There are specific requirements regarding the importation, exportation, use, storage and disposal of biological materials with potential biosecurity risks.
Imported biological materials
Imported biological materials are considered a potential biosecurity (quarantine) risk, particularly if they are used in research involving live animals or whole plants. They should therefore be considered potentially hazardous and handled and disposed of accordingly.
The Department of Agriculture and Water Resources assesses the pest and disease risk of these imported materials to human, animal and plant health and the environment prior to importation. Individual items are usually assessed as unrestricted, restricted and prohibited, with various conditions attached.
Under the Biosecurity Act 2015, which came into effect on 16 June 2016, Quarantine Approved Premises (QAPs) are now known as Approved Arrangement (AA) sites.
Researchers who wish to import or use restricted materials must obtain an import permit and may need to handle the imported biological materials or animals under an Approved Arrangement (AA) site (formerly known as a QAP).
Further information from the Australian Department of Agriculture and Water Resources:
Export Control Regulations
Australia has put in place a legislative framework that enables the Government to manage the Nation's exports of controlled goods, services and technology while protecting the country’s national interests and international obligations and commitments. Some of the regulations that make up this framework that can have implications on biological research include:
- Customs Act 1901
- Defence Trade Control Act 2012
- Weapons of Mass Destruction (Prevention of Proliferation) Act 1995
Defence and Strategic Goods List
The basis for all three of these acts is the Defence and Strategic Goods List (DSGL) which is a compilation of goods, software or technology that can be regulated by Australia when exported, supplied, brokered or published. This list has been developed in conjunction with members of various international non-proliferation and export control regimes.
The DSGL is made up of two parts. Part 1 includes military items while Part 2 include dual-use items that are supposed to be used for commercial purposes but has the capacity to be used in developing weapons of mass destruction. Part 2 consists of 9 categories and Category 1 of Part 2 list a number of human, animal, plant pathogens and toxins in their wild type and genetically modified forms. The regulated microorganisms and toxins are listed from 1C351 – 1C354. Further information, including an online DSGL tool that allows the easy identification of items, is available on the defence export control website.
Customs Act 1901
The Customs Act 1901 regulates the tangible or physical export of the DSGL items including the above mentioned microorganisms and toxins out of Australia. This would most commonly require obtaining an export permit from the relevant permit issuing agency, which in most cases would be the Department of Defence.
Defence Trade Control Act 2012
The Defence Trade Control Act 2012 regulates the intangible supply of technology relating to defence and strategic goods, such as supply by electronic means and brokering the supply of Defence and Strategic Goods (DSGL) goods and technology. Some examples of intangible means are email, fax, telephone, video conferencing, providing access to electronic files, or presentations that contain DSGL technology. The provisions apply equally to the industry, university and research sectors.
Many activities taking place within the academic community consist of information that is 'basic scientific research' or that is 'in the public domain'. Such information is exempt from export controls. For example, undergraduate teaching will be outside the scope of export controls because teaching generally does not address controlled technology, and the material used for teaching is generally already in the public domain. The same may not be true of postgraduate teaching which may involve applied or experimental research that inherently is not in the public domain. If the postgraduate teaching is based in Australia but will teach students located overseas, the supply of ‘DSGL technology’ may require a permit if it involves unpublished information.
Australian Export Controls and the Life Sciences provide a guide to understanding export control laws regarding the physical export, intangible supply, publication or brokering of life sciences related goods, software or technology.
Weapons of Mass Destruction (Prevention of Proliferation) Act 1995
The Australian Government has introduced the Weapons of Mass Destruction (Prevention of Proliferation) Act 1995 (WMD Act) as it is not possible to identify and describe all possible goods and services which could contribute to a Weapons of Mass Destruction (WMD) program. The intent of the WMD Act is to prohibit the supply or export of goods that will or may be used in, and the provision of services that will or may assist, the development, production, acquisition or stockpiling of weapons capable of causing mass destruction or missiles capable of delivering such weapons both within and outside Australia, which are not regulated under the DSGL and which are also not regulated by a sanctions-related law. The WMD Act applies to nuclear, biological or chemical weapons or missiles capable of delivering such weapons.
Please refer to the Defence Export Controls Awareness Training for more information on how these regulations may impact on your research activities.