Commonwealth of Australia
Gene Technology Act 2000
Gene Technology (Equine Influenza Vaccine) Emergency Dealing Extension Determination 2008
EXPLANATORY STATEMENT
This legislative instrument will extend the period of effect of an emergency dealing determination made under section 72B(1)) of the Gene Technology Act 2000 (the Act).
The Gene Technology (Equine Influenza Vaccine) Emergency Dealing Determination 2007 (the 2007 Determination) authorises dealings with the genetically modified organism that comprises the vaccine for equine influenza which is marketed in the United States as ‘RECOMBITEK FLU’ and in Europe as ‘PROTEQFLU’ or ‘PROTEQFLU TE’ (the GMO).
This determination will extend the period of effect of the 2007 Determination for a further 6 months.
Purpose and legislative framework
The Act is the Australian Government's component of the nationally consistent regulatory scheme for gene technology. Under the Gene Technology Agreement 2001, all States and Territories have committed to maintaining corresponding legislation. The object of the Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs).
Part 5A was inserted into the Act by the Gene Technology Amendment Act 2007 (the Amending Act). The purpose of the amendments made by the Amending Act was to increase the effectiveness of the gene technology regulatory system by increasing its responsiveness.
The emergency provisions give the Minister power to expedite an approval of dealings with a GMO in an emergency. This recognises that situations may arise in which approval of a dealing with a GMO may be required in a limited time. The emergency provisions also further the objects of the Act to protect the health and safety of people and to protect the environment.
The existence of emergency provisions in the Act is consistent with other regulatory schemes. Other relevant product regulators for vaccines, such as the Australian Pesticides and Veterinary Medicines Authority, possess the ability to expedite approvals in an emergency.
The purpose of making the 2007 Determination was to permit administration of the GMO so as to address an actual threat to the horse population in various parts of Australia from the equine influenza virus. A threat to the horse population is a threat to the environment from an animal disease.
Under section 72C(3) of the Act, the Minister may extend the period of effect of an emergency declaration. The purpose of this determination is to extend the period of effect of the 2007 Determination.
Effect of this determination
This determination will extend the period of effect of the 2007 Determination until 19 September 2008.
This determination commences on 20 March 2008, being the time when the 2007 Determination would have ceased to have effect but for the extension (see section 72C(6)).
Overview
The Gene Technology Act 2000, enacted by the Commonwealth of Australia, forms part of a nationally consistent regulatory scheme for gene technology. This Act aims to safeguard the health and safety of people and the environment by regulating dealings with genetically modified organisms (GMOs) and managing the risks associated with gene technology. In response to an actual threat posed by the equine influenza virus to the horse population in Australia, the Gene Technology (Equine Influenza Vaccine) Emergency Dealing Determination 2008 was introduced to extend the period of effect of an earlier emergency dealing determination for a further six months. This extension was necessary to continue the administration of the GMO vaccine, which is marketed in the United States as 'RECOMBITEK FLU' and in Europe as 'PROTEQFLU' or 'PROTEQFLU TE'. The determination extends the original 2007 Determination until 19 September 2008, facilitating the expedient approval process for the vaccine in an emergency, consistent with the Act’s objectives and other relevant regulatory schemes.
Scope and Application
The Gene Technology (Equine Influenza Vaccine) Emergency Dealing Extension Determination 2008 extends the duration of an earlier emergency determination made under section 72B(1) of the Gene Technology Act 2000, concerning a genetically modified organism (GMO) that forms the basis of the equine influenza vaccine. This determination specifically applies to the GMO used in vaccines marketed as 'RECOMBITEK FLU' in the United States and 'PROTEQFLU' or 'PROTEQFLU TE' in Europe. The extension, which was deemed necessary to address an actual threat to Australia's horse population from the equine influenza virus, is intended to continue until 19 September 2008. The Act itself is a Commonwealth statute forming part of Australia's nationally consistent regulatory scheme for gene technology, under which all states and territories have corresponding legislation. Its primary objective is to safeguard public health and the environment by regulating dealings with GMOs. The emergency provisions within the Act, including the authority to expedite approvals in urgent situations, ensure the scheme's responsiveness and align with other regulatory frameworks in Australia. The extension determination is effective from 20 March 2008, the date when the initial emergency determination would have otherwise expired.
Key Provisions
The main operative sections of the Gene Technology (Equine Influenza Vaccine) Emergency Dealing Extension Determination 2008 (the Determination) are sections 72B(1) and 72C(3) of the Gene Technology Act 2000 (the Act). Section 72B(1) allows the Minister to make emergency determinations regarding the regulation of genetically modified organisms (GMOs) in emergency situations, while section 72C(3) empowers the Minister to extend the period of effect of such determinations. The Determination extends the period of effect of the Gene Technology (Equine Influenza Vaccine) Emergency Dealing Determination 2007 for a further six months.
The obligations and requirements imposed by the Determination primarily revolve around the administration and use of the genetically modified organism (GMO) that comprises the equine influenza vaccine, marketed in the United States as ‘RECOMBITEK FLU’ and in Europe as ‘PROTEQFLU’ or ‘PROTEQFLU TE’. By extending the 2007 Determination, the Determination permits continued dealings with this GMO to address the threat posed by the equine influenza virus to the horse population in Australia. This includes allowing the administration of the vaccine to horses in order to safeguard animal health and, by extension, the environment.
Under the Act, the Minister has the authority to expedite approvals for dealing with GMOs in emergency situations, recognising the urgency of such scenarios. The Determination utilises this power to address the immediate threat to the horse population from the equine influenza virus. The extended period ensures that the regulatory measures put in place to handle this emergency are maintained, allowing for continued protection of the health and safety of people and the environment.
Breaches of the provisions set out in the Determination could potentially lead to civil or criminal consequences, though the Determination itself does not explicitly state the specific offences or penalties. Under the Act, unauthorised dealings with GMOs can result in civil penalties, including fines up to a maximum of $220,000 for individuals and $1,100,000 for bodies corporate, as well as potential criminal penalties. The penalties are intended to enforce compliance with the regulatory framework designed to protect health and the environment from the risks associated with gene technology.
In summary, the Determination extends the emergency dealing provisions for the equine influenza vaccine to ensure continued protection against the equine influenza virus threat. It imposes obligations on parties to comply with the extended regulatory measures and could result in significant penalties for non-compliance under the broader provisions of the Gene Technology Act 2000.