CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS REGULATIONS

SUBSIDIARY LEGISLATION 549.49

CONTAINED USE OF GENETICALLY

MODIFIED MICRO-ORGANISMS

REGULATIONS

29th April, 2008

LEGAL NOTICE 127 of 2008, as amended by Legal Notice 265 of 2010.

The title of these regulations is the Contained Use of

Genetically Modified Micro-Organisms Regulations.

PART A

Techniques of genetic modification referred to in regulation 3 are, inter alia

1. 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.

2. Techniques involving the direct introduction into a micro-organism of

heritable material prepared outside the micro-organism including micro-injection,

macro-injection and micro-encapsulation.

3. Cell fusion or hybridisation 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.

PART B

Techniques referred to in regulation 3 which are not considered to result in genetic

modification, on condition that they do not involve the use of recombinant-nucleic

acid molecules or GMMs made by techniques/methods other than techniques/

methods excluded by Schedule II, Part A

(1) in vitro fertilisation;

(2) natural processes such as: conjugation, transduction, transformation;

(3) polyploidy induction.

(1) The objective of these regulations is to lay down

measures for the contained use of genetically modified micro-

org a ni s m s wi t h a v ie w t o pr o t e c t in g h um a n he a l t h a n d t h e

environment.

(2) These regulations provide the provisions required for the

implementation in Malta of the European Council Directive 2009/

41/EC of 6th May 2009 on the contained use of genetically

modified micro-organisms (recast) and shall be read and construed

as one with such legal instrument.

(3) These regulations are to be read and construed with the

Protection of Workers from Risks related to Exposure to Biological

Agents at Work Regulations, in relation to issues in connection

with occupational health and safety.

PART I: DEFINITIONS AND EXEMPTIONS

PART A

Techniques or methods of genetic modification yielding micro-organisms to be

excluded from the Regulation on the condition that they do not involve the use of

recombinant-nucleic acid molecules or GMMs other than those produced by one or

more of the techniques/methods listed below

1. Mutagenesis.

2. Cell fusion (including protoplast fusion) of prokaryotic species that

exchange genetic material by known physiological processes.

3. Cell fusion (including protoplast fusion) of cells of any eukaryotic species,

including production of hybridomas and plant cell fusions.

4. Self-cloning consisting in 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) with or without prior enzymic or mechanical

steps, into cells of the same species or into cells of phylogenetically closely related

species which can exchange genetic material by natural physiological processes

where the resulting micro-organism is unlikely to cause disease to humans, animals

or plants.

Self-cloning may include the use of recombinant vectors with an extended history

of safe use in the particular micro-organisms.

PART B

Criteria establishing the safety of GMMs for human health and the environment

This Schedule describes in general terms the criteria to be met when establishing

the safety of types of GMMs for human health and the environment.

1. GENERAL CRITERIA

2.1. Strain verification/authentication

Identity of the strain must be precisely established. Modification must be known

and verified.

2.2. Documented and established evidence of safety

Documented evidence of the safety of the organism must be provided.

2.3. Genetic stability

Where any instability could adversely affect safety, evidence of stability is

required.

3. SPECIFIC CRITERIA

3.1. Non-pathogenic

The GMM should not be capable of causing disease or harm to a healthy human,

plant or animal. Since pathogenicity includes both toxigenicity and allergenicity, the

GMM should therefore be

3.1.1. Non-toxigenic

The GMM should not produce increased toxigenicity as a result of the genetic

modification nor be noted for its toxigenic properties.

3.1.2. Non-allergenic

The GMM should not produce increased allergenicity as a result of the genetic

modification nor be a noted allergen, having, for example, allergenicity comparable

in particular with that of the micro-organisms identified in the Protection of Workers

from Risks related to Exposure to Biological Agents at Work Regulations.

3.2. No harmful adventitious agents

The GMM should not harbour known harmful adventitious agents such as other

micro-organisms, active or latent, existing alongside or inside the GMM that could

cause harm to human health and the environment.

3.3. Transfer of genetic material

The modified genetic material must not give rise to harm if transferred nor should

it be self-transmissible or transferable at a frequency greater than other genes of the

recipient or parental micro-organism.

3.4. Safety for the environment in the event of a significant and unintended

release GMMs must not produce adverse effects on the environment, immediate or

delayed, should any incident involving a significant and unintended release occur.

PART C

Types of GMMs which meet the criteria listed in Part B can be referred to

Schedule III of the Protection of Workers from Risks related to Exposure to

Biological Agents at Work Regulations.

In these regulations, unless the context otherwise requires

"accident" means any incident involving a significant and

unintended release of GMMs in the course of their contained use

which could present an immediate or delayed hazard to human

health or the environment;

"the competent authority" means the Environment and Resources

Authority as prescribed by the Nomination of the Competent

Authority Order, and such other body or person as the Minister

responsible for the environment may by order in the Gazette

prescribe and different bodies or persons may be designated as the

competent authority for different provisions and different purposes

of these regulations;

"contained use" means any activity in which micro-organisms

are genetically modified or in which such GMMs are cultured,

stored, transported, destroyed, disposed of or used in any other

way, and for which specific containment measures are used to limit

their contact with, and to provide a high level of safety for, the

general population and the environment;

"genetically modified micro-organism" or "GMM" means a

micro-organism in which the genetic material has been altered in a

way that does not occur naturally by mating and, or natural

recombination.

