Environmental Impact Assessment Review

22 (2002) 235 – 248

www.elsevier.com/locate/eiar

Environmental risk assessment for pesticides

A tool for decision making
Antonio Finizio*, Sara Villa
Department of Environmental and Landscape Sciences (DISAT), University of Milano Bicocca,
P.zza della Scienza, 1-20126 Milan, Italy
Accepted 29 December 2001

Abstract

Pesticides are widely used to protect crops and to prevent disease. However, they can
also be the cause of environmental pollution. Today, ecological policy and management
decision makers in many countries (i.e. EU) require sound scientific information on the
environmental risk associated with pesticides in order to base and justify their decisions.
Consequently, there is a need to develop predictive tools to evaluate all potential risks of
environmental damage that might be caused by the use of plant protection products. This
paper analyses and discusses the risk assessment approach applied in the field of
pesticides. The link between environmental policy, risk assessment and risk management
will also be highlighted. D 2002 Elsevier Science Inc. All rights reserved.

1. Introduction

The use of pesticides in agriculture has been one of the most important factors
leading to increased yields and reduced product prices. Richardson (1988)
reported that pesticides can save up to 40% of crop losses, thus, economically
and socially justifying their use. From an ecological point of view, the need for
pesticides is derived from the fact that an agro-ecosystem is an open system
(artificial ecosystem) where part of the energy derived from the sun is removed
by harvesting. Consequently, the sustainability of such a system depends

* Corresponding author. Tel.: +39-2-64482742; fax: +39-2-64482795.

E-mail address: antonio.finizio@unimib.it (A. Finizio).

0195-9255/02/$ – see front matter D 2002 Elsevier Science Inc. All rights reserved.
PII: S 0 1 9 5 - 9 2 5 5 ( 0 2 ) 0 0 0 0 2 - 1
236 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248

additional energy, artificially provided by farmers through common agricultural

practices (i.e. fertilisation, irrigation, pesticide treatments, etc.).
It has been estimated that there are currently about 800 active ingredients used
world-wide as pesticides and that in 1991 (Aspelin et al., 1992), 2.53 million
metric tons of such substances were applied all over the world.
Almost 40 years have passed since Carson (1963), in her book Silent Spring,
emphasised the potential environmental hazards associated with the use of
pesticides, such as DDT and other organochlorine insecticides. Since then,
greater attention to the impact of pesticides on human health and the environment
has been paid by scientists, public opinion and regulators. The potential adverse
consequences deriving from the use of pesticides has led to the development of
special regulations. For instance, in the European Community, several directives
and regulations have been issued with the aim of safeguarding human health and
the environment from the undesirable effects of these chemicals. Consequently, in
this context, there is a need to develop scientifically defensible methods that can
be employed by environmental decision makers and regulators. Furthermore, in
our opinion, there is also a need for a common, scientifically sound language,
acceptable to industries, regulators or more generally by the so-called stake-
holders. The ecological risk assessment approach could thus contribute to debate
and give invaluable help in defining environmental guidelines for pesticides. The
present paper analyzes and discusses the risk assessment approach in the field of
pesticides, with the aim of highlighting how such an approach can be helpful in
environmental decision making.

2. Development and evolution of the environmental policy in the EU

In the past 30 years, the legislative approach concerning the production and
use of chemicals in the EU has been subject to continuous evolution, particularly
the principles underlying these regulations. During the 1960s, the main purpose
of the EU was to raise the quality of life of each EC citizen through economic
growth. Such an objective would be guaranteed by the free functioning of the
internal market and the free trade of goods (Article 2 of the EU Treaty). This
explains why in that period, norms and programmes of the EU were basically
oriented to deal with the labelling, packaging, use and circulation of dangerous
substances. Other measures were issued in order to control and regulate the
emission of chemicals into the environment (air, water). However, such an
approach was not designed to be preventive, and environmental damage due to
the use of chemical substances was largely uncontrolled. By the end of the
1970s, increased knowledge of the environmental hazard posed by the use of
chemicals led to the introduction of several regulations, such as the setting of
environmental quality standards or the ban of several molecules (DDT, PCBs).
Finally, with the introduction of the ‘‘VI amendment’’ of Directive 548/67 (Dir.
EU 831/79), the preventive approach became an integral part of EU legislation.
 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248 237

