KYB CHINA(2004年11月12日中华人民共和国国务院令第424号公布 根据2016年2月6日《国务院关于修改部分行政法规的决定》第一次修订 根据2018年3月19日《国务院关于修改和废止部分行政法规的决定》第二次修订 根据2024年12月6日《国务院关于修改和废止部分行政法规的决定》第三次修订)
(Promulgated by Decree No. 424 of the State Council of the People's Republic of China on November 12, 2004; first revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on February 6, 2016; second revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on March 19, 2018; third revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on December 6, 2024)
总 则
General Provisions
为了加强病原微生物实验室(以下称实验室)生物安全管理，保护实验室工作人员和公众的健康，制定本条例。
These Regulations are formulated to strengthen the biosafety management of pathogenic microorganism laboratories (hereinafter referred to as laboratories), and to protect the health of laboratory workers and the public.
对中华人民共和国境内的实验室及其从事实验活动的生物安全管理，适用本条例。
These Regulations apply to the biosafety management of laboratories and their experimental activities within the territory of the People's Republic of China.
本条例所称病原微生物，是指能够使人或者动物致病的微生物。
For the purposes of these Regulations, pathogenic microorganisms refer to microorganisms that can cause disease in humans or animals.
本条例所称实验活动，是指实验室从事与病原微生物菌(毒)种、样本有关的研究、教学、检测、诊断等活动。
For the purposes of these Regulations, experimental activities refer to research, teaching, testing, diagnosis and other activities conducted in laboratories involving pathogenic microorganism strains (viruses) and samples.
国务院卫生主管部门主管与人体健康有关的实验室及其实验活动的生物安全监督工作。
The competent health department of the State Council shall be responsible for the biosafety supervision of laboratories and their experimental activities related to human health.
国务院兽医主管部门主管与动物有关的实验室及其实验活动的生物安全监督工作。
The competent veterinary department of the State Council shall be responsible for the biosafety supervision of laboratories and their experimental activities related to animals.
国务院其他有关部门在各自职责范围内负责实验室及其实验活动的生物安全管理工作。
Other relevant departments of the State Council shall be responsible for the biosafety management of laboratories and their experimental activities within their respective duties.
县级以上地方人民政府及其有关部门在各自职责范围内负责实验室及其实验活动的生物安全管理工作。
Local people's governments at or above the county level and their relevant departments shall be responsible for the biosafety management of laboratories and their experimental activities within their respective duties.
国家对病原微生物实行分类管理，对实验室实行分级管理。
The state implements classified management of pathogenic microorganisms and graded management of laboratories.
国家实行统一的实验室生物安全标准。实验室应当符合国家标准和要求。
The state implements unified laboratory biosafety standards. Laboratories shall comply with national standards and requirements.
实验室的设立单位及其主管部门负责实验室日常活动的管理，承担建立健全安全管理制度，检查、维护实验设施、设备，控制实验室感染的职责。
The establishing unit of a laboratory and its competent authority shall be responsible for the daily management of the laboratory, undertake the duties of establishing and improving safety management systems, inspecting and maintaining laboratory facilities and equipment, and controlling laboratory infections.
病原微生物的分类和管理
Classification and Management of Pathogenic Microorganisms
国家根据病原微生物的传染性、感染后对个体或者群体的危害程度，将病原微生物分为四类：
The state classifies pathogenic microorganisms into four categories based on their infectivity and the degree of harm to individuals or groups after infection:
第一类病原微生物，是指能够引起人类或者动物非常严重疾病的微生物，以及我国尚未发现或者已经宣布消灭的微生物。
Category 1 pathogenic microorganisms refer to microorganisms that can cause very serious diseases in humans or animals, as well as microorganisms that have not yet been discovered in China or have been declared eradicated.
第二类病原微生物，是指能够引起人类或者动物严重疾病，比较容易直接或者间接在人与人、动物与人、动物与动物间传播的微生物。
Category 2 pathogenic microorganisms refer to microorganisms that can cause serious diseases in humans or animals and are relatively easy to transmit directly or indirectly between humans, between animals and humans, or between animals.
第三类病原微生物，是指能够引起人类或者动物疾病，但一般情况下对人、动物或者环境不构成严重危害，传播风险有限，实验室感染后很少引起严重疾病，并且具备有效治疗和预防措施的微生物。
Category 3 pathogenic microorganisms refer to microorganisms that can cause diseases in humans or animals, but generally do not pose serious harm to humans, animals, or the environment, have limited transmission risk, rarely cause serious diseases after laboratory infection, and for which effective treatment and prevention measures exist.
第四类病原微生物，是指在通常情况下不会引起人类或者动物疾病的微生物。
Category 4 pathogenic microorganisms refer to microorganisms that do not normally cause diseases in humans or animals.
第一类、第二类病原微生物统称为高致病性病原微生物。
Category 1 and Category 2 pathogenic microorganisms are collectively referred to as highly pathogenic microorganisms.
人间传染的病原微生物目录由国务院卫生主管部门商国务院有关部门后制定、调整并予以公布；动物间传染的病原微生物目录由国务院兽医主管部门商国务院有关部门后制定、调整并予以公布。
The catalog of pathogenic microorganisms that infect humans shall be formulated, adjusted, and published by the health administration department of the State Council after consultation with relevant departments of the State Council; the catalog of pathogenic microorganisms that infect animals shall be formulated, adjusted, and published by the veterinary administration department of the State Council after consultation with relevant departments of the State Council.
采集病原微生物样本应当具备下列条件：
The collection of pathogenic microorganism samples shall meet the following conditions:
(一)具有与采集病原微生物样本所需要的生物安全防护水平相适应的设备；
(1) Having equipment corresponding to the biosafety protection level required for collecting pathogenic microorganism samples;
(二)具有掌握相关专业知识和操作技能的工作人员；
(2) Having personnel with relevant professional knowledge and operational skills;
(三)具有有效的防止病原微生物扩散和感染的措施；
(3) Having effective measures to prevent the spread and infection of pathogenic microorganisms;
(四)具有保证病原微生物样本质量的技术方法和手段。
(4) Having technical methods and means to ensure the quality of pathogenic microorganism samples.
采集高致病性病原微生物样本的工作人员在采集过程中应当防止病原微生物扩散和感染，并对样本的来源、采集过程和方法等作详细记录。
Personnel collecting samples of highly pathogenic microorganisms shall prevent the spread and infection of pathogenic microorganisms during the collection process, and shall make detailed records of the source, collection process, and methods of the samples.
运输高致病性病原微生物菌(毒)种或者样本，应当通过陆路运输；没有陆路通道，必须经水路运输的，可以通过水路运输；紧急情况下或者需要将高致病性病原微生物菌(毒)种或者样本运往国外的，可以通过民用航空运输。
Transport of highly pathogenic microorganism strains or samples shall be carried out by land transportation; if there is no land route and water transportation is necessary, it may be carried out by water transportation; in emergency situations or when it is necessary to transport highly pathogenic microorganism strains or samples abroad, civil aviation transportation may be used.
运输高致病性病原微生物菌(毒)种或者样本，应当具备下列条件：
Transport of highly pathogenic microorganism strains or samples shall meet the following conditions:
(一)运输目的、高致病性病原微生物的用途和接收单位符合国务院卫生主管部门或者兽医主管部门的规定；
(1) The purpose of transport, the intended use of the highly pathogenic microorganisms, and the receiving unit comply with the regulations of the health administration department or the veterinary administration department of the State Council;
(二)高致病性病原微生物菌(毒)种或者样本的容器应当密封，容器或者包装材料还应当符合防水、防破损、防外泄、耐高(低)温、耐高压的要求；
(2) The container for highly pathogenic microorganism strains (toxins) or samples shall be sealed, and the container or packaging material shall also meet the requirements of waterproof, breakage-proof, leakage-proof, high (low) temperature resistance, and high pressure resistance;
(三)容器或者包装材料上应当印有国务院卫生主管部门或者兽医主管部门规定的生物危险标识、警告用语和提示用语。
(3) The container or packaging material shall be printed with the biohazard symbol, warning language, and prompt language prescribed by the health administrative department of the State Council or the veterinary administrative department.
运输高致病性病原微生物菌(毒)种或者样本，应当经省级以上人民政府卫生主管部门或者兽医主管部门批准。在省、自治区、直辖市行政区域内运输的，由省、自治区、直辖市人民政府卫生主管部门或者兽医主管部门批准；需要跨省、自治区、直辖市运输或者运往国外的，由出发地的省、自治区、直辖市人民政府卫生主管部门或者兽医主管部门进行初审后，分别报国务院卫生主管部门或者兽医主管部门批准。
Transport of highly pathogenic microorganism strains (toxins) or samples shall be approved by the health administrative department or veterinary administrative department at or above the provincial level. For transport within the administrative region of a province, autonomous region, or municipality directly under the Central Government, approval shall be obtained from the health administrative department or veterinary administrative department of that province, autonomous region, or municipality; for transport across provinces, autonomous regions, or municipalities directly under the Central Government or abroad, after preliminary review by the health administrative department or veterinary administrative department of the province, autonomous region, or municipality of departure, approval shall be obtained from the health administrative department or veterinary administrative department of the State Council respectively.
