Contained use of

of

genetically modified organisms

What is this
leaflet about?
This leaflet tells you about the
controls on contained use of
genetically modified organisms.
These controls are set out in the
Genetically Modified Organisms
(Contained Use) Regulations
2000, which replaced the
Genetically Modified Organisms
(Contained Use) Regulations
1992, as amended in 1996 and
1998. These Regulations are
supplemented by the sections
of the Environmental Protection
Act 1990 and the Genetically
Modified Organisms (Risk
Assessment) (Records and
Exemptions) Regulations (as
amended in 1997) which
specifically cover the control of
risks to the environment from
genetically modified animals
and plants.
2
What are genetically
modified organisms?
All living organisms – animals, plants and
micro–organisms (such as bacteria or
fungi) – carry copies of all their genes in
their cells. Those genes hold the infor­
mation that determines the organism’s
particular form and function. Specific
characteristics of an organism may be
linked to particular genes or combinations
of genes. Genetically modified organisms
(GMOs), therefore, are organisms whose
genes have been artificially altered to
modify their characteristics in some way
or other. For example, medicinal products
such as insulin, blood factor VIII and
human growth hormone, were formerly
produced from humans and animals and
some carried a slight risk of transmitting
disease. Now, with the use of genetic
modification (GM) technology, pure and
safe equivalents can be produced
using GMOs.
What is contained use?
The term ‘contained use’ covers any
activity involving GMOs in which
measures are taken to limit contact
between them and people or the
environment. It relates to the actual
process of genetic modification, and
also to the use, storage, transport and
destruction of GMOs. Typical contained
use facilities would be microbiology
laboratories, animal houses, greenhouses

or industrial production facilities.
GMOs that are deliberately introduced
into the environment for experimental
purposes, or placed on the market, for
example, as food or for medical purposes,
are obviously not contained. They are
outside the scope of the Regulations
on contained use and regulated under
other legislation; the section ‘Where
can I find out about other aspects of
genetic modification?’ tells you where
you can find out more about other
aspects of GMOs.
Why do we need controls
and Regulations?
Most contained use activities involve
organisms which do not cause disease
and are very unlikely to survive in the
environment outside a containment
facility. A small proportion of work is
carried out with more hazardous
organisms whose escape from contain­
ment could damage human health or
the environment. It is, therefore, very
important to assess the risks of all
activities and to make sure that any
necessary controls are put in place to
protect people and the environment. Risk
assessments must take account of what
could happen if GMOs came into contact
with other organisms in the environment.
The Regulations provide a framework for
making these judgments, and place clear
legal obligations on people who work
with GMOs.
Contained use of genetically modified organisms
Why did the previous
Regulations have to
be replaced?
They needed to be brought up to date to
reflect developments in GM technology.
Also, experience of operating the previous
Regulations indicated ways in which the
administrative procedures might be made
more straightforward. The overriding
objective was to maintain and improve
standards of protection for human health
and the environment.
The revision also reflects a major
amendment of the European Community
Directive on contained use of genetically
modified micro-organisms (Directive
90/219/EEC as amended by Directive
98/81/EC).
What changes do
the new Regulations
introduce?
The main changes are:
removal of the previous requirement
to categorize activities involving
genetically modified micro-organisms
(GMMs) as Type A or B, according to
their purpose and scale;
removal of the scheme for classifying
GMMs into Group I and II, according to
their inherent properties;
establishing a structured approach to
risk assessment which incorporates
elements covered by the previous
3
Contained use of genetically modified organisms
categorization (Type A/Type B) and
classification (Group I/Group II) and places
activities involving GMMs into 4 different
classes (class1 covers activities of no or
negligible risk and class 4 those of high
risk to people and the environment);
shorter and simplified notification
procedures based directly on the
outcome of risk assessment;
more detailed specifications of the
control measures appropriate to different
types of activity; and
much more information about
contained use premises and activities
to be included in the public register of
notifications.
What are the main
duties under the
Regulations?
Anyone carrying out contained use work
must comply with the Regulations and, in
particular:
notify the authorities* of their intention
to use their premises for contained use
activities for the first time;
carry out an assessment of the risks to
human health and the environment of
every contained use activity before it
begins, reviewing and revising the assess­
ment as necessary, and keeping records;
establish a genetic modification safety
committee to advise on risk assessments;
* HSE has lead responsibility for administration of the Regulations, but the Department for Environment, Food and Rural
Affairs (DEFRA), the Scottish Executive, and the National Assembly for Wales are also involved in the scrutiny of
notifications. Notifications and other communications need be sent only to the Health and Safety Executive which will
arrange circulation to other bodies as necessary.
4
classify all activities as described
under ‘How are activities classified?’ and
notify them where required;
apply the necessary containment and
control measures indicated by the risk
assessment; and
draw up emergency plans for riskier
activities, and notify any accidents that
occur.
How are activities
classified?
The risk assessment, which must be
carried out for any contained use activity,
indicates the containment and control
measures needed.
For activities involving micro-organisms,
it is necessary to decide which of the four
standard containment levels applies to the
work. The containment and control
measures which define those levels are
set out in a Schedule to the Regulations.
Anyone carrying out a risk assessment,
therefore, will need to check which level
matches the measures indicated by the
assessment. The classification of the
activity is simply read across from the
containment level:
Containment level 1 — Class 1
Containment level 2 — Class 2
Containment level 3 — Class 3
Containment level 4 — Class 4

