178 1,65E-03 6,79E+02
WP Cherries 0,151 1,54E-03 3,23E+01
WP Pears 0,055 9,51E-04 4,28E+02
Copper oxychloride FUNG
WP Plums 0,253 1,66E-03 1,36E+01
Copper sulphate FUNG L Apples 4,557 4,11E-02 8,08E+00
L Apples 0,002 3,18E-05 2,51E+02
L Cherries 0,002 9,65E-06 7,17E+01
L Pears 0,002 1,09E-05 4,64E+02
Cypermethrin INSE
L Plums 0,002 3,09E-05 7,96E+01
L Cherries 0,006 4,74E-05 1,01E+01
L Pears 0,010 6,41E-05 4,07E+01 Deltamethrin INSE
L Plums 0,022 2,03E-04 1,34E+01
L Apples 2,02E-05 3,90E-07 3,20E+03
L Cherries 3,44E-05 6,13E-07 9,52E+01
L Pears 1,85E-05 3,71E-07 5,08E+02
Dicamba HERB
L Plums 1,61E-05 2,97E-07 3,86E+01
GR Apples - - 2,56E+00
Dichlobenil HERB
GR Cherries - - 4,64E-01
L Apples 0,003 2,95E-05 4,00E+02
L Cherries 0,002 1,56E-05 1,01E+00
L Pears 0,004 3,16E-05 1,46E+02
Dichlorprop-P HERB
L Plums 0,002 1,43E-05 5,61E+00
L Apples 0,056 5,08E-04 3,21E+02
L Pears 0,059 4,81E-04 2,30E+02
L Plums 0,058 4,61E-04 1,73E+02
Diflubenzuron INSE
WP Pears 0,030 2,00E-04 1,48E+01
AC: acaricides; HERB: herbicides; FUNG: fungicides; INSE: insecticides; GR: growth regulators
* indicates confidential values
110
Table VI.3.3: Output for the Bystander and Resident case-study
as Function Formulation Crop RI bystander RI resident F
L Apples 2,073 1,87E-02 5,22E+02
Dinocap FUNG
L Pears 3,692 7,76E-02 2,67E-02
L Apples 0,095 1,81E-03 3,27E+02
L Cherries 0,128 2,27E-03 9,78E+00
L Pears 0,090 1,71E-03 1,61E+01
Diquat HERB
L Plums 0,089 1,70E-03 4,20E+01
L Apples 0,005 2,63E-04 7,62E+03
Dithianon FUNG
L Pears 0,006 3,07E-04 1,56E+03
L Apples 0,713 5,36E-03 2,42E+03
L Cherries 0,359 2,36E-03 3,13E+01
L Pears 0,800 5,85E-03 2,30E+02
Diuron HERB
L Plums 0,436 3,45E-03 6,16E+01
L Apples 0,033 3,31E-04 8,59E+02
L Pears 0,035 3,19E-04 1,31E+02 Dodine FUNG
L Plums 0,019 1,26E-04 2,19E+00
L Apples 0,010 1,06E-04 1,30E+03
L Cherries 0,017 1,26E-04 2,23E+02
L Pears 0,012 8,85E-05 5,76E+02
Fenbuconazole FUNG
L Plums 0,015 1,11E-04 3,90E+02
WG Cherries 0,035 2,30E-04 2,72E+02
Fenhexamid FUNG
WG Plums 0,031 2,08E-04 2,09E+02
WG Apples 0,002 1,52E-05 4,28E+03
WG Pears 0,002 1,92E-05 9,88E+02 Fenoxycarb INSE
WP Pears 0,002 9,37E-06 1,33E+01
Fenpyroximate AC L Apples 0,014 1,05E-04 3,12E+02
L Apples 0,001 9,00E-06 2,31E+02
Fluroxypyr HERB
L Pears 0,001 3,96E-06 7,85E+01
Fosetyl-aluminium FUNG WG Apples 2,790E-04 2,52E-06 2,49E-01
GR Cherries - - 2,98E+01
GR Pears - - 1,33E+02
L Apples - - 5,50E+03
L Cherries - - 3,05E+01
Gibberellins GR
L Pears - - 1,14E+03
L Apples 0,271 1,88E-03 1,90E+03
L Cherries 0,262 1,97E-03 1,36E+02
L Pears 0,245 2,01E-03 5,49E+02
Glufosinate-ammonium HERB
L Plums 0,234 1,62E-03 4,06E+02
L Apples 0,007 7,48E-05 8,21E+03
L Cherries 0,009 8,68E-05 3,04E+02
L Pears 0,008 7,67E-05 1,55E+03
Glyphosate HERB
L Plums 0,007 7,05E-05 6,51E+02
Imidacloprid INSE WG Plums 0,002 1,50E-05 1,13E+01
L Apples 0,017 1,13E-04 2,39E+00
L Cherries 0,003 1,92E-05 1,06E+01 Isoxaben HERB
L Plums 0,002 1,17E-05 9,67E+00
WG Apples 0,001 8,05E-06 4,66E+03
Kresoxim-methyl FUNG
WG Pears 0,001 6,17E-06 5,91E+00
Lambda-cyhalothrin INSE L Pears 0,001 5,28E-05 2,55E+02
L Apples 0,146 1,31E-03 1,59E+01
WG Apples 0,309 3,15E-03 2,05E+02
WG Pears 0,467 4,18E-03 4,95E+02
MCPA FUNG
WP Apples 0,259 1,92E-03 3,55E+02
WP Pears 0,414 5,71E-03 7,08E+02
L Apples 0,642 5,26E-03 3,60E+03
L Cherries 1,134 7,46E-03 9,62E+01
L Pears 0,556 4,33E-03 6,51E+02
Mancozeb FUNG
L Plums 0,498 3,57E-03 4,42E+01
L Apples 0,034 2,54E-04 3,60E+03
L Cherries 0,048 2,83E-04 9,62E+01
L Pears 0,037 3,01E-04 6,51E+02
Mecoprop-P HERB
L Plums 0,025 1,63E-04 4,42E+01
L Apples 0,008 7,07E-05 6,13E+03
L Cherries 0,014 8,97E-05 2,98E+01 Methoxyfenozide INSE
L Pears 0,008 5,74E-05 6,29E+02
Metsulfuron-methyl HERB WG Pears 2,920E-05 1,92E-07 1,53E+01
L Apples 0,016 2,80E-04 8,15E+03
L Cherries 0,031 2,29E-04 2,81E+02
L Pears 0,013 1,83E-04 4,27E+02
Myclobutanil FUNG
L Plums 0,023 2,62E-04 4,54E+02
AC: acaricides; HERB: herbicides; FUNG: fungicides; INSE: insecticides; GR: growth regulators; * indicates
confidential values
111
Table VI.3.3: Output for the Bystander and Resident case-study
as Function Formulation Crop RI bystander RI resident F
L Apples 0,889 5,85E-03 1,48E+02
Oxadiazon HERB
L Plums 2,436 1,60E-02 8,96E+00
L Apples 0,005 1,06E-04 4,79E+03
L Cherries 0,012 7,71E-05 2,46E+01
L Pears 0,004 8,09E-05 7,62E+02
Paclobutrazol GR
L Plums 0,029 1,94E-04 5,25E+01
L Apples 0,283 8,60E-03 1,01E+03
L Cherries 0,284 8,51E-03 3,81E+01
L Pears 0,351 1,06E-02 1,82E+02
Paraquat HERB
L Plums 0,274 8,84E-03 1,13E+02
L Apples 1,549E-04 2,57E-06 6,48E+03
L Pears 5,803E-05 5,98E-07 1,29E+02 Penconazole FUNG
WSB Apples 2,624E-05 6,31E-07 1,86E+02
L Apples 0,027 1,78E-04 1,26E+03
L Cherries 0,034 2,21E-04 2,37E+02
L Pears 0,034 2,23E-04 2,05E+02
Pendimethalin HERB
L Plums 0,026 1,68E-04 3,06E+02
WG Apples 0,001 2,27E-05 9,55E+02
WG Cherries 0,002 3,58E-05 3,24E+02
WG Pears 0,001 2,22E-05 3,72E+02
Pirimicarb INSE
WG Plums 0,002 2,80E-05 2,89E+02
Potassium hydrogen carbonate FUNG WP Apples - - 2,45E+02
Prohexadione-calcium GR WG Apples 0,002 2,19E-05 1,43E+01
L Apples 0,034 2,03E-04 5,85E+01
L Cherries 0,038 2,28E-04 2,98E+01
L Plums 0,098 5,85E-04 3,09E+01
WP Apples 0,060 3,57E-04 1,11E+03
WP Cherries 0,062 3,74E-04 7,59E+01
WP Pears 0,064 3,80E-04 1,53E+02
Propyzamide HERB
WP Plums 0,058 3,46E-04 1,29E+02
L Apples 0,035 2,44E-04 6,49E+01
Pyrifenox FUNG
L Pears 0,041 2,72E-04 7,22E+00
L Apples 0,006 5,35E-05 3,76E+03
Pyrimethanil FUNG
L Pears 0,011 1,14E-04 1,13E+01
L Apples 0,641 4,22E-03 5,60E+01
Simazine HERB
L Pears 1,018 6,70E-03 3,15E+01
L Apples 0,005 9,95E-05 6,43E+03
Thiacloprid INSE
L Pears 0,005 9,40E-05 2,02E+01
WG Apples 0,002 1,14E-05 1,24E+01
Thifensulfuron-methyl HERB
WG Pears 0,003 1,87E-05 1,53E+01
WG Apples 0,648 5,25E-03 2,43E+02
Thiram FUNG
WG Pears 0,356 5,14E-03 1,76E+02
WG Apples 0,018 1,65E-04 3,90E+03
Tolylfluanid FUNG
WG Pears 0,020 1,97E-04 8,87E+02
Triadimefon FUNG WP Apples 0,008 5,07E-05 4,92E-01
L Apples 0,136 1,10E-03 2,84E+03
L Cherries 0,148 9,72E-04 2,56E-02
L Pears 0,148 1,18E-03 2,67E-02
Triazamate INSE
L Plums 0,148 9,72E-04 4,42E-02
L Apples 0,056 3,70E-04 7,19E+00
L Pears 0,046 3,05E-04 1,09E+00 Triclopyr HERB
L Plums 0,122 8,00E-04 2,26E+00
Trifluralin HERB L Cherries 0,222 1,46E-03 1,01E+01
Vinclozolin FUNG L Apples 0,013 1,86E-04 1,02E+02
AC: acaricides; HERB: herbicides; FUNG: fungicides; INSE: insecticides; GR: growth regulators; * indicates
confidential values

112
Aggregation
The results are listed in Table VI.3.4. Table VI.3.4 mentions a few statistical parameters
which reflect the distribution of the risk for bystanders in orchards. It is obvious that the same
graphs as presented for the other indicators can alos be made for this case-study.

Table VI.3.4: Output for the Bystander case-study
Crop
apple pear plum cherry All orchards
Median RI 0,017 0,025 0,031 0,036 0,031
95
th
percentile 0,706 0,854 0,649 0,563 0,803
Min of RI values 2,017E-05 1,850E-05 1,610E-05 3,443E-05 1,610E-05
Max of RI values 4,557 3,692 2,436 1,134 4,557
Total F (number of
ha of treated area)
1,363E+05 2,189E+04 4,462E+03 2,788E+03 1,654E+05
ha with RI> 95
th

percentile
6,78E+02 4,25E+02 4,47E+01 9,62E+01 1,24E+03
% ha with RI> 95
th

percentile
0,497 1,942 1,002 3,451 0,750
% ha with RI> 1 0,389 1,941 0,201 3,452 0,641
Total RI (Sum) 13,042 11,508 4,000 6,033 34,584
Sum (RI x F) 9,73E+03 2,58E+03 3,42E+02 2,75E+02 1,29E+04

Riskiest active substances:

The riskiest active substances can be identified by determining those substances that are
above the 95
th
percentile of the total risk. The riskiest active substances can also be given for a
particular crop group or a particular pesticides group. Here the riskiest active substances are
given for orchards in general. These actives are classified by their risk index without taking
the frequency (equals the number of hectares into account).

Table VI.3.5 gives an example output table.

Table VI.3.5: The riskiest active substances (above the 95
th
percentile of the Risk Index values = 1,06) in
orchards
a.s. crop
Pesticide
group
RI F RI x F
Simazine Pears HERB 1,08 3,15E+01 3,39E+01
Mancozeb Pears FUNG 1,14 7,08E+02 8,04E+02
MCPA Cherries HERB 1,20 9,62E+01 1,15E+02
Amitrole Plums HERB 1,38 3,58E+01 4,93E+01
Amitraz Pears AC 1,92 3,93E+02 7,56E+02
Dinocap Apples FUNG 2,19 5,22E+02 1,14E+03
Oxadiazon Plums HERB 2,58 8,96E+00 2,31E+01
Dinocap Pears FUNG 3,91 2,67E-02 1,04E-01
Copper
sulphate
Apples FUNG 4,82 8,08E+00 3,89E+01

When the frequency would be taken into account, the following classification of active
substances would be obtained (Table VI.3.6):
113

Table VI.3.6: The active substances having the highest risk when the frequency is taken into account
(above the 95
th
percentile of the RI x F values = 5,47E+02) in orchards)
a.s. crop
Pesticide
group
RI F RI x F
Paraquat Apples HERB 0,60 1,01E+03 6,07E+02
Chlorpyrifos Apples INSE 0,09 7,48E+03 6,94E+02
Amitraz Pears AC 1,92 3,93E+02 7,56E+02
Amitrole Apples HERB 0,50 1,56E+03 7,76E+02
Mancozeb Pears FUNG 1,14 7,08E+02 8,04E+02
Captan Apples FUNG 0,20 5,10E+03 1,04E+03
Dinocap Apples FUNG 2,19 5,22E+02 1,14E+03
Diuron Apples HERB 0,75 2,42E+03 1,82E+03
MCPA Apples HERB 0,68 3,60E+03 2,44E+03

114
VII. Prioritisation of actions for reducing pesticide impact

In the following chapter several mitigation measures to reduce occupational exposure to
pesticides are described and quantitatively evaluated. Examples have been worked out for
standard treatment schemes for potatoes and apple orchards (see Annex X). Quantitative
assessment of the impact of reduction measures is very important for prioritizing the actions
to be implemented in reduction plans for pesticides. Such assessments are difficult to conduct
since for most reductive actions, quantitative data concerning their impact are lacking.

Reducing risk, either the hazard or the exposure, needs a systematic approach or a strategy in
which four levels of action can be distinguished on descending preference of action (Brouwer
et al., 1994). The first level of action is the reduction or elimination of the source. This can be
done by substitution of the pesticide either by less hazardous pesticides or by pesticides with
lower application rates or a combination of both. The second level is reduction of exposure by
replacement or modification of processes or equipment, by processes which result in lower
exposures. Moreover, a critical review of working methods may result in improvement
regarding exposure reduction. Examples are other application techniques, e.g. more
mechanized low-volume spraying, and mechanical clod breaking in stead of manual clod
breaking during harvesting. The third level is related to the organisation of the work and the
work practice. Reducing duration of task performance will reduce exposure time. Secondly
date and frequency of application affect the total amount applied (and total exposure of the
operator). In this way the total amount of foliar residue is also affected as well as the location
of the residue in the crop. Brouwer et al. (1994) showed that after an application in the last
growth stages the increase of foliar residue in the lower zone after application is very limited,
whereas a significant decline of the residue, possibly due to degradation but certainly due to
growth dilution can be observed. This means that only pesticides which are stable and applied
in the early stage of growth will be found on the crop during harvesting. When a pesticide is
applied in the last stage of growth, however, the residue will be found in the upper zone of the
crop. The fourth level with lowest preference is personal protection, but this option often
offers the only possibility to reduce exposure. However, personal protective equipment has to
be fitted to the hazard, therefore nature and level of exposure have to be known in order to
select appropriate and comfortable equipment for performance of the task (Brouwer et al.,
1994). For operators and re-entry workers priority has to be given to protection of the hands.
Protective gloves (nitrile for the operator and cotton for the harvester) may reduce actual
exposure significantly since no permeation and low penetration (<5%) has been observed in
laboratory studies (Van Kaayk & Lalleman, 1993).


115
1. Pesticide operator

Introduction

Pesticide operators are as mentioned before persons who mix, load and apply pesticides. Since
pesticide handlers work with the concentrated product, exposure during mixing and loading
can form an important part of the total exposure. Even if the exposure during mixing and
loading is relatively brief in comparison with the application, the preparation can contribute to
more than 50% of the total potential exposure at the time of a pesticide treatment (Vercruysse,
2000). In field crops, risk of contamination is 10 times higher during mixing/loading than
during application (Jadin & Marot et al., 2004). Operators are not only exposed to pesticides
during mixing, loading and spraying of pesticides, but also during seed treatment, application
of granules, dipping into a pesticide solution or pouring a pesticide solution onto plants
(Vercruysse & Steurbaut, 2002).

The major routes of exposure are through inhalation and dermal absorption (Lundehn et al.,
1992). The oral exposure in agriculture is of a minor importance when appropriate hygienic
measures are taken (van Hemmen, 1992). In addition, uptake through the eyes is possible
when pesticides splash up. This mainly occurs during mixing and loading activities (van
Hemmen, 1993).

Factors influencing exposure

Various factors that can effect dermal and inhalation exposure in different agricultural settings
are mentioned in the scientific literature. The most important parameters are listed below (van
Hemmen, 1992; Franklin & Worgan, 2005):

Formulation type: liquids, such as emulsifiable concentrate (EC) solutions and
aqueous suspensions are prone to splashing and occasionally spillage, resulting in
permeation of clothing and skin contact. Solids, such as wettable powders (WPs),
granules and dusts, may present a plume of dust while being loaded into application
equipment, so producing both a respiratory hazard and exposure to the face and eyes.
Some newer waterdispersable granules (WG) have been formulated to drastically
reduce this potential exposure;
Type of equipment used;
Task being performed;
Duration of activity: in addition to measuring the unit exposure for a worker on a
daily basis for a particular scenario, exposure and risk assessment requires knowledge
and characterization of the frequency and duration of exposure, both on a seasonal and
lifetime basis;
Amount of pesticide handled;
Packaging: the opening of bags, depending on type, may result in significant
exposure. The size of cans, bottles or other liquid containers may affect the potential
for spillage and splashing;
Environmental conditions: climatological factors, such as temperature and humidity,
may influence chemical volatility, perspiration rate and use of protective clothing.
Wind can have a profound effect on spray drift and resultant operator exposure;
116
Personal protective equipment: protective clothing, such as chemical-resistant
gloves, coveralls and respiratory protection (masks) can dramatically reduce skin
contact and inhalation exposure;
Hygienic behaviour: worker care with regard to pesticide handling can also have
substantial impact on exposure. Proper use and maintenance of protective clothing are
very important with regard to reduced pesticide exposures.

Specific exposure mitigation measures

Once the risk factors have been identified, it may be necessary to reduce exposure levels. This
entails exploring options for reducing exposure and recalculating the risks to see if they are
within an acceptable range. To reduce the exposure risk, measures that affect above
mentioned factors can be taken. The options range from (Brouwer et al., 1994; Franklin &
Worgan, 2005):

Replacing pesticides by less toxic ones;
Using lower dose rates;
Limiting the amount of pesticides that can be sold;
Limiting the use of certain products;
Using improved lower exposure formulation types (low emission formulations (e.g.
dry flowables, micro-encapsulated products) and packaging (use of dissolvable
sachets and ready to use packaging, these avoid opening the packaging and the
transfer of parts of the content);
Restricting the type of equipment that could be used to load and apply pesticides;
Requiring applicators to use closed-cab systems (closed-mixing loading systems
(Such a system demands packaging that can be fitted by couplings to the spraying
tank. No separate transport of the formulation from the package to the tank is needed.
Such a system could reduce exposures associated with mixing/loading up to 90-95%
(Hall, 1990)), closed cabs for application equipment);
Requiring applicators to use personal protective equipment;
Requiring appropriate hygienic behaviour of the applicators.

Regulatory agencies may also restrict the use of pesticides to trained certified applicators or
might require that registrants implement a product stewardship programme. It must be
determined whether the risk mitigation options selected are feasible and whether compliance
can be enforced. Another significant consideration is that several actions demand considerable
investments of the farmers and are unlikely to be accepted if the cost exceeds the economic
surplus (HEEPIBEE, 2006).

Control or mitigation strategies for occupational exposure are normally expressed as a
hierarchy, with engineering controls considered to be the first choice, administrative controls
the second choice and personal protection a choice of last resort (Franklin & Worgan, 2005).
This approach has a sound basis in industrial hygiene practice and is outlined explicitly in the
U.S. Occupational Safety and Health Act of 1970. For pesticide handlers, however, this
approach has not been adopted routinely. Rather, regulatory agencies worldwide have relied
heavily on chemical protective clothing to mitigate exposure, and have made the use of such
clothing a legal requirement for many compounds (U.S. EPA, 1992b; Easter & Nigg, 1992).
While this is a sensible interim strategy, it should not be considered an adequate long-term
control strategy for worker protection. Further efforts are needed to improve equipment
117
design, application procedures and pesticide formulations in order to reduce exposures.
Additionally, substitution of less hazardous compounds for pest control is certainly an
effective means of preventing health risks for pesticide handlers.

