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An Introduction to the Model National Law on Biosafety
Introduction Nations of the South are increasingly faced with the prospect of the introduction into their countries of genetically modified organisms (GMOs) and products derived from GMOs. These will enter countries of the Third World in greater abundance as the movement by consumers, manufacturers and retailers in the North to reject these GMOs and their products gains momentum. It is now widely acknowledged that serious potential risks are presented by this technology. The magnitude and scope of the consequences to human and animal health and ecosystems may be very serious and the effects irreversible, even if the probability of risk occurrence may be low. This prompted the international community to commence negotiations for a biosafety protocol under the Convention on Biological Diversity. But these negotiations have been stalemated. The protocol is not expected to emerge before the new millennium dawns. Consequently, there are no regulations in place to deal especially with the movement across boundaries of these GMOs and their products. For this reason, countries are seeking to put in place national laws. Further, there are several aspects which are best addressed exclusively by national laws. This model law has been drafted to present one possible option. The scheme of the law 1. Approval needed for all activities in relation to GMOs and products thereof The scheme of the law is to subject every activity in relation to GMOs or products derived from GMOs ("products thereof") to the regulatory control of the State. The activities are: importation, deliberate release into the environment, placing on the market and contained use. There must be formal application to, and approval by, the designated State authority for the GMOs or products thereof to be imported, introduced into the environment, placed on the market, or used in contained conditions. Without such an approval, the activity is illegal and penalties apply. 2. All GMOs and products thereof covered All GMOs, as well as products thereof, come within the ambit of the law. This would include genetically modified fruits and plants; seeds; commodities such as soya bean, maize and corn, whether for human or animal consumption; fruits modified to be vaccines for humans or animals; transgenic fish; any organism intended for production of food enzymes or pharmaceuticals, or imported for sewage treatment; propagating material for breeding purposes/green house cultivation; and products from transgenics, such as flour from transgenic corn. Products thereof are included within the scope of the law as naked DNA (the genetic material inserted into the recipient organism and which subsists in the products thereof) has been shown to survive passage through the gut and can enter the bloodstream. From there it can spread to cells in the body. Unexpected side-effects, including new diseases, can well result. Hence the need to regulate products thereof. 3. Application must be made with complete information There has, therefore, to be an application for approval. This has to be accompanied by very comprehensive information supplied by the applicant, sufficient to allow for an adequate evaluation of any foreseeable risks from allowing the activity in relation to the GMO or product thereof. Importantly, the applicant must submit a report of an assessment of risks posed by the GMO or product thereof. 4. Public participation and consultation The public is kept informed and must be given adequate notice of any application. It should also be provided with all information supplied by the applicant to the national competent authority, including the risk assessment report, and its feedback must be solicited. In addition, the competent authority may provide for public consultation. Sufficient time before a decision is reached should be given to the public to allow for such consultation. Comments given by public must be taken into account in the decision-making. The report on the evaluation of the outcome of the risk assessment must also be made available to the public. 5. Risk assessment essential An assessment of the impacts and risks posed by the GMO or product thereof to human and animal health, the environment and biological diversity must be carried out, or caused to be carried out, by the applicant. The applicant then submits a report. This report is evaluated by the competent authority and/or the panel of experts that it may set up to assist it to carry out this task. The panel is drawn from experts chosen from a wide range of disciplines. The evaluation is comprehensive, on a case-by-case basis, and is intended to deal with all the potential risks to the environment, biological diversity and animal and human health. At the conclusion of the evaluation of the applicant's report, the competent authority may, if it so decides, carry out, or caused to be carried out, a further assessment of the impacts and risks. The competent authority must prepare a report of its decision and the grounds of its decision, setting out the matters that it considered in its evaluation. The parameters for risk assessment are set out. Detailed requirements, which must be adhered to, are elaborated upon in Annex III. It is noted that the parameters for risk assessment also include socio-economic effects, ethical considerations and cultural values of the society. The risk assessment is based on the precautionary principle, that is, the absence of scientific evidence or certainty does not preclude the decision makers from denying approval of the introduction of the GMO or product thereof if this may cause, or have a proven or theoretical potential (or based on reasonable scientific theory of hazards based on deductive, circumstantial as well as inductive evidence) to cause, harm to biological diversity, ecosystems, or human or animal health. 6. Other factors essential: cost-benefit assessment, efficacy of sustainable alternatives Factors in addition to risk assessment must also be taken into account before the approval is given. Thus, there must a cost-benefit assessment of the introduction of the GMO or product thereof as well as an assessment of its contribution to sustainable development. (The possible parameters include: long-term perspectives and effects, concern for the present and future members of a society, and safeguarding environmental interests.) 7. Firm evidence of no risk essential; precautionary principle applied as well No authorization may be given unless there is firm evidence that there are no risks posed to the environment, biological diversity and human and animal health. This is a very stringent requirement. Risk is generally defined as the magnitude of the harm measured against the probability of occurence of the harm. Decisions must be based on the precautionary principle as set out in section 5 above. In other words, lack of scientific certainty does not preclude the refusal of the application or the imposition of conditions for approval if there is reason to believe harm may result. 8. Approval with or without conditions When approval is given, it may be with or without any conditions. 9. Step-by-step approval Any approval given is on a step-by-step basis. That is, it progresses from activity that is contained, then to trials that are in the open before full-fledged release is authorized. At each stage, the risks are monitored. 10. Approval may be revoked Any approval given shall be revoked if new evidence, or a review of existing information, shows potential risks, based on the precautionary principle. Alternatively, fresh or additional conditions may be imposed. There is an obligation on the applicant to provide information of any possible risks that become known to the applicant at any time. 11. Risk management measures After the approval, and at all times generally, the State may take measures to manage any risks posed by GMOs or products thereof. These include: subjecting the activity to adequate periods of monitoring (e.g., commensurate with its life-cycle or generational time) before release is allowed, prohibiting any product (e.g., those that contain antibiotic resistance markers), ordering the cessation of any activity so that measures may be taken to prevent or limit harm, and taking emergency measures. [A separate section deals with unintentional release and emergency measures.] 12. Identification and labelling All GMOs must be identified and labeled such that they can be traced. Products thereof must also be labelled stating the fact that there is evidence of the presence of GMOs in the product. Labelling is also required to indicate that the presence of GMOs in a product cannot be excluded, if this be the case. Further, the label must forewarn of any allergies, reactions or other side-effects that the GMOs or products thereof may cause. 