Before a new chemical could be placed on the market, a technical dossier

containing all the information (physical – chemical, toxicological and ecotoxico-
logical properties) needed for a preventive analysis of the risk has to be
presented by the registering company. With the Treaty of Amsterdam, signed
in 1997, the objective of the EU has widened, including specific provisions on
environmental protection, making sustainable development an explicit objective
of the EU.
In the field of pesticides, EU policy also reflected the evolution described
above. In fact, increased awareness of the environmental problems related to the
use of pesticides in agricultural practices led EU legislators to introduce the
concept of sustainable development in agriculture. The framework for sustainable
production and use of pesticides in agriculture could be described as follows:

test and assess the environmental risks of new and existing pesticides;

select the least environmentally hazardous pesticide among all the possi-
ble alternatives;

reduce emissions through the application of so-called Good Practices
in Agriculture and by favouring the presence and development of or-
ganic farms;

recognition of the role of farmers in safeguarding the environment, giving
them comprehensive information that could enhance their awareness about
environmental protection so that they may cooperate more effectively.

Taking into consideration the points described above, several directives and
regulations were laid down at different levels in the last decade with the objective
of reducing the environmental risk associated with the use of pesticides. For
instance, EC Directive 91/414 states the registration procedures for placing
pesticides on the market. A technical dossier, containing all the information
about the physical – chemical, toxicological and ecotoxicological properties for
each new active ingredient, must be provided by the agro-chemical company and
evaluated by individual Member States in terms of human and environmental risk
using the ‘‘Uniform Principles’’ scheme proposed by the EU Commission before
a pesticide can be registered.
More recently, the European Council agreed on an agricultural reform that
considers safeguarding the environment, together with the need for more
competitive European agriculture in the world market. Consequently, the Council
has established a link between basic environmental protection requirements and
direct support payments to producers (Agri-Environment agreement). For
instance, EEC Regulation 92/2078 and the Council Regulation 99/1257 provide
financial support to farmers involved in a program of farming practices which
reduce the polluting effects of agriculture and improve the quality of the
environment. In Italy, for example, each region established guidelines for farmers
who want to produce in accordance with the 92/2078 regime, indicating the
pesticides with less environmental impact for growing crops.
238 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248

Furthermore, EEC Regulation 92/2078 requires each region to demonstrate

how the environment has improved as a consequence of applying this regulation
in order to access to financial support.

3. The link between sustainable development, risk management and risk

assessment

In the previous paragraph, the development of EU legislation in managing

dangerous substances, particularly pesticides, was briefly described. This evolu-
tion determined the need for developing useful tools to analyze the costs and
benefits deriving from the use of a given chemical. In other words, sustainable
development in agriculture is possible by managing the risk associated with the
use of a particular pesticide. For instance, the decision on how to manage and
minimise the environmental risk posed by pesticides should be based on the best
possible scientific information and analysis of risk (risk assessment). The
concept of risk management and risk assessment are frequently confused and
overlapped, but they are two separate activities. It is important to keep them
separate to avoid the perception that some government decisions are made, not
on a scientific basis, but according to the willingness of regulators. A formal
separation of the process would minimise the temptation of reanalysing data after
a risk assessment, particularly when the final decision incurred high economic or
social costs (Landis et al., 1998). Furthermore, such a distinction insulates
scientific activity from political pressure and maintains the distinction between
the magnitude of a risk and its environmental, economic or social cost (Douben,
1998). Risk assessment can be defined as the process of estimating the
possibility of a particular event occurring under a set of given circumstances.
On the contrary, risk management is the process whereby decisions are made
about whether an assessed risk needs to be managed, and the means for
accomplishing it, for the protection of public health and environmental resources
(Linthurst et al., 1995). Managing risks involves making decisions based on the
information collected in the previous steps of risk assessment along with a
consideration of social and cultural values, economic realities and political
factors (Fig. 1).
The final decision of how to manage the risk associated with the use of a
pesticide (e.g. the ban on DDT) is generally political in nature, but the character-
isation of risk obtained through the risk assessment procedure should provide the
basis of that decision.