Following, several aspects are discussed more into detail:

Choice of the product
The product's choice determines the risk for the operator to a considerable extent. When
alternatives exist, these should be taken into consideration. To reduce their health hazard,
farmers may choose less harmful and less persistent products (with lower acute and chronic
toxicities). However in Belgium, only 7% of the fruit growers, 4% of the vegetable growers
and 5% of the field crop farmers consider user toxicity as a determinant factor for product's
choice (Marot et al., 2003; Jadin & Marot et al., 2004). Moreover, the knowledge of the
danger pictograms and of the risk sentences is very important. A survey carried out in 2003 in
the Walloon Brabant region showed that more or less one out of two farmers did not know the
significance of the pictograms present on the label (Jadin & Marot et al., 2004). Suppression
or use restrictions for the most harmful pesticides may be considered. Impacts on the
applicator's health of such measures depend on the considered pesticide.

Formulation type
WP formulations are particularly hazardous for pesticide operators. A Belgian study showed
that respiratory exposure during the handling of wettable powder (WP) formulations is 3 to 5
times greater than handling other formulations such as liquid formulations like emulsifiable
concentrates (EC) and soluble concentrates (SC) and waterdispersable granules (WG)
(University-Nebraska-Lincoln, 2005; Vercruysse & Steurbaut et al., 1999a). Moreover,
Vercruysse (2000) showed that the potential exposure of the hands during mixing and loading
coming from WP formulations is greater compared to that associated with liquid formulations.
Dermal exposure during handling of WP (wettable powder) formulations was very high: more
than tenfold the exposure of liquid formulations (SC) or granules (WG) (Vercruysse, 2000).
However, according to the University of Nebraska-Lincoln (2005), the skin is prone to
absorption of liquid formulations such as emulsifiable concentrates.

Since WP formulations give rise to an average tenfold higher exposure risk (Vercruysse,
2000) (see Figure VII.1.1), farmers should opt to reduce the use of WP formulations. Liquids
can be applied instead. However, the use of liquids leads to higher hazards due to the
possibility of splashing. Also the presence of organic solvents in some liquid formulations
(like EC) favour dermal absorption, and thus enhance the potential health risk for pesticide
operators. Wettable granules (WG) overcome the problems mentioned for liquids, moreover
they create less airborne dust than WP formulations (Vercruysse & Steurbaut et al., 1999a;
Marquart & Brouwer et al., 2003).
118
Attention has been paid to the development of safe formulations. With respect to exposure
during mixing/loading the pre-measured single dose products, or low emission formulations
(e.g. dry flowables, micro-encapsulated products) have the advantage that weighing can be
omitted and exposure during this activity can be limited. Micro-emulsions and suspo-
emulsions tend to enable the farmer to facilitate the application of multiple active ingredients
(Brouwer et al., 2001).

Figure VII.1.1: Potential dermal exposure via the hands during mixing-loading
(Jadin, Marot et al. 2004; Vercruysse 2000)

Equipment used
Since spray application has been labeled the least efficient industrial process on earth
(Rutherford, 1985), many efforts have been made to improve the efficiency and thus reduce
off-target emission to the environment. Operational efficiency has been improved by spray
volume reduction and computerized aids for calibration and delivery, whereas controlled
droplet application, electrically charged sprays, controlled release of pesticides, and dose
targeting are examples of optimization of pesticide use (Brouwer et al., 2001). In
greenhouses, the isolation of the emission during application can be achieved by enclosure of
the source in combination with automatic application techniques, e.g. low-volume misters, or
thermal vaporizers (e.g. for sulphur), however exposure during re-entry is likely to occur.
Reduction of exposure can also be achieved by the use of (semi-) automatic application
techniques (e.g. thermal pulse foggers, air assisted rotary disc misters) or remote controlled
techniques (e.g. spray tree). Because most of these techniques generate fine droplets decrease
of dermal exposure will sometimes be associated with increase of inhalation exposure.
Methner & Fenske (1994) demonstrated that directional ventilation, and training of spray
operators in greenhouses significantly decreases dermal exposure.

Farmers should be required to use spraying equipment that has a wash-hands can and pure
water supply in order to allow rinsing in case of accidents (CRP, 2004). Safety procedures
should be available, visible and explained (CRP, 2004). And farmers should be stimulated to
use closed-cab systems or systems equipped with a filter, which significantly reduces
operator exposure (CRP, 2004; Jadin & Marot et al., 2004). Vercruysse (2000) has shown that
orchard spraying without cab leads to a fivefold higher inhalation exposure. On the other
hand, field crop spraying with a closed cab or with a semi-open cab leads to a same range of
exposure. It is better to use a cab equipped with a filter for aerosols, dusts and vapours. The
filters must also be changed regularly.
119
Use of Personal Protective Equipment (PPE)
Reference to PPE may be found on the product label. It is essential to adhere to label
instructions regarding correct use of PPE. All PPE should be conform current standards
(CSIRO 2002).

In practice, protection of the applicator answers to a compromise between comfort and
protection. In Belgium for example, the use of PPE is very poorly adopted by the field crop
farmers with little less than 50% wearing no PPE. The field crop farmers score very badly
compared to vegetable and fruit growers (13% of the fruit growers and 11% of the vegetable
growers do not wear any PPE) (Marot et al., 2003; Maraite & Steurbaut et al., 2004).

Gloves
Wearing gloves can substantially reduce exposure with slight discomfort, since during mixing
and loading activities 80 to more than 95% of the contamination occurs via the hands
(Vercruysse, 2000). The gloves must be resistant to chemicals, leather, latex or PVC gloves
are not appropriate. Wearing nitrile rubber gloves allows a reduction of more than 99% during
mixing and loading and of 75% during application (CRP, 2004; Vercruysse, 2000). A study
performed in France with Regent 800WG showed that the exposure ranges from 107% of
the AOEL to 61% of the AOEL when wearing gloves (Arnich & Cervants et al., 2005).

Mask
Wearing a mask is recommended during mixing/loading as well as during the application,
particularly when handling powder formulations or when spraying in orchards. If the tractor's
cab is equipped with an activated carbon filter, it is not necessary to wear a mask. It is
considered that a half mask is enough if it is equipped with filters for gas and dust and
accompanied by goggles. Masks of A2B2P3 type offer a protection up to 99,9% The
replacement of the filter must be regular (CRP, 2004; PHYTOFAR & CRP et al. 2006; Jadin
& Marot et al., 2004).

Goggles
Some products are corrosive or irritating. The wearing of goggles protects the applicator
against ocular damage from splashes of such products (CRP, 2004).

Boots
Wearing boots is also recommended. The boots must be resistant to the pesticides applied
(CRP, 2004).

Coverall
The wearing of a disposable or re-usable coverall is essential, but sometimes not very
comfortable. The coverall should comply with current standards.

The penetration of pesticides through a cotton coverall can reach more than 20%. This is quite
a lot compared to a waterproof (PVC or PA) coverall which has less than 0,5% penetration.
However, a cotton coverall offers an average reduction of potential dermal exposure during
application of 63%. Even if not totally protective, it offers satisfactory protection for
application of less hazardous pesticides. Moreover the use of a cotton coverall is associated
with less discomfort. However, since trace amounts of pesticide residues cannot be removed
from cotton coveralls, they should be replaced frequently (Fishel, 2006; CRP, 2004;
Vercruysse, 2000; Jadin & Marot et al., 2004).

120
Figure VII.1.2 shows the difference in operator risk due to difference in formulation type and
PPE used.

Risk for an operator applying mancozeb in function of the PPE used and the formulation type
applied
0
10
20
30
40
50
60
70
80
SC WG WP
Formulation type
R
i
s
k
coverall
gloves
gloves+coverall
mask
mask+gloves
mask+gloves+coverall
no PPE
Figure VII.1.2: Risk for an operator applying mancozeb in function of the PPE used and
the formulation type applied (Jadin, Marot et al., 2004)

Hygienic behaviour
All equipment, clothing, gloves, boots, goggles and masks should be thoroughly washed with
soap and water (CSIRO, 2002). Indeed, an influence of maintenance, cleaning and changing
of (protective) clothing or gloves on dermal exposure is to be expected (Marquart & Brouwer
et al., 2003). After application the pesticide handler should wash his hands with water and
soap and should have a shower (PHYTOFAR & CRP et al., 2006).

As a conclusion it can be noted that improvement of farmers' behaviour with regards to
pesticide handling and wear of protective items offers prospects of significant reduction of
pesticide impact on the applicator.

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2. Re-entry worker

Agricultural workers are potentially exposed to pesticide residues when they enter pesticide
treated fields to perform a variety of manual labour tasks, such as pruning, thinning, scouting
and harvesting, required for the agricultural production of crops. These exposures can occur in
different crops throughout the growing season and can be of similar magnitude to exposures
of workers who mix, load and apply pesticides (Worgan & Rosario, 1995).

The practical options for managing exposures through the use of personal protective
equipment or engineering controls are considerably more limited for re-entry workers than for
mixer/loaders and applicators. The establishment of restricted entry intervals (REIs), which
are intended to provide sufficient time for pesticide residues to degrade to a safe level before
allowing unprotected workers to enter a field, is the primary method for managing post-
application exposures (Worgan & Franklin, 2005). Thus a REI is the minimum time (hours or
days) following application of a pesticide at which workers may re-enter agricultural fields.
REIs are established by determining the time at which the daily exposure for a given work
activity and dislodgeable foliar residue (DFR) level is equal to an established safe level for the
pesticidal active ingredient in question. Thus a suitable REI is derived on the basis of
representative dissipation studies of the active on the foliage. This determines the decrease in
exposure (thus risk) as a function of time after application. The DFR represents the potentially
available pesticide residue with which the worker may come in contact. A suitable re-entry
interval should be derived on the basis of representative dissipation studies of the a.s. on
foliage. This determines the decrease in exposure (thus risk) as a function of time after
application. Reorganising work practice, e.g. by control of the frequency of application as a
part of the Integrated Pest Management (IPM) approach, or by timing the application,
especially the final application prior to harvesting, re-entry exposure can be reduced due to
optimization of the interval between the last application and harvesting (or other crop
activities) (Brouwer et al., 2001).

Dermal exposure due to re-entry activities is strongly determined by the level of DFR. In
addition, a significant relationship between application rate and the increase in DFR has been
observed, whereas the relationship between the initial level of DFR (after application) and
actual DFR during re-entry is determined by the half-life of the pesticide. Thus, reduction of
the initial DFR and/or reduction of the actual level of DFR are key issues for exposure control
during re-entry. Reduction of the initial DFR can be achieved by the use of narrow-band
active substances that usually imply low application rates compared to wide band pesticides
primary introduced on the market. Selection of active substances with relative short half-lives
will affect the actual level of DFR during re-entry (Brouwer et al., 2001).

The formulation may also affect exposure, since for example the transfer of residues from
field strengths dust on the foliage to hands during harvesting tended to be more efficient
compared to residues of other kinds of pesticide formulations (Brouwer et al., 2001).

Automation of re-entry activities has also been effective for reduction of re-entry exposure.
The use of so-called drive-in vessels in combination with containers resulted for bulb
disinfection in significant lower exposure than manually dipping of bulbs in baskets. Another
example of automation is mechanical clod-removal which results in significant lower
exposures compared to scenarios where clod removal was performed manually (Brouwer et
al., 2001).

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For reducing inhalation exposure in greenhouses, low-volume applications can be used or
ventilation can be performed for a substantially long period (Brouwer et al., 2001).

The use of PPE is another option to reduce re-entry exposure. However, there is a major data
gap concerning the degree of penetration of pesticide residues through clothing following
contact with treated crop foliage (Worgan & Rosario, 1995). Under hot and humid working
conditions, penetration of pesticide residues through clothing may be enhanced by dampening
of the clothing with sweat (Raheel, 1991) and/or plant juices generated by contact or certain
work activities.

To conclude one can say that there are a limited number of ways to mitigate the risk
associated with worker re-entry exposure. As noted above, the REI, which is the time between
pesticide application and re-entry contact with treated foliage, is the major mechanism for
protecting workers from undue risk. PPE has an important impact in reducing the dermal
absorbed dose.

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3. Bystander/Resident

Introduction

Bystander exposure will mainly occur by contact with spray drift during application processes
in the field. Bystander exposure when spraying greenhouse crops and when applications are
performed with treated seeds, granules, plants dipped in a pesticide solution or when a
pesticide solution is poured onto the plant, is considered negligible (Vercruysse & Steurbaut,
2002). Although complete elimination of spray drift is very difficult, its magnitude can be
reduced significantly if factors which enhance creation of drift can be altered or eliminated.
Reducing spraying applications by applying treated seed or granules instead, can also
contribute to a lower bystander exposure.
Factors influencing exposure

In what follows a brief overview is presented of factors which may have an impact on the
exposure of bystanders.

Since bystander exposure mainly occurs due to spray drift, all the factors influencing drift will
have an impact on the former. The literature about spray drift is very abundant. In 2004 in
Belgium, more specifically in Flanders, an extensive literature review was conducted by the
Centrum voor Landbouwkundig Onderzoek in Merelbeke, Departement voor
Gewasbescherming, Universiteit Gent and Departement voor Agrotechniek en Economie,
Katholieke Universiteit Leuven (Het belang van drift en haar reducerende maatregelen ter
bescherming van het milieu in Vlaanderen) (Nuyttens et al., 2004).

A number of factors influence drift, including weather conditions, (relative wind speed, wind
direction, humidity and temperature), topography, the crop (stage of crop development and
canopy geometry and density) or area being sprayed, the application equipment (sprayer type,
nozzle type) used and the methods (formulation, direction and height of release, fan speed,
sprayer speed, spraying pressure) applied. Decisions (time and number of applications) taken
by the applicator also play a role (Meli et al., 2003).

Several inter-related factors affecting pesticide drift and deposition are listed in Table VII.3.1.
A brief discussion of each of these parameters follows in order to give an indication of
bystander exposure reduction possibilities.

Table VII.3.1: Inter-related factors affecting pesticide drift and deposition (Landers & Farooq, 2004)
Operator Care
& skill
Spraying
Equipment
Application
parameters
Target Weather
skill Design application rate variety wind speed
attitude Droplet size nozzle orientation canopy structure wind direction
Fan size forward speed area
Ambient
temperature
Air volume
Volatility of
spraying liquid
every row Relative humidity

Air velocity and
direction
Formulation type alternate row
Atmospheric
turbulence intensity
Time of application
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The factors influencing drift are usually grouped into five categories, which are briefly
discussed below:

Operator care and skill
In all discussions about spray drift risk, there seems to be universal agreement that the
competence of the people who apply chemicals is the foundation of all further risk
mitigation approaches. That competence implies an understanding of all important risk
factors affecting spray drift and suggests a responsible and constructive attitude on the part
of the operator (APVMA, 2005).

Spraying equipment characteristics (selection and proper operation)
Within this category spray droplet size is one of the most important factors. Smaller droplets
have greater potential for drifting off target (APVMA, 2005). Identification of a drift-prone
droplet size threshold is attractive but somewhat arbitrary. Some researchers have suggested
100m as the threshold for droplets with high drift potential, others have suggested 141m
(Spray Drift Task Force, 1997 cited by Stover et al., 2002), while still others indicate that
droplets under 200m are very prone to drift when wind speed exceeds 8 kilometres per hour
(Zhu et al., 1994 cited by Stover et al., 2002). As mentioned in Table VII.3.2 (BES, 2002),
studies performed in a wind tunnel indicated a strong non-linear increase in drift with
decreasing droplet size threshold (Taylor et al., 2004). HEEPIBEE (2006) indicates that the
droplet size above which drift potential becomes insignificant depends on wind speeds, but
lies in the range of 150 to 200 m for wind speeds of 0,5 to 4 m/s. When using conventional
spraying equipment, the total volume of spray made up of droplets less than 100 m in
diameter is relatively small, but even such small amounts may sometimes cause serious health
problems and/or damage crops in nearby fields (Ozkan et al., 1997).

Table VII.3.2: Distance covered falling 3 m in 4,8 kilometres per hour wind in function of droplet
diameter (BES, 2002)

Diameter in
m
Droplet called
Time required to fall 3
m in still air
Distance covered falling 3 m in 4,8
kilometres per hour wind
5 Fog 66 minutes 4,8 kilometres
100 Mist 10 seconds 125 metres
500 Light rain 1,5 seconds 2,1 metres
1000 Moderate rain 1 second 1,4 metres

Sprayer Speed can also be mentioned. A series of experiments with boom sprayers showed
an increase in spray drift with increasing speed (van de Zande & Stallinga et al. 2004). On
the whole, slower speeds are better. With a conventional boom-sprayer, there is really no
concern below 6-8 kilometres per hour (10 mph) (Nuyttens et al., 2004). Another study
showed that when the sprayer speed increased from 6 kilometres per hour to 10 kilometres
per hour, the potential drift doubled (Panneton, 2001). In case of air-blast sprayers, fan speed
also has an impact on drift. Field trials conducted in an orchard indicated that reducing fan
speed by 25%, resulted in considerably less drift, with coverage at 6.1m and 12.2m from the
target row being 16% and 0,20% respectively (Landers & Farooq, 2004).
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Spraying pressure has a controversial effect on drift. Indeed, results obtained from different
studies strongly vary. The spraying pressure influences not only droplet size but also droplet
speed. A high pressure decreases the droplet size (which increases spray drift), but also
increases the droplet speed (which decreases spray drift). When these two opposite effects are
balanced, the effect of the spraying pressure on spray drift is not very important compared to
other factors (pers. comm. Lebeau, 2006).

Nozzle type can also be mentioned. Nuyttens et al. (2004) showed that there are two main
classes of nozzles: flat fan nozzles (94.5%) and turbulence nozzles (5.5%). Turbulence
nozzles are mostly used in fruits crops. The flat fan nozzles can be divided in 3 groups:
standard flat fan nozzles (conventional nozzles), drift reducing flat fan nozzles: pre-orifice
nozzles and air induced flat fan nozzles. Among those, the standard flat fan nozzles are by far
the most popular (85.8%). Nozzles with drift reducing properties are not yet frequently used
(drift reducing flat fan nozzles: 2.7%; air induced nozzle: 6%).

The type of spraying equipment used, determines drift potential to a considerable extent.
The potential for drift is greater for aerial applications due to higher heights of spray release,
higher speeds of the aircraft and greater air turbulence in the wake of the aircraft that can
shatter droplets into smaller droplets which are more prone to drift (APVMA, 2005; ARS,
2006). Traditional boom spraying has some advantages in relation to spray drift such as being
able to keep spray release height low, operating at slower speeds that do no shatter droplets.
However, under specific conditions, this technique can also lead to unacceptable amounts of
spray drift (APVMA, 2005). Drift resulting of applications of around 300 litres/ha with a
boom height of 0.5 metre varies predominantly with nozzle type, nozzle size and spraying
pressure (van de Zande & Stallinga et al., 2004). However, it seems that the potential drift of
this application method does not exceed 10% of the total applied amount (Benot et al., 2005).
ULV (Ultra Low Volume Spraying) technology can be highly efficient. However, in some
cases ULV application can have a significantly higher drift potential than conventional low or
high volume application (CSIRO, 2002). Air assisted sprayers were designed to provide better
penetration of the crop canopy and control pests and diseases in the lower canopy. When there
is sufficient foliage to filter the droplets from the airstream, their use also reduces downwind
drift (Matthews, 1995). On the contrary, this method should not be used if there are small
plants or for a soil surface treatment (Matthews, 1995). In this case, the air jet increases the
risk of drift up to a 15-fold factor (Vancoillie, 2002; Panneton, 2001). When done properly,
air-assistance can decrease drift even when fine sprays and lower water volumes are used
(Wolf, 2004). The trend to using dwarf varieties and other changes in the planting of orchards
has enabled development of other equipment. Some sprayers now use cross-flow fans close to
the canopy. Other manufacturers have designed tunnel sprayers, in which a mobile canopy
protects the tree from a crosswind during application. Spray which passes through the canopy
is impacted on the tunnel and recycled (Vancoillie, 2002). When spraying an orchard in a full-
leaf situation (LAI 1.5-2) and an average wind speed of 3 m/s with cross-flow fan sprayers,
the spray-drift deposition on the soil at 4.5-5.5 m downwind of the last tree is 6.8 % of the
application rate per surface area. Compared to this reference situation a tunnel sprayer can
achieve a reduction in spray drift on the soil surface of 85-90 % and a cross-flow fan sprayer
with reflection shields of 55% (van de Zande et al. & Michielsen, 2004; Nuyttens et al.,
2004). In Belgium, tunnel sprayers are very rarely used principally because protection against
hail hampers their passage (Nuyttens et al., 2004; Lebeau, pers. comm., 2006).

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Application parameters

In this category, the formulation type is worth mentioning. Dust formulations, very popular
during the late 1940s and 1950s, caused high drift problems. Now, their use is limited. The
least drift-prone formulations of pesticides are pellets and granules. VanDyk (1998) indicated
differences in potential drift among different formulations of a same active substance. For
instance, glyphosate formulations influenced droplets size distribution and thus drift.

