정의
본 카르타헤나 의정서는 생물다양성협약(CBD)에 근거하여 '생물안전성에 관한 의정서'를 만들기 위한 논의가 진행되어 1992년 카르타헤나에서 체결국 특별의회가 개최되었다. 바이오안전성의정서는 2000년 1월 29일 캐나다 몬트리올에서 채택되었는데 첫 개최지명을 따라 이 ‘의정서를 카르타헤나의정서라고 부르게 되었다. 본 의정서는 50개국이 비준한 후 90일이 지나면 발효되기로 되어 있다. 따라서, 지난 2003년 6월 13일 Palau가 50번째로 비준하면서 2003년 9월 11일자로 그 효력이 발효되게 되었으며, 2005년 6월 현재 본 의정서에 대해 124개국이 비준해 있다. 대륙별로는 아프리카 34개국, 아시아태평양국가 28개국, 중동부유럽 18개국, 미주 23개국, 서유럽 등 20국 등 124개국이다.
‘생명공학에 의해 생산된 유전자변형생물체(Living Modified Organisms : LMOs)의 국가간 이동시 인간건강을 고려하면서, 생물다양성에 해로운 영향을 미칠 수 있는 LMO의 안전한 수송, 취급 및 이용 등에 관한 사항’을 다루는 국제적협약이라 하겠다. 의정서는 유전자변형생물체(LMOs)의 사용 용도에 따라 식용·사료용·가공용(LMO-FFPs), 밀폐사용 LMO, 환경 방출용 및 기타 LMO 등 3가지로 분류하고, 인체의약품 LMO에 대해서는 의정서 적용되지 않은 것으로 규정하고 있다.
의정서는 3가지로 분류된 LMOs에 대하여 수출입시 각각 다른 절차를 예정하고 있다. 어류를 포함한 유전자변형 수서생물은 환경 으로 방출하여 양식을 목적으로 하기 때문에 환경방출용으로 분류된다고 볼 수 있다. 그리고 수입되고 있는 대부분의 LMO는 식용 ·사료용·가공용 유전자변형생물체(LMO-FFPs : LMOs for Food, Feed, and Processing)로 들어오고 있다.
의정서 출현과정 및 채택과정
20세기에 접어들면서 세계정제가 팽창하고, 인구가 증가하며 급속한 세계화 바람으로 화석연료, 목재나 어류 같은 자연자원의 국가간 교류가 크게 증가했다. \특히 2차 세계대전 이후 목재, 어류, 물과 식량, 철과 화석연로 등의 소비가 급격히 증가함에 따라 자연자원의 무분별한 이용과 난개발은 국경을 넘어 범지구적인 문제로 확대되기 시작했다. 점차 환경에 대한 우려가 커지면서 환경은 국제정치의 주요의제가 되기 시작했다. 인간도 자연의 일부이고 근본적으로 자연에 의존할 수밖에 없는 존재이므로 지구온난화, 오존층 파괴, 해양오염 그리고 지구 생물종의 감소 등의 지구환경문제는 인류의 생존마저 위협할 수 있는 것으로 인식되었다. 따라서 이 문제를 해결하기 위해 모든 국가들이 다 같이 노력해야 한다는 공동 인식을 갖게 되었다.
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제초제 및 해충저항성을 가진 작물을 재배함으로써 생산량이 증가하고 경쟁력을 갖추게 되며 특정한 영양분을 강화시킨 농작물의 등장은 현대인에게 결핍되기 쉬운 영양분을 보충하여 줄 수도 있습니다.
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1992년 6월에 114개국 국가정상, 183개국 정부대표, 3만여명의 환경전문가가 모인 최대의 환경회의로서 Earth Summit로 불리며, 환경친화학적인 지속개발을 주제로 리우선언, 의제 21채택하고 기후변화방지협약, 생물다양성 보존협약, 산림보존원칙 합의
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지구상의 생물자원을 보존하기 위해 1987년 6월에 유엔환경계획에서 협약제정을 결정한 후 전문가회의 및 실무회의를 거쳐 초안을 작성하고, 1992년 5월 나이로비에서 채택 후 6월 리우 유엔환경개발회의에서 158개국이 서명 후 1993년 12월에 발효
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바이오의정서Biosafety Protocol
1994년 1차 생물다양성협약당사국회의에서 LMO의 환경방출로 인한 건강 및 생태계 영향 논의하고 의정서 필요성 및 형태 논의를 시작한 후, 2000년 1월 29일 특별당사국회의에서 [바이오안정성의정서] 채택
바이오안전성 관련 국제기구
유엔환경계획(United Nations Environment Program, UNEP)
유엔에서 환경논의가 이루어지는 곳은 유엔환경계획이다. 이 조직은 유엔기구에서 환경분야를 위하여 특화된 조직이다. 즉, 국제기구 중 유엔차원에서 환경분야에 비교우위를 두고 환경측면에서 공동 연구, 정책 개발 등 여러 면에서 기여하도록 하는 역할을 수행하고 있다. 1970년대 이후 국제사회는 환경문제를 개발도상국(개도국)의 개발 문제와 분리해서 다룰 수 없다는 인식 하에 유엔차원에서 이를 수용한 개념이 ‘지속가능한 발전’이다. 유엔의 경제사회이사회 산하에 설치된 지속가능발전위원회(CSD : Committee for Sustainable Development 이하에서는 줄여서 ‘지속위’라 표기)가 매년 4~5월에 개최되어 이를 다루고 있다. 따라서, 유엔환경계획은 자체의 환경관련 고유 업무를 하면서도 일종의 상위 개념인 지속가능한 발전에서 한 구성 요소를 맡은 기관이므로 환경을 사회개발, 경제문제를 동시에 고려하고 있다.
