BIOSAFETY

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

[20TH AUGUST 2007]

PART I
PRELIMINARY PROVISIONS

1.   Short title

   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;

   (b)   establish contact and maintain liaison with appropriate bodies involved in biosafety;

   (c)   promote awareness of biosafety issues;

   (d)   maintain an inventory of all premises and persons involved in biotechnology;

   (e)   approve safety aspects of import, export, manufacture, processing and selling of genetically modified organisms and products thereof;

   (f)   conduct an inquiry, including a public inquiry, into any matter requiring an investigation under this Act;

   (g)   collect or arrange for the collection of information relating to accidents involving biotechnological matter;

   (h)   collect and disseminate information on safety procedures;

   (i)   advise generally on all biosafety activities including—

      (i)   the application of biotechnology;

      (ii)   the biosafety manpower requirements of Malawi;

      (iii)   biosafety research and technology;

      (iv)   biosafety education, not only at advanced level in respect of quality and quantity of potential manpower training, but also at lower levels in respect of general science education for the public; and

      (v)   biosafety documentation, statistics, surveys and general information;

   (j)   carry out independently or in collaboration with any appropriate person, body of persons, agency or institution such surveys and investigations as he may consider necessary;

   (k)   sponsor such national and international biosafety conferences as he may consider appropriate;

   (l)   act as a channel for liaison with the outside world for the routing of information and resources of aid to assist the country’s research efforts; and

   (m)   promote and ensure the maximum coordination of and cooperation in all biosafety activities in order to benefit from the concentration of efforts and to minimize undesired duplications in order to achieve maximum efficiency from, and throughout, the entire socio-economic system.

PART III
BIOSAFETY FUND

7.   Establishment of the Biosafety Fund

   (1) There is hereby established a fund to be known as the Biosafety Fund (in this Act otherwise referred to as the “Fund”).

   (2) The Fund shall consist of—

   (a)   such sums as shall be appropriated by Parliament for the purposes of the Fund;

   (b)   all fees payable under this Act;

   (c)   the levy imposed under section 8;

   (d)   such sums or other assets as may be received for the purpose of the Fund by way of voluntary contributions or donations; and

   (e)   such sums as are paid by way of penalties or costs in respect of offences under this Act.

8.   Levy

   The Minister may, from time to time, by order published in the Gazette, impose a levy on gross or net income accruing to any person or class of persons licensed under this Act and such levy shall be applied for the objects of the Fund as the Minister may specify in the order.

9.   Vesting of the Fund in the Minister

   The Fund shall be vested in the Minister and, subject to this Act and the Finance and Audit Act, shall be administered in accordance with his directions.

10.   Advances to the Fund

   If in any financial year the income of the Fund, together with any surplus income brought forward from a previous year, is insufficient to meet the actual or estimated liabilities of the Fund, the Minister responsible for finance may make advances to the Fund in order to meet the deficiency or any part thereof and such advances shall be made on such terms and conditions, whether as to repayment or otherwise as the Minister responsible for finance may determine.

11.   Objects of the Fund

   The objects for which the Fund is established shall be the safe management of biotechnological activities.

12.   Application of the Fund

   Without derogation from the generality of section 11, the Fund may be applied to—

   (a)   research and training which is calculated to promote the safe management of biotechnological activities;

   (b)   the acquisition of land, equipment, materials and other assets and the construction of buildings in order to promote the objects of the Fund;

   (c)   the cost of any scheme which the Minister considers to be in the interest of the safe management of biotechnological activities;

   (d)   meeting any expenses arising from the establishment and maintenance of the Fund; and

   (e)   any purpose which the Minister considers to be in the interest of the objects of the Fund.

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

   (1) The Minister shall cause to be kept proper books and other records of account in respect of receipts and expenditures of the Fund in accordance with the Finance and Audit Act.

   (2) The accounts of the Fund shall be audited by the Auditor General who shall have powers conferred upon him by the Finance and Audit Act.

   (3) The Minister shall cause to be prepared, as soon as practicable, but not later than six months after the end of the financial year an annual report on all the financial transactions of the Fund.