Within the terms of this definition

(a) genetic modification occurs at least through the use of

the techniques listed in Schedule I, Part A;

(b) the techniques listed in Schedule I, Part B, are not

considered to result in genetic modification;

"micro-organism" means any microbiological entity, cellular or

non-cellular, capable of replication or of transferring genetic

material, including viruses, viroids, animal and plant cells in

culture;

"the Minister" means the Minister responsible for the

environment;

"notification" means the presentation of the requisite information

to the competent authority;

"user" means any natural or legal person responsible for the

contained use of GMMs.

PART II: ASSESSMENT

PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT

REFERRED TO IN REGULATION 4(1)

This Schedule describes in general terms the elements to be considered and the

procedure to be followed to perform the assessment referred to in regulation 4(1). It

may be supplemented, as regards in particular section B, by guidance notes which

may be issued by the competent authority.

A.

ELEMENTS OF ASSESSMENT

1. The following should be considered as potentially harmful effects

-

disease to humans including allergenic or toxic effects,

-

disease to animals or plants,

-

deleterious effects due to the impossibility of treating a disease or

providing an effective prophylaxis,

-

deleterious effects due to establishment or dissemination in the

environment,

-

deleterious effects due to the natural transfer of inserted genetic

material to other organisms.

2. The assessment referred to in regulation 4(1) should be based on the

following

(a) the identification of any potentially harmful effects, in particular those

associated with

(i) the recipient micro-organism;

(ii) the genetic material inserted (originating from the donor

organism);

(iii) the vector;

(iv) the donor micro-organism (as long as the donor micro-organism is

used during the operation);

(v) the resulting GMM;

(b) the characteristics of the activity;

(c) the severity of the potentially harmful effects;

(d) the likelihood of the potentially harmful effects being realised.

B.

PROCEDURE

3. The first stage in the assessment process should be to identify the harmful

properties of the recipient and, where appropriate, the donor micro-organism, any

harmful properties associated with the vector or inserted material, including any

alteration in the recipient's existing properties.

4. In general, only GMMs which show the following characteristics would be

considered appropriate for inclusion in Class 1 as defined in regulation 4

(i)

the recipient or parental micro-organism is unlikely to cause disease to

humans, animals or plants ( * );

(ii) the nature of the vector and the insert is such that they do not endow the

GMM with a phenotype likely to cause disease to humans, animals or

*This would only apply to animals and plants in the environment likely to be exposed.

plants ( * ), or likely to cause deleterious effects in the environment;

(iii) the GMM is unlikely to cause disease to humans, animals or plants (*)

and is unlikely to have deleterious effects on the environment.

5. In order to obtain the necessary information to implement this process the

user may firstly take into account relevant Community legislation (in particular

Council Directive 90/679/EEC). International or national classification schemes

(e.g. WHO, NIH, etc.) and their revisions due to new scientific knowledge and

technical progress may also be considered.

These schemes concern natural micro-organisms and as such are usually based on

the ability of micro-organisms to cause disease to humans, animals or plants and on

the severity and transmissibility of the disease likely to be caused. Directive 90/679/

EEC classifies micro-organisms, as biological agents, into four classes of risk on the

basis of potential effects on a healthy human adult. These classes of risk can be used

as guidance to the categorisation of the contained use activities in the four classes of

risk referred to in regulation 4(2). The user may also take into consideration

classification schemes referring to plant and animal pathogens (which are usually

established on a national basis). The abovementioned classification schemes give

only a provisional indication of the risk class of the activity and the corresponding

set of containment and control measures.

6. The hazard identification process carried out in accordance with paragraphs

3 to 5, should lead to the identification of the level of risk associated with the GMM.

7. Selection of the containment and other protective measures should then be

made on the basis of the level or risk associated with the GMMs together with

consideration of

(i)

the characteristics of the environment likely to be exposed (e.g. whether

in the environment likely to be exposed to the GMMs there are known

biota which can be adversely affected by the micro-organisms used in

the contained use activity);

(ii) the characteristics of the activity (e.g. its scale; nature);

(iii) any non-standard operations (e.g. the inoculation of animals with

GMMs; equipment likely to generate aerosols).

Consideration of items (i) to (iii) for the particular activity may increase, reduce

or leave unaltered the level of risk associated with the GMM as identified under

paragraph 6.

8. The analysis carried out as described above will finally lead to the

assignment of the activity to one of the classes described in regulation 4(2).

9. The final classification of the contained use should be confirmed by

reviewing the completed assessment referred to in regulation 4(2).

*This would only apply to animals and plants in the environment likely to be exposed.

(1) In order to ensure that the contained use of GMMs does

not produce adverse effects on human health and the environment

the user shall carry out an assessment of the contained uses as

regards the risks to human health and the environment that these

contained uses may incur, using as a minimum the elements of

assessment and the procedure set out in Schedule III, sections A

and B.

