Tools for the Characterization of Pesticide Risk in Food Products-An
Overview
Mihaela Roșca 1
, Raluca-Maria Hlihor 1,2
, Petronela Cozma 1 and Maria Gavrilescu
1
1 “Gheorghe Asachi” Technical University of Iasi, Faculty of Chemical Engineering and Environmental
Protection, Department of Environmental Engineering and Management, 73 Prof. Dr. Docent D. Mangeron
Str., 700050 Iasi, Romania 2 “Ion Ionescu de la Brad” University of Agricultural Sciences and Veterinary Medicine of Iasi, Faculty of
Horticulture, Department of Horticultural Technologies, 3 Mihail Sadoveanu Alley, 700490 Iasi, Romania 3 Academy of Romanian Scientists, 54 Splaiul Independentei, RO-050094 Bucharest, Romania
Abstract. The presence of pesticides in plant products is a consequence of their use due to farming
activities for pests and disease combating. Due to various chemical active substances used as pesticides
which can cause adverse effects on human health, it is necessary to carry out risk assessments studies
regarding the pesticides residues in fruits and vegetables. In this work, some of the most used models for
assessing risks posed by the presence of chemicals in environment are addressed: USEPA human health risk
assessment methodology, The Monte Carlo Risk Assessment (MCRA), the dynamiCROP model, DEEMTM
-
Dietary Exposure Evaluation Model and PRIMo – Pesticide Residue Intake Model. To ensure a detailed risk
estimation of pesticide we have shown that it is necessary to know information on pesticides characteristics,
food consumption estimates and effects on human health. Considering these aspects, this paper is focused on
the distribution and the levels of pesticides residues in food along with a short description of several tools
used for risk assessment and the main databases specific for each program. These tools will be further applied
for specific case studies developed within our research group.
Keywords: MCRA, dynamiCROP, DEEMTM
, USEPA model, PRIMo, pesticides databases
1. Introduction
Although the negative effects of pesticides on human health are well known worldwide, the farmers
continue to apply different types of pesticides for pests and diseases control and, consequently for increasing
fruits and vegetables production to meet the market demand [1], [2]. Food and Agriculture Organization of
the United Nations (FAO) gave an extensive definition for pesticides: “Pesticide means any substance or
mixture of substances intended for preventing, destroying or controlling any pest, including vectors of
human or animal disease, unwanted species of plants or animals causing harm during or otherwise
interfering with the production, processing, storage, transport or marketing of food, agricultural
commodities, wood and wood products or animal feedstuffs, or substances which may be administered to
animals for the control of insects, arachnids or other pests in or on their bodies. The term includes
substances intended for use as a plant growth regulator, defoliant, desiccant or agent for thinning fruit or
preventing the premature fall of fruit, and substances applied to crops either before or after harvest to
protect the commodity from deterioration during storage and transport” [3]. This definition reveals in fact
the complexity of scientific research on pesticides synthesis, properties, uses, and their effects on
environment and humans on short, medium and long terms and accounts the opportunity of our past and
present studies in this area [4]-[6].
Corresponding author. Tel.: + 0040753312588.
E-mail address: [email protected].
International Proceedings of Chemical, Biological and Environmental Engineering, V0l. 101 (2017)
DOI: 10.7763/IPCBEE. 2017. V101. 11
75
Pesticides produced and used for different proposes can be classified based on chemical family as:
organophosphates, carbamates, organochlorides, phosphorothioate, pyrethroids [2]. World Health
Organization (WHO) classifies pesticides according to their hazard potential in 5 major groups [7]: Ia -
extremely hazardous; Ib - highly hazardous; II - moderately hazardous; III - slightly hazardous; U - unlikely
to present acute hazard. Based on the principal action on pests, pesticides were classified in: insecticides,
miticides, herbicides, nematicides, fungicides, molluscicides and rodenticides [8].
The human exposure to pesticides can produce neuritis, psychiatric manifestations, hepatorenales
disorders, neurological, immunological, metabolic and endocrine diseases. The most common negative
effects associated with the presence of pesticide residues in the human body are: nausea, vomiting, blurred
vision, coma, difficulty in breathing, deficit hyperactivity disorder, disorder in fetuses and children etc. [4],
[6], [8], [9].
Based on the information provided by International Agency for Research on Cancer (IARC), most of the
pesticides used are considerate carcinogenic, probably carcinogenic or possibly carcinogenic substances to
humans. For example gamma-hexachlorocyclohexane (lindane) is included in Class 1 - carcinogenic to
humans, dichlorodiphenyltricholoroethane (DDT) in Class 2A - probably carcinogenic to humans, 2,4-
dicholorophenoxyacetic acid (2,4-D) in Class 2B - possibly carcinogenic to humans [10], [11].