出入境检验检疫机构在检验检疫过程中需要运输病原微生物样本的，由国务院出入境检验检疫部门批准，并同时向国务院卫生主管部门或者兽医主管部门通报。
If the entry-exit inspection and quarantine authority needs to transport pathogenic microorganism samples during inspection and quarantine, it shall be approved by the entry-exit inspection and quarantine department of the State Council, and shall simultaneously notify the health administrative department or veterinary administrative department of the State Council.
通过民用航空运输高致病性病原微生物菌(毒)种或者样本的，除依照本条第二款、第三款规定取得批准外，还应当经国务院民用航空主管部门批准。
If highly pathogenic microorganism strains (toxins) or samples are transported by civil aviation, in addition to obtaining approval in accordance with paragraphs 2 and 3 of this Article, approval from the civil aviation administrative department of the State Council shall also be obtained.
有关主管部门应当对申请人提交的关于运输高致病性病原微生物菌(毒)种或者样本的申请材料进行审查，对符合本条第一款规定条件的，应当即时批准。
The relevant competent departments shall review the application materials submitted by the applicant for the transport of highly pathogenic microorganism strains (toxins) or samples, and if the conditions specified in paragraph 1 of this Article are met, approval shall be granted immediately.
运输高致病性病原微生物菌(毒)种或者样本，应当由不少于2人的专人护送，并采取相应的防护措施。
Transport of highly pathogenic microorganism strains (toxins) or samples shall be escorted by no less than 2 dedicated personnel, and corresponding protective measures shall be taken.
有关单位或者个人不得通过公共电(汽)车和城市铁路运输病原微生物菌(毒)种或者样本。
Relevant units or individuals shall not transport pathogenic microorganism strains (toxins) or samples by public electric (bus) vehicles or urban railways.
需要通过铁路、公路、民用航空等公共交通工具运输高致病性病原微生物菌(毒)种或者样本的，承运单位应当凭本条例第十一条规定的批准文件予以运输。
If highly pathogenic microorganism strains (toxins) or samples need to be transported by public transport such as railway, highway, or civil aviation, the carrier unit shall transport them with the approval document specified in Article 11 of these Regulations.
承运单位应当与护送人共同采取措施，确保所运输的高致病性病原微生物菌(毒)种或者样本的安全，严防发生被盗、被抢、丢失、泄漏事件。
The carrier unit shall take measures together with the escort to ensure the safety of the transported highly pathogenic microorganism strains (toxins) or samples, and strictly prevent theft, robbery, loss, or leakage incidents.
国务院卫生主管部门或者兽医主管部门指定的菌(毒)种保藏中心或者专业实验室(以下称保藏机构)，承担集中储存病原微生物菌(毒)种和样本的任务。
The strain (poison) preservation centers or specialized laboratories (hereinafter referred to as preservation institutions) designated by the health administrative department of the State Council or the veterinary administrative department shall undertake the task of centralized storage of pathogenic microorganism strains (poison) and samples.
保藏机构应当依照国务院卫生主管部门或者兽医主管部门的规定，储存实验室送交的病原微生物菌(毒)种和样本，并向实验室提供病原微生物菌(毒)种和样本。
Preservation institutions shall, in accordance with the provisions of the health administrative department of the State Council or the veterinary administrative department, store the pathogenic microorganism strains (poison) and samples submitted by laboratories, and provide pathogenic microorganism strains (poison) and samples to laboratories.
保藏机构应当制定严格的安全保管制度，作好病原微生物菌(毒)种和样本进出和储存的记录，建立档案制度，并指定专人负责。对高致病性病原微生物菌(毒)种和样本应当设专库或者专柜单独储存。
Preservation institutions shall establish strict safety storage systems, maintain records of the entry and exit and storage of pathogenic microorganism strains (poison) and samples, establish a filing system, and designate dedicated personnel. For highly pathogenic microorganism strains (poison) and samples, separate storage rooms or cabinets shall be set up for independent storage.
保藏机构储存、提供病原微生物菌(毒)种和样本，不得收取任何费用，其经费由同级财政在单位预算中予以保障。
Preservation institutions shall not charge any fees for storing or providing pathogenic microorganism strains (poison) and samples, and their expenses shall be guaranteed by the government at the same level in the unit budget.
保藏机构的管理办法由国务院卫生主管部门会同国务院兽医主管部门制定。
The management measures for preservation institutions shall be formulated by the health administrative department of the State Council jointly with the veterinary administrative department of the State Council.
保藏机构应当凭实验室依照本条例的规定取得的从事高致病性病原微生物相关实验活动的批准文件或者设区的市级人民政府卫生主管部门或者兽医主管部门发放的实验室备案凭证，向实验室提供高致病性病原微生物菌（毒）种和样本，并予以登记。
Preservation institutions shall provide highly pathogenic microorganism strains (poison) and samples to laboratories only upon presentation of the approval document for engaging in experimental activities related to highly pathogenic microorganisms obtained by the laboratory in accordance with these regulations, or the laboratory filing certificate issued by the health administrative department of the people's government at the city level with districts or the veterinary administrative department, and shall register such provision.
实验室在相关实验活动结束后，应当依照国务院卫生主管部门或者兽医主管部门的规定，及时将病原微生物菌(毒)种和样本就地销毁或者送交保藏机构保管。
After the completion of relevant experimental activities, laboratories shall, in accordance with the provisions of the health administrative department of the State Council or the veterinary administrative department, promptly destroy the pathogenic microorganism strains (poison) and samples on site or deliver them to preservation institutions for custody.
保藏机构接受实验室送交的病原微生物菌(毒)种和样本，应当予以登记，并开具接收证明。
Preservation institutions that accept pathogenic microorganism strains (poison) and samples delivered by laboratories shall register them and issue a receipt.
高致病性病原微生物菌(毒)种或者样本在运输、储存中被盗、被抢、丢失、泄漏的，承运单位、护送人、保藏机构应当采取必要的控制措施，并在2小时内分别向承运单位的主管部门、护送人所在单位和保藏机构的主管部门报告，同时向所在地的县级人民政府卫生主管部门或者兽医主管部门报告，发生被盗、被抢、丢失的，还应当向公安机关报告；接到报告的卫生主管部门或者兽医主管部门应当在2小时内向本级人民政府报告，并同时向上级人民政府卫生主管部门或者兽医主管部门和国务院卫生主管部门或者兽医主管部门报告。
If highly pathogenic microorganism strains (poison) or samples are stolen, robbed, lost, or leaked during transportation or storage, the carrier unit, escort, and preservation institution shall take necessary control measures and report to the competent department of the carrier unit, the unit of the escort, and the competent department of the preservation institution within 2 hours, and simultaneously report to the health administrative department or veterinary administrative department of the people's government at the county level where the incident occurred; if stolen, robbed, or lost, a report shall also be made to the public security organ; the health administrative department or veterinary administrative department that receives the report shall report to the people's government at the same level within 2 hours, and simultaneously report to the health administrative department or veterinary administrative department of the people's government at the higher level and the health administrative department or veterinary administrative department of the State Council.
县级人民政府应当在接到报告后2小时内向设区的市级人民政府或者上一级人民政府报告；设区的市级人民政府应当在接到报告后2小时内向省、自治区、直辖市人民政府报告。省、自治区、直辖市人民政府应当在接到报告后1小时内，向国务院卫生主管部门或者兽医主管部门报告。
The people's government at the county level shall report to the people's government at the city level with districts or the people's government at the next higher level within 2 hours after receiving the report; the people's government at the city level with districts shall report to the people's government of the province, autonomous region, or municipality directly under the Central Government within 2 hours after receiving the report. The people's government of the province, autonomous region, or municipality directly under the Central Government shall report to the health administrative department or veterinary administrative department of the State Council within 1 hour after receiving the report.
任何单位和个人发现高致病性病原微生物菌(毒)种或者样本的容器或者包装材料，应当及时向附近的卫生主管部门或者兽医主管部门报告；接到报告的卫生主管部门或者兽医主管部门应当及时组织调查核实，并依法采取必要的控制措施。
Any unit or individual that discovers a container or packaging material of highly pathogenic microorganism strains or samples shall promptly report to the nearby health authority or veterinary authority; the health authority or veterinary authority that receives the report shall promptly organize investigation and verification, and take necessary control measures according to law.
