| Order of the President of the People's Republic of China | | 中华人民共和国主席令 |
| (No. 56) | | （第五十六号） |
| The Biosecurity Law of the People's Republic of China, as adopted at the 22nd session of the Standing Committee of the Thirteenth National People's Congress of the People's Republic of China on October 17, 2020, is hereby issued, and shall come into force on April 15, 2021. | | 《中华人民共和国生物安全法》已由中华人民共和国第十三届全国人民代表大会常务委员会第二十二次会议于2020年10月17日通过，现予公布，自2021年4月15日起施行。 |
| President of the People's Republic of China: Xi Jinping | | 中华人民共和国主席 习近平 |
| October 17, 2020 | | 2020年10月17日 |
| Biosecurity Law of the People's Republic of China | | 中华人民共和国生物安全法 |
| (Adopted at the 22nd session of the Standing Committee of the Thirteenth National People's Congress of the People's Republic of China on October 17, 2020) | | （2020年10月17日第十三届全国人民代表大会常务委员会第二十二次会议通过） |
| Contents | | 目 录 |
| Chapter I General Provisions | | 第一章 总 则 |
| Chapter II Biosecurity Risk Prevention and Control System | | 第二章 生物安全风险防控体制 |
| Chapter III Prevention and Control of Major New or Sudden Outbreaks of Infectious Diseases and Epidemics in Animals and Plants | | 第三章 防控重大新发突发传染病、动植物疫情 |
| Chapter IV Security of Biotechnology Research, Development, and Application | | 第四章 生物技术研究、开发与应用安全 |
| Chapter V Biosecurity of Pathogenic Microbe Laboratories | | 第五章 病原微生物实验室生物安全 |
| Chapter VI Security of Human Genetic Resources and Biological Resources | | 第六章 人类遗传资源与生物资源安全 |
| Chapter VII Prevention of Bioterrorism and Biological Weapon Threats | | 第七章 防范生物恐怖与生物武器威胁 |
| Chapter VIII Biosecurity Capacity Building | | 第八章 生物安全能力建设 |
| Chapter IX Legal Liability | | 第九章 法律责任 |
| Chapter X Supplemental Provisions | | 第十章 附 则 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 This Law is enacted for the purposes of maintaining national security, preventing and responding to biosecurity risks, safeguarding the lives and health of the people, protecting biological resources and the ecology and environment, promoting the sound development of biotechnology, boosting the construction of a community with a shared future for mankind, and achieving the harmonious coexistence of man and nature. | | 第一条 为了维护国家安全，防范和应对生物安全风险，保障人民生命健康，保护生物资源和生态环境，促进生物技术健康发展，推动构建人类命运共同体，实现人与自然和谐共生，制定本法。 |
| Article 2 For the purpose of this Law, "biosecurity" means that the state effectively prevents and responds to the threat of dangerous biological agents and related factors, biotechnology can develop steadily and healthily, neither the lives and health of the people nor the ecosystem is relatively in danger or under threat, and there is capability in the biological field to maintain national security and sustainable development. | | 第二条 本法所称生物安全，是指国家有效防范和应对危险生物因子及相关因素威胁，生物技术能够稳定健康发展，人民生命健康和生态系统相对处于没有危险和不受威胁的状态，生物领域具备维护国家安全和持续发展的能力。 |
| This Law shall apply to the following activities: | | 从事下列活动，适用本法： |
| (1) Preventing and controlling a major new or sudden outbreak of an infectious disease or an epidemic in animals or plants. | | （一）防控重大新发突发传染病、动植物疫情； |
| (2) Researching, developing, and applying biotechnology. | | （二）生物技术研究、开发与应用； |
| (3) Biosecurity management of pathogenic microbe laboratories. | | （三）病原微生物实验室生物安全管理； |
| (4) Biosecurity management of human genetic resources and biological resources. | | （四）人类遗传资源与生物资源安全管理； |
| (5) Preventing the invasion of alien species and protecting biodiversity. | | （五）防范外来物种入侵与保护生物多样性； |
| (6) Responding to antimicrobial resistance. | | （六）应对微生物耐药； |
| (7) Preventing biological terrorist attacks and defending against biological weapon threats. | | （七）防范生物恐怖袭击与防御生物武器威胁； |
| (8) Other biosecurity-related activities. | | （八）其他与生物安全相关的活动。 |
| Article 3 Biosecurity is an integral part of national security. In maintaining biosecurity, the overall national security concept shall be implemented, development and security shall be coordinated, and the principles of people orientation, risk prevention, classification management, and coordination and cooperation shall be upheld. | | 第三条 生物安全是国家安全的重要组成部分。维护生物安全应当贯彻总体国家安全观，统筹发展和安全，坚持以人为本、风险预防、分类管理、协同配合的原则。 |
