BIOSAFETY ACT

Arrangement of Sections

   Section

PART I
PRELIMINARY

   1.   Short title

   2.   Interpretation

   3.   Scope

PART II
THE NATIONAL BIOSAFETY AUTHORITY

   4.   Establishment of National Biosafety Authority

   5.   Functions of Authority

   6.   Scientific Advisory Committee

   7.   Functions of Scientific Advisory Committee

   8.   Composition of Scientific Advisory Committee

   9.   Institutional biosafety committees

PART III
REGULATION OF ACTIVITIES RELATING TO GENETICALLY MODIFIED ORGANISMS

   10.   Prohibition of import, export, transit, etc of genetically modified organism

   11.   No permit on crop or live stock of strategic importance

   12.   Prohibition of certain work on genetically modified organisms

   13.   Notification procedure

   14.   Public consultation, information and participation

   15.   Regulatory powers on public information, consultation and participation

   16.   Decision making procedure

   17.   Permit conditions

   18.   Criteria for decision making

   19.   Socio-economic considerations

   20.   Appeal against refusal to grunt permit

   21.   Revocation of permit

   22.   Appeal against revocation

   23.   Suspension, cancellation and loss of permit

PART IV
RISK ASSESSMENT

   24.   Risk assessment

   25.   Evaluation of risk assessment

   26.   Effect of refusal of authorisation on patents

PART V
RISK MANAGEMENT

   27.   Risk Management

PART VI
CO-EXISTENCE

   28.   Co-existence of fanning practices

PART VII
IDENTIFICATION AND LABELLING

   29.   Packaging, identification and labeling

PART VIII
EXPORT

   30.   Procedure for export

PART IX
REQUIREMENTS TOR GENETICALLY MODIFIED ORGANISM IN TRANSIT

   31.   Requirements for genetically modified organisms in transit

   32.   Regulatory powers

PART X
UNINTENTIONAL RELEASE AND EMERGENCY RESPONSE MEASURES

   33.   Emergency response plan

PART XI
CONFIDENTIAL BUSINESS INFORMATION

   34.   Protection of certain business information

   35.   Protection of intellectual property rights

PART XII
LIABILITY AND REDRESS

   36.   Liability and redress

PART XIII
INSPECTORATE

   37.   Appointment of inspectors

   38.   Seizure, disposal and destruction of genetically modified organism or product illegally imported, etc.

   39.   Disposal of abandoned consignment

   40.   Costs for sterilisation, removal, destruction, etc.

   41.   Powers of inspectors

   42.   Obstruction of inspector

   43.   Appeals against orders of destruction

PART XIV
APPEALS

   44.   Appeals tribunal

PART XV
OFFENCES AND PENALTIES

   45.   Offences and penalties

PART XVI
MISCELLANEOUS

   46.   Regulations

   47.   Transitional provisions

      FIRST SCHEDULE

      SECOND SCHEDULE

      THIRD SCHEDULE

      FOURTH SCHEDULE

      FIFTH SCHEDULE

AN ACT

to regulate the research, development, application, import, export, transit, contained use, release or placing on the market of any genetically modified organism whether intended for use as a pharmaceutical, food, feed or processing, or a product of a genetically modified organism; ensure that any activity involving the use of any genetically modified organism or a product of a genetically modified organism prevents any socio-economic impact or harm to human and animal health, or any damage to the environment, non-genetically modified crop and biological diversity; set and implement standards for the assessment, evaluation and management of any potential risk involving the use of any genetically modified organism or product of a genetically modified organism; establish the National Biosafety Authority and prescribe its powers and functions; provide for the establishment of the Scientific Advisory Committee; provide for public participation, information and consultation in the field of biosafety; provide for a mechanism for liability and redress for any harm or damage caused to human and animal health, non-genetically modified crop, socio-economic conditions, biological diversity or the environment by any genetically modified organism or a product of a genetically modified organism; provide for the formation and registration of institutional biosafety committees; and provide for matters connected with or incidental to the foregoing.

[3rd May, 2007]

Act 10 of 2007.

PART I
PRELIMINARY

1.   Short title

This Act may be cited as the Biosafety Act, 2007.

2.   Interpretation

In this Act, unless the context otherwise requires—

“advance informed agreement” means the consent obtained before any activity is undertaken based upon full disclosure of all relevant information and the taking of full responsibility by the supplier of the information for its accuracy and completeness;

“applicant” means any person making an application for the approval of the Authority, or the person to whom the approval is given;

“Authority” means the National Biosafety Authority;

“biosafety” means a set of measures, policies and procedures used or established for assessing, preventing, monitoring and managing any risk associated with genetically modified organisms to human health and safety and to the environment;

“biotechnology” means the development of products by exploiting biological processes or substances using intact original or modified organism or by using active cell components;

“Cartagena Protocol” means the Protocol on Biosafety under the Convention on Biological Diversity;

“control” means to examine, regulate, manage or direct any activity within a person’s jurisdiction;

“contained use” means any operation in which any genetically modified organism or product of a genetically modified organism is produced, grown, stored, destroyed or used in some other way in a closed system in which physical barriers are employed, either alone or together with chemical or biological barriers, to effectively prevent its contact with, and its impact on, humans, biological diversity and the external environment;

“environment” means the aggregate of surrounding objects, conditions and influences that influence the life and habits of man or any other organism or collection of organisms;

“export” means the intentional transboundary movement of any genetically modified organism or a product of a genetically modified organism from one country to another country;

“exporter” means any legal or natural person who arranges for any genetically modified organism or a product of a genetically modified organism to be exported;

“genetically modified organism” means any biological entity, capable of replication or of transferring genetic material or any plant, animal or microorganism, in which the genetic material has been altered through modern biotechnology;

“gene technology” means any technique that involves the isolation, characterisation, modification and introduction of deoxyribonucleic acid (DNA) into living cells or microorganisms;

“gene therapy” means the replacement of a defective gene in a person or animal suffering from a genetic disease;

“hazard” means an intrinsic biological, chemical or physical characteristic of a genetically modified organism, which could lead to an adverse impact on the environment and health;

“import” means the intentional transboundary movement of any genetically modified organism or a product of a genetically modified organism into one country from another country;

“importer” means any legal or natural person who arranges for any genetically modified organism or a product of a genetically modified organism to be imported;

“inspector” means any person appointed as an inspector under this Act;

“microorganism” means any cellular or non-cellular microbiological entity that is able to reproduce or transfer genetic material;

“modern biotechnology” includes the application of the following techniques—

      (a)   any recombinant nucleic technique involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism into a virus, bacterium, plasmid or other vector, and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

      (b)   any technique involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation; and

      (c)   any cell fusion, including protoplast fusion or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells;

“monitoring” means the maintaining of regular surveillance, the checking of the warning about or the recording of a situation or process;

“notification” means providing information to and. where appropriate, the lodging or depositing of samples with the Authority;

“organism” means a biological entity, cellular or non- cellular capable of metabolism, replication, reproduction or transferring genetic material and includes a microorganism;

“permit” means a permit issued under this Act;

“person” includes any research, university or other academic institution;

“placing on the market” means supplying, selling, advertising, donating or making available to any third party of any genetically modified organism or product of a genetically modified organism;

“product” means any material derived by processing, or howsoever, from any genetically modified organism;

“Registrar” means a person appointed as Registrar under this Act;

“release” means any intentional introduction into the environment, of a genetically modified organism or a product of a genetically modified organism for any commercial purpose, food aid, remediation, research purpose in any field experiment, use of a genetically modified organism or a product of a genetically modified organism in any greenhouse, aquaculture facility, animal accommodation, unless the facility is approved for contained use as part of an approved laboratory or other installation, disposal of waste containing any genetically modified organism or a product of a genetically modified organism, the import, export or transport of any genetically modified organism or a product of a genetically modified organism;

“risk” means the probability of incurring or causing a loss, injury, an adverse impact or a misfortune on any human, plant or the environment;

“risk assessment” means an evaluation of any direct or indirect, short, medium and long term risk to human or animal health, the environment, biological diversity and to the socio-economic conditions or ethical values of the people of Zambia arising from the import, transit, contained use, release or placing on the market of a genetically modified organism or a product of a genetically modified organism;

