Zambia- International treaties – Cartagena
RATIFIED INTERNATIONAL INSTRUMENTS
Zambia
Cartagena Protocol on Biosafety
Art. 2-1
The legal framework requires that the development, handling, transport, use, transfer and release of any living modified organism (LMO) be done in a way that prevents or reduces risks to biological diversity, in particular taking into account risks to human health.
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Biosafety Act [No.10] 20070424
Preamble. An Act to regulate the research, developmemnt application, impor, 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 socioeconomic impact or harm to human and animal health, or any damage to the environment, non-genetically modified crops and biological diversity. Section 24(2). The Authority shall not make any decision on any application to import, transit, make contained use of, develop, research on, release or place on the market a genetically modified organism or a product of a genetically modified organism unless an assessment of risk to human and animal health, non-genetically modified crop, biological diversity, the environment, socioeconomic conditions and cultural norms is conducted. Section 25(1). The Authority shall evaluate or cause the evaluation of any risk assessment report and consider the result of the evaluation in making any decision of any application to import, transit, develop, reserach, make contained use of, release or place on the market a genetically modified organism or a product of gentically modified organism. (2) The Authority shall, where an evaluation of a risk assessment shows that any risk cannot be avoided, reject the application of the import, transit, development, research, contained use of, release, or placing on the market of a gentically modified organism or a product of a genetically modified organism. |
Art 7.1
For LMOs intended to be intentionally introduced into the environment of the importing State, the legal framework provides for a prior informed agreement procedure (APCC) applying before the first intentional transboundary movement of LMOs.
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Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations [No.42] 20100602
Regulation 4. An application to import a genetically modified organism for direct use a s food or feed or for processing shall be in Form I set out in the First Schedule. |
Art. 8-1
The legal framework provides:
- provides for a written notification from the exporting State (or the exporter directly) to the competent national authority of the importing State before the intentional transboundary movement of an LMO referred to in Article 7-1.
- requires that the notification contain at least the information specified in Annex I to the Protocol.
- provides for a written notification from the exporting State (or the exporter directly) to the competent national authority of the importing State before the intentional transboundary movement of an LMO referred to in Article 7-1.
- requires that the notification contain at least the information specified in Annex I to the Protocol.
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Biosafety Act [No.10] 20070424
Section 30(1). Any person who intends to export a genetically modified organism or a product of a genetically modified organism shall provide to the Authority a written advance informed agreement or approval of the competent authority of the importing country. (2) The presentation of the advance informed agreement by an exporter does not in any manner absolve the exporter from complying with any other laws governing foreign trade. (3) There shall be no authorization for the re-export of a genetically modified organism or product of a genetically modified organism that is banned by the laws of the exporting country. |
Art. 8-2
The legal framework provides for legal responsibility for the accuracy of the information communicated by the exporter as part of the notification provided for in Article 8-1.
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Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations [No.42] 20100602
Regulation 14 (1). A permit shall be revoked if- (a) the permit holder provides false information in the application or declaration of information relating to shipment of genetically modified organisms; [...] (e) new information becomes available to the authority indicating that the genetically modified organism, if allowed for its intended use, will result in significant risks to human or animal health, biological diversity, non genetically modified crops or the environment. |
Art. 10-3
The legal framework requires that the importing State communicate to the notifier and to the Biosafety Clearing-House (BCH), within 270 days of the date of receipt of the notification, the decision:
- authorizing the import, with or without conditions, of the LMO and indicating how this decision will apply to subsequent imports of the same LMO; or
- prohibiting import.
- authorizing the import, with or without conditions, of the LMO and indicating how this decision will apply to subsequent imports of the same LMO; or
- prohibiting import.
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No relevant elements identified/documented |
Art. 11-1
For LMOs used directly for food (human or animal) or processed and which are likely to be the subject of a transboundary movement, the legal framework provides for an information procedure and requires that:
- any final decision concerning the use on national territory (including the placing on the market) of such an LMO must be communicated within 15 days to the BCH;
- the information communicated to the BCH contains at least the information requested in Annex II to the Protocol.
