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建立信任措施“E”

宣布立法、规章和其他措施

涉及事项立法规章其他措施12一年来有无修改
(a) 发展、生产、储存、取得或保有第一条所指微生物剂或其他生物剂或毒素、武器、设备和运载工具
(b) 微生物13 和毒素的出口
(c) 微生物13 和毒素的进口
(d) 生物安全14 和生物安保15
表格E的额外信息

In addition to the above summary, an overview of key Australian Government legislation relevant to the BWC is provided below:

Background

The following Australian Government legislation, regulations and other measures are relevant to this confidence-building measure. The Australian Government has a range of legislative and executive measures that ensure compliance with UN Security Council Resolution 1540 (2004).

Australia is fully committed to the work of the 1540 Committee in ensuring global implementation of this resolution. As well as legislation dedicated to Weapons of Mass Destruction (WMD), there is a considerable amount of health, safety and environmental legislation that controls access to hazardous biological materials.

National Health Security Act 2007

The National Health Security Act 2007 (NHS Act) was passed by the Australian Parliament in September 2007. It has two main operative parts: Part 2 of the Act enacts Australia's responsibilities under the International Health Regulations 2005 and formalises surveillance systems in Australia, while Part 3 establishes a regulatory scheme for biological agents of security concern.

Part 3 of the NHS Act enables the Department of Health and Aged Care to regulate the handling of Security Sensitive Biological Agents (SSBAs). The NHS Act establishes a two tiered list of SSBAs, a National Register that is informed by mandatory reporting, the purposes for which SSBAs may be handled, security standards (physical, personnel, information management, disposal and transport) that must be met, exemptions from regulation, and an inspection scheme to monitor compliance. The regulatory scheme monitors both known SSBAs and biological agents suspected of being SSBAs.

Security Sensitive Biological Agent Standards

The SSBA Standards set out minimum requirements relating to physical security, personnel, information management, decontamination and inactivation, disposal and transport of SSBAs and biological agents suspected of being SSBAs. They include specific directions for dealing with biosecurity risks and establish a systematic approach to the management of the security of SSBAs. The SSBA Standards are comprised of normative requirements that are mandatory and informative statements to assist in meeting the normative requirements. 

The SSBA Regulatory Scheme is further strengthened through a background checking scheme for personnel who handle SSBAs. Background checks, known as National Heath Security Checks, consist of a national criminal history check against a list of disqualifying offences and a security assessment.

The SSBA Regulatory Scheme has a comprehensive inspection scheme for facilities handling SSBAs. Registered facilities that handle Tier 1 SSBAs are inspected every 18 months. Registered facilities that handle Tier 2 SSBAs are inspected every two years. Inspections of non-registered facilities handling suspected SSBAs and spot checks are undertaken as required. Inspections continue to show a high level of compliance.

Chemical Weapons (Prohibition) Act 1994 and associated regulations

This Act is administered by the Minister for Foreign Affairs, and statutory responsibilities are held by the Australian Safeguards and Non-Proliferation Office. The Act gives effect to Australia’s obligations under the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction. The Act controls certain chemicals which may be used as weapons, including the natural toxins ricin and saxitoxin. The Act’s general purpose criterion also applies to the hostile use of any chemical, including other toxins. The Act extends to the acts of Australian citizens outside Australia. Contravention of the Act is an indictable offence.

Crimes (Biological Weapons) Act 1976

This Act, which is administered by the Attorney-General, makes it unlawful for Australians to develop, produce, stockpile or otherwise acquire or retain microbial or other biological agents or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; or weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict. The Act extends to the acts of Australian citizens outside Australia. Contravention of the Act is an indictable offence.

Crimes (Biological Weapons) Regulations 2019

These Regulations specify the way in which substances acquired under the Crimes (Biological Weapons) Act 1976 should be stored, disposed of and analysed.

Customs Act 1901 and Customs (Prohibited Exports) Regulations 1958

The Act controls the export of tangible defence and strategic dual-use goods and technologies and is administered by the Minister for Immigration and Border Protection and the Minister for Defence. Controls are executed through Regulation 13E of the Customs (Prohibited Exports) Regulations 1958 which allows the Minister for Defence, or a delegate to grant permission to export goods or technology listed in the Defence and Strategic Goods List (DSGL).

