BIOSAFETY CO-ORDINATING COMMITTEE REGULATIONS

SUBSIDIARY LEGISLATION 549.31

BIOSAFETY CO-ORDINATING COMMITTEE

REGULATIONS

13th February, 2004

LEGAL NOTICE 290 of 2002.

The title of these regulations is the Biosafety Co-ordinating

Committee Regulations.

Composition of the Biosafety Co-ordinating Committee

The Biosafety Co-ordinating Committee shall consist of

(a) the Director of the Environment Protection Directorate or his authorised

representative as Chairman of the Committee,

(b) a public officer responsible for biosafety, designated by the Chairman of

the Environment and Resources Authority,

(c) a public officer responsible for public health, designated by the Minister

responsible for public health,

(d) a public officer responsible for occupational health and safety,

designated by the Chairman of the Occupational Health and Safety

Authority,

(e) a public officer responsible for biodiversity protection, designated by

the Chairman of the Environment and Resources Authority,

(f)

a public officer responsible for agriculture and fisheries, designated by

the Minister responsible for agriculture and fisheries,

(g) a scientist to act as a representative and Chairman of the Scientific

Support and Advisory Sub-Committee,

(h) any other representative as required by the competent authority.

The objective of these regulations is to set up a committee

with the aim to achieve an integrated approach on biosafety, the

contained use of genetically-modified micro-organisms, the

deliberate release into the environment of genetically-modified

organisms and the placing of the market of genetically-modified

organisms, in order to achieve a high level of protection of human

health and the environment taken as a whole, without prejudice to

other relevant regulations.

The terms of reference of the Biosafety Co-ordinating Committee shall include the

following

(a) to ensure the implementation of the provisions of the main regulations;

(b) to evaluate the notifications required in connection with the main

regulations and these regulations;

(c) to supply the recommendations resulting from the evaluation referred to

in paragraph (b) above to the competent authority within the time-

frames set in the main regulations;

(d) to ensure that appropriate monitoring and enforcement measures are

taken in accordance with the provisions of these regulations and the

main regulations;

(e) to collaborate with relevant entities forming the BCC with respect to

monitoring, inspections and enforcement;

(f)

to deal with infringements of permit conditions;

(g) to identify any existing laboratories or installations which fall under the

scope of these regulations and the main regulations;

(h) to establish criteria for emergency plans;

(i)

to set up procedures for consultation of the public;

(j)

to establish a public register of locations utilised for the deliberate

release of genetically modified organisms;

(k) to ensure that confidentiality of information and intellectual property

rights with respect to genetically modified micro-organisms and

BIOSAFETY CO-ORDINATING COMMITTEE

genetically modified organisms are respected;

(l)

to liase with the Malta Standardisation Authority in connection with

labeling and packaging requirements and ensure that the products

placed on the market comply with specified labelling and packaging

requirements;

(m) to advise the competent authority on educational campaigns and

training exercises necessary;

(n) to liase with other entities involved in related issues, including nature

protection, phytosanitary requirements, civ.il protection, land use, waste

management, etc.;

(o) to establish a reporting system aimed at supplying the general public

and the competent authority with relevant information;

(p) to keep abreast of developments in the field of biosafety and

genetically-modified organisms;

(q) to propose any improvements required for the implementation of these

regulations and the main regulations;

(r) any other function as may be conducive to the better performance of its

functions under these regulations and the main regulations.

In these regulations, unless the context otherwise requires

"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 genetically modified micro-

organisms 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 the general population

and the environment;

"deliberate release" means any intentional introduction into the

environment of a genetically modified organism or a combination

of genetically modified organisms for which no 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" (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

(i)

genetic modification occurs at least through the use of

the techniques listed in Annex I, Part A of the

Contained Use of Genetically Modified Micro-

Organisms Regulations;

(ii) the techniques listed in Annex I, Part B, are not

considered to result in genetic modification of the

Contained use of Genetically modified Micro-

Organisms Regulations;

"genetically modified organisms" (GMO) means an organism,

with the exception of human beings, in which the genetic material

has been altered in a way that does nor 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 A of the Deliberate

Release into the Environment of Genetically Modified

Organisms Regulations;

(b) the techniques in Schedule IA, Part 2, of the Deliberate

Release into the Environment of Genetically Modified

Organisms Regulations are not considered to result in

genetic modification;

"main regulations" mean the Contained use of Genetically

Modified Micro-Organisms Regulations, and the Deliberate

Release into the Environment of Genetically Modified Organisms

Regulations;

"Minister" means the Minister responsible for the environment;

"notifier" means the person submitting the notification;

"notification" means the submission to the competent authority

of the requisite information specified in the main regulations;

"placing on the market" means making available to third parties,

whether in return for payment or free of charge;

"time-frames" means the time-frames for different notifications

and processes cited in the main regulations;

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

contained use of genetically modified micro-organisms.

The competent authority shall ensure that the conditions of,

procedure for the grant of the permit and compliance monitoring

shall be fully co-ordinated, in order to guarantee an effective

integrated approach by all authorities competent for this procedure.

For this purpose, there shall be a Biosafety Co-ordinating

Committee, hereafter referred to as the BCC or the Committee.

(1) The composition and terms of reference of the BCC

shall be as shown in Schedules I and II respectively.

(2) The competent authority shall appoint a secretary to the

Committee.

(3) The members of the Committee shall be so appointed for a

term of three years

Provided that the Chairman and the other members of the

Committee may resign their office at any time by giving notice in

writing to the Minister, and the Minister may at any time remove

the Chairman and, or any of the members of the Committee on

grounds of disability to perform their functions, bankruptcy or

neglect of duty.

(4) Without prejudice to any of these regulations, the

Committee may regulate its own procedures and meetings.

(1) A Scientific Support and Advisory Sub-Committee

may be set up by the Chairman in order to assist the BCC on

specific scientific and advisory issues

Provided that, once set up, a permanent representative of

this sub-committee will be on the BCC for a period specified in

regulation 6(3).

(2) The Chairman may set up any other sub-committees to

assist the BCC as it may be required.

Any person requiring any permit under the main

regulations shall submit the notifications for a permit to the

competent authority, which shall forward such notifications to the

Biosafety Co-ordinating Committee.

(1) Should such notifications be required under the main

regulations, individual institutions represented in the Committee

and mentioned in Schedule I shall assess the notifications in terms

of their legal remits and requirements and report back to the BCC

within the period set in the main regulations.

(2) The Committee may decide to forward the notifications to

the Scientific Support and Advisory Sub-Committee or to any other

public entity for consultation before finalising its

recommendations.

(3) Based on the assessment and consultations mentioned in

su bregul at ion s (1 ) and (2), th e Com m itt ee wil l f orward i ts

recommendations to the competent authority within the period set

in the main regulations.

(4) The

competent

authority

shall

assess

these

recommendations and the notifications and shall forward its

decision to the notifier or user on the legal basis set in the main

regulations.

Any monitoring compliance and enforcement activities of

relevance to the main regulations or the BCC shall be undertaken

by the individual institutions represented in the Committee and

mentioned in Schedule I, and the committee shall act in terms of

the legal remits and requirements of the institutions and report back

to the BCC.

Schedules I to II are being published in the English

language with the English text of these regulations.