Glossary

  • Administration office: An office within a national biosafety framework that is responsible for receiving biosafety applications for approval of GM activities.
  • Application: All forms of notification or submission to the regulatory authority for permission to carry out activities with genetically modified organisms (GMOs).
  • Applicant: An individual or institution that will notify or apply to regulatory authorities in the country when a particular GMO, or an activity involving a GMO requires notification or prior authorisation under the national regulatory policy.
  • Confidential business information (CBI): Information in applications that will be kept confidential.
  • Confined use: The research and development of GMOs in short term field or clinical trials that are managed to minimise impact on or persistence in the environment.
  • Contained use: The research and use of GMOs inside a facility that is designed to minimise the release of living organisms into the environment.
  • Event: Each individual GMO produced during the modification of a single plant species using a specific genetic construct.
  • GM activities: Activities that could be carried out with GMOs in the course of their development, testing and use. Not all countries will require permission for all activities.
  • General release: The approved, general use of a GMO with no or minimal regulation. Also termed ‘unconfined release’, and approvals may have some conditions.
  • Genetically modified organism (GMO): A plant, animal or microbe derived through recombinant-DNA techniques. The term, living modified organism (LMO) has been used where discussion focuses on the Cartagena Protocol on Biosafety.
  • GM product: Non-living products that are derived from GMOs.
  • Inspection: The check for compliance with regulatory conditions for activities with GMOs. This may include the review and investigation of facilities, materials and documents related to GMOs.
  • Monitoring: The scientific collection of biosafety data to support biosafety decisions. It also describes the systematic measurement of the effects of GMOs over time.
  • National biosafety framework (NBF): The national structures established by legislation to implement a biosafety regulatory process in a country.
  • Unconfined release: The approval for the general use of a GMO with no or minimal regulation. This is also termed ‘general release’, and may have some conditions for use appended to the approval.