The Malawi Gazette Supplement, dated 19th October, 2007, containing Regulations, Rules, etc. (No. 15A)
Government Notice No. 30
(No. 13 of 2002)
BIOSAFETY (MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS)
ARRANGEMENT OF REGULATIONS
Part II—Institutional Framework
3. National Biosafety Regulatory Committee
4. Immunity from suit
5. Tenure of office and vacancies
6. Functions of the Committee
7. Disclosure of interest
8. Appointment of the Biosafety Registrar
9. Functions of the Biosafety Registrar
Part III—Licences and Permits
12. Required information for applications for licences and permits for trial release and contained use.
14. Applications for licence for general release of genetically modified organisms
15. Risk assessment of activities
16. Licensing of facilities and maintenance of records
17. Time within which to determine applications
18. Processing of applications
19. Review of decisions
Part IV—Miscellaneous Provisions
21. Caution and determination of liability
22. Public access to information and confidentiality
23. Requirements for effective management of waste
First Schedule Required Information for Applications of Licences and Permits
Second Schedule Form C—Licence/Permit
Third Schedule Fees
Fourth Schedule Information to be Included in a Risk Assessment Report
Fifth Schedule Information to be Included in an Application for General Release or Marketing of Genetically Modified Organisms
In Exercise of the powers conferred by section 41 of the Biosafety Act, 2002, 1, Khumbo Chirwa, Minister of Lands and Natural Resources, make the following
1. These Regulations may be cited as Biosafety (Management of Genetically Modified Organisms) Regulations, 2007.
2. In these Regulations, unless the context otherwise requires—
"‘applicant” means a person who submits an application for a licence or permit under the Act;
“Committee” means the National Biosafety Regulatory Committee established under regulation 3;
“Biosafety Registrar” means the officer appointed as such under regulation 8;
“operator” means any person who conducts activities under a licence or permit issued under the Act;
“register” means a register established under regulation 8 and containing particulars of Genetically Modified Organisms and activities that are licenced or permitted under the Act;
“risks to human health” means the potential adverse effects of biotechnology activities or their products on human health;
“reviewer” means a reviewer appointed under regulation 11.
Part II—Institutional Framework
3. (1) There shall be a National Biosafety Regulatory Committee which shall consist of the following members, nominated by their institutions and appointed by the Minister—
(a) the Secretary responsible for Agriculture and Food Security or his designated representative;
(b) the Secretary responsible for Health or his designated representative;
(c) the Secretary responsible for Industry and Trade or his designated representative;
(d) the Director General of the Malawi Bureau of Standards or his designated representative;
(e) Secretary responsible for Labour or his designated representative;
(f) the Secretary responsible for Justice or his designated representative;
(g) the Director of Forestry or his designated representative;
(h) the Secretary responsible for Women and Child Welfare or his designated representative;
(i) the Secretary responsible for Nutrition, HIV and Aids or his designated representative;
(j) the Director of National Parks and Wildlife or his designated representative;
(k) the Executive Director for the Council for Non-Governmental Organizations or his designated representative;
(l) the Commissioner for Malawi Revenue Authority or his designated representative;
(m) the Inspector General of the Malawi Police Service or his designated representative; and
(o) the Executive Director for Consumers Association of Malawi or his designated representative.
(2) Members of the Committee shall be paid such an allowance as the Minister shall determine:
Provided that the Minister may make provision for reimbursement of any reasonable expense incurred by a member of the Committee in connection with the business of the committee.
(3) The Minister shall appoint the Chairperson of the National Biosafety Regulatory Committee.
(4) The members of the Committee shall, at their first meeting, elect a Vice Chairperson from amongst their number.
(5) In the absence of the Chairperson and Vice Chairperson the members of the Committee present shall elect a person from their number to preside over a meeting.
(6) The person presiding over a meeting shall exercise all the powers and perform all the duties of the Chairperson whenever the Chairperson is not present.
(7) A member of the Committee whose period of office has expired may be eligible for reappointment.
(8) Each institution shall designate a member and an alternate to serve on the Committee.
(9) The quorum for any meeting of the Committee shall be a simple majority of members.
(10) A decision on any matter before the Committee shall be by a simple majority of votes of the members present.