경제협력개발기구(OECD)
선진국간 경제협력기구로서 파리에 본부를 둔 OECD는 또 하나의 다자적인 환경 논의(선진국간)가 이루어지는 곳이다. 이 곳은 선진국간의 협력기구이지만 동 기구 내에 설치된 ‘환경정책위원회(EPOC “에폭”이라고 발음됨)’에서 회원국들은 환경 정책과 관련된 의견을 교환하고, 정보 공유, 공동 조사, 각종 환경지표 개발, 지속가능발전에 대한 지원 등을 논의하고 협력한다. 정책위인 에폭은 보통 연 2회 개최되며 각료급 회의는 5년마다 개최된다. 특히 에폭은 주요 환경이슈에 대한 정책을 개발하기 위하여 회원국간 작업반회의, 그룹, 전문가 회의 등을 통하여 정책 개발 등 각종조사, 연구작업을 수행 후 각종 보고서를 발간 한다.
세계무역기구(WTO)
GATT(General Agreement on Tariffs and Trade:관세 및 무역에 관한 일반협정) 체제를 대신하여 세계무역질서를 세우고 UR(Uruguay Round of Multinational Trade Negotiation:우루과이라운드) 협정의 이행을 감시하는 국제기구로서, 1995년 1월 1일 세계교역 증진을 위해 설립되었다. 주요 활동은 국가간 경제 분쟁에 대한 판결권과 그 판결의 강제집행권 이용, 규범에 따라 국가간 분쟁이나 마찰 조정으로 현재 2001년 144개국이 가입하고 있다. “세계무역기구(WTO)"는 환경보호론자가 가장 싫어하는 국제기구이지만, 무역관련 기구에서 환경문제를 무역문제와 관련시켜 정식으로 다루고 있으며, 특히 무역과 관련된 환경문제를 WTO 산하 무역환경위(CTE)에서 WTO 무역규범과 각종 환경 규범, 특히 다자 환경협약과의 마찰가능성과 조화방안을 강구하고 있다. 특히 2001년 도하에서 합의된 ‘도하 개발 아젠다’의 하나에 ‘무역과 환경문제’가 포함되어 있으며, 실제로 무역규범과 환경규범의 조화 방안을 찾기 위해 협상이 전개되고 있다.
위 컨텐츠는 한국바이오안전성정보센터(KBCH) 바이오안전성포탈(www.biosafeti.or.kr)의 인용자료임을 알려드립니다.
목적
바이오안전성의정서는 환경과 개발에 관한 리우선언 원칙 제15 심각한 또는 회복불가능한 손상의 위협이 있는 경우에는 완전한 과학적 확실성의 결여가 환경파괴를 방지하는 비용절약적인 조치의 실시를 지연시키기 위한 이유로 이용되어서는 안된다는 ‘리우선언 원칙 제15’에 포함된 사전예방적 접근(Precautionary Approach)에 따라 현대 생명공학기술에 의한 유전자변형생물체(LMOs)의 국가간 이동에 초점을 두고 생물다양성 및 인체건강에 미칠 수 있는 위해성으로 부터 유전자변형생물체의 이동, 취급 및 사용분야에서 적절한 보호수준을 보장하는데 기여하는 것이다(바이오안전성의정서 제1조).
사전예방원칙
바이오안전성의정서는 환경과 개발에 관한 리우선언 원칙 제15에 따른 사전예방원칙에 근거하여 바이오안전성을 확보하기 위한 적절한 보호수준을 보장하고 있다. 사전예방원칙은 의도적 환경방출용, 식용.사료용.가공용, 밀폐사용용 유전자변형생물체(LMOs) 모두에 적용된다. 바이오안전성의정서에 따르면, 인체위해성을 고려하여 생물다양성의 보전과 지속가능한 이용에 대한 유전자변형생물체(LMOs)의 잠재적인 악영향에 관한 불출분한 정보에 기인하여 과학적 확실성이 없다는 이유로 수입국이 사전예방원칙에 입각하여 그러한 잠재적인 악영향을 회피하거나 최소화하기 위해 유전자변형생물체(LMOs)의 수입에 대한 적절한 결정을 내리지 못한다(바이오안전성의정서 전문, 제1조, 제10조 제6항, 제11조 제8항).
유전자변형생물체(LMOs)의 정의
유전자변형생물체(LMOs)란 현대 생명공학기술을 이용하여 얻어진 새로운 유전물질의 조합을 포함하고 있는 모든 생물체를 말한다(바이오안전성의정서 제3조 부록 참조).
적용범위 및 대상(바이오안전성의정서 제6조, 제7조)
바이오안전성의정서는 생물다양성의 보전 및 지속가능한 사용, 인체건강에 위해성을 미칠 수 있는 유전자변형생물체(LMOs)의 국가간 이동, 경유, 취급 및 사용분야에 적용되며(바이오안전성의정서 제4조), 환경방출용 유전자변형생물체, 직접적인 식용·사료용·가공용, 경유 및 밀폐사용를 적용대상(바이오안전성의정서 제6조, 제7조)으로 구분하고 안전성확보를 위한 차별화된 교역절차를 적용하고 있다. 그렇지만, 여타 국제기구 및 국제협약에서 지정된 인체의악품용 유전자변형생물체는 그 적용이 배제된다.
