The Malawi Gazette Supplement, dated 19th October, 2007, containing Regulations, Rules, etc.                                               (No. 15A)

Government Notice No. 30

BIOSAFETY ACT
(No. 13 of 2002)

BIOSAFETY (MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS)

REGULATIONS, 2007

ARRANGEMENT OF REGULATIONS

Part I—Prei.iminary

REGULATION

1.      Citation

2.      Interpretation

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

10.     Inspectors

11.     Reviewers

Part III—Licences and Permits

    12.     Required information for applications for licences and permits for trial release and contained use.

13.     Fees

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

20.     Accidents

21.     Caution and determination of liability

22.     Public access to information and confidentiality

23.     Requirements for effective management of waste

Part I—Preliminary

Citation                 

1. These Regulations may be cited as Biosafety (Management of Genetically Modified Organisms) Regulations, 2007.

Interpretation        

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.

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—

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;

and;

(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: