Objective: The primary objective of the study is to determine the personal exposure levels to pesticides of residents living near agricultural land. The secondary objectives of the study are to evaluate the concentrations of pesticides in theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
none
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The main study parameters are the
concentration of pesticides or their metabolites in urine samples.
Secondary outcome
The secondary study parameters are the concentration of pesticides in the
outdoor and indoor environment of residents living close to agricultural land
with intensive use of pesticides.
Background summary
Rationale: The application of pesticides in the vicinity of homes has raised
concerns regarding health risks from local residents. Current authorisation
procedures of pesticides do not include a separate (independent) assessment of
risks for residents, except for residents living near greenhouses. The safety
of residents is assumed to be covered by authorisation procedures that apply to
operators, workers and bystanders. However, it is not clear if this assumption
is valid, given that residents living in the close proximity to agricultural
fields where pesticides are used intensively, if exposed at all, are likely
exposed to much lower levels. This is due to (secondary) drift, and evaporation
of pesticides from nearby agricultural land and possible accumulation of
concentrations in the home environment. This may lead to a much longer duration
of exposure than only during the period of application. These authorisation
procedures also do not take populations with a higher vulnerability into
account, such as the unborn, small children or the elderly. The Health Council
of the Netherlands recently concluded that there is very limited knowledge
about the actual exposure to pesticides of residents in the Netherlands. To
close this gap in knowledge, the Dutch government has commissioned the National
Institute for Public Health and the Environment (RIVM) to coordinate an
exposure assessment study with the objective of *acquiring data on the
(potential) exposure of residents in agricultural areas with intensive use of
pesticides*.
Study objective
Objective: The primary objective of the study is to determine the personal
exposure levels to pesticides of residents living near agricultural land. The
secondary objectives of the study are to evaluate the concentrations of
pesticides in the environment of residents living near agricultural land and
study the exposure sources and routes contributing to personal and
environmental pesticide exposures.
Study design
Study design: This is an observational study without invasive procedures. We
will perform an exposure survey in 200 households with at least two eligible
participants per household (preferably at least one adult and one child), at
locations in close vicinity to treated agricultural land (<500m). Participants
will be asked to provide repeated spot urine samples on two occasions (one
seven-day period) during the spray season and on one occasion (two-day period)
during the off-season. They will be asked to wear a wristband during these
periods to measure exposure to pestiides passively. Outdoor as well as indoor
concentrations of pesticides in air and on surfaces (dust) will be measured to
study the contribution of the different routes of personal exposure. Additional
factors that may impact personal pesticide exposure levels, such as diet and
activity patterns (the activities people do when they are out of their homes)
will be assessed by means of a questionnaire and diaries.
The study is split into two phases: A first project phase (2015-2018) in which
only flower bulb-related pesticide exposure has been assessed in a little under
100 households, and a second phase (2024-2026), again with 100 households, in
which also pesticides used on fruit will be investigated.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Burden: All subjects will provide repeated urine
samples (first morning voids, during one period of 7 consecutive days, and once
during 2 consecutive days) and fill in questionnaires and diaries. In addition,
inside as well as outside of their homes, air samples and surface samples
(dust) will be collected.
We will include children of all age groups (0-6 and 7-17 years), as children
have different activity profiles that likely impact exposure levels.
Risks: This is an observational study not involving risks for participants.
Benefit: The study has no direct benefit to the participants. The study will
deliver relevant insight into exposure levels as such, as well as into the
factors that impact exposure levels in residents in general. This will in turn
contribute to future evaluation of potential risks from the exposure to
pesticides in residents. Finally, the study will also contribute to a better
understanding of how to reduce exposure to pesticides of residents.
Yalelaan 2
Utrecht 3584 CM
NL
Yalelaan 2
Utrecht 3584 CM
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a subject must have his/her
primary place of residence at one of a pre-selected location (i.e., within 500m
of a treated agricultural field).
Exclusion criteria
- Inability to complete the administered questionnaires or communicate with the
study assistant, e.g. due to insufficient knowledge of the Dutch language or
cognitive impairment.
- Doctor diagnosed kidney or liver disease.
Design
Recruitment
Medical products/devices used
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In other registers
Register | ID |
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CCMO | NL54727.041.15 |