(11) In the case of an equality of votes, the person presiding over a meeting shall have a casting vote.
(12) The committee shall determine its own procedures for meetings.
(13) The Biosafety Registrar shall be the Secretary to the Committee.
4. No action, suit or other proceedings shall be brought or instituted personally against any member of the Committee or public officer in respect of any act done in faith in the course of carrying out the provisions of the Act or these Regulations.
5. —(1) The members of the Committee shall hold office for a period of three (3) years and may be eligible for reappointment.
(2) A member of the Committee shall cease to be a member of the Committee if—
(a) he resigns as a member of the Committee;
(b) he ceases to be a member or employee of the institution that nominated him for appointment as member of the Committee;
(c) upon, conviction of any offence, he is sentenced to a term of imprisonment without the option of a fine;
(d) he is of unsound mind or an undischarged bankrupt;
(e) he is absent from three (3) consecutive meetings of the Committe, without a valid excuse, of which he has had notice;
(f) he dies; or
(g) the member is compromised to such an extent that his ability to impartially exercise the duties of his office is seriously in question.
6. The Committee shall—
(a) evaluate all applications concerning or related to genetically modified organisms and products thereof and make recommendations to the Minister in that regard;
(b) advise, on request or of its own accord, the Minister on matters concerning genetic modification of organisms, inter alia—
(i) on all aspects relating to the introduction of genetically modified organisms into the environment;
(ii) on all proposals for specific activities or projects concerning the genetic modification of organisms;
(iii) on all aspects concerning the contained use of genetically modified organisms;
(iv) on the exportation and importation of genetically modified organisms;
(v) on the amendment or withdrawal of a licence or permit issued under the Act; and
(vi) on proposed regulations and guidelines;
(c) liaise, through the relevant institutions, with international groups or organizations concerned with biosafety and biotechnology;
(d) invite knowledgeable persons to assist the Committee on any aspect related to genetically modified organisms and;
(e) carry out such other functions that are necessary for the effective implementation of these Regulations.
7. A member of the Committee who has an interest, direct or indirect, in any matter before the Committee shall disclose such interest and shall not take part in the consideration or discussion of the matter.
8. — (1) There shall be appointed, in the public service, a Biosafety Registrar and such other suitably qualified officers as may be required for the administration of these Regulations.
(2) The Biosafety Registrar shall exercise such powers and perform such duties as may be conferred upon him by the Minister, and the Committee.
9. —(1) The Biosafety Registrar shall—
(a) ensure that the provisions of the Act and these Regulations are known to the relevant authorities and the general public;
(b) maintain a register of all biotechnological activities in Malawi and all licences and permits issued under the Act;
(c) receive all documents relating to applications and appeals and transmit them to the Committee and the Minister;
(d) liaise with the Secretariat of the Convention on Biological Diversity;
(e) transmit information on biosafety to the Biosafety Clearing House Mechanism;
(J) facilitate and ensure the training of all inspectors in relevant aspects of biosafety and biotechnology;
(g) maintain a register of experts in biotechnology and biosafety;
(h) perform any other functions as may be conferred upon him by the Minister or the Committee.
10. —(1) Subject to the provisions of section 30 (2) and (3) of the Act, the institutions represented on the Committee shall nominate from their institutions suitably qualified public officers for appointment as inspectors by the Minister in accordance with the section 30 of the Act.
(2) Where the Committee has ascertained or suspects, on reasonable grounds, that genetically modified organisms are being imported or locally produced or used contrary to the provisions of the Act, these Regulations or the conditions of a licence or permit issued thereunder, the Committee shall instruct inspectors to—
(a) require the cessation of any genetic modification activity at the facilities where the provisions of the Act or the conditions of a licence or permit have not been or are not being complied with;
(b) ensure that appropriate measures are undertaken by all users at all times with a view to protect human health and the environment from hazards;
(c) serve notice upon any person by whom or on whose behalf genetically modified organisms are being imported into, produced or used in Malawi contrary to the Act or these Regulations, for the removal of such genetically modified organisms, to a place or facility and in a manner prescribed by the Committee; or
(d) destroy such genetically modified organisms or cause them to be destroyed, subject to procedures stipulated in the guidelines issued by the Minister.
