LEGAL SUPPLEMENT to the Government Gazette of Mauritius No. 40 of 30 April, 2004
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THE GENETICALLY MODIFIED ORGANISMS ACT 2004
Act No. 3 of 2004
I assent
A R BUNDHUN
Ag. President of the Republic
15th April 2004
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ARRANGEMENT OF SECTIONS
Section
1. Short title
2. Interpretation
3. Application of Act
4. National Biosafety Committee
5. Objects of the Committee
6. Functions of the Committee
7. Application for GMO permit
8. Grant or refusal of GMO permit
9. Suspension or revocation of GMO permit
10. Prohibition notice
11. Stop order
12. Consultation on notices
13. Variation notice
14. Service of notice
15. Revocation of notices
16. Appeals
17. Confidentiality
18. Registration of facilities
19. Monitoring powers
20. Accidents
21. Labelling and identification
22. Offences
23. Jurisdiction
24. Regulations
25. Commencement
____________
AN ACT
To provide for measures to regulate the responsible planning, development, production, use, marketing and application of genetically modified organisms
Enacted by the Parliament of Mauritius, as follows -
1. Short title
The Act may be cited as the Genetically Modified Organisms Act 2003.
2. Interpretation
In this Act -
“accident” means an incident involving an unintended release of genetically
modified organisms which could have an immediate or delayed adverse impact
on the environment or human and animal health;
“applicant” means a person in control of a facility involving the genetic
modification of organisms, or of activities involving genetically modified
organisms, who applies for a GMO permit;
“authorised officer” means a public officer designated as such by the Permanent
Secretary;
“Chairperson” means the Chairperson of the Committee;
“Committee” means the National Biosafety Committee set up under section 4’
“contained use” means any operation undertaken within a facility which involves
genetically modified organisms that are controlled by specific measures to
effectively limit their contact with, and their impact on, the external environment;
“environment” has the same meaning as in the Environment Protection Act 2002;
“facility” includes, but is not limited to, the following:
(a) a building or part of a building;
(b) a laboratory;
(c) a green house;
(d) a glasshouse;
(e) an insectary;
(f) an animal house;
(g) a field;
(h) any other place,
where activities involving genetically modified organisms are carried on.
“general release” means the introduction of genetically modified organisms into
the environment by whatever means where the organisms are no longer
contained by any system of barriers or under any person’s control, so that the
organisms are likely to survive and be disseminated;
“genetically modified organism (GMO)” –
(a) means an organism, the genes or genetic material of which has
been modified in a way that does not occur naturally through
mating or natural recombination, or both; and
(b) includes any of its derivatives;
“GMO permit” means a permit issued by the Permanent Secretary under section
8;
“member” –
(a) means a member of the Committee; and
(b) includes the Chairperson;
“Minister” means the Minister to whom responsibility for agriculture is assigned;
“monitoring” means the maintaining of regular surveillance over, the checking of,
the warning about, or the recording of, any activity involving genetically modified
organisms;
“organism” –
(a) means a cellular or non-cellular biological entity, capable of
metabolism, replication, reproduction or of transferring genetic
material; and
(b) includes a microorganism;
“Permanent Secretary” means the Permanent Secretary of the Ministry;
“trial release” means the deliberate release of genetically modified organisms in
confinement into the environment under conditions where the degree of
dissemination of the genetically modified organisms is restricted by chemical,
physical or built-in barriers which prevent the survival of such organisms outside
the confined area;
“user” means a person responsible for the use of genetically modified organisms,
and includes an end-user or a consumer.
3. Application of Act
(1) This Act shall apply to the genetic modification of organisms which occurs
through –
(a) recombinant nucleic acid techniques involving the formation of
new combinations of genetic material;
(b) techniques involving the direct introduction into an organism of
foreign nucleic acid molecules; or
(c) cell fusion, including protoplast fusion, beyond the same
taxonomic family or hybridization techniques where live cells with
new combination of genetic material are formed.
(2) This Act shall not apply –
(a) to techniques involving genetic manipulation of human cells; or
(b) in cases where recombinant nucleic acid molecules or genetically
modified organisms are not employed.
4. National Biosafety Committee
(1) There is established for the purpose of this act a National Biosafety
Committee, which shall consist of –
(a) a Chairperson, with expertise in biotechnology and related fields,
appointed by the Minister;
(b) a representative of the Ministry;
(c) a representative of the Ministry responsible for environment;
(d) a representative of the Ministry responsible for health;
(e) a representative of the Ministry responsible for international trade;
(f) a representative of the Mauritius Sugar Industry Research
Institute;
(g) a representative of the University of Mauritius;
(h) a representative of the Food and Agricultural Research Council;
(i) a representative of the Mauritius Research Council;
(j) a law officer designated by the Attorney-General;
(k) a representative of consumer associations, appointed by the
Minister.
(2) (a) Every member, other than the ex-officio members, shall hold office
for 2 years and shall be eligible for reappointment.
(b) The Minister may revoke the appointment of a member referred to
in subsection 1(a) or 1(k) for any reason specified in section
37(3)(b) of the Interpretation and General Clauses Act or where
he is of opinion that the person is no longer qualified to be a
member.
(3) (a) The Committee shall meet as and when required by the
Chairperson, or upon request of not less than 3 members, but not
less than 4 times a year.
(b) 6 members shall constitute a quorum.
(4) The Committee may, with the Minister’s approval, co-opt any other
person to attend its meetings for a specific purpose, or period of time, but
without the right to vote.
(5) Where any matter is being or is to be, considered by the Committee and a
member has a direct or indirect interest in it or there is likely to be a
conflict of interest as a result of his participation in the debate, he shall
forthwith declare his interest and abstain from participating in the debate.
(6) The Minister may, at the request of the Committee, appoint independent
professionals or consultants to assist the Committee in the discharge of
its functions under this Act.
5. Objects of the Committee
The objects of the Committee shall be to advise the Minister on –
(a) all aspects concerning the importation, exportation, transit,
development, research, production, use, application, marketing,
sale and release of genetically modified organisms; or
(b) any other matter concerning genetically modified organisms that
may be referred to it.
6. Functions of the Committee
(1) The Committee shall have such functions as are necessary to further
most effectively the objects of the Committee, and in particular to –
(a) publish guidelines and a code of practice, with the approval of the
Minister, for all uses of genetically modified organisms;
(b) encourage public participation in decision-making while
maintaining confidentiality of information;
(c) advise the Permanent Secretary, as and when required, on the
appropriate strategy in cases of emergency;
(d) examine any application made pursuant to section 7, and make its
recommendations to the Permanent Secretary.
(2) In examining an application under subsection 1(d), the Committee shall
take account of the proposed activity of the GMO in respect of its likely –
(a) direct or indirect effects on the environment and human and
animal health; and
(b) social and economic effects on people and society.
7. Application for GMO permit
(1) Notwithstanding any other enactment, no person shall develop, use,
market, produce, release into the environment, transit, import or export
genetically modified organisms unless he holds a GMO permit issued
under this Act.
(2) An application shall be made to the Permanent Secretary in the form set
out in the First Schedule and on payment of a prescribed application fee.
(3) (a) The applicant shall submit a risk assessment report and a
contingency plan in the form set out in the Second Schedule.
(b) A risk assessment for the purpose of paragraph (a) shall be
carried out in a scientifically sound manner.
(4) On receipt of an application under subsection (2),
(a) the Permanent Secretary shall –
(i) cause a notice of any application for a GMO permit to be
published in the Gazette and for 3 consecutive days, in not
less than two daily newspapers;
(ii) invite all interested persons, who so wish, to lodge with the
Permanent Secretary such objections as they may have
against the application.
(b) the Minister shall make a statement in the National Assembly
informing it of such application.
(5) Any person who wishes to object to an application shall, not later than 21
days after the last date of the publication specified in subsection (4),
lodge his objection in writing with the Permanent Secretary.
(6) The Permanent Secretary -
(a) may, on receipt of an application, request the applicant to furnish
such additional information as he may consider appropriate;
(b) may, if he deems necessary, seek the views of any public
department, non-government organisation or any other person on
the application; and
(c) shall refer the application, together with any additional information
and views expressed thereon, to the Committee for its
recommendations.
