Biosafety Act 2009

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
BIOSAFETY ACT No.19-2009pmd
BIOSAFETY ACT 2009

Arrangement of Sections

PART I – PRELIMINARY

1. Short title
2. Interpretation
3. Precautionary approach
4. Act binds the Crown

PART II – ADMINISTRATIVE RESPONSIBILITIES

5. National Biosafety Advisory Committee
6. Functions of the Committee
7. District Biosafety Advisory Committees
8. Role of the Ministry
9. Powers of the Secretary
10. Other statutory powers not to be affected

PART III - IMPORT PROCEDURE

11. Notices of transboundary movements
12. Approvals for imports
13. Scientific risk assessments
14. Confidential information
15. Exemptions from the procedure
16. Review of decisions

PART IV - OTHER REGULATORY REQUIREMENTS

17. Exportation of Living Modified Organisms
18. Transit of Living Modified Organisms
19. Use for food, feed and for processing
20. Contained use
21. Unintentional releases and transboundary movements
22. Illegal releases and transboundary movements.

PART V - MISCELLANEOUS

23. Offences
24. Designated environment officers
25. Regulations

26. Delegation

27. Indemnities

“contained use” means any operation, undertaken within a facility, installation
or other physical structure, which involves living modified organisms that are
controlled by specific measures that effectively limit their contact with, and
their impact on, the external environment;

“District Committee” means a District Biosafety Advisory Committee
appointed under section 7;

“environment officer” means an officer appointed under section 24(1) of this
Act;

“export” means intentional transboundary movement from the Kingdom to
another State;

“exporter” means any person, under the jurisdiction of the State of export,
who arranges for a living modified organism to be exported;

“import” means intentional transboundary movement into the Kingdom from
another State;

“importer” means any person within the Kingdom who arranges for any
living modified organism to be imported;

“living modified organism” means any living organism that possesses a novel
combination of genetic material obtained through the use of modern
biotechnology;

“living organism” means any biological entity capable of transferring or
replicating genetic material, including sterile organisms, viruses and viroids;

“Minister” means the Minister of Environment;

“Ministry” means the Ministry of Environment;

“modern biotechnology” means the application of –

(a) in vitro nucleic acid techniques, including recombinant deoxyribonucleic
acid (DNA) and direct injection of nucleic acid into cells or organelles;

(b) fusion of cells beyond taxonomic family, that overcome natural
physiological reproductive or recombination barriers and that are not
techniques used in traditional breeding and selection; or

(c) any other process or technique prescribed by Regulations made under
this Act;

“State Party” means a Party to the Cartagena Protocol;

“Secretary” means the Secretary for Environment;

“transboundary movement” means the movement of a living modified organism
from the Kingdom to another State Party, or from another State Party to the
Kingdom, and where indicated in this Act, it may include the movement to or
from non-State Parties.

i2 The Biosafety Act – 19 of 2009

AN ACT
TO REGULATE LIVING MODIFIED ORGANISMS AND THE

APPLICATION OF MODERN BIOTECHNOLOGY

BE IT ENACTED by the King and Legislative Assembly of Tonga in the Legislature
of the Kingdom as follows:

PART I - PRELIMINARY

1. Short title

This Act may be cited as the Biosafety Act 2009.

2. Interpretation

In this Act, unless the context otherwise requires –

“Advanced Informed Agreement Procedure” means the advanced informed
agreement procedure prescribed in the Cartagena Protocol;

“biological diversity” has the same meanings and applications under the
Convention;

“Biosafety Clearing-House” means the Biosafety Clearing-House established
under the Cartagena Protocol;

“Committee” means the National Biosafety Advisory Committee established
under section 5;

“Convention” means the 1992 Convention on Biological Diversity;

“Cartagena Protocol” means the Cartagena Protocol on Biodiversity to the
Convention adopted at Montreal in January 2000 and any subsequent
amendments thereto;

I assent,

GEORGE TUPOU V,

2nd March, 2010.

Tonga. No. 19 of 2009

[29th October, 2009].

3. Precautionary approach

(1) All persons and agencies having responsibilities under this Act, or whose
functions and powers may relate to any matter or thing involving the
development, use, handling and transboundary movement of living
modified organisms and the applications of modern biotechnology within
the Kingdom, shall apply a precautionary approach when discharging
their responsibilities and functions, or exercising their powers.