实验室的设立与管理
Establishment and Management of Laboratories
国家根据实验室对病原微生物的生物安全防护水平，并依照实验室生物安全国家标准的规定，将实验室分为一级、二级、三级、四级。
The state classifies laboratories into Level 1, Level 2, Level 3, and Level 4 according to the biosafety protection level of the laboratory against pathogenic microorganisms and in accordance with the national standards for laboratory biosafety.
新建、改建、扩建三级、四级实验室或者生产、进口移动式三级、四级实验室应当遵守下列规定：
The construction, renovation, or expansion of Level 3 or Level 4 laboratories, or the production or import of mobile Level 3 or Level 4 laboratories, shall comply with the following provisions:
(一)符合国家生物安全实验室体系规划并依法履行有关审批手续；
(1) Conform to the national biosafety laboratory system plan and perform relevant approval procedures according to law;
(二)经国务院卫生主管部门审查同意；
(2) Obtain review and approval from the health authority of the State Council;
(三)符合国家生物安全实验室建筑技术规范；
(3) Comply with the national technical specifications for biosafety laboratory construction;
(四)依照《中华人民共和国环境影响评价法》的规定进行环境影响评价并经环境保护主管部门审查批准；
(4) Conduct environmental impact assessment in accordance with the Environmental Impact Assessment Law of the People's Republic of China and obtain approval from the environmental protection authority;
(五)生物安全防护级别与其拟从事的实验活动相适应。
(5) The biosafety protection level shall be compatible with the experimental activities to be conducted.
前款规定所称国家生物安全实验室体系规划，由国务院投资主管部门会同国务院有关部门制定。制定国家生物安全实验室体系规划应当遵循总量控制、合理布局、资源共享的原则，并应当召开听证会或者论证会，听取公共卫生、环境保护、投资管理和实验室管理等方面专家的意见。
The national biosafety laboratory system plan referred to in the preceding paragraph shall be formulated by the investment authority of the State Council jointly with the relevant departments of the State Council. The formulation of the national biosafety laboratory system plan shall follow the principles of total quantity control, rational layout, and resource sharing, and shall hold hearings or demonstration meetings to solicit opinions from experts in public health, environmental protection, investment management, and laboratory management.
三级、四级实验室应当通过实验室国家认可。
Level 3 and Level 4 laboratories shall pass national laboratory accreditation.
国务院认证认可监督管理部门确定的认可机构应当依照实验室生物安全国家标准以及本条例的有关规定，对三级、四级实验室进行认可；实验室通过认可的，颁发相应级别的生物安全实验室证书。证书有效期为5年。
The accreditation body designated by the Certification and Accreditation Administration of the State Council shall accredit Level 3 and Level 4 laboratories in accordance with the national standards for laboratory biosafety and the relevant provisions of these Regulations; if a laboratory passes accreditation, a biosafety laboratory certificate of the corresponding level shall be issued. The validity period of the certificate is 5 years.
从事病原微生物实验活动应当在相应级别的实验室进行。实验室从事病原微生物实验活动，其级别应当不低于病原微生物目录规定的该项实验活动所需的实验室级别。
Experimental activities involving pathogenic microorganisms shall be conducted in laboratories of the corresponding level. When a laboratory conducts experimental activities involving pathogenic microorganisms, its level shall not be lower than the laboratory level required for such experimental activities as specified in the pathogenic microorganism catalog.
一级、二级实验室仅可从事病原微生物目录规定的可以在一级、二级实验室进行的高致病性病原微生物实验活动。三级、四级实验室从事高致病性病原微生物实验活动，应当具备下列条件：
Level 1 and Level 2 laboratories may only conduct experimental activities involving highly pathogenic microorganisms that are permitted to be conducted in Level 1 and Level 2 laboratories as specified in the pathogenic microorganism catalog. Level 3 and Level 4 laboratories conducting experimental activities involving highly pathogenic microorganisms shall meet the following conditions:
(一)实验目的和拟从事的实验活动符合国务院卫生主管部门或者兽医主管部门的规定；
(1) The purpose of the experiment and the intended experimental activities comply with the provisions of the competent health department or veterinary department of the State Council;
(二)通过实验室国家认可；
(2) Pass national laboratory accreditation;
(三)具有与拟从事的实验活动相适应的工作人员；
(3) Have personnel suitable for the intended experimental activities;
(四)工程质量经建筑主管部门依法检测验收合格。
(4) The engineering quality has been inspected and accepted as qualified by the competent construction department in accordance with the law.
三级、四级实验室，需要从事病原微生物目录规定的应当在三级、四级实验室进行的高致病性病原微生物实验活动或者疑似高致病性病原微生物实验活动的，应当依照国务院卫生主管部门或者兽医主管部门的规定报省级以上人民政府卫生主管部门或者兽医主管部门批准。实验活动结果以及工作情况应当向原批准部门报告。
If a Level 3 or Level 4 laboratory needs to conduct experimental activities involving highly pathogenic microorganisms or suspected highly pathogenic microorganisms that are required to be conducted in Level 3 or Level 4 laboratories as specified in the pathogenic microorganism catalog, it shall report to the competent health department or veterinary department of the people's government at or above the provincial level for approval in accordance with the provisions of the competent health department or veterinary department of the State Council. The results of the experimental activities and the work situation shall be reported to the original approving department.
实验室申报或者接受与高致病性病原微生物有关的科研项目，应当符合科研需要和生物安全要求，具有相应的生物安全防护水平。与动物间传染的高致病性病原微生物有关的科研项目，应当经国务院兽医主管部门同意；与人体健康有关的高致病性病原微生物科研项目，实验室应当将立项结果告知省级以上人民政府卫生主管部门。
When a laboratory applies for or accepts a research project related to highly pathogenic microorganisms, it shall meet the research needs and biosafety requirements and have the corresponding level of biosafety protection. Research projects related to highly pathogenic microorganisms that are transmitted between animals shall be approved by the competent veterinary department of the State Council; for research projects related to highly pathogenic microorganisms that affect human health, the laboratory shall inform the competent health department of the people's government at or above the provincial level of the project approval results.
出入境检验检疫机构、医疗卫生机构、动物疫病预防控制机构在实验室开展检测、诊断工作时，发现高致病性病原微生物或者疑似高致病性病原微生物，需要进一步从事这类高致病性病原微生物相关实验活动的，应当在具备相应条件的实验室中进行；依照本条例的规定需要经过批准的，应当取得批准。
When entry-exit inspection and quarantine institutions, medical and health institutions, and animal disease prevention and control institutions, during testing and diagnosis in laboratories, discover highly pathogenic microorganisms or suspected highly pathogenic microorganisms and need to further engage in related experimental activities involving such highly pathogenic microorganisms, such activities shall be conducted in laboratories with appropriate conditions; if approval is required according to these regulations, approval shall be obtained.
专门从事检测、诊断的实验室应当严格依照国务院卫生主管部门或者兽医主管部门的规定，建立健全规章制度，保证实验室生物安全。
Laboratories specializing in testing and diagnosis shall strictly follow the regulations of the health administrative department of the State Council or the veterinary administrative department to establish and improve rules and regulations to ensure laboratory biosafety.
省级以上人民政府卫生主管部门或者兽医主管部门应当自收到需要从事高致病性病原微生物相关实验活动的申请之日起15日内作出是否批准的决定。
The health administrative department or veterinary administrative department of the people's government at or above the provincial level shall, within 15 days from the receipt of an application for engaging in experimental activities related to highly pathogenic microorganisms, make a decision on whether to approve.
对出入境检验检疫机构为了检验检疫工作的紧急需要，申请在实验室对高致病性病原微生物或者疑似高致病性病原微生物开展进一步实验活动的，省级以上人民政府卫生主管部门或者兽医主管部门应当自收到申请之时起2小时内作出是否批准的决定；2小时内未作出决定的，实验室可以从事相应的实验活动。
For entry-exit inspection and quarantine institutions that apply to carry out further experimental activities on highly pathogenic microorganisms or suspected highly pathogenic microorganisms in laboratories due to urgent needs of inspection and quarantine work, the health administrative department or veterinary administrative department of the people's government at or above the provincial level shall make a decision on whether to approve within 2 hours from the receipt of the application; if no decision is made within 2 hours, the laboratory may engage in the corresponding experimental activities.
省级以上人民政府卫生主管部门或者兽医主管部门应当为申请人通过电报、电传、传真、电子数据交换和电子邮件等方式提出申请提供方便。
The health administrative department or veterinary administrative department of the people's government at or above the provincial level shall facilitate applicants to submit applications by means of telegram, telex, fax, electronic data interchange, and email.