교역절차
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① 의도적 환경방출용 유전자변형생물체(바이오안전성의정서 제18조)
수입국 환경에 의도적으로 방출되는 농산물 종자, 환경정화용 미생물, 미생물 농약 등이 해당되며 이러한 유전자변형생물체는 최초 국가간 이동에 앞서 수입국의 사전승인을 요하며 엄격한 사전통보합의(Advance Informed Agreement : AIA)절차가 적용된다(바이오안전성의정서 제6조-제10조 및 제12조). 또한 취급, 운송, 포장시에 철저한 안전조치를 취해야하며 유전자변형생물체(LMOs)임을 명기해야 한다.
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② 직접적인 식용·사료용·가공용 유전자변형생물체(LMOs)
직접적인 식용·사료용·가공용 유전자변형생물체(LMOs)는 바이오안전성의정서의 사전통보합의(AIA)절차에 적용되지 않는다(바이오안전성의정서 제7조 제3항). 그렇지만, 바이오안전성의정서의 목적과 부합되는 각국의 국내법령에 따라 사전통보합의(AIA)에 준하는 절차를 적용할 수 있다(바이오안전성의정서 제11조). 또한 취급, 포장, 운송시에 환경에 방출되지 않도록 안전조치를 취해야 함은 물론 선적서류 등에 유전자변형생물체(LMOs) 포함가능성을 명기해야 한다(바이오안전성의정서 제18조).
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③ 경유 및 밀폐사용용 유전자변형생물체(LMOs)
경유 및 밀폐사용용 유전자변형생물체(LMOs)는 바이오안전성의정서의 사전통보합의(AIA)절차에 적용되지 않는다(바이오안전성의정서 제6조 제1항 및 제2항). 그렇지만, 취급, 운송, 포장시에 안전조치를 취해야 함은 물론 유전자변형생물체(LMOs)임을 명기해야 한다(바이오안전성의정서 제18조).
위해성 평가 및 관리(바이오안전성의정서 제 37조)
바이오안전성의정서는 유전자변형생물체의 위해성 평가와 위해성 관리를 통해 가능한 위해성을 최소화하기 위한 규정을 갖추고 있다. 동 의정서에 의하면, 위해성 평가는 과학적인 방법에 따라 인정된 평가기술에 의해 이루어져야 하고, 평가목적으로 제공된 정보 및 기타 이용가능한 과학적 증거에 기초하여야 한다. 이러한 위해성평가는 유전자변형생물체가 생물다양성의 보전 및 지속가능한 이용에 미칠 수 있는 부정적인 영향과 인간건강에 미칠 수 있는 위해를 고려하여 가능한 악영향을 밝혀야 한다(바이오안전성의정서 제15조). 아울러 당사국들은 위해성을 규제, 관리, 감독할 적절한 체계, 조치, 전략을 수립하고 운영해야 한다(바이오안전성의정서 제16조). 이처럼 바이오안전성의정서는 과학적인 근거 및 공인된 평가방법에 의해 위해성 평가가 실행되어야 하며, 동일한 위해성의 규제, 극복 및 통제를 위한 적절한 수단, 조치 및 전략을 수립하고 포함하는 위해성관리에 관한 일반적인 의무를 당사국에 부여하고 있다.
취급, 운송, 포장, 명기(바이오안전성의정서 제37조)
당사국은 유전자변형생물체의 국가간 이동시 취급, 포장, 운송에 대한 안전조치를 취해야 하고 유전자변형생물체임을 명기해야함은 물론, 유전자변형생물체의 용도에 따라 분류·명기하고 동반 서류에 관련 정보를 명기해야 한다.
국가연락기관 및 국가책임기관(바이오안전성의정서 제 19조)
각 당사국은 바이오안전성의정서 사무국과 연락할 국가연락기관(National Focal Point : NFP)과 국가책임기관(Competent National Authority : CNA)를 지정해야 한다. 여기서 국가책임기관은 동 의정서가 요구하는 행정적인 기능을 담당하고 해당 국가로부터 권한을 위임받는다(바이오안전성의정서 제19조).
정보공유 및 바비오안전성정보센터(바이오안전성의정서 제 20조)
생물다양성협약 제18조 제3항에 근거한 정보교환기구(Clearing House Mechanism : CHM)의 부속으로 바이오안전성정보센터(Biosafety Clearing House)를 설치하여 국제적 정보교환체계 역할을 수행하도록 한다.
공공인식과 참여(바이오안전성의정서 제23조)
당사국은 인간건강에 대한 위해를 고려하여 생물다양성의 보전 및 지속가능한 이용과 관련한 유전자변형생물체의 안전한 이동, 취급 및 사용에 대하여 공공인식, 교육 및 참여를 장려·촉진하고, 이의 이행을 위해 다른 당사국 및 국제기구와 적절히 협력해야 한다. 아울러 각국의 법령 및 규정에 따른 유전자변형생물체와 관련된 의사결정과정에 공공과 합의하고 그 결정 결과를 공공이 이용가능 하도록 하여야 한다.
비당사국(바이오안전성의정서 제24조)
당사국과 비당사국간의 유전자변형생물체의 이동은 의정서의 목적과 원칙에 부합하여야하고 당사국은 양자간, 다자간 및 지역적 협정 또는 약정을 체결할 수 있다. 아울러 당사국은 비당사국이 의정서에 따르도록 하고 비당사국의 영토에서 방출되거나 이동하는 유전자변형생물체에 대해 바이오안전성정보센터에 적절한 정보를 제공하도록 권장해야 한다.
