127 tal-2008 - Regolamenti tal-2008 dwar l-Użu Kontenut ta’ Mikro-Organiżmi Ġenetikament Modifikati

L.N. 127 of 2008

ENVIRONMENT PROTECTION ACT

(CAP. 435)

Contained Use of Genetically Modified Micro-organisms

Regulations, 2008

BY virtue of the powers conferred by articles 9, 10(2) and 11 of

the Environment Protection Act, hereinafter referred to as “the Act”,

the Prime Minister has made the following regulations>-

The title of these regulations is the Contained Use of Citation.

Genetically Modified Micro-organisms Regulations, 2008.

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 Objectives.

for the contained use of genetically modified micro-organisms with a

view to protecting human health and the environment.

(2) These regulations provide the provisions required for

the implementation in Malta of the European Council Directive

90#219#EEC of the 23rd of April 1990 on the contained use of genetically

modified micro-organisms 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, 2003, in relation to issues in connection L.N. 228 of 2003.

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.

2. 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 Legal Notice 228 of 2003 on the protection of workers from

risks related to exposure to biological agents at work.

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, 2003 (Legal Notice 228 of 2003).

In these regulations, unless the context otherwise requires>

Interpretation.

“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 Malta Environment and

Planning Authority as prescribed by the notice entitled Nomination

of the Malta Environment and Planning Authority as the competent

authority, 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 (1) ;

(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 plants (1) , or

likely to cause deleterious effects in the environment;

(iii) the GMM is unlikely to cause disease to humans, animals or plants (1) 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).

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

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).

(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) hereof

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) hereof 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) hereof

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 activities.

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: isolation (1)

Not required

Not required

Required

Required

Laboratory: sealable for fumigation

Not required

Not required

Required

Required

Equipment

Surfaces resistant to water, acids, alkalis, solvents,

Required (bench,

Required (bench,

disinfectants, decontamination agents and easy to

Required (bench)

Required (bench)

floor, ceiling,

floor)

clean

walls)

Entry to lab via airlock (2)

Not required

Not required

Optional

Required

Negative pressure relative to the pressure of the

Required except

Not required

Not required

Required

for (1)

immediate environment

Required

Required

(HEPA) (4) –

(HEPA) (5) –

Extract and input air from the laboratory should be

Not required

Not required

HEPA-filtered

extract air

input and

except for (3)

extract air

Microbiological safety post

Not required

Optional

Required

Required

In Lab =

En suite (6)

Autoclave

On site

In the Building

double ended

System of work

Restricted access

Not required

Required

Required

Required

Biohazard sign on the door

Not required

Required

Required

Required

Required

Specific measures to control aerosol dissemination

Not required

Required prevent

Required prevent

minimise

Shower

Not required

Not required

Optional

Required

Complete change

Suitable protective

Suitable

Suitable

of clothing and

clothing and

Protective clothing

protective

protective

(optional)

footwear before

clothing

clothing

footwear

entry and exit

Gloves

Not required

Optional

Required

Required

Efficient vector control (e.g. for rodents and

Optional

Required

Required

Required

insects)

Containment levels

Specifications

Waste

Inactivation of GMMs in effluent from hand-

Not required

Not required

Optional

Required

washing sinks or drains and showers and similar

effluents

Inactivation of GMMs in contaminated material

Optional

Required

Required

Required

and waste

Other measures

Laboratory to contain its own equipment

Not required

Not required

Optional

Required

An observation window or alternative is to be

Optional

Optional

Optional

Required

present so that occupants can be seen

Isolation = the laboratory is separated from other areas in the same building or is in a separated building.

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.

Activities where transmission does nor occur via airborne route.

HEPA = High efficiency particulate air.

Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air.

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

Buildings

Greenhouse: permanent structure (1)

Not required

Required

Required

Required

Equipment

Entry via a separated room with two interlocking

Not required

Optional

Optional

Required

doors

Minimise (2)

Control of contaminated run-off water

Optional

Prevent run-off

Prevent run-off

run-off

System of work

Measures to control undesired species such as

Required

Required

Required

Required

insects, rodents, arthropods

Procedures for transfer of living material between

the glasshouse/growth-room, protective structure

Minimise

Minimise

Prevent

Prevent

and laboratory shall control dissemination of

dissemination

dissemination

dissemination

dissemination

genetically modified micro-organisms

The glasshouse shall consist of a permanent structure with a continuous water proofed covering, located on a site graded to prevent

entry of surface-water run-off having self-closing lockable doors.

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

Isolation of animal unit (1)

Optional

Required

Required

Required

Animal facilities (2) separated by lockable doors

Optional

Required

Required

Required

Animal facilities designed to facilitate

Optional

Optional

Required

Required

decontamination (waterproof and easily washable

material (cages, etc.))

Required (floor

Required (floor

Floor and/or walls easily washable

Optional

Required (floor)

and walls)

and walls)

Animals kept in appropriate containment facilities

Optional

Optional

Optional

Optional

such as cages, pens or tanks

Filters on isolators or isolated room (3)

Not required

Optional

Required

Required

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.

