Maintaining Biosecurity Compliance
Investigators should ensure that at all times their work with biosecurity status materials complies with the specific conditions listed on their Department of Agriculture (DA) import permit. In addition, investigators should also ensure that all the mandatory records, labelling of imported material, evidence of disposal, etc as required by DA are maintained.
- Fit and Proper Person
As part of the application for approval of a proposed arrangement, you will need to complete a questionnaire and make a declaration.
- relevant criminal history of the applicant and relevant associates – in relation to breaches of Commonwealth law, particularly convictions relating to integrity and honesty;
- any debts owed to the Commonwealth by the applicant or relevant associates, under the Biosecurity Act or other specified legislation;
- whether the applicant or relevant associates have had arrangements or approvals suspended or revoked under the Biosecurity Act or other specified legislation.
More information can be found at the Department of Agriculture website
You can also contact the Research Compliance Officer.
- Valid Import Permits vs Active Import Permits
A 'valid' import permit is:
- an import permit which has not yet expired - ie. a permit which you can still use to import material
An 'active permit' is:
- an import permit under which biosecurity status material has already been imported and the material is still in existence, but the permit is no longer valid (ie you cannot use it to import any further material)
If you have any material that you, or someone else, imported under a Department of Agriculture (DA) import permit — irrespective how long ago it was imported, how old the permit is, whether you know the permit details, or when the permit expired — you have an 'active permit'.
The DA requires that you maintain the required records for all active permits as well as all valid permits.
- Labels on Biosecurity-Risk Material
All biosecurity-risk material must be labelled with the following mandatory information or a unique identifying number (recorded in a log book, spreadsheet or database) that can be traced back to this information:
- DA import permit number
- Import Permit Expiry date
- DA Quarantine Entry (or Order) number (QE) - Paperwork provided by DA for each Consignment that enters Australia. This is the DA record for each batch of material and is unique to that batch.
- Information Records
For all biosecurity-risk material, details must be kept in a log book/lab book/database or spreadsheet of the following information:
- DA import permit number
- Import Permit Expiry date
- DA Quarantine Entry (or Order) number (QE) - Paperwork drawn up for each consignment that enters Australia.
Unique DAFF record for each batch of material.
- Date goods were imported
- Type of sample - eg. soil; DNA; bacterial culture
- Amount of sample - eg. 40 kg; 3 x 1.5ml tubes
- Importer - name on permit and names of all people who handle the material
- Date(s) work is undertaken on material
- Sub-samples taken - eg. amount of material taken from the original batch and amount of original material remaining
- Derivatives used/created - eg. details of amplification, cloning, extraction, planting
- Information on movement or transfer - date and details of movement to biosecurity approved premises on campus
- Details of movement authority (new QE) for movement from Campus
- Destruction date - must include destruction date(s) (including by destructive analysis) for the batch.
Final destruction date for entire batch must be recorded - when all material is destroyed.
- Information for Department of Agriculture Inspections/Audits
During an DA inspection or audit you must know or be able to produce the following for the DA Officer:.
- A copy of all valid and active import permits
- Evidence you understood all conditions on the permit – you may be asked about specific conditions listed
- Evidence of required record keeping
- Evidence that you comply with all directions regarding where and how material can be handled
- Understand, comply with, and produce evidence of, disposal of biosecurity-risk material
- In Vivo Approvals
Personnel working with imported DNA and those working 'in vivo' should review carefully:
- what constitutes, from an DA perspective, 'in vitro' versus 'in vivo' work
- at what point their imported material is authorised and 'released' from biosecurity by DA
- at what point any material and/or derivatives that have been released from quarantine may once again be subject to biosecurity conditions
- the need to have separate in vitro and in vivo permits when required
- the specific disposal requirements for the imported material
- Transfer of Material between Approved Arrangement Facilities
In summary, any material to be transferred/transported:
- requires DA written approval
- must go to a facility at the correct biosecurity containment level
- must be contained, labelled and transported in accordance with Approved Arrangements (AA) and permit conditions
- can only be performed by accredited persons
Transfer of biosecurity status material between AA facilities requires DA'S prior written approval - either by way of inclusion of AA registration details on an import permit or by applying for an DA transfer approval.
It is of utmost importance that when you list AA registrations on an application for an import permit that you make sure you list ALL of the registrations that apply - ie. all of the QAPs where you propose to use your material. If you take material between facilities, check whether they are on the same or a different registration. Listing all of the relevant registration numbers will allow you to move your material between facilities on different registrations without the need for an DA transfer approval (ie. without additional cost).
At the Waite, remember especially that if your materials are received by the SARDI Quarantine Unit that you must also list the SARDI AA Registration S0195 on your permit application.
University personnel should note that an 'Application for transfer of biosecurity-risk material' is not required in the following circumstances:
- between AA facilities co-located under one registration
for example: between AA facilities in the Plant Research Centre and the Plant Genomics Centre at the Waite (both are under #S1185)
- between AA facilities for which the registration number is listed specifically on an import permit
for example: if #S0195, #S1185, #S1264 and #S1183 are each listed on your permit you can move your material between the SARDI, University and AGRF facilities across the Waite campus