| Article 4 The leadership of the Communist Party of China over national biosecurity work shall be adhered to, a national biosecurity leadership system shall be established and improved, and the construction of the national biosecurity risk prevention and control and governance system shall be strengthened, so as to improve the capabilities for national biosecurity governance. | | 第四条 坚持中国共产党对国家生物安全工作的领导，建立健全国家生物安全领导体制，加强国家生物安全风险防控和治理体系建设，提高国家生物安全治理能力。 |
| Article 5 The state shall encourage innovation in biotechnology, strengthen the building of biosecurity infrastructure and biotechnology workforce, support the development of the bioindustry, raise the level of biotechnology with innovation, and enhance the capabilities to guarantee biosecurity. | | 第五条 国家鼓励生物科技创新，加强生物安全基础设施和生物科技人才队伍建设，支持生物产业发展，以创新驱动提升生物科技水平，增强生物安全保障能力。 |
| Article 6 The state shall strengthen international cooperation in the biosecurity field, perform the obligations provided by any international treaty concluded or acceded to by the People's Republic of China, support participation in biotechnology exchange and cooperation and international rescue in biosecurity incidents, and actively participate in the research on and formulation of international rules of biosecurity, and promote the improvement of global biosecurity governance. | | 第六条 国家加强生物安全领域的国际合作，履行中华人民共和国缔结或者参加的国际条约规定的义务，支持参与生物科技交流合作与生物安全事件国际救援，积极参与生物安全国际规则的研究与制定，推动完善全球生物安全治理。 |
| Article 7 People's governments at all levels and their relevant departments shall strengthen the publicity on and dissemination of biosecurity laws and regulations and biosecurity knowledge and guide basic mass self-governing organizations and social organizations in publicity on biosecurity laws and regulations and biosecurity knowledge publicity, so as to promote the enhancement of whole society's awareness of biosecurity. | | 第七条 各级人民政府及其有关部门应当加强生物安全法律法规和生物安全知识宣传普及工作，引导基层群众性自治组织、社会组织开展生物安全法律法规和生物安全知识宣传，促进全社会生物安全意识的提升。 |
| Relevant scientific research institutions, medical institutions, and other enterprises and public institutions shall incorporate biosecurity laws and regulations and biosecurity knowledge into the content of education and training and strengthen the building of students and professionals' awareness of biosecurity and ethics. | | 相关科研院校、医疗机构以及其他企业事业单位应当将生物安全法律法规和生物安全知识纳入教育培训内容，加强学生、从业人员生物安全意识和伦理意识的培养。 |
| The news media shall give public welfare publicity to biosecurity laws and regulations and biosecurity knowledge, conduct public opinion supervision of biosecurity violations, and enhance the public awareness of social responsibility for maintaining biosecurity. | | 新闻媒体应当开展生物安全法律法规和生物安全知识公益宣传，对生物安全违法行为进行舆论监督，增强公众维护生物安全的社会责任意识。 |
| Article 8 Any entity or individual shall not endanger biosecurity. | | 第八条 任何单位和个人不得危害生物安全。 |
| Any entity or individual has the right to report an act that endangers biosecurity; and the department receiving the report shall handle it in a timely manner in accordance with the law. | | 任何单位和个人有权举报危害生物安全的行为；接到举报的部门应当及时依法处理。 |
| Article 9 For entities and individuals that have made outstanding contributions to biosecurity work, the people's governments at or above the county level and their relevant departments shall commend and reward them in accordance with the provisions issued by the state. | | 第九条 对在生物安全工作中做出突出贡献的单位和个人，县级以上人民政府及其有关部门按照国家规定予以表彰和奖励。 |
| Chapter II Biosecurity Risk Prevention and Control System | | 第二章 生物安全风险防控体制 |
| Article 10 The central national security leadership institution shall be responsible for decision-making and deliberative coordination in national biosecurity work, research on the formulation and guide the implementation of a national biosecurity strategy and relevant major policies, coordinate major matters and important work in relation to national biosecurity in an overall manner, and establish a National Biosecurity Work Coordination Mechanism. | | 第十条 中央国家安全领导机构负责国家生物安全工作的决策和议事协调，研究制定、指导实施国家生物安全战略和有关重大方针政策，统筹协调国家生物安全的重大事项和重要工作，建立国家生物安全工作协调机制。 |
