The Health, Safety and Security Department
UNIVERSITY POLICY AND
MANAGEMENT PROCEDURE
Biological Agents
Management Procedure - Biological Agents (VS2.3 - May 13)
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Statement
This Management Procedure was approved and authorised by the Health, Safety and Welfare
Committee on 11 November 2008 on behalf of the University of York Council and forms part of
the Health and Safety Policy of the University of York.
This document is a Management Procedure for good health and safety management practice.
This Management Procedure provides Heads of Departments, College Provosts and all
managers, staff and students with the necessary information to incorporate healthy and safe
practices and relevant procedures into their activities.
Divergence from this Management
Procedure may result in Heads of Departments, College Provosts and the University being
exposed to possible legal proceedings.
The use of this Management Procedure and the incorporation of its requirements into working
practices and activities will ensure that the University and its community achieves compliance
with its legal duties with regard to health and safety.
Date of Review
Date of Last Review
Date of Next Review
May 2013
October 2010
June 2015
By
By
Director of Health, Safety and Security
Director of Health, Safety and Security
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Serial
Content
Page
Statement
2
Content
3
Abbreviations
6
UNIVERSITY POLICY
7
1.
OVERALL POLICY AND SCOPE
7
2.
INTRODUCTION
7
3.1
3.2
EMERGENCY PROCEDURES AND NOTIFICATION OF
ACCIDENTS
Emergency Procedures
Notification of Accidents
4.
WHAT ARE BIOLOGICAL AGENTS?
5.
5.1
ROLES AND RESPONSIBILITIES
Biological Agents Safety Committee (BASC)
5.1.1
Committee Membership
5.1.2
Terms of Reference
University Roles
5.2.1
Biological Safety Advisor
Departmental Roles
5.3.1
Project Supervisors
Individual Workers (Includes all University Staff, Students and
5.3.2
Visitors)
Equipment
5.4.1
Microbial Safety Cabinets
5.4.2
Autoclaves
5.4.3
Sealability Testing
Estates Services
3.
5.2
5.3
5.4
5.5
7
7
8
8
9
9
9
9
10
10
10
10
11
11
11
12
12
12
ARRANGEMENTS
12
6.
6.1
6.2
6.3
12
12
13
13
13
13
14
6.4
RISK ASSESSMENT OF WORK ACITIVIES
Activities Requiring Formal Assessment
Risk Assessment Forms and Further Information
Approval of Risk Assessments
6.3.1
GM Activities
6.3.2
Other Activities with Biological Agents
Review of Risk Assessments
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Serial
Content
Page
7.
GENETIC MODIFICATION ACTIVITIES
16
8.
REGISTER OF PATHOGENS
16
9.
9.1
9.2
LOCAL RULES
What are ‘Local Rules’?
Content of ‘Local Rules’
16
16
17
10.
10.1
10.2
10.3
10.4
10.5
10.6
TRAINING AND SUPERVISION
When is Training Required?
Role of Supervisor/Group Leader
Basic Local Training Requirements for all Workers
Training Provided to non-Laboratory Staff
Local Containment Level 3 Training Requirements
Formal Training
10.6.1
Bio Safety (Including GM) Awareness of Workers
17
17
18
18
18
18
19
19
11.
11.1
OCCUPATIONAL HEALTH
Immunisation
11.1..1 Tetanus
11.1.2
Hepatitis B
Health Surveillance
11.2.1
What is it and when is it applied?
11.2.2
Animal Workers
19
19
19
19
20
20
20
12.
12.1
12.2
BIOLOGICAL SAFETY SIGNES
Provision of Biohazard Warning Signs
Where to use Biohazard Signs
20
20
21
13.
13.1
13.2
FACILITIES AND LABORATORY CONTAINMENT LEVELS
Containment Levels
Facilities
21
21
22
14.
14.1
14.2
14.3
14.4
14.5
FUMIGATION
Introduction
Risk Assessment and Procedure
Monitoring Formaldehyde Levels
Fumigating Microbial Safety Cabinets
Fumigation of Laboratories
22
22
23
23
23
24
15.
15.1
15.2
DISINFECTION AND WASTE DISPOSAL
Introduction
Disinfection
Autoclaving and Disposal of Waste from Containment Level 1 and 2
Facilities
25
25
25
11.2
15.3
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Serial
Content
Page
15.4
15.5
Autoclaving Waste from Containment Level 3 Facilities
Autoclave Bag Holders
26
26
16.
INSPECTION OF FACILITIES
26
17.
17.1
17.2
17.3
17.4
TRANSPORT OF BIOLOGICAL AGENTS
General
Transport in the United Kingdom
Transport Abroad
Importation of Biological Agents
17.4.1
Human Pathogens
17.4.2
Plant and Animal Pathogens or Materials that May Contain Them
27
27
28
28
28
28
29
18.
18.1
SECURITY
Anti-terrorism Controls on Pathogens and Toxins
28
28
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Abbreviations
ACDP
Advisory Committee on Dangerous Pathogens
ACGM
Advisory Committee on Genetic Modification
ACoP
Approved Codes of Practice
BASC
Biological Agents Safety Committee
BSA
Biological Safety Advisor
CoSHH
Control of Substances Hazardous to Health
DEFRA
Department of Environment, Food and Rural Affairs
DHSS
Director of Health, Safety and Security
EPA
Environmental Protection Act
GM
Genetically Modified
GMM
Genetically Modified Microorganisms
GMO’s
Genetically Modified Organisms
GMP
Good Microbiological Practice
HoD
Head of Department
HSE
Health and Safety Executive
HSSD
Health, Safety and Security Department
HMSWA
Management of Health and Safety at Work Act
PS
Project Supervisors
SACGMCoG
The Scientific Advisory Committee on Genetic Modification
Compendium of Guidance
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UNIVERSITY POLICY
1.
OVERALL POLICY AND SCOPE
The University is committed to preventing or adequately controlling exposure to
hazardous biological agents. This management procedure applies to all work activities
involving the handling, use, transport and storage of biological agents, including
genetically modified organisms (GMOs).
2.
INTRODUCTION
The purpose of managing activities involving biological agents (or materials that may
contain them) is to prevent or minimise risks to human health and the environment and
to set appropriate standards for control of those risks.
The management procedure is based on the requirements of national legislation and
extensive guidance produced by various expert technical advisory committees issued in
support of the Regulations.
3.
EMERGENCY PROCEDURES AND NOTIFICATION OF ACCIDENTS
3.1
Emergency Procedures
The GMO Regulations only require emergency plans to be prepared if the risk
assessment indicates that the health and safety of people outside premises, or
the wider environment, may be affected.
In practice, an emergency plan is
unlikely to be necessary for most small scale activities or those involving low
risk organisms.
If an emergency plan is required, it should:

Include measures to be taken in the event of an accident to which the plan
relates

Be reviewed and, where necessary, revised at suitably regular intervals.
The person undertaking the activity should:

Inform the emergency services and any body or authority liable to be
affected by the accident

Make the plan and any revisions of the plan publicly available.
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3.2
Notification of Accidents
The Contained Use Regulations refers to an accident as a significant and
unintended release, either within the containment facility or to the
environment, of GMOs which could cause harm to humans or the environment.
Such accidents should be immediately reported to the BSA who will inform the
DHSS, who will in turn inform the competent authority (HSE).
This
requirement is in addition to the requirement under the Reporting of Injuries,
Diseases and Dangerous Occurrences Regulations (RIDDOR) to report
accidents.
Minor spillages within the containment facility of micro-organisms used in
class 1 activities will not normally constitute significant releases of GMOs and
will not routinely require notification. This is because they would be highly
unlikely to affect people within the facility and will be easily dealt with so that
they do not reach the environment. However, such spillages must be cleaned
up with a validated disinfection procedure.
4.
WHAT ARE BIOLOGICAL AGENTS?
Biological agents include any microorganism, cell culture, or human endoparasite that
may cause infection, allergy, toxicity or otherwise cause a hazard to human health or
the environment.
Biological agents (including GMOs) may be encountered in laboratories where:

Microorganisms (bacteria, viruses, protozoa and some helminths) are
intentionally cultured or used for teaching, research or for diagnostic
purposes

Cell cultures and samples of body tissues or fluids (human or animal
origin) are handled

Laboratory animals are kept

Hazardous plants or plant materials are grown or used.
Non-laboratory workers, such as Estates Services staff, may also be involved in
activities that could lead to accidental exposure to biological agents.
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5.
ROLES AND RESPONSIBILITIES
5.1
Biological Agents Safety Committee (BASC)
5.1.1 Committee Membership
The Biological Agents Safety Committee will consist of the following members:

The Chair; appointed by Heads of Departments conducting GM/ pathogen
work and ratified by the Health Safety and Welfare Committee

Secretary

Health and Safety Advisor (Biological Sciences)

University Director of Health, Safety and Security

Representatives of supervisors of work activities involving the use of
GMOs and pathogens

Representatives of all persons having access to facilities used for genetic
modification and pathogen work, for example, technical staff, facility
managers, Union representatives

Co-opted members (internal or external to the University) to supplement
existing expertise as and when necessary.
The HSE will be notified of any significant changes to the membership.
5.1.2 Terms of Reference
The Terms of Reference for the Biological Agents Safety Committee are to:

Monitor the implementation of University policy and procedures relating
to biological agents (including GMOs and other hazardous biological
agents) to ensure compliance with legislative requirements

Keep under review the health and safety measures in all departments
relating to work involving biological agents and the contained use of
GMOs

Promote good practice by all those engaged in activities using biological
agents

Report to the Council through the Health, Safety and Welfare Committee

Review, advise on, and approve all GMO risk assessments

Review, advise on, and approve all risk assessments for biological agents
requiring statutory notification to the competent authority (HSE)

Keep under review any changes in relevant legislation and related
approved codes of practice and guidance, and inform all departments
concerned

