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Australian Export Controls and the Life Sciences

A guide to understanding export control laws regarding the physical export, intangible supply, publication or brokering of life sciences related goods, software or technology

Annex 1: Case Studies

My company supplies small quantities of triethanolamine to overseas universities for research purposes. As the quantities are small (a few ml), do I still require export approval?
Triethanolamine is listed in Control Item 1C350.46. As there is no minimum threshold, a permit would be required. The only exception would be if the triethanolamine was part of a mixture. There is a note at the end of the Control Item text that de-controls (exempts) the mixture if the triethanolamine comprises 30% or less of the mixture, in which case the mixture would not require an export permit.

There are several other de-control notes that apply to the chemicals listed in Control Items 1C350 and 1C450. If a de-control note applies, then a permit does not need to be obtained.

My research requires using a live strain of Lassa fever virus and I would like to share my research findings with collaborators overseas. I will not export the actual strain as my collaborators have their own. Do I require a permit to provide the research to my collaborators? 
Merely using a controlled pathogen does not inherently make the research controlled and there are no “use” technology controls for pathogens. Controls only apply to “development” and “production” technology, and do not apply to technology in the public domain. Therefore the technology would only be controlled if you were disclosing to collaborators a novel method to develop or produce the pathogen (this includes technology for enhancing or modifying the pathogen). In addition, the technology would only be controlled if it was specific to Lassa fever virus; “development” and “production” technology that is generic with non-controlled pathogens is not controlled. 

I am emailing results of Shiga-like Toxin producing E.coli (STEC) to a Quality Assurance Program overseas (including information on culturing strains. Do I need a permit?
From this scenario information, it is difficult to be definitive on whether a permit will be required. More detail is needed regarding the ‘emailing of results’ and what that information contains. This will determine whether the information meets the “required” technology threshold. The information regarding the ‘culturing of strains’ of Shiga-like Toxin producing E.coli (STEC) may require a permit if the information contains instructional detail on how to develop or produce a controlled pathogen and that information is not already in the public domain.

I need to export genomic segments of Choclo virus. I note that genetic elements are only controlled in 1C353 if they contain a nucleic acid sequence associated with pathogenicity. How do I make this determination?
In this case ‘associated with pathogenicity’ is elaborated on in Technical Note 2 to 1C353. This includes any specific sequence that either in itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health, or is known to enhance the ability of a listed pathogen or any other pathogen into which it may be inserted or otherwise integrated, to cause serious harm to humans, animals or plant health.

I work for the Australian subsidiary of a European pharmaceutical company. We are developing a vaccine for Nipah virus. Do I need a permit to cover all my interactions with colleagues overseas?
Nipah virus is controlled in Control Item 1C351.a.25, and so is technology for its “development” and “production”.  Although there is an exemption for “vaccines” (1C351 Note), this only applies to products in pharmaceutical formulations that are licensed by, or have marketing or clinical trial authorisation from regulators. Sending any ‘DSGL technology’ to a colleague who is an employee of the European company would require a permit. If you were to send the same technology to a colleague who is an employee of the same Australian company, but who is temporarily working at the European company, a permit is not required as the supply is to the same “person” (i.e. between employees of the same Australian company).

A permit is required for the export of any living samples of the virus that are not pharmaceutical formulations, and any novel technology that is for the “development” or “production” of Nipah virus (which includes enhancing and modifying). Technology that is generic with non-controlled pathogens is not controlled.

My research involves performing nucleic acid sequencing of controlled pathogens. Do I need a permit to provide the sequences to overseas collaborators?
No. Written nucleic acid sequences are not controlled, even if they are not in the public domain.

My research doesn’t involve a controlled pathogen, but involves using a fermenter that is controlled. DSGL Item 2E301 controls technology for the “use” of controlled fermenters - does this mean my research is controlled and requires a permit to send to overseas collaborators?
No. The “use” technology controls are applicable only to the controlled equipment, not research that is done using controlled equipment. Using controlled equipment in research does not influence the control status of the research. In this case “use” technology for the fermenter would include a maintenance manual or user manual. However, any technology that is in the public domain is not controlled - the majority of “use” technology is expected to be non-proprietary and available in the public domain, and hence not controlled.