(2) For the purposes of this section, a precautionary approach is applied if,
in the event of a threat of damage to the environment or a risk to human
health in the Kingdom, a lack of scientific certainty regarding the extent
of adverse effects is not used to prevent or avoid a decision being made
to minimise the potential adverse effects or risks arising from a living
modified organism or the application of modern biotechnology within
the Kingdom.

4. Act binds the Crown

The provisions of this Act shall bind the Crown.

PART II - ADMINISTRATIVE RESPONSIBILITIES

5. National Biosafety Advisory Committee

(1) The National Biosafety Advisory Committee is hereby established.

(2) The Committee shall consist of the Minister, who shall be the chairman,
and one representative each from:

(a) the Ministry responsible for Agriculture, Food, Forestry and
Fisheries;

(b) the Ministry of Health;

(c) the Ministry of Labour, Commerce and Industries;

(d) the Customs Division of the Revenue Services Department;

(e) each relevant non-government organisation; and

(f) the Secretary.

(3) The Secretary shall be the Acting Chairperson where the Minister is
absent.

(4) The Chairman may co-opt any person to the Committee as appropriate.

(5) The Ministry shall provide secretariat services to the Committee.

(6) The Committee shall determine its own procedures.

(7) The members of the Committee may be remunerated in accordance with
current government policies and practices.

(8) The Committee may authorise the Secretary to exercise a power related
to any of its functions in a manner which is consistent with any
procedures approved by the Committee.

(ii) otherwise identified as being or containing living modified organisms
as required by any law and by the Cartagena Protocol;

(i) arranging for certain information to be treated as confidential in accordance
with this Act and the Cartagena Protocol;

(j) facilitating and cooperating in the development and strengthening of
human resources and institutional capacities within the Kingdom in the
field of biosafety;

(k) conducting programs of public awareness and education in relation to
living modified organisms and applications of modern biotechnology,
and facilitating public participation in relation to the processes prescribed
by this Act and envisaged by the Cartagena Protocol in relation to their
use and development within the Kingdom;

(l) facilitating bilateral, regional and multilateral agreements and arrangements
regarding intentional transboundary movements of living modified
organisms, and for the sharing of information and the enhancement of
institutional capacities for the purposes of applying the provisions of
the Cartagena Protocol;

(m) ensuring that the customs and traditions of the Kingdom are taken into
account when the development and use of living modified organisms and
the application of modern biotechnology is under consideration; and

(n) the proper administration of this Act.

9. Powers of the Secretary

(1) The Secretary shall have the power to:

(a) specify the means by which scientifically based risk assessments
are to be carried out and reported upon, including:

(i) the appropriate bodies to undertake the risk assessments;

(ii) the scope of the risk assessments and the methodologies to be
applied; and

(iii) payment of the cost of risk assessments, and reimbursement
to the Government of any costs associated with undertaking
the risk assessments.

(b) require additional risk assessments to be undertaken when decisions
are to be reviewed in accordance with Article 12 of the Cartagena
Protocol;

(c) require that further information be provided under the Advanced
Informed Agreement Procedure, and in relation to any other matter
associated with meeting the obligations and exercising the rights of
the Kingdom under the Cartagena Protocol;

(d) make arrangements for the keeping of certain information
confidential in accordance with the provisions of this Act and the
Cartagena Protocol;

The Biosafety Act – 19 of 2009 36 The Biosafety Act – 19 of 2009

6. Functions of the National Biosafety Advisory Committee

(1) The Committee shall be the Competent National Authority in the
Kingdom for all matters arising from the Cartagena Protocol.

(2) The functions of the Committee as a competent authority shall be to:

(a) oversee the implementation within the Kingdom of all aspects of
the Cartagena Protocol, including the Advanced Informed Agreement
Procedure;

(b) authorise the giving of any notice required by this Act and the
Cartagena Protocol to be given by or on behalf of the Kingdom;

(c) determine and assess appropriate and cost effective means by
which risk assessments are to be undertaken in a scientifically
sound manner as required by the Cartagena Protocol;

(d) make or endorse decisions consistent with the provisions of the
Cartagena Protocol, including:

(i) the exemption of certain living modified organisms from the
requirements of Part III by the appropriate application of
Article 13 of the Cartagena Protocol; and

(ii) the review of decisions in accordance with Article 12 of the
Cartagena Protocol;