In this context, the main purpose of this paper is to make an overview on several tools used in human
health risk assessment of pesticides in food. For better understood the necessity for risk assessment generated
by the presence of pesticides in fruits and vegetables, the paper will provide some information about the
values of pesticides residues in food reported by different organizations and agencies. The description of the
risk assessment methodology, the most applied models and tools and the principals databases used for the
risk assessment programs are also provided, generating prerequisites for their application in various case
studies addressing the assessment of pesticide risk in food products.
2. Pesticide Residues in Food
Due to the negative effects on environment and human health induced by exposure to pesticides,
different organizations or authorities developed and implemented several programs to control and monitor
pesticides residues in food products (e.g. cereals, fruits, vegetables etc.). Among these, the most important
are: Pesticide Action Network for worldwide, U.S. Department of Agriculture’s (USDA) and European Food
Safety Authority (EFSA).
According to 2014 EFSA annual report on pesticide occurrence in food plants, approximately 97.1% of
the analyzed samples (summing 82,649 samples) didn’t contain pesticide residues or their concentrations
were below the maximum residue levels (MRLs). The report is based on 69.4% samples from EU and EEA
countries, 25.7% samples from the third countries, while 4.9% of the samples were of unknown origin. The
highest MRL for pesticides was found in plant samples such as spinach, beans, mandarins, carrots, rice, pears,
oranges and cucumbers [12]. In 2015, at European level 84,341 food samples were analyzed for 774
pesticides [13]. The origin of food plants were: 69.3% from EU Member States, Iceland and Norway, 25.8%
from products imported from third countries, while the rest is of unknown origin. The percentage of the
samples for which pesticides residues were not found or the concentrations were below the MRL is similar
with the percentage reported in 2014 (97.2% vs. 97.1%). In 2015, only 1.7% of samples exceeded the MRL,
increasing over the previous year (from 1.6%). The highest MRL was identified in broccoli, table grapes,
sweet peppers, peas without pods, wheat, aubergines and bananas [12], [13]. The results of pesticides
residues in conventional and organic products in 2015 reported by EFSA are shown in Fig. 1a.
In 2014, the U.S. Food and Drug Administration (FDA) regulatory pesticide residue monitoring program,
analyzed 6,638 samples for pesticides, of which 6,272 were human foods and 366 animal foods. The
majority of human foods samples (4,814) have been taken from imported products, and only 1,458 samples
came from food products obtained in the USA. Also, 70.9% of samples from domestic market and 52.9% of
samples from imported products didn’t contain pesticides residues. Pesticides found in 1.4% of samples
taken from USA products and 11.8% of samples from imported products were below the MRL. The majority
of the samples analyzed by FDA in 2014 were taken from fruits and vegetables, representing 75.7% for
76
imported products and only 36.1% for fruits and vegetables from domestic market [14]. The result
concerning pesticides residues in products from domestic market and imported (cereals, diary/eggs, fish,
fruits, vegetables and other) are presented in Fig. 1b.
66.7
43.2
32.3
15.1
28
12.7
11.7
17.1
14
13.92.5
3.4
1.3
0.4
6.8
0.6
0.7
0.3
0
1.8
0 20 40 60 80 100
Fruits and nuts
Vegetables
Cereals
Animal products
Other
% of the samples analysed w ith quantif ied residues below the MRL
03691215
% of samples analysed w ith quantif ied residues above the MRL
Conventional products (quantif ied residues ≤ MRL)
Organic products (quantif ied residues ≤ MRL)
Conventional products (quantif ied residues > MRL)
Organic products (quantif ied residues > MRL)
(a)
26.5
8.3
16
43.8
37.5
21.8
0
0.6
10.2
10.6
16.9
29.921.1
0
0.6
10.2
10.6
16.9
0
0
0
0.5
1.5
7.6
0 20 40 60 80 100
Cereals
Dairy/Eggs
Fish
Fruits
Vegetables
Other
% of the samples analysed w ith quantif ied residues below the MRL
0510152025303540
% of samples analysed w ith quantif ied residues above the MRL
Products from import (quantif ied residues ≤ MRL)
Pruducts from domestic market (quantif ied residues ≤ MRL)
Products from import (quantif ied residues > MRL)
Pruducts from domestic market (quantif ied residues > MRL)
(b) Fig. 1: (a) Pesticides residues in organic and conventional foods at European level in 2015 [13] and (b) pesticides
residues in products from import and from domestic market in USA – in 2014 [14]
3. Risk Assessment and Management
The negative effects to human health caused by the presence of pesticide residues in fruits, vegetables
and cereals are based on the gravity of exposure for short or long time and on the exposed population
category, adults being the least affected one (Fig. 2). Thus, the population exposure to different pesticide
residues in food products requires a health risk assessment [6], [15].