The DSGL specifies the goods, software or technologies that are regulated when exported, supplied, brokered or published. The list comprises two parts:

  • Part 1 of the DSGL lists munitions (or military) items, which are those goods and technologies designed or adapted for use by armed forces or goods that are inherently lethal;
  • Part 2 lists dual-use items, that is, items that may be used for commercial purposes, but may be used in military systems or for weapons of mass destruction purposes. As such, Part 2 includes human pathogens and toxins, animal pathogens, plant pathogens and equipment capable of being used to develop biological weapons.

The DSGL was updated in August 2021, following changes made to the control lists of the export control regimes of which Australia is a member. The DSGL update included a new control for the Middle East respiratory syndrome‑related coronavirus, which was recently added to the Australia Group control lists.

The Act also includes a prohibition power that allows the Minister for Defence to prohibit the export of any uncontrolled goods when the Minister believes or suspects the export may be for a military end-use that would prejudice the security, defence or international relations of Australia.

Applications to export goods listed in the DSGL are considered on a case-by-case basis against criteria specified in the Customs (Prohibited Exports) Regulations 1958 to ensure exports of military and dual-use goods are consistent with Australia's broader national interests and international obligations.

Australia’s export control policies and procedures are reviewed regularly to reflect shifts in strategic priorities and reflect changes in the various international counter-proliferation multilateral and export control regimes of which Australia is a member, including the Australia Group (AG), Proliferation Security Initiative (PSI) as well as enforcing United Nations Security Council Resolutions (UNSCRs).

The Biosecurity Act 2015 and associated regulations

The Biosecurity Act 2015 commenced on 16 June 2016 (fully replacing the Quarantine Act 1908) and is jointly administered by the Minister for Agriculture, and the Minister for Health. The Act is designed to manage the risks associated with the introduction, establishment and spread of pests and diseases affecting humans, plants, animals and the environment.  Accordingly, in conjunction with the Biological Control Act (see below), it controls the import into Australia of all biological material and may prohibit the import in some circumstances.

Those aspects of the Act that relate to human biosecurity are administered by the Minister for Health and Aged Care (Department of Health). Those aspects of the Act that relate to plant and animal biosecurity are administered by the Minister for Agriculture. All biological agents require prior permission to import.  

As per the Act, the Director of Biosecurity at the Department of Agriculture, Water and the Environment and the Director of Human Biosecurity at the Department of Health may jointly determine that specified classes of goods must not be brought or imported into Australian territory unless specified conditions (including conditions for administrative purposes) are complied with. The relevant Determination listing the specified classes of goods is the Biosecurity (Conditionally Non-prohibited Goods) Determination 2021. Goods of biological origin, including human pathogenic microorganisms and toxins, may only be imported into Australia if approval has been given by a Director of Biosecurity. In giving approval, the Director may require that the importer adhere to certain conditions or requirements, including, but not limited to, the storage, transportation, distribution and disposal of the goods, the use to which the goods may be put, and the personnel authorised to handle or use the goods.

Import conditions vary depending on the nature of the organisms, and on the risks involved. High risk organisms such as serious pathogens of humans, animals and plants which might be considered as potential biological weapons would only be permitted under the most stringent, high security conditions. Very few such imports are approved, and generally those would be for diagnostic research in preparation for emergency responses to specific serious exotic disease incursions.

Penalties for the importation of prohibited or conditionally non-prohibited goods without a permit, and for breaches of permit requirements, are severe and may include a fine, imprisonment or both.

Biological Control Act 1984 and associated regulations

This Act is administered by the Minister for Agriculture. It provides powers additional to those of the Biosecurity Act in order to regulate the release of biological agents for the control of pests, diseases and weeds. It primarily covers issues of compensation for the release of a biological control agent.

Gene Technology Act 2000 and associated regulations

The Minister for Health is the commonwealth minister responsible for gene technology regulation, including the Gene Technology Act 2000 which regulates dealings with genetically modified organisms (GMOs) to protect the health and safety of people and the environment. The legislation is administered by an independent statutory office holder, the Gene Technology Regulator, and provides a risk-based system for regulation of GMOs. There are also legislative provisions for accreditation of organisations, certification of physical containment facilities and extensive monitoring and enforcement powers.

All dealings with GMOs must be licensed by the Regulator, unless otherwise authorised under the legislation. Dealings include production, import, transport and conducting experiments with GMOs. All licence applications are subject to case-by-case scientific risk assessment and risk management.  

