161-2019 - Proposed changes to the import requirements for animal fluids and tissues for in-vitro use
11 October 2019
Who does this notice affect?
All importers of animal fluids and tissues for in-vitro use (or in-vivo use in laboratory organisms).
What will be changing?
Countries (or regions) approved for the export of animal fluids and tissues to Australia will be updated
Updated policy advice has recently been finalised regarding the lists of countries approved for sourcing of animal fluids and tissues from the following species:
- Cervines (deer)
- Ovine & Caprine
- Suid (porcine)
These lists are used to manage the import of small volumes (20ml or 20g or less - per individually packaged unit) of animal fluids or tissues; ensuring goods are sourced from countries free from significant diseases of biosecurity concern. Standard import permits are currently issued (and will continue to be issued) for goods which can meet the associated import conditions.
Please note: Several countries are no longer included in these lists; other countries have been added. The new lists have been published on the department’s website.
Samples from countries other than those listed must be treated with ionising radiation to a level that achieves a minimum absorbed dose of 50kGy (which is the same as existing conditions).
Documentation will now be required
To demonstrate compliance with the requirements of the Standard import permits, the following statements must presented on a Manufacturers declaration or Supplier declaration:
- A statement that the goods are of <<insert species of animal>> origin.
- A statement that the goods were sourced from animals residing in the following country/ies which were approved at the time of collection <<insert country/ies>>; and
- A statement that the animal fluids and tissues were sourced from animals with no clinical signs of infectious disease at the time of collection.
- A statement that the goods have not been deliberately infected with a disease agent.
If this declaration cannot be provided, the goods must be treated with ionising radiation to a level that achieves a minimum absorbed dose of 50kGy (in line with existing conditions).
When will these changes be implemented?
It is expected that these changes will be implemented as follows:
- Equine fluids and tissues from 14 October 2019
- All other species from 25 November 2019
Industry participants requesting further information are encouraged to contact the department by e-mailing firstname.lastname@example.org (Attention: ABIB Laboratory Team), or by calling 1800 900 090.