ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 2, 2022 No. KR DSM-125

About approval of rules of ensuring biological protection

According to the subitem 9) article 9 of the Law of the Republic of Kazakhstan "About biological safety of the Republic of Kazakhstan" PRIKAZYVAYU:

1. Approve the enclosed Rules of ensuring biological protection according to appendix to this order.

2. To provide to committee of sanitary and epidemiologic control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

3. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

4. This order becomes effective since November 24, 2022 and is subject to official publication.

No. KR DSM-125 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of November 2, 2022

Rules of ensuring biological protection

Chapter 1. General provisions

1. These rules of ensuring biological protection (further – Rules), are developed according to the subitem 9) of article 9 of the Law of the Republic of Kazakhstan "About biological safety of the Republic of Kazakhstan" and determine procedure for ensuring biological protection.

2. In these rules the following terms, determinations and reducings are used:

1) emergency in the field of biological safety – the situation which arose on potentially dangerous biological object (further – POBO) during the work with pathogenic biological agents (further – PBA), PBA creating real or potential possibility of penetration into air of production zone, the environment or infection with it of the person, animals and plants;

2) microbiological laboratory – potentially dangerous biological object with specially equipped rooms intended for the address with PBA including selection and research of substances and materials which contain PBA and (or) their fragments;

3) boxing of biological safety (further – BBB) – the equipment used for creation of the unidirectional air flow in the controlled working area, cleanings and disinfectings of the circulating air from the weighed dust-like and aerosol particles and also providing safe working conditions with PBA;

4) the boxed room – the isolated room equipped as appropriate for safety during the work with PBA;

5) preboxing (lock) – the room used for department of the boxed room from adjacent rooms;

6) vivarium – division of POBO where different types of laboratory animals with their subsequent transfer for carrying out research (experimental, test) and diagnostic works, and also for production needs contain and breed;

7) "infectious" zone – group of premises of microbiological laboratory where the address with PBA is performed;

8) rearing cage – division of POBO for content, removal or cultivation of insects with their subsequent transfer for carrying out research (experimental, test) works, and also for production needs;

9) check-point (further – the check point) – specially equipped place intended for ensuring control, the omission, examination of people and vehicles;

10) access control – set of the rules, actions and procedures determining procedure for the admission of persons and vehicles, their movements of POBO, and also the regulating procedure for movement of material values and property (bringing, carrying out, import, export) from object on the object providing the protecting building constructions (barriers) and the check points providing physical protection of POBO;

11) "net" zone – group of premises of microbiological laboratory where substances and materials which contain PBA and (or) their fragments do not arrive.

3. These rules extend to works with pathogenic biological agents for the purpose of their research on potentially dangerous biological objects irrespective of their departmental accessory and patterns of ownership (further - microbiological laboratory).

4. The procedure for ensuring biological protection provides procedure for the choice of the parcel of land under asset construction, designings, operation, reconstruction, repair of microbiological laboratories, procedure for water supply, water disposal, heat supply, lighting, ventilation, conditioning, work and disinfection in microbiological laboratories, procedure for ensuring biological protection in case of accidents, procedure for storage and transportation of substances and materials.

Chapter 2. Procedure for ensuring biological protection

5. In case of the choice of the parcel of land under construction of facilities the following parcels of land are not used:

1) used in the past under cattle mortuaries and places of burial of toxic waste;

2) stationary unsuccessful on settlement anthrax.

6. The area in case of the choice of the parcel of land under construction of facilities, is determined according to requirements of the state standard rates in the field of architecture, town planning and construction according to subitem 23-16) of article 20 of the Law of the Republic of Kazakhstan "About architectural, town-planning and construction activities in the Republic of Kazakhstan" (further – the state standard rates in the field of architecture, town planning and construction).

7. Buildings of microbiological laboratory are located on the independent parcels of land or on the parcel of land of the organization which part they are.

8. Microbiological laboratories are placed in the independent building, is built-in - the attached production premises of the profile organizations with separate entrance for acceptance of substances and material on research, on certain floors of factory profile buildings of the organization in the presence of separate entrance for acceptance of substances and material on research.

9. When designing objects floor area is determined by design assignment according to the state standard rates in the field of architecture, town planning and construction. Premises of microbiological laboratories are located according to appendix 1 to these rules.

10. The microbiological laboratories which are carrying out microbiological researches have at least two entrances: with sanitary propusknik for employees and for acceptance of substances and material on research.

Receipt of substances and material for research through transfer window is in addition allowed.

For the microbiological laboratories which are carrying out different types of laboratory researches availability of one room for acceptance, registration of material and its preprocessing is allowed.

11. In external barrier the locked doors, gate, gates, and also breaches, damages are applied.

12. On perimeter of barrier of the territory lighting is established.

13. Window openings, show-windows of the first floor of microbiological laboratories have durability equivalent to one of the following parameters:

1) windows with the regular glazing which is in addition protected by rolling shutters from steel sheet at least 1 millimeters thick;

2) the windows with regular glazing which are in addition protected by metal lattices (sliding or oar with the lock) or blinds of the corresponding durability;

3) windows of special design with the protective glazing steady against single blow bearing 3 blows of the steel sphere weighing 4 kilograms dumped from height of 9,5 of meters and above.

14. Premises of microbiological laboratories have constructive architectural and planning execution and equipment by the technical security systems in total providing protection against penetration.

15. Microbiological laboratories of work with toxic agents are carried out in certain rooms (rooms) or in separate fume cupboard.

16. Windows, doors of the boxed rooms and rooms are closed tightly. Window leaves are protected by grid from insects. Doors in the boxed rooms and preboxes (locks) have the surveyed windows.

17. The layout of premises of microbiological laboratories excludes recross of pure and infectious currents. On entrance door the name of microbiological laboratory and the sign "Biological Danger" is designated. On doors of rooms plates with indication of their appointment are hung out.

18. In the presence in microbiological laboratory of Item for intake of material separate toilets for personnel and the examined persons are provided.

19. The surface of floor, walls, ceiling in laboratory rooms smooth, without cracks, easily processed, steady against action washing and disinfectants, are not applied slippery floors.

20. Edges of floor coverings of "infectious" rooms for work with PBA are lifted. In the presence of ladders floor has biases.

21. In rooms in which works with flammable are carried out – and explosive substances, two exits are provided.

22. In case of reconstruction and repair of microbiological laboratories the above-stated paragraphs of these rules are complied.

23. On the objects occupied with carrying out experimental, diagnostic and production works on the address with PBA I-II of groups of pathogenicity including their storage, access control is set.

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