新建、改建或者扩建一级、二级实验室，应当向设区的市级人民政府卫生主管部门或者兽医主管部门备案。设区的市级人民政府卫生主管部门或者兽医主管部门应当每年将备案情况汇总后报省、自治区、直辖市人民政府卫生主管部门或者兽医主管部门。
The construction, renovation, or expansion of BSL-1 or BSL-2 laboratories shall be filed with the health administrative department or veterinary administrative department of the people's government at the city with districts level. The health administrative department or veterinary administrative department of the people's government at the city with districts level shall annually summarize the filing information and report it to the health administrative department or veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
国务院卫生主管部门和兽医主管部门应当定期汇总并互相通报实验室数量和实验室设立、分布情况，以及三级、四级实验室从事高致病性病原微生物实验活动的情况。
The health administrative department and the veterinary administrative department of the State Council shall regularly summarize and mutually notify the number of laboratories, the establishment and distribution of laboratories, and the situation of BSL-3 and BSL-4 laboratories engaging in experimental activities involving highly pathogenic microorganisms.
已经建成并通过实验室国家认可的三级、四级实验室应当向所在地的县级人民政府环境保护主管部门备案。环境保护主管部门依照法律、行政法规的规定对实验室排放的废水、废气和其他废物处置情况进行监督检查。
BSL-3 and BSL-4 laboratories that have been constructed and have passed national laboratory accreditation shall file with the environmental protection administrative department of the people's government at the county level where they are located. The environmental protection administrative department shall supervise and inspect the disposal of wastewater, waste gas, and other wastes discharged by laboratories in accordance with laws and administrative regulations.
对我国尚未发现或者已经宣布消灭的病原微生物，任何单位和个人未经批准不得从事相关实验活动。
No unit or individual may engage in experimental activities related to pathogenic microorganisms that have not yet been discovered in China or have been declared eradicated without approval.
为了预防、控制传染病，需要从事前款所指病原微生物相关实验活动的，应当经国务院卫生主管部门或者兽医主管部门批准，并在批准部门指定的专业实验室中进行。
For the purpose of preventing and controlling infectious diseases, if it is necessary to engage in experimental activities related to the pathogenic microorganisms referred to in the preceding paragraph, approval shall be obtained from the health administrative department or the veterinary administrative department of the State Council, and the activities shall be conducted in professional laboratories designated by the approving department.
实验室使用新技术、新方法从事高致病性病原微生物相关实验活动的，应当符合防止高致病性病原微生物扩散、保证生物安全和操作者人身安全的要求，并经国家病原微生物实验室生物安全专家委员会论证；经论证可行的，方可使用。
When a laboratory uses new technologies or methods to conduct experimental activities related to highly pathogenic microorganisms, it shall meet the requirements for preventing the spread of highly pathogenic microorganisms, ensuring biosafety and the personal safety of operators, and shall be reviewed by the National Biosafety Expert Committee for Pathogenic Microorganism Laboratories; only after the review confirms feasibility may it be used.
需要在动物体上从事高致病性病原微生物相关实验活动的，应当按照病原微生物目录的规定，在符合动物实验室生物安全国家标准的相应级别的实验室进行。
When experimental activities related to highly pathogenic microorganisms need to be conducted on animals, they shall be carried out in a laboratory of the corresponding level that meets the national standards for animal laboratory biosafety, in accordance with the provisions of the pathogenic microorganism catalog.
实验室的设立单位负责实验室的生物安全管理。
The establishing unit of a laboratory is responsible for the biosafety management of the laboratory.
实验室的设立单位应当依照本条例的规定制定科学、严格的管理制度，并定期对有关生物安全规定的落实情况进行检查，定期对实验室设施、设备、材料等进行检查、维护和更新，以确保其符合国家标准。
The establishing unit of a laboratory shall, in accordance with the provisions of these Regulations, formulate scientific and strict management systems, and regularly inspect the implementation of relevant biosafety regulations, and regularly inspect, maintain, and update laboratory facilities, equipment, materials, etc., to ensure they meet national standards.
实验室的设立单位及其主管部门应当加强对实验室日常活动的管理。
The establishing unit of a laboratory and its competent authority shall strengthen the management of the daily activities of the laboratory.
实验室负责人为实验室生物安全的第一责任人。
The laboratory director is the first person responsible for laboratory biosafety.
实验室从事实验活动应当严格遵守有关国家标准和实验室技术规范、操作规程。实验室负责人应当指定专人监督检查实验室技术规范和操作规程的落实情况。
When conducting experimental activities, the laboratory shall strictly comply with relevant national standards and laboratory technical specifications and operating procedures. The laboratory director shall designate a person to supervise and inspect the implementation of laboratory technical specifications and operating procedures.
从事高致病性病原微生物相关实验活动的实验室的设立单位，应当建立健全安全保卫制度，采取安全保卫措施，严防高致病性病原微生物被盗、被抢、丢失、泄漏，保障实验室及其病原微生物的安全。实验室发生高致病性病原微生物被盗、被抢、丢失、泄漏的，实验室的设立单位应当依照本条例第十七条的规定进行报告。
The establishing unit of a laboratory conducting experimental activities related to highly pathogenic microorganisms shall establish and improve a security system, take security measures, strictly prevent the theft, robbery, loss, or leakage of highly pathogenic microorganisms, and ensure the safety of the laboratory and its pathogenic microorganisms. If highly pathogenic microorganisms are stolen, robbed, lost, or leaked in the laboratory, the establishing unit of the laboratory shall report in accordance with Article 17 of these Regulations.
从事高致病性病原微生物相关实验活动的实验室应当向当地公安机关备案，并接受公安机关有关实验室安全保卫工作的监督指导。
Laboratories conducting experimental activities related to highly pathogenic microorganisms shall register with the local public security authority and accept supervision and guidance from the public security authority regarding laboratory security work.
实验室或者实验室的设立单位应当每年定期对工作人员进行培训，保证其掌握实验室技术规范、操作规程、生物安全防护知识和实际操作技能，并进行考核。工作人员经考核合格的，方可上岗。
The laboratory or its establishing unit shall conduct annual regular training for staff to ensure they master laboratory technical specifications, operating procedures, biosafety protection knowledge, and practical operational skills, and shall conduct assessments. Staff may only take up their posts after passing the assessment.
从事高致病性病原微生物相关实验活动的实验室，应当每半年将培训、考核其工作人员的情况和实验室运行情况向省、自治区、直辖市人民政府卫生主管部门或者兽医主管部门报告。
Laboratories conducting experimental activities related to highly pathogenic microorganisms shall report to the healthcompetent authority or veterinarycompetent authority of the province, autonomous region, or municipality directly under the Central Government every six months on the training and assessment of their staff and the operational status of the laboratory.
从事高致病性病原微生物相关实验活动应当有2名以上的工作人员共同进行。
Experimental activities involving highly pathogenic microorganisms shall be carried out jointly by two or more staff members.
进入从事高致病性病原微生物相关实验活动的实验室的工作人员或者其他有关人员，应当经实验室负责人批准。实验室应当为其提供符合防护要求的防护用品并采取其他职业防护措施。从事高致病性病原微生物相关实验活动的实验室，还应当对实验室工作人员进行健康监测，每年组织对其进行体检，并建立健康档案；必要时，应当对实验室工作人员进行预防接种。
Staff or other relevant personnel entering a laboratory conducting experimental activities related to highly pathogenic microorganisms shall obtain approval from the laboratory director. The laboratory shall provide them with protective equipment that meets protective requirements and take other occupational protection measures. Laboratories conducting experimental activities related to highly pathogenic microorganisms shall also conduct health monitoring of laboratory staff, organize annual physical examinations for them, and establish health records; when necessary, preventive vaccination shall be provided to laboratory staff.
在同一个实验室的同一个独立安全区域内，只能同时从事一种高致病性病原微生物的相关实验活动。
Within the same independent safety zone of the same laboratory, only one type of highly pathogenic microorganism may be involved in experimental activities at a time.
实验室应当建立实验档案，记录实验室使用情况和安全监督情况。实验室从事高致病性病原微生物相关实验活动的实验档案保存期，不得少于20年。
Laboratories shall establish experimental archives to record laboratory usage and safety supervision. The retention period for experimental archives of laboratories conducting experimental activities related to highly pathogenic microorganisms shall not be less than 20 years.
实验室应当依照环境保护的有关法律、行政法规和国务院有关部门的规定，对废水、废气以及其他废物进行处置，并制定相应的环境保护措施，防止环境污染。
Laboratories shall dispose of wastewater, exhaust gas, and other waste in accordance with relevant environmental protection laws, administrative regulations, and provisions of the State Council departments, and formulate corresponding environmental protection measures to prevent environmental pollution.