4. Environmental hazard and risk

Also the terms ‘‘hazard’’ and ‘‘risk’’ are frequently used interchangeably as
synonyms and overlapped. However, the conceptual meaning of these words is
 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248 239

Fig. 1. Relationship between risk assessment and risk management (modified from McDonald and
Vandenberg, 1998).

very different. A useful definition of the term ‘‘hazard’’ was given by an expert
group of the OECD (1982):
the hazard of a chemical is a function of two broad considerations, the potential
of the chemical to harm biological systems (or damage other systems) and its
potential for exposure such that harm or damage can occur.
In other words, the hazard is the function of two different parameters:
exposure and noxious effects (toxic and/or ecotoxic). The following equation
formalises the concept described above:

HAZARD ¼ EXPOSURE  EFFECTS

The multiplication sign indicates that there is no hazard if there is no exposure or

adverse effects.
On the contrary, the term ‘‘risk’’ is conceptually more complex because
it also includes the quantitative estimate of the probability of an adverse ef-
fect on a biological target (humans/environment) exposed to a chemical
substance. Thus, it could be said that risk assessment goes one step beyond
hazard evaluation.

5. The framework of the ecological risk assessment process

Ecological risk assessment ‘‘evaluates the likelihood that adverse ecological

effects may occur or are occurring as a result of exposure to one or more
stressors’’ (US EPA, 1992). The term ‘‘adverse ecological effects’’ includes all
biological and nonbiological environmental changes that society perceives as
undesirable. According to Barnthouse (1995), the US EPA definition emphas-
ised that risk assessment is not a computational technique but a decision-
making process that promotes sound environmental decisions.
240 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248

The risk assessment procedure involves the acquisition and combination of

several pieces of information regarding a chemical substance in order to answer
the following questions:

what can happen?

how likely is it that it will happen?

if it does happen, what are the consequences?

A framework of the risk assessment proposed by the US EPA and the US

National Research Council is reported in Fig. 2.
The scheme proposed in Fig. 2 includes three different steps: problem
formulation, analysis and characterisation of the risk. In the first phase (problem
formulation), the assessors should answer the following question: how could a
potential pollutant harm the structure or the functionality of a particular
ecosystem? A critical aspect of this phase is the development of a link between
measurable end-points (laboratory assays) and the objectives of management (to
preserve the structure and functionality of an ecosystem). In other words: how
can the integrity of an ecosystem be ensured by managing the ‘‘often’’ limited
information deriving from the subsequent phase analysis?
Problem formulation also depends on regulatory purposes. Generally, the kind
of risk assessment for the regulation of chemicals can be considered holistic,
whereby problem formulation is related to the probability of adverse effects
occurring on the ecosystem in general or for a particular compartment. On the
contrary, targeted risk assessment focuses on a very specific problem, such as the

Fig. 2. A risk assessment framework (from US EPA, 1996).

 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248 241

identification of the benefits deriving from certain restrictions and conditions of

use for a chemical.
In the subsequent step (analysis of risk), a technical evaluation of data
concerning both ecological exposure and effects is made. The last phase, risk
characterisation, integrates the information on exposure and effects in order to
reach a final conclusion about the estimate of risk. This process of risk
assessment is frequently iterative. This means that sometimes, on the basis of
the results obtained from risk analysis one might have to formulated further
problems, further problem formulation activities and to target more selected
endpoints. Iteration of ecological risk assessment processes is generally per-
formed in structured tiers that proceed from simple to very complex assessments
designed to answer difficult questions, such as the extent and nature of the risk or
for evaluating alternative options.

6. Risk assessment procedure for pesticides in the EU regulation

As previously reported, risk assessment is a tool for supporting a significant

number of regulatory decisions in the field of pesticides, some of which are
listed below:

Classification and labelling;

Quality criteria (water, soil and air);

Ranking and classification of pesticides;

Registration of new pesticides;

Review of existing active ingredients;

Correct management of the territory.

Some of these, particularly the role of risk assessment in the registration

procedures under EEC Directive 91/414 and in the Council Regulation 92/2078
and 99/1257, will be focused on in this report.

6.1. Risk assessment procedure in the frame of EU directive 91/414

The 91/414/EEC Directive for placing new pesticides on the market requires
the evaluation of all undesirable effects on nontarget organisms, together with
their potential level of exposure to pesticides, by quantifying the highest
predicted environmental concentration (PEC), for each compartment, through
the application of predictive models in a frame of a worst case scenario. Table 1
explains how the frame of basic risk assessment illustrated above (Fig. 2) is
basically respected under Directive 91/414/EEC.
Then the decision for placing a new active ingredient on the market
depends on a generic risk assessment based on the evaluation of the toxicity
exposure ratio (TER), i.e. the ratio between the effects on nontarget organisms
242 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248

Table 1
Adaptation of the environmental risk assessment scheme to the registration of pesticides (from
Tarazona, 1999)
Environmental risk assessment scheme Directive 91/414/EEC
(1) Problem definition Level 1./B3. Effect on non target organisms
under good agricultural practices
(2) Risk analysis including:
(a) Exposure assessment (PEC) Level 2./B8. Environmental fate and behaviour.
Worst case scenarios used as default
(b) Effect assessment Level 2./B9. Ecotoxicology. Preestablished list of
receptor endpoints
Risk characterisation TER, hazard quotient (HQ), etc. using preestablished
levels of acceptability
Risk management Level 3. Limitation of certain uses, buffer zones,
etc. to achieve levels of acceptability

(i.e. EC50) and the PEC. This ratio is calculated for each of the nontarget
organisms representative of different environmental compartments, and then
compared with a trigger value that represents the limit of the TER under which
‘‘no authorisation shall be granted—unless it can be shown that under field
conditions there is no unacceptable impact.’’ As previously described, risk
assessment is an iterative process performed in structured tiers; if the
preliminary assessment indicates that there may be concern, further evaluation
of the potential risks is required to determine impact under more environ-
mentally realistic conditions. Recently an international workshop on ‘‘Higher-
tier Aquatic Risk Assessment for Pesticides’’ (HARAP) was organised under
the auspices of the EC, SETAC-Europe and the OECD in order to better
define the approach for a higher-tier aquatic risk assessment of pesticides
(SETAC, 1999).

6.2. Risk assessment: tool for selecting and comparing pesticides

In the last few years, the risk assessment approach has also been frequently
utilised for ranking pesticides in terms of the hazard they pose to the environment
by the use of risk indexes. These indexes are developed by giving a score to a set
of physical – chemical toxicological and ecotoxicological properties of substances
under consideration. The scores are then combined through an algorithm in order
to obtain a synthetic number (index) useful for comparative purposes (Sampaolo
and Binetti, 1986; Swanson and Socha, 1997). Such an approach may be useful
for several management purposes:

To select pesticides with less environmental impact to be used in a frame of

pest management protocols according to the EU Regulation 92/2078. In
this context, farmers can identify the best available crop protection strategy
from an ecological point of view;
 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248 243

Table 2
Risk classification intervals, scores and weight for nontarget organisms in a surface water system
(PRISW-1 index)
Algae (A) Daphnia (B) Fish (C)
(EC50/PEC) Score (EC50/PEC) Score (LC50/PEC) Score
> 1000 0 >1000 0 >1000 0
1000 – 100 1 1000 – 100 1 1000 – 100 1
10 – 100 2 10 – 100 2 100 – 10 2
10 – 1 4 10 – 1 4 10 – 1 4
<1 8 <1 8 <1 8
W=3 W=4 W = 5.5
Final score: PRISW-1=(A  3)+(B  4)+(C  5.5).

To set up a priority list for planning environmental monitoring or further

experimental research;

To aid the development of criteria for ‘‘green’’ labelling of agricultural
products;

To provide a basis for the development of economic instruments which
consider the potential of individual pesticides to cause environmental
damage.

A number of research organisations throughout Europe have begun to use risk

indexes. However, with approaches greatly differing with respect to purposes,
environmental compartments considered (groundwater, surface water, air, human
impact), as well as analyses used (i.e. scores, expert systems). Recently, an
attempt to evaluate and compare the various methodologies has been made at EU
levels by the Concerted Action on Pesticide Environmental Risk Indicators
(CAPER) project (CLM, 1999).
More specifically, the CAPER project sought to compare and discuss
methodologies of eight pesticide risk indicators developed in different EU
countries. Each indicator was applied to a set of selected pesticides using a
standard data set. The results obtained were compared through statistical analysis.
According to the conclusion of the final CAPER report, the eight pesticide risk
indicators differed considerably with regard to several aspects, such as purposes,
methodologies, measured aspects, compartments and effects taken into account.
For instance, regarding the purposes of risk indicators, in some cases they
were used as a tool for selecting pesticides with the least environmental impact.
In other cases, they were developed as a tool for farmers or to advise policy
makers about the risks posed by pesticides after their use. All eight indicators
included the risk to water organisms and most of them considered the risk of
groundwater contamination and the risk for soil organisms. On the contrary,
bioaccumulation and effects on bees were included in only two indicators.
The rank obtained by applying the eight risk indicators on the previously
selected pesticides was very different when the environment as a whole was
244 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248

considered. This can be explained in view of the large differences in envir-

onmental compartments considered. On the contrary, for most indicators the
ranking of pesticides showed a significant correlation when individual compart-
ments were considered separately.
On this basis, the CAPER report recognised the need to develop a harmonised
scientific framework for EU pesticide indicators. With such a framework, the
monitoring and evaluation of pesticide policies could be coordinated and farmers’
decisions could be based on the same principles.
Recently, the Italian Environmental Protection Agency (ANPA) sponsored a
project for setting up different rating indices for pesticides for different envir-
onmental scenarios (Finizio et al., 2001). The proposed indices, fully based on the
information required by annex VI of Directive 414/91/EEC, were drawn up for
different environmental compartments (surface water, hypogean and epygean soil
systems) and different time-space scale scenarios. As a general procedure for the
development of the indexes, a PEC is calculated using either simple or more
complex dilution models. Once a PEC is obtained, TERs are calculated using
toxicity data for the selected bioindicators. To each TER value a subscore is
assigned in function of its role, arbitrarily determined, in the overall risk evaluation
and then combined by means of algorithms to obtain a single synthetic score. An
example of the index structure for surface water is reported in Table 2, whereas an
example of the results that can be obtained by its application is reported in Fig. 3.
EEC Regulation 92/2078 and successively Council Regulation 99/1257
promotes financial support for farmers involved in a program of farming practices
which reduce the polluting effects of agriculture and improve the quality of the
environment. In Italy, each region establishes several norms for farmers who want
to produce according to the 92/2078 regime. These norms indicate pesticides with
the least environmental impact on crop production. This selection has been made,
in some regions, taking into consideration the rank of pesticides obtained through
the application of the risk indexes described above.

Fig. 3. Example of the application of the PRISW-1 index: scores obtained for phenylureas herbicides.
 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248
Fig. 4. Scheme of the procedure for evaluating environmental risk distribution on the territory by integrating risk assessment procedures and GIS (modified from
Calliera et al., 1999).

245
246 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248

6.3. Risk assessment on a territorial basis

The above-described use of environmental risk assessment as described above

provides a useful tool for estimating and comparing the potential risk for a few
realistic scenarios. However, there is a need, for management purposes, to
develop methods capable of giving information on the distribution of risk due
to pesticide use on a regional scale. Recently, several international institutions
(such as OCSE, IOBC/WPRS, EU) are involved in implementing the risk
assessment process in Geographic Information Systems (GIS). Such an imple-
mentation could be very useful for environmental-oriented monitoring, or for
measuring the increased level of environmental quality derived from the
application of the so-called agri-environment agreement, according to the new
EC Directive 1257/99 on rural sustainability and development. The use of GIS
could be very helpful for describing and managing the variability of the
environment on a regional scale, as well as for obtaining realistic environmental
scenarios for the application of predictive models, and, consequently, to obtain a
more realistic predicted exposure (PEC). As an example, Fig. 4 reports a method
proposed by Calliera and et al. (1999), for assessing the environmental risk of a
pesticide for surface waters. The methodology is based on the integration of
relational and spatial databases, GIS incorporating raster and vector, mass balance
models and pesticide risk indicators. Surface water pollution is modelled by
taking into account two main processes: the load due to drift and the load due to a
rainfall-runoff event. The former is immediately consequent to pesticide applica-
tion; the second occurs a short period afterwards. Thus, two distinct PEC values

Fig. 5. Application of the pesticide risk index for surface water systems (PRISW-1) to alachlor. The
figure maps the risk for surface water systems on 130 portions of basins in which the Lombardy (Italy)
has been subdivided (modified from Verro et al., 2002).
 A. Finizio, S. Villa / Environmental Impact Assessment Review 22 (2002) 235–248 247

are estimated, differing in time. A pilot approach of this scheme was applied to
the herbicide, alachlor, on corn in Lombardy (Northern Italy) and represents the
first stage of a vaster project (Verro et al., 2002). Although the resultant alachlor
risk map (Fig. 5) represents a static image of a worst-case simulation, the main
objective was to provide information for the territory with respect to relative risk
at the watershed level, which is important in managing risks to the aquatic
environment. This information particularly focuses on investigating the driving
forces of the processes under consideration and their spatial variability in order to
improve knowledge about the territory and to indicate the need for site specific
studies on a more detailed scale.

7. Conclusions

A framework for ecological risk assessment defines the relationship between

ecological science and environmental management. The role of science in risk
assessment is to ensure that the actions implemented by environmental managers
achieve the goal and objectives defined by society (Barnthouse, 1995). To
achieve the goal of environmental sustainability there is a need for continuous
development of deeper scientific knowledge about the structure and functioning
of natural ecosystems, and on the effects that chemical substances can exert on
them. This increasing knowledge should be continuously transferred to risk
assessment procedures in order to reduce the level of uncertainty generally
associated with such procedures, and to increase their objectivity and the
possibility of validating the results obtained. Despite its limitations, there is a
large consensus in the scientific community on the usefulness of risk assessment
as an appropriate tool for attaining a reasonable compromise between a sound
scientific approach and the need for simple, transparent and pragmatic decision-
making instruments.

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Dr. Antonio Finizio obtained his degree in Agricultural Sciences at the University of Napoli in
1989 and subsequently his doctorate in Chemistry, Biochemistry and Ecology of Pesticides at the
University of Milano in 1993. He is presently a research assistant in the Department of Environmental
and Landscape Science at the University of Milano Bicocca. The research activity of Dr. Finizio is
oriented towards the two major aspects of environmental risk assessment: evaluation of the effects and
evaluation of the exposure, particularly for pesticides, with the aim of producing predictive tools for
the appropriate management of potentially dangerous chemical substances.
Dr. Finizio is a consultant of the Italian Environmental Protection Agency (ANPA) and he took
part as an expert in several international workshops on the risk assessment of pesticides.

Dr. Sara Villa obtained her degree in Natural Science at the University of Milano in 1994 and her
Doctorate in Natural and Environmental Science at the University of Milano in 1999 discussing a
thesis on ‘‘Risk assessment for nontarget organisms due to pesticide use. The Orbetello Lagoon
ecosystem.’’ Presently, she is a research assistant at the University of Milano Bicocca and is involved
in the European project BEAM (Bridging effect assessment of mixtures to ecosystem situations and
regulation). Dr. S. Villa’s research activity is in the field of ecotoxicology. She has conducted both
laboratory and field research on the environmental fate of pesticides as well as risk assessment for
nontarget organisms due to the use of such substances.
In this field, she is the author of several publications in international and national journals.