Abstract
To ensure public safety against veterinary drug residues in food products from animal sources, maximum residue limits (MRLs) should be established by scientific evidence and a transparent estimation process. The Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) developed an Excel workbook-based tool for MRLs evaluation in 2003. In this study, we developed a web-based tool for MRL evaluation, called Korean MRL evaluation tools (KMET). While KMET used algorithms of JECFA workbook, it added some databases (e.g., Korean food consumption database) and provided additional functions (e.g., selection of target marker residue). Web-based KMET enabled regulatory policy makers to update the database. All input data and output results related to MRL evaluation based on residue depletion and food consumption datasets were archived and provided overall processes from the initial depletion data entry to MRL establishment with user-friendly interface. Our results demonstrated the stepwise processes whereby MRL for trichlorfon in the muscle of Paralichthys olivaceus was established with functional descriptions of KMET. MRL for trichlorfon derived from KMET was proposed and notified by the Ministry of Food and Drug Safety in 2018.
Similar content being viewed by others
References
Baynes RE, Dedonder K, Kissell L, Mzyk D, Marmulak T, Smith G, Tell L, Gehring R, Davis J, Riviere JE (2016) Health concerns and management of select veterinary drug residues. Food Chem Toxicol 88:112–122
Boobis A, Cerniglia C, Chicoine A, Fattori V, Lipp M, Reuss R, Verger P, Tritscher A (2017) Characterizing chronic and acute health risks of residues of veterinary drugs in food: latest methodological developments by the joint FAO/WHO expert committee on food additives. Crit Rev Toxicol 47:885–899
Boon PE, Cunningham J, Moy GG, Ormerod D, Peterson BJ, Reuss R (2013) Automated programs for calculating dietary exposure. In: Moy G, Vannoort R (eds) Total Diet Studies. Springer, New York
Boushey CJ, Spoden M, Zhu FM, Delp EJ, Kerr DA (2017) New mobile methods for dietary assessment: review of image-assisted and image-based dietary assessment methods. Proc Nutr Soc 76:283–294
CODEX (2015) MRLs for veterinary drug residues in foods. http://www.fao.org/fao-who-codexalimentarius/standards/veterinary-drugs-mrls/en/. Accessed 2 Oct 2018
Croubels S, De Backer P, Devreese M (2016) GLP principles and their role in supporting pharmacokinetic and residue depletion studies for drug registration and licensing. Drug Test Anal 8:572–577
Environmental Protection Agency (2000) Risk Characterization Handbook. https://www.epa.gov/risk/risk-characterization-handbook. Accessed 2 Oct 2018
European Commission (2009) COMMISSION REGULATION (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin. http://ec.europa.eu/health/sites/health/files/files/mrl/mrl_20101212_consol.pdf. Accessed 2 Oct 2018
Fan YC, Sheu SY, Lai HT, Chang MH, Chen PH, Lei YC, Kuo TF, Wang CY (2015) Residue depletion study of danofloxacin in cultured tilapia (Oreochromis mossambicus). J AOAC Int 98:575–579
FAO (2003) Software-based workbook for statistical evaluation of residue depletion data for veterinary drugs. http://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/guidelines0/residue-depletion/en/. Accessed 2 Oct 2018
FDA (2017) FDA-iRISK 4.0. https://irisk.foodrisk.org/. Accessed 2 Oct 2018
Hsiao PF, Chang SK, Hsu TH, Li KP, Chou CC (2016) Pharmacokinetics and tissue depletion of doxycycline administered at high dosage to broiler chickens via the drinking water. Acta Vet Hung 64:472–481
JECFA (2014) Evaluation of certain veterinary drug residues in food. Seventy-eighth report of the Joint FAO/WHO Expert Committee on Food Additives WHO technical report 988