(e) monitor the development, use, handling and transboundary
movement of living modified organisms within the Kingdom, and
all matters related to the application of modern biotechnology, and
coordinate responses to unintentional and unlawful transboundary
movements;

(f) devise and implement policies consistent with this Act and the
Cartagena Protocol, and which take account of the particular
impacts of living modified organisms on communities and areas
within the Kingdom;

(g) arrange for the preparation of reports, and authorise the provision
of information in accordance with this Act and the Cartagena
Protocol; and

(h) ensure that Cabinet, and all Ministries and agencies, are fully
informed of any unintended release of living modified organisms
within the Kingdom, and of any other matter associated with living
modified organisms which may affect the well-being of the nation
or the health of its people.

7. District Biosafety Advisory Committees

(1) The Minister may appoint District Biosafety Advisory Committees
for any of the islands of the Kingdom.

(2) The members of the District Committees shall include representatives
of relevant non-government organisations active within the respective
islands.

(3) The District Committees shall be chaired by the respective Governors
or Government representatives.

(4) The functions of District Committees shall be as determined by the
Minister, and may relate to any matter concerning the use and regulation
of living modified organisms as provided for by this Act.

8. Role of the Ministry

For matters relating to the Cartagena Protocol, the Ministry shall be the
designated focal point and shall be responsible for:

(a) providing secretariat and support services to the Committee and District
Committees;

(b) communicating notices, information and reports to the Biosafety Clearing
House, and as otherwise required by the Cartagena Protocol;

(c) dealing with requests for the review of decisions in accordance with
Article 12 of the Cartagena Protocol, and referring such matters to the
Committee with such reports and additional information as is required
for a decision to be effectively reviewed;

(d) arranging for and facilitating the review of risk assessments undertaken
in accordance with this Act and the Cartagena Protocol;

(e) establishing and maintaining appropriate mechanisms, measures and
strategies for the regulation, management and control of risks associated
with living modified organisms and the application of modern
biotechnology within the Kingdom;

(f) implementing measures to control and prevent unintentional and illegal
transboundary movements of living modified organisms, and to respond
to such movements, including the taking of necessary emergency
responses;

(g) ensuring that living modified organisms which are subject to
transboundary movement are handled, packaged and transported under
conditions of safety, and that relevant international standards and rules
are applied in this regard;

(h) liaising with and providing assistance to other Ministries and agencies
to ensure that living modified organisms within the Kingdom, or proposed
to be imported into the Kingdom, are used, handled, stored and
transported in accordance with the requirements of this Act and the
Cartagena Protocol, and that –

(i) they are packaged and labelled so as to disclose their living modified
organism content; and

4 The Biosafety Act – 19 of 2009 The Biosafety Act – 19 of 2009 5

(e) communicate decisions made under this Act and in accordance with
the Cartagena Protocol, and provide information and reports
required by it;

(f) arrange for the monitoring and reporting of the effects to the
environment arising from living modified organisms and the
application of modern biotechnology within the Kingdom;

(g) approve any appropriate program of public information and
education concerning living modified organisms and the
implementation of the Cartagena Protocol; and

(h) do any other act or thing necessary to:

(i) manage the risks associated with living modified organisms
and the application of modern biotechnology within the
Kingdom;

(ii) ensure that the Ministry fulfils its role as focal point under
Article 19 of the Cartagena Protocol; and

(iii) effectively liaise with the Biosafety Clearing-House and the
Secretariat and Conference of the Parties to the Convention.

(2) Where the Committee has exercised a power under section 6(2) which
concerns a matter specified in sub-section (1), the Secretary shall exercise
the power specified in sub-section (1) in a manner which is consistent
with the decision or determination of the Committee.

10. Other statutory powers not to be affected

(1) No power or requirement provided for in any other Act is to be affected
by or derogated from, by any provision of this Act, and all approvals,
permits and licences required to be obtained in relation to the importation,
exportation, development, use, storage, handling or movement of any
living modified organism shall be obtained under any applicable Act,
notwithstanding that additional provision is made under this Act.

(2) Without limiting the generality of sub-section (1), any person seeking to
import, export, develop, use, store or handle a living modified organism
in the Kingdom shall comply with all statutory requirements applying
to the particular living modified organism under laws relating to:

(a) plant and animal quarantine and disease control;

(b) the assessment of impacts on the environment;

(c) the use of pesticides;

(d) the importation and exportation of fish and the development of
aquaculture;

(e) the carriage of goods by air or sea; and

(f) the development and use of medicinal drugs.