In some cases, there will not be an
exact match between the containment
and control measures the risk assess­
ment indicates and those specified for
any of the containment levels; the
measures will effectively fall between
two levels. In such cases, the activity
must be classified at the higher level.
For activities involving GMOs that are
not micro-organisms (ie animals and
plants), there are no standard
containment levels. Such activities are
simply classified as ‘notifiable’ or ‘non­
notifiable’ according to the nature of the
GMO itself.
Notifiable activity
Activity involving a GM animal or
plant which poses a greater risk to
human health than its unmodified
parental organism
Non-notifiable activity
Activity involving a GM animal or
plant which poses no greater
risk to human health than its
unmodified parental organism
How are premises and
activities notified?
The information which must be notified
is set out in Schedules to the Regulations.
HSE provides forms (also available on the
Internet at HSE’s website) to use for the
submission of notifications. The
notification period applicable to an
Contained use of genetically modified organisms
activity varies depending on the activity’s
classification. Also, the riskier activities
may not begin without explicit consent.
The requirements are summarized
overleaf.
How is the disposal
of GMOs controlled?
The Regulations require all GMMs to be
inactivated before they are disposed of.
The Regulations define ‘inactivation’ as
‘the complete or partial destruction of
GMMs … to provide a high level of
protection for humans and the environ­
ment’. The definition of ‘contained use’,
however, recognizes that containment
could be achieved by biological barriers,
eg a live GMM may be discharged from
a contained use facility, but would be
biologically incapable of survival. So,
discharge of GMMs without inactivation
may be allowed if the person carrying
out the activity can demonstrate that
adequate biological barriers are in place.
No discharge of non-inactivated waste
may take place unless and until the
authorities have evaluated the adequacy
of the barriers and given their permission.
Can anyone see
notified data?
Yes, but the Regulations have to maintain
a balance between the public’s right of
access to data and the right of GM
practitioners to protect their work from
5
Contained use of genetically modified organisms

their competitors. Any notified information Type of notification

may be disclosed to the public on request,
but notifiers may claim confidentiality for First use of premises
specific data, especially if they can
demonstrate that disclosure could
compromise their competitive position or
intellectual property rights. The authorities
will decide whether confidentiality claims GMMs: Class 1
are justified. Furthermore, the Regulations
specify certain core data for which
confidentiality cannot be claimed on any
grounds, except harm to intellectual
property rights. GMMs: Class 2 (first at premises)
To facilitate public access to notified
data, HSE maintains a public register
of notifications. This contains all (non­
confidential) information notified on
premises and individual activities, including GMMs: Class 2 (subsequent)
the nature of work to be carried out at
premises, the purpose of individual
activities and the characteristics of the GMMs: Class 3 or Class 4
GMOs involved. Simply to save space, (first at premises)
the full risk assessment of an activity is
not placed on the register, but may be
viewed on request. GMMs: Class 3 or Class 4 (subsequent)
The public register is held at the
following addresses:

Rose Court, 2 Southwark Bridge,

Non-notifiable GM animals/plants
London SE1 9HS Tel: 020 7717 6278

Magdalen House, Stanley Precinct,

Bootle L20 3QZ Tel: 0151 951 4772

Also, each main office of HSE will hold Notifiable GM animals/plants

those entries in the register for premises
and activities notified in its area. If you do
not know where your nearest office is, look
up ‘Health and Safety Executive’ in the