The height of the spray release also affects drift potential. Indeed, the amount of time that
droplets remain airborne and exposed to wind currents depends on the height of the release
(BES, 2002). Studies performed in a wind tunnel showed that doubling the boom height
increased airborne drift by a factor of three under certain conditions (Taylor et al., 2004). The
effect of sprayer boom height on spray drift was measured in the field. A drift reduction of
around 50% was found when lowering boom height from 0.70 m to 0.50 m as well as
lowering from 0.50 m to 0.30 m above crop canopy. Lowering further down will give even
more drift reduction, up to 90% but also causes stripes in the application (van de Zande &
Stallinga et al., 2004). Thus, the best is to use the lowest boom height that still offers
sufficient overlap given the boom movement (Wolf, 2004). In practice, this parameter is
controlled within relatively narrow limits. Aerial applicators seek a compromise between
optimal spray placement and safety and generally maintain a release height between 1 and 3
metres. Applicators using ground boom equipment are constrained, in most cases, by nozzle
design and placement that fixes release height to a narrow range in order to achieve uniform
spray deposition (APVMA, 2005).

The correct orientation of the spray release and thus of the nozzles is crucial if pesticide is
to be targeted correctly (Landers & Farooq, 2004). For example, in orchards, the applicator
should ensure that spray droplets are contained within the canopy and not directly sprayed
into the air above the canopy (CSIRO, 2002).

The time of day of application is important mainly in the way it relates to atmospheric
conditions. Evening and night-time hours are frequently associated with stable air conditions.
Stable conditions are often referred to as inversions. These are conditions where very little
air mixing occurs. Because of the low dispersion conditions, pesticide droplets may remain in
the air as a concentrated cloud and drift off target but remain concentrated. This scenario can
result in a concentrated cloud of pesticide droplets landing downwind and possibly causing
damage to non-targets. Thus, spray operations should particularly not be conducted during
inversion conditions (APVMA, 2005; BES, 2002; Thistle, 2004).

The number of applications may as well play a role. Spray drift risks for some products
may be acceptable for one or for a small number of applications, but where the residue effect
is persistent, more applications may have an additive result that raises risk to an unacceptable
level (APVMA, 2005).

Target characteristics

The stage of crop development, the canopy structure, geometry and density are also
important for drift. A crop is a complex target in which thickness, shape, and foliage density
varies. Spray drift risk, particularly for ULV applications, can be substantially increased
when a crop is too small to act as an adequate trap to capture small spray droplets.
Dormant deciduous orchards also present a higher risk situation during spray or air-blast
127
applications (APVMA, 2005). In a Belgian study performed in a semi-dwarf orchard, the
highest downwind ground deposits were measured when the trees did not have full foliage
(during blossom) (Vercruysse et al., 1999b). According to van de Zande & Stallinga et al.
(2004), spraying trees without leaves increases spray drift 2 to 3 times compared to spraying
trees with full foliage. In Belgium, many orchards have planting and pruning systems that
result in a discontinuous leaf wall. Not spraying these gaps can result in a considerable drift
quantity reduction (Jaeken et al., 1999). Trials in Italian vineyards indicated a considerable
influence of the canopy characteristics on the amount of drift deposit assessed on the ground
in the area adjacent to the vineyard sprayed. Vineyards featured by a narrower spacing and
compact vegetation gave lower drift than vineyards featured by wider spacing and thinner
canopy (Balsari & Marucco, 2004). According to Stover et al. (2002), variability in
deposition within the tree canopy appears to increase as tree canopy density increases.

Weather conditions

Wind speed and direction are the primary meteorological determinants of spray drift.
Though wind direction is not discussed in relation to the magnitude of drift, it is the critical
variable as the direction of air movement determines the direction in which pesticides will
drift. The fluctuation in wind direction can also be used as an indicator of the amount of
atmospheric turbulence and, therefore, the amount of dilution of a cloud of fine droplets
(Thistle, 2004). Wind speed influences the distance over which droplets will drift, but it does
not influence droplet size to a large extent (BES, 2002). According to APVMA (2005), a
wind speed range of 3 to 15 kilometres per hour is acceptable for most situations. Research
concerning the efficiency of herbicide applications in Oxfordshire (UK) (Skinner et al.,
1997) showed that in gentle wind (10.8-13 kilometres per hour) 87-93% of the spray was
deposited on the target area, 2-3% on the soil outside the target area, 1-4% of this by drift up
to 8 metres downwind and the remainder, up to 10% was lost by volatilization or further
spray drift. Laboratory studies indicated that a wind speed as low as 4.8-8 kilometres per
hour (3-5 mph) substantially deflected droplets <200 m in diameter. Smaller droplets were
deflected more than larger droplets (Stover et al., 2002).

Temperature and relative humidity affect the likelihood of smaller droplets impinging on
the target. At a relatively high temperature and low humidity, significant evaporation can
occur before some spray droplets reach the target, reducing the size of droplets and
increasing the influence of ambient air movement and thus increase drift. This is especially
important for droplets smaller than 70 microns. Even larger droplets evaporate to some extent
as the temperature increases or the humidity decreases (Stover et al., 2002).



128
Specific exposure mitigation measures

The exposure of bystanders can be reduced during mixing/loading, application and post-
application activities (EUROPOEM, 1996). Below specific mitigation actions are prioritized.
Since spray drift is the main source of bystanders exposure to pesticides, mitigation measures
which reduce spray drift are listed.

To avoid spray drift some elementary preconditions have to be fulfilled, before
implementation of specific measures. These preconditions concern the compliance with good
phytosanitary practices. In particular the following actions should be taken:

Avoid spraying when the weather conditions are not favourable (on windy
days, check wind speed and direction before spraying, check humidity and
temperature);
Reducing the volume of spray contained in small droplets (by choosing
particular nozzles, applying drift retardant chemicals);
Altering the flight paths of small spray droplets by mechanical means to
increase efficiency of deposition on the target (by adapting height and direction
of release, sprayer speed, fan speed, spraying pressure);
Choose low drift-prone formulations;
Take into account the stage of crop development.

After the implementation of the preconditions and in order to reduce drift even further,
specific measures can be taken. These basic anti-drift measures are presented here in order of
their efficiency. Several of these actions can be associated to obtain an even higher drift
reduction.

Modified equipment
Several recent developments have been aimed at modifying existing equipment to increase
deposition efficiency of the more effective small droplets while reducing the potential for
drift. In general, this has been accomplished by using either air-assistant technology or some
kind of shield or shroud to overcome the drift producing air currents and turbulence that occur
around the nozzle during spraying. Although air-assistant technology has been proven to be
effective in increasing deposition and thus reducing drift, this technology has currently not
widely been adopted by the pesticide applicators, because of the relatively high equipment
cost.

Management strategies
According to different spraying application scenarios, different management strategies can be
applied to reduce spray drift. These are listed in detail in the HEEPEBI Report (2006).

Natural and artificial shields/structures for spray interception
Many studies have been carried out to investigate and determine the effectiveness of different
kinds of natural and artificial shields in reducing off-target movement of droplets (e.g. Ozkan
et al., 1997; Dorr et al., 1998; Van de Zande et al., 2000). Most of the studies conducted to
evaluate the effectiveness of shields indicate that most of these devices efficiently reduce off-
target spray drift by 45 to 90% (Hewitt, 2001). Several studies showed that shelter vegetation
(natural shields) is more effective than artificial shelter in reducing drift (AEI, 1987; Holland
& Maber, 1991).
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Drift retardant chemicals
Drift retardant chemicals are utility adjuvants working on the properties of the spray solution
or the spray mixture which do not directly affect the pesticide efficacy, but make the
application process easier (McMullan, 2000). DCAs (sometimes referred to as anti-drift
agents or drift retardants) impart their effectiveness by altering the viscoelastic properties of
the spray solution (Hewitt, 2001). By altering these features, a coarser spray with a higher
volume median diameter (VMD) and lower driftable fraction will be produced (McMullan,
2000). Typically, the VMD and driftable fraction, are used to characterize a DCA.

Buffer zones
To prevent spray drift no-spray buffer zones can be required. A buffer zone is intended to
capture the major portion of driftable droplets within a treatment area to minimize risk to
adjacent protected areas (SPF, 2005; Mc Lean 2001).

Vegetation barrier
There have been a variety of research experiments on this subject, which have documented
reductions in spray drift up to 80-90%. However, there are still enormous data gaps on how to
apply such a measure accurately (Ucar & Hall 2001).

In a series of field experiments spray drift was assessed when spraying a sugar beet crop and a
potato crop. Next to the crop, the field margin was planted with a 1.25 m wide strip of
different heights of Miscanthus (Elephant grass) acting as a windbreak. The height of the
windbreak had a clear effect on spray drift deposit (van de Zande & Michielsen et al., 2004).
Spray deposit at 3-4 m distance from the last nozzle decreased significantly with increasing
heights of the Miscanthus. When Miscanthus was cut to equal height as the crop height spray
drift reduction was 55% compared to spray drift on the same distance when no windbreak was
grown. With the 0.5 and 1.0 meter above crop height levels of Miscanthus spray drift was
reduced by respectively 75% and 90%. The combination of a windbreak crop higher than the
arable crop (sugar beet or potatoes) and an air-assisted field sprayer reduced spray drift with
95-99% (van de Zande & Michielsen et al., 2004). Spray drift to the soil and air next to an
orchard might also be reduced by a wind-break of trees around the orchard. In a series of
experiments the effect of a wind-break on the emission outside the orchard was evaluated.
The alder tree wind-break around the orchard resulted in significantly lower drift to the soil
and air at the places behind the wind-break. On the soil next to the orchard, the wind-break
gave an emission reduction in the range of 68 (in the growth stage before May 1st) to more
than 90% (full leaf stage) at a distance of 0-3 m behind the wind-break. The emission to the
air next to the orchard was reduced by 84 to more than 90%, in the height range of 0-4 m
above the soil surface. Results depended on the leaf density of the wind-break and the wind
speed during the experiments (van de Zande & Michielsen et al., 2004).

Adjuvants
There is increasing interest in the use of adjuvants for reducing spray drift. Indeed, some
additives allow a narrowing in the droplets spectrum by decreasing the quantity of small drift-
prone droplets. A drift-reducing additive increases drop size by changing liquid properties
such as viscosity. The behaviour of an adjuvant depends in part on the tank mix partners.
However, some drift-reducing agents are sensitive to shearing by the pump and may even end
up producing smaller droplets than without the product. Thus, although drift-retardant
chemicals can be effective in reducing the number of drift-prone droplets, in most cases using
low-drift nozzles and operating sprayers at lower pressures seems to be a better and more
cost-effective approach to reduce spray drift. Therefore, according to different experts,
130
adjuvants should be used as a last resort (ITV & ARVALIS et al., 2005; Woods, 2004; AG,
2004; Spanoghe & Steurbaut et al., 2002; Nuyttens & Sonck et al., 2004).

Targeting technologies
Sensing and real time control of spray application can significantly reduce the amount of
pesticide required to maintain acceptable efficacy; concurrently, non-target deposition and
spray drift can be virtually eliminated through focusing pesticide deposition exclusively on
the targets. Integration of GPS systems and on-board sensors can allow real-time mitigation of
spray drift. In addition to drift mitigation, all these technologies can potentially improve
efficacy, allow greater use of reduced-risk chemicals, increase applicator productivity and
significantly improve accountability for agrochemical use (Giles, 2004).

The use of optical sensors to actuate spray nozzles in combination with nozzles spraying
individually each row of the crop can be an effective tool in reducing spray drift. By design,
the system only sprays a detected weed or pest, and since it is not spraying all the time it is
most effective for drift control because it is reducing the amount of pesticide being applied.
However, in combination with improper nozzle selection and high pressure this technology
would not be very effective (Wolf, 2004).

The behaviour of a spectrophotometric sensor system for canopy absence/presence detection
has been tested in intensive semi dwarf Belgian orchards in the full foliage growth stage. The
quantity of drift and soil deposit was reduced by 50 to 90% depending on the planting system,
on the number of sensors and on their positioning (Jaeken & Vercruysse et al., 1999).

Strategies based on the use of practical methods of dose adjustment and particularly the
approach build on the principles of Pesticide Adjustment to the Crop Environment (PACE)
has also been established to improve the control of pesticide application by achieving uniform
deposition across a wide range of different crop structures (Walklate, 2004).

The fully optimized method of dose adjustment (FO), involving spray plume adjustments to
match average tree size and suitable dose adjustments, offers the greatest potential for drift
reduction (87%) before the beginning of flowering. The tree area density method of dose
adjustment (TAD) is predicted to have a slightly lower potential for drift reduction (76%), but
avoids the necessity of adjusting the spray plume to match the size of the crop across the full
growing season. Other methods of dose adjustment, based on tree row volume (TRV) and
fruit wall area (FWA) scaling principles, are predicted to give drift reductions of 49% and
32%, respectively (Walklate, 2004).

Additional equipment that will utilize different technologies in combination with on-the-go
site-specific application practices to help reduce drift are forthcoming. Sprayers using
prescription application maps (GPS) for variable rate applications are in development (Wolf,
2004).

Each of the above technologies has seen limited adoption because of the additional cost
associated with such spraying equipment. As future application guidelines regarding increased
efficacy and spray drift minimization are established, more technologies will be developed
and adopted. These developments will require sound research to support adoption (Wolf
2004).
131
Below, specific measures are listed respectively for field crops and for orchards:

In field crops/boom spraying:
The most efficient way of drift reduction will be a vegetation barrier (higher than the
crop) associated with boom air assistance. Indeed, this will allow a drift reduction up
to 95-99% (van de Zande & Michielsen et al., 2004). It is important to note that there
are some restrictions to the use of air assistance;
Specific sprayers such as band sprayers, which can be used for weed control in sugar
beets or maize, allow drift reduction ranging from 75% to 90%, depending on the
authors (Rautmann, 2001; SPF, 2005);
Then, a vegetation barrier alone also allows reductions from 55% for the same height
than the crop up to 75% for barrier 0.5 m higher than the crop and 90% for barrier 1 m
higher than the crop (van de Zande & Michielsen et al., 2004);
Using air induction nozzles is another simple and efficient means for drift mitigation.
Indeed, dependent on nozzle size and spraying pressure, a drift reduction of 50% up to
90% is possible (Rautmann, 2001; SPF, 2005);
Use of specific spraying equipment with air assistance (used alone) will also allow to
reduce drift (pay attention to the use conditions). Sprayers with air assistance achieve
drift reduction of 50% in crops with a minimum height of 0.3 m and 75% in crops
with a minimum height of 0.5 m (Rautmann, 2001; SPF, 2005).

In orchards:
Specific sprayers such as tunnel sprayers can achieve a reduction in spray drift of 85-
90% and even up to 99%. (Nuyttens & Sonck et al., 2004); SPF, 2005; Rautmann,
2001);
Vegetation barrier acting as windbreak can also allow drift reduction ranging from
50% (without leaves) to 90% and more (full foliage growth stage). Results depend on
the leaf density and on the wind speed (van de Zande & Michielsen et al., 2004; SPF,
2005);
Other specific sprayers, that is to say cross-flow fan sprayers with reflection shields,
allows drift reduction of 55% (Nuyttens & Sonck et al., 2004);
Targeting technologies are other means for drift reduction. Depending on the used
technology and the planting system, reductions can vary largely. With systems of
canopy detection, the reduction achieved is at least 50% and up to 90% (SPF, 2005;
Jaeken & Vercruysse et al., 1999; Rautmann). Other more sophisticated technologies
allow a further reduction. However, these systems generally remain expensive (Wolf,
2004);
In air blast sprayers for orchards, air induction nozzles also lead to drift reduction.
The reduction is about 50% (SPF 2005; Rautmann, 2001). Therefore, according to
Rautmann, further steps are necessary.


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4. Quantitative assessment of mitigation measures

The impact of several reduction measures outlined above on the risk for pesticide operators,
re-entry workers and bystanders was quantitatively assessed for two standard spraying
schemes: one for potatoes and one for apple orchards (see Annex X)

Table VII.4.1 lists the reduction of risk in terms of percentage for a few reduction measures
for the spraying scheme for potatoes.

Table VII.4.1: Results of the impact of reduction measures on the total RI value for the spraying scheme
of potatoes.
% reduction compared to standard
spraying scheme Reduction measure
Operator Bystander
Mask 5 -
Gloves 84 -
Coverall 1 -
Mask +gloves + coverall 90 -
Gloves + mask 89 -
Use of Personal
Protective Equipment
Gloves + coverall 85 -
Decision support system (some fungicide treatments are left out) 17 10
Terra Nostra (some fungicide treatments are left out) 17 13.77
-75% (0,5m
high)
- 72 Drift reduction (vegetation barrier) (bystander
located at 8 m from the edge of the field)
-90% (1m high) - 86
-95% - 91 Drift Reduction (vegetation barrier and air
assistance) (bystander is located at 8 m from the
edge of the field)
-99% - 95
Buffer zone of 10 metres (bystander located at 10 metres from the
edge of the field)
- 19
Alternative defoliation 49 45
Mechanical weeding 6 10
Powder formulation suppression 60 -

The impact of a decision support system (17%/10%) and the TERRA NOSTRA-label
(17%/13.77) on the total RI value is quite similar. Both of those reduction measures have an
influence on the risk for the applicator and the bystander since these measures imply a
reduction in the use of pesticides. Alternative defoliation and mechanical weeding also limit
the risk to pesticides for applicators by reducing the applied amount. These measures lead to a
decrease in risk of respectively 49% and 6%.

In case of powder formulation suppression, the WP/WS/DS/DP-formulations have been
replaced by SL or WG formulations (Curzate M replaced by Profilux, Purivel replaced by
Reglone). SL and WG formulations have a smaller impact on the applicator especially during
mixing/loading, since powder formulations lead to a considerable inhalation exposure due to
dust emission. A reduction of 60% was calculated taking into account this action.

The main reduction measure for the applicator is the use of PPE (personal protective
equipment: mask, gloves and a coverall). It is obvious that gloves provide the best protection
for pesticide applicators, while a mask (reduction of only 5%) and a coverall (reduction of
only 1%) offer a lot less protection. Especially in case of mixing/loading, gloves and a mask
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reduce the impact of splashing and dust drift. The combination of a mask, gloves and coverall
during mixing/loading and application reduces the total risk for the applicator with 90%.

When considering bystander exposure reduction, drift reduction measures offer the best
possibility, in particular vegetation barriers associated with air-assistance provide a substantial
reduction in risk. Buffer zones of 10 meter from the edge of a field provide less protection.

Table VII.4.2 lists the reduction of risk in terms of percentage for a few reduction measures
for the spraying scheme for apple orchards.

Table VII.4.2: Results of the impact of reduction measures on the total RI value for the spraying scheme
for apple orchards.
% reduction compared to standard spraying
scheme
Reduction measure
Operator (%)
Re-entry
worker (%)
Bystander
(%)
Mask 4.13 - -
Gloves 48.81 18 -
Coverall 32.94 64 -
Mask +gloves + coverall 85.88 - -
Gloves + mask 52.94 - -
Use of Personal
Protective Equipment
Gloves + coverall 81.75 82 -
-75% (0,5m
high)
- - 74.92 Drift reduction (vegetation barrier)
(bystander located at 8 m from the edge
of the field)
-90% (1m
high)
- - 89.90
-95% - - 94.89 Drift Reduction (vegetation barrier and
air assistance) (bystander is located at 8
m from the edge of the field)
-99% - - 98.89
Buffer zone of 10 metres (bystander located at 10 metres
from the edge of the field)
- - 15.43
Powder formulation suppression 36.64 - -

Table VII.4.2 learns that the wearing of PPE is a good option for reducing the risk for
operators and re-entry workers. In orchards, the use of a coverall is almost as important as the
use of gloves. This differs from the situation in field crops, where gloves provide a lot more
protection than coveralls. This can be explained by the fact that in upward application
scenarios the body exposure is much higher compared to downward exposure scenarios. In
orchards, gloves give a reduction of approximately 48%, while a coverall provides a decrease
in risk of 33%. The risk reduction of masks equal 4%, which approximates the 5% value
obtained for the field crop scenario. For re-entry workers, the wearing of gloves and a coverall
are important. In this specific scenario, namely the harvesting of apples, body exposure is
important. This explains the high reduction impact of coveralls. In other re-entry scenarios,
where hand exposure is much more important than body exposure, the use of gloves will give
the highest reduction in exposure and associated risk.

In case of powder formulation suppression, the WP -formulation has been replaced by a WG
formulation. A reduction of 37% of the applicator risk was calculated taking this action into
account.

The largest reduction in bystander exposure is achieved for the vegetation barrier associated
with air-assistance. Comparable results are obtained as for the field crop application scenario.
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VIII. Validation

Risk per se is rather a theoretical concept than a concrete variable, and is therefore not
measurable in the real world. Hence, validation of risk indicators has to be carried out
indirectly. This can be done by different complementary approaches:

Statistic approach
The investigation of robustness and statistic reliability of the risk indicators can be studied.
One possibility is to focus on the examination of variation in temporal risk trends and the
sensitivity of trends to variability in input data. This approach provides useful information
about statistic soundness, but does not clarify the meaningfulness or plausibility of an
indicator.

Comparing indicators
If different indicators show comparable temporal risk trends this may increase their
credibility, but primarily indicates that they are driven by the same variables and does not
necessarily prove their accuracy.