“risk management” means measures necessary to prevent and manage adverse effects of any genetically modified organism or product of a genetically modified organism on human or animal health, non-genetically modified crop, biological diversity, the environment, or socio-economic conditions;

“socio-economic impact” means any direct or indirect effect to the economy, social or cultural practices, livelihoods, indigenous knowledge systems or indigenous technologies as a result of the import, transit, contained use, release or placing on the market of a genetically modified organism or a product of a genetically modified organism;

“trial release” means the release of any genetically modified organism into the environment in the open under conditions where the degree of dissemination of the genetically modified organism is prevented by chemical or physical barriers or by built-in barriers which prevent the survival of the organism in the environment;

“Tribunal” means the Tribunal established under this Act;

“use” excludes the acquisition by purchase or otherwise, by a member of the general public or any utilisation or dealing thereafter, unless specific conditions are attached to the utilization;

“user” means any natural or legal person or institution responsible for the use of a genetically modified organism; and

“waste” means any matter, whether gaseous, liquid or solid or any combination thereof, which is, in the opinion of the person in whose possession or under whose control it is, an undesirable or superfluous by-product, emission, residue or remainder of any process or activity in connection with any genetically modified organism.

3.   Scope

This Act applies to the import, development, export, research, transit, contained use, release or placing on the market of any genetically modified organism whether intended for release into the environment, for use as a pharmaceutical, for food, feed or processing, or a product of a genetically modified organism.

PART II
THE NATIONAL BIOSAFETY AUTHORITY

4.   Establishment of National Biosafety Authority

   (1) There is hereby established the National Biosafety Authority which shall be a body corporate with perpetual succession and a common seal, capable of suing and being sued in its corporate name, and with powers, subject to the other provisions of this Act, to do all such acts and things as a body corporate may by law do or perform and as are necessary for, or incidental to, the carrying out of its functions under this Act.

   (2) The provisions of the First Schedule apply to the Authority.

5.   Functions of Authority

   (1) The functions of the Authority are to—

      (a)   receive, respond to and make decisions on any notification and application, in consultation with the Scientific Advisory Committee, and in accordance with the requirements of this Act;

      (b)   establish administrative mechanisms to ensure the appropriate handling, dissemination and storage of documents and data in connection with the processing of applications and notifications and other matters covered by this Act;

      (c)   promote public awareness and education concerning the activities regulated under this Act, through the publication of guidance and other materials that explain and elaborate on the risk assessment, risk management and authorization processes;

      (d)   establish and maintain a data base on genetically modified organisms and products of genetically modified organisms intended for direct use as food or feed, or for research and production processing and make available such information to the public;

      (e)   prescribe criteria, standards and guidelines as may be necessary for the implementation of the provisions of this Act;

      (f)   take into account the policy recommendations and other guidelines of the Scientific Advisory Committee in making decisions on the import, export, development, transit, research, contained use, release or placing on the market of any genetically modified organism or product of a genetically modified organism;

      (g)   to cause the establishment and appointment of members of institutional biosafety committees at relevant institutions and constitute any other organ of experts, as appropriate, as technical and scientific advisors on issues of biosafety;

      (h)   to keep any genetically modified organism or any product of any genetically modified organism under review and where the Authority has reasonable grounds to believe that the genetically modified organism or product thereof poses any risk to human and animal health, biological diversity or the environment, to ban its transit, import, export, development, research, use or release in Zambia;

      (i)   review or have made a risk assessment of any genetically modified organism or product of any genetically modified organism;

      (j)   take any measures to protect human and animal health, biological diversity and the environment from the risks that may be posed by any genetically modified organism or product of any genetically modified organism;

      (k)   designate inspectors and undertake inspection as well as any other control measures to ensure compliance with this Act; and

      (l)   carry out any other activity which is necessary or conducive to the performance of its functions under this Act.

   (2) The Authority shall serve as the National Biosafety Focal Point and receive, process and respond to information and notifications from the Secretariat of the Cartagena Protocol on Biosafety.

