The GM Page

This page is aimed at everyone who undertakes (or who is planning to undertake) activities involving genetically modified organisms (GMOs) under conditions of containment. That is, anyone working with GMOs in laboratories, industrial production facilities, animal facilities, glasshouses and growth rooms.
Genetic modification is also known as genetic manipulation, modern biotechnology, genetic engineering, gene technology and recombinant DNA technology.
GMOs are micro-organisms, plants and animals that have had their genetic material altered by artificial means.
Activities include the making of a GMO or the use of a GMO (e.g. the culture, storage, transportation, destruction, disposal of or any other activity involving a GMO).
Containment means where the contact of the GMOs with humans and the environment is limited by the use of barriers (biological, chemical or physical) so that harm is avoided.
Contained use means an activity (in laboratories, factories, glasshouses and other forms of containment) in which organisms are genetically modified or GMOs are and for which physical, chemical or biological barriers are used to limit their contact with, and to provide a high level of protection for, humans and the environment.

Techniques used for genetically modifying organisms have been available since the 1970s and UK legislation controlling the technology has been in place since 1978.
The main purpose of the Regulations is the protection of people's health and the environment from risks associated with the contained use of genetically modified organisms.
HSE operates and enforces legislation in Great Britain that controls the safety, to humans and the environment, of activities involving GMOs in containment.

Project assessment proformas are available on the internet and lists of authorised personnel and projects are provided to project supervisors seperately.

Legal requirements that GM workers need to be aware of;

GM Work (the modification of an organism OR IT'S USE) MUST NOT COMMENCE on a proposed project or by a proposed individual until;

the risk has been assessed and recorded
the activity has been classified (1, 2, 3 or 4 for GMMs in relation to the degree of containment deemed necessary and A or B for plants and animals depending on whether the GMO has a greater degree of potential to cause harm to humans or the wider environment than the equivalent non-modified organism)
formal approval has been given by either the Genetic Modification Safety Committee (GMSC), the Biological Safety Officer (BSO) or the Chair of the GMSC.

The University MUST convene a Genetic Modification Safety Committee (GMSC) to oversee all GM work performed here.

The GMSC is appointed to advise on risk assessments and ours will approve;

projects involving the production OR USE of GMOs
the location of GM projects (labs and other facilities which must match the containment requirements of the assessment)
personnel working with GMOs. This includes undergraduate students. The competence of individual workers to perform activities must be assessed

and must ensure that

notification (via HSE) is made for certain higher risk projects
standards of occupational and environmental safety and levels of containment are appropriate to the level of risk
local rules are implemented

The HSE can inspect the premises, unannounced if they wish. HSE inspectors are enforcement officers and can advise, issue improvement and prohibition notices or prosecute.
The GM systems and facilities at the University of Bath were inspected in July 2002 and, as a result of advice given, some modifications were made to our procedures. These are reflected in the current arrangements.

How to make a GM project application.
Anyone undertaking assessments should read carefully the extensive information in the Scientific Advisory Committee on Genetic Modification (SACGM) Compendium of Guidance (available on the web - paper copies are available from the secretary to the GMSC). This will ensure that all necessary information is provided. Risks both to human health & safety and to the environment must be assessed.
You are strongly advised in the Compendium against using the previously allowed "Brenner Scheme". There are many instances when consideration of Access, Expression and Damage does not give a reliable indication of the appropriate containment level. Caution should therefore be exercised in placing too much reliance on the scheme. For this reason, no provision has been made for use of this scheme in the new forms.

Some additional help in completing the forms is available from this link. This includes help on risk assessment, containment, waste disposal and GMO characterisation (e.g. details of host strains and vectors).

The altered requirements for risk assessments necessitates the use of a new risk assessment proforma (issued in March 2001). (The previous form is no longer acceptable.)

Because the risk assessment requirements differ somewhat between types of GMO, you will need to use the correct form (or forms) for your work. These fall into the following categories:

Proformas for genetically modified microorganisms (GMMs)

Simple Class 1 projects involving GMMs
Micro-organisms other than viruses (less straightforward projects)
Human and animal viruses and viral vectors
Plant viruses

Proformas for genetically modified animals or plants

The five assessment forms available are for work to construct OR USE genetically modified organisms. It may be appropriate to complete 2 separate forms if 2 GMOs are being constructed or used in a single project, e.g. if a bacterial host (or construct) is being used to generate genetically modified DNA for insertion into a plant or animal.