Plausibility testing
Testing the plausibility of the indicators will be the main focus of our validation work. Three
main approaches can be applied: (1) sensitivity analysis: sensitivity of the indicators to input
variables; (2) reaction of the indicators to hypothetic scenarios (3) comparing with
monitoring data.

In principle, plausibility testing is complicated by the following main factors: First, results of
indicator calculations can only be understood and validated at a low aggregation level.
Second, the assessment of sensitivity and of the reaction to assumed changes (scenarios) is
dependent on the knowledge and opinion of experts and cannot be done objectively. In
addition one has to keep in mind that real risk can only be approximated. Hence, indicators
in general do not claim to be linearly related to real risk, but they do allow analysing rough
trends or rankings of pesticides or crops in connection with risk.

In this chapter, plausibility testing of the indicators is conducted. The relative impact of
variable parameters is discussed briefly and the rationale behind each of the indicators
concept on how different factors contribute to occupational exposure to pesticides is
reviewed. Where possible, indicator calculations are compared with monitoring data.




1. Pesticide Operator

Within the framework of HAIR, it was opted to use the EUROPOEM model for estimating
exposure under European conditions since in Europe this model was meant to become the
standard and the other European models would lose their value to users. Therefore existing
models will not be adapted except for specific local reasons. EUROPOEM as it is available
now has been developed by an expert group and was extended and improved with money
made available by the European Union by adding relevant studies made available to the
expert group. However, regular updates are necessary if EUROPOEM is to remain relevant.
This specifically holds for the quality of the studies in the database, most of which are not
very recent (van Hemmen et al., 2005). Industry (the European Crop Protection Agency
(ECPA)) holds some 30 studies which have been carried out recently, but have not been
added to the current EUROPOEM database.

However it has to be mentioned that EUROPOEM II has several weaknesses as there are
several datasets that have an insufficient number of data-points, particularly for
mixing/loading and hand-held application scenarios. Moreover, many studies are old and
therefore do not follow current guidelines, do not comply with Good Laboratory Practice and
equipment was used that is no longer representative of current practices.

Following the ILSI probabilistic worker exposure assessment workshop and the EUROPOEM
Steering Committee in November 2003, it has been considered that the variability within
datasets was too high and that usual algorithms to calculate exposure do not apply. Therefore
the overall quality of the database was considered insufficient for making reliable
assessments.

Pontal (2004) mentioned the following three issues on which improvement is necessary:

The overall quality of the database has to be improved in order to base exposure
assessments on reliable data. This can be achieved by removing some borderline quality
studies, by adding new studies conducted according to modern standards (ECPA EOEM
program) and by improving the documentation of the studies especially any parameters
likely to explain variability. A more detailed description of the equipment, identification
of incidents, description of the outliers and details on analytical quality are important to
register in view of better explaining variability. Variability of worker exposure is a normal
finding in agriculture as well as in industry, however this variability should be within a
reasonable range otherwise the exposure scenario should be split into different sub
scenarios and at least partially explained by the difference in equipment, protection,
incident or behaviour. An example from the EUROPOEM II database can be mentioned
within this respect. When studying the mixing/loading database for liquids, it can be
noticed that the ratio between minimum and maximum values for mixing/loading is up to
more than 20.000.000 for Potential Hand Exposure. No real explanation can be found in
the presented data to explain this variability. With such a variability, the selection of a
representative number for exposure may vary by several orders of magnitude. A guidance
has to be developed on subsetting to enable selection of data that are more appropriate to a
particular product/scenario;

The relationship between use parameters and exposure as well as scaling and mitigation
factors should be studied more extensively (statistical analysis of existing data on the
number of operations, working time, area treated and dose rate should allow to determine
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if these factors are relevant, if other factors could be added and what the best fitted
relationship is) using the largest and most homogeneous possible database. Currently a
linear relationship is assumed. This linear relationship has however never been confirmed
when looking at the database. In any cases, when there is some relationship, this is not
likely to be linear. Moreover the relationship may be obscured by other sources of
variation such as operators behaviour and the study design. Some use parameters which
could have an influence are also not taken into account. These should be studied in the
future;
A Guidance Document has to be produced to allow for a science based and consistent use
across the E.U. countries. Additional issues to be tackled are guidance for sub-setting,
rationale for selecting a given percentile, a central tendency or any other significant point,
the use of LOD/LOQ results and the use of mitigation factors. Concerning the selection of
a given percentile, no agreement exists at the time on the rationale for selecting a given
point into the distribution. The existing exposure models use different approaches to point
estimate selection, which therefore leads to discussion on a harmonised approach for
EUROPOEM. Concerning mitigation factors, existing data demonstrate that transfer of
chemicals through clothes or protective devices are more complex than a fixed percentage
as presently used. Clear rules have then to be defined to incorporate them in an
assessment, especially when no actual dermal exposure data are available.

There is thus a strong need for improvement to the European (and also the North American)
database(s). The most appropriate approach would be that industry and regulatory agencies
would come together and use the recently innovated database software (AHED) for the
purpose of entering only data from studies which fit some strict criteria. The reviewing of all
the EUROPOEM II data as well as a number of industry studies including some new studies
conducted by the ECPA (European Crop Protection Agency) for inclusion in the European
version of AHED has been finalised (about 115 studies in total) (pers. comm. Pontal, 2006).
This work started in 2004 and was sponsored by the industry (Pontal, 2004). A new frame
was established to summarise the studies and evidence of all the quality criteria of the studies
was registered as a basis for a more scientifically robust selection of studies. This was
achieved in collaboration with regulatory officials. ECPA supervised in collaboration with
key EU regulatory experts, the aforementioned actions, namely the review of existing
EUROPOEM II data, the inclusion of new studies, the generation of new ones and the writing
of a Guidance Document which implied research on statistics and agreed decisions. These
actions have been finalized and have been submitted to the European Commission (pers.
comm. Pontal, 2006).

AHED is ready for use but the EU authorities have not yet reached a decision concerning the
acceptance of AHED (pers. comm. Pontal, 2006; pers. comm. van Hemmen, 2006). If the
database behind AHED is considered appropriate for thorough data analysis a suitable tool is
thus available, hence leading to the best possible algorithms to be used in the exposure risk
assessment for regulatory purposes, in either a deterministic or probabilistic approach.

AHED is a harmonised model underpinned by high quality generic databases of field studies
relevant to European and American exposure conditions and incorporates the best features of
all the available models. The AHETF (Agricultural Handlers Exposure Task Force), in
cooperation with the European Crop Protection Association (ECPA) developed the database
software, accessible via a web-based server, for handling the data entry, calculations and data
analysis. A common database software tool will be used for risk assessments both in North
America and Europe. However, the data generated in Europe will be uploaded to the
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European version and the AHETF data will be uploaded to the North American (AHETF)
version. Thus, the software for both the European and the American version is the same, but
only the data that are applicable to each continent are uploaded in the respective databases.
The Agricultural Handlers Exposure Database only contains data that regulators have deemed
appropriate for use in a generic database (www.exposuretf.com). The AHED database is a
management system running under a Microsoft SQL server and will be able to handle
probabilistic assessments (in the future, not at the moment due to lack of data, pers. comm.
Pontal, 2006). The database will be able to provide percentiles, means and distributions of
exposure. AHED might rectify the deficiencies of EUROPOEM. Ideally this database could
have been used in the HAIR project if a decision concerning the use of AHED had already
been taken. The possible exposure reduction potential of the newer techniques is not yet
considered in the databases. Overestimation of the exposure may be the case when using the
current databases, particularly because older studies carried out with classic techniques for
classic formulations are incorporated in the datasets. This further underlines the need for
using well designed field studies representative for these new developments. Thus, in order to
keep the database up-to-date field studies should be conducted in the future to fill in the data
gaps and to gather data for new techniques and formulation types. These studies should be
designed in such a way that the results can easily be incorporated in the database. Therefore a
harmonized protocol for the conduct of field studies of operator exposure to plant protection
products should be followed.
The database integration and harmonization could be carried out under the auspice of the
Organization for Economic Co-operation and Development (OECD) where all relevant
countries from Europe and North America, as well as many other countries such as Australia,
are organized within the Working Group on Pesticides. The approach for integration and
harmonization could be prepared by a suitable expert group and the organizational structures
of the OECD are well suited for carrying this out. This would also promote harmonization of
pesticide-use scenarios throughout the world to the extent required (van Hemmen et al.,
2005).

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2. Re-Entry worker

Validation through biological monitoring

Following, an approach for validation of the re-entry worker indicator is outlined. The
methodology presented has been described previously in the EUROPOEM II Report of the
Re-Entry Working Group: Post-application exposure of workers to pesticides in agriculture
(EUROPOEM II, 2002) and proposes validation through biological monitoring.

The transfer factor concept for agricultural crop re-entry activities and the acceptance of its
validity are essential for the credibility and acceptance of the re-entry worker indicator
proposed for estimating post-application worker exposure. Biological monitoring data could
potentially be used as a means for validating the TF concept. Biological monitoring is
recognized for giving the most accurate estimate of the absorbed dose of a pesticide,
particularly if studies are designed and interpreted with the aid of human metabolism and
pharmacokinetic data. A direct comparison of the passive dosimetry and biological
monitoring approaches to the estimation of the absorbed dose would go a long way to
providing the necessary confidence in the TF concepts validity (EUROPOEM II, 2002).

The concurrent steps in the validation procedure are listed below (EUROPOEM II, 2002):

Choose a cluster group for which there are existing exposure data and transfer factors;
Conduct re-entry studies with concurrent passive dosimetry and biological monitoring
on a suitable surrogate compound that meets the relevant criteria for biological
monitoring. The surrogate compound should meet the following criteria: human
metabolism and pharmacokinetic data should be available (1), human in vivo dermal
absorption data should be available (2) and analytical methods to detect the principle
metabolites that can be refined to the required level of sensitivity should be available
(3). One such generic compound that meets the requirements is malathion. These
studies would give dermal exposure data, absorbed daily doses and DFR data to
enable the calculation of transfer factors;
Using dermal absorption data on the surrogate compound, the Absorbed Daily Dose
(ADD) could be calculated using the passive dosimetry approach. Following,
comparison could be drawn with the ADD calculated using biological monitoring
approaches;
A further comparison could be drawn between the calculated ADD from the generic
TF derived from the data within the same group and the ADDs from the passive
dosimetry and biological monitoring approaches.

An additional advantage of the validation through biological monitoring of the TF concept is
that generic TF values based on biological monitoring data in addition to those generated
using the conventional approach are obtained. Though, one condition has to be fulfilled: the
ADDs of both approaches should be comparable. The generic TF derived on the basis of
biological monitoring data would be a whole body TF and it is recognized that this would not
meet any regulatory requirement for regional body part TFs for the purpose of mitigating
excessive exposure. However, this limitation could possibly be overcome for many
crop/activity combinations on the basis that most of the dermal exposure would involve the
hands and forearms. Another advantage is that the absorbed data could be extrapolated to
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dermal exposure values if the dermal absorption characteristics of the surrogate compound are
well understood (preferably using in vivo human skin, although there are substantial
uncertainties associated with this procedure). Using the concurrent DFR data, these
extrapolated values could be another source of TFs. The above arguments in favour of doing
biological monitoring would provide the necessary confidence in the TF data used for
assessing the acceptability of the risk of crop re-entry activity for specific actives
(EUROPOEM II, 2002).

Though, some significant technical issues associated with the proposal to use biological
monitoring data can be mentioned. These are outlined below (EUROPOEM II, 2002):

The proposal has centered on doing one definitive biological monitoring study in the
belief that, if the correlation between the ADDs is found to be acceptable, then, as a
minimum, no further validation work would be needed. Doing a single study on a high
contact activity/crop combination (e.g. apple harvesting) to hopefully ensure that
measurable residues are obtained both in the passive dosimetry measurements and the
urinary metabolite analyses. But the question is whether a single study in a high
contact activity, even if a good correlation is demonstrated, is enough to ensure
confidence in the TF concept applied for activities and crops with lower potential
contact. And what about associated issues like other activities and the influence of
formulation type which also might require evaluation;
A related issue is whether a single study is likely to be wholly definitive. There will
undoubtedly be variance which might be subject to different interpretations. This
might result in a scientific need for further confirmatory validation studies;
Not only the conduct of the study involving the two types of methodology, but also the
input variables used to estimate the absorbed dose via these approaches determine the
validity of the TF concept. In the case of the passive dosimetry approach these are the
dermal absorption value used to estimate the absorbed dose from the dermal exposure
data (literature data indicate a range of 5 to 8% of the applied dose in human volunteer
studies) and the estimation method of the actual dermal exposure data. In the case of
the biomonitoring approach, the input parameters are the fraction absorbed excreted in
the urine as metabolites (90.2% from a human parental dosing), the choice of urinary
metabolites to monitor (e.g. mono- and dicarboxyllic acid, dimethyl thiophosphate),
the fraction absorbed excreted in the urine as the mono- and dicarboxyllic acid
metabolites (57% from a human dosing study), the overall calculation to estimate the
absorbed dose equivalent based upon metabolite excretion and analysis and the
sensitivity of the analytical methods for the chosen metabolites.

Biological monitoring data are often used in occupational exposure studies. However,
scientists are only beginning to understand the complexities and uncertainties involved with
the biomonitoring process (from study design, to sample collection, to chemical analysis) and
with interpreting the resulting data. An overview of concepts that should be considered when
using biomonitoring or biomonitoring data, an assessment of the current status of bio-
monitoring, and potential advancements in the field that may improve our ability to both
collect and interpret biomonitoring data are detailed by Barr et al. (2006). Issues such as the
appropriateness of biomonitoring for a given study, the sampling time frame, temporal
variability in biological measurements to non persistent chemicals, and the complex issues
surrounding data interpretation are discussed in the mentioned article. In addition,
recommendations to improve the utility of biomonitoring in farmworker studies are provided.
140
Evaluation of indicator assumptions

The validation approach outlined above could not be applied by Ghent University since bio-
monitoring data were not available to us. What could be done though was an evaluation of the
basic assumptions made in the predictive model for estimating re-entry worker exposure. This
is achieved by studying available sources in literature.

Brouwer et al. (2000) conducted a study to validate some basic assumptions made in the
predictive models for estimating worker exposure to pesticides during re-entry. Emphasis was
put on the relationship between the applied amount of active ingredient and the resulting
increase of DFR in relevant zones (crop heights), as well determining factors (i.e. application
techniques and crop density, or leaf volume index). In addition the influence of re-entry time
and crop density on transfer factors was studied. Leaf samples were collected prior to and
following the application of the pesticides abamectin, thiophanate-methyl, and methiocarb (in
seven commercial greenhouses for the cultivation of carnations) using either a high-volume
(HV) or low-volume (LV) application method. During each consecutive re-entry, both
respiratory and dermal exposure to pesticides was assessed for a period of 4 weeks, starting
from the moment of HV application. Relationships between exposure and the determinants of
exposure were analyzed using multiple linear regression analysis.

Relation DFR and Dermal & Inhalation Exposure
Schneider et al. (2002) mentioned that the potential dermal exposure levels were correlated
with the amount of dislodgeable foliar residues found on leaves. Higher dermal exposure
measurements corresponded with the increase measured in DFR. Several other studies also
indicated the direct relation between potential dermal exposure and dislodgeable foliar residue
data (Popendorf & Leffingwell, 1982; Nigg et al., 1984; Zweig et al., 1985; Krieger et al.,
1992). The former indicates that the basic assumption for exposure modeling concerning the
relation between dermal exposure and DFR data seems acceptable. Vercruysse (2000) showed
on the basis of field experiments that the variation in potential dermal exposure could be
explained by the DFR and the duration of exposure for 95% with the DFR being the most
determinant factor.

Vercruysse (2000) observed that apart from the linear relation between the DFR and the
potential dermal exposure, there is also a direct correlation between the potential inhalation
exposure and the DFR. Using multi-linear regression analysis it was indicated that the
variation in potential inhalation exposure could be explained for 78% by the DFR value and
the duration of exposure. A Dutch study, conducted in apple orchards also indicated the
importance of DFR- values as the most determinant factor for potential inhalation as well as
potential dermal exposure during re-entry activities (De Cock et al., 1998).

Relation DFR and Application Rate
The HAIR re-entry worker indicator assumes that the initial DFR can be estimated by
dividing the application rate by the leaf area index. Brouwer et al. (2000) showed that the
application rate seems to be a major determinant for an increase in DFR (T-test, = 0.01).
For the low-volume application technique, no significant relationship was observed. For the
high-volume technique and high- and low-volume techniques together, a significant
relationship was observed when using linear regression analysis. The high-volume and high-
and low-volume technique showed a variation of 66% and 63% respectively. The relatively
141
limited number of data was quoted to be the reason of the not significant relationship between
DFR and application rate for low-volume applications. A linear relationship between the
average increase of DFR and application rate was observed in several studies (Brouwer et al.,
2000; Popendorf, 1992; van Hemmen et al., 1995).

Relation DFR and crop volume
Brouwer et al. (2000) found no significant contribution of the crop volume to the variation in
DFR for high-volume as well as low-volume applications. Vercruysse (2000) found that the
leaf area index contributed to less than 5% to the total variation in potential exposure.

Transfer factors calculation
The indicator assumes default transfer factors that were calculated as the ratio of worker
exposure to DFR. Since exposure data in re-entry studies generally appear to be lognormally
distributed, as well as the TF data, DFR data should also be lognormally distributed. If TF and
exposure values have a lognormal distribution this means that log (TF) and log (Exposure) are
normally distributed. Since the TF is calculated as the ratio of worker exposure to DFR, then
log (TF) = log (Exposure) log (DFR) or equivalently log (DFR) = log (Exposure) + log
(TF). Since log (DFR) can be viewed as the sum of two normal random variables, it should
also be normally distributed. Thus, from a statistical perspective at least, DFR is expected to
follow a lognormal distribution. The assumption of the lognormal distribution of DFR values
was tested by the ARTF. A study was conducted to determine if the DFR data can be better
described by either a lognormal or a normal distribution (Korpalski et al., 2005). The data
from this study indicated that the DFR data are, at least approximately, lognormally
distributed. Several types of statistical analyses of the data indicated that for all the tested
chemicals. This study also showed that geometric mean values are more appropriate for use in
calculating transfer coefficients than arithmetic mean values since the geometric mean of
lognormal random variables also has a lognormal distribution. The same is not true for the
arithmetic mean if used instead. Therefore, use of the geometric mean DFR preserves the
lognormal distribution. This is important since the calculated TF will have a lognormal
distribution only if the exposure and DFR are lognormal random variables. When the
variability of the DFR samples is small, there is little difference between a lognormal and a
normal distribution. Thus, the arithmetic mean and geometric mean DFR values are very
similar. This was true for the majority of the re-entry studies that ARTF purchased or
conducted. Practically speaking then, the use of arithmetic or geometric means will generally
have a small impact on calculated TF values. However, in cases where the variance in the
samples is high, the use of the geometric mean instead of the arithmetic mean will result in a
smaller DFR value. In these instances, the calculated TF will increase slightly (since DFR is
in the denominator of the TF equation). Thus, the constant use of the geometric mean is a
conservative approach relative to the use of an arithmetic mean. That is, it would result in
higher calculated TFs, higher worker exposure estimates, and longer (more protective)
Restricted Entry Intervals.

Transfer factors: experimental TFs versus default TFs
When comparing experimentally derived transfer factors with the default values assumed, it
can be concluded that the current assumptions in the theoretical indicator model are
conservative. For example, the default value for the TF assumed by the EUROPOEM II Re-
Entry Working Group for carnations equals 5000 cm/hr, which compares well to the EPA
data (U.S.EPA Policy Paper on Agricultural Transfer Coefficients, aug 2001c). Comparing
this default value with experimental data from Brouwer et al. (2000) (TF=2300 cm/hr, using
142
all dermal absorption data). Calculated transfer factors for harvesting carnations using all
dermal absorption data were 2300 cm/hr. For methiocarb a lower transfer factor of
approximately 1600 cm/hr was observed. These transfer factors are considerably lower than
the default transfer factor of 5000 cm/hr proposed as a default value if experimental data are
lacking. This indicates that the current assumption in the theoretical model is quite
conservative. Research conducted by Steinbach et al. (2000) which tested the exposure of
workers in greenhouses containing treated chrysanthemums and pelargoniums whilst
performing various jobs, also indicated that current theoretical assumptions are worst case. A
transfer factor of 3500 cm/hr was derived for harvesting chrysanthemums. The
recommendation was made to conduct field trials to determine specific transfer factors and
dislodgeable residues for several re-entry scenarios as been performed on a large scale by the
Agricultural Re-entry Task Force.

To yield more realistic assessments of risk potential, measurements of exposures that are task-
specific should be conducted.

First-order decay rate
The actual amount of the DFR at the time of re-entry may differ from the initial amount of
DFR, depending on the decay rate of the pesticide and the elapsed time since application
(Brouwer et al., 2000). The process of decay may in many cases be considered as a first-order
process (Willis & McDowell, 1987). Brouwer et al. (2000) showed that the application of a
model based on a first-order decay process resulted in fairly high R and significant fit. It was
also indicated that DFR was significantly associated with re-entry time. However Nigg &
Allen (1979) indicated that not only re-entry time, but also the cumulative precipitation
influences DFR values. In conclusion, it can be said that the assumption of a first-order decay
process is acceptable.

