Imported Biologicals

Products containing biological material of human, animal, plant or microbial origin.

These can be divided into low risk and high risk groups (Table 1 below). If a product does not appear on either list, contact the Biologicals Unit to confirm the category in which the product belongs.

Table 1: Classification of Biologicals

Low Risk Biologicals - DO NOT require an Import Permit	High Risk Biologicals - Require an Import Permit
Human tissue (blood, serum, plasma), human genetic material and fluids (for therapeutic use only ). A permit is required if the material is for research purposes or in-vitro use, not connected to the diagnosis of disease in an individual.	Animal tissue extracts and fluids, animal blood, serum or plasma products, animal serum containing antibodies*
Synthetic laboratory reagents (must not be derived from animal, plant, human or microbiological substances)	Micro-organisms, animal* or microbiologically derived enzymes, hormones and proteins
Organic chemicals and substances - purified acacia gums, pure agar (agar agar), alcohols, amino acids, cellulose, dyes, esters, fish oils, gelatine, lanolin, lye water, organic acids, papain, paraffins, pectin, pine tar, plant colours, plant essences, plant extracts, plant flavours, plant oils, processed plant powders, plant waxes, rutin, shellac, squalene, starches, sugars, vitamins (not including animal products or liver extracts) and wool fats	Cell lines and products derived from cell lines (including human cell lines), culture media containing animal, plant, human* or microbial material
Non-biological buffers (eg Tris and EDTA)	Genetic material (other than human*)
Oligonucleotides and primers	Experimental, non-released vaccines
Synthetic culture media	Human faeces* or material known to be infected with a pathogenic organism

Biosecurity Australia usually recommends the appropriate level of containment. An Import Risk Analysis process is used to identify the risks involved with importing goods. Biosecurity Australia has conducted a two year review of microorganisms in consultation with the Department of Health and Ageing. This resulted in changes to some permits and the subsequent increase in containment levels for some microorganisms. It is your responsibility as researchers to carefully read and comply with all the conditions listed on your Import permit. Please DO NOT assume that a "renewed permit" will be identical to the previous expired one.

* Keep in mind that:

If your project involves human participants, you will need to seek approval of your research project from the Monash University Standing Committee on Ethics in Research involving Humans (SCERH), even if you already have approval from another Human Research Ethics Committee (HREC). Please contact the Human Ethics Officer or 9905 2052 for further information.

If your project involves the use of animals or animal tissue, regardless of the location where this activity occurs, you may need to seek clearance from a Monash Animal Ethics Committee. The Animal Ethics Approval must cover all animal research in the grant, list all investigators performing scientific procedures involving animals, and be for the entire period of the grant. Please contact the Animal Ethics Office or on 9905 5121 for further information.

If your project involves genetically modified organisms it will require approval from the Monash University Biosafety Committee (IBC 309). This also includes any "dealings" which are considered exempt under the Gene Technology Act. It is your duty to provide evidence to the IBC of approval granted by the Office of the Gene Technology Regulator or other IBC for any gene technology work carried out at another institution. Please contact the Research Compliance Officer or on 9905 5162 for further information.

Procedures must be implemented to ensure that no items subject to quarantine move outside a QAP except:

for the purpose of moving directly and securely to another QAP (of the appropriate QAP Class; often listed on your Import Permit) and
with prior written approval from AQIS

If items are being transported by a non-QAP Accredited Person (e.g. a truck driver), procedures must be implemented at the forwarding QAP to ensure that this person is made aware of the conditions relating to the transport of the items.

Checklists for transport of quarantine material are available to download from the DAFF website.

Quarantine Contact

Dr Simon Barrett
Manager
Research Ethics & Compliance
Research Office
First Floor, Building 3D, Room 108
Monash University VIC 3800
Map of Clayton Campus (pdf 904kb)

Tel: +61 (0)3 990 55162
Fax: +61 (0)3 990 53831