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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

Abstract

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.

최근, 동물 및 인체용 의약품류는 환경 중 새로운 오염물질로 부각되고 있다. 특히, 우리나라는 동물용의약품에 대한 수의사 처방제 미정착, 집약적 축산환경, 최근의 대규모 지속적 동물 전염병의 발생, 단위 육류 생산량 증대를 위한 동물용의 약품의 남용, 축산분뇨의 해양투기 전면 금지 등 축산분야의 위협적 요소와 함께 환경 중 동물용의약품의 잔류성 문제가 향후 식품오염 및 항생제 내성 유발 등의 요인으로 확대 될 우려가 크다. 그러므로 동물용의약품의 주된 환경배출 매개인 분변을 통한 토양 잔류성 검토는 지하수 오염과 지하수 또는 분변 중 잔류량의 흡수, 이행과정을 통한 농경지 작물의 오염 예방을 위해서도 동물용의약품의 인허가 단계 중 토양 잔류성을 환경 위해성 평가자료로 검토하는 것은 중요한 의의를 갖는다. 본 연구는 VICH, OECD 등의 국제적 기구에서 그 동안 제안하였거나, 검토 중인 동물용의약품의 환경위해성 평가 가이드 라인과 오랫동안 우리나라, 미국, 유럽 등지에서 정착되어 온 농약의 토양 중 잔류성 시험법, 그리고 문헌을 토대로 기 수행한 동물용의약품의 토양잔류성 시험 결과를 바탕으로 하여 동물용의약품의 환경 중 위해성 평가를 위한 토양 잔류성 시험법 가이드라인을 제안하였다. 시험법 가이드라인은 크게 실내, 실외 시험 방법과 잔류소실기의 예측으로 구성되어 있으며, 농경지토양 내 분변을 통한 노출 경로를 주안으로 하여 우리나라 환경에 적합토록 구성하였다.

Keywords

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