(7) The Committee shall endeavour to identify and evaluate the possible
adverse effects of the genetically modified organisms on the environment
and on human and animal health.
8. Grant or refusal of GMO permit
(1) The Permanent Secretary, after taking into consideration the
recommendation of the Committee, may –
(a) Subject to subsection (3), grant a GMO permit and issue such
permit on payment of the prescribed fees and on such terms and
conditions as he may deem appropriate;
(b) reject the application, giving his reasons for so doing, with a
direction to communicate the decision together with the reasons to
the applicant.
(2) The reasons on which a decision under subsection (1)(b) is made shall be
communicated, by registered post, to the applicant, within 7 days of the
decision.
(3) No GMO permit shall be issued under subsection (1) (a) except after the
relevant particulars of the intended GMO permit holder shall have been
specified in regulations made to that effect.
(4) Any regulations made under subsection (3) may be subject to a motion
for disallowance under section 20 of the Interpretation and General
Clauses Act.
9. Suspension or revocation of GMO permit
(1) Where –
(a) a permit holder changes the type of activity allowed by his permit
or otherwise breaches any of the terms and conditions of his
permit;
(b) a permit holder moves his activity from a facility specified in his
application form to a facility which, in the opinion of the Permanent
Secretary, is not a fit and proper facility;
(c) the activity of the permit holder impacts adversely on the
environment or on human and animal health, the Permanent
Secretary may by notice in writing require the GMO permit holder
to show cause, within 7 days from date of service of the notice,
why his permit ought not to be suspended or revoked.
(2) Where the Permanent Secretary is satisfied that, having regard to all the
circumstances of the case, it is expedient to do so, he may suspend the
permit for such period as is reasonable in the circumstances, or revoke
the permit.
(3) The Permanent Secretary shall communicate, by registered post, any
decision under subsection (2) to the GMO permit holder within 7 days of
the decision.
10. Prohibition notice
(1) Where he is of the opinion that a facility or the manner in which the facility
is carrying on its activities involves a serious risk to environment or to
human or animal health, the Permanent Secretary may serve, or cause to
be served, a prohibition notice on the person owning, or managing, or in
charge of, or in control of the facility.
(2) A prohibition notice may be served whether or not –
(a) the facility, or the manner in which the activity is carried on,
constitutes a contravention of this Act;
(b) there is in force in relation to the facility a GMO permit issued
under this Act;
(c) there is before any Court of law or before a Judge sitting in
Chambers any case involving the subject matter in relation to
which a notice is being issued, unless the Court or Judge has
issued an order preventing the Permanent Secretary from issuing
the prohibition notice.
(3) A prohibition notice shall –
(a) state the Permanent Secretary’s opinion;
(b) specify the risk involved, as well as the way in which the facility, or
the manner in which the activity is carried on, is suspected to give
rise to the risk;
(c) specify the measures that shall be taken to eliminate the risk and
the period within which they shall be implemented;
(d) specify –
(i) the facility, or any aspect of the facility, that is prohibited
from operation or performance; or
(ii) any conditions subject to which the activity may be
resumed.
(4) A prohibition notice shall not be a bar to a prosecution for any offence,
even if there are consultations with the person served with the notice.
(5) Any person who fails to comply with a prohibition notice, shall commit an
offence.
11. Stop order
(1) Where a person commences or carries on any development or activity
without the relevant GMO permit issued under this Act, the Permanent
Secretary may, where such development or activity contravenes this Act,
serve, or cause to be served, on that person, or any person responsible
for the giving of instructions for the carrying on of such development or
activity, a stop order prohibiting the development or the activity.
(2) Any person who fails to comply with a stop order issued under subsection
(1) shall commit an offence.
12. Consultation on notices
(1) Before or at any time after issuing a notice, the Permanent Secretary
shall as far as he deems practicable, consult –
(a) the person affected;
(b) the Committee.
(2) The Permanent Secretary may consult a technical advisory committee set
up by him, or any public department, on a notice.