The human health risk assessment has the role to estimate the nature and likelihood of adverse health
effects produced by the exposure to pesticides, now or in the future. The types of exposures to pesticides
from different environmental compartments of concern and the steps involved in risk assessment are shown
in Fig. 2.
Risk assessment is based on scientific knowledge with consideration of inherent uncertainties. Risk
assessment and management are described as continuous processes [16], so after the human health risk
assessment was done in the risk management process, a number of measures for reduction of the negative
77
effects produced by pesticides are necessary to be taken. In this step, the risk managers must weight policy
alternatives by integrating risk assessment results with social, economic, and political factors. Examples of
approaches for risk management which can be used to reduce the human risk are as follows [17]: unrestricted
use of pesticides if these have low risk; restricting its use to certified application in case of pesticides with
medium risk; lowering application rates; reducing the number of applications; increasing application
intervals; providing longer intervals between application and harvest; using alternative application methods.
Fig. 2: Groups of humans affected by pesticides and steps in risk assessment
4. Tools for Risk Assessment
Risk assessment of pesticides in foods can be performed using several methods and tools, which can be
applied for the evaluation of professional and non-professional risks [18]. The most important models and
tools were developed by the European Food Safety Authority (EFSA) and US Environmental Protection
Agency (USEPA).
The Monte Carlo Risk Assessment (MCRA) software tool was developed by European Commission
under the supervision of National Institute for Public Health and the Environment for the Netherlands
(RIVM) through the ACROPOLIS project. The development of the software tool had as a basis the
fundamental objective of the ACROPOLIS project to improve risk assessment strategies in Europe and to
develop a framework for cumulative and aggregate risk assessment of pesticides [19], [20]. This tool can be
applied for probabilistic exposure and risk assessment of chemicals in the diet. Other exposure routes such as
inhalation or dermal contact could be considered. With MCRA 8, the Cumulative Exposure Assessment for
chemicals grouped in a Cumulative Assessment Group for which a single health effect is considered relevant
can be also performed [19], [21].
For risk assessment with the help of MCRA system statistical models, shared data and data uploaded by
the user are considered together. The scalability of the software allows processing of cumulative assessment
groups of pesticides containing up to 100 active substances [20]. MCRA can be used for several options,
such as [19]: acute (short-term) risk assessment; chronic (long-term) risk assessment; empirical or parametric
modeling of residue level; modeling of processing effects, unit variability and nondetected levels;
bootstrapping to assess the uncertainty of percentiles; comparison with deterministic point estimates (IESTI).
Monte Carlo simulation provides several advantages over deterministic, or “single-point estimate”
analysis [19]: probabilistic results; graphically represented results; sensitivity analysis; scenario analysis;
correlation of inputs.
The dynamiCROP model was developed for quantification and evaluation of human health impacts
caused by direct application of plant protection products onto agricultural field crops, such as wheat, and
subsequent intake by humans via ingestion. A transparent matrix algebra framework is at the basis of the
software running [22], [23]. A dynamic analysis for the ingestion pathway of different plant protection
products represent the main scope of the software [23].
This model developed for human health impacts evaluation due to uptake of pesticides into multiple crop
types is able to answer four questions [22]:
78
(i) how can health impacts induced by human intake of pesticides via ingestion of different food crops be
characterized and evaluated in a transparent, consistent and concise way?
(ii) how the dynamic behavior of pesticides in crops and the subsequent human intake are influenced by
crop characteristics, substance properties and application times?
(iii) what are the differences between crop-specific characterization factors from direct pesticide
application to different food crops and generic characterization factors from continuous, diffuse emissions to
the environment?
(iv) how can substitution of pesticides be evaluated and their health impacts compared on a similar
functional basis?
Therefore, if the dynamiCROP model is applied, a risk and/or an impact assessment for human health
from indirect exposure via ingestion of food products due the direct application of plant protection products
will be provided. Since dynamiCROP uses a spatial domain approach, there is no impediment in the
assessment of human health impacts for application pattern, crop production area, population etc. performed
according to the underlying input parameters [23]. The dynamiCROP model was fully parameterized by
developing crop-specific regression models with focus on the system driving aspects, such as time to crop
harvest, degradation in and on crops, residence time in soil and some substance properties [23].
