Financial Support

Biosafety systems impose financial costs for implementation and for compliance.

Implementation Costs

Costs of establishing and operating a biosafety system include:

• Education of policy makers and stakeholders

• Development of regulations

• Development and distribution of procedural information

• Training for reviewers

• Administrative expenses of the biosafety review committee

• Salary and support for paid staff

• Pre-release site visits (if required)

• Inspections during and upon termination of the field-test release

• Follow-up monitoring

• Training for inspectors

• Documentation and record keeping

In some countries, applicants are charged fees to cover these costs. While this approach may be suitable for applicants from the private sector, where such costs are viewed as a normal part of doing business, applicants from national research institutes, universities, and other public sector organizations may find the costs prohibitive.

Compliance Costs

Compliance costs are those incurred by the GMO developer in meeting regulatory requirements. Included are expenses for:

• Generating data needed for the application

• Implementation of risk-management measures

• Post-release monitoring prescribed as a condition of approval

• Reporting and documentation

For GMOs that have undergone prior review in another country, requiring a complete replication of the data, particularly food-safety data, is a costly process difficult to justify. The financial outlay for collecting a new set of data may preclude some applicants from testing GM products.

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