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CBA1 Guidance notes


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These notes relate to notification duties under the Control of Substances Hazardous to Health (COSHH) Regulations.  You may have similar duties under other legislation, for example The Specified Animal Pathogens Order, and you should ensure that you have complied with all relevant requirements.
If, however, you have already made a notification of the use of a biological agent(s) under the Genetically Modified Organisms (Contained Use) Regulations, then no further notification under COSHH is required.
What do I need to notify?

You need to notify:

  • First use of biological agents in Hazard Groups 2, 3 or 4 at a particular premises.
  • Subsequent use of any of the agents listed in Part V of Schedule 3 at a particular premises.
  • Consignment of biological agents in Hazard Group 4 from/to a premises.
When should I notify?

You should let us have a completed form at least 20 days in advance of any planned work.  This time allows HSE to assess the information you have given and request further information if required.  If you need to start work in less than 20 days, then you should contact us by phone in the first instance so we can consider your request.

Where do I send the form?

If this form is completed online, it can be returned by Email using the option provided. 

Please note, this form can only be saved onto your hard drive once the 'Continue' button has been pressed. There is an option on the 'Next Action Page' to save and print your form. If you try and save this document onto your hard drive without pressing the 'Continue' button your form will appear blank to HSE when sent by email.

Any relevant attachments should be sent separately to the following Email address:

bioagents@hse.gsi.gov.uk

If you wish to send this form (and any relevant attachments) by post, please send them to the following address:

COSHH Notifications
Building 5S.2 Redgrave Court
Merton Road
Bootle
Merseyside
L20 7HS

Section 1

Purpose of Notification - Definitions

What is first use?

This means the first time that deliberate work with a particular Hazard Group 2, 3 or 4 agent has ever been carried out at your premises since the duty to notify first came into force in COSHH 1994 on 16/1/95.  You may have carried out work with such agents prior to this date, if this is the case, under the law you were not actually working with the agents when the regulations first came into force.  If you re-start work with this agent now however, then you should notify us as though it were the first time you had used the agent, i.e. first use.

Deliberate work means carrying out activities such as propagation, for example, as would occur in bacteriology, virology, mycology and parasitology laboratories.
Even if you obtain an agent, say just to lodge in a culture collection, you will need to maintain that collection.  This is likely to involve work with the agent, e.g. growing the agent to check on viability and so you would need to notify.
What is subsequent use?

If you have made a first notification under COSHH in respect of any agent in Hazard 3 or 4 and certain Hazard Group 2 agents (listed in Part V to Schedule 3) and then decide to use a different agent from that in the original notification, you will need to notify us.  In practice, this means if you work with a different Part V agent after COSHH 2002 comes into force to that which you were working with prior to that date, you need to notify this change under subsequent use.

Section 2

Who is the person responsible for health and safety?

This is not necessarily the health and safety advisor/officer or biological safety advisor/officer.  The legal responsibility for health and safety rests primarily with the employer but in practice the responsibility is delegated down the line management chain.  You should give details of the local 'manager' who has responsibility for health and safety in the department, etc where the work is to be carried out (see ACDP guidance - The management, design and operation of microbiological containment laboratories).

Section 3

What agents are in Part V?

All Hazard Group 3 and 4 agents (including those which you may have provisionally classified in these groups as well as the following Hazard Group 2 agents:

Bordetella pertussis

Corynebacterium diphtheriae

Neisseria meningitidis

What if I am working with materials that contain biological agents?

Many types of diagnostic work, e.g. in haematology, immunology or clinical chemistry laboratories will involve handling specimens etc which are likely to contain biological agents.  As long as the work that is undertaken with such specimens does not require the deliberate propagation or concentration of the agents, then there is no need to notify either first use or subsequent use.

If, however, you provide a diagnostic service for a Hazard Group 4 agent(s), then you need to notify in advance of carrying this out for the first time.
What if the agent I want to work with doesn't appear on the Approved List of biological agents?

COSHH requires that if you work with an agent that does not have an approved classification, you must classify the agent yourself according to the criteria in Schedule 3.  If the agent is classified as being in either Hazard Group 2, 3 or 4, then work with agent will need to be notified (or re-notified, as appropriate).

Section 4

How much information must I give about risk assessments and preventative and protective measures?

It is not sufficient to simply state that you are using an agent in HG3 and will be using CL3 containment.  Although this is not an approval system, we need sufficient information to demonstrate that you have identified hazards associated with the agent in conjunction with the work that is to be carried out.  You should then be able to identify in what circumstances staff (and others) could be exposed to a source of infection during the work, i.e. the risk(s).

The measures that will be applied to prevent or control that risk may be standalone procedures, e.g. a local code of practice or else they may be contained in standard operating procedures/protocols.  These procedures may be linked directly to the assessment or else be standalone.  Again, we need sufficient information to indicate the measures that will be used for the work that is to be carried out - these may vary according to particular activities being undertaken although the work may constitute, for example, one research project.
Section 5

Transport

You need to notify if you intend to transport a HG4 agent from your premises to another in the UK.  You also need to notify if you are importing a HG4 agent into the UK from elsewhere or exporting an agent (to cover movement of the agent from your premises to the departure point).