13. No confidentiality of business information in some situations The provisions seek to strike a balance between the right of the public to all information on the risks associated with GMOs or products thereof, and the right of the applicant to protect its commercial interests from competitors. There is a presumption that all information disclosed may be made available to anyone who seeks it. However, the applicant may ask the competent authority to keep certain information confidential on the ground that its competitor may be able to acquire and use the information and harm the applicant's competitive business position. The competent authority then decides whether confidentiality should be granted. The competent authority determines the claim for confidentiality according to the normal criteria,1 namely: that the information is not known generally among, or readily accessible to, persons within the circle that normally deal with the kind of information in question; that the information has commercial value because it is secret; and that reasonable steps have been taken to keep the information secret. In addition, the applicant must also show that the disclosure of that information will harm the competitive position of the company in a 'manner contrary to honest commercial practice.' On this basis, the claim does not extend to: (a) description of the GMOs or products thereof, names and addresses of the applicant, purpose and location of the import, deliberate release (including the location and scale of the release), contained use or placing on the market of the GMOs or products thereof; (b) methods and plans for monitoring of the GMOs or products thereof and for emergency response; (c) the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects; (d) the fact that the GMOs or products thereof have been banned or subject to stringent conditions. Confidentiality cannot be claimed vis-a-vis the competent authority in respect of information required for the evaluation of foreseeable risks, nor for information required for monitoring, supervision or enforcement work. Further, and in any event, the claim for confidentiality may be overridden in the public interest. 14. No export without prior informed consent There can be no export of GMOs or products thereof unless the State is satisfied that the country of import gives its prior informed consent. The exporter must provide the national competent authority with a written advance informed agreement of the competent authority of the State of the importer. There is an absolute prohibition on the export of any GMOs or products thereof that are banned in the country. 15. Liability and redress The liability provisions impose strict liability for any damage caused by the introduction of a GMO or product thereof. Liability attaches to any person or entity responsible for the harm. Liability also attaches to officers of a corporation unless they can show that they did all that was possible to prevent the activity in relation to the GMO or product thereof. If more than one person is responsible, then liability is joint and several. All that is needed is to prove that one or more persons proceeded against could have caused the damage. Liability is not only for personal injury, damage to property and financial loss. It extends to damage caused to the environment and to biological diversity. The person or entity responsible must bear the costs for reinstatement, rehabilitation or clean-up measures and for loss or damage caused by taking preventive measures. Liability also extends to harm or damage caused directly or indirectly to the economy, social or cultural practices, livelihoods, and indigenous knowledge systems and technologies. The applicant must also indemnify any other person responsible for the activity. The indemnity extends to any civil liability for failure to label seeds, food, food ingredients or animal feed containing or derived from GMOs unless the applicant can show that all reasonable steps were taken to prevent such failure. The time limit to bring an action is extended to a reasonable time after the affected person could reasonably be expected to have learnt of the harm. In ascertaining this, due account must be taken of the time the harm takes to manifest itself as well as the time it takes to co-relate the harm caused with the GMOs or products thereof. The fact that the competent authority has consented to the application is no defence to any action brought. A wide category of persons is given the right to institute legal action. This includes, in addition to those directly affected, groups who bring an action on behalf of those who are unable to do so. Any person may also bring an action in the public interest or for protecting the environment or biological diversity. 16. Criminal proceedings A person, upon conviction, may also be ordered to pay costs for the rehabilitation of the environment. The Minster (or any designated body) must initiate this remedy in writing and in the same proceedings. Any judgement given is enforceable as any other judgement in a civil action. The court can also order the offender, upon conviction, to pay any monetary advantage obtained by the wrongful conduct as well as the costs of the prosecution. An employer can also be held liable for acts or omissions of his/her employees if he/she fails to take reasonable steps to prevent the acts or omissions from taking place. 17. Protected disclosures Whistleblowers are protected against victimisation, sacking or other punishments so long as any disclosure is made in good faith and on reasonable belief of risks posed by the GMOs or products thereof. The disclosure must be made to the relevant authority. Disclosure to the media is subject to more stringent conditions. There must be clear and convincing grounds, and the disclosure must be necessary to avert an imminent and serious threat to human or animal health, the environment or biological diversity. There is also a prohibition on bribing a person to refrain from making the disclosure and on threats made to prevent whistleblowing. 18. Punishable conduct and penalties Conduct that is illegal and punishable is clearly identified. This includes: carrying out any activity without any approval or in violation of conditions imposed; false, misleading or deceptive labeling; exporting without the prior informed consent of the importing country; selling any GMOs or products thereof without approval; participation in any proceedings where there is a clear conflict of interest and failing to have a valid insurance cover in respect of activity related to GMOs or products thereof. Punishment upon conviction includes imprisonment and this can also be imposed on the responsible officer of a corporation. A person or corporation convicted of certain more serious offences, namely, activity without approval; failure to supply the required information and providing false, misleading and deceptive information to secure an approval, is prohibited from engaging in any activity in relation to GMOs or products thereof. The repeated commission of other offences results in the imposition of a similar disability. 19. Institutional arrangements The law also provides for institutional arrangements: which Ministry (and the Minister) or authority is to be in charge, the designation of the competent authority, the functions of this authority, and the appointment of the independent body of experts. The competent authority oversees the implementation of the law. It could be appointed by a designated body - the Government, Parliament or a specific Minister. It is independent. It may also name an independent panel of experts to assist it to carry out the vital evaluation of the risk assessment report submitted by the applicant. No person can sit on the panel if there could be a conflict of interest by the person so doing. The panel consists of experts drawn from a wide range of interdisciplinary fields with expertise on GMOs or products thereof as well as the receiving environment. Other experts may be appointed on an ad hoc basis. Further, any institution involved in any activity relating to GMOs or products thereof is required to establish biosafety committees at the institutional level to ensure control and safety. 20. Regulations The Minister is given power to make regulations for the effective implementation of the law. 21. Transitional provisions There is also a transitional provision. It subjects the introduction into the country of GMOs or products thereof, prior to the coming into force of the law, to the same procedures and requirements for approval within an extended time frame.