KCDC (2014) Korea National Health and Nutrition Examination Survey (KNHANES). https://knhanes.cdc.go.kr/knhanes/main.do. Accessed 6 Nov 2018
KREI (2014) Food balance sheet. Korea Rural Economic Institute. http://www.krei.re.kr/krei/index.do. Accessed 6 Nov 2018
Lee H, Lee K, Park JY, Min SG (2017) Korean Ministry of Environment’s web-based visual consumer product exposure and risk assessment system (COPER). Environ Sci Pollut Res Int 24:13142–13148
Lim JA, Kwon HJ, Ha M, Kim H, Oh SY, Kim JS, Lee SA, Park JD, Hong YS, Sohn SJ, Pyo H, Park KS, Lee KG, Kim YD, Jun S, Hwang MS (2015) Korean research project on the integrated exposure assessment of hazardous substances for food safety. Environ Health Toxicol 30:e2015004
Lima AL, Barreto F, Rau RB, Silva GRD, Lara LJC, Figueiredo TC, Assis DCS, Cançado SV (2017) Determination of the residue levels of nicarbazin and combination nicarbazin-narasin in broiler chickens after oral administration. PLoS One 12:e0181755
MFDS (2015) Korean food standard code (Osong, Korea). http://www.mfds.go.kr/. Accessed 20 Nov 2018
MFDS (2016) MRLs for veterinary drugs and their metabolites. http://www.mfds.go.kr/. Accessed 2 Oct 2018
Ministry of the Interior (2016) eGovernment Standard Framework. http://www.egovframe.go.kr/EgovAdtView_Eng.jsp. Accessed 2 Oct 2018
NIFS (2014) Aquatic Medicine Catalogue. National Institution of Fisheries and Science, Busan, p 95
Nunes KSD, Vallim JH, Assalin MR, Queiroz SCN, Paraíba LC, Jonsson CM, Reyes FGR (2018) Depletion study, withdrawal period calculation and bioaccumulation of sulfamethazine in tilapia (Oreochromis niloticus) treated with medicated feed. Chemosphere 197:89–95
RIVM. (2017) ConsExpo. http://www.rivm.nl/en/Topics/C/ConsExpo. Accessed 2 Oct 2018
Sanders P, Henri J, Laurentie M (2016) Tools to evaluate pharmacokinetics data for establishing maximum residue limits for approved veterinary drugs: examples from JECFA's work. Drug Test Anal 8:565–571
SAS Institute (2004) SAS/STAT 9.1 User’s Guide. https://support.sas.com/documentation/onlinedoc/91pdf/sasdoc_91/stat_ug_7313.pdf. Accessed 2 Oct 2018
Wang J, MacNeil JD, Kay JF (2011) Chemical analysis of antibiotic residues in food. Wiley, Hoboken
Wang Y, Rodríguez De Gil P, Chen YH, Kromrey JD, Kim ES, Pham T, Nguyen D, Romano JL (2017) Comparing the performance of approaches for testing the homogeneity of variance assumption in one-factor ANOVA models. Educ Psychol Meas 77:305–329
Woo SJ, Lee HH, Chung JK (2016) Simultaneous determination of trichlorfon and dichlorvos residues in olive flounder (Paralichthys olivaceus) by liquid chromatography-mass spectrometry: validation and application to pharmacokinetics. RRJPPS 5:85–95
Xie S, Pan Y, Chen D, Qu W, Sattar A, Cheng G, Liu Z, Wang L, Tao Y, Yuan Z (2017) Quantitative analysis of bacitracin in porcine edible tissues by high-performance liquid chromatography–electrospray ionization tandem mass spectrometry and its application to residue depletion study. Food Anal Methods 10:539–548
Funding
This work was supported by the Ministry of food and drug safety, Republic of Korea in 2016 (16162MFDS588) and 2017 (17161MFDS651).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflicts of interest
The authors declare that they have no conflict of interest.
Additional information
Responsible editor: Philippe Garrigues
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Kang, HS., Kwon, N.J., Jeong, J. et al. Web-based Korean maximum residue limit evaluation tools: an applied example of maximum residue limit evaluation for trichlorfon in fishery products. Environ Sci Pollut Res 26, 7284–7299 (2019). https://doi.org/10.1007/s11356-019-04314-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11356-019-04314-y