Guidance for University Departments and Functions

Guidance for University
Departments and Functions

April 2011

Safety Services Office

Hazardous Biological Agents

- contents -

Section Page Number

1.  Introduction 1

2.  Hazard Identification and risk assessment 1

3.  Authorising work with hazardous biological agents 2

4.  Maintenance of records 3

5.  Training 3

6.  Personal Protective Equipment (PPE) 4

7.  Health monitoring and immunization 5

8.  Storage of biological agents 5

9.  Transport of biological agents 6

10.  Disposal of biological agents 6

11.  Disinfection 7

12.  Ancillary staff 8

13.  Emergency procedures 9

Appendix 1: Hazard Groups for cell lines and other materials 10

Appendix 2: Levels of containment 12

Appendix 3: Safe handling of human blood, blood products

and unfixed human tissue 16

Appendix 4: Microbiological safety cabinets 20

Appendix 5: Chemical disinfection of surfaces and equipment 22

Appendix 6: Sharps 24

References 26

This document does not deal with the following activities:

· Genetic modification

· Agents that are pathogenic to plants

· Work with animals

· Experiments involving Group 4 pathogens.

For further advice, contact:
Dr Sarah Nelson
Biological & Chemical Safety Officer
Safety Services Office
ex 2020 / or:
Dr David Widdowson
Director of Safety Services
Safety Services Office
ex 2425

1.  INTRODUCTION

15

“Biological agent” means any micro-organism, cell culture, or human endoparasite, including any which have been genetically modified, which may cause any infection, allergy, toxicity or otherwise create a hazard to human health.

Biological agents are classified into four hazard groups by the Health and Safety Executive (HSE), according to their ability to cause infection, the severity of the disease that may result, the risk that infection may spread into the community, and the availability of vaccines and effective treatment. For the purposes of these definitions, “disease” refers to disease caused by infection.

Any biological agent, which appears in a classification list approved by the HSE (referred to as an “approved classification”; http://www.hse.gov.uk/pubns/misc208.pdf) falls into the hazard group specified there. The correct group for an unlisted agent must be determined by consideration of the infection criteria listed below, and taking into account the relevant factors used in making the risk assessment required by COSHH.

Hazard Group 1: A biological agent unlikely to cause human disease.

Hazard Group 2: A biological agent that can cause human disease and may be a hazard to employees; it is unlikely to spread to the community and there is usually effective prophylaxis or effective treatment available.

Hazard Group 3: A biological agent that can cause severe human disease and presents a serious hazard to employees; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available.

Hazard Group 4: A biological agent that causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available.

2. HAZARD IDENTIFICATION AND RISK ASSESSMENT

Heads of Departments must establish procedures for assessing the hazards and risks associated with biological agents handled in the Department or during incidental contact (e.g. when working with drains). Assessments must conform to the requirements of the relevant sections of the Control of Substances Hazardous to Health (COSHH) Regulations 2002 (as amended) and the associated Approved Code of Practice (see reference 1). These Regulations require that:

(a)  Employers shall ensure that exposure is either prevented or, where this is not reasonably practicable, adequately controlled.

(b)  If it is not reasonably practicable to prevent exposure to biological agents, the biological agent involved in the activity should be the least harmful that the nature of the activity will permit. Often there will be no choice, but some selection may be possible, for example in teaching and some types of research.

The level of containment applied must be determined by carrying out a risk assessment as required by COSHH (the General Approved Code of Practice gives guidance on risk assessment). This assessment should include consideration of:

·  the biological agents that may be present;

·  what hazard groups they belong to;

·  what form they are in (including the possibility that they may form spores or cysts that are resistant to disinfection, or go through a developmental cycle in which there are non-infectious forms or dependence on an intermediate host);

·  the disease(s) they may cause;

·  how and where they are present and how they are transmitted;

·  the likelihood of exposure and consequent disease (including the identification of workers who may be particularly susceptible, for example because they are immuno-compromised), drawing on evidence of the prevalence of infection or other ill effect as experienced within a particular type of work or workplace;

·  whether the nature of the activity will permit substitution by a less hazardous agent;

·  the control measures to be applied, and minimisation of the number of people exposed;

·  the need for monitoring procedures;

·  the need for health surveillance procedures.

3. AUTHORISING WORK WITH HAZARDOUS BIOLOGICAL AGENTS

Heads of Departments must institute procedures to ensure that:

·  The University Safety Services Office is informed of plans to work with hazardous biological agents in Hazard Groups 2 and above, or where doubt exists concerning the classification of an agent.

Notification should be made by completing the Application to handle hazardous biological agent form (http://www.le.ac.uk/safety/forms/index.html#h). If handling of Hazard Group 3 agents is proposed, the Biological Safety Officer must be consulted first and a Hazard Group 3 application form must be completed.

Applications will be referred to the Biological Safety Officer. It will be of advantage to Departments if plans are discussed with the Biological Safety Officer at the earliest possible stage. Applications will be assessed, and the appropriate Hazard Group and Level of Containment will be confirmed to the project proposer, together with other relevant advice.

·  Changes in existing procedures that result, or are likely to result, in enhanced risk from hazardous biological agents, are notified forthwith to the Safety Services Office.

·  Work with hazardous biological agents is prohibited until written permission has been received from the University Safety Services Office.

4. MAINTENANCE OF RECORDS

Heads of Departments must establish procedures:

·  by means of which the Safety Services Office is notified concerning receipt*, possession and storage of Groups 2 and 3 hazards, and,

·  which allow the Safety Services Office to keep records of:

·  Microorganisms within hazard Groups 2 and 3.

·  Microbial toxins.

·  Animal and human cell lines.

·  Members of a Department working with agents that are designated as significantly hazardous (Group 3 and some Group 2 agents).

·  to ensure that the Safety Services Office is notified of the location of all microbiological safety cabinets.

*The University Statement on Safety in Laboratories describes rules for receiving substances into Departments.

5. TRAINING

Heads of Departments are responsible for establishing and enforcing rules which require that:

·  members of a Department are properly trained in safe working practices;

·  training in safe working practices is an integral part of undergraduate courses where potentially hazardous biological materials are handled. Undergraduates may handle Group 2 agents provided they are adequately trained and supervised, but note section (3) above;

·  Good Microbiological Practice is adopted incorporating aseptic techniques together with a high standard of hygiene;

(i) Manipulations should be carried out in uncluttered areas.

(ii) Suitable disinfectants should be readily available (see Appendix 5).

(iii) Minor cuts and abrasions should be covered by waterproof plasters.

(iv) Hands should be washed frequently and thoroughly, and when individuals leave laboratories.

(v) Sharp implements such as needles, scalpels and scissors should be handled with care (the use of such implements should be minimised as far as possible) (see Appendix 6).

(vi) Cultures should be handled so as to minimise the generation of aerosols.

(vii) A safety cabinet must be used if there is risk of aerosol generation. A summary of the properties of safety cabinets is given in Appendix 4.

·  mouth pipetting is prohibited;

·  smoking, chewing, eating and drinking (by members of Departments and visitors in laboratories where hazardous biological agents are handled) are prohibited.

6. PERSONAL PROTECTIVE EQUIPMENT

Heads of Departments must establish and enforce procedures, which ensure that:

·  Appropriate protective clothing and equipment is worn in laboratories where hazardous biological agents are handled.

Ordinary front fastening laboratory coats are adequate for work with Group 1 and Group 2 hazards, but as these are gradually replaced, it is strongly advised that the replacements are high-necked side or back fastening coats with elastic cuffs.

Gloves that have been used in work with hazardous biological agents must be removed before leaving the laboratory, or before touching any equipment etc. used by others. In particular, such gloves must not be worn when opening doors, operating apparatus controls etc.

·  Wearing laboratory coats is prohibited in areas where food and drink is consumed.

·  Wearing of protective clothing (including gloves) is minimised in general access areas.

·  Laboratory coats are removed before members of Departments visit toilets.

·  Laboratory coats are changed and laundered regularly.

For members of Departments using and studying Group 3 hazards, laboratory coats should be changed daily; for other levels, laboratory coats should be changed at least weekly.