Model National Biosafety Law A law to provide for the regulation of the import, deliberate release into the environment, placing on the market, and the contained use of genetically modified organisms (GMOs) and products derived from GMOs. 1. Interpretation 1.1 In this Act (a) 'applicant' means the natural or legal person making the application for the approval by the competent authority, and where the context so requires, the person to whom the approval is given; (b) 'advance informed agreement' means the consent obtained before any activity is undertaken based upon full disclosure of all relevant matters; (c) 'competent authority' means the authority designated or established by [to name]2 which will carry out the functions under this Act; (d) 'contained use' means any operation in which GMO(s) or products thereof are 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 and/or biological barriers, to effectively limit their contact with, and their impact on, the general population,3 biological diversity and the external environment; (e) 'deliberate release' or 'release' means any intentional introduction into the environment, including any production or use that is not contained use, of GMO(s) or products thereof; this includes releases for: commercial purposes, remediation, research purposes in field experiments, use of GMO(s) or products thereof in greenhouses, aquaculture facilities, animal accommodation unless the facility is approved for contained use as part of an approved laboratory or other installation, disposal of waste containing GMO(s) or products thereof, and transport of GMO(s) or products thereof; (f) 'export' means the intentional transboundary movement from one country to another country; (g) 'exporter' means any legal or natural person who arranges for GMO(s) or products thereof to be exported; (h) 'genetically modified organism (GMO)' means any biological entity capable of replication or transfer of genetic information, and includes plants, animals, bacteria and all other kinds of micro-organisms, cell cultures (prokaryotic or eukaryotic) created and propagated as such, viruses, and plasmids and other kinds of vectors, in which the genetic material has been altered in a way that does not occur naturally, by means of cell or gene technology; Gene technology refers to techniques that involve the isolation, characterisation, modification and introduction of DNA into living cells or viruses; Cell technology refers to techniques for the production of living cells with new combinations of genetic material by the fusion of two or more cells.4 (i) 'import' means the intentional transboundary movement into one country from another country; (j) 'importer' means any legal or natural person who arranges for GMO(s) or products thereof to be imported; (k) 'notification' means providing information to and, where appropriate, the lodging or depositing of samples with the competent authority; (l) 'placing on the market' means supplying or making available to third parties GMO(s) or products thereof; (m) 'person' includes both natural and legal entities. This includes: corporations, universities and research institutes; (n) 'products thereof' means any material derived by processing, or howsoever otherwise, from any GMO(s); (o) 'risk assessment' means the evaluation of the direct and indirect risks to human and animal health, the environment, biological diversity and to the socio-economic conditions and ethical values of the country or its populace which may be posed by the import, contained use, deliberate release or placing on the market of GMO(s) or products thereof. This includes the evaluation of secondary and long-term effects; (p) 'socio-economic impact' means the direct or indirect effects to the economy, social or cultural practices, livelihoods, indigenous knowledge systems, or indigenous technologies as a result of the import, release, contained use or placing on the market of GMO(s) or products thereof; (q) 'use' excludes the acquisition by purchase or otherwise by a member of the general public and utilisation or dealing thereafter unless specific conditions are attached to the utilization. 2. The scope of the Act 2.1 This Act shall apply to the import, deliberate release, contained use, and placing on the market of GMO(s)5 and products thereof. 3. Approval of activity 3.1 There shall be no import, deliberate release, contained use, or placing on the market of GMO(s) or products thereof without the prior written approval of the competent authority. 4. Notification and approval procedure 4.1 Any person who intends to import, release, use in contained conditions or place on the market GMO(s) or products thereof shall submit an application in writing to the competent authority for authorization. 4.2 The application shall include the information set out in Annex I, in particular: (a) general information; (b) information relating to the GMO(s) or products thereof; (c) information relating to the conditions of release, contained use or placing on the market and, where appropriate, the receiving environment; (d) information on the interaction between the GMO(s) or products thereof and the environment; (e) information on monitoring, control, waste treatment and emergency response plans; (f) in case of an application for contained use, an impact assessment setting out the consequences of unintentional release of the GMO(s) or products thereof; (g) a report on the impacts and risks posed by the GMO(s) or products thereof to human and animal health, biological diversity and the environment in accordance with the guidelines set out in Annex III of this Act; (h) information on results from deliberate releases in the country and other countries of the GMO(s) or products thereof previously or currently carried out by the applicant; (i) information on previous approvals or rejections of the GMO(s) or products thereof by any other country, where approval is sought; (j) information on where and for what purposes the GMO(s) or products thereof will be marketed, together with detailed instructions for use and the proposed labelling and packaging, fulfilling the requirements specified in Annex II, Part C; (k) such other information as may be required by the competent authority. 5. Public participation 5.1 The competent authority shall, upon receipt of the information referred to in section 4.2, make available the said information to the public. 5.2 The public may make comments within such period as may be specified by the competent authority. 5.3 (a) The competent authority shall also provide for public consultation. In such event, the public shall be informed of the consultation through the national media and enough time before the decision is made shall be given for the consultation. (b) The competent authority shall also undertake consultations with such expert bodies as are concerned with the preservation of the natural environment, human and animal health, and representatives of the farming industry, including organic farmers. 5.4 Comments made by the public under sections 5.2 and 5.3 shall be taken into account by the competent authority in making its decision. 5.5 The competent authority shall make available to the public: (a) information on all GMO(s) or products thereof which have received, or have been denied, authorisation, as the case may be, for import, deliberate release (including the location of the release), placing on the market or contained use; (b) the risk assessment report in respect of the GMO(s) or products thereof; and (c) the report on the evaluation of the outcome of the risk assessment, as specified in section 6.7. 