사회·경제적 고려(바이오안전성의정서 제26조)
당사국은 수입결정시 국제적 의무에 부합하되 유전자변형생물체가 생물다양성의 보전 및 지속가능한 이용, 특히 지역사회의 생물다양성에 대한 가치를 고려할 수 있다고 언급하고 있어서, 소위 사회·경제적 요소가 국가결정을 위한 근거로 이용될 수 있음을 규정하고 있다. 아울러 관련 사회·경제적 영향 등에 대한 관련연구과 정보교환을 위한 협력을 요구하고 있다.
책임 및 피해배상(바이오안전성의정서 제27조)
당사국회의의 역할을 수행하는 당사국총회의 제1차 회의에서 책임과 피해배상문제에 관한 국제법상의 절차를 분석하고 고려하여 유전자변형생물체의 국가간 이동에 의해 초래될 손해에 대한 책임과 피해배상 분야에 있어 적절한 국제규정과 절차를 마련하기 위한 작업과정을 채택하고 이러한 과정을 4년 이내에 완료할 수 있도록 노력한다고 규정하고 있다.
발효(바이오안전성의정서 제37조)
바이오안전성의정서는 협약 당사국 중 최종 50번째 비준, 수락, 승인서 또는 가입서가 기탁된 날로부터 90일 이후에 발효한다.
위 컨텐츠는 한국바이오안전성정보센터(KBCH) 바이오안전성포탈(www.biosafeti.or.kr)의 인용자료임을 알려드립니다.
의정서전문(영어)
The Parties to this Protocol,
Being Parties to the Convention on Biological Diversity, hereinafter referred to as "the Convention", Recalling Article 19, paragraphs 3 and 4, and Articles 8 (g) and 17 of the Convention, Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention to develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement, Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on biological diversity, taking also into account risks to human health, Recognizing that modern biotechnology has great potential for human well-being if developed and used with adequate safety measures for the environment and human health, Recognizing also the crucial importance to humankind of centres of origin and centres of genetic diversity, Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms, Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development, Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements, Understanding that the above recital is not intended to subordinate this Protocol to other international agreements, Have agreed as follows:
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Article 1 : OBJECTIVE
Article 2 : GENERAL PROVISIONS
- 1. Each Party shall take necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol.
- 2. The Parties shall ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account risks to human health.
- 3. Nothing in this Protocol shall affect in any way the sovereignty of States over their territorial sea established in accordance with international law, and the sovereign rights and the jurisdiction which States have in their exclusive economic zones and their continental shelves in accordance with international law, and the exercise by ships and aircraft of all States of navigational rights and freedoms as provided for in international law and as reflected in relevant international instruments.
- 4. Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for in this Protocol, provided that such action is consistent with the objective and the provisions of this Protocol and is in accordance with that Party's other obligations under international law.
- 5. The Parties are encouraged to take into account, as appropriate, available expertise, instruments and work undertaken in international forums with competence in the area of risks to human health.
Article 3 : USE OF TERMS
For the purposes of this Protocol:
- a. "Conference of the Parties" means the Conference of the Parties to the Convention;
- d. "Exporter" means any legal or natural person, under the jurisdiction of the Party of export, who arranges for a living modified organism to be exported;
- f. "Importer" means any legal or natural person, under the jurisdiction of the Party of import, who arranges for a living modified organism to be imported;
- g. "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;
- h. "Living organism" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids;
- i. "Modern biotechnology" means the application of:
(ⅰ)In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
(ⅱ) Fusion of cells beyond the taxonomic family, hat overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;
- j. Regional economic integration organization" means an organization constituted by sovereign States of a given region, to which its member States have transferred competence in respect of matters governed by this Protocol and which has been duly authorized, in accordance with its internal procedures, to sign, ratify, accept, approve or accede to it;
Article 4 : SCOPE
Article 5 : PHARMACEUTICALS
Article 6 : TRANSIT AND CONTAINED USE
For the purposes of this Protocol:
- 1. "Notwithstanding Article 4 and without prejudice to any right of a Party of transit to regulate the transport of living modified organisms through its territory and make available to the Biosafety Clearing-House, any decision of that Party, subject to Article 2, paragraph 3, regarding the transit through its territory of a specific living modified organism, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to living modified organisms in transit.
Article 7 : APPLICATION OF THE ADVANCE INFORMED AGREEMENT PROCEDURE
- 1. Subject to Articles 5 and 6, the advance informed agreement procedure in Articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import.
- 2. "Intentional introduction into the environment" in paragraph 1 above, does not refer to living modified organisms intended for direct use as food or feed, or for processing.
- 3. Article 11 shall apply prior to the first transboundary movement of living modified organisms intended for direct use as food or feed, or for processing.
Article 8 : NOTIFICATION
- 1. The Party of export shall notify, or require the exporter to ensure notification to, in writing, the competent national authority of the Party of import prior to the intentional transboundary movement of a living modified organism that falls within the scope of Article 7, paragraph 1. The notification shall contain, at a minimum, the information specified in Annex I.
- 2. The Party of export shall ensure that there is a legal requirement for the accuracy of information provided by the exporter.
Article 9 : ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION
- 1. The Party of import shall acknowledge receipt of the notification, in writing, to the notifier within ninety days of its receipt.
- 2. The acknowledgement shall state:
(a) The date of receipt of the notification;
(b) Whether the notification, prima facie, contains the information referred to in Article 8;
(c) Whether to proceed according to the domestic regulatory framework of the Party of import or according to the procedure specified in Article 10.
- 3. The domestic regulatory framework referred to in paragraph 2 (c) above, shall be consistent with this Protocol.
