Biological Safety Policy

It is the policy of Loughborough University to ensure that all work involving the use of biological material is subject to the standards of control necessary to prevent, or where this is not possible to minimise, risks to human health, safety and the environment.

Effective biological safety management requires consideration of the safe, responsible, sustainable and economical use of biological material – from procurement, storage, use, transport and through to disposal. All aspects of biological material use are governed by a comprehensive set of legislation to ensure the risks posed by substances which may be harmful to health or to the environment are suitably controlled.

This policy applies to all work (handling, use, transportation, storage and disposal) involving Genetically Modified Organisms (GMO), microorganisms, cell cultures, parasites, human or animal tissue (including blood, urine and other body products) or plant material which gives rise to a risk of infection, allergy or toxicity or have a detrimental effect on the wider environment.

The policy applies to:

• All staff, students (both postgraduate and undergraduate) and personnel (e.g. contractors and visitors) at workplaces under the control of Loughborough University.
• All ACDP Hazard groups (1-4) biological material classified as hazardous under Control of Substances Hazardous to health (COSHH) Regulations 2002
• All materials that may contain biological materials (including blood, bodily fluids)
• All genetically modified organisms as classified under the Genetically Modified Organisms (Contained Use) Regulations 2014
• Animal pathogens covered under Specified Animal Pathogen Order 2008
• Controlled or prohibited plants, plant products or plant seeds under section 1-6 of the Plant Health Order 2015
• Biological Material that are covered under Schedule 5 of the Anti-Terrorism, Crime and Security Act 2001
• All work carried out with Waste Water

Please note there are additional policies/procedures for biological material that falls under the Human Tissue Act and Ethics Approval. Please see the University HTA Licence Compliance Quality Manual and University Ethics guidelines for further information.

• Control of Substances Hazardous to Health Regulations (COSHH) 2002
• Genetically Modified Organisms (Contained Use) Regulations 2014
• Specified Animal Pathogen Order 2008
• Plant Health Order 2015
• Anti-Terrorism, Crime and Security Act 2001
• Animal By-Products (Enforcement) (England) Regulations 2013
• The Controlled Waste (England and Wales) Regulations 2012
• The Hazardous Waste (England and Wales) Regulations 2005
• Pollution Prevention and Control Act 1999
• Environmental Protection Act (EPA) 1990 Part II (Waste on Land)
• The Hazardous Waste (Miscellaneous Amendments) Regulations 2015

The following sections outline the responsibilities of the Duty Holders:

The following requirements relate to both the purchase and acquisition of all biological material.

Biological material may only be procured and delivered through the University system by current members of staff and post graduate research students for use in legitimate university activities. Each School/Service must have a procedure in place to manage the authorisation, purchase, acquisition, recording and receipt of this material in line with the relevant legislation. Currently only biological material hazard groups 1 and 2 can be purchased and GM class 1.

Staff purchasing/acquiring biological material that require licences or registration must liaise with their SSO/DSO and the University Biological Safety Officer to ensure the university has the correct licence and the appropriate authorities are notified.

If ordering on agresso use code P_LYG for biological material and P_LYH for genetically modified material.

Prior to acquiring new cell lines or biological material, line managers/academic supervisors must ensure that a suitable biological (and if appropriate) GMO risk assessment is completed according to the requirements outline under the specific regulations.

When acquiring previously held substances, line manager/academic supervisors must ensure an up to date risk assessment exists to cover the task for which the material is to be used for.

With biological material it is important to understand the provenance of the material.

Therefore, when acquiring from other organisations it is important to get as much detail on the material (origin, what has been done to it, sequence, virulence information, screening etc).

All biological material procured or gifted into the university must be accompanied by a Material Transfer Agreement (MTA).

Please note any biological material that falls under the Human Tissue Act must go through the correct governance process. If the biological material is HTA relevant or if you believe it maybe, please contact either your School’s Persons Designated (PD) or the University Designated Individual (DI) for HTA.

