Laws of Malawi

BIOSAFETY

Muli bwanji!Lilongwe

CHAPTER 60:03
BIOSAFETY

ARRANGEMENT OF SECTIONS

    SECTION

PART I
PRELIMINARY

    1.    Short title

    2.    Interpretation

    3.    Application

PART II
ADMINISTRATION

    4.    Administration of the Act

    5.    Appointment of other officers

    6.    Functions of the Minister

PART III
BIOSAFETY FUND

    7.    Establishment of the Biosafety Fund

    8.    Levy

    9.    Vesting of the Fund in the Minister

    10.    Advances to the Fund

    11.    Objects of the Fund

    12.    Application of the Fund

    13.    Books and other records of account, audit and reports of the Fund

    14.    Holdings of the Fund

    15.    Financial year

PART IV
LICENCES AND PERMITS

    16.    Licensing authority

    17.    GMO licence

    18.    Special arrangements

    19.    Other classes of licences

    20.    Exemptions

    21.    Application for a licence

    22.    Matters to be considered before issuing a licence

    23.    Issue of licences

    24.    Suspension and revocation of a licence

    25.    Variation of a licence

PART V
CONTAINERS, PACKAGES AND IDENTIFICATION OF GENETICALLY MODIFIED ORGANISMS OR PRODUCTS THEREOF

    26.    Labelling

    27.    Leaflets

PART VI
PROMOTION OF SALES OF GENETICALLY MODIFIED ORGANISMS OR PRODUCTS THEREOF

    28.    Regulations on advertisement

    29.    Meaning of advertisement

PART VII
INSPECTION

    30.    Inspection

    31.    Entry into premises

    32.    Mode of inspection

    33.    Non-disclosure of information

    34.    Inspectors not to be personally liable for acts done by them under this Act

PART VIII
APPEALS

    35.    Appeals

    36.    Appeals committee

    37.    Powers of the appeals committee

PART IX
MISCELLANEOUS PROVISIONS

    38.    Secrecy to be observed

    39.    Offences

    40.    Penalty for offences

    41.    Regulations

    

13 of 2002
G.N. 26/2007

    An Act to provide for the safe management of biotechnological activities and to provide for matters connected therewith and incidental thereto

PART I
PRELIMINARY PROVISIONS

1.    Citation

    This Act may be cited as the Biosafety Act.

2.    Interpretation

    In this Act, unless the context otherwise requires—

    “accident” means any incident involving an unintended general release of biotechnological products which could have an immediate or delayed adverse impact on the environment;

    “appeals committee” means an appeals committee appointed under section 35;

    “biotechnology” means any technique that uses living organisms or parts of organisms to—

    (a)    make or modify products;

    (b)    improve plants or animals: or

    (c)    develop micro-organisms for specific purposes;

    “contained use” means any activity in which organisms are genetically modified or in which genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of and for which physical barriers or a combination of physical, chemical or biological barriers are used to limit contact thereof with the environment;

    “environment” means the aggregate of surrounding objects, conditions and influences that affect the life and habits of man or any other organisms or collection of organisms;

    “Fund” means the Biosafety Fund established under section 7;

    “general release” means the introduction of genetically modified organisms into the environment, by whatever means, where the organisms are no longer under the control of any person;

    “gene therapy” means a technique for delivering functional genes to replace aberrant ones into living cells by means of a genetically modified vector or by physical means in order to genetically alter the living cell;

    “genetically modified organism” means an organism whose genes or genetic material has been modified in a way that does not occur naturally through mating or natural recombination;

    “hazard” means an intrinsic biological chemical or physical characteristic of genetically modified organisms or products thereof which could lead to an adverse impact on the environment;

    “inspector” means a person appointed as an inspector under section 30;

    “organism” means any biological entity, whether microscopic or not, capable of replication;

    “permit” means a permit issued under section 18;

    “risk” means the combination of the magnitude of the consequences of a hazard, if it occurs, and the likelihood that the consequences will occur;

    “trial release” means the deliberate release of genetically modified organisms into the environment under conditions where the degree of dissemination of the genetically organisms is limited by chemical or physical barriers or by built-in barriers which prevent the survival of such organisms in the environment;

    “waste” means any matter, whether gaseous, liquid, solid or any combination thereof, which is an undesirable or superfluous by-product, emission, resolve or remainder of any process or activity in connexion with genetically modified organisms.

3.    Application

    This Act shall apply to—

    (a)    the genetic modification of organisms;

    (b)    the importation, development, production, testing, release, use and application of genetically modified organisms; and

    (c)    the use of gene therapy in animals, including human beings.

PART II
ADMINISTRATION

4.    Administration of the Act

    This Act shall be administered by the Minister responsible for environmental affairs, and such other officers subordinate to him as may be appointed under this Part, whose offices shall be public offices.

5.    Appointment of other officers

    In addition to the Minister, there shall be appointed in the public service such other officers subordinate to the Minister, as may be required for the proper performance of his functions.

6.    Functions of the Minister

    The Minister shall—

    (a)    formulate and review guidelines on biosafety;

…

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