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National Regulations

Most national governments have established regulations to help ensure the safe and responsible use of new technology, including genetic modification. Not all countries have implemented these regulations, however. National biosafety regulations generally require that research and development is carried out safely, that the products are tested thoroughly before they are used. In most countries, regulatory approval is required before some biotechnology products reach the market.

The safety of products of modern biotechnology generally falls under existing animal, food and plant regulations. Many countries have additional, specific biosafety regulations to ensure risk assessment reviews for genetically modified organisms and some countries include a socio-economic review to identify any social or economic risk that may result from the use of new products.

The wide range of products derived from genetic modification means that many government agencies are involved in safety assessments and approvals. For example, agricultural agencies review plant and animal safety; health agencies regulate food and medicine safety; environmental agencies review environmental impact; trade and industry agencies monitor economic impact; forestry agencies review the impact of genetically modified trees and tree products, etc.


International Regulations

International regulations become important when farmers plan to export or import genetically modified crops. In addition to the World Trade Organisation requirements for fair trade and pest and disease control, the Cartagena Protocol on Biosafety has specific requirements on movement of living GMOs. For plants, this includes seed, grain, tubers, seedlings, or cuttings that could grow if planted in the importing country. The Cartagena Protocol requires that the importer of living GMOs must get advanced agreement from the importing country authorities for the movement of living GMOs into every country. This decision requires a risk assessment that considers safety to human health and to the environment, and so these decisions can take time.

For commercial farmers planning to export genetically modified seed, grain or plants, a lot of paper work has to precede the first shipment and several months may be needed for this. Once the first shipment has been approved, the Protocol does not require additional risk assessments, but some countries do. It is up to the importer to ensure that each importing country’s requirements are met.

For smallholder farmers, the most likely ‘shipment’ of GM products across international borders will happen with informal movement of plant material and harvests between communities on each side of a national border. National regulators usually take informal movement across international boundaries into account when they first approve the planting of new GM crops. Some authorities require labelling for planting material, farmer education and sometimes the signing of farmer agreements, if they wish to limit the amount of planting material that moves informally across borders.

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