   (3) In furtherance of its functions under sub-section (2 ), the Authority shall—

      (a)   facilitate regional and international information exchange and sharing relating to genetically modified organisms or products of genetically modified organisms or any other matter connected therewith; and

      (b)   declare through the Secretariat of the Protocol that—

      (i)   any genetically modified organism or product of a genetically modified organism intended as food or teed or for processing shall be imported only after it is subjected to a full risk assessment in accordance with this Act; and

      (ii)   any application to import a genetically modified organism or product of a genetically modified organism shall require a risk assessment any time a new genetically modified organism is posted in the Clearing House under the Protocol.

6.   Scientific Advisory Committee

   (1) There is hereby established a Scientific Advisory Committee for the purpose of conducting risk assessments and providing scientific and other technical advice and assistance to the Authority.

   (2) The Authority shall appoint the members of the Scientific Advisory Committee.

   (3) A member of the Scientific Advisory’ Committee shall hold office for a period of three years and may be re-appointed for a further like period.

   (4) The office of a member becomes vacant—

      (a)   upon the member’s death;

      (b)   if the member is adjudged bankrupt;

      (c)   if the member is absent from three consecutive meetings of the Committee of which the member has had notice, without the prior approval of the Committee;

      (d)   upon the expiry of one month’s notice of the member’s intention to resign from office, given by the member in writing to the Authority;

      (e)   upon the expiry of one month’s notice of the member’s removal given to the member in writing by the Authority;

      (f)   if the member becomes mentally or physically incapable of performing the duties of a member of the Committee;

      (g)   if the member is convicted of an offence under this Act;

      (h)   if the member is convicted of an offence under any other written law and sentenced therefor to imprisonment for a term of six months or more; or

      (i)   if the member acquires any interest in a biotechnology enterprise or any commercial enterprise likely to benefit directly from biotechnology or its products.

7.   Functions of Scientific Advisory Committee

The Scientific Advisory Committee shall—

      (a)   conduct risk assessments;

      (b)   review risk assessment and risk management measures;

      (c)   recommend containment measures, limitations on the duration of authorizations, reporting mechanisms, remedial measures, monitoring procedures and other appropriate and scientifically sound conditions and risk management measures;

      (d)   provide policy recommendations and guidelines to the Authority; and

      (e)   provide such other advice and assistance as the Authority may request.

8.   Composition of Scientific Advisory Committee

   (1) The Scientific Advisory Committee shall consist of nine scientific experts from any of the following fields—

      (a)   breeding and genetics;

      (b)   agronomy;

      (c)   weed science;

      (d)   pathology;

      (e)   molecular biology;

      (f)   food science;

      (g)   toxicology;

      (h)   ecology;

      (i)   entomology;

      (j)   virology;

      (k)   microbiology; and

      (l)   pharmacology,

   (2) The Chairperson of the Scientific Advisory Committee shall be elected by members of the Committee.

   (3) The Committee may, tor the purpose of performing its functions under this Act constitute any sub-committees and designate chairpersons of the sub-committees, who shall be drawn from the members of the Scientific Advisory Committee.

   (4) The Scientific Advisory Committee may appoint as members of any sub-committee constituted under sub-section (3) persons from any government agency, independent institution, research institute, university or any other academic institution.

   (5) The Scientific Advisory Committee may recommend to the Authority the appointment of any additional members of any sub-committee as may be required for purposes of this Act.

   (6) The Scientific Advisory Committee may recommend the appointment of any expert advisor from any relevant scientific discipline not otherwise adequately represented on the Scientific Advisory Committee or any sub-committee.

   (7) A member or advisor of the Scientific Advisory Committee or any sub-committee, shall publicly disclose any actual or potential conflict of interest relating to any risk assessment or any other matter upon which the Scientific Advisory Committee or any sub-committee may be consulted by the Authority.

   (8) Any person with any actual or potential interest with regard to a particular matter which is the subject of discussion or consideration by the Scientific Advisory Committee shall not participate in any risk assessment, discussion or deliberation concerning that matter and shall be removed from the Committee or sub-committee where any actual or potential conflict impair the person’s ability to serve in an independent or impartial manner.