14. Confidential information

(1) When giving notice under section 11 or providing any additional
information that is required, the notifier may indicate that certain
information is of a confidential nature, if it is information other than:

(a) the name and address of the notifier;

(b) a general description of the living modified organism or organisms;

(c) a summary of the risk assessment undertaken; and

(d) any proposed methods and plans for emergency response.

(2) If the Secretary is satisfied that the nature of the information justifies it
being kept confidential, the information may only be provided to members
of the Committee, persons undertaking the relevant risk assessment and
environment officers.

(3) No person, to whom the information has been provided under sub-
section (2), may disclose it to any other person, and it may not be used
for any commercial purpose within the Kingdom, except with the written
consent of the notifier.

(4) If the Secretary is not satisfied that the nature of the information justifies
it being kept confidential:

(a) the notifier shall be advised of the Secretary’s decision;

(b) reasons for the decision shall be provided upon request from the
notifier;

(c) the Secretary shall consult with the notifier if requested; and

(d) the decision may be reviewed under section 16.

15. Exemptions from the procedure

(1) The Committee may exempt the importation of a living modified organism
from the provisions of this Act where the notice given under section 11
indicates that the living modified organism is:

(a) to be in transit through the Kingdom;

(b) to be the subject of contained use within the Kingdom;

(c) is for direct use as food, feed or for processing;

(d) of a type that the State Parties to the Cartagena Protocol have
agreed is unlikely to have adverse effects on biological diversity or
pose a risk to human health;

(e) of a type that the Committee considers to be within the scope of
any notice given under Article 13 of the Cartagena Protocol, and if
all requirements of other laws are met in relation to its import into
the Kingdom; and

The Biosafety Act – 19 of 2009 710 The Biosafety Act – 19 of 2009

(3) Nothing in this Act shall affect or derogate from the exercise of any
power under any Act, or the obligation to comply with any Act relating
to:

(a) the importation, exportation and transportation of living organisms;

(b) the assessment of impacts of activities on the environment;

(c) the protection of human health;

(d) the development, sale and use of therapeutic goods;

(e) the establishment and undertaking of business activities; and

(f) consumer protection and the provision of product information to
consumers.

PART III - IMPORT PROCEDURE

11. Notices of transboundary movements

(1) No living modified organism may be imported into the Kingdom unless
notice of the intended transboundary movement has been given to the
Secretary by the exporter or the competent authority of the country
from where the living modified organism is to be exported.

(2) A notice given under sub-section (1) shall be:

(a) in the prescribed form;

(b) accompanied by the prescribed fee; and

(c) delivered to the Secretary.

(3) The Secretary shall acknowledge the receipt of the notice within 90
days of its receipt, and the acknowledgement shall state:

(a) the date of receipt of the notice;

(b) whether the notice appears to be in compliance with sub-section
(2)(a); and

(c) whether an approval is required from the Committee under
section 12, or that it has determined that the approvals required by
other applicable laws in the Kingdom shall be sufficient
authorisation for the intended transboundary movement.

(4) Any failure to acknowledge receipt in accordance with sub-section (3)
shall not be deemed to be consent to the importation of the living
modified organism.

12. Approvals for imports

(1) Subject to section 15, this section shall apply to all imports of living
modified organisms notified under section 11, unless the Secretary has
given notice under section 11(3)(c), that the Committee has determined
that other applicable laws shall constitute sufficient authorisation.

(2) Subject to sub-section (1), no living modified organism may be imported
into the Kingdom unless approval for the transboundary movement has
been given by the Committee under this section.

(3) After consideration of the intended transboundary movement of any
living modified organism under section 13, the Committee shall, within
270 days of the receipt of the notice relating to it,:

(a) approve the import, with or without conditions;

(b) prohibit the import;

(c) request additional information from the notifier;

(d) advise the notifier that the time required for the determination of
the matter is to be extended by a stated period; or

(e) defer a decision until the costs associated with the required risk
assessment have been paid.

(4) Reasons for any decision shall be provided to the notifier, unless the
decision is an unconditional approval for the import.

(5) Any failure to communicate a decision in accordance with sub-
section (3) may not be deemed to be consent to the importation of the
living modified organism.

