Application of Plant Protection Products (PPP) in Apple Orchards (aPPPle)

Pilot Study on the Exposure of Operators, Residents and Workers to Plant Protection Products Used in Apple Orchards and Possible Health Effects

The aim of the aPPPle pilot study is to test feasibility and generate first results in preparation for a main study. The aPPPle study will investigate the exposure of operators, workers and residents to plant protection products (PPP) and potential physiological effects on blood biomarkers. The target plants are apple crops, as application occurs at higher altitudes and therefore higher drift/exposure is expected compared to ground-level application. The substances to be investigated are acetamiprid (an insecticide) and dithianon and dodine (two fungicides).

Study Overview

• Status: Recruiting
• Conditions: Dermal Exposure; Inhalative Exposure; Metabolites in Urine; Effekt Biomarker in Blood

• Study Type: Observational
• Enrollment (Estimated): 16

Contacts and Locations

• Study Contact: Name: Prof. Dr. Cornelia Weikert; Phone Number: +49 301841255000; Email: cornelia.weikert@bfr.bund.de
• Study Contact Backup: Name: Dr. Anna Lechner; Phone Number: +49 301841255015; Email: anna.lechner@bfr.bund.de

Study Locations

• Germany
  • Berlin, Germany, 10589
    • Recruiting
    • Federal Institute for Risk Assessment
    • Contact: Prof. Dr. Cornelia Weikert; Phone Number: +49 301841255000; Email: cornelia.weikert@bfr.bund.de
    • Contact: Prof. Dr. Cornelia Weikert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Users, residents and workers:

people from "Altes Land", a large apple-growing region in northern Germany

Control: live at least 10 km and max. 150 km away from agricultural apple orchards

Description

Inclusion Criteria:

• belonging to one of the defined study groups
• over 18 years of age at the time of recruitment
• person can understand the language and content of the study requirements
• person is capable of consenting to participate in the study and has given written consent to participate in the aPPPle study
• person has health insurance

Exclusion Criteria for residents and control:

person has direct professional contact with the tested substances acetamiprid, dithianon or dodine

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Operators; People who apply plant protection products to apple crops.
Workers; People who do manual work in apple cultivation, like pruning or harvesting.
Residents; People whose place of residence is adjacent to the orchard under investigation.
Control; People whose place of residence is at least 10 km away from agricultural apple orchards and a maximum of 150 km away from the apple orchard under investigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of plant protection substances/metabolites in different matrices	The concentrations of the investigated substances/their metabolites will be analysed in urine, patches (to assess dermal exposure of the body), hand wipes (to assess dermal exposure of the hands), filters of an personal air sampler (to assess inhalation exposure), hair samples and gras samples	Operators: during the observed work with PPP and for urine up to 48 hours after; resident: during the observed application and for urine up to 48 hours after; workers: during work in the orchards and for urine up to 48 hours a; control: at one time point
Effect biomarkers in blood and metabolome in plasma	Defined effect biomarkers in blood as well as the metabolome in plasma will be analysed before and after application of plant protection products to observe possible early physiological changes. The following effect biomarkers in the blood will be measured: c-reactive protein, fasting glucose, HbA1c, cortisol, oxidized LDL, complete blood count, thyrotropin (TSH), free T3 (fT3), free T4 (fT4), gamma GT, GOT (ASAT), GPT (ALAT), bilirubin, cystatin C, urea	enrollment until 7 days after application/work in the apple orchards; for people from the control group at one time point

Collaborators and Investigators

• Sponsor: German Federal Institute for Risk Assessment
• Collaborators: Federal Ministry of Food and Agriculture; ESTEBURG Obstbauzentrum Jork Kompetenzzentrum für den norddeutschen Obstbau

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: exposure study; plant protection products; human biomonitoring; effect biomarker
• Other Study ID Numbers: 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No