6. Risk assessment 6.1 (a) The applicant shall carry out, or cause to be carried out, an assessment of the impacts and risks posed by the GMO(s) or products thereof to human and ani- mal health, the environment and biological diversity based upon the guidelines in Annex III. (b) A report in respect of the said assessment shall be prepared and submitted by the applicant to the competent authority as required by section 4.2(g). 6.2 (a) An evaluation of the risk assessment report shall be made by the competent authority. (b) The evaluation of the risk assessment report shall be done on a case-by-case basis and in accordance with the guidelines set out in Annex III. (c) The competent authority may/shall appoint an independent interdisciplinary panel of experts, pursuant to sections 19.3 and 19.4,6 to assist it to carry out the evaluation of the risk assessment report. 6.3 At the completion of the evaluation of the risk assessment report, the competent authority may, where it deems necessary to do so, conduct, or cause to be conducted, an assessment of risks. 6.4 Without prejudice to the guidelines set out in Annex III, the risk assessment and the evaluation of the risk assessment report should take into account, inter alia, the following: (a) all relevant scientific evidence and experience; (b) the general characteristics of both the GMO or product thereof and the parent organism(s), the vector(s) used, the genetic modification(s) and the novel trait(s), including marker trait(s) and other sequences even when not expressed; (c) the native environment(s) or host range of the recipient organism and donor organism(s); (d) the intended use(s) of the GMO or product thereof and the nature of the receiving and surrounding environment(s); (e) potential impacts of the GMO or product thereof, on the environment, including long-term, direct and indirect ecological impacts, particularly on centers of origin and areas with high genetic diversity of taxa related to the GMO or product thereof; (f) effects, long-term and direct or indirect, of the GMO or product thereof on human, plant and animal health; (g) socio-economic impacts; (h) conformity with ethical and cultural values and norms; (i) details of risk assessments completed elsewhere. 6.5 In evaluating the risk assessment report, the competent authority and/or the panel as the case may be, shall, in addition to the guidelines, also consider and duly determine whether the import, release, contained use or placing on the market of the GMO(s) or products thereof will: (a) benefit the country; and (b) contribute to, and not undermine, sustainable development. 6.6 The competent authority and/or the panel, as the case may be, shall also consider the efficacy of sustainable alternatives to the introduction of the GMO(s) or products thereof as well as safer alternative technologies. 6.7 The competent authority and/or the panel, as the case may be, shall, upon completion of the evaluation, produce a report which shall include the following: (a) the decision; (b) the grounds for the decision; (c) the matters considered and determined by the competent authority and/or the panel, as the case may be, in sections 6.5 and 6.6. 6.8 The competent authority may require the applicant to bear all, or any part of, the costs for evaluating the risk assessment report and/or for carrying out the risk assessment. 7. The decision-making procedure 7.1 The competent authority shall inform the applicant in writing of its decision that the import, release, placing on the market, or contained use, as the case may be, of the GMO(s) or products thereof is: (a) approved; (b) approved with such conditions as it may specify; or (c) denied. 7.2 The competent authority may request for such further information as it may deem necessary before making its decision. 7.3 Any approval shall state that the activity approved shall be carried out step-by-step and that assessment of risks should be conducted at each step, provided that the competent authority may in appropriate cases not require this procedure if it is satisfied that no risk is posed to human and animal health, biological diversity and the environment. 7.4 Any approval for release or contained use shall require the applicant to carry out monitoring and evaluation of risks after the GMO(s) or products thereof have been imported, released, used in contained conditions or placed on the market. 7.5 No approval shall be given unless there is firm and sufficient evidence that the GMO(s) or products thereof pose no risk to human and animal health, the environment and biological diversity. 7.6 In any event, where there is reason to believe harm or damage may result, lack of scientific evidence or certainty should not be used as a basis for not taking preventive measures including refusing the application or imposing any condition or limitation on an approval. 7.7 Without prejudice to section 6 of this Act, no approval shall be given for the deliberate release or placing on the market of GMO(s) or products thereof which are plants and seeds for agricultural purposes until the competent authority has received the results of research on the effect of the use of such GMO(s) or products thereof. 7.8 The competent authority shall, as a condition for approval, require the applicant to take out a policy of insurance against liability to pay compensation for damages. 7.9 The applicant shall not carry out any activity in relation to GMO(s) or products thereof until an approval for so doing has been obtained under this Act. 8. Review of decision 8.1 (a) Any approval given shall either be revoked, or subjected to conditions in addition to those originally imposed if, in the opinion of the competent authority, new information or a review of existing information about the GMO(s) or products thereof establishes risks to human or animal health, biological diversity or the environment, based on the precautionary principle as set out in section 7.6 hereof. (b) If any approval is revoked, the competent authority may also, where applicable, order the destruction of any growing organism and the sterilisation of the soil in which they are being grown, in whatever way it deems appropriate. (c) No compensation shall be payable as a consequence of the revocation of an approval or an order for sterilisation. 8.2 Where after the approval has been granted new information becomes available on the possible risks to human or animal health, biological diversity or the environment, the applicant shall immediately notify the competent authority. 9. Risk management 9.1 The competent authority may impose such measures as may be necessary to prevent adverse effects of the GMO(s) or products thereof on human or animal health, biological diversity or the environment. 