13. Scientific risk assessments

(1) Decisions made under section 12(3) shall be based upon risk assessments
which shall:

(a) comply with any general requirements imposed by the Committee;

(b) be in accordance with any requirements imposed by the Secretary
under this Act;

(c) be undertaken in a scientifically sound manner taking into account
recognised risk assessment methodologies and techniques;

(d) be based upon the information supplied in the notice given under
section 11 and other available scientific evidence to identify and
evaluate possible adverse effects on biological diversity and risks
to human health; and

(e) be reviewed and assessed by the Secretary.

(2) Risk assessments shall be undertaken by the exporter and the cost of
them shall be the responsibility of the notifier or the exporter, unless the
Secretary determines otherwise.

(3) Nothing in this Act shall prevent a risk assessment being undertaken in
conjunction with any assessment required under any other Act applying
to the importation of a living modified organism.

8 The Biosafety Act – 19 of 2009 The Biosafety Act – 19 of 2009 9

(f) a pharmaceutical for human consumption that is addressed by
other relevant agreements and subject to the control of other
international organisations.

(2) The Committee may, in granting an exemption under sub-section (1),
impose any conditions or requirements relating to the use, storage,
handling or movement of the living modified organism to minimise any
impact on biological diversity or risk to human health.

(3) The Committee may, in granting an exemption for living modified
organisms intended for direct use as food, feed or for processing, require
that the first import of such an organism shall be subject to a risk
assessment in accordance with Annex III of the Cartagena Protocol and
approval by the Committee, and any decision in relation to that import
shall be given not later than 270 days after notice has been given.

Provided that the failure to make or communicate a decision within
270 days may not be deemed to be consent to the importation of the
living modified organism.

16. Review of decisions

(1) An exporter or person who has given notice under section 11 may
request the Minister to review any decision made by the Committee or
the Secretary under this Act , on the grounds that:

(a) a change in circumstances has occurred that may influence the
outcome of the risk assessment upon which a decision has been
based; or

(b) additional relevant scientific or technical information has become
available since the decision was made.

(2) Upon receipt of a request under sub-section (1), the Minister shall
respond in writing to the request within 30 days of its receipt, and shall:

(a) provide the reasons given for the decision that is the subject of the
request for review;

(b) indicate whether a further risk assessment is to be undertaken;

(c) refer the matter, together with all relevant information that has
been provided in support of the request, to the Committee; and

(d) otherwise deal with the review of the decision in the manner
prescribed by Regulations.

(3) The Committee may review and change any decision made under this
Act on the grounds stated in sub-section (1) on its own motion, and in
that event the notifier shall be informed of the change of decision within
30 days.

(4) No change of decision made under this section shall avoid the requirement
to give notices under section 11 for subsequent imports of the living

and shall consult with any affected or potentially affected country
to enable them to determine appropriate responses, including the
taking of emergency measures.

(4) A notice given under sub-section (3) shall comply with Article 17(3) of
the Cartagena Protocol.

22. Illegal releases and transboundary movements

(1) No person may permit, arrange, assist with, counsel, procure, aid or
abet a release of a living modified organism within the Kingdom, if the
release:

(a) does not require approval under this Act; or

(b) arises from the breach of a condition of any approval given under
this Act.

(2) No person may permit, arrange, assist with, counsel, procure, aid or
abet a transboundary movement of a living modified organism from the
Kingdom, if the transboundary movement –

(a) does not require approval consistent with the Cartagena Protocol;
or

(b) arises from the breach of a condition of any approval given in
relation to it.

(3) In addition to any other penalty imposed for a breach of this section, the
person responsible for the breach may be ordered to pay the costs
associated with the disposal of the living modified organism, including
all costs associated with its repatriation from or destruction in any
country to which it has been permitted to move.

PART V - MISCELLANEOUS

23. Offences

(1) Any person who:

(a) imports a living modified organism into the Kingdom in respect of
which no notice has been given as required under this Act;

(b) fails to give any notice required under this Act;

(c) fails to fully disclose all information known to be relevant to the
living modified organism in a notice or application relating to it;

(d) imports a living modified organism into the Kingdom without having
an approval required under this Act;

(e) fails to comply with any condition or requirement imposed under
this Act;

(f) fabricates any risk assessment, or misrepresents any matter
associated with a risk assessment, undertaken in accordance with
this Act;

The Biosafety Act – 19 of 2009 1114 The Biosafety Act – 19 of 2009

modified organism to which the change of decision relates, or prevent
the Secretary from requiring that risk assessments be undertaken in
relation to the subsequent imports.