- 4. A failure by the Party of import to acknowledge receipt of a notification shall not imply its consent to an intentional transboundary movement.
Article 10 : DECISION PROCEDURE
- 1. Decisions taken by the Party of import shall be in accordance with Article 15.
- 2. The Party of import shall, within the period of time referred to in Article 9, inform the notifier, in writing, whether the intentional transboundary movement may proceed:
- 3. Within two hundred and seventy days of the date of receipt of notification, the Party of import shall communicate, in writing, to the notifier and to the Biosafety Clearing-House the decision referred to in paragraph 2 (a) above:
(a) Approving the import, with or without conditions, including how the decision will apply to subsequent imports of the same living modified organism;
(b) Prohibiting the import;
(c) Requesting additional relevant information in accordance with its domestic regulatory framework or Annex I; in calculating the time within which the Party of import is to respond, the number of days it has to wait for additional relevant information shall not be taken into account; or
(d) Informing the notifier that the period specified in this paragraph is extended by a defined period of time.
- 5. A failure by the Party of import to communicate its decision within two hundred and seventy days of the date of receipt of the notification shall not imply its consent to an intentional transboundary movement.
- 7. The Conference of the Parties serving as the meeting of the Parties shall, at its first meeting, decide upon appropriate procedures and mechanisms to facilitate decision-making by Parties of import.
Article 11 : PROCEDURE FOR LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING
Article 12 : REVIEW OF DECISIONS
Article 13 : SIMPLIFIED PROCEDURE
- 1. A Party of import may, provided that adequate measures are applied to ensure the safe intentional transboundary movement of living modified organisms in accordance with the objective of this Protocol, specify in advance to the Biosafety Clearing-House:
(a) Cases in which intentional transboundary movement to it may take place at the same time as the movement is notified to the Party of import; and
(b) Imports of living modified organisms to it to be exempted from the advance informed agreement procedure. Notifications under subparagraph (a) above, may apply to subsequent similar movements to the same Party.
- 2. The information relating to an intentional transboundary movement that is to be provided in the notifications referred to in paragraph 1 (a) above, shall be the information specified in Annex I.
Article 14 : BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND ARRANGEMENTS
- 1. Parties may enter into bilateral, regional and multilateral agreements and arrangements regarding intentional transboundary movements of living modified organisms, consistent with the objective of this Protocol and provided that such agreements and arrangements do not result in a lower level of protection than that provided for by the Protocol.
- 2. The Parties shall inform each other, through the Biosafety Clearing-House, of any such bilateral, regional and multilateral agreements and arrangements that they have entered into before or after the date of entry into force of this Protocol.
- 3. The provisions of this Protocol shall not affect intentional transboundary movements that take place pursuant to such agreements and arrangements as between the parties to those agreements or arrangements
- 4. Any Party may determine that its domestic regulations shall apply with respect to specific imports to it and shall notify the Biosafety Clearing-House of its decision.
Article 15 : RISK ASSESSMENT
- 2. The Party of import shall ensure that risk assessments are carried out for decisions taken under Article 10. It may require the exporter to carry out the risk assessment.
- 3. The cost of risk assessment shall be borne by the notifier if the Party of import so requires.
Article 16 : RISK MANAGEMENT
- 1. The Parties shall, taking into account Article 8 (g) of the Convention, establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment provisions of this Protocol associated with the use, handling and transboundary movement of living modified organisms.
- 3. Each Party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including such measures as requiring a risk assessment to be carried out prior to the first release of a living modified organism.
- 4. Without prejudice to paragraph 2 above, each Party shall endeavour to ensure that any living modified organism, whether imported or locally developed, has undergone an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use.
- 5. Parties shall cooperate with a view to:
Article 17 : UNINTENTIONAL TRANSBOUNDARY MOVEMENTS AND EMERGENCY MEASURES
- 2. Each Party shall, no later than the date of entry into force of this Protocol for it, make available to the Biosafety Clearing-House the relevant details setting out its point of contact for the purposes of receiving notifications under this Article.
- 3. Any notification arising from paragraph 1 above, should include:
(b) Information on the circumstances and estimated date of the release, and on the use of the living modified organism in the originating Party;
(c) Any available information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measures;
(d) Any other relevant information; and
(e) A point of contact for further information
Article 18 : HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION
- 2. Each Party shall take measures to require that documentation accompanying:
(b) Living modified organisms that are destined for contained use clearly identifies them as living modified organisms; and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the living modified organisms are consigned; and
(c) Living modified organisms that are intended for intentional introduction into the environment of the Party of import and any other living modified organisms within the scope of the Protocol, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter.
3. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall consider the need for and modalities of developing standards with regard to identification, handling, packaging and transport practices, in consultation with other relevant international bodies.
Article 19 : COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL POINTS
- 3. The Secretariat shall forthwith inform the Parties of the notifications it receives under paragraph 2 above, and shall also make such information available through the Biosafety Clearing-House.
Article 20 : INFORMATION SHARING AND THE BIOSAFETY CLEARING-HOUSE
- 1. A Biosafety Clearing-House is hereby established as part of the clearing-house mechanism under Article 18, paragraph 3, of the Convention, in order to:
- 2. The Biosafety Clearing-House shall serve as a means through which information is made available for the purposes of paragraph 1 above. It shall provide access to information made available by the Parties relevant to the implementation of the Protocol. It shall also provide access, where possible, to other international biosafety information exchange mechanisms.