The project is proposed, the location of the work is identified, the risk of harm assessed and a containment level is suggested by completing a form (or possibly 2). All the relevant documentation is requested in word-processed format.

The project supervisor needs to arrange for the relevant project assessment form(s) to be downloaded from the internet (they are "read-only" files) and completed as a word-processed document. This can be saved back onto your own drive (use a different file name) before forwarding to gm@lists.bath.ac.uk for review before printing (a colour printer is NOT necessary).

Forward the signed paper copy of the completed form(s) to the GMSC secretary.

Authorised GM project assessments will be returned to the originating supervisor with a "supervision" sheet appended to the front. This is to record signatures of AUTHORISED GM personnel who are working on that project.

Classification of Activities for GMMs
Activities involving genetically modified microorganisms should be classified into one of 4 classes on the basis of which containment level (determined as part of the risk assessment) is appropriate for the work:

Containment level 1 – Activity Class 1
Containment level 2 – Activity Class 2
Containment level 3 – Activity Class 3
Containment level 4 – Activity Class 4

There are useful tables on the classification of some GMMs in part 2 of the SACGM compendium.

Containment Levels for GMMs
The detail in Schedule 8 of the Regulations is much greater than in the previous regulations. More guidance is given in the SACGM Compendium of Guidance. Conditions are similar, but not identical, to previous requirements and checks should be made to ensure that premises come up to the required standard.

Inactivation of GMMs before Disposal
Guidance is given in ACGM Newsletter No. 29 on interpretation of the requirement to inactivate GMM by validated means. The planned method for this must be included as part of the risk assessment for all projects, whatever the Class. As a general guide, autoclave any waste if possible.

Containment Levels for GM Plants and Animals

Activities with GM plants and animals are not assigned activity classes as are GMMs. Instead they should be assigned to one of Containment Levels depending on the assessed level of risk. These are:

Containment Level A for NON-NOTIFIABLE projects
Containment Level B for NOTIFIABLE projects

and the level depends simply on whether the GMO has a greater degree of potential to cause harm to humans or the wider environment than the equivalent non-modified organism.

Refer to part 4 (plants) and Part 5 (animals) of the SACGM compendium

How to get people authorised to conduct GM work;
Personnel details (including relevant practical experience) are needed, together with the numbers or titles of projects the person is expected to work on. Again, all the relevant documentation is requested in word-processed format.

Relevant practical experience usually means good microbiological practice (GMP) and an outline of the type of work previously performed involving cells (i.e. "2 years culturing E. coli" or "Final year undergraduate project involving culturing GM yeast".

Undergraduate students. In the departments of Biology & Biochemistry and Pharmacy & Pharmacology, first-year students undergo a course in GMP. For subsequent practical classes or research projects involving Class 1 GMOs it is simply a case of supervisors registering them by sending a list of such students to the GMSC secretary.

Staff and postgraduate students.

Download the personnel application form from the internet ("read-only") and complete it as a word-processed document. This can be saved back onto your local disc drive (use a different file name) and then forwarded to gm@lists.bath.ac.uk for comments before being printed out for signatures.
Again, forward the completed signed paper copy(ies) to the GMSC secretary.

Authorised GM project assessments will be returned to the originating supervisor with a "supervision" sheet appended to the front. This is to record signatures of AUTHORISED GM personnel who are working on that project.

Lists of authorised GM personnel

Lists of currently authorised GM personnel and of authorised GM personnel who have left the University are also available to project supervisors. (Please contact gm@lists.bath.ac.uk.)
PLEASE ENSURE THESE LISTS REMAIN CONFIDENTIAL.

Lists of authorised GM projects

Lists of currently authorised GM projects and of lapsed GM projects are also available to project supervisors. (Please contact gm@lists.bath.ac.uk.)
PLEASE ENSURE THESE LISTS ALSO REMAIN CONFIDENTIAL.

Timetable for applications

GM Work MUST NOT COMMENCE on a proposed project or by a proposed individual until formal approval has been given by either the GMSC, the BSO or the Chair of the GMSC.

The GMSC secretary will acknowledge receipt of completed forms as soon as possible.

If necessary the Biological Safety Officer (BSO) or other key member of the GMSC will seek additional information to clarify submitted details. The BSO or the Chair of the GMSC will formally respond to the applications (projects and personnel) within one calendar month.