14.   Holdings of the Fund

   (1) All sums received for the purposes of the Fund shall be paid into a bank account and no amount shall be withdrawn therefrom except by means of cheques signed by such persons as are authorized in that behalf by the Minister

   (2) Any part of the Fund not immediately required for the purposes of the Fund may be invested in such manner as the Minister responsible for finance, may determine.

15.   Financial year

   The financial year of the Fund shall be the period of twelve months commencing on 1st July in one year and ending on the 30th June of the following year:

   Provided that the first financial year of the Fund may be a period shorter or longer than twelve months as the Minister shall determine, but in any case not longer than eighteen months.

PART IV
LICENCES AND PERMITS

16.   Licensing authority

   The Minister shall be the licensing authority responsible for the granting, renewal, variation, suspension and revocation of licences under this Act.

17.   GMO licence

   Subject to the provisions of this Act and except in accordance with a licence granted under this section (hereinafter referred to as a “GMO licence”), no person shall engage in—

   (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.

18.   Special arrangements

   (1) The Minister may grant a permit to an applicant authorizing him to engage in activities mentioned in section 17 for—

   (a)   scientific research or experimental purposes; or

   (b)   emergency supply of food for human beings.

   (2) An application for permit under subsection (1) shall be made in the prescribed form and shall be accompanied by the prescribed fees.

   (3) A permit issued under subsection (1) may exempt the holder thereof from any or all provisions of this Act.

   (4) The Minister may, by notice in writing given to the holder of a permit under subsection (1)—

   (a)   revoke the permit; or

   (b)   vary or revoke the conditions to which the permit is subject or specify further conditions.

19.   Other classes of licences

   (1) Subject to the provisions of this Act and except in accordance with a licence granted under this section (hereinafter referred to as a “product licence”), no person shall, in the course of business earned on by him—

   (a)   sell, supply, export or import genetically modified organisms or products thereof;

   (b)   procure for sale, supply or exportation of genetically modified organisms or products thereof; and

   (c)   procure the manufacture of genetically modified organisms or products thereof for sale, supply or export.

   (2) No person shall in the course of any business carried on by him, manufacture genetically modified organisms or products thereof except in accordance with a licence granted for that purpose (hereinafter referred to as a “manufacturer’s licence”).

   (3) No person shall, in the course of any business carried on by him, sell or supply genetically modified organisms or products thereof by way of wholesale dealing except in accordance with a licence granted for that purpose (hereinafter referred to as a “wholesale dealer’s licence”).

   (4) No person other than a person lawfully carrying on a retail pharmacy business shall sell or supply genetically modified organisms or products thereof by way of dispensing except in accordance with a licence granted for that purpose (hereinafter referred to as a “dispensing licence”).

20.   Exemptions

   The provisions of section 19 shall not apply to the importation of genetically modified organisms or products thereof in such circumstances as may be specified by the Minister in a notice published in the Gazette.

21.   Application for a licence

   (1) Any application for a licence under this Act shall be made in the prescribed form.

   (2) Any application referred to in subsection (1) shall contain a description of products to which the licence will relate.

22.   Matters to be considered before issuing a licence

   Where an application is made for a licence under this Act the Minister shall, before issuing the licence to which the application relates, consider the following—

   (a)   the safety of genetically modified organisms or products thereof of each description to which the application relates;

   (b)   the efficacy of genetically modified organisms or products thereof of each such description for the purposes for which the organisms or products are proposed to be administered;

   (c)   the quality of products of each description, according to the specification and the method or proposed method of manufacture of genetically modified organisms or products thereof, and the organisms or products when sold or supplied will be of that quality;

   (d)   the operations and procedures proposed to be carried out pursuant to the licence;

   (e)   the premises in which operations and procedures are to be carried out;

   (f)   the equipment which is or will be available on the premises for carrying out operations and procedures;

   (g)   the qualifications of the person under whose supervision operations and procedures will be carried out;

   (h)   the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, genetically modified organisms or products thereof manufactured or assembled in pursuance of the licence;

   (i)   the premises on which genetically modified organisms or products thereof of the description to which the application relates will be stored;

   (j)   the equipment which is or will be available for storing products on those premises;

   (k)   the equipment and facilities which are or will be available or distributing genetically modified organisms or products thereof from those premises; and

   (l)   the arrangement made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of genetically modified organisms or products thereof stored on or distributed from those premises.