13. Variation notice
(1) Any person affected by a notice, may apply to the Permanent secretary
for an amendment of the notice.
(2) The Permanent Secretary, on his own initiative, or on application, may
amend a notice by causing to be served on the person affected a
variation notice.
(3) A variation notice shall –
(a) refer to the notice which is amended;
(b) specify the amendment to the notice;
(c) where necessary, vary the date specified in the notice.
(4) A variation notice shall supersede the notice to which it refers to the
extent of the amendment.
14. Service of notice
(1) A notice issued under this Act shall be served –
(a) personally on the person affected, or in the case of a body
corporate, at its registered address; or
(b) by registered post sent to, or by leaving a copy at, the last known
address of the person affected.
(2) Where service could not be effected by the means referred to in
subsection (1), the service shall be effected by affixing a copy of the
notice –
(a) at the facility which is the subject matter of the notice;
(b) where a contravention is being committed, or has been
committed, or is suspected to have been committed.
(3) A certificate of an authorised officer or any other officer of the Ministry as
to service under subsection (1) shall be prima facie evidence of effective
service of the notice on the person affected.
15. Revocation of notices
Where he is satisfied that –
(a)(i) the measures required to be taken in a notice have been
implemented; and
(ii) there exists no further risk to the environment or to human
or animal health caused by the activity or the manner in
which the activity is carried on; or
(b) the notice is not, or will not be effectual,
the Permanent secretary may revoke a notice and shall inform the person
affected in writing.
16. Appeals
(1) Any person who feels aggrieved by a decision taken by the Permanent
Secretary may, within 21 days of the communication of the decision to
him, and on payment of the prescribed fee, appeal against the decision to
the Appeal Board appointed under subsection (2) by a written notice
together with the grounds of appeal.
(2) The Minister shall appoint on an ad hoc basis an Appeal Board
comprising a Chairperson, who shall be a barrister with at least 5 years
standing at the bar, and 2 members, being persons with expert
knowledge in the field of biotechnology or related fields.
(3) A person appointed under subsection (2) shall challenge himself if he has
any direct or indirect interest in the subject matter of the appeal.
(4) Any appeal lodged before the Appeal Board shall be dealt with as
expeditiously as possible and the Appeal Board shall endeavour to
dispose of the appeal within 6 months from the date the appeal was
lodged.
(5) The Appeal Board may, after giving the parties to the appeal an
opportunity of being heard, pass such orders as it thinks fit, confirming,
varying or setting aside the decision appeal against.
(6) The Appeal Board shall send, by registered post, a copy of every order
made by it to the parties to the appeal within 7 days.
17. Confidentiality
(1) No person shall disclose any information acquired by him through the
exercise of his powers or the performance of his duties under this Act
other than –
(a) the description of any genetically modified organism, the name
and address of any applicant, the purpose of the contained use or
release and the place of use;
(b) the methods and plans for the monitoring of genetically modified
organisms in case of accident;
(c) the evaluation of any foreseeable disruptive impacts on human or
animal health or on the environment; or
(d) any other information as may be approved by the Permanent
Secretary.
(2) Where an applicant withdraws an application, any person who has
knowledge of the details of the application shall respect the confidentiality
of the information supplied.
(3) Nothing in the subsection (1) or (2) shall prevent the disclosure of
information –
(a) in so far as if is necessary for the proper application of this Act; or
(b) for the purpose of any legal proceedings under this Act.
18. Registration of facilities
(1) The Permanent Secretary shall keep a register of all facilities.
(2) Every GMO permit holder responsible for the management of any facility
shall register the facility with the Permanent Secretary.
(3) The register shall contain the –
(a) name and address of the GMO permit holder;
(b) details of the activities carried on; and
(c) location and description of the facility.
19. Monitoring powers
(1) Subject to subsection (2), where an authorised officer reasonably
believes that a facility is being used for any activity involving genetically
modified organisms, including contained use, trial release or general
release, he may enter and inspect the facility for the purpose of inspecting
and monitoring the activities carried on therein and to ensure compliance
with this Act, any regulations made thereunder and any GMO permit
issued under this Act.
