Guidance on Estimating Soil Persistence and Degradation Kinetics from Environmental Fate Studies on Veterinary Pharmaceuticals for Environmental Risk Assessment

동물용의약품의 환경 중 위해성 평가를 위한 토양 잔류성 시험법 가이드라인

  • Kwon, Jin-Wook (National Veterinary Research & Quarantine Service (NVRQS))
  • Received : 2011.01.27
  • Accepted : 2011.02.15
  • Published : 2011.03.31


BACKGROUND: To assess and prevent the environmental impacts and risks by veterinary pharmaceuticals, Guidance on Estimating Soil Persistence and Degradation Kinetics from Environmental Fate Studies on Veterinary Pharmaceuticals for Environmental Risk Assessment was proposed. METHODS AND RESULTS: Proposed guidance was coined by VICH, EU guideline, OECD guideline and soil dissipation studies for the purpose of international harmonizing. Guidance was also modified from pesticide soil persistence testing guidelines of US, EU, and Korea, with practical approaches adopting in-use test guideline for Korea. CONCLUSION(S): Proposed guidance are consisted of three parts; Laboratory Soil Experiment, Field Soil Dissipation Study, and Estimation of $DT_{50}/DT_{90}$. Proposed guidance is to be available for the requirement for registration of veterinary pharmaceuticals with fit for purpose in Korea.


Environment;Guidance;Risk assessment;Soil persistence;Veterinary pharmaceuticals


  1. Agrochemical Control Act, 2009. ACT No. 9658, May 8, 2009, Chapter III, Registration, ETC. of Agrochemicals, Article 8. Registration of items produced in Republic of Korea
  2. Agriculture Canada, 1987, 1992. Environmental Chemistry and Fate. Guidelines for registration of pesticides in Canada.
  3. Committee for Medicinal Products for Veterinary Use (CVMP), 2008. Revised guideline on environmental impact assessment for veterinary medicinal products (Doc. Ref. EMEA/CVMP/ERA/418282/2005-Rev.1).
  4. Dolliver, H., Kumar, K., Gupta, S., 2007. Sulfamethazine uptake by plants from manure-amended soil, J. Environ. Qual. 36, 1224-1230.
  5. EU, 1991. COUNCIL DIRECTIVE, concerning the placing of plant protection products on the market, 91/414/EEC.
  6. EU, 1998. Directive 81/852/EEC, Environmental risk assessment for veterinary medicinal products other then GMO containing and immunological products, January 1998, EMEA/CVMP/055/96.
  7. European Public Health Alliance, 2006. FOCUS, The Final Report of the Work Group on Degradation Kinetics of FOCUS (FOrum for the Co-ordination of pesticide fate models and their USe): Guidance document on estimating persistence and degradation kinetics from environmental fate studies on pesticides in EU Registration, Sanco/10058/2005, version 2.0, June 2006.
  8. Jiemba, P.K.J., 2002. The potential impact of veterinary and human therapeutic agents in manure and biosoilds on plants grown on arable land: a review, Agriculture, Ecosystems and Environment 93 267-278.
  9. OECD, 2002. Aerobic and Anaerobic Transformation in Soil, OECD Guideline for Testing of Chemicals 307, adopted 24. April 2002.
  10. OEPP/EPPO (European and Mediterranean Plant Protection Organization), 1993. Decision-making scheme for the environmental risk assessment of plant protection products. Chapters4. Bulletin OEPP/EPPO Bulletin 23, 1-165
  11. RDA, 1993. Test Guideline of Pesticide Soil Residue Test.
  12. RDA, 1997. Notification No. 1997-3 of the Rural Development Administration, Standard and Test method for Pesticide Registration.
  13. SETAC, 1995. Procedures for Assessing the Environmental Fate and Ecotoxicity of Pesticides. Mark R. Lynch, Ed.
  14. VICH, 2001. Environmental Impact Assessment (EIAs) for veterinary medicinal products (VMPs) - Phase 1 VICH GL6 (Ecotoxicity - Phase 1).
  15. VICH, 2005. Environmental Impact Assessment (EIAs) for Veterinary Medicinal Products (VMPs) - Phase II VICH GL38 (Ecotoxicity Phase II).
  16. Sarmah, A.K., Meyer, M.T., Boxall, A.B.A., 2006. A global perspective on the use, sales, exposure pathways, occurrence, fate and effects of veterinary antibiotics in the environment, Chemosphere 65, 725-759.
  17. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 1996, 7 U.S.C §136 US.
  18. Vaclavik, E., Halling-Sørensen, B. and Ingerslev, F., 2004. Evaluation of manometric respiration tests to assess the effects of veterinary antibiotics in soil, Chemosphere 56, 667-676.

Cited by

  1. Environmental impact assessment of veterinary drug on fish aquaculture for food safety vol.8, pp.5-6, 2016,