Sustaining and maintaing functionality

  1. Continuous improvement

    Countries preparing their NBFs need to be aware that the development of an administrative system for biosafety is a work in continuous progress. Biotechnology is a rapidly evolving field in which new issues and activities are constantly emerging, and governments have to be able to deal with changes in their national priorities and in public concerns. An administrative system is best designed to evolve according to changing circumstances or demand. For example, in many countries, it may take many applications per year to justify a stand-alone biosafety administration office, as in most instances the submission of applications starts slowly, and builds up to a point where more staff and resources are needed.

    The development of an administrative system is an ongoing, iterative exercise, and feedback during the implementation of the NBF gives a country an opportunity to ensure that the NBF is able to respond to changing needs, priorities and circumstances. In developing and implementing NBFs, countries need to make sure that there is a mechanism for gathering information on how the NBF systems work in practice, what problems are arising, and how the NBF responds to changing circumstances. This feedback could come from the biosafety bodies established to carry out certain functions, the applicants who use the biosafety administration system, the interested public who accesses information from the system, or an auditor general’s office that is responsible for reviewing the operations of government. All of this feedback will indicate how well the administration is working in practice.

    In this regard, it is important to get some of the basic aspects of the regulatory policy and administrative system clearly defined from the start. These include:

    • a clear definition of the objective of the legislation
    • the importance of definitions which in turn prescribe the scope and the applicability of the regulations and will be central to any legal interpretation of the legislation, and
    • the authority under which the biosafety process is implemented. This is particularly important when dealing with multiple centres of responsibility.
  2. Qualities of biosafety administrative systems

    The following questions are useful for determining the most useful qualities of an administrative system:

    • Clarity
      • Is it clear what processes and procedures apply to GMOs, GM derived products and activities involving GMOs?
      • Will users of the system – be they government, the public, or applicants – understand how the administrative system works?
      • Is a clear message or are consistent instructions being communicated through the country’s policy, laws, websites, employees, messages to the media, ?
    • Transparency
      • Is the system transparent?
      • Can applicants and others stakeholders find out and understand how the administrative system works?
      • Is it possible to follow the decision making process from the initial filing of an application through to the final decision?
    • Consistency
      • Are terms and definitions used throughout the administrative system in a consistent manner?
    • Practicality
      • Is the process workable?
      • Can the process work in practice as well as on paper?
      • Are the resources available to implement this process?
      • Do the stakeholders understand the process?
      • Are they willing to comply with it or will it create enforcement problems?
    • Authority
      • What sorts of authority are required to implement the administrative system procedures? For example, the authority to inspect private property or the authority to request test data from an applicant.
      • Does the institution that is being charged with implementing this process actually have the authority to implement?
    • Participation
      • Is the system participatory?
      • Are there mechanisms for all interested stakeholders to participate in the decision process?
      • Is public participation allowed at various stages in the decision-making process?
    • Effectiveness
      • Does the administrative system achieve its objective?
    • Predictability
      • How predictable is the administrative system?
      • Has it been designed in such a way that applicants and other stakeholders can expect the administrative system to work in a predictable manner?
      • Is it clear to applicants and other stakeholders who is responsible for taking decisions and on what basis?
      • Are the time frames, for example, clear and definite?
    • Enforceability
      • Do the resources exist to carry out this enforcement?
      • Is enforcement likely to be a problem or will there be willing compliance?
      • Can there be non-governmental enforcement through the help of industry and/or the public?
      • What sort of training will be needed if existing enforcement mechanisms are to be used?
    • Adaptability
      • How adaptable does the system need to be?
      • How adaptable is it?
      • Will changes be difficult, costly, or confusing?
      • Are the elements that will most likely need changing relatively easy to change?
  3. Reviewing biosafety administration

    Once a country has developed its NBF it needs to ensure that the component systems work well in practice, and are responsive to changing needs, priorities and circumstances.

    Review of biosafety processes, guidelines, regulations and even laws is a necessary component of any regulatory system. Processes should be reviewed annually to understand where they are not efficient and what changes are needed to improve functionality. These changes should be made immediately and should be reflected in all the guidance documentation, standard operating procedures and other checklists.