- any final decision concerning the use on national territory (including the placing on the market) of such an LMO must be communicated within 15 days to the BCH;
- the information communicated to the BCH contains at least the information requested in Annex II to the Protocol.
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No relevant elements identified/documented |
Art. 15-2
The legal framework requires the importing State to ensure that a risk assessment is carried out before taking a decision under Article 10 (LMOs intended to be intentionally introduced into the environment).
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Biosafety Act [No.10] 20070424
Section 24(2). The Authority shall not any decision on any application to import, transmit, make contained use of, develop, research on, release or place on the market a genetically modified organism or a product of a genetically modified organism unless an assessment of risk to human and animal health, non genetically modified crop, biological diversity, the environment, socioeconomic conditions and cultural norm is conducted. (3) A risk assessent of a genetically modified organism shall be carried out by an applicant or the scientific advisory committee, as the case may be, in a scientifically sound manner, on a case by case basis, in accordance with the Fourth Schedule. (5) The Authortiy shall reject an application where an independent risk assessment cannot be undertaken or its independence verified. Section 25(1). The Authority shall evaluate or cause the evaluation of any risk assessment report and consider the result of the evaluation in making a decision on any application to import, transit, develop, research, make contained use, release or place on the market a genetically modified organism or a product of genetically modified organism.(2) The Authority shall, where an evaluation of a risk assessment shaows that any risk cannot be avoided, reject the application for the import, transit, research, develop, make contained use of, release or place on the market, a genetcally modified organism or a product of genetically modified organism. |
Art. 16-1
The legal framework requires the establishment of appropriate mechanisms, measures and strategies aimed at regulating, managing and controlling the risks linked to the use, handling and transboundary movements of LMOs.
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Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations [No.42] 20100602
Regulation 3. A person shall not import an genetically modified organism for direct use as food or feed or for processing unless- (a) importation is duly authorized by the authority; (b) the genetically modified organism is authorized for commercial distribution as food or feed in the country of origin; (c) regardless of the intended use, the genetically modified organism poses no significant risk to human or animal health, biological diversity, non genetically modified crop or the environment. |
Art. 16-2
The legal framework requires the establishment of risk-based measures to prevent the adverse effects of the LMO on the conservation and sustainable use of biological diversity (including risks to human health) on the territory of the importing State.
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Biosafety Act [No.10] 20070424
Section 27(2). Without limiting the generality of the foregoing, the Authority may— (a) require any genetically modified organism to undergo a period of observation commensurate with its life cycle or generation time, at the cost of the applicant, before and after it is put to its intended use; (b) prohibit the import, development, research on, transit, contained use, release or placing on the market of any genetically modified organism or a product of a genetically modified organism, if it contains any characteristic or trait which poses any risk to human and animal health, non-genetically modified crop, the environment and biological diversity; (c) order the cessation of any activity, which is being undertaken in violation of any of the provisions of this Act or any decisions made under it; (d) order the cessation of any activity involving a genetically modified organism or a product of a genetically modified organism that is known to cause risks to human and animal health, non-genetically modified crop, the environment or biological diversity; (e) require the person responsible for any activity under this Act to take such measures as may be necessary to prevent or limit any harm to human and animal health, the environment, non-genetically modified crop, biological diversity or socio-economic conditions, to implement remedial measures or restore the environment to its previous state as far as is feasible; (f)undertake measures, as necessary, at the cost of the person responsible, in the event that the person responsible fails to undertake any safety measures prescribed by the Authority; (g) take measures, as necessary, in the case of imminent or serious danger to human and animal health, the environment, biological diversity, non-genetically modified crop, socio-economic conditions or order public caused by a genetically modified organism or a product of a genetically modified organism at the cost of the person responsible for causing the danger; (h) require an applicant to submit reports periodically in respect of any monitoring and evaluation of risks carried out after any approval of the import, research, transit, development, contained use, release or placing on the market of a genetically modified organism or a product of genetically modified organism; (i)restrict or prohibit the development, research, production, transit, import, release, contained use or placing on the market of any genetically modified organism or a product of a genetically modified organism; and (j) assess and prohibit the import, transit, research, development, production, contained