Receive and consider reports on facility inspections

To meet at least once every term, and additionally as necessary

To make all information relating to the committee’s activities freely
available on request (subject to compliance with the Data Protection Act
and any specific sensitivities relating to the work activities)
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


5.2
To advise Heads of Department on all matters relating to GMOs and
dangerous pathogens
The Biological Safety Advisor shall advise the Committee on all matters
related to biological safety and, where necessary, report on the
implementation of policy for the Committee’s consideration
The committee will apply equality of opportunity for all individuals in its
work.
University Roles
5.2.1 The Biological Safety Advisor
The Biological Safety Advisor shall be responsible for:

Offer practical advice to individuals involved in activities using biological
agents

Advise the University, all departments and project supervisors of any
changes to legislation and relevant codes of practice and guidance

Ensure all statutory notifications are in place (includes premises and
activity notifications)

Check that facilities are appropriate

Assist in the provision of suitable and sufficient training for those
involved in activities using hazardous biological agents (see Section 10)

Advise on the formulation of local rules (see Section 9)

Ensure emergency plans are in place where required

Assist in the auditing and inspection of GM facilities

Authority to stop GM activities where the containment measures are
considered insufficient to control the risks

Maintain a record of risk assessments for all GM activities and other
activities using hazardous biological agents

Maintain a register of current GM activities and workers

Maintain a register of all hazardous biological agents (typically Hazard
Groups 2 and above)

Liaise with external agencies on behalf of the University.
5.3
Departmental Roles
5.3.1 Project Supervisors
Project Supervisors are defined as permanent members of staff who have been
awarded a grant to conduct work with biological agents (including GMOs).
They shall accept full responsibility for all aspects of safety for those working
with them, including activities involving GMOs.
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The Project Supervisor shall be responsible for:

Ensuring that a suitable and sufficient assessment of risks is performed for
all GM work activities and all other activities involving hazardous
biological agents (typically those organisms in hazard group 2 and above)
before the work starts

Ensuring that risk assessments are reviewed whenever there are
significant changes to the work and at least every 1 to 2 years to ensure
that they remain relevant and up-to-date

Ensuring that laboratory facilities meet the required standards and the
BSA has inspected and approved the facilities before work starts

Ensuring that all persons working under their supervision have received
appropriate training (see Section 9) including awareness of risks and
appropriate control measures to apply

Ensuring that they provide or organise appropriate supervision to assess
competence of persons under their control to work safely.
5.3.2 Individual Workers (Includes all University Staff/Students/Visitors)

Ensuring that they comply with this Management Procedure

Report any incidents, accidents or defects in equipment relating to the
handling of biological materials to their Supervisor and the DSO/BSA

Adopt safe practices in activities involving biological material, in
particular to carry out the work only in designated areas, to wear
appropriate protective equipment and clothing, and to dispose of waste in
the specified manner

Adopt good personal hygiene standards (including washing hands, no
eating or drinking, no application of cosmetics or manipulation of contact
lenses in designated areas)

Co-operate with their supervisors and any other person appointed to
advise or monitor health and safety in the local arrangements for
biological safety.
5.4
Equipment
Departments are responsible for the maintenance and testing of equipment
used in biological containment facilities.
This includes arranging the
examination and testing of microbial safety cabinets and autoclaves used to
inactivate biological waste material.
5.4.1
Microbial Safety Cabinets
Microbial safety cabinets (a form of local exhaust ventilation) must be examined
and tested at intervals not exceeding 14 months as required by the ‘Control of
Substances Hazardous to Health’ (COSHH) Regulations. Cabinets should be
tested more frequently (typically at six-monthly intervals) for Hazard Group 3
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organisms, especially for those organisms spread by airborne or droplet routes
of infection.
5.4.2
Autoclaves
Autoclaves must be serviced regularly as recommended by the manufacturers
by a competent person according to a ‘written scheme of examination’. In
addition, the pressure system must be inspected regularly (at least every 14
months) to establish it is fit for continued use. It is also essential that all
autoclaves used to treat biological waste are calibrated annually. This will
typically involve the use of calibrated thermocouples placed strategically within
the chamber of each type of load normally treated.
5.4.3 Sealability Testing
University Containment Level 3 facilities and some animal holding rooms are
sealed to permit disinfection by fumigation, preventing escape of fumigant
during the process. It is the responsibility of departments to arrange annual
testing of these facilities to ensure their sealable status.
5.5
Estates Services
Estates Services are responsible for the general maintenance of all laboratory
and horticultural facilities.
In addition, they are also responsible for the
maintenance and periodic examination and testing of ventilation systems
associated with laboratory rooms and connected to microbial safety cabinets.
Records of maintenance/examination must be kept and made available for
internal and external inspections.
ARRANGEMENTS
6.
RISK ASSESSMENT OF WORK ACTIVITIES
6.1
Activities Requiring Formal Assessment
A suitable and sufficient risk assessment must be prepared in advance of the
following work activities:

All work involving the use of GMOs (includes work with GM
microorganisms, plants and animals)

All work involving human pathogens (Hazard Group 2 organisms and
above) or materials that may contain them

All work involving ACDP Hazard Group 1 organisms where a significant
risk is identified
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
6.2
Work involving the use of Department for Environment Food and Rural
Affairs (DEFRA) licensed plant and animal pathogens.
Risk Assessment Forms and Further Information
Copies of all risk assessment templates, along with further detailed information
and guidance on their completion, are available on the web sites of the
Department of Biology and the HSSD.
6.3
Approval of Risk Assessments
All risk assessments for activities described above require approval before work
commences.
6.3.1 GM Activities
A summary of the risk assessment process for GM activities is outlined below in
the Genetic Modification Risk Assessment Process Map.
All Class 1 GM microbial activities or those involving transgenic plants and
animals requiring standard containment measures must have provisional
approval by the Biological Safety Advisor before work can start. The activity
will also require review and final approval by the Biological Agents Safety
Committee.
All GM microbial activities assigned Class 2 or above, or transgenic plant and
animal activities requiring a high level of containment (not provided by the
standard measures), must have approval by the Biological Agents Safety
Committee before work can commence.
Some of these activities may also
require notification to the Health and Safety Executive (HSE) and / or licence
from DEFRA before work starts.
6.3.2 Other Activities with Biological Agents
All activities involving the deliberate use of Hazard Group 2 organisms, or
materials that may contain Hazard Group 2 organisms, or above must have the
approval of the Biological Safety Advisor before the work commences.
All activities involving Hazard Group 3 organisms or other biological agents
requiring notification to the HSE must have the approval of the Biological
Agents Safety Committee before work starts.
All relevant licences from DEFRA must also be in place before work can start.
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6.4
Review of Risk Assessments
Risk assessments must be reviewed whenever there are significant changes to
the work which alters the nature of the risks, and at least every 1-2 years to
ensure that they remain relevant and reflect the risks of the current activity. A
copy of the revised assessment, for an activity involving significant changes,
must be sent to the Biological Safety Advisor for approval before work re-starts.
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Genetic Modification Risk Assessment Process Map
Health, Safety and Security Department
Internal Process – Genetic Modification Risk Assessment
Project Supervisor (PS)
Prepares Risk Assessment for
Genetic Modification (GM) activity
Copy of GM Risk Assessment is sent to the
Biological Safety Advisor (BSA)
For approval
All other GM Activities including:
1. GMM – Provisional Class 1
1. GMM Class 2 activities or above
2. Plants and Animals – Provisional low/
negligible risk requiring basis
containment measures
2. High risk GM Plant and Animal work
Work can ONLY commence after:
Provisional approval given by the BSA
(within 2 weeks)
Make any necessary changes and wait for
approval
1. Approval by full Biological Agents
Safety Committee (BASC)
2. Any statutory notification period has
lapsed
3. HSE Consent received (if required)
YES
NO
GM Work Activity undertaken
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7.
GENETIC MODIFICATION ACTIVITIES
Detailed information and guidance for work activities involving the use of GMOs is
available on the Biology and HSSD web sites.
8.
REGISTER OF PATHOGENS
A register of all human (Hazard Group 2 or above), animal and plant pathogens is
maintained by the BSA.
Prior approval must be given by the BSA before new
pathogenic organisms are brought to the University to ensure:



Facilities are appropriate
An approved risk assessment and ‘local rules’ are in place
Any statutory notifications or licences (e.g. for plant and animal pathogens) are
in place.
9.
LOCAL RULES
9.1
What are ‘Local Rules’?
Local rules or local codes of practice provide specific information on the
arrangements or working practices for working safely day-to-day with
biological agents (including GM Organisms) in the laboratory. They form part
of the process of giving information on safe working, e.g. by serving as a
checklist for identifying areas which staff should understand before being
judged as competent. However, thorough training and instruction on their
day-to-day application is needed for them to work effectively.
Each laboratory must have clear documented local rules indicating the working
practices that must be followed for activities in that laboratory. These should be
freely accessible either by being put on display or through individual issues.
The Research Group Leader/Principal Investigator of a given research group, or
the supervisor/manager of a unit or work area, is responsible for ensuring local
rules are in place and are complied with.
A basic code of practice/local rules to cover work with hazard group 1 organisms
requiring Containment Level 1 facilities can be based upon accepted good
microbiological practice (GMP), as included in the description of CL1
requirements.
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Model local rules should be tailored for local conditions and activities. The safe
working practices adopted must reflect the assessment of risks involved,
influenced by factors such as the biological agents involved and the type of work
being carried out. Risk assessments should include cross-reference to the local
rules. This pre-empts any need to write out or duplicate the information within
the risk assessment and ensures consistency in standards.
9.2
Content of ‘Local Rules’
The Content and form of local rules/local code of practice should include:

An introduction which explains the purpose of the local code of practice and
the scope of activities covered, references other health and safety documents.

