国家卫生健康委办公厅关于在新冠肺炎疫情常态化防控中进一步加强实验室生物安全监督管理的通知

各省、自治区、直辖市及新疆生产建设兵团卫生健康委：　　为落实《国务院应对新型冠状病毒感染肺炎疫情联防联控机制关于做好新冠肺炎疫情常态化防控工作的指导意见》（国发明电〔2020〕14号，以下简称《指导意见》）要求，确保疫情防控期间实验室生物安全，防范发生次生灾害，现就做好实验室生物安全监督管理工作提出如下要求：　　一、严格执行新型冠状病毒实验活动管理要求　　根据新型冠状病毒(以下简称新冠病毒)传播特性、致病性和临床资料等信息，该病毒按照第二类病原微生物进行管理。各地卫生健康行政部门应当要求生物安全实验室严格按照防护要求开展相关实验活动：新冠病毒培养、动物感染实验应当在生物安全三级及以上实验室开展；未经培养的感染性材料的操作应当在生物安全二级及以上实验室进行，同时采用不低于生物安全三级实验室的个人防护；灭活材料的操作应当在生物安全二级及以上实验室进行；不涉及感染性材料的操作，可以在生物安全一级实验室进行。　　二、做好实验室生物安全服务保障和规范管理　　各地卫生健康行政部门要做好检测实验室备案管理工作，压实实验室设立单位主体责任，督促相关单位加强实验操作技术、个人防护、检测样本处置等方面的培训与考核，规范实验人员新冠病毒样本检测操作流程，提升检测能力，保障检测人员和周围环境安全。　　三、加强新冠病毒毒株及相关样本管理　　各地卫生健康行政部门要依法依规严格管理新冠病毒毒株和相关样本，确保安全。　　（一）新冠病毒毒株及样本运输。新冠病毒毒株及潜在感染性材料运输应当按照《可感染人类的高致病性病原微生物菌（毒）种或样本运输管理规定》管理。各地根据疫情防控形势需要，在运输环节中，对“应检尽检”人员检测样本严格按照高致病性病原微生物样本管理；对“愿检尽检”人员检测样本，经样本运出单位生物安全专家委员会进行风险评估后，可按照普通样本管理。“应检尽检”和“愿检尽检”人员范围按照《指导意见》执行。各省级卫生健康行政部门要加强对毒株及相关样本保存单位的监督管理，严格防范和杜绝未经审批擅自运输的情况发生。　　（二）相关样本处置。各省级卫生健康行政部门要根据疫情防控需要和实验室生物安全有关要求，及时研判提出新冠病毒实验室检测生物样本处置意见。对确需保存的，应当尽快指定具备保存条件的机构按照相对集中原则进行保存，或送至国家级菌（毒）种保藏中心保藏；对无需保存的，由相关机构按照生物安全有关要求及时处理。　　（三）毒株分离和保藏。请各省级卫生健康行政部门督促辖区内高等级生物安全实验室将新冠病毒毒株分离、分享等相关情况及时报送我委科教司，同时指导实验室在分离出新冠病毒毒株后90天内，向国家级菌（毒）种保藏中心申请保藏，完成相关实验活动后及时将新冠病毒毒株送交保藏机构保藏。请各省级卫生健康行政部门在办理有关实验室和各级菌（毒）种保藏机构向其他实验室或外单位提供新冠病毒毒株或以新冠病毒作为母本病毒的疫苗株的准运手续时，及时将准运证书复印件提供给我委科教司。　　四、加强实验室生物安全监管　　各省级卫生健康行政部门要切实加强组织领导，提升实验室生物安全监管能力，按照属地化、分级分类的原则开展实验室生物安全监管工作，强化新冠病毒实验活动监督检查，指导辖区内相关机构加强生物安全管理，严格按照《病原微生物实验室生物安全管理条例》及相关技术规范要求开展实验活动，防止实验室泄露或人员感染，确保实验室生物安全万无一失。  国家卫生健康委办公厅2020年7月6日

Notice from the General Office of the National Health Commission to Health Commissions of all provinces, autonomous regions, municipalities directly under the Central Government, and Xinjiang Production and Construction Corps

To implement the requirements of the Guiding Opinions on Doing a Good Job in the Regular Prevention and Control of the COVID-19 Epidemic issued by the State Council's Joint Prevention and Control Mechanism for the Response to the COVID-19 Epidemic (State Council Document [2020] No. 14, hereinafter referred to as the Guiding Opinions), ensure laboratory biosafety during the epidemic prevention and control, prevent secondary disasters, the following requirements are hereby put forward for strengthening the supervision and management of laboratory biosafety:

1. Strictly Implement the Management Requirements for Experimental Activities Involving SARS-CoV-2
Based on the transmission characteristics, pathogenicity, clinical data and other information of SARS-CoV-2 (hereinafter referred to as the novel coronavirus), this virus shall be managed as a Class II pathogenic microorganism. Local health administrative departments shall require biosafety laboratories to carry out relevant experimental activities in strict accordance with the protection requirements:
- Cultivation of SARS-CoV-2 and animal infection experiments shall be carried out in biosafety level 3 (BSL-3) or higher laboratories;
- Operations on unpropagated infectious materials shall be carried out in biosafety level 2 (BSL-2) or higher laboratories, with personal protection no lower than that required for BSL-3 laboratories;
- Operations on inactivated materials shall be carried out in biosafety level 2 (BSL-2) or higher laboratories;
- Operations not involving infectious materials may be carried out in biosafety level 1 (BSL-1) laboratories.

2. Do a Good Job in Laboratory Biosafety Service Guarantee and Standardized Management
Local health administrative departments shall strengthen the filing management of testing laboratories, fulfill the main responsibility of the institutions establishing the laboratories, urge relevant units to strengthen training and assessment on experimental operation techniques, personal protection, disposal of test samples and other aspects, standardize the operation procedures for experimental personnel to conduct SARS-CoV-2 sample testing, improve testing capabilities, and ensure the safety of testing personnel and the surrounding environment.

3. Strengthen the Management of SARS-CoV-2 Strains and Relevant Samples
Local health administrative departments shall strictly manage SARS-CoV-2 strains and relevant samples in accordance with laws and regulations to ensure their safety.

(1) Transportation of SARS-CoV-2 Strains and Relevant Samples
Transportation of SARS-CoV-2 strains and potentially infectious materials shall be conducted in accordance with the Administrative Provisions on the Transportation of Highly Pathogenic Microbial Strains (Cultures) or Samples That Can Infect Humans. According to the needs of epidemic prevention and control, in the transportation link, test samples from "all persons who should be tested" shall be managed strictly as highly pathogenic microbial samples; test samples from "all persons who wish to be tested" may be managed as ordinary samples after risk assessment is conducted by the biosafety expert committee of the sample exporting unit. The scope of "all persons who should be tested" and "all persons who wish to be tested" shall be implemented in accordance with the Guiding Opinions. All provincial-level health administrative departments shall strengthen the supervision and management of units storing SARS-CoV-2 strains and relevant samples, and strictly prevent and put an end to unauthorized transportation without approval.

(2) Disposal of Relevant Samples
All provincial-level health administrative departments shall, in accordance with the needs of epidemic prevention and control and relevant requirements for laboratory biosafety, timely analyze and put forward disposal opinions on biological samples from SARS-CoV-2 laboratory testing. For those that do need to be stored, the provincial-level departments shall promptly designate institutions with storage conditions to store them in accordance with the principle of relative concentration, or send them to the National Pathogenic Microbial Strain (Culture) Collection Center for storage; for those that do not need to be stored, relevant institutions shall dispose of them in a timely manner in accordance with biosafety requirements.

(3) Isolation and Storage of Strains
All provincial-level health administrative departments are requested to urge high-level biosafety laboratories under their jurisdiction to timely report relevant information such as the isolation and sharing of SARS-CoV-2 strains to the Department of Science and Education of the National Health Commission. At the same time, they shall guide laboratories to apply to the National Pathogenic Microbial Strain (Culture) Collection Center for storage within 90 days after isolating SARS-CoV-2 strains, and promptly submit the strains to the storage institution for storage after completing relevant experimental activities. All provincial-level health administrative departments are requested to timely provide a copy of the transportation permit to the Department of Science and Education of the National Health Commission when handling the transportation approval procedures for laboratories and pathogenic microbial strain (culture) collection institutions at all levels to provide SARS-CoV-2 strains or vaccine strains using SARS-CoV-2 as the parent virus to other laboratories or external units.

4. Strengthen Laboratory Biosafety Supervision
All provincial-level health administrative departments shall effectively strengthen organizational leadership, improve the capacity for laboratory biosafety supervision, carry out laboratory biosafety supervision work in accordance with the principles of territorial management, classification and grading, strengthen supervision and inspection of experimental activities involving SARS-CoV-2, guide relevant institutions under their jurisdiction to strengthen biosafety management, carry out experimental activities in strict accordance with the Regulations on the Administration of Biosafety of Pathogenic Microbial Laboratories and relevant technical specifications, prevent laboratory leaks or personnel infections, and ensure absolute safety of laboratory biosafety.

General Office of the National Health Commission
July 6, 2020