Facilities

Under the provisions of the Act, certain dealings with GMOs must be conducted within physical containment facilities. They are divided into 4 groups of physical containment (PC) levels based on structural and procedural requirement. These are referred to as PC1 – PC4. These include:

• Laboratories
• Animal facilities
• Plant facilities
• Insectaries
• Aquaria

Certification of Facilities

The purpose of certification is to satisfy the Regulator that the containment facility:

• Protects persons outside the facility from exposure to GMOs;
• Prevents release of GMOs into the environment; and
• Protects the safety of people working with GMOs inside the facility.

Types of contained facilities and their requirements:

*PC2 Large Scale: certified for work involving greater than 25 Litres of GMO culture

Certified Facilities are identified by the stickers on the entrance. The information contained on these stickers includes:

• Certification number (Cert e.g., XXX/2007);
• Certification area (e.g., Room X, Y & Z)
• Validity date

Inspections of Facilities

Certified facilities must be inspected on an annual basis. Members of the Monash IBC perform the inspections and non compliance issues are reported to the Biosafety Officer.
 
For 2007, unannounced inspections by IBC members will be carried out to ensure compliance with the guidelines and regulations at all times. A schedule for inspections of facilities has been prepared. Inspections may involve examining records, and checking the general knowledge of staff regarding procedures and requirements for working with GMOs (e.g. disposal and transport of GMOs, spills etc.).

Renewal, Amendments or surrender of Certifications

Facilities are certified for different times depending on their type and level of containment. The duration is clearly indicated on the stickers on the entrance to each facility.

To renew, add or remove rooms (areas) to existing Certifications, please send a written request (email is acceptable) to the Secretary with the details of the changes.

To surrender a certification, you must:

• Ensure that all the GMOs are removed form the facility (stored or moved to another certified facility).
• Ensure the facility is decontaminated.
• Send written notification to the Secretary (e.g., email) and include:
  • Location and Certification number to be surrendered.
  • Confirmation that GMOs are no longer used or present in the facility.