(2) The assessment referred to in sub-regulation (1) shall result

in the final classification of the contained uses in four classes

applying the procedure set out in Schedule III, which will result in

the assignment of containment levels in accordance with sub-

regulations (6) and (7)

Class 1: activities of no or negligible risk, for which

level 1 containment is appropriate.

Class 2: activities of low risk, for which level 2

containment is appropriate.

Class 3: activities of moderate risk, for which level 3

containment is appropriate.

Class 4: activities of high risk, for which level 4

containment is appropriate.

(3) Where there is doubt as to which class is appropriate for the

proposed contained use, the more stringent protective measures

shall be applied unless sufficient evidence, in agreement with the

Competent Authority, justifies the application of less stringent

measures.

(4) The assessment referred to in sub-regulation (1) shall

especially take into account the question of disposal of waste and

effluents. Where appropriate, the necessary safety measures shall

be implemented in order to protect human health and the

environment.

(5)

A record of the assessment referred to in sub-regulation (1)

shall be kept by the user and made available in an appropriate form

to the Competent Authority as part of the notification pursuant to

regulations 6, 8 and 9 or on request.

(6) The user shall apply, except to the extent that paragraph 2

of Schedule IV allows other measures to be applied, the general

principles and the appropriate containment and other protective

measures set out in Schedule IV corresponding to the class of the

contained use, so as to keep workplace and environmental exposure

to any GMMs to the lowest reasonably practicable level, and so

that a high level of safety is ensured.

(7) The assessment referred to in sub-regulation (1) and the

containment and other protective measures applied shall be

reviewed periodically, and forthwith if

(a) the containment measures applied are no longer

adequate or the class assigned to the contained uses is

no longer correct, or

(b) there is reason to suspect that the assessment is no

longer appropriately judged in the light of new

scientific or technical knowledge.

CONTAINMENT AND OTHER PROTECTIVE MEASURES

General principles

1. These tables present the normal minimum requirements and measures

necessary for each level of containment.

Containment is also achieved through the use of good work practices, training,

containment equipment and special installation design. For all activities involving

GMMs the principles of good microbiological practice and the following principles

of good occupational safety and hygiene, shall apply

(i)

to keep workplace and environmental exposure to any GMM to the

lowest practicable level;

(ii)

to exercise engineering control measures at source and to supplement

these with appropriate personal protective clothing and equipment

when necessary;

(iii)

to test adequately and maintain control measures and equipment;

(iv)

to test, when necessary, for the presence of viable process organisms

outside the primary physical containment;

(v)

to provide appropriate training of personnel;

(vi)

to establish biological safety committees or subcommittees, if

required;

(vii)

to formulate and implement local codes of practice for the safety of

personnel, as required;

(viii) where appropriate to display biohazard signs;

(ix)

to provide washing and decontamination facilities for personnel;

(x)

to keep adequate records;

(xi)

to prohibit eating, drinking, smoking, applying cosmetics or the

storing of food for human consumption in the work area;

(xii)

to prohibit mouth pipetting;

(xiii) to provide written standard operating procedures where appropriate to

ensure safety;

(xiv) to have effective disinfectants and specified disinfection procedures

available in case of spillage of GMMs;

(xv)

to provide safe storage for contaminated laboratory equipment and

materials, when appropriate.

2. The titles of the tables are indicative

Table I A presents minimum requirements for laboratory activities.

Table I B presents additions to and modifications of Table I A for glasshouse/

growth-room activities involving GMMs.

Table I C presents additions to and modifications of Table I A for activities with

animals involving GMMs.

Table II presents minimum requirements for activities other than laboratory

In some particular cases, it might be necessary to apply a combination of

measures, from Table I A and Table II, of the same level. In some cases users may,

with the agreement of the competent authority, not apply a specification under a

particular containment level or combine specifications from two different levels.

In these tables "optional" means that the user may apply these measures on a case-

by-case basis, subject to the assessment referred to in regulation 4(1).

Table I A

Containment and other protective measures for laboratory activities

Containment levels

Specifications

Laboratory suite

Not required

Not required

Required

Required

isolation ( 1 )

Laboratory: sealable

Not required

Not required

Required

Required

for fumigation

Equipment

Surfaces resistant to

Required

Required

Required

Required

water, acids, alkalis,

(bench)

(bench)

(bench,

(bench,

solvents,

floor)

f l o o r,

disinfectants,

ceiling,

decontamination

walls)

agents and easy to

clean

Not required

Not required

Optional

Required

Entry to lab via

airlock ( 2 )

Negative pressure

Not required

Not required

Required

Required

relative to the

except for

( 1 )

pressure of the

immediate

environment

Extract and input air

Not required

Not required

Required

Required

from the laboratory

( H E PA )

( H E PA )

( 4 )

( 5 ) - input

s h o u l d b e H E PA -

-

filtered

extract air

and

except for

extract air

( 3 )

