Contained Use of Genetically Modified Organisms

8/9/2019 Contained Use of Genetically Modified Organisms

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Contained use ofContained use ofgenetically modified organismsgenetically modified organisms


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What is thisleaflet 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.

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All living organisms animals, plants and

microorganisms (such as bacteria or

fungi) carry copies of all their genes in

their cells. Those genes hold the infor

mation that determines the organisms

particular form and function. Specific

characteristics of an organism may be

of genes. Genetically modified organisms

(GMOs), therefore, are organisms whose

genes have been artificially altered to

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

safe equivalents can be produced

using GMOs.

What is contained use?

The term contained use covers any

activity involving GMOs in which

between them and people or the

environment. It relates to the actual

process of genetic modification, and

also to the use, storage, transport and

use facilities would be microbiology

laboratories, animal houses, greenhouses

What are genetically

modified organisms?

linked to particular genes or combinations

modify their characteristics in some way

or other. For example, medicinal products

disease. Now, with the use of genetic

modification (GM) technology, pure and

measures are taken to limit contact

destruction of GMOs. Typical contained


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Contained use of genetically modified organisms

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or industrial production facilities.

GMOs that are deliberately introduced

are obviously not contained. They are

on contained use and regulated under

can I find out about other aspects of

genetic modification? tells you where

you can find out more about other

aspects of GMOs.

and Regulations?Most contained use activities involve

organisms which do not cause disease

environment outside a containment

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

necessary controls are put in place to

protect people and the environment. Risk

could happen if GMOs came into contact

with other organisms in the environment.

making these judgments, and place clear

legal obligations on people who workwith GMOs.

They needed to be brought up to date to

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

90/219/EEC as amended by Directive

98/81/EC).

What changes do

The main changes are:

removal of the previous requirement

to categorize activities involving

their purpose and scale;

GMMs into Group I and II, according to

their inherent properties;

establishing a structured approach to

risk assessment which incorporateselements covered by the previous

into the environment for experimental

purposes, or placed on the market, for

example, as food or for medical purposes,

outside the scope of the Regulations

other legislation; the section Where

Why do we need controls

and are very unlikely to survive in the

facility. A small proportion of work is

activities and to make sure that any

assessments must take account of what

The Regulations provide a framework for

Why did the previous

Regulations have tobe replaced?

reflect developments in GM technology.

Also, experience of operating the previous

Regulations indicated ways in which the

modified micro-organisms (Directive

the new Regulationsintroduce?

genetically modified micro-organisms

(GMMs) as Type A or B, according to

removal of the scheme for classifying


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classification (Group I/Group II) and placesactivities 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.

duties under theRegulations?Anyone carrying out contained use work

particular:

* 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

establish a genetic modification safety

committee to advise on risk assessments;

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*

under How are activities classified? and

apply the necessary containment and

control measures indicated by the risk

assessment; and

draw up emergency plans for riskier

classified?The risk assessment, which must be

indicates the containment and control

measures needed.

,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

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




categorization (Type A/Type B) and

What are the main

must comply with the Regulations and, in

notify the authorities

ment as necessary, and keeping records;


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.

classify all activities as described

notify them where required;

activities, and notify any accidents that

occur.

How are activities

carried out for any contained use activity,

For activities involving micro-organisms

set out in a Schedule to the Regulations.


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In some cases, there will not be an

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.

plants), there are no standard

containment levels. Such activities are

simply classified as notifiable or non

notifiable according to the nature of the

Notifiable activityActivity involving a GM animal or

plant which poses a greaterrisk to

human health than its unmodified

parental organism

Non-notifiable activityActivity involving a GM animal or

plant which poses no greater

risk to human health than its

unmodified parental organism

activities notified?The information which must be notified

HSE provides forms (also available on the

submission of notifications. The

notification period applicable to an

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classification. Also, the riskier activities

The requirements are summarized

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,

could be achieved by biological barriers,

eg a live GMM may be discharged from

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

authorities have evaluated the adequacy

of the barriers and given their permission.

notified data?

a balance between the publics right ofaccess to data and the right of GM

practitioners to protect their work from

exact match between the containment

For activities involving GMOs that are

not micro-organisms (ie animals and

GMO itself.

How are premises and

is set out in Schedules to the Regulations.

Internet at HSEs website) to use for the

activity varies depending on the activitys

may not begin without explicit consent.

overleaf.

How is the disposalof GMOs controlled?

The Regulations require all GMMs to be

inactivated before they are disposed of.

The Regulations define inactivation as

however, recognizes that containment

a contained use facility, but would be

biologically incapable of survival. So,

may take place unless and until the

Can anyone see

Yes, but the Regulations have to maintain


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First use of premises

GMMs: Class 1

GMMs: Class 2 (first at premises)

GMMs: Class 2 (subsequent)

GMMs: Class 3 or Class 4

(first at premises)

GMMs: Class 3 or Class 4 (subsequent)

Non-notifiable GM animals/plants

Notifiable GM animals/plants

their competitors. Any notified information

may be disclosed to the public on request,but notifiers may claim confidentiality for

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

confidentiality cannot be claimed on any

property rights.

data, HSE maintains a public register

of notifications. This contains all (non

confidential) information notified on

premises and individual activities, including

the nature of work to be carried out at

premises, the purpose of individual

activities and the characteristics of the

GMOs involved. Simply to save space,

the full risk assessment of an activity is

viewed on request.

The public register is held at the

following addresses:

London SE1 9HS

Magdalen House, Stanley Precinct,

Bootle L20 3QZ

Also, each main office of HSE will hold

those entries in the register for premises

and activities notified in its area. If you donot know where your nearest office is, look

Type of notification

are justified. Furthermore, the Regulations

specify certain core data for which

grounds, except harm to intellectual

To facilitate public access to notified

not placed on the register, but may be

Rose Court, 2 Southwark Bridge,

Tel: 020 7717 6278

Tel: 0151 951 4772

up Health and Safety Executive in the



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Notification period

None; the premises may begin undertaking

contained use work as soon as HSE acknowledges

receipt of the notification andthe premises have

complied with the notification requirements for the

is Class 1, the premises notification must include a

risk assessment and some other information

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

such an activity is to be the first at new premises,

the premises notification must include a risk

assessment and some other information specific

Must be notified 45 days before it is intended

to begin.

No.

No.

submission of the notification unless the

authorities have written within that

period agreeing to an earlier start.

No.

consent - or let the notifier know why

consent is being withheld - within

30 to 90 days.

consent - or let the notifier know why

consent is being withheld - within

30 to 45 days.

No.

submission of the notification unless the

authorities have written within thatperiod agreeing to an earlier start.

first intended activity.

Class 1 activities do not have to be notified. If,

however, the first intended activity at new premises

specific to that activity.

plants do not have to be notified. If, however,

to that activity.

Consent required?

No; the activity may begin 45 days after

Yes; the authorities must issue a

Yes; the authorities must issue a

No; the activity may begin 45 days after



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genetic modification?

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

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

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

telephone directory for your area or tele

phone HSEs 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

contained inA guide to the Genetically

Modified Organisms (Contained Use)

Regulations 2000 (HSE Books 2000,

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.

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

copy of the Compendium, please contact

the Secretariat of the Advisory

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Where can I find out

about other aspects of

Other government departments also

(Deliberate Release) Regulations which

govern experimental release and

marketing of GMOs. DEFRA is also

GM Policy and Regulatory Unit

Tel: 0131 247 2000

What further informationis available?The full text of the Regulations is

ISBN 0 7176 1758 0) which also provides

fuller explanation of the Regulations

You can also place orders by telephoning

HSE Books on 01787 881165.

The Health and Safety Executive and

activity. For details of how to obtain a

Committee on 020 7717 6245.



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Novel Foods and Novel Food Ingredients

FSA Novel Foods Division,

Horseferry Road, London SW1P 3WG

The Department of Health (DH) has

responsibility for the general human

health and food safety aspects of GMOs,

including medical applications of GM

for the Gene Therapy Advisory

protocols for gene therapy trials and for

which regulates all activities involving the

The Medicines Control Agency (MCA) has

efficacy of medicines.

DH Biotechnology Unit, Skipton House,

80 London Road, Elephant and Castle,

MCA, c/o Information Centre Central

The Home Office regulates the use of

protected animals (ie all vertebrates and

Octopus vulgaris), including those that

have been genetically modified, for

The relevant legislation is the Animals

(Scientific Procedures) Act 1986.

Coroners Unit, 50 Queen Annes Gate,

(DTI) has overall responsibility forsponsoring the industrial application of

ensuring that the implications for

account in the formulation of

publishes the BioGuide which provides

the biotechnology community with an

essential summary of current regulations

and procedures and of the support

elsewhere.

DTI Chemicals and Biotechnology

Road, London, SW1W 9SS

9

the application of the EC Regulation on

which governs the marketing of GM foods.

Room 239c, Ergon House, PO Box 31037,

Tel: 020 7238 6379

Fax: 020 7238 6382

technology. It provides the secretariats

Committee (GTAC) which assesses

the United Kingdom Xenotransplantation

Interim Regulatory Authority (UKXIRA)

transplants from one species to another.

responsibility for the safety, quality and

London, SE1 6LW

Tel: 020 7972 5347

Fax: 020 7972 5155

GTAC Secretariat, DH, Wellington House,

135155 Waterloo Road, London, SE1 8UG

Tel: 020 7972 4021

Fax: 020 7972 4196

UKXIRA Secretariat, DH, Wellington House,

133155 Waterloo Road, London, SE1 8UG

Tel: 020 7972 4921/4822

Fax: 020 7972 4852

Enquiry PointTel: 020 7273 0000

Fax: 020 7273 0353

experimental or other scientific purposes.

Home Office Animals By-Laws and

London, SW1 9AT

Tel: 020 7273 2861

Fax: 020 7273 2423

The Department of Trade and Industry

biotechnology. It is also responsible for

industrial competitiveness are taken into

Government policy in this area. DTI

available from the Government and

Directorate, 151 Buckingham Palace

Tel: 020 7215 2914

Fax: 020 7215 1379


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Contained Use of Genetically Modified Organisms