- Commenced on 20 August 2007
- [This is the version of this document at 31 December 2014.]
- [Note: This version of the Act was revised and consolidated in the Fifth Revised Edition of the Laws of Malawi (L.R.O. 1/2018), by the Solicitor General and Secretary for Justice under the authority of the Revision of the Laws Act.]
Part 1 – Preliminary provisions
1. Short titleThis Act may be cited as the Biosafety Act.
2. InterpretationIn 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. ApplicationThis Act shall apply to—
Part II – Administration
4. Administration of the ActThis 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 officersIn 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 MinisterThe Minister shall—
Part III – Biosafety Fund
7. Establishment of the Biosafety Fund
8. LevyThe 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 MinisterThe 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.[Cap. 37:01]
10. Advances to the FundIf 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 FundThe objects for which the Fund is established shall be the safe management of biotechnological activities.
12. Application of the FundWithout derogation from the generality of section 11, the Fund may be applied to—
13. Books and other records of accounts, audit and reports of the Fund
14. Holdings of the Fund
15. Financial yearThe 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 authorityThe Minister shall be the licensing authority responsible for the granting, renewal, variation, suspension and revocation of licences under this Act.
17. GMO licenceSubject 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—
18. Special arrangements
19. Other classes of licences
20. ExemptionsThe 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
22. Matters to be considered, before issuing a licenceWhere 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—
23. Issue of licences
24. Suspension, and revocation of a licence
25. Variation of a licenceSubject 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
Part VI – Promotion of sales of genetically modified organisms or products thereof
28. Regulations on advertisementThe Minister may make regulations which may prohibit issue of advertisements—
29. Meaning of advertisement
Part VII – 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 ActAn inspector shall not be personally liable in respect of any act done by him in good faith in the course of his employment and in the execution or purported execution of any duty under this Act.
Part VIII – Appeals
36. Appeals committee
37. Powers of appeals committee
Part IX – Miscellaneous provisions
38. Secrecy to be observed
39. OffencesAny person who—
40. Penalty for offences
History of this document
31 December 2014 this version
20 August 2007