Microbiological

Not required

Optional

Required

Required

safety post

Autoclave

On site

In

the

En suite

In lab =

( 6 )

double-

building

ended

System of work

Restritted access

Not required

Required

Required

Required

Biohazard sign on the

Not required

Required

Required

Required

door

Specific measures to

Not required

Required

Required

Required

control

aerosol

minimise

prevent

prevent

dissemination

Shower

Not required

Not required

Optional

Required

Protective clothing

Suitable

Suitable

Suitable

Complete

protective

protective

protective

change of

clothing

clothing and

clothing

clothing

(optional)

and

footwear

footwear

before

entry and

exit

Gloves

Not required

Optional

Required

Required

Containment levels

Specifications

Efficient vector

Optional

Required

Required

Required

control (e.g. for

rodents and insects)

Waste

Inactivation

of

Not required

Not required

Optional

Required

GMMs in effluent

from hand-washing

s i n k s o r d r a in s a n d

showers and similar

effluents

Inactivation

of

Optional

Required

Required

Required

GMMs

in

contaminated

material and waste

Other measures

Laboratory to contain

Not required

Not required

Optional

Required

its own equipment

An

observation

Optional

Optional

Optional

Required

window or alternative

is to be present so that

occupants can be seen

( 1 ) Isolation = the laboratory is separated from other areas in the same building or is in a separated

building.

( 2 ) Airlock = entry must be through an airlock which is a chamber isolated from the laboratory. The

clean side of the airlock must be separated from the restricted side by changing or showering

facilities and preferably by interlocking doors.

( 3 ) Activities where transmission does not occur via airborne route.

( 4 ) HEPA = High efficiency particulate air.

( 5 ) Where viruses which are not retained by HEPA filters are used, extra requirements will be

necessary for extract air.

( 6 ) With validated procedures, allowing the safe transfer of material into an autoclave outside the

lab, and providing an equivalent level of protection.

Table I B

Containment and other protective measures for glasshouses and growth-rooms

The terms "glasshouse'' and "growth-room" refer to a structure with walls, a roof

and a floor designed and used principally for growing plants in a controlled and

protected environment.

All provisions of Table I A shall apply with the following additions/modifications

Containment levels

Specifications

Building

Greenhouse

Not required

Required

Required

Required

permanent structure

( 1 )

Equipment

Entry via a separated

Not required

Optional

Optional

Required

room with two

interlocking doors

Control

of

Optional

Minimise

Prevent

Prevent

run-off ( 2 )

contaminated run-off

run-off

run-off

water

System of work

Measures to control

Required

Required

Required

Required

undesired species

such as insects,

rodents, anthropods

Procedures

for

Minimise

Minimise

Prevent

Prevent

transfer of living

dissemina-

dissemina-

dissemina-

dissemina-

material between the

tion

tion

tion

tion

glasshouse/growth-

room, protective

structure

and

laboratory shall

control dissemination

of

genetically

modified micro-

organisms

( 1 ) The glasshouse shall consist of a permanent structure with a continuous waterproofed covering,

located on a site graded to prevent entry of surface-water run-off having self-closing lockable doors.

( 2 ) Where transmission can occur through the ground.

Table I C

Containment and other protective measures for activities in animal units

All provisions of Table I A shall apply with the following additions/modifications

Containment levels

Specifications

Facilities

Optional

Required

Required

Required

Isolation of animal

unit ( 1 )

Animal facilities ( 2 )

Optional

Required

Required

Required

separated by lockable

doors

Animal facilities

Optional

Optional

Required

Required

designed to facilitate

decontamination

(waterproof and

easily

washable

material (cages, etc.))

Floor and/or walls

Optional

Required

Required

Required

easily washable

(floor)

(floor and

(floor and

walls)

walls)

Animals kept in

Optional

Optional

Optional

Optional

appropriate

containment facilities

such as cages, pens or

tanks

Filters on isolators or

Not required

Optional

Required

Required

isolated room ( 3 )

( 1 ) Animal unit: a building, or separate area within a building containing facilities and other areas

such as changing rooms, showers, autoclaves, food storage areas, etc..

( 2 ) Animal facility: a facility normally used to house stock, breeding or experimental animals or

one which is used for the performance of minor surgical procedures.

( 3 ) Isolators: transparent boxes where small animals are contained within or outside a cage; for

large animals, isolated rooms may be more appropriate.

Table II

Containment and other protective measures for other activities

Containment levels

Specifications

General

Vi a b l e

micro-

Optional

Required

Required

Required

organisms should be

contained in a system

which separates the

process from the

environment (closed

system)