| Provinces, autonomous regions, and municipalities directly under the Central Government shall establish a biosecurity work coordination mechanism and organize the coordination and supervise the advancement of biosecurity-related work within their respective administrative areas. | | 省、自治区、直辖市建立生物安全工作协调机制，组织协调、督促推进本行政区域内生物安全相关工作。 |
| Article 11 The National Biosecurity Work Coordination Mechanism, composed of the health, agriculture and rural affairs, science and technology, foreign affairs, and other competent departments of the State Council and relevant military agencies, shall analyze and judge the national biosecurity situation and organize the coordination and supervise the advancement of national biosecurity-related work. The National Biosecurity Work Coordination Mechanism shall establish an office responsible for the routine work of the coordination mechanism. | | 第十一条 国家生物安全工作协调机制由国务院卫生健康、农业农村、科学技术、外交等主管部门和有关军事机关组成，分析研判国家生物安全形势，组织协调、督促推进国家生物安全相关工作。国家生物安全工作协调机制设立办公室，负责协调机制的日常工作。 |
| The member entities of the National Biosecurity Work Coordination Mechanism and other relevant departments of the State Council shall be responsible for biosecurity-related work according to the division of responsibilities. | | 国家生物安全工作协调机制成员单位和国务院其他有关部门根据职责分工，负责生物安全相关工作。 |
| Article 12 The National Biosecurity Work Coordination Mechanism shall establish an expert committee to provide decision-making advice on research on the national biosecurity strategy and the formulation and implementation of policies. | | 第十二条 国家生物安全工作协调机制设立专家委员会，为国家生物安全战略研究、政策制定及实施提供决策咨询。 |
| The relevant departments of the State Council shall organize the establishment of expert advisory committees on biosecurity technology in related fields and industries to provide advice, evaluation, demonstration, and other technical support for biosecurity work. | | 国务院有关部门组织建立相关领域、行业的生物安全技术咨询专家委员会，为生物安全工作提供咨询、评估、论证等技术支撑。 |
| Article 13 All local people's governments shall be responsible for the biosecurity work in their respective administrative areas. | | 第十三条 地方各级人民政府对本行政区域内生物安全工作负责。 |
| The relevant departments of local people's governments at or above the county level shall be responsible for biosecurity-related work according to the division of responsibilities. | | 县级以上地方人民政府有关部门根据职责分工，负责生物安全相关工作。 |
| Basic mass self-organizations shall assist local people's governments and relevant departments in effectively conducting work such as the prevention and control of biosecurity risks, emergency response, and publicity and education. | | 基层群众性自治组织应当协助地方人民政府以及有关部门做好生物安全风险防控、应急处置和宣传教育等工作。 |
| A relevant entity or individual shall cooperate in effectively conducting work such as the prevention and control of biosecurity risks and emergency response. | | 有关单位和个人应当配合做好生物安全风险防控和应急处置等工作。 |
| Article 14 The state shall establish a monitoring and early warning system of biosecurity risks. The National Biosecurity Work Coordination Mechanism shall organize the establishment of a national monitoring and early warning system of biosecurity risks to heighten capabilities to identify and analyze biosecurity risks. | | 第十四条 国家建立生物安全风险监测预警制度。国家生物安全工作协调机制组织建立国家生物安全风险监测预警体系，提高生物安全风险识别和分析能力。 |
| Article 15 The state shall establish a biosecurity risk investigation and assessment system. The National Biosecurity Work Coordination Mechanism shall regularly organize investigation and assessment of biosecurity risks based on data, materials, and other information on risk monitoring. | | 第十五条 国家建立生物安全风险调查评估制度。国家生物安全工作协调机制应当根据风险监测的数据、资料等信息，定期组织开展生物安全风险调查评估。 |