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.

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

Viable micro-organisms should be contained in a

Optional

Required

Required

Required

system which separates the process from the

environment (closed system)

Required,

Required,

Required,

Control of exhaust gases from the closed system

Not required

prevent

prevent

prevent

dissemination

dissemination

dissemination

Control of aerosols during sample collection,

Required,

Required,

Required,

Optional

addition of material to a closed system or transfer

prevent

prevent

prevent

of material to another closed system

dissemination

dissemination

dissemination

Inactivation of bulk culture fluids before removal

Required, by

Required, by

Required, by

Optional

from the closed system

validated means

validated means

validated means

Seals should be designed so as to minimise or

Minimise

Minimise

Prevent

Prevent

prevent release

dissemination

dissemination

dissemination

dissemination

The controlled area should be designed to contain

Optional

Optional

Required

Required

spillage of the entire contents of the closed system

The controlled area should be sealable to permit

Not required

Optional

Optional

Required

fumigation

Equipment

Entry via airlock

Not required

Not required

Optional

Required

Surfaces resistant to water, acids, alkalis, solvents,

Required (bench,

Required (bench

Required (bench

Required (bench

disinfectants, decontamination agents and easy to

floor, ceiling,

if any)

if any)

if any, floor)

clean

walls)

Specific measures to adequately ventilate the

controlled area in order to minimise air

Optional

Optional

Optional

Required

contamination

The controlled area should be maintained at an air

Not required

Not required

Optional

Required

pressure negative to the immediate surroundings

Required (extract

Extract and input air from the controlled area

Required (input

Not required

Not required

air, optional for

should be HEPA filtered

and extract air)

input air)

System of work

Closed systems should be located within a

Not required

Optional

Required

Required

controlled area

Access should be restricted to nominated personnel

Not required

Required

Required

Required

only

Biohazard signs should be posted

Not required

Required

Required

Required

Personnel should shower before leaving the

Not required

Not required

Optional

Required

controlled area

Containment levels

Specifications

Complete

Required (work

Required (work

Personnel should wear protective clothing

Required

change before

clothing)

clothing)

exit and entry

Waste

Inactivation of GMMs in effluent from

Not required

Not required

Optional

Required

handwashing sinks and showers or similar effluents

Inactivation of GM Ms in contaminated material

Required, by

Required, by

Required, by

Optional

and waste including those in process eft1uent

validated means

validated means

validated means

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 into the

Environment of Genetically Modified Organisms Regulations, 2002 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

- 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 contained

uses, the user shall be required to submit to the 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

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

€2.98 (Lm1.28)

(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 Class 1 contained

use may proceed immediately following notification.

(2) Users of GMMs in Class 1 Contained Use shall be

required to keep a record of each assessment referred to in sub-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 Contained Use of

Class 2.

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 45 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 45 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 Contained Use of

uses to be carried out in premises notified in accordance with regulation Class 3 and Class 4.

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 45 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 90 days after submission of the notification,

in other cases.

(1) The person submitting a notification or requesting 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 or a request for permission, 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 would prejudice

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

regulations.

(1) (a) If new information subsequently becomes New information on

risks of contained

available to the Competent Authority which could have significant use.

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 sub-regulation 4(2) thereof< 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 but not exceeding one

thousand euro< on a second or subsequent convictions for an offence

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

but not exceeding two thousand five hundred euro 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 but not exceeding two

thousand euro< on a second or subsequent convictions for an offence

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

but not exceeding three thousand five hundred euro 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 but not

exceeding six thousand euro< on a second or subsequent convictions

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

thousand five hundred euro, but not exceeding twenty-five thousand

euro 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 but not exceeding

twenty-five thousand euro< on a second or subsequent convictions

for an offence under Class 4, a fine (multa) of not less than twenty-

five thousand euro, but not exceeding thirty-five thousand euro 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 been

found guilty of committing an offence against these 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 and

not more than five hundred euro, 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 Applicability of the

Criminal Code.

Code shall apply, mutatis mutandis, to proceedings in respect of offences Cap. 9.

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 sub-

regulation (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 Public consultation.

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 Emergency Plans.

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, 2003, 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 Communication

with other Member

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

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 Fee for notification

the Competent Authority under regulation 6, in accordance with of

premises.

the applicable fees indicated in Part A of Schedule VI, whichever

is appropriate<

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

the Competent Authority under regulations 7, 8 and 9, in accordance of

contained use.

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 Fee for an amended

notification of a

Competent Authority under regulation 11, in accordance with the contained use.

applicable fees indicated in Part C of Schedule VI, whichever is

appropriate<

(2) The Competent Authority may carry out, or arrange Agency

investigations.

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 Recovery of costs or

charges.

any payment due to it arising from a requirement under regulation 17

(4).

PART VII> OTHER PROVISIONS

The Schedules I to IV to these regulations are being published

published in English

in the English language with the English text of these regulations.

The Contained use of genetically modified micro-organisms

Regulations, 2002, is hereby repealed.