三级、四级实验室应当在明显位置标示国务院卫生主管部门和兽医主管部门规定的生物危险标识和生物安全实验室级别标志。
BSL-3 and BSL-4 laboratories shall display at conspicuous locations the biohazard signs and biosafety laboratory level signs prescribed by the healthcompetent authority and veterinarycompetent authority of the State Council.
从事高致病性病原微生物相关实验活动的实验室应当制定实验室生物安全事件应急处置预案，并向该实验室所在地的省、自治区、直辖市人民政府卫生主管部门或者兽医主管部门备案。
Laboratories conducting experimental activities related to highly pathogenic microorganisms shall formulate emergency response plans for laboratory biosafety incidents and file them with the healthcompetent authority or veterinarycompetent authority of the province, autonomous region, or municipality directly under the Central Government where the laboratory is located.
国务院卫生主管部门和兽医主管部门会同国务院有关部门组织病原学、免疫学、检验医学、流行病学、预防兽医学、环境保护和实验室管理等方面的专家，组成国家病原微生物实验室生物安全专家委员会。该委员会承担从事高致病性病原微生物相关实验活动的实验室的设立与运行的生物安全评估和技术咨询、论证工作。
The healthcompetent authority and veterinarycompetent authority of the State Council, together with relevant departments of the State Council, shall organize experts in etiology, immunology, laboratory medicine, epidemiology, preventive veterinary medicine, environmental protection, and laboratory management to form a National Expert Committee on Biosafety of Pathogenic Microorganism Laboratories. This committee undertakes biosafety assessment, technical consultation, and demonstration work for the establishment and operation of laboratories conducting experimental activities related to highly pathogenic microorganisms.
省、自治区、直辖市人民政府卫生主管部门和兽医主管部门会同同级人民政府有关部门组织病原学、免疫学、检验医学、流行病学、预防兽医学、环境保护和实验室管理等方面的专家，组成本地区病原微生物实验室生物安全专家委员会。该委员会承担本地区实验室设立和运行的技术咨询工作。
The healthcompetent authority and veterinarycompetent authority of the province, autonomous region, or municipality directly under the Central Government, together with relevant departments of the same level of government, shall organize experts in etiology, immunology, laboratory medicine, epidemiology, preventive veterinary medicine, environmental protection, and laboratory management to form a regional Expert Committee on Biosafety of Pathogenic Microorganism Laboratories. This committee undertakes technical consultation work for the establishment and operation of laboratories in the region.
实验室感染控制
Laboratory Infection Control
实验室的设立单位应当指定专门的机构或者人员承担实验室感染控制工作，定期检查实验室的生物安全防护、病原微生物菌(毒)种和样本保存与使用、安全操作、实验室排放的废水和废气以及其他废物处置等规章制度的实施情况。
The entity establishing the laboratory shall designate a specialized institution or personnel to undertake laboratory infection control work, and regularly inspect the implementation of regulations on biosafety protection, preservation and use of pathogenic microorganism strains (viruses) and samples, safe operations, disposal of wastewater and exhaust gas discharged from the laboratory, and other waste disposal.
负责实验室感染控制工作的机构或者人员应当具有与该实验室中的病原微生物有关的传染病防治知识，并定期调查、了解实验室工作人员的健康状况。
The institution or personnel responsible for laboratory infection control work shall have knowledge of infectious disease prevention and control related to the pathogenic microorganisms in the laboratory, and regularly investigate and understand the health status of laboratory staff.
实验室工作人员出现与本实验室从事的高致病性病原微生物相关实验活动有关的感染临床症状或者体征时，实验室负责人应当向负责实验室感染控制工作的机构或者人员报告，同时派专人陪同及时就诊；实验室工作人员应当将近期所接触的病原微生物的种类和危险程度如实告知诊治医疗机构。接诊的医疗机构应当及时救治；不具备相应救治条件的，应当依照规定将感染的实验室工作人员转诊至具备相应传染病救治条件的医疗机构；具备相应传染病救治条件的医疗机构应当接诊治疗，不得拒绝救治。
When a laboratory worker develops clinical symptoms or signs of infection related to experimental activities involving highly pathogenic microorganisms conducted in the laboratory, the laboratory head shall report to the institution or personnel responsible for laboratory infection control work, and at the same time arrange for a person to accompany the worker for immediate medical consultation; the laboratory worker shall truthfully inform the diagnosing medical institution of the types and risk levels of pathogenic microorganisms recently contacted. The medical institution receiving the patient shall provide timely treatment; if it does not have the appropriate treatment conditions, it shall transfer the infected laboratory worker to a medical institution with appropriate infectious disease treatment conditions in accordance with regulations; a medical institution with appropriate infectious disease treatment conditions shall accept and treat the patient and shall not refuse treatment.
实验室发生高致病性病原微生物泄漏时，实验室工作人员应当立即采取控制措施，防止高致病性病原微生物扩散，并同时向负责实验室感染控制工作的机构或者人员报告。
When a leak of highly pathogenic microorganisms occurs in the laboratory, laboratory workers shall immediately take control measures to prevent the spread of highly pathogenic microorganisms, and at the same time report to the institution or personnel responsible for laboratory infection control work.
负责实验室感染控制工作的机构或者人员接到本条例第四十三条、第四十四条规定的报告后，应当立即启动实验室生物安全事件应急处置预案，并组织人员对该实验室生物安全状况等情况进行调查；确认发生实验室感染或者高致病性病原微生物泄漏的，应当依照本条例第十七条的规定进行报告，并同时采取控制措施，对有关人员进行医学观察或者隔离治疗，封闭实验室，防止扩散。
Upon receiving the reports specified in Articles 43 and 44 of these Regulations, the institution or personnel responsible for laboratory infection control work shall immediately activate the laboratory biosafety incident emergency response plan, and organize personnel to investigate the biosafety status of the laboratory and other circumstances; if it is confirmed that a laboratory infection or leak of highly pathogenic microorganisms has occurred, it shall report in accordance with Article 17 of these Regulations, and at the same time take control measures, conduct medical observation or isolation treatment for relevant personnel, seal the laboratory, and prevent spread.
卫生主管部门或者兽医主管部门接到关于实验室发生工作人员感染事故或者病原微生物泄漏事件的报告，或者发现实验室从事病原微生物相关实验活动造成实验室感染事故的，应当立即组织疾病预防控制机构、动物疫病预防控制机构和医疗机构以及其他有关机构依法采取下列预防、控制措施：
When the health authority or veterinary authority receives a report of a laboratory worker infection accident or pathogenic microorganism leak incident, or discovers that a laboratory engaged in experimental activities involving pathogenic microorganisms has caused a laboratory infection accident, it shall immediately organize disease prevention and control institutions, animal disease prevention and control institutions, medical institutions, and other relevant institutions to take the following prevention and control measures in accordance with the law:
(一)封闭被病原微生物污染的实验室或者可能造成病原微生物扩散的场所；
(1) Seal the laboratory contaminated by pathogenic microorganisms or the site that may cause the spread of pathogenic microorganisms;
(二)开展流行病学调查；
(2) Conduct epidemiological investigation;
(三)对病人进行隔离治疗，对相关人员进行医学检查；
(3) Isolate and treat patients, and conduct medical examinations for relevant personnel;
(四)对密切接触者进行医学观察；
(4) Conduct medical observation of close contacts;
(五)进行现场消毒；
(5) Carry out on-site disinfection;
(六)对染疫或者疑似染疫的动物采取隔离、扑杀等措施；
(6) Take measures such as isolation and culling of infected or suspected infected animals;
(七)其他需要采取的预防、控制措施。
(7) Other preventive and control measures that need to be taken.
医疗机构或者兽医医疗机构及其执行职务的医务人员发现由于实验室感染而引起的与高致病性病原微生物相关的传染病病人、疑似传染病病人或者患有疫病、疑似患有疫病的动物，诊治的医疗机构或者兽医医疗机构应当在2小时内报告所在地的县级人民政府卫生主管部门或者兽医主管部门；接到报告的卫生主管部门或者兽医主管部门应当在2小时内通报实验室所在地的县级人民政府卫生主管部门或者兽医主管部门。接到通报的卫生主管部门或者兽医主管部门应当依照本条例第四十六条的规定采取预防、控制措施。
When a medical institution or veterinary medical institution and its medical staff on duty discover a patient with an infectious disease related to highly pathogenic microorganisms, a suspected patient, or an animal with or suspected of having an epidemic disease caused by a laboratory infection, the medical institution or veterinary medical institution that provides diagnosis and treatment shall report to the healthcompetent authority or veterinarycompetent authority of the people's government at the county level where it is located within 2 hours; the healthcompetent authority or veterinarycompetent authority that receives the report shall notify the healthcompetent authority or veterinarycompetent authority of the people's government at the county level where the laboratory is located within 2 hours. The notified healthcompetent authority or veterinarycompetent authority shall take preventive and control measures in accordance with Article 46 of these Regulations.
