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Export Controls on Materials, Equipment and Technology used in the Biotech Industry

The export or supply of some types of materials, equipment and technology used in the Biotech Industry may require approval to comply with the Customs (Prohibited Exports) Regulations 1958, the Weapons of Mass Destruction (Prevention of Proliferation) Act 1995, or Sanctions Regulations.

What is controlled for export?

Biological materials:

  • human pathogens and zoonoses- including viruses, rickettsiae, and bacteria;
  • animal pathogens - including viruses and mycoplasmas toxins; and
  • plant pathogens - including viruses, bacteria and fungi.
Note: Please refer to the Specific Pathogens List for further information.

These biological materials can take the form of:

  • isolated live cultures;
  • deliberately inoculated or contaminated living material; and
  • genetically modified organisms or genetic elements.

Handling equipment for biological materials:

  • complete facilities (P3 and P4 containment level);
  • fermenters having a capacity of 20 litres or more and capable of cultivating pathogenic microorganisms or viruses, or capable of toxin production;
  • centrifugal separators capable of continuous separation with flow rates exceeding 100 litres per hour;
  • cross (tangential) flow filtration equipment capable of separating
  • pathogenic microorganisms, viruses, toxins or cell cultures having a total filtration area of 1m2 or more;
  • cross (tangential) flow filtration equipment components including modules, elements, cassettes, cartridges, units and plates, that have a filtration area of 0.2m2 or more; and
  • steam sterilisable freeze drying equipment with a condenser capacity exceeding 10kg of ice in 24 hours.

Protective and containment equipment:

  • full suits, half suits, hoods that use an external air supply and operate at a positive pressure;
  • class III biological safety cabinets or equivalent isolators;
  • chambers designed for aerosol challenge testing with a capacity of 1m3 or more;
  • gas masks (and canisters therefor), suits, gloves, shoes for protection against biological agents; and
  • decontamination equipment for biological agents.

Biological agent detection equipment:

  • detection or identification equipment, and components therefor.

Spraying or fogging systems designed or modified to fit onto aircraft:

  • complete systems, spray booms or arrays of aerosol generating units, with a flow rate greater than 2 litres per minute and capable of delivering an initial droplet size of 50 μm or less.

Technology:

Technology including technical data or technical assistance relating to the development, production and in some cases the use of controlled materials and equipment used in the Biotech Industry is also controlled when exported in tangible form.

Technical data may take the form of blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions.

Technical assistance is skill, knowledge, consulting services and may involve the transfer of technical data.

Development is related to all stages prior to serial production, such as: design, design research, design analysis, design concepts, assembly and testing of prototypes, pilot production schemes, design data, process of transforming design data into a product, configuration design, integration design, layouts.

Production means all production phases, such as: construction, production engineering, manufacture, integration, assembly (mounting), inspection, testing and quality assurance.

Use means operation, installation (including on-site installation), maintenance (checking), repair, overhaul and refurbishing.

Note: The Defence Trade Controls Act 2012 introduced controls on the supply or export of this technology in intangible form; such as email and fax - see Strengthened Export Controls below.

What is an export?

Goods that leave Australia with an intention to be landed outside Australia are considered to be an export. This includes goods and technologies sent by air and sea, through a freight forwarder, Australia Post, or carried in personal (checked-in or hand) luggage. Goods and technology sent overseas for sale, demonstration, repairs or return to the manufacturer are considered to be an export. Goods and technologies that have been temporarily imported under a Customs carnet are also subject to export controls when leaving Australia.

What are export controls?

The Australian Government controls the export of certain goods and technologies from Australia. Permission is required to export restricted goods and technologies. Defence Export Controls (DEC) is one of many agencies that provide permission to export restricted goods. We regulate the export of goods controlled under Regulation 13E of the Customs (Prohibited Export) Regulations 1958 and administer the Weapons of Mass Destruction (Prevention of Proliferation) Act 1995 (the WMD Act).

