Biological safety

The purpose of the Anti-terrorism Crime and Security Act is to help ensure that Governments have, in the light of terrorist attacks, the necessary powers to counter the threat to the UK. Part 7 and Schedules 5 and 6 of the Act places an obligation on managers of laboratories and other premises holding stocks of specified disease-causing micro-organisms and toxins (listed in Schedule 5) to notify their holdings, and to comply with any reasonable security requirements which the police may impose. It also requires managers of laboratories and other premises, on request, to furnish the police with details of people with access to the dangerous substances held there. The Secretary of State is given power to direct that a named individual must not be allowed access to such disease strains or the premises in which they are held.

The University BSO audits Schools on their holdings and liases with the police regarding work with and the secure design of premises holding scheduled material.

Pathogens are infectious agents, such as viruses, and the control and containment requirements, particularly under SAPO, are to prevent the release or escape of dangerous animal pathogens into the environment where they may cause serious animal or human disease. This document contains guidance on the controls on animal pathogens that Defra licences under the Importation of Animal Pathogens Order 1980 and the Specified Animal Pathogens Order (SAPO) 2008.

Bristol University has been granted a single license under SAPO with annexes approved for individual activities. The Dean of Medical and Veterinary Sciences is the designated license holder. Anyone planning to obtain or work with a specified animal pathogen must contact the Biological Safety Advisor well in advance as changes to the license may require an inspection from HSE and can take 3-6 months to complete.

COSHH includes cell culture in the definition of a biological agent as they may be infected with adventitious biological agents such as mycoplasmas (e.g. Mycoplasma pneumoniae) or viruses. Sometimes they may have also been infected intentionally. The nature of cell culture systems also means that they are often able to sustain and allow amplification of such agents during use. In addition, cells may also present other hazards to human health, such as the ability to produce toxins or allergens. An assessment of the risks must therefore be undertaken before work involving any cell cultures commences.

Transport of dangerous goods is regulated to prevent, as far as practicable, harm to persons or the environment and damage to property during all stages of the transport chain. The United Nations has developed a harmonised system for hazard classification and risk reduction methods for the different modes of transport (road, rail, sea and air) which are reflected in national and international regulations for the transport of dangerous goods. This guidance is concerned with the transport of biological materials including cells, tissues, pathogens, toxins and associated refrigerants (e.g. dry ice). It also covers material that is exempt from the relevant regulations. The guidance should only be used with appropriate training.

Summary of revisions since version 1.1:

• Changes to minimum marking and labelling dimensions
• Transport of formaldehyde (possibly relevant to research material)
• De minimis quantities designation that may affect some toxins
• Changes to the transport of refrigerants by road, including new labelling/signage that may be required (amended April 2013)
• Section on animal pathogens and animal products revised to incorporate regulatory changes.

The effectiveness of disinfectants is influenced by many factors and disinfectants should be used in accordance with manufacturer's instructions and efficacy data. Virkon is used extensively in the University and so efficacy data from the manufacturer is reproduced in this document. The manufacturer should be consulted for up to date data and to obtain specific reports. Other reliable sources of information (e.g. research publications) may also be used for determining efficacy in any given situation and be referenced in the activity risk assessment. In all cases, the conditions of use in the laboratory should equate to the validation methods cited in the sources of information used. Where necessary, and proportionate to the risk, in-house experimental data may be required to be confident of effectiveness.

Waste must be segregated into a number of distinct fractions to satisfy legislative requirements and University environmental policies. Biological research and teaching laboratories generate certain wastes that should or in some cases must be decontaminated before disposal as they contain or might contain substances that are infectious (to humans, animals or plants) and/or because they contain GMOs. This guidance supplements the Sustainability hazardous waste disposal charts by providing guidance on how these waste materials from laboratories should be segregated and decontaminated using local procedures prior to disposal or be disposed of directly via incineration. The University maintains its own incinerator for the treatment of some hazardous waste which is also managed by Sustainability.

This risk assessment template can be used to assess the hazards and risks from an activity involving deliberate work with an infectious or harmful biological agent or work with primary human or animal tissue, blood, excreta or other body fluids. The aim of the assessment is to identify those at risk from infection or other harm and the measures required to eliminate or control the risks to human health and safety and the environment to an acceptable level.

A risk assessment of activities involving genetically modified organisms is required under the Genetically Modified Organisms (Contained Use) Regulations and Environmental legislation. The regulations require the assessment to consider risks to human health and also the environment. This form will assist this process where mico-organisms or cell cultures are genetically modified. Other forms exist for animals and plants. This risk assessment will normally also satisfy the COSHH risk assessment requirements for biological hazards.

The assessment must be undertaken by the responsible person (usually the principal investigator (PI) on a project) before work with or storage of GMOs commences, irrespective of where they were actually made. It will determine an appropriate containment level for handling the GMO and thereby assign an activity classification. Risk assessments must be reviewed by BGMSC and may require notification and payment of a fee to HSE.

A risk assessment of activities involving genetically modified organisms is required under the Genetically Modified Organisms (Contained Use) Regulations and Environmental legislation. The regulations require the assessment to consider risks to human health and also the environment. This form will assist this process where animals are genetically modified. Other forms exist for micro-organisms, cell cultures and plants. This risk assessment will normally also satisfy the COSHH risk assessment requirements for biological hazards.

The assessment must be undertaken by the responsible person (usually the principal investigator (PI) on a project) before work with or storage of GMOs commences, irrespective of where they were actually made. It will determine an appropriate containment level for handling the GMO and thereby assign an activity classification. Risk assessments must be reviewed by BGMSC and may require notification and payment of a fee to HSE.

A risk assessment of activities involving genetically modified organisms is required under the Genetically Modified Organisms (Contained Use) Regulations and Environmental legislation. The regulations require the assessment to consider risks to human health and also the environment. This risk assessment will normally also satisfy the COSHH risk assessment requirements for biological hazards.

The assessment must be undertaken by the responsible person (usually the principal investigator (PI) on a project) before work with or storage of GMOs commences, irrespective of where they were actually made. It will determine an appropriate Containment Level for handling the GMM and thereby assign an activity classification. Risk assessments must be reviewed by BGMSC and may require notification and payment of a fee to HSE.

To help ensure that ASU staff take appropriate precautions when coming into contact with animals deliberately infected with micro-organisms (including GMOs) or injected with other hazardous substances, research staff are required to provide information on health and safety risks to the persons responsible for the day to day care of the animals involved in their work.

This form (and updates) should be completed and a copy sent to the appropriate person responsible for the ASU facility (to be) used. The responsible person in the ASU facility should ensure that this information is discussed with the appropriate staff and the necessary precautions taken.

Before equipment can be released from a hazardous area for servicing, maintenance, repair or disposal the likelihood of contamination with hazardous biological, chemical or radioactive material must be assessed and the appended permit template should be used to assist in this task and provide information on decontamination to anyone subsequently handling the equipment. This task must be undertaken by or with the person responsible for health and safety within the area housing the equipment (e.g. PI, laboratory manager, RPS etc.).

The appended permit template covers biological and chemical contamination and incorporates and supersedes the radioactivity clearance certificates RP15 and RP15a.

The permit must accompany the equipment when leaving the hazardous area. Suppliers should also be given a copy in advance of this removal so that any precautionary measures can be discussed and implemented

Full laboratory inspections should take place annually or every six months for high hazard areas with intermediate regular inspections by laboratory staff taking place in each laboratory. This inspection form could be used for a full inspection and as guidance for other inspections. It has been divided into several sections: a general section applicable to all facilities; and optional sections that address particular types of hazards that might be present in a laboratory. The inspection team should decide which of the optional sections are applicable before each inspection or audit takes place. Therefore, although the form appears long it may not always be necessary to complete all sections. The form is also suitable for SSAs to issue to laboratory supervisors or managers for a self assessment type inspection.

Completed inspection forms with updated actions should be retained (either in each laboratory or collated by the SSA) for at least 3 years and be available for inspection by Safety and Health Services advisors during routine inspections or health and safety audits. Forms may also be required as evidence to give to external regulators or insurance inspectors.

A Permit-to-work (PTW, a form of risk assessment) must be completed and issued by the host department before maintenance staff or contractors are allowed access to any laboratory areas. The information provided should be sufficient to enable such operatives to carry out their work safely in an environment where they cannot reasonably be expected to understand or perceive all of the potential hazards. The person issuing this permit must themselves have sufficient knowledge of the laboratory activities undertaken in the areas covered by the permit. For radiation controlled areas the DRPS must also complete Form RP10 and link it to this permit.

Risk assessments should be reviewed annually or earlier if anything about the work has changed or if new information becomes available to ensure that assessments remain valid. Your local biological safety officer (DBSO) must also be consulted about any amendments to a project risk assessment as it may be necessary to seek BGMSC and enforcing authority approval.

Risk assessments should be read by all personnel involved in the assessed work and each person should sign to acknowledge that they understand the assessment. Their qualifications and experiences that make them suitable for this work should also be recorded. All personnel working with biologically hazardous materials must be registered with BGMSC and an on-line form is available on our website for this purpose.

Significant changes to projects will require a review of the risk assessment by the PI and consultation with and approval by BGMSC. In some circumstances this may also necessitate notification of a significant change in hazard profile and risk control measures to HSE and payment of a fee. The UBSO and BGMSC will advise you if this is likely to be required.

Please be aware that an activity cannot be de-registered at the University or with HSE if hazardous biological materials associated with that activity remain on University premises.

If you are leaving the University of Bristol to work at another institution then it may be possible to transfer your HSE notification(s) to that institution. Please contact the UBSO for advice well before you are due to move as this could save you time and money on notification fees.

This video will open in a new window and is streamed directly from Sigma-Aldrich. A higher quality DVD presentation is available for groups to view in the Safety Training Room at Safety and Health Services by arrangement in advance with the Biological Safety Officer.