Document ID: chunk:federal_register_of_legislation:F2011L00992:body:0:p19
Version: federal_register_of_legislation:F2011L00992
Segment Type: other
Provision Reference: 
Character Range: 51176–54330

are easy to see).

Decontamination methods
      3.1.6                  A person who personally conducts the decontamination process must ensure the requirements outlined below, for the respective method of decontamination, are complied with.

      3.1.7                  Decontamination may be effected by autoclaving using a combination of temperature and time that has been validated as effective for the decontamination of the GMOs.

      3.1.8                  The temperature and time controls of an autoclave used for decontaminating GMOs must be calibrated by a qualified person at least once every 12 months to determine the actual temperature and time at which the autoclave runs as compared to the autoclave gauges. The results of each year's calibration must be kept for the previous 5 years and made available to the Regulator if requested.

NOTE: Calibration does not necessarily require adjustment of the autoclave controls. If the autoclave cannot be adjusted and is significantly out, then the set temperature, for example, can be adjusted to compensate the difference by using the data from the calibration.

      3.1.9                  If an autoclave is used to decontaminate GMOs, the effectiveness of decontamination by the autoclave must be monitored at least once per month by the use of:
          (a) thermocouples or resistance thermometers, to ensure that the required temperature has been achieved; or
          (b) chemical indicators which use a combination of moisture, heat and time and which progressively change colour with the time exposed at the specified temperature; or
          (c) biological indicators such as spore strips; or
          (d) enzyme indicators.

      The results of each month's monitoring tests must be kept for the previous 12 months and made available to the Regulator if requested.

NOTE: Autoclaving is considered the most reliable means of decontamination, however, it is recognised that this method is not applicable in all situations. The reliability of autoclaves is predicated on correct usage and monitoring of the process. AS/NZS 2243.3:2010, Section 10.6, is a recommended source of guidance on using autoclaves.

      3.1.10             If using other heat-based equipment for decontaminating GMOs, the effectiveness of decontamination equipment must be monitored at least once per month.  The results of each month's monitoring tests must be kept for the previous 12 months and made available to the Regulator if requested.

      3.1.11             Decontamination may be effected by incineration in a high temperature, high efficiency incinerator that has been approved by the relevant government authority in the jurisdiction where the incinerator is located.

      3.1.12             Decontamination may be effected by any other heat-based equipment using a combination of temperature and time that has been validated as effective for the decontamination of the GMOs.

      3.1.13             If using other heat-based equipment for decontaminating GMOs the temperature and time controls of the equipment must be calibrated by a qualified person at least once every 12