(2) Where the authorised officer reasonably believes that any activity
specified in subsection (1) is being carried on in a dwelling house, he may
enter and inspect either with the consent of the owner or occupier of the
dwelling house, or in virtue of a warrant to that effect issued by a
Magistrate.
(3) The authorised officer may, in the course of an inspection –
(a) secure copies of any relevant document kept in the facility;
(b) secure, on reasonable grounds, any material which he believes to
be evidential material.
20. Accidents
(1) Every person who is informed or becomes aware of an accident shall
immediately notify the Permanent Secretary.
(2) Where a GMO permit holder notifies an accident, he shall supply to the
Permanent Secretary –
(a) all relevant information on the circumstances of the accident, the
identity, quantity and quality of genetically modifies organisms
released and any other information necessary to assess the
impact of the accident on the environment and on human and
animal health; and
(b) the details of any emergency measures taken to avoid or mitigate
any adverse impact on the environment and human and animal
health.
(3) The Permanent Secretary shall appoint on an ad hoc basis a Special
Committee comprising a Chairperson and 2 members, being persons
having wide expertise in the field relating to the accident, to enquire into
the circumstances of the accident and make a report with
recommendations to the Permanent Secretary.
(4) The Permanent Secretary may, after taking into consideration the report
and recommendations of the Special Committee, and where he considers
that the accident has had an adverse impact on the environment or on
human or animal health, take a decision under section 9(2).
(5) The Permanent Secretary shall inform as soon as reasonably practicable
any other country of any accident which may have an impact on that
country’s environment or on human and animal health in that country.
21. Labelling and identification
(1) Every GMO permit holder shall ensure that any genetically modified
organisms is clearly identified and labelled, specifying the relevant traits
and characteristics of the product.
(2) The labelling of any genetically modified organisms shall comply with
such requirements as may be prescribed.
22. Offences
(1) A person who –
(a) fails to comply with any condition, permit, or prohibition under this
Act;
(b) obstructs or hinders an authorised officer in the exercise of his
functions under this Act;
(c) provides information under this Act which is false or misleading in
any material particular;
(d) otherwise contravenes this Act,
shall commit an offence and shall, on conviction, be liable –
(i) on a first conviction to a fine not exceeding Rs 50,000 and
to imprisonment for a term not exceeding 2 years;
(ii) on a second or subsequent conviction, to a fine not
exceeding Rs 100,000 and to imprisonment for a term not
exceeding 4 years.
(2) In addition to any penalty under subsection (1), the Court may order the
forfeiture of any animal, plant, organism or any article used in, or
connected in any way with, the commission of an offence.
23. Jurisdiction
(1) An authorised officer may swear an information and conduct prosecution
in respect of an offence under this Act before a Magistrate.
(2) Notwithstanding section 114 of the Courts Act and section 72 of the
District and Intermediate Courts (Criminal Jurisdiction) Act, a magistrate –
(a) shall have jurisdiction to try an offence under this Act; and
(b) may impose any penalty and forfeiture provided by this Act.
24. Regulations
(1) The Minister may make such regulations as he thinks fit for the purposes
of this Act.
(2) Any regulations made under subsection (1) may –
(a) provide for the levying of fees and charges;
(b) lay down requirements for laboratory development of genetically
modified organisms;
(c) set out standards to which facilities for activities involving
genetically modified organisms should conform;
(d) make provision for quarantine, transit, marketing, sale, transport,
handling and packaging of genetically modified organisms;
(e) provide for liabilities of GMO permit holders in respect of prejudice
caused by their activities to other persons;
(f) amend the Schedules.
(3) Regulations made under this Act may provide that any person who
contravenes them shall commit an offence and shall, on conviction, be
liable to a fine not exceeding 50,000 rupees and to imprisonment for a
term not exceeding 2 years.
25. Commencement
(1) Subject to subsection (2), this Act shall come into operation on a date to
be fixed by Proclamation.
(2) Different dates may be fixed for the coming into operation of different
sections of this Act.
Passed by the National Assembly on the twenty-third day of March two thousand
and four.
André Pompon
Clerk of the National Assembly