发生病原微生物扩散，有可能造成传染病暴发、流行时，县级以上人民政府卫生主管部门或者兽医主管部门应当依照有关法律、行政法规的规定以及实验室生物安全事件应急处置预案进行处理。
When the spread of pathogenic microorganisms occurs and may cause an outbreak or epidemic of infectious diseases, the healthcompetent authority or veterinarycompetent authority of the people's government at or above the county level shall handle the situation in accordance with the provisions of relevant laws and administrative regulations and the emergency response plan for laboratory biosafety incidents.
监 督 管 理
Supervision and Administration
县级以上地方人民政府卫生主管部门、兽医主管部门依照各自分工，履行下列职责：
The healthcompetent authority and veterinarycompetent authority of the local people's government at or above the county level shall, according to their respective division of responsibilities, perform the following duties:
(一)对病原微生物菌(毒)种、样本的采集、运输、储存进行监督检查；
(1) Supervise and inspect the collection, transportation, and storage of pathogenic microorganism strains (toxins) and samples;
(二)对从事高致病性病原微生物相关实验活动的实验室是否符合本条例规定的条件进行监督检查；
(2) Supervise and inspect whether laboratories engaged in experimental activities related to highly pathogenic microorganisms meet the conditions stipulated in these Regulations;
(三)对实验室或者实验室的设立单位培训、考核其工作人员以及上岗人员的情况进行监督检查；
(3) Conduct supervision and inspection of the training and assessment of laboratory staff and personnel on duty by the laboratory or its establishing unit;
(四)对实验室是否按照有关国家标准、技术规范和操作规程从事病原微生物相关实验活动进行监督检查。
(4) Conduct supervision and inspection of whether the laboratory conducts experimental activities related to pathogenic microorganisms in accordance with relevant national standards, technical specifications, and operating procedures.
县级以上地方人民政府卫生主管部门、兽医主管部门，应当主要通过检查反映实验室执行国家有关法律、行政法规以及国家标准和要求的记录、档案、报告，切实履行监督管理职责。
The health administrative departments and veterinary administrative departments of local people's governments at or above the county level shall effectively perform their supervision and management duties mainly by inspecting records, archives, and reports that reflect the laboratory's compliance with relevant national laws, administrative regulations, and national standards and requirements.
县级以上人民政府卫生主管部门、兽医主管部门、环境保护主管部门在履行监督检查职责时，有权进入被检查单位和病原微生物泄漏或者扩散现场调查取证、采集样品，查阅复制有关资料。需要进入从事高致病性病原微生物相关实验活动的实验室调查取证、采集样品的，应当指定或者委托专业机构实施。被检查单位应当予以配合，不得拒绝、阻挠。
When performing supervision and inspection duties, the health administrative departments, veterinary administrative departments, and environmental protection administrative departments of people's governments at or above the county level have the authority to enter the inspected unit and the site of pathogenic microorganism leakage or diffusion to investigate, collect evidence, and collect samples, as well as to consult and copy relevant materials. If it is necessary to enter a laboratory engaged in experimental activities related to highly pathogenic microorganisms for investigation, evidence collection, and sample collection, a professional institution shall be designated or commissioned to carry out the work. The inspected unit shall cooperate and shall not refuse or obstruct.
国务院认证认可监督管理部门依照《中华人民共和国认证认可条例》的规定对实验室认可活动进行监督检查。
The certification and accreditation supervision and management department of the State Council shall conduct supervision and inspection of laboratory accreditation activities in accordance with the provisions of the Regulations of the People's Republic of China on Certification and Accreditation.
卫生主管部门、兽医主管部门、环境保护主管部门应当依据法定的职权和程序履行职责，做到公正、公平、公开、文明、高效。
The health administrative departments, veterinary administrative departments, and environmental protection administrative departments shall perform their duties in accordance with statutory authority and procedures, achieving fairness, impartiality, openness, civility, and efficiency.
卫生主管部门、兽医主管部门、环境保护主管部门的执法人员执行职务时，应当有2名以上执法人员参加，出示执法证件，并依照规定填写执法文书。
When law enforcement personnel of the health administrative departments, veterinary administrative departments, and environmental protection administrative departments perform their duties, there shall be at least two law enforcement personnel present, they shall present their law enforcement credentials, and fill out law enforcement documents in accordance with regulations.
现场检查笔录、采样记录等文书经核对无误后，应当由执法人员和被检查人、被采样人签名。被检查人、被采样人拒绝签名的，执法人员应当在自己签名后注明情况。
Documents such as on-site inspection records and sampling records, after being verified as correct, shall be signed by the law enforcement personnel and the inspected person or the sampled person. If the inspected person or the sampled person refuses to sign, the law enforcement personnel shall sign and note the circumstances.
卫生主管部门、兽医主管部门、环境保护主管部门及其执法人员执行职务，应当自觉接受社会和公民的监督。公民、法人和其他组织有权向上级人民政府及其卫生主管部门、兽医主管部门、环境保护主管部门举报地方人民政府及其有关主管部门不依照规定履行职责的情况。接到举报的有关人民政府或者其卫生主管部门、兽医主管部门、环境保护主管部门，应当及时调查处理。
The health administrative departments, veterinary administrative departments, environmental protection administrative departments, and their law enforcement personnel shall consciously accept supervision from society and citizens when performing their duties. Citizens, legal persons, and other organizations have the right to report to the higher-level people's government and its health administrative departments, veterinary administrative departments, or environmental protection administrative departments any failure of the local people's government or its relevant departments to perform their duties in accordance with regulations. The relevant people's government or its health administrative department, veterinary administrative department, or environmental protection administrative department that receives the report shall promptly investigate and handle the matter.
上级人民政府卫生主管部门、兽医主管部门、环境保护主管部门发现属于下级人民政府卫生主管部门、兽医主管部门、环境保护主管部门职责范围内需要处理的事项的，应当及时告知该部门处理；下级人民政府卫生主管部门、兽医主管部门、环境保护主管部门不及时处理或者不积极履行本部门职责的，上级人民政府卫生主管部门、兽医主管部门、环境保护主管部门应当责令其限期改正；逾期不改正的，上级人民政府卫生主管部门、兽医主管部门、环境保护主管部门有权直接予以处理。
If a higher-level health administrative department, veterinary administrative department, or environmental protection administrative department of a people's government discovers a matter that falls within the scope of duties of a lower-level health administrative department, veterinary administrative department, or environmental protection administrative department of a people's government, it shall promptly notify that department to handle the matter; if the lower-level department fails to handle it promptly or does not actively perform its duties, the higher-level department shall order it to make corrections within a specified time limit; if it fails to make corrections within the time limit, the higher-level department has the authority to directly handle the matter.
法 律 责 任
Legal Liability
三级、四级实验室未经批准从事病原微生物目录规定的应当在三级、四级实验室进行的高致病性病原微生物实验活动或者疑似高致病性病原微生物实验活动的，由县级以上地方人民政府卫生主管部门、兽医主管部门依照各自职责，责令停止有关活动，监督其将用于实验活动的病原微生物销毁或者送交保藏机构，并给予警告；造成传染病传播、流行或者其他严重后果的，由实验室的设立单位对主要负责人、直接负责的主管人员和其他直接责任人员，依法给予撤职、开除的处分；构成犯罪的，依法追究刑事责任。
If a Level 3 or Level 4 laboratory engages in experimental activities with highly pathogenic microorganisms or suspected highly pathogenic microorganisms that, according to the catalog of pathogenic microorganisms, should be conducted in a Level 3 or Level 4 laboratory without approval, the health administrative department or veterinary administrative department of the local people's government at or above the county level shall, in accordance with their respective duties, order the cessation of the relevant activities, supervise the destruction or delivery of the pathogenic microorganisms used in the experimental activities to a preservation institution, and issue a warning; if the spread or epidemic of an infectious disease or other serious consequences are caused, the establishing unit of the laboratory shall, in accordance with the law, impose sanctions of removal from office or expulsion on the principal responsible person, the directly responsible supervisor, and other directly responsible personnel; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
卫生主管部门或者兽医主管部门违反本条例的规定，准予不符合本条例规定条件的实验室从事高致病性病原微生物相关实验活动的，由作出批准决定的卫生主管部门或者兽医主管部门撤销原批准决定，责令有关实验室立即停止有关活动，并监督其将用于实验活动的病原微生物销毁或者送交保藏机构，对直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任。
If a health administrative department or veterinary administrative department, in violation of the provisions of these Regulations, approves a laboratory that does not meet the conditions specified in these Regulations to engage in experimental activities related to highly pathogenic microorganisms, the health administrative department or veterinary administrative department that made the approval decision shall revoke the original approval decision, order the relevant laboratory to immediately cease the relevant activities, and supervise the destruction or delivery of the pathogenic microorganisms used in the experimental activities to a preservation institution, and impose administrative sanctions on the directly responsible supervisor and other directly responsible personnel in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
因违法作出批准决定给当事人的合法权益造成损害的，作出批准决定的卫生主管部门或者兽医主管部门应当依法承担赔偿责任。
If the illegal approval decision causes damage to the lawful rights and interests of the party concerned, the health administrative department or veterinary administrative department that made the approval decision shall bear compensation liability in accordance with the law.