Summarises the significant findings of relevant risk assessments

Identification and description of the area to be covered and the containment
level required to control the agents being used

A description of the nature and range of agents which workers might be
exposed to

An outline of how workers are most likely to be exposed to infectious agents
(i.e. the risks) and the safe working practices required to ensure work is
done safely

Local rules of conduct for workers and appropriate guidance for ancillary
and maintenance staff, contractors and visitors

Procedures for waste disposal and disinfection (routine and in the event of
an emergency)

Procedures for the maintenance, examination and testing of equipment such
as microbial safety cabinets

Emergency procedures, including the procedures for dealing with accidents
and incidents involving biological agents, and who should be contacted in
the event of an accident involving an injury or infection

Health Surveillance arrangements and immunisation policy if required,

A list of general procedures specifying which workers are authorised to
carry out particular procedures

Key training requirements for workers and training records
demonstrating that training has been provided.
10.
TRAINING AND SUPERVISION
10.1
When is Training Required?
Training will be required for all persons:

On recruitment
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

10.2
When a significant change to work, equipment, work activity or
responsibilities takes place, especially where increased risks may be
involved
For refresher training (where appropriate) to maintain standards.
Role of Supervisor/Group Leader
The project supervisor is responsible for ensuring that all their workers receive
adequate training. In addition, the supervisor must monitor the work to ensure
that working practices are being adhered to. The level of training provided
should be appropriate to the level of risk and complexity of the work being
undertaken to ensure competence of workers.
10.3
Basic Local Training Requirements for all Workers
Basic local training requirements for workers must include information on:

The nature of the hazards being used

The risks (to human health and the environment) likely to be encountered
in their work

Preventive and protective measures used to control risks

The requirements of the local rules/local code of practice, including the
safe working practices and procedures to be followed e.g. disinfection,
waste disposal, transport, storage and emergency spillage

Safe use of equipment such as the microbial safety cabinet

Procedure for reporting accidents.
All persons should also receive appropriate supervision as provided by, or
organised by, the project supervisor. This should be related to the level of work
to ensure that standards are maintained. Once satisfied with the competence of
the worker, the supervisor can allow them to continue without constant
supervision.
10.4
Training Provided to Non-Laboratory Staff
Training should not be limited to those working at the bench. Other staff such
as cleaners, porters, maintenance staff, external contractors must also receive
appropriate information, instruction and training about the hazards that they
may encounter when working in the laboratory.
10.5
Local Containment Level 3 Training Requirements
Training requirements at containment level 3 are more detailed and formal. In
addition to those requirements outlined above for all workers, key
competencies for those working at CL3 include:
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

Full understanding of emergency procedures e.g. emergency room or
cabinet fumigation
Full training where applicable on fumigation procedures.
Written records of training are an essential requirement for all individuals
working at Containment Level 3. These should include details of what training
has been provided and signed off by both the trainer and trainee.
10.6
Formal Training
10.6.1 Biological (Including GM) Safety Awareness Training for Workers
All individuals working with GMOs or pathogens are expected to attend the
formal ‘Biological (Including GM) Safety Awareness Training for Workers’
training session organised once a term (further information and details). The
main aims of this course are to explain the purpose of the regulations and
typical containment measures used to protect human health and the
environment.
11.
OCCUPATIONAL HEALTH
11.1
Immunisation
Immunisation and regular booster injections should be given, if appropriate, as
a supplementary safety precaution for those who may be exposed to pathogenic
microorganisms.
Immunity levels should be checked before or after
immunisation where this is provided as a control measure against infection.
The University’s Occupational Health Advisor is available to give confidential
advice to individuals that may require immunisation.
11.1.1 Tetanus
All staff and students are strongly advised to check with their General
Practitioner (GP) that they have had a full course of Tetanus.
This is
particularly important for those whose work may bring them into contact with
soil and animals.
11.1.2
Hepatitis B
Laboratory workers processing samples containing human blood and body
fluids are recommended to get immunised against Hepatitis B (if not already),
by contacting the University’s Occupational Health Advisor (OHA).
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11.2
Health Surveillance
11.2.1 What is it and when is it applied?
Health Surveillance is typically applied if working with a hazardous substance
(including biological agents):

That produces an identifiable disease or adverse health effect that can be
related to exposure.

Where there is reasonable likelihood that the disease or effect may occur
under the conditions of work.

For which there are valid techniques for detecting the disease or effect.
The GMO Regulations do not include a specific requirement for health
surveillance for GM work.
The University’s OHA should be contacted for further information or advice on
health surveillance requirements.
11.2.2 Animal Workers
All staff, postgraduate and undergraduate research workers must register for
health surveillance before working with animals. This involves:

Pre-employment screening/pre-access to animal facility screening

Health monitoring (after 6 weeks, 6 months followed by yearly) involving
health questionnaire and lung function test.
12.
BIOLOGICAL SAFETY SIGNS
Signs should be provided where there is a residual risk to persons, even after applying
all the appropriate control measures to reduce risk.
This relates to provision of
biohazard warning signs and signs indicating that access is restricted and, where
appropriate, who is authorised to enter.
12.1
Provision of Biohazard Warning Signs
It should be emphasised that biohazard warning signs should be used
sparingly. They must only be used to warn of a biological hazard. They should
be placed at the entrance to containment facilities, on safety cabinets and on
incubators and storage equipment outside the facilities.
They may also be
placed on large items of equipment inside the facility and biohazard tape may
be used to mark areas of bench where microbiological hazards are handled.
Biohazard signs are primarily intended for areas where there is a risk of
infection and not for other biological risks (e.g. biting or scratches, toxins or
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dangerous animals). Biohazard signs should be maintained in good order and
must be removed when they are no longer relevant.
12.2
Where to use Biohazard Signs
Biohazard signs must be used:

Where ACDP or ACGM Group 3 hazards are handled in laboratories or
other facilities

Where ACDP or ACGM Group 2 hazards are handled in the laboratory
provided there is a significant risk that accidental exposure would lead to
infection

Where animals are infected (deliberately or otherwise) with organisms
pathogenic to humans and where there is a significant risk that accidental
exposure would lead to infection.
Biohazard signs may be used:

Where ACDP or ACGM Group 2 hazards are handled but the risk is
minimal

Where human tissue is stored or used.
Other signs, e.g. where access is restricted or by authorised persons only,
should be provided to indicate the restrictions and, where appropriate, the
persons authorised to enter or use equipment. The containment level of the
facility should also be indicated on the biohazard warning sign to indicate
whether the facility is level 2 or 3.
13.
FACILITIES AND LABORATORY CONTAINMENT LEVELS
13.1
Containment Levels
Deliberate work with biological materials, including wild-type microorganisms
and GMOs, is normally undertaken in containment laboratories.
There are four different levels of containment (levels 1 – 4) for laboratory work,
each containment level being directly related to each equivalent Hazard Group.
Thus organisms categorised as Hazard Group 1 (lowest hazard rating) should
normally be handled in Laboratory Containment Level 1 facilities, and likewise
up to Hazard Group 4 (highest hazard rating) in Containment Level Four
facilities (none located within the University).
The requirements of each laboratory containment level are made up of a
combination of physical parameters and work practices.
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Details of the
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containment measures are defined by three similar, but separate systems of
containment from:



Advisory Committee on Dangerous Pathogens (ACDP)
Advisory Committee on Genetic Modification (ACGM)
Department of Food and Rural Affairs (DEFRA).
The level of containment under which particular work should be undertaken is
determined as part of the risk assessment.
The standards required are
described in legislation and supporting guidance. Where the work involves the
use of, for example, a human and animal pathogen, a combination of the
standards for all relevant containment levels will be required.
13.2
Facilities
Work with biological materials must only be undertaken in facilities that are
suitable for the purpose and approved by the Biological Safety Advisor. The
standards required are described in the legislation and supporting guidance.
Such facilities are described as containment laboratories or rooms. There are
different levels of containment and the one required for a particular work
activity is determined as part of the risk assessment process.
The Group Leader has a responsibility to ensure that the level of containment
required for a particular facility is correctly identified to those involved in the
design and/or refurbishment of containment facilities, including the relevant
Estates Services and Buildings Project Manager and the BSA.
The Group
Leader should also ensure the requirements of the department and workers
who will use the facility are made clear and taken into account in the design
process. The Head of Estates Operations is responsible for ensuring that all
new building and refurbishment work in containment laboratories meets the
required/agreed specification.
14.
FUMIGATION
14.1
Introduction
Microbiological safety cabinets and some facilities, including Containment Level
3 laboratories and some animal rooms, are periodically fumigated to inactivate
any hazardous biological agents that may be present.
Fumigation with formaldehyde vapour is a recognised and commonly used
method for this type of equipment and facility.
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However, formaldehyde
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vapour has irritant and toxic properties and carries a risk of respiratory and / or
skin sensitisation reactions.
At the higher concentrations used for room
fumigations it is extremely hazardous and exposure to such levels, even for a
short time, could result in very serious harm.
Fumigation systems using
hydrogen peroxide are available and increasingly being used as an alternative
to formaldehyde vapour. Although such chemicals are less hazardous than
formaldehyde, there are still risks associated with the procedures and
appropriate control measures are required in order to carry out the work safely.
14.2
Risk Assessment and Procedure
A detailed risk assessment and procedure must be documented and approved
by the Biological Safety Advisor in advance of all fumigation activities.
All laboratory groups are responsible for ensuring appropriate systems are in
place to provide safe and suitable procedures for fumigation in biological
laboratories and associated facilities. In conjunction they must ensure adequate
and appropriate instruction, training and supervision is provided for workers
undertaking fumigation procedures. They should also ensure that suitable
arrangements are in place to monitor and review working practices.
14.3
Monitoring Formaldehyde Levels
If formaldehyde vapour is used as a fumigant, it is important that the long term
(8 hour time weighted average reference period) and short term (15 minute
reference period) ‘workplace exposure limit’ of 2 ppm is not exceeded at any
stage of the process. A formaldehyde meter is available from the Biological
Safety Advisor to monitor levels during the fumigation procedure.
14.4
Fumigating Microbial Safety Cabinets
Microbiological safety cabinets used to handle hazardous microorganisms (i.e.
Hazard Group 2 organisms or above), must be fumigated in the following
circumstances:

After a major spillage or a spillage where inaccessible surfaces have been
contaminated

Before any maintenance work on the cabinet where access to potentially
contaminated parts is necessary (including filter and pre-filter changes)

Before carrying out filter penetration tests

When there are any changes in the nature of the work that result in
significantly different risks.
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Fumigation must be carried out only by a trained responsible person with
adequate knowledge of the procedure and the precautions to be followed.
Where the cabinet has been used for hazardous microorganisms, HEPA filters
should be handled only with appropriate protective clothing (laboratory coat
and heavy duty gloves) even after fumigation. Such filters must either be
autoclaved prior to disposal in the ‘offensive waste’ stream or be securely
wrapped in yellow bags for disposal as clinical waste.
The cabinet must be sealed before fumigation to prevent leakage of
formaldehyde into the laboratory. It should be checked to ensure that the
closure panel/‘night door’ has been properly and securely located and a good
seal has been achieved. Where necessary sealing tape should be used to ensure
there is no leakage. With Class III or hybrid (Class I/Class III) cabinets a
blanking plate should be fitted over the inlet filter.
If the cabinet is a recirculation type, there must be a safe means of venting the
formaldehyde vapour to atmosphere (the outside) such as by the use of a
fumigation adaptor kit (see below). This must be fitted to the cabinet prior to
commencing fumigation.
14.5
Fumigation of Laboratories
Formaldehyde fumigation of laboratories or other rooms must be carried out
only by named trained personnel. Fumigation procedures for Containment
Level 3 facilities must be validated to demonstrate decontamination efficacy.
This involves undertaking test fumigation with spore strips being placed at
strategic locations around the laboratory.
Prior to undertaking fumigation with formaldehyde vapour, it must be
thoroughly checked and confirmed that the room is properly sealed and there
will be no release of gas to other areas. Any significant escape of formaldehyde
would constitute an uncontrolled release of a hazardous chemical and would be
a reportable incident to the Health and Safety Executive.
There must be a means of exhausting the formaldehyde vapour from the
laboratory/room that avoids the need for any person to enter the area where the
formaldehyde has been released. The extract must be a total loss system with no
possibility of formaldehyde being ducted to other areas. This could be by the
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use of a ducted microbiological safety cabinet to exhaust the fumigant to
atmosphere and via room extract ductwork. The recognised method is to have a
switch external to the room to allow extraction of the formaldehyde without
entering the room. The Biological Safety Advisor must be consulted before any
other method is adopted. It should also be possible to operate, without entering
the room, any dampers that may be installed if their opening is necessary to
ventilate the room.
A record must be kept, for at least 5 years, of all fumigations of
rooms/laboratories including date, personnel involved and the results of air
monitoring on completion of the procedure.
15.
DISINFECTION AND WASTE DISPOSAL
15.1
Introduction
All biological material (liquids and contaminated solids) must be inactivated
before release from departmental facilities.
Typical methods used include
disinfection and sterilisation by autoclave treatment.
15.2
Disinfection
The use of chemical disinfectants, normally in the form of proprietary products
specifically for use in laboratories, is a widespread and important control
technique in biological laboratories.
Laboratories handling microorganisms
and other hazardous biological materials should routinely use appropriate
disinfectants, effective against target organisms, to decontaminate surfaces and
equipment, and prevent microbial growth in spent culture fluids etc.
Each laboratory group must ensure there is a clear documented disinfection
policy indicating suitable concentrations, contact times and applications for all
disinfection requirements within the group.
15.3
Autoclaving and Disposal of Waste from Containment Level 1 and 2
Facilities
Containment level 1 and 2 facilities should have access to an autoclave either
within the laboratory suite or elsewhere within the building. If the waste is
transported to autoclave facilities outside a laboratory suite, a robust, leak proof
container should be used.
Autoclaved waste from CL1 and CL2 facilities is routinely placed in ‘offensive
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waste bags’ by the autoclave technicians and disposed of via the ‘offensive
waste’ route via a contractor.
15.4
Autoclaving Waste from Containment Level 3 Facilities
Containment Level 3 (CL3) facilities must have an autoclave either within the
laboratory or within the laboratory suite itself. Only authorised staff should
undertake the decontamination of waste.
If the waste has to be removed from the CL 3 facility for autoclaving in an
adjacent laboratory, it must be transported in a robust, leak proof container
fitted with a lid. The lid of the container should only be removed when the
container has been placed in the autoclave to allow steam penetration.
The autoclave must be available for immediate use once the waste arrives. This
requires close co-ordination between the staff of the CL3 laboratory, and those
in charge of the autoclaving facilities.
The container must be surface decontaminated with a suitable disinfectant
before removal from the containment laboratory.
Autoclaved waste from CL3 laboratories must be disposed of in the Clinical
Waste Bins, for collection by an authorised disposal company, before final
incineration.
15.5
Autoclave Bag Holders
Autoclave bag holders must be appropriate for the laboratory facility and type
of material to be autoclaved. Laboratories handling pathogens must use either
an autoclaveable bin or traditional autoclave bag stand (with or without foot
operated lid). Standard plastic bins are only acceptable for work activities
involving non-pathogenic organisms operating at Containment Level 1, and
these should be periodically disinfected. To avoid unnecessary problems with
contamination, plastic bins should be used without manually operated lids,
unless required for containment of materials such as GM seed.
16.
INSPECTION OF FACILITIES
Facilities handling hazardous biological agents will be subject to scheduled
inspections as organised by the Genetic Modification & Dangerous Pathogens
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Safety Committee. The inspection process aims to assess the:




Suitability of the general facilities (laboratory or greenhouse)
Suitability of working practices and whether they are being followed
Awareness of the hazardous nature of organisms used by workers and
how harm could arise (i.e. the risks)
Understanding of the relevance and need for specific containment
measures.
Inspections will be prioritised, with particular attention given to facilities
handling the most hazardous organisms and those facilities that give most
concern.
17.
TRANSPORT OF BIOLOGICAL AGENTS
17.1
General
Certain biological samples, cultures and other materials fall within the
description of dangerous goods for carriage and both national and international
legislation demand stringent requirements must be met if the goods are
transported by any means.
All workers in the University must ensure
Regulations applicable to the transport of biological materials are complied
with for each particular consignment and not carry, consign, package or play
any other role in the transport chain if they are not competent to do so. The
Department of Biology Supplies & Goods Services staff or the Biological Safety
Advisor should be contacted for advice on the requirements for transportation
of biological agents in the UK or abroad.
All persons undertaking any role in the transport chain must be properly
trained and have an understanding of the relevant Regulations to ensure they
are able to undertake their responsibilities to the required standards.
Even if the particular biological material to be transported is not hazardous and
does not fall under the description of dangerous goods, the item still must be
packed safely for carriage.
Any problems occurring during transport, such as leakage or breakage, should
be reviewed in order that corrective measures can be taken to prevent any
recurrence. If workers in the University receive packages that are not properly
packaged or labelled they should contact the originator to advise of the problem
and ask that any future packages meet the legislative standards.
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17.2
Transport in the United Kingdom
Department of Biology Supplies and Goods Services should be contacted for
guidance on transport of biological materials in the UK.
17.3
Transport Abroad
For transport of samples abroad, anyone sending biological materials by air
must ensure they comply with the IATA Dangerous Goods Regulations.
Department of Biology Supplies and Goods Services should be contacted for
guidance on transport of biological materials abroad.
17.4
Importation of Biological Agents
17.4.1 Human Pathogens
There is no requirement under health and safety law to obtain a licence to
import human pathogens into the UK, other than the requirement under
COSHH to notify the movement of HG4 agents. There is a requirement to
notify first use of HG2-HG4 agents at particular premises, but this relates to use
of agents in the laboratory, not the consignment of those agents. This only
applies to human pathogens; licences are required for the importation of animal
and plant pathogens (see below). Contact Biological Safety Advisor for further
information if required.
17.4.2 Plant and Animal Pathogens or Materials that May Contain Them
Importation of certain plant and animal pathogens, or pests, or any material
(e.g. soil) that may be carrying such pathogens or pests, is strictly controlled by
legislation enforced by Department of the Environment, Food and Rural Affairs
(DEFRA). Rigorous licensing requirements are in place for both import and
possession of many types of materials. Contact the BSA for further information
if required. It is the responsibility of the individual importing the material to
obtain any licences required.
18.
SECURITY
18.1
Anti-terrorism Controls on Pathogens and Toxins
Certain pathogens and toxins are controlled under the Anti-terrorism, Crime
and Security Act 2001. The controlled agents are listed in Schedule 5 of this Act.
Particular reference should be made to the notes accompanying Schedule 5
detailing that the legislation extends:
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

In the case of pathogens - not only to include the pathogen itself but also
any genetic material containing any nucleic acid sequence associated with
the pathogenicity of the micro-organism and any genetically modified
organism containing any such sequence
In the case of toxins (reference to which includes subunits of the toxin) not only to include the toxin itself but also any genetic material containing
any nucleic acid sequence for the coding of the toxin and any genetically
modified organism containing any such sequence.
Under this legislation, the holding, be it in storage or in use, of any microorganism or toxin or relevant genetic material on Schedule 5, is subject to
notification to the Home Office. There are some exceptions to this requirement
(for example for some toxins if the quantity held is less than 5mg) as detailed
in The Security of Pathogens and Toxins (Exceptions to Dangerous Substances)
Regulations 2002.
Any notifications that need to be made to the Home Office for holdings within
the University will be made by the HSSD. Individuals who have any materials
controlled under this legislation should inform the University BSA of any
holdings on University premises, or in advance of any intentions to acquire
such material, in order that the relevant notification can be made to the Home
Office. The HSSD will co-ordinate notifications and is the primary point of
contact for the Home Office, and for the Police Counter-Terrorism Officer, in
this regard.
All enquiries individuals receive from any sources about such materials must
be referred to the HSSD before any information is provided.
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