Control of exhaust

Not required

Required,

Requ ired ,

Required,

gases from the closed

minimise

prevent

prevent

system

dissemina-

dissemina-

dissemina-

tion

tion

tion

Con tr ol o f aero so ls

Optional

Required,

Requ ired ,

Required,

during

sample

minimise

prevent

prevent

collection, addition of

dissemina-

dissemina-

dissemina-

material to a closed

tion

tion

tion

system or transfer of

material to another

closed system

Inactivation of bulk

Optional

Required, by

Requ ired ,

Required,

culture fluids before

validated

by

by

removal from the

means

validated

validated

closed system

means

means

Seals should be

Minimise

Minimise

Prevent

Prevent

designed so as to

dissemina-

dissemina-

dissemina-

dissemina-

minimise or prevent

tion

tion

tion

tion

release

The controlled area

Optional

Optional

Required

Required

should be designed to

contain spillage of the

entire contents of the

closed system

The controlled area

Not required

Optional

Optional

Required

should be sealable to

permit fumigation

Equipment

Entry via airlock

Not required

Not required

Optional

Required

Surfaces resistant to

Required

Required

Required

Required

water, acids, alkalis,

(bench if

(bench if

(bench if

(bench,

solvents,

any)

any)

any, floor)

f l o o r,

disinfectants,

ceiling,

decontamination

walls)

agents and easy to

clean

Specific measures to

Optional

Optional

Optional

Required

adequately ventilate

the controlled area in

order to minimise air

ventilation

The controlled area

Not required

Not required

Optional

Required

should be maintained

at an air pressure

negative to the

immediate

surroundings

Containment levels

Specifications

Extract and input air

Not required

Not required

Required

Required

from the controlled

(extract

(input and

area should be HEPA

a ir,

extract air)

filtered

optional

for input

air)

System of work

Closed

systems

Not required

Optional

Required

Required

should be located

w i t h in a c o n t r o l l e d

area

Access should be

Not required

Required

Required

Required

restricted

to

nominated personnel

only

Biohazard signs

Not required

Required

Required

Required

should be posted

Personnel should

Not required

Not required

Optional

Required

shower before leaving

the controlled area

Personnel should

Required

Required

Required

Complete

wear

protective

(work

(work

change

clothing

clothing)

clothing)

before exit

and entry

Waste

Inactivation

of

Not required

Not required

Optional

Required

GMMs in effluent

from hand-washing

sinks and showers or

similar effluents

Inactivation

of

Optional

Required, by

Required,

Required,

GMMs

in

validated

by

by

contaminated

means

validated

validated

material and waste

means

means

including those in

process effluent

before final discharge

(1) Without prejudice to regulation 4(1), these regulations

shall not apply

(a) where genetic modification is obtained through the use

of the techniques or methods listed in Schedule II, Part

A, or

(b) for contained uses involving only types of GMMs

meeting the criteria listed in Schedule II, Part B which

establish their safety to human health and the

environment. These types of GMMs are listed in

Schedule II, Part C.

(2) Regulation 4(2), 4(5), 4(6), 4(7) and regulations 6 to 11

shall not apply to the transport of GMMs by road, sea or air.

(3) These regulations shall not apply to the storage, culture,

transport, destruction, disposal or use of GMMs which have been

placed on the market in accordance with the Deliberate Release

i n t o t h e E n v i r o n m e n t o f G e n e t i c a l l y M o d i f i e d O rg a n i s m s

Regulations, or pursuant to other relevant legislation, which

provides for a specific environmental risk assessment similar to

that laid down in the said regulations, provided that the contained

use is in accordance with the conditions, if any, of the consent for

placing on the market.

PART III: PERMITTING AND PENALTIES

PART A

Information required for the notification referred to in regulation 6

name of user(s) including those responsible for supervision and safety,

information on the training and qualifications of the persons responsible

for supervision and safety,

details of any biological committees or subcommittees,

address and general description of the premises,

a description of the nature of the work which will be undertaken,

the class of the contained uses,

only for Class 1 contained uses, a summary of the assessment referred

to in regulation 4(1) and information on waste management.

PART B

Information required for the notification referred to in regulation 8

the date of submission of the notification referred to in regulation 6,

the name of the persons responsible for supervision and safety and

information on the training and qualification,

the recipient, donor and/or parental micro-organism(s) used and, where

applicable, the host-vector system(s) used,

the source(s) and the intended function(s) of the genetic material(s)

involved in the modification(s),

identity and characteristics of the GMM,

the purpose of the contained use including the expected results,

approximate culture volumes to be used,

description of the containment and other protective measures to be

applied, including information about waste management including the

wastes to be generated, their treatment, final form and destination,

a summary of the assessment referred to in regulation 4(1),

the information necessary for the competent authority to evaluate any

emergency response plans if required under regulation 16.

PART C

Information required for the notification referred to in regulation 9

(a)

the date of submission of the notification referred to in regulation 6,

the name of the persons responsible for supervision and safety and

information on the training and qualification;

(b)

the recipient or parental micro-organism(s) to be used,

the host-vector system(s) to be used (where applicable),

the source(s) and intended functions(s) of the genetic material(s)

involved in the modification(s),

identity and characteristics of the GMM,

the culture volumes to be used;

(c)

description of the containment and other protective measures to be

applied, including information about waste management including the

type and form of wastes to be generated, their treatment, final form and

destination,

the purpose of the contained use including the expected results,

description of the parts of the installation;

(d)

information about accident prevention and emergency response plans, if

any specific hazards arising from the location of the installation,

the preventive measures applied such as safety equipment, alarm

systems and containment methods,

procedures and plans for verifying the continuing effectiveness of the

containment measures,

a description of information provided to workers,

the information necessary for the competent authority to evaluate any

emergency response plans if required under regulation 16;

(e)

a copy of the assessment referred to in regulation 4(1).

