Complying with Defence Export Controls: a working perspective

RCPA and then RCPAQAP have been providing proficiency testing programs (PTP) for infectious diseases since 1968 when the RCPAQAP Microbiology program commenced. Since then, two other infectious disease programs have been introduced, Molecular Infectious Diseases (2005) and Biosecurity (2009). The latter is funded by the Australian Government Department of Health to provide PTP for Security Sensitive Biological Agents (SSBA), other potential agents and disease threats to Australia following the introduction of the SSBA Regulatory Scheme in 2008. In recent years the Biosecurity program has produced PTP in response to the outbreaks of Ebola, Middle East Respiratory Syndrome (MERS CoV), and Zika virus and more recently, the SARS-CoV-2 (COVID-19) pandemic.

These programs are provided in accordance with ISO/IEC 17043:2010 Conformity assessment – General requirements for proficiency testing. RCPAQAP is also accredited as a Proficiency Testing Scheme Provider through the National Association of Testing Authorities (NATA).

Key requirements for RCPAQAP Infectious Diseases PTPs are that they should:

• include specimens containing microorganisms causing infectious diseases (includes inactivated materials) that are current and prevalent in Australia and/or worldwide. There is a need for flexible panel composition depending on the availability of material and relevancy in infectious disease diagnoses in a clinical setting;

• contain panels of specimens presented as unknowns with the requirement that there be no disclosure of the panel contents prior to the PTP closing for result submission;

• allow for dynamic enrolments, often programs are purchased just prior to PTP dispatch;

• maintain complete anonymity and confidentiality regarding participation and results submitted.

The Government’s Export Control Policies are designed to encourage the export of defence and dual-use goods, which is consistent with Australia’s broad national interests and biosecurity response^1,2. However, the introduction of the Defence Trade Controls Act in 2012 as part of a wider international regulatory counter-proliferation framework, had the potential to completely disrupt the RCPAQAP business model in the provision of infectious disease PTP.

Australia’s export control system is part of an international effort to stem the proliferation of conventional, chemical, biological, and nuclear weapons and the systems that deliver them. Many goods designed for legitimate civil purposes can also contribute to the development of Weapons of Mass Destruction (WMD) or be used for a military end-use. Australia has a legislative framework that ensures that the Government can manage the Nation’s exports of controlled goods, services and technology (Figure 1). The policies reflect the Government’s commitment to ensure the export of defence and dual-use goods is consistent with Australia’s national interests and international obligations^1,2. The policies and procedures are regularly reviewed to address any changes in strategic circumstances and priorities. In order to strengthen Australia’s export controls, and to stop technology that can be used in conventional and weapons of mass destruction programs, Defence worked with stakeholders to address concerns with the Defence Trade Controls Act 2012. As a result, amendments to the Act were adopted through the Defence Trade Controls Amendment Bill 2015 (DTC Amendment Bill).

Figure 1.  The legislative framework that governs Australia’s export of controlled goods.

Australia’s defence export control list, the Defence and Strategic Goods List (DSGL)³, is drawn directly from, and agreed to, by the multilateral export control regimes of which Australia is a member. This list specifies the goods, software or technology subject to the export controls administered by Defence and is broken into two parts (Figure 2).

Figure 2.  The categories included in the Defence and Strategic Goods List.

Applications to export defence and dual-use goods are considered on a case-by-case basis. All applications are assessed to determine whether the controlled activity would be prejudicial to the security, defence or international relations of Australia. In the Defence and Strategic Goods List³ RCPAQAP material comes under Part 2 Dual-use list, Category 1 – Materials, Chemicals, Microorganisms and Toxins.

Since 2012, when the DEC was first introduced, RCPAQAP was able to obtain permits for the DSGL listed live organisms that were included in the surveys with relative ease. However, processing the applications took several weeks as the controls and application processes were new.

In 2017, there was a significant revision to the regulations introduced for genetic elements control, which included inactivated pathogens. Prior to this, genetic elements were controlled if they contained nucleic acid sequences associated with pathogenicity of organisms listed under 1C351 and 1C352. The nucleic acid sequence in itself or through its transcribed or translated products had to represent a significant hazard to human, animal or plant health; or had to be known to enhance the ability of a specified micro-organism, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to humans, animals or plant health.

After discussions with international export control regimes, and notably the Australia Group⁴, the DEC regulations were amended to include the control of inactivated organisms. This also has a revised definition of what is now considered to be ‘recoverable’.

This change to Entry 1C353 for genetically modified organisms and genetic elements had the potential to cause the most disruption to the RCPAQAP business model since many PTP were prepared from inactivated material. From the RCPAQAP perspective, Table 1 lists what is currently being done to mitigate the issues and concerns that the organisation had with complying with the DEC regulations.

Table 1.  RCPAQAP experience with DEC Regulations.

Defence Export Controls are an essential regulatory component involving the exportation of organisms of security and biothreat relevance in compliance with Australian legislation. This paper discusses strategies that RCPAQAP have developed to detail a user-end experience with Defence Export Controls in the hope of highlighting the important considerations, to which those involved in the exportation of controlled goods must adhere.

The authors declare no conflicts of interest.