OGTR certification of facilities for work with GMOs

Does my facility need to be certified by the OGTR?

Does my facility need to be certified by the OGTR?
  • A facility - laboratory, animal facility, plant facility, arthropod facility etc - will need to be certified by the OGTR before it can be used for work conducted under an NLRD or DNIR authorisation.
  • Facilities in which only exempt dealings are conducted do not need to be certified, but must meet some minimum containment requirements.
  • All facilities used for work with genetically modified animals must be certified by the OGTR.Facilities that have been certified by the OGTR will display signage on all entrances to the facility.  A PC2 Certified Facility will display an orange Certification sticker, as well as biohazard stickers. (insert photo).

University inspection and OGTR approval

Does my facility need to be certified by the OGTR?
  • Ensure that some of the research personnel who will use the facility are present at the time of inspection.
  • Ensure that copies of training records, SOPs, risk assessments and relevant certificates (e.g. for autoclaves or biosafety cabinets) are available.
  • Provided that the facility meets the relevant requirements, an application for certification will be sent to the OGTR by the Biosafety Office.
  • If the application is approved, the OGTR will provide certification and biohazard signs which are to be displayed at the entrances to the facility.
  • Note that the process can take up to 4 months, including a 90 working day OGTR assessment period.

General

  • The facility must continue to comply with the relevant Certification requirements
  • The facility will be inspected at least annually
  • In addition to scheduled annual inspections, Certified Facilities can be inspected by representatives of the UWA IBC or OGTR Officers without prior notice.

Varying a certification

A variation is required if, for example, the area covered by an existing certification is to change by adding or removing a room. All certification variations must be approved in writing by the OGTR. If a room is to be added to a current certification it:
  1. Must meet the relevant certification requirements
  2. Must be inspected by a representative of the UWA IBC

Suspending a certification

Suspension of a certification may be required at times, for example, to enable renovations to take place. A suspension allows non-GMO dealings to continue without the need for compliance with certified facility conditions. Once a certification is suspended by the OGTR:

  • No dealings with GMOs that are NLRDs or DNIRs can be conducted in the facility until the suspension is lifted by the OGTR
  • Certification and biohazard signs must be covered during the suspension period
  • Dealings with GMOs can only resume when the OGTR has lifted the suspension.
  • Before a suspension can be lifted, the facility:
    • Must meet the relevant requirements
    • Must be inspected by a representative of the UWA IBC

Surrendering a certification

When a facility no longer needs to be certified by the OGTR, the certification can be cancelled or 'surrendered'. Before a certification can be surrendered:

  • All GMOs must be destroyed or moved to another OGTR-Certified Facility
  • The facility must be decontaminated - this usually means swabbing surfaces with 80% v/v ethanol but the choice of disinfectant depends on the organisms that were used in the facility
  • The Biosafety Office will notify the OGTR that the facility is no longer required. After a Facility Certification has been surrendered:
    • No dealings with GMOs that are NLRDs or DNIRs can be conducted in the facility
    • All certification and biohazard signs must be removed from the entrances