Notice of Hunan Provincial Department of Science and Technology and other eight departments on printing and distributing the implementation plan of biosafety supervision of experimental animals in Hun

Hunan Provincial Department of Science and Technology and other eight departments

On printing and distributing the "Biosafety of Experimental Animals in Hunan Province"

Notice of the Supervision Implementation Plan

Xiang Kefa [2023〕87number

HNPR—2023—04005

Municipal Science and Technology Bureau, Education Bureau, Ecology and Environment Bureau, Agriculture and Rural Bureau, Health and Wellness Committee, Forestry Bureau, Market Supervision Bureau, Customs, and all relevant units:

The implementation plan of biosafety supervision of experimental animals in Hunan Province is hereby printed and distributed to you, please follow it.

 

Attachment: Implementation Plan for Biosafety Supervision of Laboratory Animals in Hunan Province

 

Hunan Provincial Department of Science and Technology

education department of hunan

Hu’ nan province ecological environment department

Hunan Provincial Department of Agriculture and Rural Affairs

Hunan Provincial Health and Wellness Committee

Hunan Forestry Bureau

Hunan province market supervision management bureau

People’s Republic of China (PRC) Changsha Customs

2023yearsixmoon25sun

 

attachment

Implementation Plan of Biosafety Supervision of Laboratory Animals in Hunan Province

 

In order to standardize the biosafety management of experimental animals in accordance with the law and effectively build a biosafety barrier for experimental animals in our province, this implementation plan is formulated in accordance with the relevant provisions such as the Biosafety Law of People’s Republic of China (PRC), the Animal Epidemic Prevention Law of People’s Republic of China (PRC), the regulations on the biosafety management of pathogenic microorganism laboratories, the regulations on the management of experimental animals, the measures for implementing the regulations on the management of experimental animals in Hunan Province, and the implementation plan for implementing the Biosafety Law of People’s Republic of China (PRC) in Hunan Province, combined with the actual situation of this province.

I. General requirements

(A) the guiding ideology

Adhere to the spirit of the important instructions of the Supreme Leader General Secretary on national biosafety, integrate the biosafety of experimental animals into the overall layout of biosafety, strengthen the bottom line thinking and sense of responsibility, improve the supervision system and working mechanism, promote the integration of legal management and scientific and technological innovation, implement the biosafety supervision of experimental animals throughout their life cycle, and strengthen“Peacetime tube"and“In a hurry"To build a scientific and efficient biosafety governance pattern for experimental animals.

(2) Basic principles

oneAdhere to supervision according to law and regulations. Focusing on the core of decentralization and standardizing the use of power, we will earnestly“The law cannot be done without authorization, and the statutory duty must be", carry out supervision work according to law.

2Adhere to the classification and supervision by industry. implement“Who is in charge and who is in charge?"and“Territorial management and hierarchical responsibility"It is required that the administrative departments of science and technology at the provincial, city and county levels and the administrative departments of related industries should carry out biosafety supervision of experimental animals by classification and industry according to the assigned work responsibilities.

threeAdhere to the supervision of scientific innovation. Advocate the integration of management and innovation, broaden the supervision ideas, innovate the supervision methods, establish a long-term mechanism, improve the supervision efficiency, and promote the institutionalization, standardization and scientific supervision of laboratory animal biosafety.

(3) Regulatory orientation

The biosafety of experimental animals referred to in this scheme refers to effectively preventing and responding to the threats of dangerous biological factors and related factors in the field of experimental animals, maintaining the stable and healthy development of experimental animal biotechnology, and keeping the human health and environmental ecosystem related to experimental animals in a relatively non-dangerous and non-threatening state. Biosafety supervision of experimental animals focuses on effectively preventing and responding to the epidemic situation of major infectious diseases and the threat of dangerous biological factors in experimental animals, standardizing the research and development, production and use, teaching and demonstration behavior of biotechnology in experimental animals, ensuring the safety of biological genetic resources, preventing bioterrorism attacks, preventing the threat of biological weapons, and forming a coordinated and coordinated supervision system covering the whole province.

Second, the division of responsibilities

In the biological safety supervision of experimental animals, the administrative department of science and technology is the lead responsible unit, the provincial departments such as education, ecological environment, agriculture and rural areas, health and hygiene, forestry and market supervision and Changsha Customs are the responsible units for industry management and collaborative supervision, and the production (management) and use units (including teaching demonstration units) of experimental animals are the main responsible units for implementing the supervision requirements.

(1) Responsibilities of the administrative department of science and technology

oneThe Provincial Department of Science and Technology is in charge of the biosafety supervision of experimental animals in the province, and should assume the main supervisory responsibilities, take the lead in organizing the formulation of regulatory norms and emergency response plans, establish a technical expert consultation library, and carry out business guidance and technical training for the municipal and county-level administrative departments of science and technology. according to“Double random and one open"The principle, from time to time to have obtained the license of experimental animal production (business) and the use of units (including teaching demonstration units) to supervise and inspect the biological safety management, and announce the inspection results to the public, and track and urge the rectification in place for the problems found. Strengthen public supervision, announce the way of reporting, accept and verify public reports, and report telephone numbers:0731–88988731(Provincial Science and Technology Department duty room),0731–88988860(Provincial Laboratory Animal Management Office). Establish and improve the accountability and accountability mechanism, and seriously investigate the responsibility of units and individuals that have caused biosafety accidents due to illegal production (operation) or use of experimental animals, and deal with them according to laws and regulations. According to the requirements of the coordination mechanism in the field of national security biology and public health in Hunan Province, strengthen cooperation with relevant industry management departments, gradually establish a biosafety information sharing system, and form a joint regulatory force according to the principles of daily co-management, information sharing and resource sharing.

2. The municipal (state) administrative department of science and technology is responsible for fulfilling the responsibility of biological safety supervision of experimental animals within its administrative area, guiding the subordinate administrative departments of science and technology to carry out daily supervision, strengthening public supervision, publishing the reporting methods, and accepting and verifying public reports. build“Immediate report of problems"System, the laboratory animal biosafety problems and hidden dangers found, fill in the laboratory animal biosafety problem information table (see Annex), and report to the Provincial Department of Science and Technology and track and urge the problem to be rectified in place.

threeThe county (city, district) administrative department of science and technology is responsible for the daily supervision and inspection of the biosafety of experimental animals within its jurisdiction. By strengthening information communication with relevant administrative departments, widely publicizing, mobilizing social forces, strengthening social public supervision, publishing reporting methods, accepting and verifying public reports, etc., it actively discovers the biosafety violations such as unlicensed production (management) and use of experimental animals within its jurisdiction, and establishes.“Immediate report of problems"System, fill in the laboratory animal biosafety information table (see Annex), and report it to the administrative department of science and technology of the superior city (state) in a timely manner, ask for disposal opinions and urge the rectification to be put in place. For incidents beyond the disposal authority or capacity, they should actively participate in the investigation and disposal of incidents under the leadership of the people’s government at the same level.

(2) Responsibilities of other relevant departments

Education, ecological environment, agriculture and rural areas, health, forestry, customs and other departments at all levels should strengthen biosafety supervision and education and training for enterprises and institutions, various laboratories, schools and other institutions that produce and use experimental animals and their related products in the industry, strengthen information communication with the administrative departments of science and technology, strengthen biosafety awareness, formulate management systems, clarify management responsibilities, and improve biosafety risk prevention capabilities. When dealing with the epidemic situation of infectious diseases caused by experimental animals, organize human resources to participate in the epidemic situation according to needs. Market supervision departments at all levels should cooperate with the administrative department of science and technology, establish relevant information sharing mechanisms, and crack down on experimental animals and products illegally flowing into the food market according to law. The Customs is responsible for strengthening the quarantine inspection of entry-exit experimental animals in the port supervision according to law.

(three) the responsibilities of the production (management) and use units of experimental animals (including teaching demonstration units)

Units and individuals engaged in the conservation, breeding, production, supply, transportation and related commercial operations of experimental animals and related products, and units and individuals using experimental animals and related products for scientific research, experiments and teaching demonstrations, are responsible subjects for implementing the requirements of biosafety supervision, and undertake their daily management responsibilities.

Third, the content and process of supervision

(1) Regulatory contents

The supervision of the production (management) and use units (including teaching demonstration units) of experimental animals mainly includes the following contents:

oneObtain the production license or use license of experimental animals according to law, and carry out various activities according to the permitted scope. Involving national or provincial key protected wild animal experimental animals, shall comply with the relevant provisions of the "People’s Republic of China (PRC) Wildlife Protection Law".

2Establish an effective biosafety management system, timely assess biosafety risks, formulate biosafety emergency response plans, and conduct biosafety emergency drills at least once a year.

threeEngaged in the experimental activities of pathogenic microorganisms in experimental animals, we should strictly abide by the relevant national standards, laboratory technical specifications and operating procedures, and take effective safety precautions. It is forbidden to engage in the research, development and application of experimental animal biotechnology that endangers public health, damages biological resources, destroys ecosystems and biodiversity, etc.

fourEncourage the scientific and technological innovation of experimental animals, strictly implement the ethical review of experimental animals, follow the principles of substitution, reduction and optimization, and use the correct methods to dispose of experimental animals. Carry out daily monitoring of experimental animal diseases and establish monitoring files to ensure traceability at any time.

fiveEquip the staff with necessary biological safety protection equipment, organize the staff to carry out health examination every year, establish health files, and carry out vaccination when necessary to ensure the health and safety of the staff.