11. —(1) The Committee may, before it considers any application for a licence or a permit, appoint one or more experts in any relevant field to review the application so as to provide the Committee with sufficient information to enable it make an informed decision.
(2) In the performance of the powers of appointment in accordance with subregulation (1) above, the Committee shall ensure that the composition of the reviewers reflects the expertize necessary to undertake a proper review of the subject in question and shall determine the size of each review team.
(3) The reviewers shall be responsible for reviewing risk assessment reports and auditing processes in order to establish the impact of the biotechnological activities on the environment and human health.
(4) The reviewers shall submit a report to the Committee, in respect of any assessment undertaken, giving, inter alia,—
(a) an opinion of the viability of the project under consideration;
(b) a description of any measures or actions that need to be taken to ensure the safe use of genetically modified organisms; and
(c) an outline of any gaps, deficiencies and the adverse human and environmental concerns.
(5) The reviewers shall, when compiling their report, have regard to the provisions of regulation 15.
Part III—Licences and Permits
12. —(1) Any person making an application for a licence or a permit for trial release and contained use under the Act shall provide to the Committee the information contained in the First Schedule hereto.
(2) Notwithstanding the provisions of subregulation (1) a permit referred to in the said subregulation shall not be required for organisms that are used under conditions of contained use in academic and research facilities.
(3) A licence or permit issued under the Act shall be in the format contained in the Second Schedule hereto and shall be valid for a period of one (1) year.
(4) Any person making an application for a licence or permit to export or import genetically modified organisms shall take into account the requirements of the Cartagena Protocol on Biosafety.
13. —(1) Any person making an application or granted a licence or permit under these Regulations shall pay the fees set out in the Third Schedule hereto and the fees shall accompany each application or be paid before any licence or permit is granted, as the case may be.
(2) The Committee may recommend to the Minister to exempt indigenous Malawian researchers from paying fees under these Regulations.
(3) The Minister, on the recommendation of the Committee, shall determine the fees under these Regulations and may revise the fees from time to time.
14. —(1) A person who has been granted a licence or permit under the Act and proposes to release into the environment genetically modified organisms, shall make an application for a licence to the Minister in accordance with requirements contained in the Fifth Schedule hereto.
(2) The applicant shall publish the application for the proposed general release of genetically modified organisms in two (2) widely circulating newspapers.
(3) The publication referred to in subregulation (2), shall contain the following details—
(a) full name and address of the applicant;
(b) a full description of the genetically modified organisms that the applicant proposes to release;
(c) a description of the proposed general release including the area and environment in which the release is to take place;
(d) a request that interested parties submit comments or objections in connection with the intended release to the Biosafety Registrar within a period specified in the notice:
Provided that such period shall not be less than thirty (30) days after the date on which the notice appears in newspaper; and
(e) the address of the Biosafety Registrar, to which comments or objections may be submitted.
(4) The Biosafety Registrar shall refer any comments or objections received from interested parties to the Committee.
(5) The Committee shall, when reviewing an application for general release, consider all the comments and objections referred to the Committee in connection with the said application.
15. —(1) A licence shall be issued unless a suitable and sufficient assessment of the risks that may be created thereby to the environment or human health is undertaken.
(2) The applicant shall conduct risk assessment in a scientifically sound manner, appropriate to the type of permit or licence being sought and in accordance with internationally recognized risk assessment techniques and shall, inter alia, take into account available information concerning any potential exposure to the genetically modified organisms.
(3) Risk assessments shall be based on the information included in the application and shall also cover the information set out in the Fourth Schedule hereto and any other available scientific evidence.
(4) Lack of scientific knowledge or lack of consensus on the safe use of genetically modified organisms shall not in itself be interpreted as indicating a particular level of risk, an acceptable risk or an absence of risk.
16. —(1) Subject to the provisions of subregulation (4), all facilities, for the purpose of carrying out genetic modification of organisms activities, shall be registered and licensed for such purposes.
(2) An application for the registration and licensing of a facility shall be made in a prescribed form and accompanied by a locality map that clearly indicates where the facility is situated and the construction materials to be used.
(3) Applications for licensing a facility that has already been active prior to the commencement of these Regulations, shall be made within six (6) months from the date of the commencement of these Regulations: