농식품 안전성 조사 효율성 제고를 위한 시스템 구축

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(1)C2008-50 | 2008. 12.. 발 간 등 록 번 호 11-1541204-000004-01. 농식품 안전성 조사 효율성 제고를 위한 시스템 구축. 임 현 훈 영. 연 구 위 원. 곽 민 정. 평택대학교. 이 최 김 손. 계 지 성 은. 선임연구위원 부연구위원 연. 구. 원.

(2) 연구 담당 이계임 최지현 김성훈 손은영. 연구위원 선임연구위원 부연구위원 연구원. 연구 총괄, 1~3장, 5~6장 집필 4장 5절 집필 4장 1~4절 집필 자료 수집 및 분석, 2장집필. 곽민정. 평택대학교 교수. 5장 집필.

(3) 머 리 말. 식품안전에 대한 소비자의 관심과 불신이 확대됨에 따라 농산물품질관리원 에서는 1994년부터 안전성 조사업무를 실시하였으며, 이후 안전성 조사건수를 확대하고 분석수준을 높여 부적합품 유통을 사전에 차단하는 것을 목표로 안 전관리에 노력하고 있다. 한편 지난 15년간 실시되어온 안전성 조사 업무는 조 사 확대와 부적합률 감소를 목표로 추진되어 왔으며, 조사물량을 과학적 기준 에 의하기 보다는 사회적 요구에 따라 빠르게 확대해온 측면이 있다. 이 연구는 농산물 안전성 조사가 안전성 관리의 정책목표를 달성하고 나아 가 국내 농산물 안전성 제고에 기여할 수 있도록 업무의 효율성을 제고시킬 수 있는 방안을 마련하고자 추진되었다. 현행 농산물 안전성 조사체계에 대한 평 가, 외국의 안전성 조사 사례 분석, 전문가 대상 조사 등을 바탕으로 적정 조사 물량 산정방식 검토, 합리적인 조사대상 선정, 시료채취 및 사후관리 개선, 조 사기반 확충 등 구체적인 개선방안을 제시하였다. 이 연구의 결과가 안전성 조사체계를 효율적으로 개편하는데 기초자료로 활 용되기를 기대한다. 연구진행과정에서 적극적으로 도움을 주신 농산물품질관 리원 본원의 담당자 여러분, 설문조사에 응해주신 농산물품질관리원 지원･출 장소와 지방자치단체 담당자여러분께 감사드린다. 또한 해외사례 관련 정보 수 집에 참여해준 외부 전문가 여러분께도 감사드린다.. 2008. 12. 한국농촌경제연구원장 오 세 익.

(4) iii. 요. 약. 이 연구는 농산물 안전성 조사가 안전성 관리의 정책목표를 달성하고 나아 가 국내 농산물 안전성 제고에 기여할 수 있도록 업무의 효율성을 제고시킬 수 있는 방안을 마련하는 데 목적이 있다. 현행 농산물 안전성 조사체계에 대한 평가, 외국의 안전성 조사 사례 분석, 안전성 조사 업무를 담당하고 있는 전문 가 대상 조사 등을 바탕으로 과학적인 안전성 조사물량 산정방식을 재설계하 고, 농산물 안전성 조사제도의 개선방향을 제시하고자 한다. 농산물 안전성 조사는 1996년부터 본격적으로 실시된 이후 2007년 150품목 68천건까지 확대되어 왔지만, 조사물량 및 물량 배분 근거가 미흡하고 시료 채 취의 어려움에 당면하는 등 문제점이 나타나고 있다. 이 연구에서는 농산물 안 전성 조사제도의 현황과 문제점을 검토하고, 미국･호주･EU･일본･대만의 안전 성 조사 사례를 비교하였다. 농산물 안전성 조사체계에 대한 평가를 위해 농산물품질관리원과 지방자치 단체를 대상으로 한 설문조사를 실시하였다. 농산물 안전성 조사의 물량배분･시 료채취･부적합 발생 시 관리현황 등 농산물 안전성 조사업무 전반을 검토하였으 며, 조사업무의 효율성을 제고할 수 있는 방안이 조사되었다. 과학적인 안전성 조사물량 산정방식의 재설계를 위해 국내외 산정방식에 대 한 평가와 적정 산정방식 개발이 추진되었으며, 조사표본 규모 결정 시 부적합 율 산정의 정확도를 목표로 고려하는 방법과 최소 검출력을 기초로 표본 규모 를 산출하는 방법을 동시에 적용하여 표본 수 결정의 가이드라인을 결정하였다. 전체 농산물 안전성 조사물량 규모는 분석실 능력 평가를 바탕으로 하였다. 마지막으로 농산물 안전성 조사제도의 개선방향을 제시하였다. 단기적으로 농 산물품질관리원의 안전성 조사업무는 생산단계 안전성 확보를 주요 목적으로 산지 위해물질 규제조사가 추진되어야 할 것이다. 식품에 대한 사전 감시기능 강화가 중요하므로 생산단계에서 규제모니터링(기본품목, 자율품목, 업무 협조 품목)과 탐색모니터링이 추진될 필요가 있다. 탐색모니터링은 농약사용기준 및.