When premises are to be used for the first time for

c on t a i ned use s , t he u s e r sha ll b e r e qu i re d to s ub m it to th e

competent authority, before commencing such use, a notification

containing at least the information listed in Schedule V, Part A.

Fees

Part A: First time use of facility

Class 1 - €500

Class 2 - €1,200

Class 3 - €4,700

Class 4 - €15,000

Part B: Individual contained use activities

Class 1 - €30

Class 2 - €800

Class 3 - €4,500

Class 4 - €10,000

Part C: Amended Notification

Class 1 - €30

Class 2 - €500

Class 3 - €1,500

Class 4 - €7,000

(1) For the first time or subsequent Class 1 contained uses

to be carried out in premises notified in accordance with regulation

6, a notification containing the information listed in Schedule V,

Part B (excluding the summary of assessment referred to in

regulation 4(1)), shall be submitted to the competent authority. The

C lass 1 co nt ain ed u se m ay proce ed im m ed iat el y fo ll o wi ng

notification.

(2) Users of GMMs in Class 1 contained use shall be required

to keep a record of each assessment referred to in regulation 4(5),

which shall be made available to the competent authority on

request.

(1) For the first and subsequent Class 2 contained uses to

be carried out in premises notified in accordance with regulation 6,

a notification containing the information listed in Schedule V, Part

B shall be submitted to the competent authority.

(2) If the premises have been the subject of a previous

notification to carry out Class 2 or a higher class of contained uses

and any associated consent requirements have been satisfied, the

Class 2 contained use may proceed immediately following the new

notification

Provided that the applicant can, however, himself request a

decision on a formal authorisation from the competent authority.

The decision must be made within a maximum of forty-five days

from the notification.

(3) If the premises have not been the subject of a previous

notification to carry out Class 2 or a higher class of contained uses,

the Class 2 contained use may, in the absence of any indication to

the contrary from the competent authority, proceed forty-five days

after submission of the notification referred to in sub-regulation

(1), or earlier with the agreement of the competent authority.

(1) For the first and subsequent Class 3 or Class 4

contained uses to be carried out in premises notified in accordance

4. with regulation 6, a notification containing the information listed in

Schedule V, Part C shall be submitted to the competent authority.

(2) A Class 3 or higher class of contained use may not proceed

without the prior consent of the competent authority which shall

communicate its decision in writing

(a) at the latest forty-five days after submission of the new

notification, in the case of premises which have been

the subject of a previous notification to carry out Class

3 or a higher class of contained uses and where any

associated consent requirements have been satisfied

for the same or a higher class than the contained use

with which it is intended to proceed;

(b) at the latest ninety days after submission of the

notification, in other cases.

(1) The person submitting a notification in order to obtain

a permit for activities referred to in regulations 6, 7, 8 and 9,

hereinafter referred to as the applicant, shall submit his request in

writing to the competent authority prior to carrying out such

activities.

(2) In order to enable the competent authority to adequately

assess a notification and issue a permit, the application shall be

accompanied by the relevant documents and any other requisite

information as specified and required by the competent authority.

The applicant shall clearly indicate whether the application

prejudices any enforcement case, court case or other causes

currently sub-judice.

(3) The competent authority shall examine the conformity of

the notifications with the requirements of these regulations, the

accuracy and completeness of the information given, the

correctness of the assessment referred to in regulation 4(1) and the

class of contained uses and, where appropriate, the suitability of

the containment and other protective measures, the waste

management, and emergency response measures.

(4)

If necessary, the competent authority may

(a) ask the user to provide further information or to

modify the conditions of the proposed contained use or

to amend the class assigned to any contained use;

Provided that in this case the competent authority may

require that the contained use, if proposed, does not

begin, or, if in progress, is suspended or terminated,

until the competent authority has given its approval on

the basis of the further information obtained or of the

modified conditions of the contained use;

(b) limit the time for which the contained use should be

permitted or subject it to certain specific conditions.

(5) For the purpose of calculating the periods referred to in

regulations 8 and 9, any period of time during which the competent

authority

(a) is awaiting any further information which it may have

requested from the notifier in accordance with sub-

regulation (4)(a), or

(b) is carrying out a public inquiry or consultation in

accordance with regulation 15,

shall not be taken into account.

(6) Whenever the competent authority issues a permit, it may

impose such conditions as it may deem fit and appropriate.

(7) Whenever the competent authority refuses such permit, it

shall inform the applicant of the reasons for such refusal.

(8) The period of validity of such permit shall also be

established at the discretion of the competent authority.

(9) The applicant shall provide a copy of any published results

and other publications relevant to this permit to the competent

authority within three months from the date of publication.

(10) The competent authority shall not issue or renew any permit

if the applicant in question has not fulfilled or honoured any of the

conditions or obligations arising from any other permit issued by

the competent authority under these regulations and, or the related

CONTAINED USE OF GENETICALLY

MODIFIED MICRO-ORGANISMS

regulations.