- 3. Without prejudice to the protection of confidential information, each Party shall make available to the Biosafety Clearing-House any information required to be made available to the Biosafety Clearing-House under this Protocol, and:
(a) Any existing laws, regulations and guidelines for implementation of the Protocol, as well as information required by the Parties for the advance informed agreement procedure;
(b) Any bilateral, regional and multilateral agreements and arrangements;
(c) Summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordance with Article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology;
(d) Its final decisions regarding the importation or release of living modified organisms; and
Article 21 : CONFIDENTIAL INFORMATION
- 1. The Party of import shall permit the notifier to identify information submitted under the procedures of this Protocol or required by the Party of import as part of the advance informed agreement procedure of the Protocol that is to be treated as confidential. Justification shall be given in such cases upon request.
- 3. Each Party shall protect confidential information received under this Protocol, including any confidential information received in the context of the advance informed agreement procedure of the Protocol. Each Party shall ensure that it has procedures to protect such information and shall protect the confidentiality of such information in a manner no less favourable than its treatment of confidential information in connection with domestically produced living modified organisms.
- 4. The Party of import shall not use such information for a commercial purpose, except with the written consent of the notifier.
- 6. Without prejudice to paragraph 5 above, the following information shall not be considered confidential:
(a) The name and address of the notifier;
(b) A general description of the living modified organism or organisms;
(c) A summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and
(d) Any methods and plans for emergency response.
Article 22 : CAPACITY-BUILDING
- 1. The Parties shall cooperate in the development and/or strengthening of human resources and institutional capacities in biosafety, including biotechnology to the extent that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in developing country Parties, in particular the least developed and small island developing States among them, and in Parties with economies in transition, including through existing global, regional, subregional and national institutions and organizations and, as appropriate, through facilitating private sector involvement.
- 2. For the purposes of implementing paragraph 1 above, in relation to cooperation, the needs of developing country Parties, in particular the least developed and small island developing States among them, for financial resources and access to and transfer of technology and know-how in accordance with the relevant provisions of the Convention, shall be taken fully into account for capacity-building in biosafety. Cooperation in capacity-building shall, subject to the different situation, capabilities and requirements of each Party, include scientific and technical training in the proper and safe management of biotechnology, and in the use of risk assessment and risk management for biosafety, and the enhancement of technological and institutional capacities in biosafety. The needs of Parties with economies in transition shall also be taken fully into account for such capacity-building in biosafety.
Article 23 : PUBLIC AWARENESS AND PARTICIPATION
- 1. The Parties shall:
- 2. The Parties shall, in accordance with their respective laws and regulations, consult the public in the decision-making process regarding living modified organisms and shall make the results of such decisions available to the public, while respecting confidential information in accordance with Article 21.
- 3. Each Party shall endeavour to inform its public about the means of public access to the Biosafety Clearing-House.
Article 24 : NON-PARTIES
- 1. Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol. The Parties may enter into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding such transboundary movements.
Article 25 : ILLEGAL TRANSBOUNDARY MOVEMENTS
- 1. Each Party shall adopt appropriate domestic measures aimed at preventing and, if appropriate, penalizing transboundary movements of living modified organisms carried out in contravention of its domestic measures to implement this Protocol. Such movements shall be deemed illegal transboundary movements.
- 2. In the case of an illegal transboundary movement, the affected Party may request the Party of origin to dispose, at its own expense, of the living modified organism in question by repatriation or destruction, as appropriate.
- 3. Each Party shall make available to the Biosafety Clearing-House information concerning cases of illegal transboundary movements pertaining to it.
Article 26 : SOCIO-ECONOMIC CONSIDERATIONS
Article 27 : LIABILITY AND REDRESS
Article 28 : FINANCIAL MECHANISM AND RESOURCES
- 1. In considering financial resources for the implementation of this Protocol, the Parties shall take into account the provisions of Article 20 of the Convention.
- 2. The financial mechanism established in Article 21 of the Convention shall, through the institutional structure entrusted with its operation, be the financial mechanism for this Protocol.
- 3. Regarding the capacity-building referred to in Article 22 of this Protocol, the Conference of the Parties serving as the meeting of the Parties to this Protocol, in providing guidance with respect to the financial mechanism referred to in paragraph 2 above, for consideration by the Conference of the Parties, shall take into account the need for financial resources by developing country Parties, in particular the least developed and the small island developing States among them.
- 4. In the context of paragraph 1 above, the Parties shall also take into account the needs of the developing country Parties, in particular the least developed and the small island developing States among them, and of the Parties with economies in transition, in their efforts to identify and implement their capacity-building requirements for the purposes of the implementation of this Protocol.
- 5. The guidance to the financial mechanism of the Convention in relevant decisions of the Conference of the Parties, including those agreed before the adoption of this Protocol, shall apply, mutatis mutandis, to the provisions of this Article.
- 6. The developed country Parties may also provide, and the developing country Parties and the Parties with economies in transition avail themselves of, financial and technological resources for the implementation of the provisions of this Protocol through bilateral, regional and multilateral channels.
Article 29 ; CONFERENCE OF THE PARTIES SERVING AS THE MEETING OF THE PARTIES TO THIS PROTOCOL
- 1. The Conference of the Parties shall serve as the meeting of the Parties to this Protocol.
- 3. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, any member of the bureau of the Conference of the Parties representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from among the Parties to this Protocol.