23.   Issue of licences

   (1) If the Minister is satisfied that the applicant is a fit and proper person to engage in activities set out in section 17 or to carry on any business set out in section 19, the Minister may issue to the applicant the licence appropriate to such business subject to such general or special conditions as the Minister may consider appropriate to impose.

   (2) A licence issued under subsection (1) shall be in such form, and shall be for such duration, as may be prescribed.

   (3) Where the Minister considers that the applicant is not fit and proper person to whom a licence should be issued, he shall refuse to issue a licence.

24.   Suspension and revocation of a licence

   (1) Subject to this Part, the Minister may—

   (a)   suspend licence for such period as he may determine;

   (b)   revoke the licence; or

   (c)   vary the provisions of the licence.

   (2) The suspension or revocation or a licence under this section may be limited to biotechnological products of one or more descriptions, or to any particular premises or to a particular part of any premises.

25.   Variation of a licence

   Subject to section 21, the Minister may on the application of holder of a licence under this Part vary the provisions of the licence in accordance with any proposals contained in the application, if the Minister is satisfied that the variation will not adversely affect the safety, quality or efficacy of genetically modified organisms or products thereof.

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

26.   Labelling

   (1) No person shall, in the course of a business carried on by him, sell or supply or have in his possession for the purpose of selling or supplying genetically modified organisms or products thereof in a container or package which is not labelled in accordance with regulations made under section 41.

   (2) Without prejudice to subsection (1), no person shall, in the course of a business carried on by him, sell or supply, genetically modified organisms or products thereof of any description in a container or package which is labelled or marked in such a way that the container or package—

   (a)   falsely describes the genetically modified organisms or product; or

   (b)   is likely to be misleading as to the nature, efficacy or quality of genetically modified organism or product or as to the uses or effects of genetically modified organisms or product of that description.

   (3) Any person who contravenes this section shall be guilty of an offence.

27.   Leaflets

   (1) No person shall, in the course of a business carried on by him, supply or have in his possession for the purpose of supplying together with genetically modified organisms or products thereof a leaflet relating to such organisms or products which does not comply with regulations made under section 41.

   (2) Without prejudice to subsection (1), no person shall, in the course of a business carried on by him, supply together with genetically modified organisms or products thereof or have in his possession for the purpose of so supplying a leaflet which—

   (a)   falsely describes genetically modified organisms or products thereof to which it relates; or

   (b)   is likely to be misleading as to the nature, efficacy or quality of such genetically modified organisms or products thereof.

   (3) Any person who contravenes this section shall be guilty of an offence.

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

28.   Regulations on advertisement

   The Minister may make regulations which may prohibit issue of advertisements—

   (a)   relating to genetically modified organisms or products thereof of a description or a class specified in the regulations;

   (b)   likely to lead to the use of genetically modified organisms or products thereof or any other substance or article, for the purpose of treating or preventing a disease so specified or of ascertaining the existence, degree or extent of a physiological condition so specified or of permanently or temporarily preventing or otherwise interfering with the normal operation of a physiological function so specified or for the purpose of artificially inducing a condition of body or mind so specified;

   (c)   likely to lead to the use of genetically modified organisms or products thereof of a particular description or class specified in the regulations or the use of any other substance or article of a description or class so specified for any such purpose as is mentioned in paragraph (b); and

   (d)   relating to genetically modified organisms or products thereof and containing a word or phrase specified in the regulations, as being a word or phrase which, in the opinion of the Minister, is likely to mislead the public as to the nature or effects of the organisms or products.

29.   Meaning of advertisement

   (1) In this Part “advertisement” includes every form of advertising, whether in a publication, or by the display of any notice or by means of any catalogue, price list, letter, whether circular or addressed to a particular person, or by exhibition of a photograph or a cinematograph film, or by way of sound recording, sound broadcasting or television.

   (2) Notwithstanding anything contained in subsection (1), “advertisement” does not include spoken words except—

   (a)   words forming part of a sound recording or embodied in a sound-track associated with a cinematograph film;

   (b)   words broadcast by way of sound broadcasting or television or transmitted to subscribers to a diffusion service; and

   (c)   anything spoken in public.

   (3) Save as regulations made under section 28 may otherwise provide, the following shall not for purposes of this Part constitute an advertisement—

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