What types of goods and technologies are controlled under Regulation 13E?

The Defence and Strategic Goods List (DSGL) is the complete list of goods and technologies that are controlled for export under Regulation 13E. Part 1 of the DSGL , the Munitions List, includes items that are designed or adapted for use by armed forces, or goods that are inherently lethal. This includes non-military firearms and ammunition, commercial explosives and initiators. Items in Part 1 commence with the prefix ML.

Part 2 of the DSGL , the Dual-use List contains dual-use goods and technologies. These are items are developed to meet commercial needs but may be used either as military components, or in the development or production of military systems, or weapons of mass destruction (WMD).

Further information on the DSGL is available on the Defence and Strategic Goods List page.

What types of goods and services are controlled under the WMD Act?

The WMD Act enables the Government to control the export or supply of goods or services that may assist a WMD program. The WMD Act does not, however, contain a list of goods and services that may be controlled.

Further information on the WMD Act is available from Weapons of Mass Destruction (Prevention of Proliferation) Act 1995 page.

Some items not listed in the DSGL may have have WMD utility. Items used in WMD programs include:
  • HEPA filters
  • Biological material growth media (e.g. casein)
  • Biological material handling equipment, protective and containment equipment, and dissemination equipment that are below the DSGL thresholds
  • Specially designed components or accessories for the above equipment
  • Other biological material that can harm people, crops or animals
  • Castor beans
  • Spray drying equipment
  • Gas and fluid modelling software

Strengthened Export Controls

Australia has strengthened export controls by bringing legislation into line with international standards. During a two-year transition period, Defence worked with stakeholders to address concerns with the Defence Trade Controls Act 2012, and as a result, amendments to the Act were adopted through the Defence Trade Controls Amendment Act 2015.

The Defence Trade Controls Amendment Act 2015, which received Royal Assent on 2 April 2015, expands the existing defence exports control regime to cover:

  • the intangible supply and publication of DSGL technology and;
  • brokering of DSGL goods and technology.

The offence provisions of the Act, for supplying and publishing DSGL technology and for brokering DSGL goods and technology, came into force on 2 April 2016. They will not be applied retrospectively.

Further information on the new controls is available on the Supply, Publication and Brokering pages on this website.

What about Sanctions?

Sanctions imposed by the United Nations Security Council, as well as by the Australian Government, place restrictions on the supply, sale or transfer of a range of goods on the DSGL , as well as a number of additional military and WMD dual-use goods, to certain countries.  Sanctions also impose restrictions on commercial dealings with designated companies in certain countries, including some involved in the extractive industries sector.
 
Australian laws giving effect to United Nations Security Council or autonomous sanctions are administered by the Department of Foreign Affairs and Trade (DFAT).  Information concerning these laws may be found on DFAT 's website.

Further information on sanctions is also available on the Sanctions page.

How do I get permission to export goods and technologies that may be controlled?

You should submit an Application to Export Controlled Goods and Technology form to us if you intend to export and believe your goods and technology are controlled. If you are unsure about the control status of the goods or technology to be exported, you may also submit an Application to Export Controlled Goods and Technology form, to ask us to establish their control status.

Further information on theses proccess is available on the Apply for a licence or permission to export controlled goods or technology page and Understand the status of goods and technology page.


Note: Permission must be obtained prior to exporting controlled goods and technologies to any overseas destination.

Are there penalties for exporting goods without permission?

Export control legislation contains offences for the unlawful export or supply of controlled goods and services. DEC is committed to ensuring that exporters are aware of the legislative requirements that apply as non-compliance can lead to significant penalties.

Further information on the penalties associated with unlawful export of controlled goods, services and technology is available on the Penalties page.

Where can I get more information?

If you are unsure if your goods, technologiy or services are controlled for export, you should seek advice from DEC. More information on the export controls administered by us is available throughout this website.

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