3 March 2025
Who does this notice affect?
Importers and customs brokers associated with importing laboratory microorganisms and infectious agents under a standard permit, including those who currently hold a standard permit to import microbes or related material.
What has changed?
In March 2024, the department completed a scientific review of the biosecurity risks associated with the taxa included on the list of standard laboratory microorganisms and infectious agents (the list). As a result of the review, the department identified microorganisms and infectious agents (taxa) that will require amendment or removal from the list to manage biosecurity risk to an appropriate level.
On 21-22 March 2024, the department published this BICON Alert and Import Industry Advice Notice to open consultation for importers to provide feedback on proposed changes prior to any official amendments to the list of standard laboratory microorganisms and infectious agents.
The consultation period closed on 1 May 2024. The department has considered all feedback provided during the consultation period and has considered the level of biosecurity risk posed by the taxa, including seeking additional biosecurity policy advice where required. The final changes to the list are outlined below in Table 1. Based on the feedback received from consultation, the department was able to retain on the list many of the taxa considered by stakeholders to be significant.
Table 1: Proposed changes and final changes to the standard list
| Type of change (pre-consultation) | Current entry | Proposed changes (pre-consultation) | Final changes (post-consultation) |
|---|---|---|---|
| Entries to be removed from the standard list | Aspergillus spp. | Entries to be removed | Aspergillus spp. will be removed, however the following Aspergillus species only will be added: Aspergillus alabamensis |
| Enterobacter spp. | Enterobacter spp. will be removed, however the following Enterobacter species only will be added: Enterobacter aerogenes | ||
| Nippostrongylus brasiliensis | No changes from the proposed. The following species will be removed: Nippostrongylus brasiliensis | ||
| Pristionchus americanus | |||
| Pristionchus maupasi | |||
| Pristionchus pacificus | |||
| Rhabditis myriophila | |||
| Rhodococcus spp. | The following Rhodococcus species only: Rhodococcus aetherivorans | No changes from the proposed. Rhodococcus spp. will be removed, however the following Rhodococcus species only will be added: Rhodococcus aetherivorans | |
| Entries requiring updates to taxonomy | Vaccinia virus (cowpox) | Two separate entries: Vaccinia virus and Cowpox virus | No changes from the proposed. Vaccinia virus and Cowpox virus will be split into two separate entries. |
| Bacillus aminoglucosidicus | Bacillus pumilus (formerly known as B. aminoglucosidicus) | No changes from the proposed. Bacillus aminoglucosidicus will reflect updated taxonomy. | |
| B. pumilis syn. B. mesentericus, B. aminoglucosidicus | No changes from the proposed. Bacillus pumilus will reflect updated taxonomy. | ||
| Human metapneumovirus | Metapneumovirus hominis (Human metapneumovirus) | No changes from the proposed. Human metapneumoviruswill reflect updated taxonomy. | |
| Paenibacillus brasiliensis | Paenibacillus brasilensis | No changes from the proposed. Paenibacillus brasiliensis will reflect correct spelling. | |
| Genera requiring exclusions due to recent policy advice | Bartonella spp. | Bartonella spp. (excluding B. bacilliformis) | No changes from the proposed. Bartonella spp. will be kept on the list, excluding B. bacilliformis. |
| Clostridium spp. | Clostridium spp. (excluding C. botulinum) | No changes from the proposed. Clostridium spp. will be kept on the list, excluding C. botulinum. | |
| Cryptococcus spp. | Cryptococcus spp. (excluding C. gatii and C. neoformans) | Cryptococcus spp. will be kept on the list, including C. gatii and C. neoformans. | |
| Mycobacterium spp. (excluding M. bovis and M. caprae) | Mycobacterium spp. (excluding M. bovis, M. caprae, and M. tuberculosis complex) | Mycobacterium spp. will be kept on the list, excluding M. bovis, M. caprae, and only the drug-resistant strains of M. tuberculosis complex. | |
| Species requiring removal of exclusions due to recent policy advice | Vibrio cholerae (excluding serotype 01 and serotype 0139) | Vibrio cholerae | Vibrio cholerae will be kept on the list, excluding serotype 01 and serotype 0139. |
Why was the list reviewed?
The standard laboratory microorganisms and infectious agents list is a list of 200 taxa commonly imported for laboratory use. These microorganisms and infectious agents may be used in vitro and in vivo in laboratory organisms without biosecurity containment. The department uses the list across a range of commodities, including cloning and expression vectors and viral vectors, animal fluids and tissues and laboratory materials.
A review of the standard laboratory microorganisms and infectious agents was commenced to ensure the biosecurity risk of these taxa was still managed to an appropriate level. The review considered current biosecurity policy and scientific advice for the agents on the list, and where required, new policy and scientific advice was sought. Taxonomic changes that have occurred since the list was established were also reviewed.
Changes to permit content
Please see Table 1 to view the proposed changes and the final changes to the list. Note that some of the proposed changes sent on 21-22 March 2024 differ from the final changes outlined in Table 1.
Additionally, the layout of your permit will differ, as the list will no longer be included as an Appendix within your permit. The Appendix will be replaced with a link to a web list published on the department’s website. Moving to a web list will enable the department to readily update the list when changes are necessary, such as taxonomic changes. It is your responsibility as an importer to check for any changes to the list to ensure that your goods are compliant with import requirements.
How will my current permit be affected?
If you currently hold an import permit with the list of standard laboratory microorganisms and infectious agents, the department will send you a Notice of Intention to vary your import permit outlining the changes, followed by a Notice of Decision after the changes are implemented. Your permit will remain active, and you can continue to import goods provided that all import conditions can be met.
Advice for importers of taxa recommended for removal from the list
If you would like to continue importing taxa (or derivatives thereof) that will be removed from the list, a non-standard permit will be required. Non-standard import permit risk assessments are conducted on a case-by-case basis. Please note that there may be additional import conditions for these agents such as biosecurity containment and/or physical containment in order to manage the biosecurity risk of the goods to an appropriate level.
You can apply for a non-standard import permit through BICON under the Case: Microorganisms and infectious agents (and derivatives). Please advise us of your import permit application number so that your application may be prioritised. You can do this by emailing the Laboratory and Human Tissues section at imports@aff.gov.au (“attention: LHT” in email subject line) by 24 March 2025. Please note that this does not guarantee that the department will issue a non-standard import permit before the changes to the list are finalised.
Please reach out to the Laboratory and Human Tissues section if you have any questions or concerns.
Future changes to the list
While the present changes relate to existing standard laboratory microbes, the department will soon commence assessment of additional microbes to determine if they are suitable to add to the list. This will allow importers flexibility to import a broader range of microbes and related material under a standard permit. Please ensure you are subscribed to BICON alerts to receive updates about these changes.
Further information
Further information on the current policies for importing biological material for laboratory use can be found on the department’s website.
If you have any questions relating to this Alert, please contact the Laboratory and Human Tissues team via email at imports@aff.gov.au or by phone at 1800 900 090.