Approved sources of tissue cultures free of media

Tissue-culture plantlets can be imported into Australia either:

• with growing media (in-agar), or
• without growing media (ex-agar)

Import requirements differ depending on the pathways

In-agar tissue culture

Tissue culture imported with growing media may be sourced from any offshore facility, provided the consignment complies with all import conditions in BICON.

Ex-agar tissue culture

Tissue cultures imported without growing media must be sourced from a facility recognised by the department as an approved source.

Tissue cultured plants imported without media from an un-approved facility may require additional onshore measures, including post-entry quarantine in Australia.

If you are unsure whether your tissue culture is in agar or ex agar, we recommend contacting your supplier or the department.

What is an approved source of tissue culture free of media (ex-agar)?

An approved source is an offshore tissue culture production facility that has been assessed and approved by the department for the export of ex-agar tissue culture to Australia.

The department maintains an approved source list in the table below. Consignments imported as ex-agar will be cross-referenced against this approved source list to verify whether the goods are compliant with import conditions.

Importers must also hold a valid import permit and check the specific import conditions for species they wish to import.

Please refer to the department’s biosecurity import conditions database for all applicable import conditions – BICON.

What is the approval process?

Facilities seeking recognition as an approved source must submit a formal written application to the department.

Applications are assessed to determine whether the facility has the appropriate systems and controls in place to manage the biosecurity risks in accordance with Australia’s appropriate level of protection (ALOP).

Assessments comprise of an end-to-end review and may include:

• document reviews
• systems and traceability assessments
• review of testing and quality assurance arrangements
• engagement with the exporting country National Plant Protection Organisation (NPPO)
• onsite verification activities as required

The department has developed the document Requirements for facilities to export tissue culture free of media to Australia to support applicants seeking approved source recognition.

Prioritisation of applications

Once a formal application has been received, the department will review all information provided to help inform how the request will be prioritised for completion on our work program.

Applications are prioritised based on the following factors:

• Available departmental resources
• Alignment with departmental work program priorities
• Complexity of application
• Pathway risk
• Projected trade
• Whole of industry benefit
• Readiness of facility to export
• Order of applications received

Assessment timeframe

Timeframes for assessing ex-agar applications may vary depending on:

• The quality and completeness of information provided
• Complexity of production pathways
• Responsiveness of applicants and associated entities
• NPPO engagement
• Competing departmental priorities

The department does not prescribe fixed timeframes for completion of approved source assessments.

Certification periods and ongoing assurance obligations

Approved sources are recognised following successful assessment outcomes.

Recognition remains subject to ongoing compliance with import requirements and pathway assurance outcomes.

The department may undertake:

• Periodic compliance reviews
• Document verification activities
• Targeted audits
• Traceability activities
• Broader verification and inspection activities

Major or repeated non-compliance that is not appropriately remediated, may result in regulatory intervention by the department, including suspension or removal of approval status.