Regulation

GM organisms are subject to tight regulatory approvals in countries where they are developed and grown. These regulations allow GM research only in suitably approved containment facilities and by organizations and staff who have the appropriate qualifications and experience.

For GM crops, field evaluation is an essential component of the development and delivery process. Special approvals are required for conducting such trials. In some countries, the approval process is relatively straightforward although the approval times can range from several months to well over a year and appear to be increasing. This means that GM lines being evaluated are often not the latest, or most suitable, for analysing trait expression. In some jurisdictions, notably in some European countries, the costs of running a GM field trial are prohibitive and trials are frequently destroyed by anti-GM lobby groups.

Full commercial release of a GM crop will require full regulatory approval both in the country of production and in all the jurisdictions where the GM product may be imported. Since 1995, the time to obtain regulatory approval has increased markedly in the USA and indeed no new crop obtained approval in the USA in the 5 years from 2000 (Jaffe, 2005).

Commercial seed companies have rarely provided estimates of the costs to deregulate a biotechnology crop. However, the costs are 'many times higher than the regulatory costs for a non-GM plant variety, which range from US$5000 to US$11,000' (Oborne, 2009). Table 12.8 provides a summary of some of the cost estimates.

The international regulatory requirements are derived from the 1992 Rio Declaration on Environment and Development, Principle 15 'where there are threats of serious or irreversible damage, lack of scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation' (UNEP, 1992). This requires extensive evaluation and testing of any GM crop.

Table 12.7. Monsanto's product pipeline (modified from Monsanto, 2008).

Proof of concept

Early product development

Advanced development

Pre-launch

Key activities

Average duration Average probability of success

Gene optimization Crop transformation Field evaluation

12-24 months 25%

Large-scale transformation Trait development Pre-regulatory data

12-24 months 50%

Trait integration Expanded field trials Regulatory data generation 12-24 months 75%

Regulatory submission Seed bulk-up Pre-marketing

12-36 months 90%

Table 12.8. Costs to deregulate a GM crop.

Cost estimate (US$) Source

40-50 million Anecdotal from multinational companies

6-15 million for a herbicide-tolerant maize Kalaitzandonakes et al. (2006) 'Up to 13.5 million' Organisation for Economic Co-operation and

Development (OECD) report (Oborne, 2009)

The requirements for international movement of a GM product are outlined in the Cartagena Protocol on Biosafety (CBD, 2007) and 'Contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms ...'. This agreement prescribes a process for the transport of GM products between countries known as the Advanced Informed Agreement Procedure, which requires the exporter to provide detailed information to the importing country. The importing country must have a competent national authority, which can acknowledge receipt of information, authorize shipment or give reasons for rejection. This procedure only applies to the first movement of the GM product and is not required if the GM plant is in transit, for contained use or will go directly into food or feed and will be rendered non-viable. Governments are also able to notify the Biosafety Clearing House of approval and provide detailed information supporting this (CBD, 2009). This provides a central repository of regulatory and evaluation information on GM crops and products.

As with regulations for GM research, field evaluation and commercial release, the regulations covering the acceptance and use of GM foods vary greatly between countries with the most stringent in the European Union. An extensive literature has been developed around the safety assessment of GM foods (FAO/WHO, 2000). The complexities associated with both the development and the release of GM crops has meant that most commercially grown GM crops have been released by the private sector. However, in some countries, notably China, strong public sector and government support for GM crops has led to the development and release of several GM crops.

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