Biosecurity is the Institutional and personal security measures designed to prevent the loss, theft, misuse, diversion or intentional release of pathogens and toxins.
In Australia there are several legislation that are associated with biosecurity. These include,
- The Biosecurity Act 2015
- Regulations related to the use of Security Sensitive Biological Agents (SSBAs)
- Export Control Regulations
The Biosecurity Act 2015
The main purpose of the Biosecurity Act 2015 is to protect Australia’s unique environment by preventing or minimizing the risk of unwanted pests and diseases entering Australia. This act is administered by the Department of Agriculture and Water Resources (DAWR)
How does this act apply to research staff and students?
Mainly under two scenarios:
- When importing biological material into Australia
- When working with any exotic biological material in Australia
a) Importing biological material into Australia
If you wish to import a biological material into Australia, as a first step, please refer to the DAWR’s online resource known as the Biosecurity Import Conditions System (BICON). This system accommodates the Australian Government's Biosecurity import conditions database for more than 20,000 plants, animals, minerals and biological products. Some products and material are not permitted to be brought into Australia at all while some material and products will only be allowed to be brought in after meeting import conditions that address the biosecurity risks posed by them. Many products require an import permit before they can be brought into Australia. Therefore before importing any biological product or material please refer to the BICON to determine whether the product or material you wish to import:
- Is permitted to be brought into Australia
- Is subjected to import conditions
- Requires supporting documentation
- Needs treatment
- Requires an import permit.
Please note that at the moment all import permits are handled at the school level. Therefore please contact your school’s laboratory services manager to find out more details on how you could apply for an import permit if BICON indicates that the product or material you wish to import requires an import permit.
b) Working with exotic biological material in Australia
Working or handling certain exotic biological material require something called an ‘approved arrangement site’. These sites which were previously known as ‘Quarantine Approved Premises’ allow the operator of the site to manage biosecurity risks associated with the exotic biological material according to departmental requirements, using their own premises, facilities, equipment and people, without constant supervision by the department with occasional compliance monitoring or auditing.
Depending on the type of activities that need to be undertaken and the associated biosecurity risks, the department has prescribed 8 classes of AA sites.
The AA sites used for research, analysis and/or testing of imported biological material including microorganisms, animal and human products and soil are known as Class 5 AA sites. Class 5 sites are described under four biosecurity containment (BC) levels from 5.1 to 5.4 as given below, based on the biosecurity risks associated with the biological material to be handled at each level.
5.1 – Biosecurity containment level 1
AA sites used for goods subjected to biosecurity control of low hazard where standard safe containment practice is adequate to address biosecurity risk.
5.2 – Biosecurity containment level 2
AA sites used for goods subjected to biosecurity control of low to moderate risk to animals, plants or humans if disease is spread to the community or environment.
5.3 – Biosecurity containment level 3
AA sites used for goods subjected to biosecurity control which pose significant risks to animals, plants or humans if pest or disease associated with them spread outside the AA site and from which significant economic impact would result in the community or environment.
5.4 – Biosecurity containment level 4
AA sites used for goods subjected to biosecurity control which pose serious life-threatening risks to animals, plants or humans if pests or disease associated with them spread outside the AA site and from which substantial economic impact would result to people, the community or environment.
The handling of the material under biosecurity control in an approved arrangement site can be undertaken only by either, personnel who have successfully completed the AA accreditation training and maintain a current Accredited Person status, or by personnel who are under the direct supervision of an Accredited Person. More information about AA accreditation training can be found here which can be completed either online or in-house.
Regulations related to the use of Security Sensitive Biological Agents (SSBAs)
Security Sensitive Biological Agents (SSBAs) are a number of microorganisms and toxins regulated by the Department of Health under the National Health Security Act 2007 and the supporting National Health Security Regulations 2008, as these have the potential to be used for acts of bioterrorism or biocrime.
Part 3 of the National Health Security Act 2007 establishes the regulatory scheme for entities and facilities that handle suspected or known SSBAs while the National Health Security Regulations 2008 support the National Health Security Act 2007 by providing operational details about the SSBA Regulatory Scheme.
The purpose of the SSBA Regulatory Scheme is to stipulate a legislative framework for managing the security of SSBAs while ensuring that occasions for acts of bioterrorism or biocrime to occur using harmful biological agents will be restricted. The scheme is based on risk management principles to achieve a balance between counter-terrorism concerns and the interests of the regulated community so that full access to SSBAs can still be provided for those with a legitimate need such as those that require the use of SSBAs for legitimate research purposes. The SSBA Regulatory Scheme also aims to fulfit Australia's obligations under the Biological and Toxins Weapons Convention and UN Security Council Resolution 1540.
The list of SSBAs given below, consists of two tiers. Tier 1 agents are those that pose the highest security risk to Australia, while Tier 2 agents pose a high security risk.
The List of Security Sensitive Biological Agents (March 2016)
Abrin (5 mg)
African swine fever virus
Bacillus anthracis (Anthrax – virulent strains)
Capripoxvirus (Sheep pox virus and Goat pox virus)
Botulinum toxin (0.5 mg)
Classical swine fever virus
Clostridium botulinum (Botulism; toxin-producing strains)
Foot-and-mouth disease virus
Francisella tularensis (Tularaemia)
Highly pathogenic influenza virus, infecting humans
Lumpy skin disease virus
Ricin (5 mg)
Yellow fever virus (non-vaccine strains)
Variola virus (Smallpox)
Yersinia pestis (Plague)
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
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 have been agreed upon 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 complete Defence and Strategic Goods List (DSGL) including the regulated microorganisms and toxins that are listed from 1C351 – 1C354 can be accessed here.
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.
More information on Export Controls Regulations
Please refer to the Defence Export Controls Awareness Training for more information on how these regulations may impact your research activities.