Study protocol for the Korean Human Exposure Safety Survey (KoHESS): a national biomonitoring program for food and consumer product safety

This protocol paper describes the design and methodology of the Korean Human Exposure Safety Survey (KoHESS), a three-year national biomonitoring program (2023-2025). Korea's Act on Risk Assessment of Products for Human Use necessitates scientific evidence for aggregate exposure assessment and cumulative risk evaluation of hazardous substances in food and consumer products. Existing biomonitoring programs primarily focus on environmental exposures, limiting comprehensive assessment of products regulated by the Ministry of Food and Drug Safety. KoHESS employs repeated cross-sectional surveys targeting approximately 5,000 Koreans aged 3-79 years per cycle, using complex stratified multistage sampling for national representativeness. Data collection includes standardized anthropometric measurements, biological samples (blood, urine), comprehensive exposure source surveys, and 2-day 24-hour dietary recalls. Chemical analyses using liquid chromatography-tandem mass spectrometry and inductively coupled plasma mass spectrometry measure 24 perfluoroalkyl and polyfluoroalkyl substances compounds, 25 phthalate metabolites, and 7 heavy metals, with quality assurance through certified reference materials. KoHESS will provide scientifically robust data for establishing safety standards, enable advanced exposure modeling, facilitate risk assessments reflecting cumulative exposures, support targeted protection for vulnerable populations, and contribute to international biomonitoring networks while promoting preventive hazardous substance management systems.