Inhalation exposure in outdoor conditions
Several studies have shown that outdoor inhalation exposure for re-entry workers is
considered less important compared to the dermal exposure they receive (Vercruysse, 2000;
EUROPOEM II, 2002). Vercruysse (2000) compared the geometric mean of the transfer
factors for potential inhalation exposure and total potential dermal exposure obtained via field
experiments using the statistical program SPSS. The conducted T-test showed that the transfer
factors differed significantly at the 99% confidence interval (=0.01). Based on the difference
(order four of magnitude) the potential inhalation exposure was appreciated less important
than dermal exposure. EUROPOEM II (2002) assumed the same since inhalation exposure,
which potentially may occur to residual vapour and airborne aerosols, is restricted to a
relatively short period after application, e.g. for outdoor crops only during the time the spray
is drying or in greenhouses within a few hours after application. Outdoors there will be a rapid
dissipation of vapour and aerosols, leading to much lower inhalation potential than indoors.
Therefore, inhalation exposure was considered less important for re-entry workers in case of
outdoor scenarios within the framework of HAIR.

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3. Bystander/Resident

The bystander indicator is validated by comparing the indicator results to monitoring data.
However, available monitoring data concerning bystander exposure are scarce. The influence
of the different input parameters on the outcome of the indicator is also briefly discussed.

Validation through biological monitoring

In the case of bystander exposures, which may occur by several routes, the best method of
measurement will often be by biomonitoring, provided that there is a suitable analyte. Data on
concentrations of pesticides or their metabolites in humans, especially in blood or urine, can
be used in conjunction with appropriate pharmacokinetic information to provide robust
information on the total amount to which individuals are exposed. Over recent years, a
number of biomonitoring studies have been published, mainly from the United States,
including several that have investigated people living on farms where pesticides are used.
These studies support the view that background exposures to pesticides in rural residents are
relatively low, and that maximum exposures on days when spraying takes place are well
below the maximum exposures incurred by operators. They also suggest that a significant
contribution to the exposures of farming families comes from pesticides brought into the
home on the hands and clothes of family members who work with pesticides (ACP, 2005).
Recently the ACP recommended that the PSD commissioned a biomonitoring study of
bystanders, and this investigation is now underway.

It must be recognised, however, that at best, biomonitoring studies of this type can only
demonstrate that exposures are generally lower than those predicted by models. If higher
exposures occurred with any frequency, they would be detected, but because of limitations of
sample size, the possibility of occasional extreme outliers cannot be ruled out (ACP, 2005).

Evaluation of indicator assumptions

Spray drift module for assessing dermal exposure
Spray drift deposition is dependent on a variety of environmental, crop and application
factors. Increased wind speed (Kaul et al., 2001) and driving speed (Arvidsson, 1997) can
lead to higher drift rates. Increasing spray boom height and different nozzle types may also
have a significant effect (Elliot & Wilson, 1983). A variety of techniques are also available to
reduce drift, for example using coarser nozzles, modifying the spraying angle, spraying
pressure and driving speed, or using air-assisted techniques. Such approaches can reduce
spray drift by more than 50% (Taylor et al., 1989). Clearly then, selection of an appropriate
spray drift database is very much dependent on a matter of judgement and applicability, but
this also leads to a degree of uncertainty.

For the FOCUS approach which is used within the framework of HAIR to assess dermal
exposure for bystanders, spray drift deposition is based on the German drift database
(Rautmann, 2000; Ganzelmeier et al., 1995). These data were generated from a series of
studies (at a number of locations and with a variety of crops) whose objective was to
determine the absolute level of drift in practice under a variety of conditions. However, even
this extended database partly reflects environmental crop and application factors prevailing in
144
Germany. This may become clear from comparison with other spray drift databases, such as
the Dutch database. The Dutch IMAG institute performed spray drift deposition
measurements for several crops at various sites in the Netherlands. Van de Zande et al. (2001)
compared the 90
th
percentile values derived from Ganzelmeier et al. (1995) and Rautmann
(2000) with 90
th
percentiles obtained from the Dutch database. A good correspondence
between the German and Dutch 90
th
percentiles for spray drift deposition was found in
orchards. However, for four arable crops Van de Zande et al. (2001) found that 90
th

percentiles as estimated from the Dutch database were typically five times larger than the 90
th

percentile from the German database. A preliminary analysis suggests that the difference may
be mainly caused by differences in nozzle types (less or more advanced) and in crop height,
related to spray boom height (pers. comm. Van de Zande, 2001; pers. comm. Rautmann,
2001). This comparison suggests that further refinement of drift estimates may be useful
when more specific situations need to be assessed. However, up to now, the German database
still is the most comprehensive, widely available dataset and therefore this database was
selected for inclusion in the indicator. Vercruysse (2000) conducted spray drift experiments
and compared the downwind drift deposition data with those from Ganzelmeier et al. (1995).
Not linear regression analysis showed that the drift deposition data from both studies could be
well described by a power function. Moreover, the difference in drift deposition between both
studies did not differ significantly (T-test, =0.05), despite of the higher values from
Vercruysse (2000). De Heer et al. (1985) also obtained drift deposition values within the
same range as Ganzelmeier et al. (1995).

A realistic field study conducted by Mazzi et al. (1999) measured potential bystander
exposures in sloped vineyards in Italy. The dermal exposures obtained from this study were 2
to 10 times lower than the ones calculated using the BBA drift tables.

Currently the Centrum voor Landbouwkundig Onderzoek in Merelbeke, Departement
voor Gewasbescherming, Universiteit Gent and Departement voor Agrotechniek en
Economie, Katholieke Universiteit Leuven are developing and validating a Computational
Fluid Dynamics (CFD) drift-prediction model for field spraying applications. This model will
be able to predict drift for a wide range of variables such as weather conditions (wind speed
and wind direction, humidity, temperature), spray application technique (nozzle type, spray
pressure, forward driving speed of the sprayer, boom height and boom length) and
surrounding characteristics (canopy type and canopy height). The droplet diameter
distributions and velocities of sprays are used to develop the CFD model, they are obtained
by PDPA laser measurements. Field experiments are performed under a wide range of
conditions (weather, spray technique and surroundings) to validate the model
(http://www.biw.kuleuven.be/aee/vcbt/drift/).

In what follows a short overview is given of the influence of the different input parameters on
the outcome of a bystanders exposure.
145
The factors influencing dermal exposure are discussed below.

Distance from the edge of the field to the bystanders location (= x)
The distance from the edge of the field or more exactly from the last nozzle of the spray
boom, to the bystanders location determines the extent of spray drift deposition on the
bystander. Table VIII.3.1 lists the calculated drift deposition loadings for different crops and
distances from the edge of the field. Figure VIII.3.1 gives a clear picture of the influence of
the distance from the edge of the field to the bystanders location on drift deposition for arable
crops (e.g. potatoes) and fruit crops (early and late growth stages).

Table VIII.3.1: Drift deposition data for different distances from the last nozzle of the spray boom to the
bystander.
Crop
Distance to field
(m)
Drift deposition (%) (90
th
percentile)
Potential dermal exposure
(mg/workday)
5 0,57 0,24
8 0,36 0,15
10 0,29 0,12
Potatoes
20 0,15 0,06
5 19,88 8,40
8 13,96 5,90
10 11,81 4,99
Orchards early
20 2,76 1,17
5 8,41 3,55
8 4,73 2,00
10 3,60 1,52
Orchards late
20 1,08 0,46

Influence of crop type and distance from the edge of the field on drift
deposition loading
0,00
2,00
4,00
6,00
8,00
10,00
12,00
14,00
16,00
18,00
20,00
0 5 10 15 20 25
Distance from the edge of the field (m)
D
r
i
f
t

d
e
p
o
s
i
t
i
o
n

(
%

A
R
)
potatoes
fruit crops early
fruit crops late

Figure VIII.3.1: Influence of crop type and distance from the edge of the field on drift deposition loading

What can be concluded from Table VIII.3.1 and Figure VIII.3.1 is that the major differences
between the downwind drift deposition data account for the differences in potential dermal
exposure of bystanders for different crops. It is also very clear that drift deposition decreases
with longer distances from the edge of the field. For fruit crops and hops the crop growth
stage also influences the drift deposition, and following dermal exposure. Indeed, when the
foliage of a crop is still under development, the filtering effect of the leaves on the spray will
be smaller than in later growth stages, resulting in a higher potential dermal exposure for
bystanders. Vercruysse (2000) also concluded in accordance with Ganzelmeier et al. (1995)
that drift deposition values significantly differed according to the crop growth stage (T-test,
146
=0.05) and this for all distances from the edge of the field. Fox et al. (1993) also found
higher drift deposition values in early growth stages compared to late.

Influence of crop height and distance from the edge of the field
Influence of crop height and distance from the edge of the field
on drift deposition loading
0,00
0,50
1,00
1,50
2,00
2,50
3,00
3,50
4,00
0 5 10 15 20 25
Distance from the edge of the field (m)
D
r
i
f
t

d
e
p
o
s
i
t
i
o
n

(
%

A
R
)
Vegetables < 0,5 m
Vegetables > 0,5 m

Figure VIII.3.2: Influence of crop height and distance from the edge of the field on drift deposition
loading
In case of vegetable spray drift deposition depends on the height of the crop. Figure VIII.3.2
clearly shows that for higher vegetable crops the drift deposition loading, expressed as a
percentage of the application rate, is considerably higher at relative short distances from the
edge of the field. The difference in spray drift deposition between high and low crops
decreases with increasing distance from the field.

Exposed Area
The HAIR bystander indicator assumes a default value for this parameter of 0.4225 m per
person (total uncovered area: head, back & front of the neck, forearms, upper arms and
hands) in case of adults. For children a higher default value is assumed (see earlier).

Airborne drift module for assessing inhalation exposure
Two methods were proposed for assessing potential bystander inhalation exposure accounting
for different cases of data availability. The first method estimates a bystanders exposure
based on the potential inhalation exposure of the operator, the daily work rate and the typical
spraying duration. The second method makes use of default values derived from field trials
conducted by the Central Science laboratory within the framework of the EUROPOEM II
project.

Both approaches were compared based on a standard treatment scheme for potatoes (Annex
X). To calculate the bystanders exposure, the following assumptions were taken into account
for both calculation approaches:

147
Method 1:
I
a
= 0.008 mg a.s./kg a.s. applied (inhalation exposure for an applicator using the
EUROPOEM I surrogate exposure value)
WR = 9 ha/d (typical value for arable crops)
ST = 7 min/ha (typical for arable crops in Belgium) (Pineda, 1998)
Exposure duration of one minute
Ab
D
= 0.1

Method 2:
Inhaled amount of spray liquid equals 0.03 ml/m (90
th
percentile value, EUROPOEM II,
2002)
Spraying volume is set to 200 l/ha (typical value for arable crops in Belgium) (Pineda,
1998)
Inhalation rate is set to 1.25 m/hr
Exposure duration of one minute
Ab
D
= 0.1

The results for the inhalation exposure for the active substances listed in the standard spraying
scheme are presented in Table XI.10.2-3 (see Annex X). When comparing both methods, it is
obvious that the second method is more conservative than the first one. The second approach
for calculating inhalation exposure gives rise to values which are a factor 2.73 larger than the
values calculated using approach one. This implies a significant difference between both
methods. But which impact does this have on the overall bystander risk index? Statistical
analysis conducted with S-plus version 6.1 professional showed that the RI values calculated
using both methods do not differ significantly (One-way ANOVA, =0.05, p = 0.96) up to a
distance of 20 m. This can be explained by the fact that bystander exposure mainly occurs
through the dermal exposure route. The second method for assessing inhalation exposure is
preferred since this approach calculates bystanders inhalation exposure on the basis of
experimental data and is the more conservative method. Moreover inhalation data from field
experiments conducted by Vercruysse (2000) correlated very well to the CSL data. However,
data from Mazzi et al. (1999) showed 20 fold higher inhalation exposures compared to the
CSL data. Moreira et al. (1999) mentioned that a model based on the amount of airborne drift
droplets of active substance at a certain distance from the field, would probably give a better
correlation with the potential inhalation exposure of the bystander.

Both the ACP and the RCEP recommended validation of the previous approaches. They
should be supported by monitoring of representative pesticides in a range of field conditions.
Such monitoring should include measurements of concentrations in air for extended periods
after spraying to contribute to better understanding of possible exposure other than through
immediate spray drift. The ACP suggested a stepwise approach be taken to such research,
with the aim of identifying potential worst-case scenarios (ACP, 2005).

148
The factors influencing inhalation exposure for both indicator approaches are listed below.

Method 1:
I
a
,

ST and WR vary according to crop type and application technique. The exposure duration
is set to a default value of 1 minute.

Method 2:
The inhaled amount of spray liquid varies according to crop type and application technique as
well as the spraying volume applied. The inhalation rate is set to a default value of 1.25 m
per hour.

USES approach for assessing bystander/residential exposure nearby greenhouses
Mensink (2004) validated the module for assessing acute exposure nearby greenhouses.
Model analysis, including validation of the calculation procedure, was only possible to a
limited extent and in a theoretical way, due to a general lack of measurements under
controlled conditions. Therefore further work is required.

However, in spite of this data lack, some cautious comparisons between estimated and
measured concentrations were made. The estimations of only a few measurements inside a
greenhouse (Baas & Huygen, 1992) could be compared with the calculation scheme
outcomes. A reasonable goodness of fit was found between estimated and empirically derived
data for dichlorvos inside greenhouses. Theoretically, the initially measured concentrations
should equal the estimated concentrations, immediately after application (thus at t=0). This
seems least valid when non or slightly (e.g. fenbutatinoxide) volatile pesticides are considered
or when high-volume techniques (i.e. with the lowest ) are applied. For highly volatile
pesticides, therefore, the calculation scheme seems to yield rather realistic concentrations
inside the greenhouse, whereas in other scenarios the outcomes seem to overestimate these
actual concentrations. In conclusion, the calculation schemes for the different scenarios
probably reflect a worst-case approach, except for highly volatile pesticides. The likelihood
of underestimating exposure of nearby residents to these pesticides seems small, whereas
overestimating exposure to less volatile pesticides may still occur.

Comparing the concentrations inside the greenhouse with measured values inside the
greenhouse shows that the estimated concentrations are within 55-450% of the measured
concentrations (Mensink, 2004). The proposed calculation approach compared with the
model calculations of an earlier USES version yields an outdoor concentration of 1-67% of
the USES 4.0 estimations. It is interesting to note that the EPA estimated a concentration
inside a greenhouse one hour after using dichlorvos, with closed roof and sides - so
comparable with the lack of ventilation via windows as in the USES proposal - of 9803 g/m
at a dosage of 3.2 kg/ha dichlorvos. This dosage would calculate a C
gh,inair,t=1h
of 7536 g/m
according to the proposed calculation scheme: 24% lower, though the order of magnitude of
the EPA model (Mensink, 2004).

There are almost no data available about cause-effect relations between pesticide use and
emissions to open air nearby greenhouses under controlled conditions. Some older research
with methylbromide was used for preliminary validation. Its horticultural use in greenhouses
has by now been banned in several Member States (Mensink, 2004). Fumigation at 700 kg/ha
showed during the first hours after application at 20 m distance gas-phase concentrations of
5900 g/m (WHO & IPCS, 1995). The proposed calculation scheme yields 34489 g/m,
which is six times higher. The difference may be explained by the use of gas-tight film in the
149
experiments, yielding a very small ventilation rate, probably smaller than the ventilation flow
rate of a closed greenhouse.

Dependent on the input parameters and their variation, and based on realistic dosages, the
outcomes of the calculations may vary substantially (up to circa five orders of magnitude,
when varying wind speed and ventilation flow rate), indicating a large range of exposure
conditions. Although the outcomes had been expected to represent realistic worst-case
conditions - which implies that the underlying assumptions show both a worst-case and a
realistic component -, the realism scale is difficult to judge. Taking into account that the
calculations have been based on processes (volatilisation, deposition, ventilation) and that
various aspects of the calculation scheme have been based on experimental values
(ventilation flow rate constants, deposition rate constants, values), the scheme is
supposedly realistic. However, the assumptions in the calculation scheme cannot be tested
sufficiently as actual measurements of both concentrations inside the greenhouse and in lee
side eddies are very scarce or lacking. As mentioned before, some comparisons with
measured concentrations inside greenhouses were made, and - cautiously concluded - these
comparisons reveal that the scheme may be realistic for volatile pesticides, but probably not
for less volatile pesticides. This is, however, based on only a few measurements on dichlorvos
and methylbromide, and less volatile pesticides as parathion-ethyl and fenbutatinoxide.

The approach presented assumes that substantial emissions occur during the first hours after
application with closed windows (conform Baas & Huygen, 1992), only acute exposure (up to
a few hours) is thus taken into account. Longer, e.g. subacute exposure (roughly up to circa
four weeks after application) may not be relevant assuming that after a few hours the larger
part of gas-phase pesticides in or around greenhouses has been dissipated. The likelihood of
subacute (or longer: semi-chronic and chronic) exposure should take into account the
pesticide emission patterns over weeks to years. Then other potential peak emissions - e.g. re-
opening ventilation windows prior to personnel re-entry - may be investigated as well. Such
an investigation will have to focus on (very) low concentrations of gas-phase pesticides,
which still is a tedious, laborious and costly affair (Mensink, 2004).

For use in risk assessment procedures, it may cautiously be concluded that if for less volatile
pesticides no toxicologically relevant exposure is indicated by the calculations, the pesticide
can be considered to be used safely, respecting nearby residents. If the calculations reveal a
substantial and possibly toxicologically relevant exposure, submitted data should be
reconsidered and a higher tier exposure assessment should be an option. Besides being a
systematic help in analysing preliminary exposure scenarios (via USES, via related scientific
research), the calculation scheme may be helpful for other purposes as well. It may e.g. be
helpful in the area of triggering higher-tier studies, in this case: to obtain more reliable
exposure data and subsequent decision-making (Mensink, 2004). By using the proposed
calculation scheme the outcomes may reveal e.g. whether:

empirical higher-tier data should be required from the registrant when certain trigger
values are exceeded (e.g. higher-tier data on pesticide emissions in relation to droplet
distributions, fluxes, concentrations, inhalatory toxicity);
risk mitigating measures (energy, screens, lower dosages,) should be required.

150
The USES approach has several limitations (Mensink, 2004):

Degradation in air has not been taken into account due to a lack of data. The pesticides
that have been studied, however, are probably resistent against photochemical degradation
during the first hours after application. In this way, the likelihood of overestimating gas-
phase pesticide concentrations within the first hour seems limited. It should be noted
though that the WHO indicated that diclorvos is rapidly degraded in air, its rate depending
on air humidity (WHO & IPCS, 1995);
The calculation scheme in the present report is not designed for use in site-specific
assessments. It is only applicable for generic assessments;
When the assessment in USES is in accordance with the proposed calculation scheme of
Mensink (2004), then particular technical and physical standard conditions are the
starting points. However, these conditions can be adapted, to a certain extent;
It is recognised that certain process formulations are based on limited research and need
to be improved. Further research may reveal further improvements of the calculation
scheme;
The outcomes are based on a dosage frequency of one, whereas multiple dosages
regularly occur under horticultural conditions;
Re-volatilisation after deposition (as subsequent delivery) has not been taken into
account. Inclusion of that aspect would require temperature as input. Therefore,
underestimation of gas-phase pesticide concentrations inside greenhouses may occur;
The decrease of the gas-phase pesticide concentration in greenhouses is assumed to be due
to deposition and ventilation only. Partitioning into droplets e.g. has not been taken into
account. Therefore overestimation of gas-phase pesticide concentrations inside
greenhouses may occur.