It is a requirement to know where all your biological material is stored and therefore some type of inventory is required. This listing should be electronic, backed up and secure.

Storage vessels (freezers, fridges or cryotanks) should be labelled with biohazard labels and secured where possible.

Inventories of regulated biological material such as HTA relevant or GMO’s must be formally audited by the School/Service at least annually to ensure traceability. Audits must be documented, and the results kept for 3 years.

All work involved with biological material needs to be risk assessed. This is to ensure safety for the employees/students and the environment but also compliance with all the regulations. The risk assessments will allow the user to understand the hazard group, GM class, whether it is HTA relevant and what containment level it must be.

The risk assessment must consider:

• Hazard group of biological material
• Provenance, cell species, tissue and cell line type
• Route of infection • Risk factors (Enhanced virulence, low multiplication of infection)
• Infective dose (Dose of biological agent required to cause initial infection in host)
• Containment level
• Controls required
• Possible incidental exposures
• Blood borne viruses/Allergens
• Occupational health and health surveillance requirements
• Emergency arrangements

All biological material transferred between laboratories within Loughborough University should only be carried where absolutely necessary. It is important to avoid the need to carry them through communal areas or circulation routes. Where this cannot be avoided transport must be such as to avoid or reduce the risk of spillage.

All material must be transported within secondary containment, with adequate absorbent material and the associated risk assessment must include contingency plans for if the materials spills on route. Please refer to local School procedures or Biological Safety general guidance document for further information.

If you wish to transport biological material outside the university then you must consult your School’s SSO/Biological Responsible Person for advice.

Transport of biological material is covered by the Carriage of Dangerous Goods and use of Transportable Pressure Equipment Regulations 2009. Speak to the UH&SS for more information.

Staff or students wishing to transfer biological material to another organisation must arrange a formal Materials Transfer Agreement (contact Research Office for further details). Please note if the biological material is HTA relevant you must contact the Designate Individual before proceeding.

It is important for Schools/Services to consider the waste disposal route before purchasing or using biological material for the first time. A suitable waste disposal route must be identified. All biological material must be disposed of in a way to ensure complete deactivation. For GMO’s the disposal method must be validated.

Biological/GM risk assessments must provide information relating to appropriate decontamination procedures.

All equipment which has been used in conjunction with biological material must be decontaminated and assessed for any residual risk posed before it is released for maintenance, repair or disposal. Please speak to the University Biological Safety Officer for clearance certificates.

Extractions clearance certificates must be approved and issued by UH&SS.

See guidance document on Waste Disposal, Disinfection and Decontamination of biological material for more guidance. (Available from hse@lboro.ac.uk)

In the event of a serious incident, arrangements must be in place to make hazard information readily available to individuals (including security and external emergency services) attending the incident to enable the appropriate action to be taken.

Where there is serious risk to health, immediate steps should be taken to mitigate the effects, provide information to those who may be affected and restore the situation to normal.

Emergency procedures and arrangements should have been identified by the risk assessments; this should consider what to do in the event of fire, first aid and spills/unintended release of a biological material.

See guidance document on Incidental exposure to biological material (available from hse@lboro.ac.uk)

All staff and students must have suitable instruction and training to enable them to work with biological material safely. Instruction should include:

• Information on the biological material
• Risk to health presented using the biological material
• Relevant workplace exposure limits • Relevant safety data information
• Biological/GM Risk assessment training
• HTA training (if applicable)
• Precautions to take to prevent or reduce exposure
• Correction operation and use of equipment and control measures
• Correct disposal route
• Emergency procedures and spill response

An appropriate level of supervision should be determined by risk assessment. Everyone working with the biological material should be able to demonstrate they are competent to use them safely.

Training needs must be reviewed on a regular basis or when there are significant changes to the work.

COSHH determines biological material as the following:

• Biological agent with an approved classification (i.e. known bacteria/viruses)
• Cell cultures
• Parasites that live within their host
• Bodily fluids including blood or urine

Hazard Groups and Containment

Biological agents can be classified into 4 groups based on the hazard to human health. See ACDP Approved List of Biological Agents for classification.

Hazard Group 1 Unlikely to cause disease

Hazard Group 2 May cause disease, low hazard, spread unlikely, and Prophylaxis/treatment available

Hazard Group 3 Severe disease possible, hazardous, spread possible, Prophylaxis/treatment available

Hazard Group 4 Causes severe disease, serious hazard and high risk of spread, prophylaxis/treatment not normally available.

The required degree of containments for biological material varies depending on the hazard group to which the biological material belongs. The 4 hazard groups require increasing levels of containments, designated as containment levels (CL) 1-4 (Schedule 3 COSHH). Containment level 2 and above must be signed off by UH&SS.

Biological material that has not been assigned a hazard group must be risk assessed accordingly. However, the following must always be treated as hazard group 2 or above:

• Human tissue/bodily fluids
• Unscreened cell lines
• Genetically modified cell lines
• Primary cells
• Untreated soil

Please note laboratory workers cannot work on their own bodily fluids.

COSHH risk assessments must be reviewed regularly, following any significant change, incident or where the results of any relevant exposure monitoring indicate that existing control measures are not effective.

Suitable measures must be implemented to prevent exposure to substances hazardous to health or where this is not reasonably practicable, ensure exposure is adequately controlled.

Schools/Services must ensure any engineered control measures (e.g. MSC’s) are in efficient state, good repair and are within any applicable examination and testing period before use. PPE issued to staff/students must be suitable for the purpose intended, fits correctly, is stored properly and is regularly checked.

Notifications for COSHH

COSHH requires the University to notify the HSE for the following:

• First use of biological agents in Hazard Groups 2, 3 or 4.
• Subsequent use of any of the agents listed in Part V of Schedule 3 to COSHH.

The Genetically Modified Organisms (Contained Use) Regulations 2014 regulates the safe use of genetically modified organisms (GMOs) in containment. The regulations cover both the human health and environmental risks from work involving GMOs which includes modified cell cultures. For larger GMOs (animals/plants) these regulations only cover the risks to human health with the environmental risks being covered by provisions in the Environment Protection Act (EPA) and its sub-ordinate regulations.

No-one may commence any activity involving GMOs (including but not limited to, their use; culture; storage; transport; destruction; or disposal) or introduce GMOs into the environment without first consulting with the University Biological Safety Officer, undertaking a risk assessment of the activity that has been peer reviewed by the GM/Biosafety committee.

Loughborough university only has a licence for class 1 GM work. Therefore, all GM risk assessment must be approved through the GM/Biosafety Committee to ensure the work falls into this classification.

All class 1 GM work must be carried out in a containment level 2 laboratory.

Some biological material although only classified with an ACDP hazard group 1 may be pathogenic (harmful) to animals. It is therefore necessary to ensure the biological material you require is not classified as a Specified Animal Pathogen.

Specified Animal Pathogens in groups 2-4 will required approval from the University biological safety officer and a DEFRA licence.

Plant Health Order is concerned with controlled or prohibited plants, plant products or plant pest (Schedule 1-6).

To order, receive or work with any items covered under the Plant Health Order a Plant Health Licence will be required.

Procedures must be in place to identify activities which involve the use of category 1 or 2 precursor chemicals as outlined in EC regulation number 273/2004 and obtain a relevant licence for category 1 precursors, application to the Home Office prior to work with those substances commencing. Therefore before work can begin with these chemicals the chemical safety officer must authorised to ensure the University has the correct licence.

Under Schedule 5 of the Anti-Terrorism, Crime and Security Act (ATCSA) 2001 list biological material that is restricted further. Any work with biological material list under Schedule 5 Part 7 (Pathogens and toxins) requires notification to the Home Office (carried out by University Biological Safety Officer) and visits from a Counter Terrorism Security Advisor (CTSA).

Schedule 5 includes micro-organisms, nucleic acid sequences associated with pathogenicity/or GMOs and toxins.

Further Reading: Secure Hazardous Materials to Help Prevent Terrorism