The legislation requires licensing for ‘higher risk’ GMOs, which would include those that could potentially be used as biological weapons or for other malicious purposes, including those that involve: modifications that may alter pathogenicity, virulence, host range or treatment of a microorganism; cloning or high expression of toxin genes; or animals, plants or fungi that are capable of secreting infectious agents as a result of the genetic modification. Work with such ‘higher risk’ GMOs is typically for medical, veterinary or agricultural research purposes and licence conditions include requirements that dealings be conducted in facilities certified by the Regulator to the appropriate physical containment (PC) level.

There are significant penalties for dealing with GMOs without a licence, and for breaches of licence conditions, which may include a fine, imprisonment or both.

Therapeutic Goods Act 1989 and associated regulations

The Therapeutic Goods Administration (TGA) is part of the Health Products Regulation Group of the Australian Government Department of Health and regulates therapeutic goods for human use under this Act. The Act covers the import, manufacture, supply and export of therapeutic goods, and includes pathogenic micro-organisms where these are included in vaccines for human use.

Prior to initial supply for human use, products must be entered in the Australian Register of Therapeutic Goods (the Register). Vaccines are registrable products and undergo evaluation by the TGA prior to entry in the Register.

Weapons of Mass Destruction (Prevention of Proliferation) Act 1995 and associated regulations

The Act is administered by the Minister for Defence and complements the existing controls contained in the Customs Act 1901 and Customs (Prohibited Exports) Regulations 1958. The Act and the associated Regulations provide the legislative basis for controlling the movement of goods and provision of services where there is reason to believe or suspect that the goods or services may be used in, or assist a weapons of mass destruction (WMD) program. The WMD Act defines a WMD program as a plan or program for the development, production, acquisition or stockpiling of nuclear, biological or chemical weapons or missiles capable of delivering such weapons.

The Minister for Defence may prohibit the export or supply of goods, or the provision of services if the Minister has reason to believe or suspect that it may contribute to a WMD program, including a biological weapons program. Penalties for conducting a transaction that has been prohibited by the Minister for Defence or failing to comply with conditions specified in a notice are severe and may include imprisonment.

The Act applies to Australian citizens and persons normally resident in Australia (including foreigners but only applies to their activities that take place within Australia) and bodies incorporated in Australia or an external Territory. The Act provides a mechanism for exporters to obtain written guidance from the Minister on whether he or she has reason to suspect that the goods may be used in a WMD program.

Defence Trade Controls Act 2012 and associated regulations

The Act is administered by the Minister for Defence and introduced controls on the supply and publishing of technology and the brokering of goods and technology listed in the Defence and Strategic Goods list (DSGL). The offence provisions of the Act came into force on 2 April 2016.

The Act regulates the:

  • intangible supply (such as transfer by electronic means) of technology listed in the DSGL
  • arranging the supply (brokering) of goods and technology that are either: listed in Part 1 of the DSGL, or are listed in Part 2 where they may be for a military or WMD end use
  • publication of technology listed in Part 1 of the DSGL.

The Act also includes prohibition powers that allow the Minister for Defence to prohibit the supply, brokering or publication of goods and technology on the DSGL when the Minister believes the activity would prejudice the security, defence or international relations of Australia.

Australian course on the United Nations Secretary-General’s Mechanism (UNSGM)

In October 2016, Australia hosted the first Southern Hemisphere UNSGM training course, with a focus on investigating the alleged use of biological weapons. The UNSGM was developed in the late 1980s to carry out prompt investigations in response to allegations brought to the UN Secretary-General’s attention concerning the possible use of chemical and biological and toxin weapons. The Australian course included participants from Australia, Canada, China, New Zealand, Philippines, Republic of Korea, Russia, South Africa and Thailand. The training program, developed with the UN Office of Disarmament Affairs (UNODA), strengthened the response capacity in the Asia-Pacific, encouraged greater interoperability and sharing of expertise and skills between members of the UNODA roster of qualified experts, increased awareness of issues related to the alleged use of biological weapons, and increased regional awareness of the UNSGM.  In 2022, Australia continued to support the UNSGM through nominating qualified experts and expert consultants for the roster, providing expert advice and assisting in the preparation training materials.

附件
N/A

(12) 包括准则。

(13) 《公约》所指可导致人类、动物和植物发生疾病的微生物。

(14) 按照卫生组织《实验室生物安全手册》最新版本或同等的国家准则或国际准则。

(15) 按照卫生组织《实验室生物安全手册》最新版本或同等的国家准则或国际准则。