PART IV - OTHER REGULATORY REQUIREMENTS

17. Exportation of Living Modified Organisms

(1) A person who, exports any living modified organism from the Kingdom
to a State Party, shall, prior to the export of the organism, give written
notice to:

(a) the Secretary; and

(b) the competent authority in the country where the organism is
being exported to.

(2) A notice given under sub-section (1) shall:

(a) contain the information specified in Annex 1 to the Cartagena
Protocol;

(b) contain any further information required by the Ministry or the
relevant competent authority; or

(c) otherwise be in compliance with any Regulation prescribing matters
relevant to the export of living modified organisms from the
Kingdom.

(3) No export of a living modified organism may be made from the Kingdom
to any State Party unless:

(a) it is approved by the competent authority of the State Party;

(b) it is in accordance with any conditions imposed by the relevant
competent authority; and

(c) it has any other approval required under any law.

(4) No living modified organism may be exported to a non-State Party
without the approval of the Committee.

18. Transit of Living Modified Organisms

No living modified organisms may be brought into the Kingdom in transit to
any other country unless:

(a) notice has been given under section 11;

(b) any condition imposed under section 15(2) is complied with; and

(c) the requirements of any law relating to customs and excise, quarantine
and any other relevant matter are complied with.

19. Use for food, feed and for processing

(1) No person may use any living modified organism as food, feed or for
processing in the Kingdom, unless:

(a) section 15(3) has been complied with, if it is being imported into
the Kingdom for the first time; and

(b) all relevant laws regulating its use are complied with, in every case.

(2) The Ministry shall, where approval is given for the direct use of a living
modified organism as food, feed or for processing under any relevant
law, and the living modified organism may be subject to transboundary
movement from the Kingdom:

(a) notify the Biosafety Clearing-House in accordance with Annex II
of the Cartagena Protocol, within 15 days of an approval for export
being given; and

(b) give other notices and information in accordance with Article 11(1)
and 11(3) of the Cartagena Protocol.

20. Contained use

Any contained use of a living modified organism within the Kingdom shall be
in accordance with any condition, requirement or restriction:

(a) imposed under any relevant law; and

(b) prescribed by Regulations, which shall not be inconsistent with the
procedures and requirements imposed under any relevant law.

21. Unintentional release and transboundary movements

(1) Any person who permits or becomes aware of an unintentional release
of a living modified organism into the environment within the Kingdom,
or an unintentional transboundary movement of a living modified
organism from the Kingdom, shall immediately notify the Ministry and
provide such information as the Secretary may require.

(2) An unintentional release or transboundary movement of a living modified
organism for the purposes of this section, is one which –

(a) does not require approval under this Act; or

(b) arises from the breach of a condition of any approval given under
this Act, but which has not been intentionally released or moved
by any person having control of it.

(3) Upon receiving a notice under sub-section (1), the Ministry shall
immediately give notice of the unintentional release or transboundary
movement to:

(a) the members of the Committee;

(b) the Biosafety Clearing-House;

(c) any affected or potentially affected State Party or non-State Party;
and

(d) any other international organisation which the Secretary determines,

12 The Biosafety Act – 19 of 2009 The Biosafety Act – 19 of 2009 13

(g) fabricates or misrepresents any scientific or technical information
relied upon for the purposes of requesting a review of any decision
under this Act;

(h) exports a living modified organism from the Kingdom in respect of
which no notice has been given under this Act;

(i) exports a living modified organism from the Kingdom without
having an approval under this Act;

(j) fails to notify the Ministry of an unintentional release of a living
modified organism or an unintentional transboundary movement
of a living modified organism; or

(k) fails to comply with any other obligation or requirement imposed
under this Act,

commits an offence and shall be liable upon conviction to a fine not
exceeding $500,000 or to imprisonment for a term not exceeding 10
years, or to both.

(2) Any person who provides false information in or for any notice given
under this Act or when required under this Act to provide any information,
commits an offence and shall be liable upon conviction to a fine not
exceeding $15,000.

(3) Any person who divulges or deals with confidential information contrary
to section 13(2) or (3) commits an offence and shall be liable upon
conviction to a fine not exceeding $15,000.