In respons to these limitations Mensink (2004) formulated recommendations to the present
approach in anticipation of proper and useful experimental research. Such proper and useful
research should focus on technical aspects as:

The validity of the proposed calculation scheme: analytical measurements (monitoring)
both inside and outside greenhouses under controlled conditions should be included. If the
validity is not shown, the impact of various process-based parameters (e.g. rate constants)
and other parameters (e.g. K
gh
and ) has to be analysed. The role of temperature should
be taken into account. Prospective investigations should also take into account that
greenhouses can be expected to be largely scaled-up. Currently, there is no guarantee that
the calculation outcomes are more reliable than the outcomes of previous USES versions,
particularly in view of the poor validation status. Until better input data are available to
adjust and improve the exposure assessment for horticultural workers and nearby
residents, it should be realised that from a scientific point of view, lack of data - exposure
data for residents nearby greenhouses in particular - should be reflected in relatively large
uncertainty margins;
Concerning risk assessment for residents nearby greenhouses, exposure assessment
should have sufficient resolution in order to be compared with inhalatory no-effect levels
for humans. Therefore it is important to develop exposure models on equal terms with the
effects assessment. The availability of a very detailed and realistic exposure assessment
should not be undone by very rough limit values (that do not need such a detailed
exposure assessment). Thus, the effects assessment should be better founded. Only then,
monitoring over longer periods may reveal indications for sub-acute, semi-chronic or
chronic effects. Moreover, there is also not much known about pesticide cocktails that
151
may show cumulative effects when pesticides are simultaneously applied, or about the
(potential) effects of small concentrations over a longer period of exposure (if realistic)
(Leistra et al., 2001);
Only three volatility classes have been taken into account conform Leistra et al. (2001),
whereas previous versions of USES discern five volatility classes. In this way, the scheme
could be refined;
The scenario causing the least pesticide emissions is one for a moderately volatile
pesticide and not for a slightly volatile pesticide as one could intuitively expect. It should
be investigated whether this difference is real, as there seems no plausible explanation for
this difference;
The values are based on experimental recoveries, immediately after application
(gasphase concentrations at t=0). The advantage of such correction factors is that they
refer to actual conditions, and that they are easy to substitute by more extensive data in
this field. However, as they refer to a few experiments with three different pesticides only,
their foundations are weak (no testing whether values are statistically significant).
Besides, the effects of the temperature under the experimental conditions were not clearly
reported. It is therefore recommended that further experiments should aim at a more solid
determination of useful and reliable values. Mass balances will be helpful to validate
these values. This recommendation had also been postulated in (Baas & Huygen, 1992).
In conclusion, the quality of the available values does not seem to legitimate yet their
inclusion in the USES proposal. As an example it can be mentioned that it is not clear why
the values for dichlorvos (0.42 and 0.60, therefore 0.51 as average) were lower than
those for the less volatile parathion-ethyl (0.71), whereas the application technique was
the same (LVM) (Baas & Huygen et al., 1992). This may have been due to a larger
preference of dichlorvos to partition to condensation droplets (pers. comm. Deneer,
Alterra to RIVM, 2004). Processes may therefore be more complex than the calculation
scheme suggests. One may wonder whether such complex and simultaneously occurring
processes as volatilisation, deposition and ventilation can be modelled sufficiently by such
a straightforward approach as presented by Mensink (2004). Experiments of Wang &
Deltour (1999) showed some of the complexities of modelling air movements in large
multi-span greenhouses. They found that in a 1728 m completely closed Venlo-type
greenhouse, a surprisingly strong airflow inside the greenhouse was caused by a strong
external wind (8.33 m/s). These internal airflows were in the reverse direction as the
external wind and probably induced by buoyancy forces and forced convection due to
leakage. This may disprove that higher wind speeds cause lower lee side eddy
concentrations, as assumed by the proposed calculation scheme;
The assumption of photochemical stability of dichlorvos, parathion-ethyl and
fenbutatinoxide during at least the first hours after application should be better
investigated. The inclusion of such data in (re)registration dossiers should be considered.
In recapitulation, it seems reasonable to advance the next zero hypothesis (H
0
): highly, or
under some application conditions (i.e. space treatment) also moderately, volatile
pesticides will show measurable gas-phase concentrations inside a greenhouse conform
the proposed calculation scheme. The estimations may deviate increasingly (estimations
increasingly exceeding measured concentrations) for scenarios with supposedly less gas-
phase emissions. Due to the nearly complete lack of measurements in ambient air nearby
greenhouses under controlled conditions, (almost) immediately after pesticide
applications, statements on validity of the scheme are not possible yet.
152
IX. Conclusion

Following the switch in responsibility from DG SANCO to EFSA the required high priority
of an improved human exposure assessment was achieved. Significant progress has been
made in the area of occupational exposure assessments for pesticides. However, the currently
used approaches are based on very old exposure data, some of which were considered
inappropriate or even wrong by the EUROPOEM expert group. This holds mainly for
operator exposure. Currently a large set of new data, developed according to the recent views
on how to collect exposure data, are on hold within industry. Industry is prepared to make
these data publicly available in an improved approach such as AHED (van Hemmen pers.
comm., 2006). The re-entry worker and bystander risk assessments are currently not carried
out in line with the proposals of EUROPOEM II and recent extensive reviews have led to the
conclusion that residential exposure assessment is strongly needed. These issues imply the
need for an intensive human exposure discussion and innovative approaches for assessing
human exposure. Therefore van Hemmen (pers. comm., 2006) proposes to install an expert
group with national experts under the umbrella of EFSA (PPR Panel) with support of industry
experts, similar to the EUROPOEM expert group.

In recent years, there has been considerable activity in harmonizing the different approaches
and methods for assessing occupational exposure. A series of workshops designed to promote
harmonization have been pivotal to the successes to date (Henderson et al., 1993; Curry et al.,
1995; Bergeron et al., 1997, van Hemmen & Van der Jagt, 2001). However, given the rapid
evolution of the scientific discipline of occupational exposure assessments, continued
progress is very important. There are still numerous opportunities for improving the
consistency, transparency and efficiency of occupational exposure assessments through
harmonization. Norman (2005) identified several items which need to be considered as
priorities for harmonization. These priorities are listed below and can be considered as good
starting points in the view of future discussions on human exposure.

First of all a common understanding of the terminology used in occupational exposure
assessments is an important prerequisite to effective harmonization. For example, inconsistent
use of terms such as exposure/dose and upper bound/worst-case is confusing and can be
impediment to effective harmonization (Norman, 2005).

Secondly a framework should be established for post-application agricultural exposure
assessments and exposure assessments for residents living in agricultural areas in order to
address data requirements. In case of post-application exposure more effort is required to
reach consensus on specific inputs, including selection of day zero default residue values
and generic transfer coefficients. EUROPOEM II has proposed a harmonized approach, but
up to now this approach has not yet officially been adopted. In addition, default dissipation
kinetics merit discussion. Some jurisdictions have assumed 10% per day, while others assume
no dissipation. Further research is also needed in order to develop approaches for estimating
inhalation exposure of agricultural workers to volatile pesticides. This research should
consider outdoor re-entry workers as well as greenhouse workers. Regarding residents living
in agricultural areas, an approach could be developed based on additional field work and the
EUROPOEM approach for bystanders (van Hemmen, 2006). Recent extensive reviews
indicated the importance of such residential exposure (and thus) risk assessments. Moreover,
since many jurisdictions waive the requirement for a quantitative exposure and risk
assessment on a case-by-case basis, citing negligible exposure, clear guidance on what
153
constitutes negligible exposure should be provided and a harmonized set of criteria for
making this determination should be established (Norman, 2005).

A third option for further harmonization is the standardization of data requirements. For
conventional pesticides an assessment of exposure is required if the proposed use pattern
indicates potential handler exposure (either occupational or residential) or agricultural re-
entry exposure. The extent to which exposure assessments are required for residential re-entry
scenarios or bystanders is less uniform. For these scenarios, data requirements should be well
established and standardized. For example, subpopulations of bystanders which merit
quantitative exposure assessments (e.g. residential exposure in agricultural areas) have to be
identified (Norman, 2005). Specifically for childrens exposure assessments a lot of
improvement is required, particularly in Europe.

Moreover, methodological guidance on several topics has to be provided in order to obtain
the necessary data. Guidance is needed on: 1) how to conduct exposure studies to measure
post-application exposure & residential exposure in agricultural settings; 2) how to derive
transfer metrics for post-application exposure scenarios in agricultural settings, when the
treated surface of interest is not foliage, e.g. soil; 3) how to validate the in vitro dermal
absorption methodology; 4) how to interpret residues remaining on washed skin in in vivo
dermal absorption studies; 5) how to conduct dermal absorption studies with human
volunteers in this way that ethical issues are respected (Norman, 2005).

Concerning database development, it should be noted that updating datasets is very
important. For mixer/loader/applicator databases, such as EUROPOEM, updating is essential
so that a broader range of mixer/loader and applicator functions can be reflected and newer
trends in agricultural application technology can be captured. This need has been recognized.
For harmonized exposure assessment between North America and Europe, the use of the
AHED database, which combines the PHED and EUROPOEM database has been proposed.
Region-specific considerations could be accommodated by additional subsetting options.
Regarding the development of databases for agricultural workers, a lot of improvement is still
required. For agricultural worker assessments in the EU there is a fundamental shortage in
data. Also for bystanders and residents there is a fundamental lack of data (Norman, 2005).

Regarding modelling initiatives there is an urgent need in developing guidance regarding
model validation criteria, good modelling practices and criteria for model-based assessments
(Norman, 2005).

Current challenges in the field of data analysis and interpretation of data from occupational
exposure studies are numerous. It is important that consistent approaches to data analysis be
adopted in order to facilitate review sharing and consistent decision-making. Areas where
there is currently divergence in approaches, or no clearly outlined approach, are noted below
(Norman, 2005):

Harmonization of exposure factors (including physiologiocal (body weight,
body surface, life expectancy,), pesticide usage (hectare treated per day,
application rates, equipment used,) and lifestyle factors (human activity
data)). Standardization is necessary;
Mathematical approach: Guidance for selecting an appropriate mathematical
approach (deterministic versus probabilistic) for a give exposure scenario and
guidance regarding conduct of acceptable probabilistic assessments is needed;
154
Harmonized guidance for specific data analysis issues (i.e. corrections for
incomplete field recovery, interpretation of residues present below the limit of
detection, guidance for interpretation of outliers and atypical observations);
Harmonized guidance for appropriate expressions of exposure (daily,
time-weighted average or amortized expressions of exposure).

An aspect that should also be considered in the near future is the selection of central tendency
and appropriate metrics for risk assessment addressing significant toxicity endpoints.
Regardless of the mathematical approach used, it is important that harmonized guidance exists
for metric selection. Guidance should be based on a number of considerations, including data
quality, data quantity, distribution type, duration of exposure and nature of the toxicology
endpoint. In the U.S. recent consulations on central tendency selection for the Pesticide
Handlers Exposure Database (PHED) resulted in general guidance that may be applicable
beyond PHED. This consulation resulted in the following general guidance recommendations
(Norman, 2005):
For short-term exposures, the median is the appropriate measure of central
tendency. This guidance is based on the recognition that, for the two most
prevalent distribution types (log-normal and normal), the median approximates
the mean (i.e. geometric mean for log-normal distribution and arithmetic mean
for normal distributions;
For longer term exposures, the arithmetic mean is the most appropriate
measure of central tendency. This is based on the recognition that the central
limit theorem dictates that with multiple exposure events, the average of these
events will converge to the arithmetic mean of the original distribution from
which the events were drawn, and that the distribution of those averages will
follow a normal distribution, regardless of the form of the original underlying
distribution;
For risk assessments addressing significant acute toxicity endpoints, the
arithmetic mean or another reasonably high-end measure of exposure should
be selected. Such high-end measures of exposure could include an upper
percentile from a probabilistic output or a maximum. Guidance is needed on
what considerations should lead to the use of such high-end measures of
exposure. Factors to be incorporated would need to include the nature of the
toxicological endpoint, existing toxicologically based uncertainty or safety
factors, and the confidence in the exposure estimates;

Such guidance requires international debate and consensus as there can be differences among
what regulatory authorities will utilize and this can lead to divergence in country-specific
asessments. Guidance is also required on the appropriate use of time-weighted average and
amortized exposure estimates as the selection of a daily versus time-weighted average versus
a lifetime daily average exposure can lead to divergent risk assessment outcomes. Guidance in
this area would be a function of several factors, including exposure duration, frequency and
interval, the toxicology endpoint, mechanism of action considerations and documented
sensitivities to specific subpopulations. Harmonized decision logic is required. An important
aspect would be addressing appropriate data analysis approaches for generating time-
weighted average or lifetime average exposures across age categories, including juvenile
categories (Norman, 2005).
155
Regarding research needs, there is a requirement to develop harmonized priorities for
research that would strengthen risk assessment methodologies for pesticides. This would
imply the development of an effective communication strategy so that funding bodies and the
research communities are informed about those priorities (Norman, 2005).

Concerning exposure mitigation, harmonization is needed regarding the degree of protection
provided by personal protective equipment (clothing, gloves, respirators) and engineering
controls (mixing/loading systems, cabs,). This should be feasible as region-specific
considerations should be minor (Norman, 2005). The Netherlands has commissioned TNO to
prepare a document based on recent data and on approaches taken on, throughout Europe and
North America, on the possibilities of harmonization of PPE efficacies as used for risk
management purposes. This report is due by the end of 2006 and is based on frequent
consultation of national authorities in the EU and North America (van Hemmen pers. comm.,
2006). Labeling of pesticides and the establishment of re-entry intervals should also be
harmonized (Norman, 2005).

Concerning occupational and residential risk assessment convergence to a common
expression of risk is feasible and would promote harmonization. Currenly the EU applies
Acceptable Operator Exposure Levels to compare the exposure to, while the U.S. uses
Margins of Exposure. Moreover, route-specific assessments should be considered when the
toxicology database indicates the need for such assessments or when appropriate toxicology
studies exist using the dominant route of exposure. Guidance is needed on when and how to
do this. Also, consistent approaches to application of uncertainty and safety factors are
needed. In the EU, there is consensus on the use of 10 to account for interspecies differences
in toxic response to a chemical, but there are different approaches in the intraspecies factor.
These differences have not been fully resolved (Hamey, 2000). There is also a need for a
coordinated method for developing aggregate and cumulative risk assessments (Norman,
2005).

Enhancing harmonization can also be achieved by means of cooperative regulatory
activities. In 1999, a cooperative international review team, comprised of Canada, the United
States, Australia and the European Union (Ireland), participated in a pilot project that focused
on exchange and utilization of each others reviews. The pilot project confirmed that the
shared approach to review being taken by regulatory agencies worldwide, leads to more
efficient regulatory systems, while still allowing each country to uphold their own rigorous
standards for health and environmental protection (Norman, 2005).

It is clear that a lot of work still needs to be done.

156
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http://www.ppo.wur.nl/NL



XI. Annexes

Annex I: EUROPOEM

Description of the EUROPOEM model

The EUROPOEM Database is a generic database of monitored operator exposure studies
relevant to plant protection products in European agriculture. The objective of the
EUROPOEM Database Project was to develop a generic model for use in risk assessment
procedures. The data for the database were delivered by industry, governments and academia
and have to fulfil certain quality criteria for field and laboratory measurements. The major
quality criteria are as follows: (1) good documentation, describing in detail the study design,
participants and results; (2) representativeness of the study for European situations; (3)
adequate sampling methodology applied to different workers under varying conditions of
equipment and climate for a large part of the work shift (this excludes at least in part the
sampling of single workers for many times); (4) adequate chemical analysis, with appropriate
quality controls.

The EUROPOEM Database includes exposure data on mixer/loaders, applicators and
mixer/loader/applicators of pesticides. Also the exposure of bystanders is included in the
database. EUROPOEM contains up to 600 individual replicates, covering exposure with
several techniques, such as boom sprayers, air blast applications, and hand-held applications.

The EUROPOEM project has established the basis for a three-tiered harmonised risk
assessment framework. In a first tier, default exposure values, derived from all available
exposure data are used. In the second tier further data for protection factors from dermal
uptake and effectiveness of protective clothing are considered. Ultimately, assessment in the
third tier would use actual exposure data for specific products derived from dedicated field
studies, possibly involving biological monitoring.

The database allows selection of parameters for calculations, statistical analysis and exposure
summaries. The EUROPOEM Database may be used for exposure prediction, model
validation, risk analysis, comparison of application techniques, exposure study design,
determination of required need of protective measures, as well as pesticide product
authorization.

(EUROPOEM, 1996)











Spreadsheet of the EUROPOEM model













EUROPOEM I Surrogate values segregated for Mixer/Loader only

Table XI.1.1: Surrogate values segregated for mixer/loader only
Formulation type
Application
equipment
Route of exposure Potential exposure n
A
(mg/kg a.s.)
Hands 100 (8) (indicative)
Dermal (body and.
hands)
100 (10) indicative
Vehicle-mounted
(all types)
Inhalation 1 (11) (indicative)
Hands no good data to be considered
Dermal (body and
hands)
no data available
Wettable powder
(WP)

Hand-held (all
types)
Inhalation no good data (too small dataset)
Hands 1 (9) (indicative)
Dermal (body and
hands)
2 (22) (indicative)
Vehicle-mounted
(all types)
Inhalation 0,1 (17) (indicative)
Hands no good data
Dermal (body and
hands)
no good data
Wettable granule
(WG)
Hand-held (all
types)
Inhalation 0,1 (16) (indicative)
Hands 20 (41)
Dermal (body and
hands)
20 (87)
Vehicle-mounted
(all types)
Inhalation 0,005 (45)
Hands 120 (36)
Dermal (body and
hands)
130 (51)
Liquid
Hand-held (all
types)
Inhalation 0,1 (indicative) (20)
Indicative: low confidence value
n
A
: number of measurements on which the surrogate exposure values are based







EUROPOEM I Surrogate values segregated for Applicator only

Table XI.1.2: Surrogate values segregated for applicator only
Spraying direction Application equipment Route of exposure
Potential exposure n
A
(mg/kg
a.s.) EUROPOEM I
Hands 2 (40)
Dermal (no hands) 0,6 (41)
Dermal (body and
hands)
3 (30) Downwards
Vehicle-mounted
(ground boom sprayers)
Inhalation 0,008 (45)
Hands 11 (22)
Dermal (no hands) 63 (22)
Dermal (body and
hands)
76 (22) Upwards
Vehicle-mounted
(broadcast air-assisted)
< 400 l/ha
Inhalation 0,03 (18)
Hands 11 (13)
Dermal (no hands) 63 (25)
Dermal (body and
hands)
76 (25) Upwards
Vehicle-mounted
(broadcast air-assisted)
> 400 l/ha
Inhalation 0,03 (26)
Hands 65 (indicative) (32)
Dermal (no hands) 1100 (indicative) (24)
Dermal (body and
hands)
1200 (indicative) (24) Upwards Hand-held (all types)
Inhalation 1 (indicative) (23)
Hands 100 (indicative) (25)
Dermal (no hands) 250 (indicative) (25)
Dermal (body and
hands)
300 (indicative) (25) Downwards Hand-held (all types)
Inhalation 0,01 (indicative) (7)
Indicative: low confidence value
n
A
: number of measurements on which the surrogate exposure values are based

EUROPOEM I Surrogate values segregated for Mixer, Loader and Applicator only

Table XI.1.3: Surrogate values segregated for mixer/loader and applicator only
Formulation Type Application equipment Route of exposure Potential exposure
Hands 10 (indicative)
Body (no hands) 15 (indicative)
Dermal (body and hands) 30 (indicative)
Vehicle-mounted (ground
boom sprayers)
Inhalation 0,02 (indicative)
Hands 1350 (indicative)
Body( no hands) 130 (indicative)
Dermal (body and hands) 1370 (indicative)
Liquid
Hand-held (indoors)
Inhalation 0,3 (indicative)
Indicative: low confidence value




Table XI.1.4: Database used to calculate the operator exposure indicator according to EUROPOEM I
Product
Formulation
Application
equipment
Indoor/Outdoor
Spraying
direction
MixLoadInhal MixLoadDermal ApplicInhal ApplicHand ApplicDermal
Liquid Mechanical Outdoors Downwards 0,005 20 0,008 2 0,6
Liquid Mechanical Outdoors Upwards 0,005 20 0,03 11 63
Liquid Manual Outdoors Downwards 0,1 120 0,01 100 250
Liquid Manual Outdoors Upwards 0,1 120 1 65 1100
Liquid Manual Indoors Downwards 0,1 1
E
-9 0,3 1350 130
Liquid Manual Indoors Upwards 0,1 1
E
-9 0,3 1350 130
WP Mechanical Outdoors Downwards 1 100 0,008 2 0,6
WP Mechanical Outdoors Upwards 1 100 0,03 11 63
WP Manual Outdoors Downwards 1 100 0,01 100 250
WP Manual Outdoors Upwards 1 100 1 65 1100
WP Manual Indoors Downwards 1 1
E
-9 0,3 1350 130
WP Manual Indoors Upwards 1 1
E
-9 0,3 1350 130
WG Mechanical Outdoors Downwards 0,1 1 0,008 2 0,6
WG Mechanical Outdoors Upwards 0,1 1 0,03 11 63
WG Manual Outdoors Downwards 0,1 21* 0,01 100 250
WG Manual Outdoors Upwards 0,1 21* 1 65 1100
WG Manual Indoors Downwards 0,1 1
E
-9 0,3 1350 130
WG Manual Indoors Upwards 0,1 1
E
-9 0,3 1350 130
Granule Mechanical Outdoors Downwards 0,1 2 1
E
-9 1
E
-9 1
E
-9
Granule Manual Outdoors Downwards 0,1 21* 1
E
-9 1
E
-9 1
E
-9
Granule Manual Indoors Downwards 0,1 21* 1
E
-9 1
E
-9 1
E
-9
* Source: German model because of absent data in the EUROPOEM database (Lundehn et al, 1992)







The EUROPOEM II Project

The EUROPOEM II Project was set up with a number of related objectives dealing with field
measurements of worker and environmental exposure to pesticides and the validation of
existing models for predictive exposure evaluation. A key element to achieving the principal
objectives was the use of validated methods of field exposure measurements which could be
used by workers in a range of European countries. Therefore common protocols were
prepared during the EUROPOEM II project and followed to generate data required for the
model validation procedures (EU, 2002).