The SACGM Compendium of Guidance can be accessed on the web. The address is http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/index.htm. Copies of the paper document can also be loaned from the GMSC secretary.

Part 1: Introduction to the legislation and general health and safety issues [423kb]
Part 2: Risk assessment of genetically modified microorganisms (other than those associated with plants) [2.17mb]
Part 3: Containment and control of activities involving genetically modified microorganisms [1.05mb]
Part 4: Genetic modification work that involves plants (including plant-associated genetically modified microorganisms) [1.19mb]
Part 5: Genetic modification of animals [308kb]
Part 6: Guidance on the use of genetically modified microorganisms in a clinical setting [615kb]
List of abbreviations [51kb]

Notification of projects to the HSE

Depending on the type of work and the Containment Level required, a project may need to be notified to the HSE by the Biological Safety Officer. The main aspects are summarised as follows:

GMMs
class 1 activities with GMMs do not have to be notified. (However, you may not begin work until the proposal has been approved by the GMSC);
the first planned class 2 activity at a premises with GMMs must be notified 45 days before the intended start date (unless consent has already been granted for class 3 or 4 activities when the activity can start as soon as the HSE acknowledges receipt of the notification);
subsequent class 2 activities do not require the 45 day advance notification, but may not begin until the HSE acknowledges receipt of the notification and an activity reference number has been assigned;
the first class 3 or 4 activity with GMM must be notified 90 days before the intended start and work cannot begin until a consent has been issued by the HSE;
subsequent class 3 or 4 activities must be notified 45 days before the intended start and work cannot begin until a consent has been received.

GM Animals and Plants
Activities involving modified animals and plants which do not pose a greater risk to human health or the wider environment than the unmodified parental organism do not need to be notified;
Where activities pose a greater risk than the unmodified parental organism, projects must be notified 45 days before the intended start date, although consent from the HSE is not required.

Costs of notification
The latest (April 2009) list of charges is available on the web at <http://www.hse.gov.uk/biosafety/gmo/acgm/acgmwarn.htm>. Charges must be met from departmental or research budgets.

Public Register

The new regulations make the presumption that all information notified to the HSE may be disclosed to the public unless:

the notifier can justify withholding the information on specific grounds; and

the HSE agrees.

An extensive paper, Confidentiality and Disclosure of Notified Data, gives guidance and should be studied by anybody concerned with disclosure issues.

Current Regulations and Guidance
There have been strict safety regulations controlling all contained use work with GMOs in the UK since 1978. The legislation has developed over the years, partly due to changing technology and increased knowledge, but also because of the coming into being of a European Directive on the contained use of genetically modified micro-organisms (GMMs) - Directive 90/219/EEC.

The Genetically Modified Organisms (Contained Use) Regulations 2000 (SI 2000 No. 2831) came into force on 15^th November 2000 and replace the 1992 Regulations (amended in 1996). The text of the Regulations can be found on the HMSO web-site at: <http://www.hmso.gov.uk/si/si2000/20002831.htm>

The HSE has published A Guide to the Genetically Modified Organisms (Contained Use) Regulations 2000 (ISBN 0-7176-1758-0; £13-50) which can be loaned from these people or any member of the GMSC.

The HSE has also published a free booklet Contained Use Of Genetically Modified Organisms (INDG86(rev2)) which can be obtained from HSE Books (tel. 01787-881165; fax 01787-313995). This gives a very clear and simple summary of the Regulations, the main changes from the previous regulations and the types of notifications that need to be made. Copies are available from the GMSC secretary.

The Scientific Advisory Committee on Genetic Modification has also published the SAGGM Compendium of Guidance (ISBN 0-7176-1763-3; £12.50) which can be viewed on the web at <http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/index.htm>

The Compendium of Guidance is prepared, in consultation with HSE, by the SACGM which was appointed by the Health and Safety Commission as part of its formal advisory structure. The guidance represents what is considered to be good practice The Compendium aims to provide detailed advice about:
- assessing risks to human health and the environment;
- appropriate containment measures to ensure that any risks identified are controlled so as to ensure safety.

It also outlines regulatory requirements which must be complied with.

Following this guidance is not compulsory and we are free to take other action. But if we do follow this guidance we will normally be doing enough to comply with the law. Health and safety inspectors seek to secure compliance with the law and may refer to this guidance as illustrating good practice.