use, release or placing on the market of a genetically modified organism or a product of a genetically modified organism that is being or is likely to be used for a hostile purpose. (3) The Authority shall, where it has reasonable grounds to believe that any genetically modified organism or a product of a genetically modified organism has caused or is likely to cause serious danger or any adverse effect to human or animal health, non-genetically modified crop, biological diversity or the environment, and that immediate action or redress is required, take such measures as are necessary, without prior notice, to prevent or limit any harm to human or animal health, non-genetically modified crop, biological diversity or the environment and all the costs and expenses for such measures or remedial action shall be borne by, or be recoverable from, the person responsible for the harm. |
Art. 16-3
The legal framework provides for appropriate measures to prevent unintentional transboundary movements of LMOs.
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Biosafety Act [No.10] 20070424
Section 33(1). The Authority shall, for purposes of managing any unintentional release or emergency arising from an accident with a genetically modified organism or a product of a genetically modified organism— (a) require a permit holder to prepare an emergency plan for the protection of human and animal health, nongenetically modified crops, biological diversity and the environment outside the area of release or contained use in the event of an accident; (b) require the notification of any hazards in writing by a permit holder of any appropriate emergency services; (c) require a permit holder to inform any persons likely to be affected by the accident on safety measures and procedures; and (d) require the update periodically by a permit holder of any information relating to safety measures and the making available of the information to the general public. (2) A permit holder shall inform the Authority immediately of any accident and provide the following information: (a) the circumstances of the accident; (b) the identity and quantity of any genetically modified organism released unintentionally; (c) any measure necessary to assess the effects of any accident on human and animal health, biological diversity and in general, the environment; and (d) the emergency measures taken or to be taken. (3) The Authority shall, upon receipt of any information under subsection (2)— (a) ensure that a permit holder responsible for any accident takes measures to neutralise risks to human and animal health, non-genetically modified crop, biological diversity and the environment; and (b) inform relevant government and non-governmental organisations in countries likely to be affected and the Biosafety Clearing House. |
Art. 16-4
The legal framework requires that any LMO, imported or developed locally, be subjected before use to an appropriate observation period corresponding to its life cycle or training time.
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Biosafety Act [No.10] 20070424
Section 27(2). Without limiting the generality of the foregoing, the Authority may— (a) require any genetically modified organism to undergo a period of observation commensurate with its life cycle or generation time, at the cost of the applicant, before and after it is put to its intended use; |
Art. 18-1
The legal framework provides that LMOs that are the subject of an intentional transboundary movement under the Protocol are to be handled, packaged and transported under conditions of safety taking into account the relevant international rules and standards.
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Biosafety Act [No.10] 20070424
Section 29(1). Any genetically modified organism or product of a genetically modified organism shall be clearly identified and labeled as such in accordance with this Act or any regulations enacted thereunder. (2) The identification required for purposes of subsection (1) shall specify the relevant traits and characteristics given in sufficient detail for purposes of traceability. (3) Any genetically modified organism or any product of a genetically modified organism shall be clearly labeled and packaged in the manner provided for in paragraph C of the Third Schedule. |
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Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations [No.42] 20100602
Regulation 10. The permit holder shall comply with the following conditions: (a) the genetically modified organism shall be imported solely and exclusively for direct use as food or feed, or for processing into food and not for field testing or propagation; (b) the genetically modified organism shall be maintained and disposed of in such a manner as to prevent any risks to umna or animal health, biological diversity, non genetically modified crops or the environment; (c) all packaging materials, shipping containers and all other materials accompanying the genetically modified orgnaism shall be treated or disposed in such a manner as to prevent any risk to human or animal health, biological diversity and non genetically modified crops and the environment; [...] (e) genetically modified organisms shall be identified with a label showing the permit number, name of gentically modified organism and date of importation; [...] (j) the permint holder shall comply with such other conditions as the authority may consider necessary or desirable to prevent any risk to human or animal health, biological diversity, non genetically modified crop and the environment. |
Art. 18-2
The legal framework requires:
a) For LMOs used directly for food or processed: documentation clearly indicating:
- that they “may contain” LMOs;
- they are not intended to be intentionally introduced into the environment;
- the contact details of the person to contact for any further information.
