National biosafety offices have a wide range of responsibilities. These include the general administration of biosafety processes in the country, development of biosafety policy, staff training, outreach and training for stakeholders and the public, interaction with regional and international stakeholders, and keeping politicians informed about national biosafety.
The components of a national biosafety framework (NBF) are interdependent. The national policy on biosafety provides the rationale for the development of a regulatory system for biotechnology and guides how decisions will be made regarding the development, testing and use of GMOs. The regulatory system forms the basis for the administrative systems for handling applications and decision-making, systems for follow up and compliance, and mechanisms for public awareness, education, participation and access to information.
Administrative systems for handling applications, decision-making on GMOs, monitoring, inspections and enforcement of biosafety decisions form a central pillar of any NBF. Countries wishing to enable access to genetically modified biotechnology tools will need to set up an appropriate administrative system that builds on existing systems, and is able to implement the regulatory system required by the national biosafety regulations and policy.
The biosafety review process involves a large volume of documentation, movement of documents and tracking of input and responses from many stakeholders. Add to this the requirement for securing confidential business information and the legal nature of the decisions that will derive from the biosafety reviews, and it becomes clear that the national biosafety office needs to be well managed and functional in all aspects of its administration.
In developing a regulatory system to suit the requirements of a country, the relevant government bodies must develop and implement administrative systems that will enable them to carry out the day-to-day activities required by the legislation. In many cases, these can build on the current systems rather than creating new, stand alone entities. It may be more effective to build onto an existing administrative system rather than to create something new. However, the choice of how to develop the administrative system will depend on each country’s particular situation, needs and priorities.