USEPA human health risk assessment methodology focuses on the estimation of the nature and
probability of adverse health effects in humans due the exposure at chemicals found in the environmental
compartments. To apply the USEPA strategy for risk assessment several questions are requested be the
starting point of the procedure, namely [24], [25]:
(i) what types of health problems are caused by pesticides in the environment?
(ii) what is the chance that people will experience problems when exposed to different levels of
pesticides?
(iii) is there a low level below which some chemicals don’t pose a human health risk?
(iv) what pesticides are people exposed to and for how long?
(v) are legal limits for pesticide residues in food (tolerances or maximum residue limits) protective of
human health?
(vi) are people more likely to be susceptible or exposed to pesticides because of factors such as age,
genetics, pre-existing health conditions, ethnic practices, gender, where they work, where they play, what
they eat, etc.
The methodology of human health risk assessment proposed by USEPA follows the 4 major steps of risk
assessment. The risk to human health from pesticide exposure depends on both the toxicity of the pesticide
and the likelihood of people coming into contact with it, and can be expressed as Eq. (1) [8], [25].
RISK = TOXICITY x EXPOSURE (1)
Therefore, assessment of risk generated by the toxicity of pesticide residues in food for acute
toxicological effects and chronic toxicological effects (noncancer risk) is expressed as a Population
Adjusted Dose (PAD), and represent the reference dose (RfD) divided by any additional safety factor [25].
The toxicity for acute effects is expressed as an acute PAD (aPAD) and can be calculated using Eq. (2).
The acute RfD (aRfD) in this case is an estimation of the level of one-day exposure to a pesticide residue that
is believed to have no significant deleterious effects and can be calculated by Eq. (3). The aRfD is the value
of the report between No Observed Adverse Effect Level (NOAEL) from acute animal toxicity studies and
the appropriate uncertainty factors. In case of chronic toxicological effects, the toxicity is expressed as a
chronic PAD (cPAD) (Eq. 4). For the chronic RfD (Eq. 5), the level of daily exposure to a pesticide residue
is considered over a 70-year life span, and it is believed that harmful effects are not significant for this level.
NOAEL is taken from studies addressing chronic animal exposures [25].
FQPAtoUniqueFactorSafety
aRfDaPAD
(2)
79
FactorsyUncertaint
NOAELaRfD
(3)
FQPAtoUniqueFactorSafety
cRfDcPAD
(4)
FactorsyintUncerta
NOAELcRfD
(5)
The acute food risk is expressed as a percentage of the aPAD (% aPAD) (Eq. 6) and, if the value
calculated of % aPAD is less than 100, the risk is being considered as acceptable. The chronic food risk (%
cPAD) is expressed similarly with the acute food risk, and can be calculated using Eq. (7) [25].
100//
//%
daykgmgaPAD
daykgmgExposureFoodaPAD
(6)
100//
//%
daykgmgcPAD
daykgmgExposureFoodAveragecPAD
(7)
Linear cancer risk is expressed as a probability and is calculated using Eq. (8). For carcinogenic effects,
the toxicity portion of the risk is expressed as a cancer potency factor (q*) [25].
1day/kg/mg
*qday/kg/mgExposureFoodAverageriskCancer
(8)
Based on data acceptable for the consumption, daily intake (ADI) and Acute References Doses (ARfD)
values, the risk can be calculated. The estimated daily intake (EDI) of pesticide residues is calculated as
given by Eq. (9):
wieghtbodymean
RLFEDI ii
(9)
where: Fi- food consumption data, RLi - residue level in fruits and vegetables.
The long-term risk assessment is performed by calculating the hazard quotient (HQ) (Eq. 10):
100ADI
EDIHQ
(10)
After the calculation of HQs the values are summed up to give a chronic hazard index (cHI) (Eq. 11):
HQcHI (11)
DEEMTM
- Dietary Exposure Evaluation Model is a software developed by Novigen Sciences, Inc. in
2000, to be used for the estimation of population exposure due to consumption of food with pesticides. The
first version of this software and the data about food consumption provided by the USDA Continuing
Surveys of Food Intake by Individuals (CSFII) reported in 1992 and 1996 was used. The DEEM™ program
includes four software modules: the main DEEM™ module, the acute analysis module, the chronic analysis
module, and the RDFgen™ residue distribution module [26], [27]. The main DEEM™ module creates and
edit residue files for specific chemical or cumulative applications, and represents the base for the DEEM™
Acute, Chronic, and RDFgen™ modules. The RDFgen™ module is used to create summary statistics and
Residue Distribution Files based on USDA Pesticide Data Program (PDP) monitoring data or user-provided
residue data. The Acute analysis and Chronic analysis modules based on USDA consumption data provide
information on dietary exposure assessment. For acute, chronic, and/or cancer risk assessment using DEEM-
FCID software it is necessary to insert the data by types of information, as follows [27]: (1) pesticide’s
toxicological data; (2) residue concentrations in foods; (3) any adjustment factors related with the potential
constituent levels in the diet of people. The program can be used to estimate total exposure for different
groups of population divided by age, gender or ethnicity [27].