This project was undertaken to fill the data gaps for Southern European countries and Finland,
where hand-held pesticide application methods were commonly used for both outdoor and
indoor crops. Existing models such as the UK POEM (Predictive Operator Exposure Model)
and the German exposure model had few data for hand held application methods. However,
existing data indicated that levels of worker exposure were higher with such application
methods than for the application methods involving tractor mounted or tractor drawn sprayers.
The initial literature searches revealed that specifically for high volume application of
pesticides to greenhouse crops with hand held equipment no suitable data were available. And
this is the most commonly used application method for pesticides in greenhouses in Southern
Europe, and was identified by members of the EUROPOEM Group as a high priority for data
generation. Phase I of this project generated over 100 data sets for the priority application
scenarios, using a common OECD guideline protocol. This protocol for potential operator
exposure assessments was included in the first annual report of the EUROPOEM Working
Group and a version published as part of a number of poster presentations and refereed
papers. The protocols were critically discussed by stakeholders and scientists before the
technical work began. For full details on the analytical methodology I refer to the EU R 20489
Report The assessment of operator, bystander and environmental exposure to pesticides
(EU, 2002). Commonly grown crops were selected for the studies, which include the worst
case conditions. i.e. tall crops such as cucumbers, green beans or melons. The majority of the
applications were done with high volume application and all were with hand-held equipment.
Potential dermal and inhalation exposure data were collected for the applicator, and where
possible associated workers such as hose men. Potential inhalation and dermal bystander
exposure data were also collected in some field studies. The Expert Group of EUROPOEM
(European Predictive Operator Exposure Model) used these datasets to supplement the
database for operator exposure. The levels of potential dermal exposure that were measured
were found to be similar to many of the existing datasets for comparable application
scenarios. The spread of the data was also as expected, with the potential dermal exposure
slightly greater for hand held methods than for the application methods involving tractor
powered sprayers.

In the second phase of the EUROPOEM II project the protective factors of commonly worn
coveralls in Southern Europe were investigated. Field and laboratory studies with a range of
coveralls were carried out to quantify likely levels of penetration. Due to the warm climatic
conditions in Southern Europe impermeable coveralls are rarely worn. Therefore, the types of
coveralls worn tend to be permeable, such as cotton or cotton polyester mixtures. The results
from the conducted studies indicate that these types of coveralls can give the operator some
degree of protection during pesticide application. However the degree of protection varies
with the rate of liquid contamination of the coverall.


In the final phase a modelling exercise was performed and this appeared to be successful, with
a large number of datasets being added to the EUROPOEM database. The levels of potential
dermal exposure to pesticides for hand held applications in Southern Europe tended to fit in
with expectations based on the limited datasets available from studies conducted in Northern
Europe. The data seemed variable, but this reflected the wide range of application and
cropping conditions encountered across Southern Europe.

All the data gathered during the EUROPOEM II project assisted in the consolidation and
validation of the EUROPOEM model both by supplementing its database with field
measurements relevant to Southern European conditions and by corroborating of working
assumptions in regard of personal protective equipment and skin absorption, which mitigate
the likely exposure resulting from contamination by pesticides occurring during their use. All
the data gathered during the EUROPOEM II project should be communicated to the users of
the computer program.




EUROPOEM II Surrogate exposure values segregated for Mixer/Loader only

Table XI.1.5: Surrogate values segregated for mixer/loader only
Formulation type
Application
equipment
Route of exposure Potential exposure n
A
(mg/kg a.s.)
Hands
43,024 (11) (max);
30,513 (11) (75
th
)
6,2 (14) (geometric mean)
Dermal (body excl.
hands)
10,715 (27) (90
th
);
6,753 (27) (75
th
)
3,0 (27) (geometric mean)
Vehicle-mounted (all
types)
Inhalation
0.385 (21) (90
th
)
0,0527 (21) (75
th
)
0,025 (27) (geometric mean)
Hands
12,96 (2) (75
th
) no good data to be
considered
Dermal (body excl.
hands)
no data available
Wettable powder
(WP)

Hand-held (all types)
Inhalation
0,940 (3) (75
th
) no good data (too small
dataset)
Hands
1.319 (15) (max)
0,86 (15) (75
th
)
0,20 (24) (geometric mean)
Dermal (body excl.
hands)
4.501 (47) (90
th
)
1,565 (47) (75
th
)
0,47 (47) (geometric mean)
Vehicle-mounted (all
types)
Inhalation
0.034 (41) (90
th
)
0.034 (41) (75
th
)
0,012 (42) (geometric mean)
Hands
13,23 (8) (max) no good data
5,833 (8) (75
th
) no good data
Dermal (body excl.
hands)
6,874 (8) (max) no good data
1,468 (8) (75
th
) no good data
Wettable granule
(WG)
Hand-held (all types)
Inhalation
0.02089 (16) (max)
0.03062(16) (75
th
)
0,0037 (16) (geometric mean)
Hands
19.834 (59) (75
th
)
6,8 (59) (geometric mean)
Dermal (body excl.
hands)
1.730 (111) (75
th
)
0,5 (111) (geometric mean)
Vehicle-mounted (all
types)
Inhalation
0,002894 (70) (75
th
)
0,001 (72) (geometric mean)
Hands
519 (17) (max)
159 (17) (75
th
)
59 (17) (geometric mean)
Dermal (body excl.
hands)
255 (32) (90
th
)
38,33 (32) (75
th
)
9,3 (32) (geometric mean)
Liquid
Hand-held (all types)
Inhalation
0,09 (18) (90
th
)
0,022 (18) (75
th
)
0,025 (20) (geometric mean)
n
A
: number of measurements on which the surrogate exposure values are based

It has to be noted that further well-designed field studies should be carried out to provide a
sound basis for describing exposures for these scenarios. The available datasets for granules
and wettable powders are very weak, and for mixing and loading for hand-held equipment
virtually non existent. Data for wettable dusts are also lacking.


EUROPOEM II Surrogate values segregated for Applicator only
Table XI.1.6: Surrogate values segregated for applicator only
Spraying direction Application equipment Route of exposure
Potential exposure n
A
(mg/kg
a.s.) EUROPOEM II
Hands
0.702 (88) (75
th
)
0,12 (88) (geometric mean)
Dermal (no hands)
0,747 (104) (75
th
)
0,030 (104) (geometric mean)
Downwards
Vehicle-mounted
(ground boom sprayers)
Inhalation
0,0286 (104) (75
th
)
0,0027 (108) (geometric mean)
Hands
17,314 (34) (90
th
)
9,724 (34) (75
th
)
3,9 (35) (geometric mean)
Dermal (no hands)
40,66 (71) (75
th
)
16 (71) (geometric mean)
Upwards
Vehicle-mounted
(broadcast air-assisted)
(< 1200 l/ha)
Inhalation
0,127 (30) (90
th
)
0,046 (30) (75
th
)
0,018 (58) (geometric mean)
Hands
1341 (90
th
) (49)
647 (75
th
) (49)
109 (geometric mean) (49)
Dermal (no hands)
2162 (75
th
) (69)
458 (geometric mean) (66)
Downwards (<1,0m) Hand-held (all types)
Inhalation
0,125 (75
th
) (78)
0,21 (geometric mean) (48)
Hands
265 (75
th
) (63)
42 (geometric mean) (63)
Dermal (no hands)
857 (75
th
) (127)
251 (geometric mean) (122)
Upwards (> 1,0m) Hand-held (all types)
Inhalation
0,156 (75
th
) (103)
0,1 (geometric mean) (93)
n
A
: number of measurements on which the surrogate exposure values are based

EUROPOEM II Surrogate values segregated for Mixer, Loader and Applicator only

Table XI.1.7: Surrogate values segregated for mixer/loader and applicator only
Formulation Type Application equipment Route of exposure Potential exposure
Hands
27,120 (90
th
) (23)
8,428 (75
th
) (23)
3,7 (geometric mean) (23)
Body (no hands)
14,520 (90
th
) (43)
8,486 (75
th
) (43)
3,7 (geometric mean) (43)
Vehicle-mounted (ground
boom sprayers)
Inhalation
0,560 (max) (30)
0,065 (75
th
) (30)
0,0017 (geometric mean) (30)
Hands
1346 (max) (16)
55,151 (75
th
) (16)
30 (geometric mean) (16)
Body( no hands)
392 (90
th
) (31)
38,283 (75
th
) (31)
24 (geometric mean) (31)
Liquid
Hand-held
Inhalation
0,087 (90
th
) (21)
0,0245 (75
th
) (21)
0,055 (geometric mean) (20)


Annex II: Grouping of formulation types into categories

Table XI.2.1: Grouping of formulation types
Formulation Type Symbol Formulation Category
Microgranules MG Granule
Fine granules FG Granule
Fumigation granules FW Granule
Tablets TB Granule
Granule GR Granule
Emusifiable granule EG WG
Water dispersable granules WG WG
Water soluble granules SG WG
Water soluble bags WB WG
Capsule suspension CS Liquid
emulsifiable concentrate EC Liquid
Oil in water emulsion EW Liquid
Suspension concentrate SC Liquid
Soluble concentrate SL Liquid
Combi pack (liquid-liquid) KL Liquid
Micro emulsion ME Liquid
Liquid destined for use in a non-diluted form AL Liquid
Aquaous emulsion EW Liquid
Suspension concentrates for seed treatments FS Liquid
Latex PA Liquid
Suspo-emulsion SE Liquid
Dispersable concentrate DC Liquid
Liquids for seed treatments LS Liquid
Liquid for ULV applications UL Liquid
Liquid mineral oil HM Liquid
Liquid unspecified LI Liquid
Wettable powder WP Powder
Water soluble powder SP Powder
Dust powder DP Powder
Powder PP Powder
Wettable powder for humid treatments WS Powder
Powders for dry seed treatment DS Powder

Annex III: Linking crops and application methods & categorizing them

Table XI.3.1: Crop grouping according to the location of cultivation (Indoor/Greenhouse or Outdoor/Field/Orchard) and application method
Crop group Crops
Indoor (greenhouse)/Outdoor (field)
cultivation
Application Method
Common Wheat
Durum Wheat
Rye
Barley (Spring & Winter)
Oats
Grain Maize
Rice
cereals
Other cereals (Corn, Spelt, Triticale)
Outdoor Mechanical outdoors downwards
Pulses Fodder Peas
Pulses
Pulses Fodder Field Beans
Outdoor Mechanical outdoors downwards
Potatoes Early Potatoes, Storage Potatoes, Seed Potatoes Outdoor Mechanical outdoors downwards
Sugar beet Sugar beet Outdoor Mechanical outdoors downwards
Tobacco
Hops
Cotton/Flax
Oil seed or fibre plants (Rape, Turnip, Sunflower,
Soya, Chicory ((Ordinary & Coffe), other)
Aromatic, Medicinal and Culinary Plants (Herbs:
Basil, Mint)
Industrial plants
Other industrial plants
Outdoor Mechanical outdoors downwards
Fodder Fodder Roots and Brassicas Outdoor Mechanical outdoors downwards
Fresh vegetables (Alfalfa, Artichokes, Asparagus,
Broccoli, Brussels Sprouts, Cabbage, Canola,
Carrot, Cauliflower, Celery, Chinese Leaves,
Chervil, Chives, Clover, Cucumber, Fennel,
Garlic, Gherkin, Kale, Lettuce, Leek, Ley, Onion,
Parsley, Radish, Rhubarb, Scorzonera, Shallot,
Sorrel, Spinach, Tomato)
Melons
Outdoor (Open Field & Market
Gardening: Fresh Vegetables,
Melons & Strawberries)
Strawberries
Outdoor Mechanical outdoors downwards


Table XI.3.1: Crop grouping according to the location of cultivation (Indoor/Greenhouse or Outdoor/Field/Orchard) and application method
Crop group Crops
Indoor (greenhouse)/Outdoor (field)
cultivation
Application Method
Fresh Vegetables (Aubergine, Been, Beet,
Cauliflower, Celery, Courgette, Cucumber, Currant,
Cutbeet, Endive, Gherkin, Lettuce, Pepper, Seed,
Sweet Pepper, Tomato & Watercress)
Melons
Strawberries
Flowers and Ornamental Plants
Greenhouse Crops (Vegetables,
Melons & Strawberries;
Flowers & Ornamental Plants
& Permanent Crops)
Permanent Crops Under Glass (Grapes)
Indoor Handheld Application
Outdoor Flowers and
Ornamental Plants
Flowers and Ornamental Plants Outdoor Mechanical outdoors downwards
Nurseries
Vineyards (raisins, table grapes, other wines, quality
wine)
Olive plantations (oil production, table olives)
Citrus plantation (oranges)
Fruit and Berry (temperate climate, subtropical
climate) & Nuts
(Apple, Blackberry, Currants, Cherry, Dewberry,
Gooseberry, Kiwi, Pear, Peach, Raspberry, Plum)
Permanent crops
Other Permanent Crops
Outdoor Mechanical outdoors upwards
Rough Grazings Permanent grassland and
meadows Pasture and Meadows
Outdoor Mechanical outdoors downwards
Temporary Grass
Other Green Fodder (Green Maize, Leguminous
Plants)
Forage plants
Other
Outdoor Mechanical outdoors downwards
Other Other Outdoor Mechanical outdoors downwards








Table XI.3.2: Grouping of application equipment types into broad categories
Application Equipment Specified Application Equipment Category
Broadcast to ground
Ground Boom Sprayer
Ground Boom Sprayer automatic boom
Ground Boom Sprayer golf cart
Ground Boom Sprayer manual Boom
Ground Boom Sprayer simultaneous incorporation
Ground Boom Sprayer self propelled
Ground Boom Sprayer tractor
Ground Boom Sprayer trailed
Ground Boom Sprayer tractor mounted
Ground Boom Sprayer tractor simultaneous incorporation
Ground Boom Sprayer tractor trailed
Groundboom Sprayer
Ground Boom Sprayer Unimog
Solid Broadcast Sprayer Solid Broadcast
8 row cyclopanter
Other Vehicle
8 row planter
Mechanical downwards
Air-assisted Broadcast (tractor drawn Air-O-Fan airblast)
Air-assisted Broadcast (tractor drawn FMC 1087 airblast)
Air-assisted Broadcast (tractor mounted jet sprayer)
Air-assisted Broadcast (tractor drawn PTO-driven airblast)
Air-assisted Broadcast (radial sprayer)
Air-assisted Broadcast (tractor mounted vaporiser)
Broadcast air Assisted Sprayer
Broadcast Air Assisted Sprayer
Broadcast air Assisted Sprayer Tractor Mounted
Aerial
Aerial ULVA Aerial
Fixed Wing Aircraft
Mechanical upwards
Knapsack Motorised
Hand Held Airblast Sprayer
Knapsack Mistblower
Handheld upwards
Batch Mixing from Spray Pistol
Hand Held High Pressure Lance
Hand-Held Lance
Hand-Held Lance/Pistol
Hand-Held Pistol
Knapsack Sprayer Downwards
Knapsack Sprayer
Pedestrian Controlled Sprayer
Pedestrian Controlled Self-Propelled Broadcast Air Assisted Sprayer
Hand Held
Hand Held Sprayer
Spot Gun
Handheld downwards





Annex IV: Exposure mitigation efficiency

In May 2006 a draft version of a discussion paper on the use of PPE coefficients for handling
of agrochemical, microbiological and biocidal pesticides written by Gerritsen-Ebben, R.M.G.,
Brouwer, D.H. and van Hemmen, J.J. was circulated to regulatory authorities and industry
sectors that have contributed to the collection of information. This document is at this
moment being thoroughly reviewed by industry and regulatory agencies. Their reactions,
suggestions and critics are being submitted to the authors.

On request of the Dutch Ministry of Social affairs and Employment, TNO has investigated
current views and facts on the use of default values or approaches for the estimation of
exposure mitigation efficiency (reduction effectiveness) of PPE in registration of pesticides.
On the basis of this research it is hoped that an internationally harmonized set of PPE
protection actors for regulatory use, can be devised.

In the draft document several recommendations for the future proposed by competent
authorities are listed. All these should be taken into account when proposing an international
harmonized set of PPE protection actors for regulatory use (Gerritsen-Ebben et al, 2006.).

Within the framework of the EUROPOEM II project information was gathered from several
European regions on the availability and use of garment type. This information indicated that
there was little use of garments that were classified as chemical protective equipment
specifically recommended for protection against pesticides. Where coveralls are worn, they
tend to consist of cotton or cotton/polyester material and tended to be general workwear rather
than PPE specifically for protection against chemicals. PPE for chemical protection
(protection against liquids) is CE marked as Type 3 (most protection), Type 4 or Type 6 (least
protection). Occasional use of garments constructed of man-made fabrics such as Tyvek does
occur, particularly in Finland. However, coveralls made from a cotton/polyester mixture are
the most typical type of garment used for regions of Europe where field studies are taking
place, i.e. Almeria and Seville (Spain), Lisbon (Portugal), Albenga (Italy), Crete (Greece) and
Kuopio (Finland). Testing of a range of cotton and cotton polyester garments was initiated
following published CEN and prEN methods (EN 468:1995 and prEN13034:1997, clause 6.2)
(EU, 2000).

These coveralls were tested in laboratory and field conditions to quantify the penetration of
the whole garment and also the material itself. The data showed that the penetration of PPE
during field use often exceeds the 10% assumption made in predictive operator exposure
models. This applies for both laboratory and field studies. In the laboratory tests the cotton
coveralls had penetration rates of 20% to 30% of the external loading, which was similar to
the performance under field conditions. However, the Tyvek coverall, which is classified as
chemical protective PPE, performed better in the laboratory (5% penetration) than in the field
(29 to 49% penetration). Under the limited field tests conducted, the cotton coveralls were
seen to have less penetration than the Tyvek. For washed cotton or cotton polyester coveralls
the material penetration was approximately 30 to 50%. The field and laboratory tests have
shown that the penetration of garments depends not only on the amount of liquid
contamination during the work task, but also on the rate of contamination. In the climates of
Southern Europe liquid penetration will tend to dry on the outside of protective clothing.
However, the distribution of the liquid contamination is also a key factor. In extreme cases,
the coverall contamination may be low (e.g. 20 ml/hr), but if the majority of this liquid

contamination is localised in a small area the % penetration may be high, even though most of
the coverall remains dry or free from contamination. Such areas of the coverall receiving
lesser amounts of contamination are less likely to be penetrated. This needs to be borne in
mind when considering how total coverall contamination relates to absorbed dose of pesticide
(EU, 2000).

The protective factor of coveralls which are worn by pesticide applicators and re-entry
workers needs to be considered. Several key factors affect the protective factor of coveralls,
including human behaviour, which has to be investigated in upcoming research projects (EU,
2000). The reference made in EU (2000) to respective European standards for design,
performance and selection of PPE for use with pesticides should broaden the future
applicability of the data gathered within this EU project, because the process of harmonization
across the European Union should bring about greater consistency in utilisation of PPE within
the wide range of commercial conditions under which it is used.

One of the ways of overcoming potential problems associated with the exposure of pesticide
applicators is improved levels of training. Over the last years there has been a marked
improvement in operator training in certain regions, such as Southern Spain. In other regions,
progress has not been as noticeable. Problems of lack of training result in a lack of awareness
of the hazardous nature of pesticides, and the need for simple equipment or procedures to help
mitigate the exposure to pesticides (EU, 2000).

The development of European legislation, requiring pesticide applicators to have formal
training will address the problem of pesticide applicators not adhering to basic safety
instructions on pesticide labels, e.g. wearing gloves when handling the concentrated product.
Training and instruction of the use of application equipment should also lead to the following
of good practice, and ultimately the safe use of pesticides, for both the user (operator), the
environment, and in the end the consumer of the produce.





Annex V: Dermal absorption

Tier 1
A conservative value of 100% is often used for dermal absorption. It is noteworthy that the
California Department of Pesticide Research uses a first tier default of 50% for regulatory
purposes.

Tier 2
A more refined default may be justifiable taking into account a number of considerations such
as the physicochemical properties of the substance and the toxicological database. A weight-
of - evidence approach should be used, i.e. both the physicochemical information and the
toxicological database should support the reduced default. Unfortunately clear cut-off values
for negligible, low and/or high dermal absorption of chemicals cannot be derived from data
present in the open literature (Durkin et al., 1995). De Heer et al. (1999) proposed to refine
the dermal absorption defaults based on theoretical considerations on skin permeation. It
might be expected that there is an optimum in log K
ow
and a maximum in molecular weight
for facilitating percutaneous absorption. The following criteria were proposed by de Heer et
al. (1999) to discriminate between chemicals with high and low dermal absorption:

10% dermal absorption is used in cases where MW>500 g/mol and log Kow is
smaller than -1 or higher than 4, or otherwise;
100% dermal absorption is maintained.

A deviation of 10% or 100% can be chosen on a case by case basis, taking into account all
data available.

Tier 3
This tier involves generation of experimental data on dermal absorption.

(Hakkert et al., 2005)

Further investigation of dermal absorption is required if potential dermal exposure data are to
be used to underpin reliable predictive modelling of the absorbed dose of pesticides. During
application activities, the dermal absorption percentage is not a constant. Moreover, dermal
absorption differs with changing formulation type.



