BIOSAFETY: SUBSIDIARY LEGISLATION

BIOSAFETY: SUBSIDIARY LEGISLATION

BIOSAFETY (MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS) REGULATIONS

ARRANGEMENT OF REGULATIONS

    REGULATION

PART I
PRELIMINARY

    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

    24.    Advertisements

    25.    Guidelines

    26.    Appeals

        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

G.N. 30/2007

BIOSAFETY (MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS) REGULATIONS

PART I
PRELIMINARY

1.    Citation

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

2.    Interpretation

    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 licensed 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.    National Biosafety Regulatory Committee

    (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

    (n)    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 connexion 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…