sixEquipped with necessary facilities and equipment to prevent experimental animals from escaping; There are facilities and equipment for the harmless treatment of sewage, dirt, dead animals and diseased animal products that are suitable for its scale, and the harmless treatment is carried out in time, or a third party with corresponding qualifications is entrusted for the harmless treatment, and it is strictly forbidden for the used experimental animals to enter the market. Timely carry out daily isolation and disinfection, harmless disposal and establish record ledger.

sevenTransport experimental animals in accordance with the relevant national regulations on the transport of live animals, and use qualified transport cages to prevent experimental animals from escaping and other animals from entering; Vehicles shall be cleaned and disinfected in time before loading and after unloading.

eightInfected experimental animals and their excreta, animal products, animal excreta in vehicles and contaminated articles such as padding, packaging materials and containers shall be disposed of in accordance with relevant state regulations, and shall not be disposed of at will.

nineThe teaching of demonstration animal experiments should comply with the Notice of the Ministry of Science and Technology on Issuing the Guiding Opinions on Treating Experimental Animals Well.〔2006〕398) and the general office of the Ministry of Education "Notice on Strengthening the Safety Management of Animal Experiments in Colleges and Universities" (Teaching Hall〔2011〕oneNumber)Relevant requirements, teaching demonstration animals should come from the administrative license unit of experimental animal production or provide legally effective animals.The production (supply) unit of material quality quarantine certificate shall strengthen the safety evaluation and supervision of animal experimental sites (including test benches, floors, tools, freezers and reagents, energy, medicines, etc.), and strengthen the implementation of animal experimental safety education and training, protective measures, operating procedures, harmless disposal of animal carcasses and wastes after experiments and emergency response plans.

(2) Supervision process

The administrative department of science and technology performs the main responsibility of supervision, and constructs a closed-loop supervision chain of the whole process of finding, reporting, rectifying and evaluating the biosafety problems of experimental animals.

one. discovery link. In accordance with the responsibilities of the administrative department of science and technology, take various ways to find out the biosafety problems and hidden dangers of experimental animals in time;

2Report link. Report the biosafety problems and hidden dangers of experimental animals step by step, and report the particularly important and significant problems to the Provincial Health and Health Committee, the lead unit of the coordination mechanism in the field of national safety biology and public health in Hunan Province, according to the provisions of the Emergency Plan for Laboratory Animal Biosafety in Hunan Province;

threeRectification link. In view of the problems and hidden dangers existing in the supervision content, take effective measures to rectify them in place;

four. evaluation link. with“Change now and stand for a long time."We should analyze the causes of problems, sum up experiences and lessons, strengthen guidance and coordination, and constantly improve the supervision system and mechanism of laboratory animal biosafety.

Fourth, safeguard measures

(A) to strengthen organizational leadership

The administrative departments of science and technology at all levels and the management departments of relevant industries must fully realize the necessity and importance of biosafety supervision of experimental animals, correctly handle the relationship between fulfilling supervision duties and service innovation, pay attention to the combination of inspection and guidance, punishment and education, supervision and service, and ensure that supervision is not absent, right and offside. The management of the production (management) and use units (including teaching demonstration units) of experimental animals should attach great importance to the biosafety management of experimental animals in their own units and departments, and earnestly assume the main responsibility of biosafety management of experimental animals.

(B) the implementation of work responsibilities

The administrative departments of science and technology at all levels and the administrative departments of relevant industries should earnestly fulfill their supervisory responsibilities according to the requirements of this scheme, supervise and guide the production (management) and use units (including teaching demonstration units) of experimental animals, establish and improve the organization and management system for the biosafety supervision of experimental animals, compact the responsibilities of the main responsible persons, and form a management system with full participation, full-time coverage and full-time operation.

(3) Strengthen publicity and education

combine“four·15"National Safety Education Day, Science and Technology Activity Week and other activities will be held to publicize the biosafety knowledge of experimental animals through various channels and forms, actively guide relevant responsible subjects to enhance their biosafety awareness, enhance the public’s awareness of biosafety knowledge of experimental animals, strengthen the public opinion monitoring and guidance of experimental animals on safety issues, and create a good atmosphere for the society to attach importance to, support and participate in biosafety supervision of experimental animals.

(D) Increase investment.

The administrative departments of science and technology at all levels should establish and improve the financial guarantee system, and provide stable financial support for the daily supervision, emergency response and personnel training of experimental animals. The production (management) and use units of experimental animals (including teaching demonstration units) should further increase the investment in the biosafety of experimental animals, reserve necessary emergency materials such as therapeutic drugs, articles for harmless disposal of experimental animals, safety protection articles, disinfection drugs and appliances, and continuously improve the level and ability of biosafety risk prevention of experimental animals.

This implementation plan shall come into force as of the date of promulgation and shall be valid for a period of time.fiveYears.

 

        (Annex omitted)