卫生主管部门或者兽医主管部门对出入境检验检疫机构为了检验检疫工作的紧急需要，申请在实验室对高致病性病原微生物或者疑似高致病性病原微生物开展进一步检测活动，不在法定期限内作出是否批准决定的，由其上级行政机关或者监察机关责令改正，给予警告；造成传染病传播、流行或者其他严重后果的，对直接负责的主管人员和其他直接责任人员依法给予撤职、开除的行政处分；构成犯罪的，依法追究刑事责任。
If a health administrative department or veterinary administrative department fails to decide whether to approve an application from an entry-exit inspection and quarantine institution for conducting further testing activities on highly pathogenic microorganisms or suspected highly pathogenic microorganisms in a laboratory due to the urgent needs of inspection and quarantine work within the statutory time limit, the superior administrative organ or supervisory organ shall order correction and issue a warning; if the spread or epidemic of an infectious disease or other serious consequences are caused, administrative sanctions of removal from office or expulsion shall be imposed on the directly responsible supervisor and other directly responsible personnel in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
违反本条例规定，在不符合相应生物安全要求的实验室从事病原微生物相关实验活动的，由县级以上地方人民政府卫生主管部门、兽医主管部门依照各自职责，责令停止有关活动，监督其将用于实验活动的病原微生物销毁或者送交保藏机构，并给予警告；造成传染病传播、流行或者其他严重后果的，由实验室的设立单位对主要负责人、直接负责的主管人员和其他直接责任人员，依法给予撤职、开除的处分；构成犯罪的，依法追究刑事责任。
If, in violation of the provisions of these Regulations, experimental activities related to pathogenic microorganisms are conducted in a laboratory that does not meet the corresponding biosafety requirements, the health administrative department or veterinary administrative department of the local people's government at or above the county level shall, in accordance with their respective duties, order the cessation of the relevant activities, supervise the destruction or delivery of the pathogenic microorganisms used in the experimental activities to a preservation institution, and issue a warning; if the spread or epidemic of an infectious disease or other serious consequences are caused, the establishing unit of the laboratory shall, in accordance with the law, impose sanctions of removal from office or expulsion on the principal responsible person, the directly responsible supervisor, and other directly responsible personnel; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
实验室有下列行为之一的，由县级以上地方人民政府卫生主管部门、兽医主管部门依照各自职责，责令限期改正，给予警告；逾期不改正的，由实验室的设立单位对主要负责人、直接负责的主管人员和其他直接责任人员，依法给予撤职、开除的处分；有许可证件的，并由原发证部门吊销有关许可证件：
If a laboratory commits any of the following acts, the health administrative department or veterinary administrative department of the local people's government at or above the county level shall, in accordance with their respective duties, order correction within a time limit and issue a warning; if correction is not made within the time limit, the establishing unit of the laboratory shall, in accordance with the law, impose sanctions of removal from office or expulsion on the principal responsible person, the directly responsible supervisor, and other directly responsible personnel; if a license is held, the original licensing authority shall revoke the relevant license:
(一)未依照规定在明显位置标示国务院卫生主管部门和兽医主管部门规定的生物危险标识和生物安全实验室级别标志的；
(1) Failing to display, in a conspicuous position, the biohazard sign and the biosafety laboratory level sign as specified by the health administrative department and veterinary administrative department of the State Council in accordance with the regulations;
(二)未向原批准部门报告实验活动结果以及工作情况的；
(2) Failing to report the results of experimental activities and work conditions to the original approving department;
(三)未依照规定采集病原微生物样本，或者对所采集样本的来源、采集过程和方法等未作详细记录的；
(3) Failing to collect pathogenic microorganism samples in accordance with the regulations, or failing to make detailed records of the source, collection process, and methods of the collected samples;
(四)新建、改建或者扩建一级、二级实验室未向设区的市级人民政府卫生主管部门或者兽医主管部门备案的；
(4) Failing to register the construction, renovation, or expansion of a Level 1 or Level 2 laboratory with the health authority or veterinary authority of the city with districts;
(五)未依照规定定期对工作人员进行培训，或者工作人员考核不合格允许其上岗，或者批准未采取防护措施的人员进入实验室的；
(5) Failing to conduct regular training for staff as required, or allowing staff who have failed assessment to work, or approving entry of personnel without protective measures into the laboratory;
(六)实验室工作人员未遵守实验室生物安全技术规范和操作规程的；
(6) Laboratory staff failing to comply with laboratory biosafety technical specifications and operating procedures;
(七)未依照规定建立或者保存实验档案的；
(7) Failing to establish or maintain laboratory records as required;
(八)未依照规定制定实验室生物安全事件应急处置预案并备案的。
(8) Failing to develop and file an emergency response plan for laboratory biosafety incidents as required.
从事高致病性病原微生物相关实验活动的实验室的设立单位未建立健全安全保卫制度，或者未采取安全保卫措施的，由县级以上地方人民政府卫生主管部门、兽医主管部门依照各自职责，责令限期改正；逾期不改正，导致高致病性病原微生物菌(毒)种、样本被盗、被抢或者造成其他严重后果的，责令停止该项实验活动，该实验室2年内不得从事高致病性病原微生物实验活动；造成传染病传播、流行的，该实验室设立单位的主管部门还应当对该实验室的设立单位的直接负责的主管人员和其他直接责任人员，依法给予降级、撤职、开除的处分；构成犯罪的，依法追究刑事责任。
If the establishment unit of a laboratory engaged in experimental activities related to highly pathogenic microorganisms fails to establish a sound security system or take security measures, the health authority or veterinary authority of the local people's government at or above the county level shall, within their respective responsibilities, order rectification within a time limit; if rectification is not made within the time limit, resulting in the theft, robbery, or other serious consequences of highly pathogenic microorganism strains or samples, the experimental activity shall be ordered to stop, and the laboratory shall not engage in highly pathogenic microorganism experimental activities for 2 years; if it causes the spread or epidemic of infectious diseases, the competent department of the laboratory's establishment unit shall also impose demotion, dismissal, or expulsion on the directly responsible supervisors and other directly responsible personnel of the establishment unit according to law; if a crime is constituted, criminal liability shall be pursued according to law.
未经批准运输高致病性病原微生物菌(毒)种或者样本，或者承运单位经批准运输高致病性病原微生物菌(毒)种或者样本未履行保护义务，导致高致病性病原微生物菌(毒)种或者样本被盗、被抢、丢失、泄漏的，由县级以上地方人民政府卫生主管部门、兽医主管部门依照各自职责，责令采取措施，消除隐患，给予警告；造成传染病传播、流行或者其他严重后果的，由托运单位和承运单位的主管部门对主要负责人、直接负责的主管人员和其他直接责任人员，依法给予撤职、开除的处分；构成犯罪的，依法追究刑事责任。
If the transport of highly pathogenic microorganism strains or samples is carried out without approval, or if the carrier, after approved transport, fails to fulfill protection obligations, resulting in the theft, robbery, loss, or leakage of highly pathogenic microorganism strains or samples, the health authority or veterinary authority of the local people's government at or above the county level shall, within their respective responsibilities, order measures to eliminate hazards and give a warning; if it causes the spread or epidemic of infectious diseases or other serious consequences, the competent department of the consignor and carrier shall impose dismissal or expulsion on the principal responsible persons, directly responsible supervisors, and other directly responsible personnel according to law; if a crime is constituted, criminal liability shall be pursued according to law.