Annex VI: Inhalation absorption

In this document it is assumed as a default that the inhalation absorption factor equals 100%.
Due to the difficulty in determining the fraction of the active substance, measured in the
breathing zone, that is really inhaled, one often assumes that the potential and actual exposure
are equal. It is thus assumed that all the contamination that is really inhaled is effectively
absorbed by the lungs. This certainly leads to an overestimation since part of the particles that
are present in the air are initially too large for inhalation (Anderson et al., 1976). Moreover,
the largest part of the particles that penetrate nose and mouth are absorbed by much less
efficient mechanisms than those operative in the lungs. Part of the particles present in nose
and mouth can be swallowed and ingested in the gastro-intestinal system where chemicals are
only absorbed in a small degree or liable to degradation. Another part of the inhaled active
substance can be exhaled. According to Chester (1993), an inhalation absorption factor of
50% is still too conservative. Brouwer and van Hemmen (1997) found that for propoxur only
40% of the inhaled active substace is really absorbed.



Annex VII: Agricultural Default Transfer Coefficients

Source: Science Advisory Council for Exposure. Policy 003.

The following is a reference in case no post application exposure data are available. Its
purpose is to add consistency to the choice of the default transfer coefficients under such
circumstances. It is specifically designed for agricultural workers. The generic default values
in the table are not supported quantitatively but were derived by exposure assessors based on
their best judgement from their experience with the transfer coefficients used for these crops
and agricultural activities in pesticide specific assessments.

Table XI.7.1: Crop grouping according to the potential for dermal transfer
Low dermal transfer Medium dermal transfer High dermal transfer
Alfalfa Beans, Bush Bananas (unbagged)
Artichokes Caneberries & bushberries Beans, Pole
Asparagus Cantaloupe Corn
Bock Choy Cranberries Tomato
Broccoli Cucumbers
Brussels Sprouts Eggplant
Cabbage Gourds
Celery Herbs, medium-growing
Chick peas Melon
Collards Okra
Herbs, low-growing Peanut
Kale Pepper
Lettuce Pumpkin
Mustard greens Rice
Pineapple Squash
Small grains (barley, wheat, oats) Strawberries
Spinach Zucchini
Swish Chard
Watercress

Table XI.7.2: Default transfer coefficients for agricultural activities
Crop group/site Activitiesr Default transfer coefficient
Harvesting (hands) 2500
Scouting 1000 Low dermal transfer
Irigating 1000
Harvesting (hands) 4000
Scouting 4000
Irigating 4000
Medium dermal transfer
Stake/Tie 4000
Harvesting (hands) 10.000
Scouting 4000
Irigating 4000
High dermal transfer
Stake/Tie 4000
Turfgrass Mow, maintain 1000
Cut, roll, harvest 10.000
Harvest (hand), gridle, cane, tie,
prune, tip, thin
15.000
grapes
Irigating 4000
Tree crops (fruit & nut)
All activities (Harvest (hand),
summer shake, prune, rake, pole
and pickup (nuts), prop
10.000


Table XI.7.2: Default transfer coefficients for agricultural activities
Crop group/site Activitiesr Default transfer coefficient
Cut, Harvesting (flowers) 10.000
Prune (roses) 10.000
Sort & pack 2500
Ornamentals indoor
Irrigating 4000
Transplant ball/burlap) 10.000
Sort & pack 2500
Ornamentals outdoor (shrubs,
trees)
Irrigating 4000
Mushrooms Cut/Harvest/ Sort & pack 2500
Dig/harvest by hand 10.000
Tubers (onions)
Sort & pack 2500
Early season scouting 1000
cotton
Late season scouting 4000
Hoeing, weeding 1000
Till/disc negligible
Plant mechanically negligible
Build furrows negligible
Plant by hands 10.000
All
Aligning plants (potato pieces,
sugar cane)
10.000


Annex VIII: Foliar half life times

The values for the foliar half life times listed in the table below were obtained from the
SWAT pesticide database for default chemicals.





























Annex IX: Estimated number of workdays a year

Several institutions were contacted in order to obtain estimates of the number of workdays
that farmworkers come into contact with the crop during the growth season. We limited the
estimations to the number of days that farmworkers are busy harvesting the crops, since the
only transfer factors available are associated with the harvesting activity. It should be noted
that the best way to obtain these data is by conducting surveys among the farmworkers and
this for the different crops. First of all crops requiring a lot of hand labour need to be
determined. This can be done on the basis of surveys. It has to be mentioned that the crops
requiring hand labour will vary among the Member States of the EU, since each Member
State has its own specific agricultural systems with varying degree of mechanisation. A
thorough review by experts from universities and delegants of the Department of Agriculture
of the estimated number of workdays is highly desirable.

Within the framework of HAIR preliminary estimations of the number of workdays are
proposed for various crops. For each crop the number of workdays a year was estimated on
the basis of expert judgment and scientific publications. It is imported to mention that surveys
should be conducted in the future to obtain more scientifically based estimates of the number
of work days a year for a farmworker in a particular crop. This parameter is of extreme
importance because it indicates the exposure duration of a farmworker.

Research from Larson (2000) determined peak hand labor season dates specific for several
North American States. These estimates were obtained from Usual Planting and Harvesting
Dates and information prepared by the Offices of Rural Health and Resource Development.

In the table below (Table VIII.9.1) the peak season length in work days for several crops is
presented for Belgium. Data that were used to estimate the number of workdays come from
the following sources:

Dedeene, L. & De Kinder, G. (2004). Groente & Fruit Encyclopedie. Kosmos-
Z&K Uitgevers B.V., Utrecht, 405p.(1);
Dekkers, W.A. (2002). Kwantitatieve Informatie. Akkerbouw en
Vollegrondsgroenteteelt 2002. Praktijkonderzoek Plant en Omgeving, PPO-
publicatie nr 301, 317p. (2);
Ministerie van Middenstand en Landbouw (2001). Brochure: de Belgische
landbouwteelten: een overzicht. 76p. (3);
Naets, W. (2005). Verwerkingsmachines in de aspergeteelt. Eindwerk tot het
behalen van de Bachelorgraad gegradueerde in Landbouw en Biotechnologie.
Katholieke Hogeschool Kempen, 47p. (4);
Peppelman, G. & Groot, M.J. (2004) Kwantitatieve Informatie voor de Fruitteelt
2004. Praktijkonderzoek Plant & Omgeving, PPO publicatie nr 611, 154p. (5);
Schreuder, R. & van der Wekken, J.W. (2005). Kwantitatieve Informatie
Bloembollen en Bolbloemen 2005. Praktijkonderzoek Plant & Omgeving, PPO
publicatie nr 719, 215p. (6);
Vermeulen, P.C.M., Nienhuis, J.K., van der Meer, R.W. & Hendrix, A.T.M.
(2001). Beroepsbevolking in de glastuinbouw. Praktijkonderzoek Plant &
Omgeving, PPO publicatie 527,56p. (7);
Van de Voorde, S. (2004). Oogst van bloemkool voor de verse markt: traditioneel
versus gemechaniseerd. Eindwerk tot het behalen van de Bachelorgraad

gegradueerde in Landbouw en Biotechnologie. Katholieke Hogeschool Kempen,
33p. (8);
van Woerden, S.C. (2006) Kwantitatieve Informatie voor de glastuinbouw 2006:
Groenten snijbloemen potplanten. Praktijkonderzoek Plant & Omgeving, PPO
publicatie 594, 277p. (9);
Janssens, B., Kroeze, G. & van der Voort, M. (2004). Arbeidsomstandigheden in
de vollegrondsgroenteteelt. Een inventarisatie van de knelpunten en
oplossingsrichtingen rondom piekarbeid. Praktijkonderzoek Plant & Omgeving,
PPO publicatie 2.04.10, 65p. (10).


Table XI.9.1: Number of workdays a year that farmworkers perform harvesting activities in several crops.
Crop group Crops
Relevant Scenario
(Yes/No) according to the assumptions
made in POCER II
Number of workdays (days)
Common Wheat -
Durum Wheat -
Rye -
Barley (Spring & Winter) -
Oats -
Grain Maize -
cereals
Other cereals (Corn, Spelt & Triticale)
No (mechanical harvest)
(pers. comm. Vleminckx, 2006)
-
Pulses Fodder Peas
Pulses
Pulses Fodder Field Beans
No (one-time mechanical harvest for
industry)
(pers. comm. Vleminckx, 2006)
-
Early Potatoes -
Storage Potatoes -
Potatoes
Seed Potatoes
No, only scouting and inspecting of crops
(mechanical harvest)
(pers. comm. Vleminckx, 2006)
-
Sugar beet Sugar beet
No (pers. comm. Vleminckx, 2006,
mechanical harvest)
-
Tobacco Yes 72 (pers. comm. D. Bogaert, 2006)
Hops
No (pers. comm. Vleminckx, 2006,
mechanical harvest)
-
Cotton/Flax
No (pers. comm. Vleminckx, 2006,
mechanical harvest)
-
Oil seed or fibre plants (Rape, Turnip,
Sunflower, Soya, Chicory (Ordinary &
Coffe), other)
No (pers. comm. Vleminckx, 2006) -
Aromatic, Medicinal and Culinary Plants
(Herbs: Basil, Mint)
No (pers. comm. Vleminckx, 2006) -
Industrial plants
Other industrial plants No (pers. comm. Vleminckx, 2006) -
Fodder Roots and Brassicas -
Peas - Fodder
Maize
No (labour extensive crop)
-




Table XI.9.1: Number of workdays a year that farmworkers perform harvesting activities in several crops.
Crop group Crops
Relevant Scenario
(Yes/No) according to the
assumptions made in POCER II
Number of workdays (days)
Asparagus Yes (source: 10) 60 (source: 4)
Broccoli (summer+fall) Yes (source: 10) 96 (source: 1)
Brussels Sprouts No (source: 10) -
Cabbage No (source: 10) -
Carrot No (source: 10) -
Cauliflower Yes (source: 10) 72 (source: 8)
Chinese Leaves Yes 48 (source: 1)
Chichory Yes 72 (source: 1)
Cucumber Yes 24 (source: 1)
Gherkin Yes 24 (source: 1)
Kale No (source: 10) -
Spring 48 (source: 1)
Lettuce
Summer-fall
Yes
96 (source: 1)
Leek (fall late) Yes (source: 10) 48 (source: 1)
Onion No (www.msp-onions.nl) -
Parsley Yes 120 (source: 1)
Radish Yes 120 (source: 1)
Rhubarb Yes 72 (source: 1)
Scorzonera No (source: 10) -
Spinach No (source: 10) -
Fresh vegetables
Tomato Yes 48 (source: 1)
Melons Melon and Watermelon Yes 48 (source: 1)
June bearing 24 (source: 1)
Outdoor: Open Field &
Market Gardening
Strawberries
Ever bearing
Yes (source: 10)
72 (source: 1)







Table X.9.1: Number of workdays a year that farmworkers perform harvesting activities in several crops.
Crop group Crops
Relevant Scenario
(Yes/No) according to the
assumptions made in POCER
II
Number of workdays (days)
Aubergine Yes 51 (source: 8)
Courgette (2 cultures a season) Yes 77 (source: 8)
Early (3 cultures a
season)
74 (source: 8)
Cucumber
Late (3 cultures a
season)
Yes
80 (source: 8)
Endive (2 cultures a season) Yes 23 (source: 8)
Lettuce (5 cultures a season) Yes 80 (source: 8)
Green 150 (source: 8)
Red 91 (source: 8)
Yellow 99 (source: 8)
Pepper
Orange
Yes
106 (source: 8)
Radish Yes 50 (source: 8)
Mooring rope 85 (source: 7)
Intermediate type 39 (source: 8)
Fresh Vegetables
Tomato
Flesh type
Yes
32 (source: 8)
Melons Yes
Fresh Fruit
Strawberries Yes 85 (source: 8)
Chrysant Yes 86 (source: 7)
Small flower 200 (source: 7)
Flowers and
Ornamental Plants Rose
Large flower
Yes
130 (source: 7)
Greenhouse Crops
Permanent Crops
Under Glass
Grapes, etc. Yes
Outdoor Flowers and
Ornamental Plants
Flowers and Ornamental Plants Yes 95 (assumed default)



Table XI.9.1: Number of workdays a year that farmworkers perform harvesting activities in several crops.
Crop group Crops
Relevant Scenario
(Yes/No) according to the
assumptions made in POCER
II
Number of workdays (days)
Nurseries Yes 72 (assumed default)
Vineyards (raisins, table grapes, other wines, other wines, quality
wine)
Yes 60 (source: 1)
Olive plantations (oil production, table olives) Yes 48 (source: 1)
Citrus plantation (oranges) Yes 72 (www.gumtree.com)*
Nuts Yes 48 (source: 1)
Apple Yes
48 (pers. comm. De Schaetzen (PCF),
2006)
Apricots Yes 12 (source: 1)
Blackberries Yes 24 (source: 1)
Blewberries Yes 30 (source: 1)
Cherries Yes 48 (source: 1)
Cranberries Yes 30 (source: 1)
Currants Yes 48 (source: 1)
Dewberries Yes 48 (source: 1)
Gooseberry Yes 24 (source: 1)
Kiwi Yes 48 (source: 1)
Peach Yes 48 (source: 1)
Pears Yes
48 (pers. comm. De Schaetzen (PCF),
2006)
Plums and Prunes Yes 48 (source: 1)
Raspberries Yes 24 (source: 1)
Permanent crops
Orchards
Strawberries Yes 72 (source: 1)
Rough Grazings Permanent grassland and
meadows Pasture and Meadows
No (pers. comm. Vleminckx,
2006)
-
Temporary Grass
Other Green Fodder (Green Maize, Leguminous Plants) Forage plants
Other
No (pers. comm. Vleminckx,
2006)
-
Other Other
No (pers. comm. Vleminckx,
2006)
-


Annex X: Spraying schemes used for validation and prioritisation

Table XI.10.1: Treatment scheme on a sensible potato variety (14 anti-mildow treatments moderate
Date of
application
Product
Active
Substance
Formulation
Dose
(kg a.s./ha)
AOEL
(mg a.s./kg
b.w./d)
1/mei
Luxan Linuron
500
linuron SC 0,5 0,009
1/mei Challenge aclonifen SC 1,2 0,032
1/mei metribuzin WG 0,35 0,013
1/mei
Artist
flufenacet WG 0,48 0,017
4/jun Penncozeb mancozeb WG 1,5 0,035
11/jun Penncozeb mancozeb WG 1,875 0,035
16/jun cymoxanil WP 0,1125 0,03
16/jun
Curzate M
mancozeb WP 1,625 0,035
21/jun Penncozeb mancozeb WG 1,875 0,035
28/jun dimethomorf WG 0,1875 0,09
28/jun
Acrobat extra
mancozeb WG 1,6675 0,035
5/jul cymoxanil WG 0,15 0,03
5/jul
Tanos
famoxadone WG 0,15 0,0048
13/jul Penncozeb mancozeb WG 1,875 0,035
20/jul dimethomorf WG 0,1875 0,09
20/jul
Acrobat extra
mancozeb WG 1,6675 0,035
27/jul cymoxanil WP 0,1125 0,03
27/jul
Curzate M
mancozeb WP 1,625 0,035
2/aug Shirlan fluazinam SC 0,15 0,0024
10/aug Shirlan fluazinam SC 0,15 0,0024
17/aug zoxamide WG 0,1494 0,3
17/aug
Unikat Pro
mancozeb WG 1,2006 0,035
23/aug zoxamide WG 0,1494 0,3
23/aug
Unikat Pro
mancozeb WG 1,2006 0,035
26/aug
Ranman
component A
cyazofamide SC 0,08 0,3
3/sep Purivel metoxuron WP 1,2 0,028
10/sep Reglone diquat SL 0,6 0,001


Table XI.10.2: Potential bystanders inhalation exposure calculated using both approaches
Date of application Active Substance
Inhalation exposure
method 1 (mg/d)
Inhalation exposure
method 2 (mg/d)
1/mei linuron 0,00057 0,00156
1/mei aclonifen 0,00137 0,00375
1/mei metribuzin 0,00040 0,00109
1/mei flufenacet 0,00055 0,00150
4/jun mancozeb 0,00171 0,00469
11/jun mancozeb 0,00214 0,00586
16/jun cymoxanil 0,00013 0,00035
16/jun mancozeb 0,00186 0,00508
21/jun mancozeb 0,00214 0,00586
28/jun dimethomorf 0,00021 0,00059
28/jun mancozeb 0,00191 0,00521
5/jul cymoxanil 0,00017 0,00047
5/jul famoxadone 0,00017 0,00047
13/jul mancozeb 0,00214 0,00586
20/jul dimethomorf 0,00021 0,00059
20/jul mancozeb 0,00191 0,00521
27/jul cymoxanil 0,00013 0,00035
27/jul mancozeb 0,00186 0,00508
2/aug fluazinam 0,00017 0,00047
10/aug fluazinam 0,00017 0,00047
17/aug zoxamide 0,00017 0,00047
17/aug mancozeb 0,00137 0,00375
23/aug zoxamide 0,00017 0,00047
23/aug mancozeb 0,00137 0,00375
26/aug cyazofamide 0,00009 0,00025
3/sep metoxuron 0,00137 0,00375
10/sep diquat 0,00069 0,00188


Table XI.10.3: Bystanders risk index calculated using approach 2 (most consetvative)
Risk Index method 2
Date of application Active Substance
5 m 10 m 20 m
1/mei linuron SC 0,5 0,009
1/mei aclonifen SC 1,2 0,032
1/mei metribuzin WG 0,35 0,013
1/mei flufenacet WG 0,48 0,017
4/jun mancozeb WG 1,5 0,035
11/jun mancozeb WG 1,875 0,035
16/jun cymoxanil WP 0,1125 0,03
16/jun mancozeb WP 1,625 0,035
21/jun mancozeb WG 1,875 0,035
28/jun dimethomorf WG 0,1875 0,09
28/jun mancozeb WG 1,6675 0,035
5/jul cymoxanil WG 0,15 0,03
5/jul famoxadone WG 0,15 0,0048
13/jul mancozeb WG 1,875 0,035
20/jul dimethomorf WG 0,1875 0,09
20/jul mancozeb WG 1,6675 0,035
27/jul cymoxanil WP 0,1125 0,03
27/jul mancozeb WP 1,625 0,035
2/aug fluazinam SC 0,15 0,0024
10/aug fluazinam SC 0,15 0,0024
17/aug zoxamide WG 0,1494 0,3
17/aug mancozeb WG 1,2006 0,035
23/aug zoxamide WG 0,1494 0,3
23/aug mancozeb WG 1,2006 0,035
26/aug cyazofamide SC 0,08 0,3
3/sep metoxuron WP 1,2 0,028
10/sep diquat SL 0,6 0,001


Table XI.10.4: Treatment scheme for apple orchards
Date of
application
Product
Active
Substance
Formulation
Dose
(kg a.s./ha)
AOEL
(mg a.s./kg
b.w./d)
3/26/2005 Dodine dodine SC 0.800 0.19
4/1/2005 Dodine dodine SC 0.800 0.19
4/5/2005 Dodine dodine SC 0.800 0.19
4/13/2005 Captan captan WG 1.760 0.125
Scala pyrimethanil SC 0.300 0.6*
4/18/2005
Delan dithianon WG 0.338 0.03*
4/21/2005 Captan captan WG 1.760 0.125
Calypso thiachloprid SC 0.180 0.02
Captan captan WG 1.200 0.125 4/28/2005
Scala pyrimethanil SC 0.300 0.6*
Steward indoxacarb WG 0.075 -
Captan captan WG 1.200 0.125 5/2/2005
Geyser difenconazool EC 0.038 0.13*
Pirimor pirimicarb WG 0.375 0.14*
Captan captan WG 1.200 0.125 5/10/2005
Scala pyrimethanil SC 0.300 0.6*
captan captan WG 1.200 0.125
Topaz penconazool EC 0.025 0.7* 5/19/2005
Zolone fosalone SC 0.750 -
Insegar fenoxycarb WG 0.150 0.4*
Captan captan WG 1.600 0.125 5/25/2006
Systhane myclobutanil EW 0.070 0.03
Delan dithianon WG 0.338 0.03*
6/1/2005
Geyser difenconazool EC 0.038 0.13*
6/20/2005 Delan dithianon WG 0.338 0.03*
Delan dithianon WG 0.338 0.03*
Topaz penconazool EC 0.025 0.7* 6/28/2005
Insegar fenoxycarb WG 0.150 0.4*
Delan dithianon WG 0.338 0.03
7/4/2005
Systhane myclobutanil EW 0.070 0.03
boscalid WG 0.202 -
7/23/2005 Bellis
pyraclostrobin 0.102 0.015
boscalid WG 0.202 -
8/1/2005 Bellis
pyraclostrobin 0.102 0.015
boscalid WG 0.202 -
8/10/2005 Bellis
pyraclostrobin 0.102 0.015
Mimic tebufenozide SC 0.180 0.007
8/15/2005
Captan captan WG 1.760 0.125
8/26/2005 Topsin thiofanaatmethyl SC 0.700 0.08*
9/1/2005 TMTD thiram WP 2.400 0.02*
9/13/2005 Captan captan WG 1.600 0.125
10/12/2005 Topsin thiofanaatmethyl SC 0.700 0.08*
11/10/2005 Koper koperoxychloride WG 1.500 0.05
11/23/2005 Koper koperoxychloride WG 2.500 0.05
*
confidential data

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