As part of a regulatory submission, Covance was approached by a European company who had been asked by regulators to supply additional operator exposure data. The substance under investigation contained both a pesticide and growth inhibitor, which is applied as a dust to stored potatoes. The mode of application meant existing models were inappropriate, so a field trial and residue analysis were both necessary to monitor the specific application method. The timeline for running the trial and analyzing data to meet a regulatory deadline was short - around six months.

1. Crop Protection Case Study
Background
As part of a regulatory submission, Covance was approached by a European company who had been asked
by regulators to supply additional operator exposure data. The substance under investigation contained both
a pesticide and growth inhibitor, which is applied as a dust to stored potatoes. The mode of application meant
existing models were inappropriate, so a field trial and residue analysis were both necessary to monitor the
specific application method. The timeline for running the trial and analyzing data to meet a regulatory deadline
was short – around six months.
The Challenges
The key challenges for this operator exposure trial were the short turnaround for study completion and data
generation – within a fixed regulatory window – and designing a trial that accounted for different application settings.
▶ Identification of appropriate farms growing the test crop with test-adherent storage facilities:
The study was commissioned in February 2017 and had to be completed by fall of that year. Finding farms with
potato crops due for harvest within this window was the first challenge. The study also required the use of the
specific application technique to potatoes stored in three different ways, which meant sourcing stores appropriate
for each different technique.
▶ Validation of study methods in a limited timescale:
Checks on the stability of the test material in the field were needed before the study commenced, with validation
of the analytical approach required before the analysis of collected samples could be initiated.
▶ Reproducible study design that could use real-life agricultural practices:
The study needed to monitor various store approaches, which had been identified during the preliminary
on-site survey taken by the Field Trials team. Samples of the clothing items – both protective outer and inner
clothing – had to be gathered and tested quickly due to the photosensitivity of one of the test compounds.
The Solution
With this time-critical challenge, study success relied on the smooth integration of the activities of the Covance Field
Trials and Residue Analysis teams.
Extended network-enabled identification of appropriate field sites
The Field Trials team, through their network of growers, co-operators and other contract research organizations
across Europe, identified 12 different study sites in the target country, at which potato crops were due to be harvested
between June and August. Early crop potatoes had to be used to enable study completion by fall. The farms were
HOW INTEGRATION OF FIELD TRIALS
AND RESIDUE ANALYTICS TEAMS
OPTIMIZED STUDY COMPLETION TIMES

2. assessed to confirm that their agricultural practice for treating potatoes post-harvest was typical and
that they adhered to the application and storage approaches, and had storage facilities adherent to the
study plan.
Integrated project planning and collaborative working between Field Trials and Residue
Analysis teams optimized study design and study completion timeframe
The Field Trials and Residue Analysis teams have overlapping skill sets and expertise, which allowed
them to plan and run the field study and subsequent analytics efficiently. Members from both teams
were on-site during the field study to ensure seamless operation of each study phase. Proactive project
planning took some activities off the critical path to improve the delivery timescale; for example,
validation of the analytic approach was run parallel to the field study phase.
Precision logistics ensured equipment was in the right place at the right time
Cost-effective and timely delivery of the wide range of equipment required for the different phases of
the study was facilitated by joint logistics planning.
Adaptation of existing sample-handling methodology accommodated the large size and extent
of test samples
For this operator exposure study, over 800 samples of both protective clothing and undergarments
had to be tested. These bulky items required rapid handling and careful storage, especially given the
light sensitivity of one of the test compounds. Having residue analysis staff on-site during the field
study facilitated this, while laboratory-based teams prepared appropriate laboratory storage space and
equipment for rapid analytic processing, as well as performing any final validation tests in anticipation
of the receipt of study samples.
Conclusions
The integration of the Covance Field Trials and Residue Analysis teams ensures efficient delivery of
complex studies in a timely and cost-effective manner. Our well-established joint-working practices can
be employed flexibly to meet the needs of our clients and their regulatory deadlines.
Visit www.covance.com/crop-protection to find out more.
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