We have provided a contents list for the compendium, enabling you to link to any of it's sections. A paper copy of the Compendium can be loaned from these people.

Assessments of environmental risks associated with genetically modified non micro-organisms (eg whole plants and animals) are covered by section 1O8(1)(a) of the Environmental Protection Act 1990 together with the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996. Guidance is available in the SACGM Compendium for containment measures necessary for minimising the environmental risks.

Main Changes from the Previous Regulations

The requirement to classify activities involving modified micro-organisms (GMMs) into Group I or II and type A or B is removed.
a structured approach to risk assessment is introduced whereby GMMs are classified into 4 classes, with equivalent containment levels;
shorter and simpler notification procedures;
more detailed specification of control measures including inactivation of GMMs in waste;
much more information about premises and activities is to be included on the public register; and
separate requirements for GM animals and plants

Definition of GM

Genetic modification in relation to an organism means the altering of the genetic material in that organism in a way that does not occur naturally by mating or natural recombination or both and within the terms of the definition given in the The Genetically Modified Organisms(Contained Use) Regulations 2000 (under "interpretation") and through the use of techniques listed in Part I of Schedule 2;

recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;
techniques involving the direct introduction into an organism of heritable genetic material prepared outside the organism, including micro-injection, macro-injection and micro-encapsulation;
cell fusion or hybridization techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

The techniques listed in Part II of Schedule 2 are not considered to result in genetic modification provided that they do not involve the use of genetically modified organisms made by techniques other than those listed in Part III or the use of recombinant nucleic acid molecules, namely -

in vitro fertilisation;
natural processes including conjugation, transduction or transformation;
polyploidy induction.

These Regulations (except regulation 17) shall not apply to the following techniques of genetic modification, provided that they do not involve the use of recombinant nucleic acid molecules or of genetically modified organisms other than those recombinant nucleic acid molecules or genetically modified organisms produced by one or more of the following techniques of genetic modification -

mutagenesis;
cell fusion (including protoplast fusion) of prokaryotic species which can exchange genetic material through homologous recombination;
cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions;
self-cloning, where the resulting organism is unlikely to cause disease or harm to humans, animals or plants.

"self-cloning" means the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent), whether or not altered by enzymic or mechanical processes, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by homologous recombination; and
self-cloning may include the use of recombinant vectors, with an extended history of safe use in the particular organism, to manipulate and reinsert the nucleic acid sequences, but the vectors shall not consist of any genetic elements other than those designed for vector structure, vector replication, vector maintenance or marker genes.

General principles of Good Microbiological Practice and of good occupational safety and hygiene

Schedule 7. The general principles of good microbiological practice and of good occupational safety and hygiene are as follows -

keeping workplace and environmental exposure to any genetically modified micro-organism to the lowest reasonably practicable level;
exercising engineering control measures at source and supplementing these with appropriate personal protective clothing and equipment where necessary;
testing adequately and maintaining control measures and equipment;
testing, where necessary, for the presence of viable process organisms outside the primary physical containment;
providing appropriate training of personnel;
formulating and implementing local codes of practice for the safety of personnel, as required;
displaying biohazard signs where appropriate;
providing washing and decontamination facilities for personnel;
keeping adequate records;
prohibiting in the work area eating, drinking, smoking, applying cosmetics or the storing of food for human consumption;
prohibiting mouth pipetting;
providing written standard operating procedures where appropriate to ensure safety;
having effective disinfectants and specified disinfection procedures available in case of spillage of genetically modified micro-organisms; and
providing safe storage for contaminated laboratory equipment and materials where appropriate.

Members of the Genetic Modification Safety Committee

Names are available from gm@lists.bath.ac.uk.)

The current secretary of the GMSC
Please contact gm@lists.bath.ac.uk for the name of the current secretary.

Paper documents

SACGM Compendium of Guidance, ISBN 0-7176-1763-7, March 2000
A Guide to the Genetically Modified Organisms (Contained Use) Regulations 2000, ISBN 0-7176-1758-0

are both available as paper documents from the Biological Safety Officer BSO), Assistant BSO or the GMSC secretary. All these can be contacted on gm@lists.bath.ac.uk

This document was drafted by Peter Jewell in February 2001

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Page created by Pete Jewell	Last modified on October 9th 2009