   (9) The Minister may, by statutory instrument, make regulations for—

      (a)   the rules of procedure and the operations of the Scientific Advisory Committee and any sub-committee;

      (b)   any matter necessary for the effective and transparent operation of the Scientific Advisory Committee and any sub-committee;

      (c)   the terms of reference and competence of the Scientific Advisory Committee;

      (d)   the mechanisms and procedures for the appointment of members and chairpersons of the Scientific Advisory Committee and any sub-committee;

      (e)   the manner of appointment of any advisor and the participation of any advisor in the deliberations and discussions of the Scientific Advisory Committee or any sub-committee;

      (f)   the declaration and manner of dealing with any conflict of interest among the members or advisors of the Scientific Advisory Committee or any sub-committee;

      (g)   the remuneration of the members or advisors of the Scientific Advisory Committee or any sub-committee; and

      (h)   the protection of confidential information for purposes of this Act by any member or advisor of the Scientific Advisory Committee or any sub-committee.

9.   Institutional biosafety committees

   (1) Any institution that is involved in the import, development, research, transit, export, handling, contained use, release or placing on the market of any genetically modified organism or product of a genetically modified organism shall establish an institutional biosafety committee to institute and control safety mechanisms and approval procedures at the institutional level.

   (2) Any institutional biosafety committee established under sub-section (1) shall register with the Authority in such manner and upon payment of such fee as may be prescribed.

PART III
REGULATION OF ACTIVITIES RELATING TO GENETICALLY MODIFIED ORGANISMS

10.   Prohibition of import, export, transit, etc of genetically modified organism or product of genetically modified organism

   (1) A person shall not research on. develop, produce, import, export, transit, carry out any contained use, release or place on the market any genetically modified organism or any product of a genetically modified organism or deal in any manner with any genetically modified organism or a product of a genetically modified organism without the prior approval of the Authority.

   (2) Sub-section (1) applies to any traditional breeding method which results in or is likely to result in any genetically modified variety.

   (3) Any approval or authorisation of the Authority for any activity relating to any genetically modified organism or any product of any genetically modified organism shall be through the issuance of a permit.

   (4) Any person who contravenes sub-section (1) commits an offence and is liable, upon conviction, to a tine not exceeding five hundred thousand penalty units or to imprisonment tor a term not exceeding ten years or to both.

11.   No permit on crop or live livestock of strategic importance

   (1) The Authority shall not grant any approval for the importation, development, production, release into the environment or placing on the market of any genetically modified organism or product of a genetically modified organism relating to any crop or livestock of strategic importance to national food security.

   (2) The Minister may, for the purpose of sub-section (1), by statutory instrument make provision for a list of any strategic crop or livestock of national importance and food security.

12.   Prohibition of certain work on genetically modified organisms

A person shall not conduct the following activities—

      (a)   any gene therapy or somatic gene therapy for improving or enhancing any desired human characteristic for non-medical reasons; and

      (b)   use of any genetically modified organism or a product of a genetically modified organism that does not accord with the public interest, morality or cultural and ethical values of the people of Zambia.

13.   Notification procedure

   (1) Any person who intends to conduct research on. develop, apply, import, transit, release, place on the market or carry out any contained use of any genetically modified organism or product of any genetically modified organism shall submit an application in writing to the Authority for authorisation.

   (2) The application referred to under sub-section (1) shall include the following information—

      (a)   the information set out in the Second Schedule, Third Schedule and any other information as may be prescribed under this Act;

      (b)   an assessment report on risks that may be posed by the genetically modified organism or product of a genetically modified organism upon the environment, biological diversity or human health, non-genetically modified crop including the consequences of any unintentional release;

      (c)   any information from any previous or current release of the genetically modified organism or product of a genetically modified organism in the country or in any other country;

      (d)   information on any previous approvals or rejections of the genetically modified organism or any product of the genetically modified organism by any other country;

      (e)   if the request for approval is for the purposes of research and development, the recommendations of the relevant institutional biosafety committee;

      (f)   a clear and sequential description of the steps to be taken in the implementation of the project, and the monitoring and evaluation that will be made at the end of each step and the method of disposing off any waste;

      (g)   the place where and the purpose for which the genetically modified organism or the product of a genetically modified organism is planned to be developed, used, kept, released or marketed, including detailed instructions for the use and a proposed labeling and packaging scheme in accordance with the provisions of this Act;

      (h)   a declaration confirming that the information provided is correct including, where appropriate, an undertaking from the originator of such information affirming its accuracy and completeness; and

      (i)   a clear environmental monitoring plan.