Laboratory coats used by members of Departments using and studying Group 3 and designated Group 2 hazards must be autoclaved before laundering.

·  Separate, well-defined storage areas are provided for street clothes and for protective clothing (including laboratory coats).

·  Gloves appropriate for the work are available in all laboratories (see the University Glove Selection guidance document for further details).

·  Eye and face protection is available in all laboratories.

·  Only high-necked side or back fastening laboratory coats with elastic cuffs are worn in Containment Level 3 areas.

·  All PPE is checked and cleaned at suitable intervals.

·  When discovered to be defective, PPE is repaired or replaced before further use.

·  Any PPE that may be contaminated by biological agents must be decontaminated and cleaned or, if necessary, destroyed.

7. HEALTH MONITORING AND IMMUNIZATION

Heads of Departments must establish procedures by which:

·  Details of persons working with hazardous biological material are notified to the Safety Services Office;

·  Appropriate immunisation is offered to these persons, as required by the COSHH Regulations;

·  Women of child-bearing age can consult with the Safety Services Office if they propose to work with teratogenic agents, e.g. rubella, cytomegalovirus, Toxoplasma gondii.

Members of a Department may be required to:

(a) undergo medical examination;

(b) undergo immunisation procedures (the Approved List (reference 3) gives an indication of where there is an effective vaccine available);

(c) provide serum samples for future reference.

8. STORAGE OF BIOLOGICAL AGENTS

Heads of Departments must establish procedures, which ensure that:

·  Biological agents are stored and transported in robust leak-proof containers with uncontaminated external surfaces.

Refrigerators and freezers containing hazardous biological agents should be locked. During defrosting of a refrigerator, the contents must be stored safely. Discarded material must be thawed before being autoclaved or incinerated.

Liquid nitrogen banks must be kept in areas that can be readily disinfected if an ampoule explodes. Members of Departments must wear visors when banks are opened. Ampoules containing Group 3 and designated Group 2 hazards must be opened in a Class I safety cabinet.

Desiccation and freeze drying - Hazardous biological agents should, if possible, be preserved using methods other than freeze drying in view of the risk of implosion and aerosol formation. Suitable microbiological safety cabinets must be used for opening ampoules containing Group 3 and designated Group 2 biological agents. In this operation, gloves must be worn. Both top and plug should be treated as if contaminated.

·  Hazardous biological agents in store are labelled with the name of the agent, the identity of an appropriate responsible member of the Department, the nature of the substance and date of acquisition.

·  Records of stored materials are kept.

·  Periodic stock checks are carried out.

·  Surplus materials are safely discarded.

·  Research workers destroy, in an approved manner, unwanted materials when their appointment ends or when the relevant research is terminated.

·  Research workers, at the end of their term of employment, signify in writing that all hazardous biological agents used in their research have been destroyed in an approved manner or otherwise properly accounted for.

9. TRANSPORT OF BIOLOGICAL AGENTS

Heads of Departments must establish and enforce procedures, which ensure that:

·  Packages containing biological agents are packaged and transported in accordance with packaging and transport regulations.

If advice is required on the packaging or transport of biological materials/dangerous goods, please email the details of the request to where your request will be forwarded to the Dangerous Goods Advisor appointed to act as the consultant to the University.

10. DISPOSAL OF BIOLOGICAL AGENTS

Heads of Departments must establish and enforce procedures, which ensure that:

·  All material containing biological agents is rendered safe before disposal.

These include:

(a) cultures of uncharacterised organisms isolated from the environment
(b) unfixed tissues, cells, body fluids and other products from human and non-human primates or animals

(c) contaminated media.

Materials, which cannot be either autoclaved or incinerated, must be disinfected by validated means.

·  Waste containers are not overfilled and are strong enough to prevent spillage of contents during normal handling.

·  Storage areas are of adequate size and provide an impervious hard standing with wash down facilities.

·  Storage areas are secure from unauthorised access.

Waste containers should be transported to safe storage areas as soon as possible.

·  Visible hazard warning signs are removed from sterilised waste before being placed in bins for collection.

If it is not possible to remove hazard signs from bags, these bags must be placed inside other bags made from opaque materials.