(5) iv 농산물의 잔류허용기준이 마련되지 않은 품목군이나 신종유해물질 등을 대상 으로 한다. 유통단계 대상 품목은 우리나라 안전성 수준을 대표할 수 있는 다소 비 식품과 식품의 특성상 부적합률이 높을 것으로 우려되는 품목들 중에서 생산 단계 조사를 시행하는 품목으로 선정하여 유통단계까지 연계조사를 추진할 필요 가 있다. 장기적으로는 식품안전관리 일원화 추진과 이력추적관리 등 조사기반 확충 가정 하에 안전성 수준 진단, 정책수행 효과 평가 및 국민의 유해물질 섭 취량 산정을 위한 잔류조사체계를 구축해야 한다. 품목별로 분산운영 되던 조 사업무가 통합될 경우 자원의 비효율적인 유사한 조사관련 업무가 조정됨에 따라 효율적 관리가 가능하며, 전담조직을 확대함으로써 전문화된 조사체계 구 축이 가능할 것으로 기대된다. 생산단계 규제모니터링 대상품목은 2001~2007년간 농산물품질관리원의 중 점관리대상 품목 중에서 생산통계가 조사되는 품목을 우선적으로 선정하였으 며, 기본관리 품목 중에서 부적합률이 발생하거나 2005~2007년간 평균 생산규 모가 5만톤 이상인 품목을 대상으로 포함하였다. 또한 생산통계가 없으나 안전 성 조사실적상 부적합률이 우려되며 소비량도 상당 수준에 달하여 지속적인 관리가 필요한 것으로 사료되는 품목을 조사대상에 추가하였다. 2009년도 전 체 농산물 안전성 분석규모는 분석능력을 감안 시 50천건 수준이며, 기본 품목 의 표본규모는 가이드라인에 근거할 경우 50개 품목 기준으로 생산단계 13,163 개, 유통단계 6,730개이다. 지역별 조사물량 배분은 생산량에 따른 확률 비례 추 출과 인구비례에 따른 확률 비례 추출을 감안한다. 안전성 조사 시 농가의 반발과 회피를 감소시키기 위해 시료에 대한 유상 지 급과 안전성 조사 수행 시 인센티브 지급이 필요하다. 생산단계 안전성 조사에 서 부적합 판정을 받을 경우 처벌 목적의 규정보다는 부적합품의 시장출하는 막고, 해당 농가에게 경고하는 형식의 사후관리가 필요할 것으로 보인다. 그 밖에 맞춤형 농정과 관련된 농업경영체 등록제를 기초로 소면적 작물에 대한 생산통계를 구축하고, 소면적 작물의 잔류허용기준과 식중독균･곰팡이 균･기생충란 등의 안전기준을 설정해야 한다. 또한 안전성 조사 업무에 대한 소비자 홍보와 교육 효과를 유도하는 방안을 검토할 필요가 있다..

(6) v ABSTRACT. A Study for the Efficient Management of Food Safety Inspection Programs about Agricultural Products. In Korea, National Agricultural Products Quality Management Service (NAQS) has conducted food safety inspection programs about agricultural products after 1996, and the number of items and samples inspected by NAQS in 2007 were 150 items and 68 thousand samples, respectively. Even though NAQS keeps endeavoring to increase the level of food safety of agricultural products, the current inspection system still has several problems including following: unclear standards to decide the numbers of samples and farmers' resistance about sampling in field. The main goal of this research is to analyze the inspection programs of NAQS and to suggest the more efficient food safety inspection system about agricultural products. Survey analyses and interviews were conducted to analyse the current status of inspection programs of NAQS, and the case studies about the food safety inspection system of U.S, Australia, EU, Japan, and Taiwan were performed to deduce the implications. The research also developed the method to derive the minimal numbers of samples for inspection, which is statistically reliable. The research showcases the basic strategies for the efficient management of food safety inspection programs of NAQS as follows: first, strengthening of functions for inspection before the stage of selling agricultural products, second, integration of management system for food safety inspection, third, establishment of inspection system at the national level, forth, Improvement of methods for inspection, fifth, clear sharing of roles between central government and local governments. Basically, discussion and suggestions in this paper will offer the guidelines to increase the level of efficiency of food safety inspection of NAQS.. Researchers: Kyei-Im Lee, Ji-Hyeon Choi, Sounghun Kim and Eun-Young Son Research period: 2008. 8 ~ 12 E-mail address: lkilki@krei.re.kr.

(7) vii. 차. 제1장 서. 례. 론. 1. 연구의 필요성 및 목적 ··············································································· 1 2. 선행연구 검토 ······························································································ 3 3. 연구 내용과 방법 ························································································· 5 제2장 농산물 안전성 조사의 현황과 문제점 1. 농산물 안전성 조사 현황 ··········································································· 8 2. 농산물품질관리원 안전성 조사의 문제점 ··············································· 33 제3장 농산물 안전성 조사 업무 평가 1. 조사 개요 ···································································································· 37 2. 농산물 안전성 조사 업무 현황 ································································ 38 3. 농산물품질관리원의 안전성 조사 업무 평가 ········································· 40 4. 물량 배정 업무현황과 문제점 ·································································· 43 5. 시료채취 및 안전성 검사업무의 현황과 문제점 ···································· 45 6. 사후관리 현황 ···························································································· 53 7. 농산물 안전성 조사 업무의 개선방안 ····················································· 55 제4장 주요국의 안전성 조사 현황 1. 미국 ············································································································· 57 2. 호주 ············································································································· 91 3. EU ············································································································· 102 4. 일본 ··········································································································· 115 5. 대만 ··········································································································· 126.

(8) viii 제5장 적정 표본수 산출과 표본추출 방법 1. 농산물 품목별 적정 표본수 산출방법 ··················································· 133 2. 국내외 안전성 조사의 표본 검출방식 검토 ········································· 136 3. 품목별 적정 표본수와 표본추출방법 ····················································· 145 제6장 농산물 안전성 조사제도 개선방안 1. 농산물 안전성 조사의 기본 방향 ·························································· 149 2. 농산물 안전성 조사 추진방안 ································································ 152 3. 효율적 업무개선방안 ··············································································· 159 부록 1: 미국 PDP의 연도별 분석 대상 농약 ··············································· 171 2: 일본의 리스크 관리 표준 절차서의 주요 내용 ······························ 182 3: 표본규모산출 참고자료 ······································································ 185 참고문헌 ············································································································· 195.

(9) ix. 표 차 례. 제2장 표 2-1. 농산물 안전성 조사 단계별 비교 ····················································· 9 표 2-2. 안전성 조사 인프라 ·········································································· 11 표 2-3. 중점관리 품목 ··················································································· 12 표 2-4. 기본관리 품목 ··················································································· 13 표 2-5. 2008년 지원별 조사 계획: 잔류 농약 ············································ 16 표 2-6. 조사대상 유해물질 ············································································ 17 표 2-7. 지원의 조사 물량 배정 기준: 예시 ················································ 19 표 2-8. 농산물 중 중금속 허용기준 ····························································· 21 표 2-9. 지원 및 지역 정밀 분석실 분석기반 현황 ···································· 24 표 2-10. 농산물 안전성 연도별 조사실적 ··················································· 25 표 2-11. 2008년 상반기 중점관리 30개 품목의 안전성 조사 실적 ········· 26 표 2-12. 농산물 모니터링 현황(1996-2007) ················································ 28 표 2-13. 식약청 모니터링 추진실적 ····························································· 30 표 2-14. 소면적 재배 작목 현황 ·································································· 36 제3장 표 3-1. 설문 수거 현황 ················································································· 37 표 3-2. 식품과 농산물 평균 조사건수(2007년 기준) ································· 38 표 3-3. 농산물 조사품목 ················································································ 39 표 3-4. 농산물품질관리원의 안전성 조사 목적 ·········································· 40 표 3-5. 유통단계 모니터링 조사 목적 ························································· 40 표 3-6. 단계별 안전성 조사 담당 비중 ······················································· 41 표 3-7. 간이검사의 정밀검사로 대체에 대한 의견 ···································· 42.

(10) x 표 3-8. 간이검사 물량의 정밀검사 대체 가능 정도 ·································· 42 표 3-9. 안전정 조사 절차에서 어려운 점 ··················································· 42 표 3-10. 안전성 조사물량 배정방식의 적합성 ············································ 43 표 3-11. 조사물량 배정방식의 개선방안 ····················································· 44 표 3-12. 조사물량 배정이 적정하지 않은 이유 ·········································· 44 표 3-13. 생산단계 시료채취 시 문제점 ······················································· 45 표 3-14. 생산단계 시료채취에 응하는 비중 ··············································· 46 표 3-15. 생산단계 시료채취 시 시료대금 지불 여부 ································ 46 표 3-16. 시료채취 시 농가 반발 이유 ························································· 47 표 3-17. 생산단계 시료채취 어려움 해결방법 ············································ 47 표 3-18. 산지단계 안전성 조사 인센티브 제공 여부 ································ 48 표 3-19. 산지 안전성 조사단계에서 제공할 수 있는 인센티브 ··············· 48 표 3-20. 출하단계(모니터링) 시료채취 시 문제점 ····································· 49 표 3-21. 출하단계, 유통단계 농산물 시료 수거 장소 ······························· 49 표 3-22. 출하단계(모니터링) 시료채취시 시료대금 지불 여부 ················ 50 표 3-23. 출하단계(모니터링) 시료대금 지불 방법 ····································· 50 표 3-24. 출하단계 시료채취 농가 선정 방법 ············································· 51 표 3-25. 이력추적 불가능 사례 여부(2007년 기준) ··································· 51 표 3-26. 모니터링 조사의 중복성 평가 ······················································· 51 표 3-27. 시료채취에 응하는 비중 ································································ 52 표 3-28. 안전성 검사 애로사항 ···································································· 52 표 3-29. 부적합률 발생 원인 ········································································ 53 표 3-30. 부적합률 높은 품목 ········································································ 53 표 3-31. 농산물 부적합품에 대한 처리 방법 ············································· 54 표 3-32. 산지단계에서 부적합품 적발 사례 조치에 대한 평가 ··············· 54 표 3-33. 안전성 검사 업무 개선 사항 ························································· 55 표 3-34 기타 안전성 평가 지표 ··································································· 56.

(11) xi 제4장 표 4-1. 미국의 주요 잔류물질 모니터링 프로그램 ···································· 58 표 4-2. 인구 비례에 따른 양상추 샘플링 사례: 주별 ······························· 62 표 4-3. 인구 비례에 따른 양상추 샘플링 사례: 세부 지역별 ·················· 63 표 4-4. PDP 샘플 채취량 ·············································································· 64 표 4-5. 샘플링 계획 ······················································································· 65 표 4-6. 샘플 채취 전 준비 사항 ·································································· 66 표 4-7. 주요 대상 식품 (2003년까지의 PDP) ············································· 70 표 4-8. 1993～2003년까지의 모니터링 결과 ··············································· 71 표 4-9. 식품별 검출 비율 ·············································································· 72 표 4-10. 가공에 따른 농약 검출 비율 ························································· 73 표 4-11. 신선 과일 및 채소류 샘플링 현황 ··············································· 74 표 4-12. 가공 과일 및 채소류 샘플링 현황 ··············································· 74 표 4-13. 기타 샘플링 현황 ············································································ 75 표 4-14. 샘플링 대상 식품의 원산지 비율 ················································· 75 표 4-15. 2006년 PDP 결과 ········································································· 76 표 4-16. 집중 모니터링 현황 ········································································ 79 표 4-17. 샘플링 지역 및 샘플 건수: 2006년 ·············································· 80 표 4-18. TDS 대상 식품 및 물질 ································································ 84 표 4-19. TDS 분석 대상 물질 ······································································ 85 표 4-20. MDP의 분석 미생물 ······································································· 88 표 4-21. MDP의 분석 품목 ·········································································· 89 표 4-22. 미국의 농산물 안전성 조사 체계 요약 ········································ 90 표 4-23. 호주의 주요 잔류물질 모니터링 프로그램 ·································· 91 표 4-24. ATDS의 조사 대상 식품 분류 ······················································ 97 표 4-25. ATDS 대상 식품 (22회: 농산물) ·················································· 98 표 4-26. 잔류농약에 대한 위해평가 결과 (20회) ······································· 99.

(12) xii 표 4-27. 호주의 농산물 안전성 조사 체계 요약 ······································ 101 표 4-28. EFSA의 협력 기관 ······································································· 105 표 4-29. 농약의 최대허용기준 관련 법률 ················································· 106 표 4-30. EU의 주요 잔류물질 모니터링 프로그램 ·································· 107 표 4-31. 샘플 채취 가이드라인: 신선 농산물의 벌크(Bulk) 상태 ········· 109 표 4-32. 국가 단위 농약 모니터링 현황 (2005년 기준) ························· 110 표 4-33. 국가 단위 농약 모니터링 샘플의 국가별 분포 (2005년 기준) ···· 111 표 4-34. EU 협력 농약 모니터링 현황 (2005년 기준) ··························· 111 표 4-35. EU 협력 농약 모니터링 샘플의 국가별 분포 (2005년 기준) ···· 112 표 4-36. EU의 농산물 안전성 조사 체계 요약 ········································ 114 표 4-37. EU의 주요 잔류물질 모니터링 프로그램 ·································· 115 표 4-38. 조사구분별 위해요인과 조사대상 비교 ······································ 117 표 4-39. 서베일런스 및 모니터링 계획 ····················································· 118 표 4-40. 유해 화학 물질에 대한 검사 및 모니터링 연차 계획 대상 (2008년) ··· 119 표 4-41. 샘플링 가이드라인(예시) ······························································ 121 표 4-42. 동경도의 2008년 산지 조사 결과 ··············································· 123 표 4-43. 일본의 농산물 안전성 조사 체계 요약 ······································ 125 표 4-44. 대만의 단계별 농산물 안전성 검사체계 ···································· 127 표 4-45. 대만의 농산물 농약잔류검사(정밀검사) 실적, 2006 ················· 129 표 4-46. 대만 주요채소 및 잡곡류 농약잔류검사 실적, 2006 ················ 130 표 4-47. 대만의 채소류 조사처별 농약잔류검사 실적, 2007 ·················· 130 표 4-48. 대만의 농산물 안전성 조사 체계 요약 ······································ 132 제5장 표 5-1. 부적합률 추정의 정확도를 기준으로 구한 표본수 ····················· 134 표 5-2. 최소 검출력 산출방식 ···································································· 136 표 5-3. 주요 50개 품목 조사 물량과 부적합률 ········································ 137 표 5-4. 표본수 배정 ····················································································· 141.

(13) xiii 표 5-5. 시도별 층별 공통 표본수 ······························································ 142 표 5-6. 시도별 주산지 추가 표본수 ··························································· 143 표 5-7. 시･도별 원표본수와 축소 표본수 ················································· 143 표 5-8. 기본 표본수와 축소 표본수 ··························································· 144 표 5-9. 단계별 조사물량 산정 방식 ··························································· 146 제6장 표 6-1. 식품안전행정이 생산부처로 일원화된 사례 ································ 150 표 6-2. 주요국의 안전성 검사 용어 비교 ················································· 153 표 6-3. 주요국의 안전성 조사 담당 기관 ················································· 155 표 6-4. 안전성 조사 대상품목 선정(안) ···················································· 160 표 6-5. 지원 분석실 표준 모델 ·································································· 162 표 6-6. 지역 분석실 모델 ············································································ 163 표 6-7. 산출된 조사물량 ·············································································· 165 부록 부표 2-1. 농림성의 관리 대상 유해물질 우선순위 선정 기준 ··············· 182 부표 2-2. 농림성에서 설정한 우선 관리대상 유해물질 ··························· 184 부표 3-1. 최소 검출력 산출방식(한 개 이상 부적합물량) ······················ 185 부표 3-2. 최소 검출력 산출방식(두 개 이상 부적합물량) ······················ 188 부표 3-3. 최소 검출력 산출방식(세 개 이상 부적합물량) ······················ 191 부표 3-4. 부적합률 추정의 정확도 기준 표본수 ·········································· 194.