11.(1)(a) If new information subsequently becomes available to

the competent authority which could have significant

consequences for the risks posed by the contained use,

the competent authority may require the user to modify

the conditions of, or suspend or terminate, the

contained use.

(b) Where a user becomes aware of new information or

modifies the contained use in a way which could have

significant consequences for the risks posed by it, the

user shall discontinue the contained use and, as soon

as practicable, inform the competent authority.

(2) Prior to resuming a contained use discontinued in

accordance with sub-regulation (1), the user shall -

(a) review the assessment carried out in accordance with

regulation 4, and the class and level of containment

applied in accordance with regulation 4(2); and

(b) submit an amended notification to the competent

authority.

(3) For the purposes of sub-regulation (2) the provisions in

relation to the submission of a notification by a user in accordance

with regulations 6, 8 or 9, and to the processing and determination

of such a notification by the competent authority in accordance

with regulation 10, shall apply, as appropriate, to an amended

notification as if it were a notification under regulations 6, 8 or 9.

(1) Any person shall be guilty of an offence under these

regulations if

(a) he fails to comply with any provision of these

regulations or fails to comply with permit conditions

or with any order lawfully given in terms of any

provision of these regulations; or

(b) he contravenes any restriction, prohibition or

requirement imposed by or under these regulations; or

(c) he acts in contravention of any of the provisions of

these regulations; or

(d) he makes a statement or presents information or

documentation, which such person knows to be false

for the purpose of obtaining the approval or

continuation of a permit in line with regulations 6, 8, 9

or 11(2)(b); or

(e) he conspires or attempts to conspire, aids or attempts

to aid, abets or attempts to abet, counsel or attempt to

counsel, procures or attempt to procure any other

person to contravene the provisions of these

regulations or to fail to comply with any such

provisions, including any order lawfully given in terms

of any of the provision of these regulations, or to

contravene any restriction, prohibition or requirement

imposed by or under the said regulations or by virtue

thereof.

(2) Any person who commits, or attempts to commit an offence

against these regulations shall, on conviction, be liable to the

following range of penalties

(a) on first conviction for an offence under Class 1 a fine

(multa) of not less than five hundred euro (€500) but

not exceeding one thousand euro (€1,000); on a second

or subsequent convictions for an offence under Class

1, a fine (multa) of not less than one thousand euro

(€1,000), but not exceeding two thousand five hundred

euro (€2,500) or to imprisonment for a term not

exceeding two years or to both such fine and

imprisonment;

(b) on first conviction for an offence under Class 2 a fine

(multa) of not less than one thousand euro (€1,000) but

not exceeding two thousand euro (€2,000); on a

second or subsequent convictions for an offence under

Class 2, a fine (multa) of not less than two thousand

euro (€2,000), but not exceeding three thousand five

hundred euro (€3,500) or to imprisonment for a term

not exceeding two years or to both such fine and

imprisonment;

(c) on first conviction for an offence under Class 3 a fine

(multa) of not less than two thousand five hundred

euro (€2,500) but not exceeding six thousand euro

(€6,000); on a second or subsequent convictions for an

offence under Class 3, a fine (multa) of not less than

four thousand five hundred euro (€4,500), but not

exceeding twenty-five thousand euro (€25,000) or to

imprisonment for a term not exceeding two years or to

both such fine and imprisonment;

(d) on first conviction for an offence under Class 4 a fine

(multa) of not less than twelve thousand euro

(€12,000) but not exceeding twenty-five thousand euro

(€25,000); on a second or subsequent convictions for

an offence under Class 4, a fine (multa) of not less

than twenty-five thousand euro (€25,000), but not

exceeding thirty-five thousand euro (€35,000) or to

imprisonment for a term not exceeding two years or to

both such fine and imprisonment

Provided that the Court shall order any person who has

b e e n f o u n d g u i l t y o f c o m m i t t i n g a n o ff e n c e a g a i n s t t h e s e

regulations to pay for the expenses incurred by the competent

authority as a result of the said offence, including any remedying

action for any damage caused by the said offence, the revocation of

the permit issued by the competent authority and the confiscation

of the corpus delicti, including any expenses incurred for the

keeping and transport of the said corpus delicti.

(3) The Court shall order the offender to remove the causes of

the offence and to undo anything which was done without a permit

within a time sufficient for the purpose to be fixed by the Court;

and, if the offender fails to comply with any such order within the

time so fixed, he shall be liable to a fine (multa) of not less than

sixty euro (€60) and not more than five hundred euro (€500), as the

Court may fix, for every day that the default continues after the

expiration of the said time.

(4) The provisions of articles 23 and 30 of the Criminal Code

shall apply, mutatis mutandis, to proceedings in respect of offences

against these regulations, so however that the disqualification from

holding or obtaining a licence or permit from the competent

authority shall in no case be for less than one year.

(5) Notwithstanding the provisions of article 370 of the

Criminal Code, proceedings for an offence against these

regulations shall be held before the Court of Magistrates (Malta) or

the Court of Magistrates (Gozo), as the case may be, and shall be in

accordance with the provisions of the Criminal Code regulating the

procedure before the said courts as courts of criminal judicature.

