30 March 2021
Who does this notice affect?
The department is providing an update to relevant industry representatives and importers of bulk Foetal Bovine Serum (FBS) for in-vitro use, regarding changes to the department’s process for assessing applications to import FBS into Australia.
What has changed?
In early 2019, the department wrote to industry representatives and importers of bovine serum and plasma, and related products, to inform them of changes to the department’s permit assessment process for FBS. These assessment changes were implemented to provide the department with greater assurance of the sourcing and processing of FBS for import, to ensure the animal biosecurity risks are adequately managed to meet Australia’s Appropriate Level of Protection.
The changed assessment process includes a requirement for the department to understand the competent authority’s oversight of FBS production and processing for export in the country from which the FBS is sourced. To-date, the department has approved for bulk FBS for in-vitro use (that has not been irradiated) to be produced for export to Australia from:
- the United States
- New Zealand.
While imports from other countries may be possible, a thorough assessment of the relevant competent authority’s regulatory processes and oversight will be required before a permit can be issued. Prospective importers or overseas government authorities may apply for such an assessment to occur, noting that such competent authority assessments can take some time and are dependent on the competent authority in question as well as the resources available within the department.
Because FBS is used widely in research and to produce pharmaceutical and veterinary products, and has the potential to harbour significant diseases, the department has continued to review the import requirements for FBS. The department expects to seek industry input on this review in the latter half of 2021.
For further information about the update above, please contact the department via: email@example.com.