An introduction to the model national law on Biosafety

by Gurdial Singh Nijar

(Draft )


Nations of the South are increasingly faced with the prospect of the introduction into their countries of genetically modified organisms(GMOs) as, or in, products. 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 products gains momentum. It is now widely acknowledged that serious potential risks are presented by this technology. This prompted the international community to commence negotiations for a biosafety protocol under the Convention on Biological Diversity. But these negotiations have been stalemated. Consequently, there are no regulations in place to deal especially with the movement across boundaries of these GMOs and their products. Also, there are several aspects which need to be addressed exclusively by national laws.

This model law has been drafted to present one possible option.

The scheme of the law

1. Authorization needed for all activities and for all GMOs and derived products

The scheme of the law is to subject every activity in relation to GMOs to the regulatory control of the State. There must be formal authorisation before the GMO can be imported, introduced into the environment, placed on the market, or used in contained conditions. Without such an authorisation, the activity is illegal and penalties apply.

2. All GMOs covered

All GMOs, as well as products made from GMOs, come within the law. This would cover 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.

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 to allow for an adequate evaluation of any foreseeable risks from allowing the activity in relation to the GMO or derived products.

4. Risk Assessment essential

Before approval is given, there has to be a risk assessment by an independent body of experts chosen from a wide range of disciplines. The risk assessment is comprehensive, on a case by case basis, and intended to deal with all the potential risks to the environment and animal and human health. The guidelines, which must be adhered to, are set out in an Appendix III. 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 derived products if this may cause, or have a proven or theoretical potential to cause harm to biodiversity, ecosystems, or human, plant or animal health.

5. Other factors essential

Factors in addition to risk assessment must also be taken into account before authorization is given. Thus there must a cost benefit assessment of the introduction of the GMO or derived product as well as an assessment of its contribution to sustainable development. Any adverse socio-economic effects must also be considered.

6. 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 and human and animal health.

This is a very stringent requirement. As a fall back position the decision can be based on the precautionary principle as set out in paragraph 4 above.

7. Approval with or without conditions

When approval is given, it may be with or without any conditions.

8. 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.

9. 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 him at any time.

10. Public consultation

The public must be given adequate notice of any application. They should also be given all information supplied by the applicant to the national competent authority. Public consultation should precede the making of a decision. Sufficient time before a decision is reached should be given to the public to allow for such consultation. Comments given by the public must be taken into account in the decision-making.

11. Risk management measures

After the approval, and at all times generally, the State may take measures to manage any risks posed by GMOs and derived products. These include : subjecting the activity to adequate periods of monitoring ( example, commensurate with its life-cycle or generational time) before its allowed to be released, prohibiting any product (example, 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.

12. Identification and labelling

All GMOs must be identified in a particular manner; and derived products are required to be labelled in a prescribed manner. Further, the label must forewarn of any allergy that the GMO or derived product may cause.

13. No confidentiality of business in some situations

No confidentiality of business information can be claimed for information that is required for evaluation of foreseeable risks; nor can any information be with-held which will impede the State in its monitoring, supervision or enforcement work.

14. No export without prior informed consent

There can be no export of GMOs or derived products unless the State is satisfied that the country of import gives its prior informed consent.

15. Liability

The liability provisions impose strict liability for any damage caused by the introduction of the GMO or derived products. Liability attaches to any person or entity responsible for the harm. If there is more than one person responsible, then liability is joint and several. Liability extends to environmental damage caused/ the person or entity responsible must bear the costs for the clean-up and consequential damage.

16. Punishable conduct and penalties

There is a section in the law that identifies conduct that is illegal and punishable. This includes: carrying out any activity without any approval; or in violation of conditions imposed; or false, misleading or deceptive labelling; or exports without the prior informed consent of the importing country; or sells any GMOs or derived products without approval. Punishment includes imprisonment and this can be imposed on the responsible officer of a corporation as well.

17. Institutional arrangements

The law also provides for institutional arrangements : the Ministry( and the Minister) who 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.

18. Regulations

The Minister is given power to make regulations for the effective implementation of the law.

19. Transitional provisions

There is also a transitional provision. It subjects the introduction into the country of GMOs or derived products prior to the coming into force of the law to the same procedure and requirement for approval.

(* Gurdial Singh Nijar is a senior practising lawyer in Malaysia and Legal Advisor to the Third World Network.)