- 4. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall keep under regular review the implementation of this Protocol and shall make, within its mandate, the decisions necessary to promote its effective implementation. It shall perform the functions assigned to it by this Protocol and shall:
(b) Establish such subsidiary bodies as are deemed necessary for the implementation of this Protocol;
(c) Seek and utilize, where appropriate, the services and cooperation of, and information provided by, competent international organizations and intergovernmental and non-governmental bodies;
(d) Establish the form and the intervals for transmitting the information to be submitted in accordance with Article 33 of this Protocol and consider such information as well as reports submitted by any subsidiary body;
(e) Consider and adopt, as required, amendments to this Protocol and its annexes, as well as any additional annexes to this Protocol, that are deemed necessary for the implementation of this Protocol; and
(f) Exercise such other functions as may be required for the implementation of this Protocol.
- 5. The rules of procedure of the Conference of the Parties and financial rules of the Convention shall be applied, mutatis mutandis, under this Protocol, except as may be otherwise decided by consensus by the Conference of the Parties serving as the meeting of the Parties to this Protocol.
- 6. The first meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be convened by the Secretariat in conjunction with the first meeting of the Conference of the Parties that is scheduled after the date of the entry into force of this Protocol. Subsequent ordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held in conjunction with ordinary meetings of the Conference of the Parties, unless otherwise decided by the Conference of the Parties serving as the meeting of the Parties to this Protocol.
Article 30 : SUBSIDIARY BODIES
- 1. Any subsidiary body established by or under the Convention may, upon a decision by the Conference of the Parties serving as the meeting of the Parties to this Protocol, serve the Protocol, in which case the meeting of the Parties shall specify which functions that body shall exercise.
- 3. When a subsidiary body of the Convention exercises its functions with regard to matters concerning this Protocol, any member of the bureau of that subsidiary body representing a Party to the Convention but, at that time, not a Party to the Protocol, shall be substituted by a member to be elected by and from among the Parties to the Protocol.
Article 31 : SECRETARIAT
- 1. Any subsidiary body established by or under the Convention may, upon a decision by the Conference of the Parties serving as the meeting of the Parties to this Protocol, serve the Protocol, in which case the meeting of the Parties shall specify which functions that body shall exercise.
Article 32 : RELATIONSHIP WITH THE CONVENTION
Except as otherwise provided in this Protocol, the provisions of the Convention relating to its protocols shall apply to this Protocol.
Article 33 : MONITORING AND REPORTING
Article 34 : COMPLIANCE
The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, consider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and to address cases of non-compliance. These procedures and mechanisms shall include provisions to offer advice or assistance, where appropriate. They shall be separate from, and without prejudice to, the dispute settlement procedures and mechanisms established by Article 27 of the Convention.
Article 35 : ASSESSMENT AND REVIEW
The Conference of the Parties serving as the meeting of the Parties to this Protocol shall undertake, five years after the entry into force of this Protocol and at least every five years thereafter, an evaluation of the effectiveness of the Protocol, including an assessment of its procedures and annexes.
Article 36 : SIGNATURE
This Protocol shall be open for signature at the United Nations Office at Nairobi by States and regional economic integration organizations from 15 to 26 May 2000, and at United Nations Headquarters in New York from 5 June 2000 to 4 June 2001.
Article 37 : ENTRY INTO FORCE
- 3. For the purposes of paragraphs 1 and 2 above, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization.
Article 38 : RESERVATIONS
No reservations may be made to this Protocol.
Article 39 : WITHDRAWAL
Article 40 : AUTHENTIC TEXTS
Annex 1 : Information required in notifications under articles 8, 10 and 13
- (a) Name, address and contact details of the exporter.
- (b) Name, address and contact details of the importer.
- (c) Name and identity of the living modified organism, as well as the domestic classification, if any, of the biosafety level of the living modified organism in the State of export.
- (d) Intended date or dates of the transboundary movement, if known.
- (e) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.
- (f) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.
- (g) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.
- (h) Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the living modified organism.
- (i) Intended use of the living modified organism or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology.
- (j) Quantity or volume of the living modified organism to be transferred.
- (k) A previous and existing risk assessment report consistent with Annex III.
- (l) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.
- (m) Regulatory status of the living modified organism within the State of export (for example, whether it is prohibited in the State of export, whether there are other restrictions, or whether it has been approved for general release) and, if the living modified organism is banned in the State of export, the reason or reasons for the ban.
- (n) Result and purpose of any notification by the exporter to other States regarding the living modified organism to be transferred.
- (o) A declaration that the above-mentioned information is factually correct.
Annex 2 : Information required concerning living modified organisms intended for direct use as food or feed, or for processing under article 11
- (a) The name and contact details of the applicant for a decision for domestic use.
- (b) The name and contact details of the authority responsible for the decision.
- (c) Name and identity of the living modified organism.
- (d) Description of the gene modification, the technique used, and the resulting characteristics of the living modified organism.
- (e) Any unique identification of the living modified organism.
- (f) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.
- (g) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.
- (h) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.
- (i) Approved uses of the living modified organism.
- (j) A risk assessment report consistent with Annex III.
- (k) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.
Annex 3 : Risk assessment
Objective
- 2. Risk assessment is, inter alia, used by competent authorities to make informed decisions regarding living modified organisms. General principles
- 3. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.
- 4. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk.
- 5. Risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.
- 8. To fulfil its objective, risk assessment entails, as appropriate, the following steps:
(b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism;
(c) An evaluation of the consequences should these adverse effects be realized;
(d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized;
(e) A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks; and
- 9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following subjects:
(b) Donor organism or organisms. Taxonomic status and common name, source, and the relevant biological characteristics of the donor organisms;
(c) Vector. Characteristics of the vector, including its identity, if any, and its source or origin, and its host range;
(d) Insert or inserts and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the function it specifies, and/or characteristics of the modification introduced;
(e) Living modified organism. Identity of the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the recipient organism or parental organisms;
(f) Detection and identification of the living modified organism. Suggested detection and identification methods and their specificity, sensitivity and reliability;
(g) Information relating to the intended use. Information relating to the intended use of the living modified organism, including new or changed use compared to the recipient organism or parental organisms; and
의정서전문(한글)
바이오안전성에 대한 카르타헤나 의정서
이 의정서의 당사국들은, 이하 “ 협약 ”으로 지칭되는 “ 생물다양성에 관한 협약 ”의 당사국으로서, 협약 제19조 제3항 및 제4항과 제8조(g) 및 제17조를 상기하며, 생물 다양성의 보전 및 지속적 이용에 부정적 영향을 미칠 수도 있는 현대생명공학 기술을 사용하여 만들어진 모든 유전자변형생물체의 국가간 이동에 초점을 두고, 특히 사전통보합의와 관련한 적절한 절차를 고려하여 바이오안전성에 관한 의정서 논의를 진행시키도록 한 1995년11월17일의 협약 당사국총회 결정Ⅱ/5를 상기하며, 환경과 개발에 관한 리우선언 원칙 제15에 포함된 사전예방 접근방식을 재확인하고, 현대생명공학기술이 급속히 확산하고 있으며, 인체 건강에 미치는 위해에 대한 고려는 물론이고 현대생명공학기술이 생물다양성에 잠재적으로 미칠 수 있는 부정적 영향에 대한 공공의 우려가 증가하고 있음을 인식하고,현대생명공학기술이, 환경과 인간 건강을 고려한 적절한 안전관리 조치와 병행하여 개발되고 이용된다면, 인류 복지에 크게 기여할 수 있는 잠재력이 있음을 인정하고, 기원 중심지 및 유전자 다양성 중심지가 인류에게 매우 중요함을 인정하고, 유전자변형생물체와 관련해 이미 알려져 있거나 잠재되어 있는 위해에 대해 개발도상국을 비롯한 많은 국가들이 질적으로나 양적으로 대처할 수 있는 능력이 불충분함을 고려하며, 무역 및 환경에 관한 여러 협약들이, 지속가능한 개발을 달성함에 있어 상호보완적이 되어야 함을 인정하고,기존의 국제협약에 따른 당사국의 권리와 의무에 어떤 변화를 의미하는 것으로 의정서가 해석되어서는 아니 된다는 점을 강조하며, 그렇다고 해서 이 의정서가 여타 국제협약들에 종속됨을 의미하지는 않는다는 점을 이해하면서, 다음과 같이 합의하였다.
각제목을 클릭하시면 해당 내용의 전문을 보실 수 있습니다.
환경과 개발에 관한 리우선언 원칙 제15에 포함된 사전예방적 접근방법에 따라, 이 의정서의 목적은 현대 생명공학기술로부터 탄생된 유전자변형생물체의 안전한 이동, 취급 및 사용분야에 있어 생물다양성의 보전 및 지속가능한 이용에 부정적 영향을 미칠 가능성과 인간건강에 대한 위해를 고려하고, 특히 국가간 이동에 초점을 두어 적절한 보호수준을 보장하는데 기여하는 것이다.
이 의정서는 인간건강에 대한 위해를 고려한 생물다양성의 보전 및 지속가능한 이용에 부정적 영향을 미칠 가능성이 있는 모든 유전자변형생물체의 국가간 이동, 경유, 취급 및 사용에 적용된다.
제4조에도 불구하고 수입결정전에 모든 유전자변형생물체로 하여금 위해성 평가를 받게 할 수 있는 당사국의 권리를 침해하지 않으면서, 이 의정서는 여타 관련 국제협약 및 기구에 의하여 지정된 인체의약품용 유전자변형생물체의 국가간 이동에는 적용하지 아니한다.
이 의정서에서 다르게 규정되지 않는 한, 이 의정서와 관련된 협약의 규정은 이 의정서에도 준용된다.
각 당사국은 이 의정서에 따른 각자의 의무이행을 감시하고, 이 의정서 당사국회의 역할을 수행하는 당사국총회 결정에 따라 정기적으로 의정서 이행을 위해 취한 조치에 대해 이 의정서 당사국회의 역할을 수행하는 당사국총회에 보고하여야 한다.
이 의정서 당사국회의 역할을 수행하는 당사국총회는 제1차 회의에서 이 의정서 규정의 준수를 증진하고 비준수 문제를 해결하기 위한 협력절차와 제도적 체계를 고려하고 승인한다. 이러한 절차와 체계는 적절한 경우 조언 또는 지원을 제공하기 위한 규정을 포함한다. 이러한 절차와 체계는 협약 제27조에 의해 설립된 분쟁해결절차 및 체계를 침해하지 않고 별개로 취급된다.
이 의정서 당사국회의 역할을 수행하는 당사국총회는 의정서 발효 5년후에, 그리고 그후 적어도 매 5년마다 의정서의 절차 및 부속서에 대한 평가를 포함하여 의정서의 효과에 대한 평가를 수행하여야 한다.
이 의정서는 2000년 5월 15일부터 26일까지 나이로비에서, 2000년 6월 5일부터 2001년 6월 4일까지 뉴욕에 있는 국제연합본부에서 국가 및 지역경제통합기구의 서명을 위하여 개방된다.
이 의정서에 대하여는 어떠한 유보도 할 수 없다.
아랍어, 중국어, 영어, 불어, 러시아어 및 스페인어본이 동등하게 정본인 이 의정서의 원본은 국제연합 사무총장에게 기탁된다.