有下列行为之一的，由实验室所在地的设区的市级以上地方人民政府卫生主管部门、兽医主管部门依照各自职责，责令有关单位立即停止违法活动，监督其将病原微生物销毁或者送交保藏机构；造成传染病传播、流行或者其他严重后果的，由其所在单位或者其上级主管部门对主要负责人、直接负责的主管人员和其他直接责任人员，依法给予撤职、开除的处分；有许可证件的，并由原发证部门吊销有关许可证件；构成犯罪的，依法追究刑事责任：
If any of the following acts occur, the health authority or veterinary authority of the local people's government at or above the city with districts where the laboratory is located shall, within their respective responsibilities, order the relevant unit to immediately cease the illegal activity, supervise the destruction of the pathogenic microorganisms or their delivery to a preservation institution; if it causes the spread or epidemic of infectious diseases or other serious consequences, the unit or its superior competent department shall impose dismissal or expulsion on the principal responsible persons, directly responsible supervisors, and other directly responsible personnel according to law; if a license is held, the original licensing authority shall revoke the relevant license; if a crime is constituted, criminal liability shall be pursued according to law:
(一)实验室在相关实验活动结束后，未依照规定及时将病原微生物菌(毒)种和样本就地销毁或者送交保藏机构保管的；
(1) After the relevant experimental activity ends, the laboratory fails to promptly destroy the pathogenic microorganism strains and samples on site or deliver them to a preservation institution for custody as required;
(二)实验室使用新技术、新方法从事高致病性病原微生物相关实验活动未经国家病原微生物实验室生物安全专家委员会论证的；
(2) The laboratory uses new technologies or methods to engage in experimental activities related to highly pathogenic microorganisms without the review of the National Expert Committee on Biosafety of Pathogenic Microorganism Laboratories;
(三)未经批准擅自从事在我国尚未发现或者已经宣布消灭的病原微生物相关实验活动的；
(3) Conducting experimental activities related to pathogenic microorganisms that have not yet been discovered in China or have been declared eradicated without approval;
(四)在未经指定的专业实验室从事在我国尚未发现或者已经宣布消灭的病原微生物相关实验活动的；
(4) Conducting experimental activities related to pathogenic microorganisms that have not yet been discovered in China or have been declared eradicated in an unapproved specialized laboratory;
(五)在同一个实验室的同一个独立安全区域内同时从事两种或者两种以上高致病性病原微生物的相关实验活动的。
(5) Simultaneously conducting experimental activities related to two or more types of highly pathogenic microorganisms in the same independent safety area of the same laboratory.
认可机构对不符合实验室生物安全国家标准以及本条例规定条件的实验室予以认可，或者对符合实验室生物安全国家标准以及本条例规定条件的实验室不予认可的，由国务院认证认可监督管理部门责令限期改正，给予警告；造成传染病传播、流行或者其他严重后果的，由国务院认证认可监督管理部门撤销其认可资格，有上级主管部门的，由其上级主管部门对主要负责人、直接负责的主管人员和其他直接责任人员依法给予撤职、开除的处分；构成犯罪的，依法追究刑事责任。
If an accreditation body accredits a laboratory that does not meet the national biosafety standards or the conditions specified in these Regulations, or fails to accredit a laboratory that meets such standards and conditions, the certification and accreditation supervision and administration department of the State Council shall order correction within a time limit and give a warning; if it causes the spread or epidemic of infectious diseases or other serious consequences, the certification and accreditation supervision and administration department of the State Council shall revoke its accreditation qualification, and if it has a superior authority, the superior authority shall impose removal from office or expulsion on the main responsible person, the directly responsible supervisor, and other directly responsible personnel in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
实验室工作人员出现该实验室从事的病原微生物相关实验活动有关的感染临床症状或者体征，以及实验室发生高致病性病原微生物泄漏时，实验室负责人、实验室工作人员、负责实验室感染控制的专门机构或者人员未依照规定报告，或者未依照规定采取控制措施的，由县级以上地方人民政府卫生主管部门、兽医主管部门依照各自职责，责令限期改正，给予警告；造成传染病传播、流行或者其他严重后果的，由其设立单位对实验室主要负责人、直接负责的主管人员和其他直接责任人员，依法给予撤职、开除的处分；有许可证件的，并由原发证部门吊销有关许可证件；构成犯罪的，依法追究刑事责任。
If a laboratory worker develops clinical symptoms or signs related to the experimental activities of pathogenic microorganisms conducted in the laboratory, or if a leak of highly pathogenic microorganisms occurs in the laboratory, and the laboratory head, laboratory worker, or specialized institution or personnel responsible for laboratory infection control fails to report in accordance with regulations or fails to take control measures in accordance with regulations, the health authority or veterinary authority of the local people's government at or above the county level shall, within their respective responsibilities, order correction within a time limit and give a warning; if it causes the spread or epidemic of infectious diseases or other serious consequences, the establishing unit shall impose removal from office or expulsion on the main responsible person, the directly responsible supervisor, and other directly responsible personnel of the laboratory in accordance with the law; if there is a license, the original licensing department shall revoke the relevant license; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
拒绝接受卫生主管部门、兽医主管部门依法开展有关高致病性病原微生物扩散的调查取证、采集样品等活动或者依照本条例规定采取有关预防、控制措施的，由县级以上人民政府卫生主管部门、兽医主管部门依照各自职责，责令改正，给予警告；造成传染病传播、流行以及其他严重后果的，由实验室的设立单位对实验室主要负责人、直接负责的主管人员和其他直接责任人员，依法给予降级、撤职、开除的处分；有许可证件的，并由原发证部门吊销有关许可证件；构成犯罪的，依法追究刑事责任。
If a party refuses to accept the investigation, evidence collection, sample collection, or other activities lawfully conducted by the health authority or veterinary authority regarding the spread of highly pathogenic microorganisms, or refuses to take preventive or control measures in accordance with these Regulations, the health authority or veterinary authority of the local people's government at or above the county level shall, within their respective responsibilities, order correction and give a warning; if it causes the spread or epidemic of infectious diseases or other serious consequences, the establishing unit of the laboratory shall impose demotion, removal from office, or expulsion on the main responsible person, the directly responsible supervisor, and other directly responsible personnel of the laboratory in accordance with the law; if there is a license, the original licensing department shall revoke the relevant license; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
发生病原微生物被盗、被抢、丢失、泄漏，承运单位、护送人、保藏机构和实验室的设立单位未依照本条例的规定报告的，由所在地的县级人民政府卫生主管部门或者兽医主管部门给予警告；造成传染病传播、流行或者其他严重后果的，由实验室的设立单位或者承运单位、保藏机构的上级主管部门对主要负责人、直接负责的主管人员和其他直接责任人员，依法给予撤职、开除的处分；构成犯罪的，依法追究刑事责任。
If pathogenic microorganisms are stolen, robbed, lost, or leaked, and the transport unit, escort, storage institution, or establishing unit of the laboratory fails to report in accordance with these Regulations, the health authority or veterinary authority of the local people's government at the county level shall give a warning; if it causes the spread or epidemic of infectious diseases or other serious consequences, the superior authority of the establishing unit of the laboratory, transport unit, or storage institution shall impose removal from office or expulsion on the main responsible person, the directly responsible supervisor, and other directly responsible personnel in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
保藏机构未依照规定储存实验室送交的菌(毒)种和样本，或者未依照规定提供菌(毒)种和样本的，由其指定部门责令限期改正，收回违法提供的菌(毒)种和样本，并给予警告；造成传染病传播、流行或者其他严重后果的，由其所在单位或者其上级主管部门对主要负责人、直接负责的主管人员和其他直接责任人员，依法给予撤职、开除的处分；构成犯罪的，依法追究刑事责任。
If a storage institution fails to store the bacterial (viral) strains and samples submitted by the laboratory in accordance with regulations, or fails to provide bacterial (viral) strains and samples in accordance with regulations, the designated department shall order correction within a time limit, recover the illegally provided bacterial (viral) strains and samples, and give a warning; if it causes the spread or epidemic of infectious diseases or other serious consequences, the unit to which it belongs or its superior authority shall impose removal from office or expulsion on the main responsible person, the directly responsible supervisor, and other directly responsible personnel in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
县级以上人民政府有关主管部门，未依照本条例的规定履行实验室及其实验活动监督检查职责的，由有关人民政府在各自职责范围内责令改正，通报批评；造成传染病传播、流行或者其他严重后果的，对直接负责的主管人员，依法给予行政处分；构成犯罪的，依法追究刑事责任。
If the relevant competent department of the local people's government at or above the county level fails to perform its duties of supervision and inspection of laboratories and their experimental activities in accordance with these Regulations, the relevant people's government shall, within its respective responsibilities, order correction and circulate a notice of criticism; if it causes the spread or epidemic of infectious diseases or other serious consequences, administrative sanctions shall be imposed on the directly responsible supervisor in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
附 则
Supplementary Provisions
军队实验室由中国人民解放军卫生主管部门参照本条例负责监督管理。
Military laboratories shall be supervised and managed by the health authority of the People's Liberation Army with reference to these Regulations.
本条例施行前设立的实验室，应当自本条例施行之日起6个月内，依照本条例的规定，办理有关手续。
Laboratories established before the implementation of these Regulations shall, within 6 months from the date of implementation, go through the relevant procedures in accordance with the provisions of these Regulations.
本条例自公布之日起施行。
These Regulations shall come into force as of the date of promulgation.