9.2 Without affecting the generality of the foregoing, such measures may include the following: (a) subject any GMO(s) or products thereof to undergo a period of observation commensurate with its life-cycle or generation time, at the cost of the original applicant, before it is put to its intended use, provided that this does not result in continuous trials in the field and/or in contained use; (b) restrict or prohibit the import, release, contained use or placing on the market of any GMO(s) or products thereof; (c) order the cessation of any activity that is being undertaken in violation of any of the provisions of this Act or any decisions made under this Act; (d) order the cessation of any activity that is shown to cause risk to human or animal health, biological diversity or the environment; (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 or damage to human or animal health, biological diversity or the environment, or to restore the environment to its previous state as far as feasible. In the event any action as aforesaid is not undertaken by the person responsible for the activity within a reasonable time after notification, the competent authority may undertake the necessary measures and all costs and expenses shall be borne by, or be recoverable from, the person responsible; (f) in case of imminent and serious danger to human or animal health, biological diversity or the environment, and where immediate intervention is required, the competent authority shall take such measures as are necessary without prior notice, and all costs and expenses shall be borne by, or be recoverable from, the person responsible; (g) require the applicant to submit reports periodically in respect of the monitoring and evaluation of risks carried out after the approval of the GMO(s) or products thereof have been imported, released, placed on the market or used in contained conditions; (h) prohibit the import, release, contained use or placing on the market of the GMO(s) or products thereof if the competent authority is satisfied that it contains characteristics or specific traits which pose risks to human or animal health, the environment, or biological diversity. 10. Unintentional release and emergency measures 10.1 The competent authority shall ensure that, where necessary, before any release is made or contained use carried out: (a) an emergency plan is drawn up for the protection of human and animal health, biological diversity and the environment in the event of an accident and the appropriate emergency and other services are informed of this plan in writing; and (b) information on safety measures and procedures to adopt in the case of an accident is supplied to persons liable to be affected by the accident. The information shall be updated and supplied periodically. It shall also be made available to the general public. 10.2 The applicant shall inform the competent authority of any accident immediately and provide the following information : (a) the circumstances of the accident; (b) the identity and quantity of the GMO(s) or products thereof released; (c) any measures necessary to assess the effects of the accident on the environment, biological diversity and human and animal health; and (d) the emergency measures taken or intended to be taken. 11. Identification and labelling 11.1 Any GMO(s) or products thereof shall be clearly identified and labelled as such, and such identification shall specify the relevant traits and characteristics in sufficient detail for purposes of traceability. 11.2 Products containing, or consisting of, GMO(s) shall be clearly labelled and packaged in accordance with Annex II, part C, and comply with such further requirements, if any, imposed by the competent authority, to indicate that it is, or has been, derived from GMO(s); and, where applicable, whether it may cause reactions, allergies or other side-effects. 12. Confidential business information 12.1 The competent authority shall protect information which it determines as being confidential after a claim for confidentiality is made by the applicant. 12.2 In no case may the following information supplied by the applicant be kept confidential: (a) description of the GMO(s) or products thereof, names and addresses of the applicant, purpose and location of the import, deliberate release (including the location and scale of the release), contained use or placing on the market of the GMO(s) or products thereof; (b) methods and plans for monitoring of the GMO(s) or products thereof and for emergency response; (c) the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects; (d) the fact that the GMO(s) or products thereof have been banned or subject to stringent conditions. 12.3 The competent authority may make available the information, referred to in section 4.2, to the public pursuant to sections 5.1 and 5.5, notwithstanding that the information may be commercially confidential, if it decides that it is in the public interest to do so. 12.4 If the applicant withdraws the application before approval, the competent authority must respect the confidentiality of the information determined as being confidential. 12.5 Any person carrying out any activity under this Act shall supply information necessary for the competent authority to carry out its supervisory, monitoring or enforcement tasks or to deal with any emergency measures in relation to the activity and there shall be no claim of confidentiality in relation to such information. 13. Export of GMO(s) or products thereof 13.1 Any person who intends to export GMO(s) or products thereof shall provide to the competent authority a written advance informed agreement of the competent authority of the importing country. 13.2 The presentation of the advance informed agreement by an exporter shall in no way absolve the exporter from complying with any other laws governing foreign trade. 13.3 The submission of the advance informed agreement shall not preclude the country of the exporter from taking into account other considerations before approving the export. 13.4 There shall be no authorization for the export of GMO(s) or products thereof that are banned by the laws of the exporting country. 14. Appeal 14.1 Any person aggrieved by any decision of the competent authority may, at any time within the period of ...... month(s) beginning from the date of receipt of the decision, appeal to such adjudicatory and/or administrative authority as may be set up by law. 14.2 In this section 'decision' includes any act, omission, refusal, direction, imposition of condition(s) or order. 15. Liability and redress 15.1 Any person who carries out any activity in relation to GMO(s) or products thereof shall be strictly liable for any harm, injury or loss caused directly or indirectly by such GMO(s) or products thereof or any activity in relation to them. The harm, injury or loss includes personal injury, damage to property, financial loss and damage to the environment or to biological diversity. 15.2 Liability shall attach to the applicant, the person responsible for the activity which results in the damage, injury or loss, as well as to the provider, supplier or developer of the GMO(s) or products thereof. 15.3 Where liability under this section is incurred by a body corporate, any director, manager, secretary or similar officer of the body corporate shall be similarly liable unless he/she can show that he/she did everything in his/her power to prevent the import, deliberate release, placing on the market or contained use which caused the damage in question. 15.4 If there is more than one person responsible for the damage, injury or loss, then the liability shall be joint and several. 15.5 Where proceedings are brought against more than one person it shall not be a requirement for the person bringing the proceedings to identify the person who caused the damage in question, provided that he/she can prove that one or more of the persons so proceeded against could have caused the damage. 15.6 In the case of harm to the environment or to biological diversity, redress shall include the costs of reinstatement, rehabilitation or clean-up measures actually incurred or to be incurred and, where applicable, the costs of preventive measures and any loss or damage caused by the taking of the preventive measures; provided that the person responsible may be required to carry out the reinstatement or rehabilitation at its own cost and to the satisfaction of the competent authority. 15.7 Liability shall also extend to harm or damage caused directly or indirectly by the GMO(s) or products thereof to the economy, social or cultural practices, livelihoods, indigenous knowledge systems, or indigenous technologies. Such harm includes the following: disruption or damage to production systems, agricultural systems, reduction in yields, and damage to the economy of an area or community. 15.8 (a) An applicant shall indemnify: (i) any other person who deliberately releases or markets GMO(s) or products thereof; and (ii) any person who manufactures, processes or markets food, food ingredients or animal feed containing or derived from GMO(s) against any civil liability where the GMO(s) or products thereof in question was first imported, deliberately released, used in contained conditions, or placed on the market by the applicant. (b) An applicant shall indemnify against any civil liability any person who fails to label seeds, food, a food ingredient or animal feed containing or derived from GMO(s), but where the applicant can show that he took all reasonable steps to prevent such failure the indemnity shall not apply. 15.9 The right to bring any action to redress the harm caused by the GMO(s) or products thereof shall lapse only after a reasonable period7 from the date on which the affected person or community could reasonably be expected to have learned of the harm, taking due account of: (a) the time the harm may take to manifest itself; and (b) the time that it may reasonably take to co-relate the harm with the GMO(s) or products thereof, having regard to the situation or circumstance of the person or community affected. 15.10(a) Any person or group of persons may be entitled to bring a claim and seek relief in respect of the breach or threatened breach of any provision of this Act, including any provision relating to damage to the environment and biological diversity: (i) in that person's or group of person's interest; (ii) in the interest of, or on behalf of, a person who is, for practical reasons, unable to institute such proceedings; (iii) in the interest of, or on behalf of, a group or class of persons whose interests are affected; (iv) in the public interest; and (v) in the interest of protecting the environment or biological diversity. (b) No costs shall be awarded against any of the above persons who fail in any action as aforesaid if the action was instituted reasonably out of concern for the public interest or in the interest of protecting the environment or biological diversity. 15.11 It shall not be a defence to any claim for compensation or damage that the activity had been consented to by the competent authority. 16. Protected disclosures 16.1 Notwithstanding the provisions of any other law, no person is civilly or criminally liable or may be dismissed, disciplined, prejudiced or harassed on account of having disclosed any information, if the person in good faith reasonably believed at the time of the disclosure that he/she was disclosing evidence of any risks posed by GMO(s) or products thereof to human or animal health, the environment or biological diversity in accordance with section 16.2. 16.2 Section 16.1 applies only if the person concerned (a) disclosed the information to: (i) any authority which has the jurisdiction over matters pertaining to the protection of human or animal health, the environment or biological diversity; (ii) any authority having powers of prosecution or enforcement; or (iii) parliament including State legislatures or any committees thereof; (b) disclosed the information concerned to one or more news media and on clear and convincing grounds believed at the time of the disclosure: (i) that the disclosure was necessary to avert an imminent and serious threat to human or animal health, the environment or biological diversity, to ensure that such a threat was properly and timeously investigated, or to protect himself/herself against serious or irreparable harm from reprisals; or (ii) giving due weight to the importance of open, accountable and participatory administration, that the public interest in disclosure of the information clearly outweighed any need for non-disclosure; or (c) disclosed information which, before the time of the disclosure of the information, had become available to the public, whether in the country or elsewhere. 16.3 Section 16.1 applies whether or not the person disclosing the information concerned has used or exhausted any other applicable external or internal procedure to report or otherwise remedy the matter concerned. 16.4 No person may induce any other person to exercise or refrain from exercising his/her right as aforesaid by giving or promising any advantage. 16.5 No person may threaten to take any action against any other person for exercising or intending to exercise his/her right as aforesaid. 17. Offences and penalties 17.1 Any person who (a) imports, releases, places on the market or makes contained use of any GMO(s) or products thereof without the written approval of the competent authority; (b) violates any conditions attached to the grant of approval under this Act; (c) fails to furnish any information as required by the provisions of this Act; (d) provides false, misleading or deceptive information under section 4.2 in order to secure an approval; (e) does not label, package or identify any GMO(s) or products thereof in accordance with this Act or with any conditions imposed under this Act; (f) labels, packages or identifies any GMO(s) or products thereof in a manner that is false, misleading or deceptive or in contravention of any regulation made under this Act; (g) exports GMO(s) or products thereof without the advanced informed agreement of the importing country; (h) participates in any proceedings in respect of a subject matter in which he/she has any direct or indirect interest of any kind; (i) fails to have a valid policy of insurance against liability to pay compensation for damage; or (j) violates any other provision of this Act or any condition or requirement imposed under this Act; commits an offence and is liable on conviction to imprisonment for a term not exceeding ............ years or to a fine or to both. 17.2 (a) Any person shall, upon conviction of an offence un- der sections 17.1(a), (b) or (d), be prohibited from engaging in any activity in relation to GMO(s) or products thereof. (b) Such order of prohibition shall extend to any corporation, body or legal entity which may be used to avoid the effect of the said order. 17.3 Any person who repeatedly commits any offence other than that stated in section 17.2(a) may be prohibited from engaging in any activity in relation to GMO(s) or products thereof. 17.4 Where the offence is committed by a corporation, and where the court feels that a custodial sentence ought to be imposed, the executive officer in charge at the time the offence is committed shall be liable to imprisonment. 18. Criminal proceedings 18.1 Whenever any person is convicted of an offence under this Act and it appears that such person has by that offence caused loss or damage, including the cost incurred or likely to be incurred by any organ of state in rehabilitating the environment or preventing damage to the environment, the court may in the same proceedings at the written request of the Minister or other organ of state and in the presence of the convicted person, ascertain the amount of the loss or damage so caused. 18.2 The court may then give judgement therefore against the convicted person, and such judgement shall have the same force and effect and be executable in the same manner as if it had been given in a civil action duty instituted before a competent court. 18.3 The court may also summarily enquire into and assess the monetary value of any advantage gained or likely to be gained by such person in consequence of that offence, and, in addition to any other punishment imposed in respect of that offence, the court may order the award of damages, compensation or a fine equal to the amount so assessed. 18.4 The court convicting such person may also, upon application by the public prosecutor or another organ of state, order such person to pay the reasonable costs incurred by the public prosecutor and the organ of state concerned in the investigation and prosecution of the offence. 18.5 Whenever any manager, agent or employee does or omits to do an act which it had been his/her task to do or to refrain from doing on behalf of the employer and which would be an offence under this Act for the employer to do or omit to do, and the act or omission of the manger, agent or employee occurred because the employer failed to take all reasonable steps to prevent the act or omission in question, then the employer shall be guilty of the said offence and liable on conviction to the penalty specified under this Act, including an order under sections 18.2, 18.3 and 18.4, and proof of such act or omission by a manager, agent or employee shall constitute prima facie evidence that the employer is guilty under this subsection. 18.6 Whenever any manager, agent or employee does or omits to do an act which it had been his/her task to do or to refrain from doing on behalf of the employer and which would be an offence under this Act for the employer to do or omit to do, he/she shall be liable to be convicted and sentenced in respect thereof as if he/she were the employer. 19. Institutional arrangements 19.1 The Government shall designate or establish a competent authority to implement, enforce and generally carry out the provisions of this Act. 19.2 The functions of the competent authority shall include the following: (a) to handle all enquiries, applications and approvals under this Act; (b) to review any decision made under this Act; (c) to make available any information to, and receive comments from, the public as is provided for under this Act; (d) to carry out its functions in relation to risk assessment as set out in section 6; (e) to impose measures for risk management under this Act; (f) to enforce identification, labelling and packaging provisions; (g) to establish mechanisms to facilitate the collection, storage and dissemination of data on local conditions, such as agronomic, epidemiological, logistic and environmental data; (h) to establish mechanisms for exchange of information with other countries, particularly those in the region; (i) to do all that may be deemed necessary to implement the policy and provisions of this Act. 19.3 The competent authority shall establish an independent body of experts, as provided for in section 6.2(c), drawn from, but not restricted to, the disciplines and fields of expertise set out in section 19.4 to assist it to carry out its functions of risk assessment under the provisions of this Act. 19.4 The experts appointed should, wherever possible, be from the following disciplines, particular regard being paid in each case to include those disciplines which can make critical inputs: ecology (in the field of community and population, ecosystem, soil and water studies), molecular genetics, population genetics, taxonomy, agronomy, virology, microbiology, marine biology, microbial physiology, pathology, entomology, atmospheric physics, veterinary science, laboratory applications and industrial processes, food safety, social sciences (such as sociology, anthropology, etc. as appropriate in each case) and economics. 19.5 The experts to be empanelled for making any particular assessment shall, as far as is possible, be familiar with and have expertise in: (a) the class or order of the host(s) and the donor(s) family, genus or species to be introduced; and (b) the dynamics of the receiving environment including those environments which may be potentially affected. 19.6 No person shall sit as a member of the risk assessment body in respect of a subject matter in which he/she has any direct or indirect interest of any kind, or if, for any reason, there is, or there is likely to be, a conflict of interest as a result of his/her participation in the proceedings of the said body. 19.7 The competent authority may, at the request of the panel dealing with a particular assessment or on its own initiative, nominate such other person(s) to be members of the said panel on an ad hoc basis for purposes of making the assessment. 20. Institutional Biosafety Committees 20.1 Institutions that are involved in any activity relating to GMO(s) or products thereof shall establish Institutional Biosafety Committees to ensure and control safety at the institutional level. 21. Regulations 21.1 The Government may make regulations for the better carrying into effect the purposes and provisions of this Act, and in particular, and without prejudice to the generality of the foregoing, for all or any of the following matters: (a) application and approval of, and other matters relating to, the import, release, placing on the market, or contained use of GMO(s) or products thereof; (b) transport, storage, handling and laboratory practices in relation to GMO(s) or products thereof; (c) prescribing fees, costs and/or expenses for approval, risk assessment, risk management, investigations, supervision, enforcement and control done under this Act or any regulations made thereunder; (d) prescribing criteria, parameters or standards for risk assessment or risk management or for such matter required to be done under this Act; (e) labelling, identification and packaging of GMO(s) or products thereof; (f) any matter or thing which by this Act is authorized, required or permitted to be prescribed or which is necessary or expedient to be prescribed for carrying this Act into effect. 22. Transitional provisions 22.1 After the date of the entry into force of this Act, any person carrying out any activity in relation to GMO(s) or products thereof shall submit an application for approval for the said activity in accordance with the provisions of this Act. 22.2 This application shall be submitted to the competent authority within a time limit to be determined by the competent authority. 22.3 If the application has been made within the prescribed time limit, the activity in respect of which the application is made may continue until a decision is made by the competent authority under section 7 of this Act. 22.4 Any application pending at the date of the entry into force of this Act shall be subject to the provisions of this Act. 23. Entry into force 23.1 This Act shall enter into force on a date decided by the Minister. 23.2 The Minister may decide that different parts of the Act may enter into force at different times. 24. Annexes 24.1 The Annexes and any regulations made under or pursuant to this Act shall be an integral part of this Act.
ANNEX I* Information Required for the Application
I. General information A. Name and address of applicant B. Information on personnel and training 1 Name of person(s) responsible for planning and carrying out the release, including those responsible for supervision, monitoring and safety, in particular, name and qualification(s) of the responsible scientist(s) 2. Information on training and qualification(s) of personnel involved in carrying out the release II. Information relating to the GMO(s) or products thereof A. Characteristics of a) the donor, b) the recipient or c) (where appropriate) parental organism(s) 1. Scientific
name (a)
Classification of hazard according to existing national rules concerning
the protection of human health and/or environment 12. Nature of indigenous vectors: (a)
Sequence 13. History of previous genetic modifications B. Characteristics of the vector 1. Nature
and source of the vector C. Characteristics of the GMO(s) or products thereof 1. Information relating to the genetic modification: (a)
Methods used for the modification 2. Information on the final GMO(s) or products thereof: (a)
Description of genetic trait(s) of phenotypic characteristics and in particular
any new traits and characteristics which may be expressed or no longer
expressed (i)
Toxic or allergenic effects of the non-viable GMO(s) or products thereof
and/or their metabolic products III. Information relating to the conditions of release and the receiving environment A. Information on the release 1. Description
of the proposed deliberate release, including the purpose(s) and foreseen
products B. Information of the environment (both on the site and in the wider environment) 1. Geographical
location and grid reference of the site(s) (in case of notifications the
site(s) of release will be the foreseen areas of use of the product) IV. Information relating to the interactions between the GMO(s) or products thereof and the environment A. Characteristics and factors affecting survival, multiplication, gene expression and dissemination 1. Biological
features which affect survival, multiplication and dispersal B. Interactions with the environment 1. Predicted
habitat of the GMO(s) or products thereof (a)
post-release transfer of genetic material from GMO(s) or products thereof
into organisms in affected ecosystems 4. Likelihood
of post-release selection leading to the expression of unexpected and/or
undesirable traits in the GMO(s) or products thereof C. Potential environmental impact 1. Potential
for excessive population increase in the environment V. Information on monitoring, control, waste treatment and emergency response plans A. Monitoring techniques 1. Methods
for tracing the GMO(s) or products thereof, and for monitoring their effects
B. Control of the release 1. Methods
and procedures to avoid and/or minimize the spread of the GMO(s) or products
thereof beyond the site of release or the designated area for use C. Waste treatment 1. Type
of waste generated D. Emergency response plan 1. Methods
and procedures for controlling the GMO(s) or products thereof in case
of unexpected spread * Based largely on Annex 2 of the Danish Statutory Order No. 1098 of December 11, 1992 on the Approval of Experimental Release and of Marketing of Genetically Modified Organisms and Annex IIIA of the European Directive on the Deliberate Release into the Environment of Genetically Modified Organisms (Directive 90/220/EEC).
ANNEX II* Additional Information Required in the Case of Notification for Placing on the Market A. The following information shall be provided in the notification for placing on the market products, in addition to that of Annex I: 1. Name
of the product and name(s) of GMO(s) contained therein B. The following additional information shall be provided when required/relevant: 1. Measures
to take in case of unintended release or misuse C. The following information concerning labellingof products thereof shall be provided on a label and/or in accompanying documents: 1. The
words "This product contains GMO(s)" whenever there is evidence of the
presence of GMO(s) in the product * Based largely on Annex 3 of the Danish Statutory Order No. 1098 of December 11, 1992 on the Approval of Experimental Release and of Marketing of Genetically Modified Organisms and Annex IV of the European Directive on the Deliberate Release into the Environment of Genetically Modified Organisms (Directive 90/220/EEC).
ANNEX III* Risk Assessment
The risk assessment shall take the following parameters into consideration: A. General principles 1. The guiding principle of risk assessment is the precautionary approach. Where the transboundary movement, or use or handling of GMO(s) or products thereof may cause, or has a proven or theoretical potential (or based on reasonable scientific theory of hazards based on deductive, circumstantial as well as inductive evidence) to cause harm to biodiversity, ecosystems, human or animal health, the lack of full scientific certainty or consensus regarding the level of risk should not be interpreted as the lack of risk, or as acceptable risk. 2. The risk assessment should take into account, inter alia, all relevant scientific theory, evidence and experience, including previous risk assessments. This enables the risk assessment to evolve in the light of new evidence and knowledge; a GMO or product thereof previously considered acceptable may no longer be acceptable, and vice versa. 3. It shall be accepted as a principle underlying the risk assessment that every transgenic line is different because of random insertion, even if they are made with the same vector system, the same gene constructs and the same variety, and that it has to be well characterised to be stable for at least five generations under a reasonable range of environmental conditions that it may encounter. 4. The risk assessment should take into account, inter alia: (a)
All relevant scientific theory, evidence and experience; B. Specific information requirements The information required for risk assessment should include the following: 1. Characteristics
of donor and recipient organisms or parental organisms: 2. Characteristics of the vector(s): (a)
Nature and source of the vector(s) 3. Characteristics of the GMO or product thereof: (a)
The description of the modifications made using gene technology 4. Characteristics of resuscitated organisms and gene(s) and fossil DNA sequences: Resuscitated organism (a)
Scientific name and taxonomy DNA sequences from fossils or from resuscitated organism (a)
Scientific name and taxonomy of the species whether resuscitated or a
fossil 5. Safety considerations for human and animal health: Information on the GMO or product thereof and information on the donor and recipient organisms as well as the vector before it was disarmed or disabled in cases where it has been disarmed or disabled, regarding: (a)
Capacity for colonization (i)
Diseases caused and mechanism of pathogenicity, including invasiveness
and virulence, and property of virulence 6. Environmental considerations: Information on the GMO or product thereof and information on the donor and recipient organisms as well as the vector before it was disarmed or disabled in cases where it has been disarmed or disabled, regarding: (a)
Factors affecting the survival, reproduction and spread of the GMO or
product thereof in the environment 7. Socio-economic considerations: (a)
Anticipated changes in the existing social and economic patterns resulting
from the introduction of the GMO or product thereof | ||
Model
National Biosafety Law