| Under any of the following circumstances, relevant departments shall promptly investigate and assess biosecurity risks and take necessary risk prevention and control measures in accordance with the law: | | 有下列情形之一的，有关部门应当及时开展生物安全风险调查评估，依法采取必要的风险防控措施： |
| (1) Discovering a possibility of biosecurity risks via monitoring risks or receiving a report. | | （一）通过风险监测或者接到举报发现可能存在生物安全风险； |
| (2) Formulating or adjusting a biosecurity-related catalog or list in order to determine the key fields and key projects for supervision and administration. | | （二）为确定监督管理的重点领域、重点项目，制定、调整生物安全相关名录或者清单； |
| (3) The occurrence of a major new or sudden outbreak of an infectious disease, an epidemic in animals or plants, or any other incident that endangers biosecurity. | | （三）发生重大新发突发传染病、动植物疫情等危害生物安全的事件； |
| (4) Other circumstances entailing investigation and assessment. | | （四）需要调查评估的其他情形。 |
| Article 16 The state shall establish a biosecurity information sharing system. The National Biosecurity Work Coordination Mechanism shall organize the establishment of a unified National Biosecurity Information Platform, and relevant departments shall submit biosecurity data, materials, and other information to the National Biosecurity Information Platform to achieve information sharing. | | 第十六条 国家建立生物安全信息共享制度。国家生物安全工作协调机制组织建立统一的国家生物安全信息平台，有关部门应当将生物安全数据、资料等信息汇交国家生物安全信息平台，实现信息共享。 |
| Article 17 The state shall establish a biosecurity information release system. Major biosecurity information such as the overall national biosecurity situation, major biosecurity risk alerts, major biosecurity incidents, and information on their investigation and handling shall be released by the member entities of the National Biosecurity Work Coordination Mechanism according to the division of responsibilities; and other biosecurity information shall be released by the relevant departments of the State Council and local people's governments at or above the county level and their relevant departments in accordance with their responsibilities and powers. | | 第十七条 国家建立生物安全信息发布制度。国家生物安全总体情况、重大生物安全风险警示信息、重大生物安全事件及其调查处理信息等重大生物安全信息，由国家生物安全工作协调机制成员单位根据职责分工发布；其他生物安全信息由国务院有关部门和县级以上地方人民政府及其有关部门根据职责权限发布。 |
| No entity or individual shall fabricate or spread false biosecurity information. | | 任何单位和个人不得编造、散布虚假的生物安全信息。 |
| Article 18 The state shall establish a biosecurity catalog and list system. The State Council and its relevant departments shall, as needed for biosecurity work, formulate, release, and dynamically adjust catalogs or lists in relation to biosecurity-related materials, equipment, technology, activities, data on important biological resources, infectious diseases, animal and plant diseases, and invasive alien species, among others. | | 第十八条 国家建立生物安全名录和清单制度。国务院及其有关部门根据生物安全工作需要，对涉及生物安全的材料、设备、技术、活动、重要生物资源数据、传染病、动植物疫病、外来入侵物种等制定、公布名录或者清单，并动态调整。 |
| Article 19 The state shall establish a biosecurity standards system. The standardization department of the State Council and other relevant departments of the State Council shall formulate and improve relevant standards in the biosecurity field in accordance with the division of responsibilities. | | 第十九条 国家建立生物安全标准制度。国务院标准化主管部门和国务院其他有关部门根据职责分工，制定和完善生物安全领域相关标准。 |
| The National Biosecurity Work Coordination Mechanism shall organize relevant departments to strengthen the coordination and connection of biosecurity standards in different fields and establish and improve the biosecurity standards system. | | 国家生物安全工作协调机制组织有关部门加强不同领域生物安全标准的协调和衔接，建立和完善生物安全标准体系。 |
| Article 20 The state shall establish a biosecurity review system. For major matters and activities in the biological field that affect or may affect national security, the relevant departments of the State Council shall conduct biosecurity review to effectively prevent and eliminate biosecurity risks. | | 第二十条 国家建立生物安全审查制度。对影响或者可能影响国家安全的生物领域重大事项和活动，由国务院有关部门进行生物安全审查，有效防范和化解生物安全风险。 |
| Article 21 The state shall establish a coordinated, connected, orderly, and efficient biosecurity emergency response system providing unified leadership. | | 第二十一条 国家建立统一领导、协同联动、有序高效的生物安全应急制度。 |
| The relevant departments of the State Council shall organize the formulation of emergency plans for biosecurity incidents in related fields and industries and carry out emergency drills, emergency handling, emergency rescue, post-incident recovery, and other work in accordance with the emergency plans and unified arrangements. | | 国务院有关部门应当组织制定相关领域、行业生物安全事件应急预案，根据应急预案和统一部署开展应急演练、应急处置、应急救援和事后恢复等工作。 |
| Local people's governments at or above the county level and their relevant departments shall formulate and organize, guide, and supervise the formulation by relevant enterprises and public institutions of emergency plans for biosecurity incidents, strengthen emergency preparedness, personnel training, and emergency response drills, and conduct emergency response to biosecurity incidents, emergency rescue, post-incident recovery, and other work. | | 县级以上地方人民政府及其有关部门应当制定并组织、指导和督促相关企业事业单位制定生物安全事件应急预案，加强应急准备、人员培训和应急演练，开展生物安全事件应急处置、应急救援和事后恢复等工作。 |
| The Chinese People's Liberation Army and the Chinese People's Armed Police Force shall, in accordance with the order of the Central Military Commission, participate in the emergency response to and rescue in biosecurity incidents in accordance with the law. | | 中国人民解放军、中国人民武装警察部队按照中央军事委员会的命令，依法参加生物安全事件应急处置和应急救援工作。 |
| Article 22 The state shall establish an investigation and source tracing system for biosecurity incidents. In the event of a major new or sudden outbreak of an infectious disease, epidemic in animals or plants, or unexplained biosecurity incident, the National Biosecurity Work Coordination Mechanism shall organize investigation and source tracing, determine the nature of the incident, comprehensively assess the impact of the incident, and give opinions and recommendations. | | 第二十二条 国家建立生物安全事件调查溯源制度。发生重大新发突发传染病、动植物疫情和不明原因的生物安全事件，国家生物安全工作协调机制应当组织开展调查溯源，确定事件性质，全面评估事件影响，提出意见建议。 |
| Article 23 The state shall establish national rules of access for animals and plants, products of animals and plants, and high-risk biological agents that enter the country for the first time or resume entry after a suspension. | | 第二十三条 国家建立首次进境或者暂停后恢复进境的动植物、动植物产品、高风险生物因子国家准入制度。 |
| Persons, means of transport, containers, goods, objects, packaging, and ballast water discharges by ships on international voyages entering and leaving China shall meet China's requirements of biosecurity management. | | 进出境的人员、运输工具、集装箱、货物、物品、包装物和国际航行船舶压舱水排放等应当符合我国生物安全管理要求。 |
| The Customs shall handle discovered inbound, outbound, and transit biosecurity risks in accordance with the law. Any person, means of transport, goods, object, or the like assessed as carrying a high biosecurity risk shall enter China through a designated border port and be subjected to strict risk prevention and control measures. | | 海关对发现的进出境和过境生物安全风险，应当依法处置。经评估为生物安全高风险的人员、运输工具、货物、物品等，应当从指定的国境口岸进境，并采取严格的风险防控措施。 |
| Article 24 The state shall establish a response system for major overseas biosecurity incidents. In the event of a major overseas biosecurity incident, the Customs shall take emergency biosecurity prevention and control measures in accordance with the law, strengthen document verification, increase the proportion of inspections, and suspend the entry of relevant persons, means of transport, goods, and objects, among others. When necessary, with the approval of the State Council, measures such as temporary closure of relevant ports and blockade of relevant borders may be taken. | | 第二十四条 国家建立境外重大生物安全事件应对制度。境外发生重大生物安全事件的，海关依法采取生物安全紧急防控措施，加强证件核验，提高查验比例，暂停相关人员、运输工具、货物、物品等进境。必要时经国务院同意，可以采取暂时关闭有关口岸、封锁有关国境等措施。 |
| Article 25 The relevant departments of people's governments at or above the county level shall carry out biosecurity supervision and inspection work in accordance with the law, and entities and individuals inspected shall cooperate, truthfully make explanations, and provide materials, without refusal or obstruction. | | 第二十五条 县级以上人民政府有关部门应当依法开展生物安全监督检查工作，被检查单位和个人应当配合，如实说明情况，提供资料，不得拒绝、阻挠。 |
| Supervision and inspection work related to high professional and technical requirements and difficult law enforcement business shall be participated in by biosecurity professional technicians. | | 涉及专业技术要求较高、执法业务难度较大的监督检查工作，应当有生物安全专业技术人员参加。 |
| Article 26 The relevant departments of people's governments at or above the county level may take the following measures in accordance with the law when exercising biosecurity supervision and inspection: | | 第二十六条 县级以上人民政府有关部门实施生物安全监督检查，可以依法采取下列措施： |
| (1) Entering an entity inspected, location, or venue for a suspected biosecurity violation to conduct on-site monitoring, investigation, inspection, or verification. | | （一）进入被检查单位、地点或者涉嫌实施生物安全违法行为的场所进行现场监测、勘查、检查或者核查； |
| (2) Requesting information from a relevant entity or individual. | | （二）向有关单位和个人了解情况； |
| (3) Consulting and copying relevant documents, materials, archives, records, vouchers, or the like | | （三）查阅、复制有关文件、资料、档案、记录、凭证等； |
| (4) Placing under seal a venue or facility for a suspected biosecurity violation. | | （四）查封涉嫌实施生物安全违法行为的场所、设施； |
| (5) Impounding a tool, equipment, or related object for committing of a suspected biosecurity violation. | | （五）扣押涉嫌实施生物安全违法行为的工具、设备以及相关物品； |
| (6) Other measures prescribed by laws and regulations. | | （六）法律法规规定的其他措施。 |
| The information on biosecurity violations by relevant entities and individuals shall be included in the National Credit Information Sharing Platform in accordance with the law. | | 有关单位和个人的生物安全违法信息应当依法纳入全国信用信息共享平台。 |
| Chapter III Prevention and Control of Major New or Sudden Outbreaks of Infectious Diseases and Epidemics in Animals and Plants | | 第三章 防控重大新发突发传染病、动植物疫情 |
| Article 27 The health, agriculture and rural affairs, forestry and grasslands, customs, and ecology and environment departments of the State Council shall establish new or sudden outbreaks of infectious diseases, epidemics in animals and plants, entry and exit quarantine, and biotechnology environmental safety monitoring networks, organize the layout and construction of monitoring stations, improve the monitoring information reporting system, conduct active monitoring and pathogenic testing, and incorporate them into the national monitoring and early warning system of biosecurity risks. | | 第二十七条 国务院卫生健康、农业农村、林业草原、海关、生态环境主管部门应当建立新发突发传染病、动植物疫情、进出境检疫、生物技术环境安全监测网络，组织监测站点布局、建设，完善监测信息报告系统，开展主动监测和病原检测，并纳入国家生物安全风险监测预警体系。 |
| Article 28 Disease prevention and control institutions, animal disease prevention and control institutions, and plant disease and pest prevention and control institutions (hereinafter collectively referred to as the “specialized institutions”) shall conduct active monitoring of infectious diseases, animal and plant diseases, and diseases of unknown causes included in the monitoring scope, collect, analyze, and report monitoring information, and forecast the occurrence and trends of prevalence of new or sudden outbreaks of infectious diseases and animal and plant diseases. | | 第二十八条 疾病预防控制机构、动物疫病预防控制机构、植物病虫害预防控制机构（以下统称专业机构）应当对传染病、动植物疫病和列入监测范围的不明原因疾病开展主动监测，收集、分析、报告监测信息，预测新发突发传染病、动植物疫病的发生、流行趋势。 |
| The relevant departments of the State Council, local people's governments at or above the county level, and their relevant departments shall issue early warnings in a timely manner based on forecasts and their responsibilities and powers and take corresponding prevention and control measures. | | 国务院有关部门、县级以上地方人民政府及其有关部门应当根据预测和职责权限及时发布预警，并采取相应的防控措施。 |
Article 29 Any entity or individual that discovers an infectious disease, or an animal or plant disease, shall promptly report to a medical institution, or relevant specialized institution or department.
．．．．．． | | 第二十九条 任何单位和个人发现传染病、动植物疫病的，应当及时向医疗机构、有关专业机构或者部门报告。
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