(6) Notwithstanding the provisions of the Criminal Code, the

Attorney General shall always have a right of appeal to the Court of

Criminal Appeal from any judgement given by the Court of

Magistrates (Malta) or the Court of Magistrates (Gozo) in respect

of proceedings for any offence against these regulations.

The competent authority may organise inspections and

other control measures to ensure user compliance with these

regulations.

PART IV: PUBLIC CONSULTATION AND CONFIDENTIALITY

(1) Where disclosure of data related to these regulations,

affects one or more of the following -

(a) the confidentiality of the proceedings of public

authorities, international relations and national

defence,

(b) public security,

(c) matters which are, or have been, sub judice, or under

enquiry (including disciplinary enquiries), or which

are the subject of preliminary investigation

proceedings,

(d) commercial and industrial confidentiality, including

intellectual property,

(e) the confidentiality of personal data and, or files,

(f)

material supplied by a third party without that party

being under a legal obligation to do so,

(g) material, the disclosure of which would make it more

likely that the environment to which such material is

related would be damaged,

the notifier may indicate the information in the notifications

submitted pursuant to these regulations that should be treated as

confidential

Provided that a verifiable justification must be given in

such cases.

(2) The competent authority shall decide, after consultation

with the notifier, which information will be kept confidential and

shall inform the notifier of its decision.

(3) In no case may the following information, when submitted

according to regulations 6, 8 or 9, be kept confidential

(a) the general characteristics of the GMMs, name and

address of the notifier, and location of use,

(b) class of contained use and measures of containment,

(c) the evaluation of foreseeable effects, in particular any

harmful effects on human health and the environment.

(4) The competent authority shall not divulge to third parties

any information decided to be confidential according to

subregulation (2) and notified or otherwise provided pursuant to

these regulations, and shall protect intellectual property rights

relating to the data received.

(5) If, for whatever reasons, the notifier withdraws the

notification, the competent authority must respect the

confidentiality of the information supplied.

Without prejudice to regulation 14, the competent authority

may hold public consultations on aspects of the proposed contained

use where it considers to be appropriate.

PART V: ACCIDENTS AND EMERGENCY PLANS

(1) The competent authority shall ensure that before a

contained use commences

(a) an emergency plan is drawn up for contained uses

where failure of the containment measures could lead

to serious danger, whether immediate or delayed, to

humans outside the premises and, or to the

environment, except where such an emergency plan

has been drawn up under other relevant legislation;

(b) information on such emergency plans, including the

relevant safetymeasures to be applied, is supplied in an

appropriate manner, and without them having to

request it, to bodies and authorities liable to be

affected by the accident. The information shall be

updated at appropriate intervals. It shall also be made

publicly available.

(2) The competent authority shall at the same time make

available to other Member States concerned, the same information

as that which is disseminated to their nationals.

(1) In the event of an accident, the user shall be required

to inform immediately the competent authority and provide the

following information

(a) the circumstances of the accident,

(b) the identity and quantities of the GMMs concerned,

(c) any information necessary to assess the effects of the

accident on the health of the general population and

the environment,

(d) the measures taken.

(2) The user shall also inform the competent authority, cited in

the Protection of Workers from Risks related to Exposure to

Biological Agents at Work Regulations, of such accident.

(3) Where information is given pursuant to sub-regulation (1),

the competent authority, in collaboration with the competent

authority cited in sub-regulation (2), shall be required to

(a) ensure that any measures necessary are taken, and

immediately alert other Member States which could be

affected by the accident,

(b) collect, where possible, the information necessary for

a full analysis of the accident and, where appropriate,

make recommendations to avoid similar accidents in

the future and to limit the effects thereof.

(4) In the event of an accident, the competent authority, in

collaboration with the competent authority cited in sub-regulation

(2), may require the user to defray or contribute towards any or all

of the costs incurred by it arising from such accident.

The competent authority shall consult with other Member

States, likely to be affected in the event of an accident, on the

proposed implementation of emergency plans.

PART VI: FEES

(1) A fee shall be paid to the competent authority in

respect of

(a) a notification of a first time use of a premises given to

the competent authority under regulation 6, in

accordance with the applicable fees indicated in Part A

of Schedule VI, whichever is appropriate;

(b) a notification of an individual contained use given to

the competent authority under regulations 7, 8 and 9,

in accordance with the applicable fees indicated in

Part B of Schedule VI, whichever is appropriate;

(c) an amended notification of a contained use given to

the competent authority under regulation 11, in

accordance with the applicable fees indicated in Part C

of Schedule VI, whichever is appropriate.

(2) The competent authority may carry out, or arrange to have

carried out, such additional investigations as it considers necessary,

as part of its examination or monitoring of a notification of a

contained use to enable it properly to assess the notification and

may require the user to defray or contribute towards the cost of any

such investigations.

(3) The competent authority may recover the amount of any

payment due to it arising from a requirement under regulation

17(4).

PART VII: OTHER PROVISIONS

Schedules I to VI are being published in the English

language with the English text of these regulations.