S.I. No. 146/1994 - Safety, Health and Welfare At Work (Biological Agents) Regulations, 1994.

1. Viable organisms should be handled in a system which physically separates the process from the environment

Yes

Yes

Yes

2. Exhaust gases from the closed system should be treated so as to

Minimise release

Prevent release

Prevent release

3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to

Minimise release

Prevent release

Prevent release

4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been

Inactivated by validated means

Inactivated by validated chemical or physical means

Inactivated by validated chemical or physical means

5. Seals should be designed so as to

Minimise release

Prevent release

Prevent release

6. Closed systems should be located within a controlled area

Optional

Optional

Yes and purpose built

( a ) Biohazard signs should be posted

Optional

Yes

Yes

( b ) Access should be restricted to nominated personnel only

Optional

Yes

Yes, via an airlock

( c ) Personnel should wear protective clothing

Yes, work clothing

Yes

A complete change

( d ) Decontamination and washing facilities should be provided for personnel

Yes

Yes

Yes

( e ) Personnel should shower before leaving the controlled area

No

Optional

Yes

( f ) Effluent from sinks and showers should be collected and inactivated before release

No

Optional

Yes

( g ) The controlled area should be adequately ventilated to minimise air contamination

Optional

Optional

Yes

( h ) The controlled area should be maintained at an air pressure negative to atmosphere

No

Optional

Yes

( i ) Input air and extract air to the controlled area should be HEPA filtered

No

Optional

Yes

( j ) The controlled area should be designed to contain spillage of the entire contents of the closed system

No

Optional

Yes

( k ) The controlled area should be sealable to permit fumigation

No

Optional

Yes

( l ) Effluent treatment before final discharge

Inactivated by validated means

Inactivated by validated chemical or physical means

Inactivated by validated chemical or physical means

GIVEN under my Official Seal, this 17th day of May, 1994.

RUAIRÍ QUINN,

Minister for Enterprise and

Employment.

EXPLANATORY NOTE.

These Regulations implement Council Directives 90/679/EEC of 26 November, 1990, and 93/88/EEC of 12 October, 1993, on the protection of workers from risks related to exposure to a biological agent at work. The Regulations define biological agents. Biological agents thus include bacteria, viruses and fungi. The Regulations draw a distinction between incidental exposure to a biological agent and exposure arising from their deliberate use (Regulation 3 (

f

)). Employers must identify the biological agent to which workers are, or may be, exposed. They must assess the risk, making use of the classification referred to in Regulation 2 and the Fourth Schedule, and proceed in accordance with the remaining Regulations where appropriate. Specific Regulations set out action to be taken in Veterinary and Health Care facilities and in industrial processes.

7. Effective vector control e.g. rodents and insects

Recommended

Yes

Yes

8. Surfaces impervious to water and easy to clean

Yes, for bench

Yes, for bench and floor

Yes, for bench, walls, floor and ceiling

9. Surfaces resistant to acids, alkalis, solvents, disinfectants

Recommended

Yes

Yes

10. Safe storage of a biological agent

Yes

Yes

Yes, secure storage

11. An observation window, or alternative, is to be present, so that occupants can be seen

Recommended

Recommended

Yes

12. A laboratory is to contain own equipment

No

Recommended

Yes

13. Infected material including any animal is to be handled in a safety cabinet or isolator or other suitable containment

Where appropriate

Yes, where infection is by airborne route

Yes

14. Incinerator for disposal of animal carcases

Recommended

Yes (available)

Yes, on site

EIGHTH SCHEDULE

CONTAINMENT MEASURES AND CONTAINMENT LEVELS FOR INDUSTRIAL PROCESSES

Regulations 12 (2) (

a

) and 12 (2) (

d

)

The measures contained in this Schedule shall be applied according to the nature of the activities, the assessment of risk to employees, and the nature of the biological agent concerned.

Containment Measures

Containment Levels

2

3

4

S.I. No. 146 of 1994.

SAFETY, HEALTH AND WELFARE AT WORK (BIOLOGICAL AGENTS) REGULATIONS, 1994.

INDEX OF REGULATIONS

Regulation