14.   Public consultation, information and participation

   (1) The Authority shall consult the public prior to the grant of any authorisation under this Part, in such manner and within such period as may be prescribed.

   (2) The Authority shall for purposes of this Part, consult with any relevant institution responsible for the conservation, management or protection of the environment, human and animal health, and farming local communities.

   (3) The Authority shall, upon receipt of an application and the information referred to in section 13, avail the information to the public and any relevant government institution.

   (4) The public shall make comments on the application in the manner and within such period as may be prescribed.

   (5) The Authority shall, in making or reviewing its decision regarding any application, take into account the views or concerns of the public, any relevant institution or other stakeholder made in accordance with the provisions of this Act.

   (6) The Authority shall inform the public on the following matters—

      (a)   information on any genetically modified organism or any product of a genetically modified organism which has been granted or denied authorisation for import, transit, release, including the location of the release, placing on the market or contained use;

      (b)   any risk assessment report relating to a genetically modified organism or product of a genetically modified organism; and

      (c)   any report on the evaluation of the risk assessment.

15.   Regulatory powers on public information consultation and participation

The Minister may, by statutory instrument, in consultation with the Authority, make regulations providing tor—

      (a)   the procedure and manner of consulting or making information available to the members of the public for purposes of this Act;

      (b)   the procedure and manner of submission of any comments or objections by members of the public under this Act;

      (c)   the conduct of public hearings pursuant to this section;

      (d)   the forms and procedure to be used for purposes of this section;

      (e)   the period within which the public may make submissions to the Authority and decisions made relating to any application; and

      (f)   any other matter to give effect to the provisions of this section for purposes of this Act.

16.   Decision-making procedure

   (1) The Authority shall, within such period as may be prescribed, inform the applicant in writing and the public of its decision.

   (2) The Authority may approve or reject the application or approve the application on such terms and conditions as it may determine.

   (3) The Authority may, prior to making a decision in relation to any application under this Part, request the applicant to submit further and additional information as the Authority may consider necessary for purposes of this Act.

   (4) The Authority shall, where an applicant fails to submit any further or additional information requested under sub-section (3), reject the application.

   (5) The Authority shall, where it rejects an application give reasons to the applicant for the rejection.

17.   Permit condition

   (1) An approval for a permit shall require the holder to carry out the activity in a step-by-step sequence and to conduct an assessment of risks at each step.

   (2) Any approval for the import, transit, placing on the market, release or contained use of a genetically modified organism or product of a genetically modified organism shall require the permit holder to carry out monitoring and evaluation of risks on a continuous basis for a period commensurate with the life cycle of the species as the Authority may determine.

   (3) A permit holder shall, where any new information becomes available on any potential risks to human or animal health, biological diversity or the environment, notify the Authority within forty eight hours from the time the information becomes available.

   (4) A permit issued under this Part shall be used solely by the person to whom it is issued and is not transferable to any other person.

18.   Criteria for decision making

   (1) No approval shall be given unless there is firm and sufficient evidence that the genetically modified organism or product of a genetically modified organism poses minimum risk to human and animal health, non-genetically modified crop, biological diversity or the environment.

   (2) The Authority shall not give any approval for a permit where there is reason to believe that any harm or damage may be caused to human and animal health, non-genetically modified crop, biological diversity or the environment although there is lack of scientific evidence or certainty.

   (3) Lack of scientific evidence shall not be used as a basis for not taking preventive measures where there is reason to suspect threats of any damage to socio-economic conditions, human and animal health, non-genetically modified crop, biological diversity or the environment.

   (4) The Authority may reject an application under this Part on grounds of public interest.

   (5) The Authority shall not grant any approval for a permit if—

      (a)   the applicant fails to meet any condition precedent to the issue of the permit;

      (b)   the applicant fails to submit the assessment results of the effect of the use of any genetically modified organism or product of a genetically modified organism on human and animal health, non-genetically modified crop, biological diversity or the environment;

      (c)   any permit previously held by the applicant has been revoked by the Authority;

      (d)   the applicant has been convicted of an offence under this Act;

      (e)   the Authority is satisfied that in the interest of protecting human and animal health, non-genetically modified crop, biological diversity and the environment, the permit should not be issued; and

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