6

Notification period
None; the premises may begin undertaking
contained use work as soon as HSE acknowledges
receipt of the notification and the premises have
complied with the notification requirements for the
first intended activity.
Class 1 activities do not have to be notified. If,
however, the first intended activity at new premises
is Class 1, the premises notification must include a
risk assessment and some other information
specific to that activity.
Must be notified 45 days before it is intended to
begin (unless consent has already been granted
for Class 3 or Class 4 activities, in which case the
activity may begin as soon as HSE acknowledges
receipt of the notification).
Must be notified, but may begin as soon as HSE
acknowledges receipt of the notification.
Must be notified 90 days before it is intended to
begin.
Must be notified 45 days before they are intended
to begin.
Activities involving non-notifiable animals or
plants do not have to be notified. If, however,
such an activity is to be the first at new premises,
the premises notification must include a risk
assessment and some other information specific
to that activity.
Must be notified 45 days before it is intended
to begin.
Contained use of genetically modified organisms
Consent required?
No.
No.
No; the activity may begin 45 days after
submission of the notification unless the
authorities have written within that
period agreeing to an earlier start.
No.
Yes; the authorities must issue a
consent - or let the notifier know why
consent is being withheld - within
30 to 90 days.
Yes; the authorities must issue a
consent - or let the notifier know why
consent is being withheld - within
30 to 45 days.
No.
No; the activity may begin 45 days after
submission of the notification unless the
authorities have written within that
period agreeing to an earlier start.
7
Contained use of genetically modified organisms
telephone directory for your area or tele­
phone HSE’s InfoLine on 08701 545500.
That part of the register covering
premises and activities in Scotland is
also held at:
Belford House, 59 Belford Rd, Edinburgh
EH4 3UE Tel: 0131 247 2000
What further information
is available?
The full text of the Regulations is
contained in A guide to the Genetically
Modified Organisms (Contained Use)
Regulations 2000 (HSE Books 2000,
ISBN 0 7176 1758 0) which also provides
fuller explanation of the Regulations’
requirements in non-legal language.
Copies of the guide can be purchased
by completing and sending off the order
form on the back cover of this leaflet.
You can also place orders by telephoning
HSE Books on 01787 881165.
The Health and Safety Executive and
the Advisory Committee on Genetic
Modification have produced a Compen­
dium of Guidance for people carrying out
contained use activities. This offers
detailed technical advice on risk assess­
ment and control for different sorts of
activity. For details of how to obtain a
copy of the Compendium, please contact
the Secretariat of the Advisory
Committee on 020 7717 6245.
8
Where can I find out
about other aspects of
genetic modification?
Other government departments also
have responsibilities for genetic
modification activities.
The Department for Environment,
Food and Rural Affairs (DEFRA) is
responsible for the control of environ­
mental risks caused by contained use of
GM animals or plants. It also operates
the Genetically Modified Organisms
(Deliberate Release) Regulations which
govern experimental release and
marketing of GMOs. DEFRA is also
responsible for the agricultural
implications of GMOs (eg plant variety
and seeds legislation, plant and animal
health aspects, pesticide controls and
general impact on agriculture).
The Department for Environment, Food
and Rural Affairs
GM Policy and Regulatory Unit
Ashdown House
123 Victoria Street
London
SW1E 6DE
The Food Standards Agency (FSA) was
established in April 2000 and is responsibie
for the safety and labelling of GM food and
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the application of the EC Regulation on
Novel Foods and Novel Food Ingredients
which governs the marketing of GM foods.
FSA Novel Foods Division,
Room 239c, Ergon House, PO Box 31037,
Horseferry Road, London SW1P 3WG
Tel: 020 7238 6379
Fax: 020 7238 6382
The Department of Health (DH) has
responsibility for the general human
health and food safety aspects of GMOs,
including medical applications of GM
technology. It provides the secretariats
for the Gene Therapy Advisory
Committee (GTAC) which assesses
protocols for gene therapy trials and for
the United Kingdom Xenotransplantation
Interim Regulatory Authority (UKXIRA)
which regulates all activities involving the
transplants from one species to another.
The Medicines Control Agency (MCA) has
responsibility for the safety, quality and
efficacy of medicines.
DH Biotechnology Unit, Skipton House,
80 London Road, Elephant and Castle,
London, SE1 6LW
Tel: 020 7972 5347
Fax: 020 7972 5155
GTAC Secretariat, DH, Wellington House,
135–155 Waterloo Road, London, SE1 8UG
Tel: 020 7972 4021
Fax: 020 7972 4196
UKXIRA Secretariat, DH, Wellington House,
133–155 Waterloo Road, London, SE1 8UG
Tel: 020 7972 4921/4822
Fax: 020 7972 4852
Contained use of genetically modified organisms
MCA, c/o Information Centre Central
Enquiry Point
Tel: 020 7273 0000
Fax: 020 7273 0353
The Home Office regulates the use of
protected animals (ie all vertebrates and
Octopus vulgaris), including those that
have been genetically modified, for
experimental or other scientific purposes.
The relevant legislation is the Animals
(Scientific Procedures) Act 1986.
Home Office Animals By-Laws and
Coroners Unit, 50 Queen Anne’s Gate,
London, SW1 9AT
Tel: 020 7273 2861
Fax: 020 7273 2423
The Department of Trade and Industry
(DTI) has overall responsibility for
sponsoring the industrial application of
biotechnology. It is also responsible for
ensuring that the implications for
industrial competitiveness are taken into
account in the formulation of
Government policy in this area. DTI
publishes the BioGuide which provides
the biotechnology community with an
essential summary of current regulations
and procedures and of the support
available from the Government and
elsewhere.
DTI Chemicals and Biotechnology
Directorate, 151 Buckingham Palace
Road, London, SW1W 9SS
Tel: 020 7215 2914
Fax: 020 7215 1379
9
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