c) For LMOs intended to be intentionally introduced into the environment of the importing State as well as any other LMOs covered by the Protocol: documentation:
- clearly indicating that they are LMOs;
- specifying their identity and relevant traits and characteristics;
- indicating any safety rule to be observed for the handling, storage, transport and use of these organisms;
- indicating the contact details of the person to be contacted for any further information and, where applicable, the name and address of the importer and exporter;
- containing a declaration certifying that the movement complies with the requirements of the Protocol applicable to the exporter.
a) For LMOs used directly for food or processed: documentation clearly indicating:
- that they “may contain” LMOs;
- they are not intended to be intentionally introduced into the environment;
- the contact details of the person to contact for any further information.
c) For LMOs intended to be intentionally introduced into the environment of the importing State as well as any other LMOs covered by the Protocol: documentation:
- clearly indicating that they are LMOs;
- specifying their identity and relevant traits and characteristics;
- indicating any safety rule to be observed for the handling, storage, transport and use of these organisms;
- indicating the contact details of the person to be contacted for any further information and, where applicable, the name and address of the importer and exporter;
- containing a declaration certifying that the movement complies with the requirements of the Protocol applicable to the exporter.
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Biosafety Act [No.10] 20070424
Section 29(4). The Minister may, in consultation with the Authority, by statutory instrument, make provision for— (a) the manner of labeling, identification and packaging of any genetically modified organism or a product of a genetically modified organism; (b) the manner of indicating any genetically modified organism that may or is likely to cause allergies or pose any other risk to human or animal health, nongenetically modified crop, biological diversity or the environment; (c) the measures to be taken by a producer, researcher, importer, exporter or any other person dealing with any genetically modified organism so as to protect consumers; (d) the prevention of fraudulent practices in the packaging, identification and labeling of any genetically modified organism or product of a genetically modified organism; (e) the segregation of genetically modified organisms from non-genetically modified organisms; (f)the threshold level for purposes of identification of any genetically modified organism or a product of a genetically modified organism; and (g) any other matter necessary to give effect to the provisions of this Part. |
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Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations [No.42] 20100602
Regulation 10. The permit holder shall comply with the following conditions: (a) the genetically modified organism shall be imported solely and exclusively for direct use as food or feed, or for processing into food and not for field testing or propagation; (b) the genetically modified organism shall be maintained and disposed of in such a manner as to prevent any risks to umna or animal health, biological diversity, non genetically modified crops or the environment; (c) all packaging materials, shipping containers and all other materials accompanying the genetically modified orgnaism shall be treated or disposed in such a manner as to prevent any risk to human or animal health, biological diversity and non genetically modified crops and the environment; [...] (e) genetically modified organisms shall be identified with a label showing the permit number, name of gentically modified organism and date of importation; [...] (j) the permint holder shall comply with such other conditions as the authority may consider necessary or desirable to prevent any risk to human or animal health, biological diversity, non genetically modified crop and the environment. |
Art. 21 - 3
The legal framework protects confidential information received under the Protocol (including confidential information received under the PIAP procedure provided for in Articles 7, 8 9 and 10) as favorably as confidential information relating to LMOs of national origin.
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Biosafety Act [No.10] 20070424
Section 34(1). A person shall apply to the Authority in the prescribed manner upon payment of a prescribed fee, for the treatment of any information as confidential for business purposes. (2) The Authority shall, after consultation with the applicant, determine the information which may be kept confidential and shall inform the applicant of its decision and the reasons therefor. (3) The following information shall not be kept confidential: (a) any description of a genetically modified organism or a product of a genetically modified organism; (b) the name, address or other particulars of the applicant; (c) the purpose and location of the import, transit, development, research, production, contained use, release or placing on the market of a genetically modified organism or a product of a genetically modified organism; (d) any methods and plans for monitoring of a genetically modified organism or a product of a genetically modified organism and for any emergency response; and (e) the evaluation of any foreseeable effects, in particular any pathogenic or ecologically disruptive effects. (4) A person shall not disclose any confidential information. (5) Any person who contravenes subsection (4) commits an offence and is liable, upon conviction to a fine not exceeding two hundred thousand penalty units or to imprisonment for a term not exceeding five years, or to both. (6) The Authority shall not, where an applicant withdraws an application before approval, disclose any confidential information relating to the application. (7) The Authority may, where it determines that it is in the public interest to do so, make available to the public any information referred to under section thirteen notwithstanding that it may be commercially confidential. 35. Notwithstanding subsection (3) of section thirty-four, the Authority shall, where it is satisfied on the basis of evidence submitted to it by the applicant and, after consultation with the applicant, that it is necessary to withhold for a specified time, some of the information specified in subsection (3) in order to protect the applicant’s intellectual property rights, withhold that information to the extent and for so long as it is necessary to protect the rights. |
Art. 23-1
The legal framework provides for measures to encourage:
(a) public awareness, education and participation regarding the safe transfer, handling and use of LMOs for the conservation and sustainable use of biological diversity, taking also into account the risks for human health;
b) access to information on LMOs that can be imported.
(a) public awareness, education and participation regarding the safe transfer, handling and use of LMOs for the conservation and sustainable use of biological diversity, taking also into account the risks for human health;
b) access to information on LMOs that can be imported.
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Biosafety Act [No.10] 20070424
Section 5(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; |
Art. 23-2
The legal framework provides:
a) public consultation when taking decisions relating to LMOs;
(b) making the outcome of these decisions available to the public, while respecting the confidentiality of the information.
a) public consultation when taking decisions relating to LMOs;
(b) making the outcome of these decisions available to the public, while respecting the confidentiality of the information.
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Biosafety Act [No.10] 20070424
Section 14(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 thirteen, 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 authorization 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. |
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Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations [No.42] 20100602
Regulation 7(1). An applicant shall, within fifteen days from the receipt of the acceptance of the application from the authority, publish a notice, in at least two newspapers of general circulation in Zambia, inviting interested parties to send their comments or objections on the proposed importation for direct use as food, feed or for processing, to the authority within a period of fifteen days from the date of publication of the notice. |
Art. 25-1
The legal framework provides for national measures to prevent and suppress illicit transboundary movements of LMOs.
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Biosafety Act [No.10] 20070424
Section 31(1). A person shall not make any transboundary movement of a genetically modified organism or a product of a genetically modified organism otherwise than with the written consent of the Authority. (2) A person shall not transport or transit any genetically modified organism or a product of any genetically modified organism through Zambia without authorization from the Authority. (3) Any person who contravenes this section commits an offence and is liable, upon conviction, to a fine not exceeding five hundred thousand penalty units or to imprisonment for a period not exceeding ten years, or to both. Section 32. The Minister may, by statutory instrument in consultation with the authority, provide for- (a) the packaging, handling and transportation of genetically modified organism, or a product of any genetically modified organisms in transit; (b) the conditions to be met or measured to be taken by any person responsible for the transit of genetically modified organism or a product of a genetically modified organism. |