PRIMo – Pesticide Residue Intake Model was developed initially by EFSP for risk assessment of
temporary MRLs. Presently, it can be applied for chronic and acute risk assessment. For assessing risk with
this model, there are currently used data about national food consumption and unit weights (data provided by
the Member States of European Union) and different implemented and internationally agreed risk assessment
methodologies to assess the short-term (acute) and long-term (chronic) exposure of consumers. Using
PRIMo model, chronic and acute dietary consumer exposure to pesticide residues can be estimated for
children and adults [28].
80
5. Databases for Risk Assessment
The methods and tools for risk assessment and risk management of pesticides in fruits and vegetables
require many input data on the maximum residue level, the physico-chemical properties of pesticides
(potential for leaching, sorption, volatilization, photodegradation, microbial or chemical degradation etc.),
the toxicology/ ecotoxicology, potential effects on human health etc. Consequently, various organizations
such as the World Health Organization (WHO), Environmental Protection Agency (USEPA), European
Commission and others developed on-line databases, which provide parts of the necessary input data for the
methods and tools used in risk assessment. Several databases are presented below:
- IRIS (Integrated Risk Information System) is a database elaborated and maintained by the US
Environmental Protection Agency and contains information on the human health effects caused by exposure
to various substances from environment. This database was developed in order to facilitate the risk
assessments, decision-making processes and regulatory activities by providing information about the
chemical substances toxicology. In the files provided by IRIS for different pesticides, values of oral
reference doses and inhalation reference concentrations (RfDs and RfCs) for chronic noncarcinogenic health
effects and hazard identification, oral slope factors, and oral and inhalation unit risks for carcinogenic effects
can be found [29].
- PPDB (Pesticide Properties DataBase) – was developed by the Agriculture and Environment
Research Unit (AERU) at the University of Hertfordshire in 2007 with the purpose to support risk
assessments and management of pesticides. PPDB database holds data about chemical identity,
physicochemical proprieties, human health and ecotoxicological effects for almost 2300 pesticide (synthetic
and natural including those with veterinary applications) and over 700 records for associated metabolites
approved for use in the EC and other countries The information provided by this database can be accessed on
the PPDB website, or through the IUPAC website [30].
- EU - Pesticides database was developed and maintained by European Commission with the leading
goal to give the necessary data about the pesticide residues in fruits and vegetables (378 products), the
Maximum Residue Levels (MRLs) for different pesticides and different data about 1,359 active substances.
This database is used especially by the member states of EU for risk assessment and management of
pesticides in food plants [31].
- European Chemicals Agency (ECHA) (the new version of European Chemical Substances
Information System (ESIS)) is a source of information on the chemicals manufactured and imported in
Europe, and provide data on their hazardous properties, classification and labeling [32].
- International Uniform Chemical, Information Database (IUCLID) is a software program which
provides information on environmental fate and pathways, ecotoxicity/ toxicity and physical-chemical
proprieties of chemical substances [33].
- US ECOTOX database represents a source for chemical environmental toxicity data on aquatic life,
terrestrial plants and wildlife [34].
6. Conclusions
Pesticides are intensively used in the pest control by the farmers, being found in variable quantities in
different food plants. Their negative effects to human health are especially visible for fetuses and children.
For a good management of pesticides usage, different organizations, such as EFSA or USEPA developed
different software tools to facilitate risk assessment strategies of pesticides residues found in food. These
programs were developed based on mathematical models and could be implemented by considering different
databases such as IRIS, PPDB, EU - Pesticides database, ECHA, IUCLID or US ECOTOX. In applying
these software packages for modeling risks to human health, data on pesticides characteristics and
concentrations, food consumption and effects to human health are essential. Extensive work is still necessary
in understanding the behavior, fate and transport of pesticides along different environmental compartments
so as to implement robust risk assessment strategies.
7. Acknowledgements
81
This work was supported by a grant of the Romanian National Authority for Scientific Research and
Innovation, CNCS/CCCDI - UEFISCDI, project number PN-III-P2-2.1-PED-2016-1662, within PNCDI III.
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