24. Designated environment officers

(1) The Minister may, by notice in the Gazette, designate any person as an
environment officer for purposes of exercising the powers under this
Act.

(2) For the purposes of enforcing the provisions of this Act, all environment
officers may exercise the powers relating to investigating, monitoring,
prosecuting and preventing the continuation of any breach that are
vested in them in any other Act.

(3) In relation to any living modified organism which has been imported
into the Kingdom in contravention of this Act, or which is or remains in
the Kingdom in breach of this Act or any condition imposed under it, an
environment officer may:

(a) seize the living modified organism;

(b) destroy the living modified organism as determined by the
Committee; or

(c) deliver the living modified organism to an officer of another Ministry
to be dealt with in accordance with law.

The Biosafety Act – 19 of 2009 15

(4) Nothing in this Act shall affect the powers to search, seize and deal with
items under laws relating to plant and animal quarantine, customs and
excise and any other law that has application to the development, use,
handling, storage or movement of living modified organisms.

25. Regulations

(1) The Minister may, with the consent of Cabinet, make Regulations for
the purposes of implementing the provisions of this Act and the
Cartagena Protocol, which are not inconsistent with this Act.

(2) Without limiting the generality of sub-section (1), the Regulations may
make provision in relation to:

(a) any forms or fees relating to any notice, approval or other procedure
under this Act;

(b) the keeping of information confidential as provided by this Act;

(c) any requirements, consistent with laws regulating the carriage of
goods by air or sea, relating to the transportation of living modified
organisms;

(d) emergency responses to any unintentional or unlawful release of a
living modified organism, or any other release which has, or may
have, an adverse impact on biological diversity or which poses a
risk to human health; and

(e) the application of agreed rules and procedures relating to liability
and redress for damage resulting from transboundary movements
of living modified organisms.

(3) Regulations made under sub-section (1) may prescribe offences and
impose penalties of fines not exceeding $10,000.

26. Delegation

The Minister may delegate in writing any of his powers under this Act to
designated environment officers.

27. Indemnities

No person exercising any power under this Act shall be liable for any loss or
damage in relation to any exercise of such power.

Passed by the Legislative Assembly this 29 day of October 2009.

16 The Biosafety Act – 19 of 2009 i

LAO FAKAANGAANGA KI HE MALU ‘O E NGAAHI ME’AMO’UI 2009

Fokotu’utu’u ‘o e Ngaahi Kupu

KONGA 1-TALATEU

1. Hingoa nounou

2. ‘Uhinga’i lea

3. Founga tokanga

4. Ha’i ‘e he Lao ‘a e Kalauni

KONGA II – NGAAHI FATONGIA PULE

5. Kômiti Fale’i Fakafonua ki he Malu ‘o e Me’amo’ui

6. Ngaahi fatongia ‘o e Kômiti

7. Ngaahi Kômiti Fale’i Fakavahe ki he Malu ‘o e Me’amo’ui

8. Fatongia ‘o e Potungâue

9. Ngaahi mafai ‘o e Sekelitali

10. ‘Ikai uesia ‘a e ngaahi mafai fakalao kehe

KONGA III - FOUNGA NGÂUE HÛ MAI

11. Fanongonongo ‘o e fe‘aveaki fakavaha’afonua

12. Ngaahi ngofua ke hû mai

13. Sivi fakasaienisi ‘o e ala ke hoko

14. Fakamatala fakapulipuli

15. Faka’atâ mei he founga ngâue

16. Vakai’i ‘a e ngaahi tu’utu’uni

KONGA IV - NGAAHI FIEMA’U PULE’I KEHE

17. Hû atu ‘o e Me’amo’ui kuo Liliu hono Fa’unga Fakaenatula

18. Fakafou ‘o e Me’amo’ui kuo Liliu hono Fa’unga Fakaenatula

19. Ngâue’aki ki he me’atokoni, fafanga mo e ngaohi’aki

20. Ngâue’aki fakangatangata

21. Tukuange mo e fe‘aveaki fakavaha’afonua ‘ikai‘ilo ki ai

22. Tukuange mo e fea‘aveaki fakavaha’afonua ta’efakalao

KONGA V - NGAAHI ME’A KEHE

23. Ngaahi Hia

24. Kau ‘ofisa ‘atakai kuo vahe’i

25. Ngaahi Tu’utu’uni

26. Vahe’i

27. Malu’i

Related Laws