I’m doing research related to a current pandemic that involves a controlled pathogen. My research is specifically on the synthesis of proteins for use in antibody-based assays. This technology could be used for the development of the controlled pathogen. As technology for the “development” and “production” of the pathogen is controlled, does this mean my research requires a permit in order to share with international collaborators?
Not all technology that could feasibly contribute to the “development” or “production” of a controlled pathogen is controlled. The threshold test used is, is the technology specific or detailed enough to be solely relied on to develop or produce a listed chemical, pathogen, toxin, genetic element or genetically modified organism? If the answer is yes, that technology has met the “required” threshold and is controlled and will require an export permit. In this case, the technology is too generic and far removed - a lot more work and knowledge would be required.

I export inactivated controlled pathogens. Would I still require a permit for their export?
Yes. Controlled pathogens remain controlled even if they have been inactivated (unless it can be confirmed by the exporter that sufficient disruption has taken place that no infectious nucleic acid fragments remain). Genetic elements associated with the pathogenicity or toxicity of ‘DSGL-listed items’ are also controlled. This includes intact, naturally derived or synthetically produced nucleic acid which codes for a toxin or a pathogenic determinant that is readily recoverable such as a microbial lysate or purified nucleic acid.

I am researching conotoxin for use in pharmaceutical applications. As this is a controlled toxin, does this mean all my research is controlled and requires a permit? 
A pharmaceutical formulation of conotoxin would be exempt if it is pre-packaged and authorised for distribution as a medical product (Note 2 to 1C351). In addition, a conotoxin vaccine would also be exempt from control, provided it was in a pharmaceutical formulation and had regulatory authorisation as per the “vaccine” definition.

Examples of aspects of technology that would be controlled are:

  • technology describing methods for isolating the active peptides, if not in the public domain (technology exemptions would include public domain information specific to conotoxins or technology that is generic with non-listed toxins);
  • technology on how to modify a conotoxin (including decreasing or increasing its pathogenicity), if not in the public domain;
  • technology on how to produce a conotoxin via synthetic biology, if not in the public domain (however written nucleic acid sequences are not controlled); and
  • technology on how to produce large quantities of a conotoxin (e.g. for vaccine mass-production), whether though synthetic biology or traditional growth methods.

I am taking a laptop overseas with manuscripts involving DSGL-listed organisms. I am meeting with collaborators and will be sharing information. Do I need a permit?
Firstly, it is unlikely that the manuscripts on the laptop contain controlled technology. The controlled threshold for ‘DSGL technology’ is high and a number of exemptions apply (such as ‘pre-publication activities’; ‘in the public domain’; being considered ‘Basic Scientific Research’ and meeting the ‘required’ threshold – all these exemptions are discussed in this Guide).

If a person stores controlled ‘DSGL technology’ on a laptop, Defence advises that a permit should be obtained before the laptop is taken out of Australia. The permit would give permission for a person to take the controlled ‘DSGL technology’ stored on the laptop outside Australia, provided it is for their personal use and not to be transferred.

It is important to note that the laptop itself is not controlled; it is only because controlled ‘DSGL technology’ is stored on the device.

Defence is currently working with the Department of Immigration and Border Protection and drafters in the Office of Parliamentary Counsel to amend the export control regulations so that this permit requirement is removed. Until such time, a permit would be required if the laptop stores controlled ‘DSGL technology’.

I am presenting at an overseas conference on a DSGL-listed organism. Do I need a permit?

It is very unlikely you will need a permit to present at a conference or to send (or take) a presentation to a conference. It would be rare for technology contained in a conference paper or presentation to meet the specific thresholds in the DSGL that would make it controlled. DSGL thresholds are very specific and generally high and it would be rare for a conference paper to contain information that met these thresholds. Also, showing the slides at the conference would be a publication, so the forwarding of the slides to the conference organisers would be exempt as it is considered to be a pre-publication supply.  Any researcher who believes their conference paper meets the DSGL threshold should contact Defence Export Controls for an assessment.

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