You only have to notify if you are moving the HG4 agent itself, not if you are sending material containing or thought to contain the HG4 agent for:
  • diagnostic purposes, e.g. a clinical specimen; or
  • disposal, e.g. human or animal remains or contaminated material.
You don't need to notify if you are transporting a patient (human or animal) infected with a HG4 agent for the purposes of medical treatment.  There is guidance available on the transport of human patients contained in ACDP guidance on the Management and control of viral haemorrhagic fevers and the DH guidance Hendra virus and Nipah virus: management and control.
When should I notify?

You should let us have a completed form at least 30 days in advance of any planned movement of the agent.  This time allows HSE to assess the information you have given and request further information if required.  If you need to transport the agent in less than 30 days, then you should contact us by phone in the first instance so that we can consider your request.

What packaging should I use?

Packages that are being sent by road or rail should comply with the requirements set out in the Carriage of Dangerous Goods (Classification, Packaging and Labelling) and Use of Transportable Pressure Receptacles Regulations and the accompanying Approved Methods for classification, packaging and labelling.

A HG4 agent would be classified as Class 6.2 under the regulations as it is an 'infectious substance' for the purposes of transport.  It would be assigned to UN No 2814: Infectious substance affecting humans.  The packaging would need to meet the requirements of Packaging Instruction 620 which consists of:
  1. Inner packaging comprising:
    1. Leakproof primary receptacle(s);
    2. A leakproof secondary packaging; and
    3. Other than for solid infectious substances, an absorbent material in sufficient quantity to absorb the entire contents placed between the primary receptacle(s) and the secondary packaging; if multiple primary receptacles are placed in a single secondary packaging, they shall be individually wrapped so as to prevent contact between them;
  2. An outer packaging of adequate strength for its capacity, mass and intended use.  The smallest external diameter should be at least 100 mm.

Packages being sent by air should comply with the ICAO Technical Instructions - the packaging requirements are essentially similar to the above.  If you are notifying the importation of a HG4 from overseas, the person sending the package should have ensured that these instructions are complied with but you should discuss this with them.  Packages that have been packaged in accordance with the ICAO instructions are suitable for transport by road or rail.

Because of the special nature of the agents, transport of Hazard Group 4 biological agents means that those carrying out the consignment have to comply with certain other requirements of the Carriage of Dangerous Goods Regulations, such as the appointment of dangerous goods safety advisors.  Although the driver training requirements only apply to vehicles over 3.5 tonnes, drivers should still have sufficient training to enable them to carry out any relevant duties under the regulations.

What arrangements should I make for the day of transport itself?

If you are transporting the agent by road, you need to ensure that:

  1. the packaging is accompanied by a competent person with knowledge of the biological agent and the appropriate action to be taken in the event of an accident;

  2. the vehicle used for transport is equipped with suitable means for effective decontamination in the event of a spillage, e.g. protective clothing and gloves, disinfectant, absorbent materials and a container for contaminated waste.  The details of the decontamination procedure should be included in the risk assessment for the consignment;

  3. there is a means of prompt communication with a second party who should be available in the event of an incident, e.g. by a person following in a separate vehicle, or by use of a cellular telephone.  This provides a back-up for decontamination in the event of an accident and continuing the journey if the carrier vehicle can no longer be used;

  4. you inform the recipient of the package of the date, precise time of dispatch, and the route to be followed.  They should then make sure they are available to receive the package and then notify you of its safe arrival;

  5. your local police force and that of the recipient should be informed of the date and time of despatch, and the route to be followed.  If the route crosses the boundaries of other forces, then these too should be informed.  The police should also be instructed that in the event of an incident they should:

    1. not tamper with the package;
    2. notify you (if the person accompanying the package is unable to assist) and the recipient who may be required to advise on the appropriate action to be taken; and
    3. notify HSE.

If you are transporting the agent by air, you should ensure that:

  1. the airport authority is notified as far as possible in advance and arrangements made for the movement of the consignment by liaison with other authorities where appropriate; 
  2. if, on arrival at the airport, transportation is to continue by road then the guidance given above applies;
  3. you notify the recipient of the date, time of despatch and flight details, i.e. flight number, route and time of arrival.  As above, the recipient should then be available to receive the package and notify you of safe arrival;
  4. if you import the agent from another country, you should ensure that a suitable and sufficient risk assessment has been carried out and the appropriate regulatory requirements are met (for example, export licence).
Annex A - List of biological agents in Part V of Schedule 3 of COSHH 2002
1.  Any Group 3 or 4 agent (i.e. including those provisionally classified by an employer).

2.  The following Group 2 agents:

Bordetella pertussis

Corynebacterium diphtheriae

Neisseria meningitidis

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Updated 20.10.15