Asia-Pacific Perspectives on Biotechnology and Bioethics (original) (raw)

Which little piggy to market? : legal challenges to the commercialisation of agricultural genetically modified organisms in Australia

2019

Type of Scheme 35 2.6.2 Cooperative Legislative Scheme 35 2.6.3 GT Agreement 36 2.7 GT ACT 2000 (CTH) 36 2.7.1 Definitions 37 2.7.2 GM Products. 40 2.7.3 Gene Technology Regulator 41 2.8 APPROVED DEALINGS .41 2.8.1 Exempt Dealings 42 2.8.2 Notifiable Low Risk Dealings 42 IV 2.8.3 Dealings Listed on GMO Register 43 2.8.4 Licensed Dealings 44 (a) DNIR licence • 45 (b) DIR licence 46 2.8.5 Risk Assessment and Licence Approvals 47 (a) GTR's approach 48 (b) Analysis of approach. 50 2.8.6 Licence beem and Conditions 54 2.9 OTHER MATTERS DEALT WITH IN THE GTACT 56 2.9.1 Summary 56 2.9.2 Confidential Commercial Information 57 2.9.3 Offences and Penalties 59 2.9.4 Monitoring and Enforcement 60 2.9.5 Right of Review 61 (a) Rights of commercialisers 61 (b) Rights of third parties 63 2.10 FOOD REGULATION.. 64 IX 1 4.4 CONFIDENTIAL INFORMATION 176 4.4.1 Legal Requirements far Protection as Confidential Information.. (a) Basic principles , 176 (b) Franklin v Giddins , 177 4.4.2 Application to GMOs and their Products t 17S (a) Information concerning GMOs and their products 178 Co) Practical value of protection as confidential information... 180 43 CONCLUSION 181 CHAPTER 5-TORT LIABILITY FOR GMO RELEASES 183 X 5.2-4 Substantial and Unreasonable Interference , 201 (a) Purpose of defendant's conduct 203 (b) Compliance with relevant regulations 204 (c) Plaintiffs abnormal sensitivity 206 (d) Locality 209 (e) Precautions taken by defendant. 212 (f) Frequency, duration and time of interference 214 (g) Defendant's motive , , 215 *j (b) Whether GMO releases cause substantial and unreasonable d \ interference 215 1 5.2.5 Defences to Nuisance 217 (a) "Coming to the nuisance' and consent .. (b) Statutory authorisation 218 (c) Act of god 5.2.6 Remedies 5.2.7 Conclusion with respect to Case Studies ,... (a) Will there have been an interference with an interest in property? , (b) Will the interference be substantial and unreasonable? 5.3 NEGLIGENCE...

Risk assessment and management of genetically modified organisms under Australia's Gene Technology Act

2006

Compared to both Canada and the United States, Australia has been slow to approve commercial planting of transgenic crops. Two probable reasons exist for the slow approval rate of transgenic crops in Australia. The first reason is community perceptions about the risks associated with transgenic technologies. The second is the regulatory framework currently employed to approve commercial releases. This paper examines some of the potential regulatory issues that may be affecting the review process and approval of transgenic technologies. First we provide a brief introduction to the regulatory structure in Australia, second we consider the impact of regional, national and state jurisdictions, third we argue that the regulator needs to consider the use of benefits analysis in decision making, fourth we argue for the use of probabilistic risk assessments in certain circumstances, and fifth we look at potential problems inherent in majority voting in a committee and recommend alternatives.

Local Certification: Genetically Modified Organisms and Commercialization

Kertha Patrika, 2021

Local government requires a regulatory framework as a base of Genetically Modified Organisms’ (GMO) development and expansion in order to support food sovereignty. In regions of Indonesia, GMO products could be strengthened through local certification. The involvement of the government is vital in supporting the economical activities of entrepreneurs in certain regions. Researchers are interested in further discussion on, “Local Certification: Genetically Modified Organisms’ Commercialization”. The studies focus on the urgency for local certification in GMO products and the commercialization of local certification towards GMO Products of region in Indonesia. This is normative research through a statute approach, which concerns legal basis for local government authority regarding agricultural products’ affairs. The research suggested that urgency for local certification in every region is very much needed to bolster food production with GMO technology base as part of the geographical...

Regulatory aspects for Biologic Product licensing in Australia

International Journal of Drug Regulatory Affairs, 2019

The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person. The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will: Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1). Explains the Australian regulatory requirements for supplying of Biologicals Explains what is required for the market authorization as per TGA especially for Biologicals.

Regulation of genetically modified foods in Australia and New Zealand

Food Control, 2003

Food standards in Australia and New Zealand build on the level of food safety that is generally accepted by the community. An explicitly cautious approach is applied in cases where there is no established history of safe human consumption, as is the case for foods produced using gene technology. Novel foods, including genetically modified (GM) foods, undergo a mandatory pre-market safety assessment and approval process. The approach used in Australia and New Zealand to assess the safety of foods produced using gene technology draws on concepts and principles that have been developed internationally.

US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars

Plant Biotechnology Journal, 2007

This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.

Gene Technology Regulation and the Environment Protection and Biodiversity Conservation Act 1999 (Cth)

2019

Diverse risks arise from the release of genetically modified organisms into the environment, including possible environmental and socio-economic impacts. Not all risks are addressed by the national GMO regulatory regime created by the Gene Technology Act 2000 (Cth). Some risks, namely socio-economic impacts, are instead addressed by recently introduced State moratorium legislation. Yet others, in particular some environmental concerns, are assessed under the Environment Protection and Biodiversity Conservation Act 1999 (Cth) but only if the operation of that Act is triggered. This article considers the interaction of the regulation of agricultural GMO releases by the Gene Technology Act 2000 (Cth), State moratorium legislation and the Environment Protection and Biodiversity Conservation Act 1999 (Cth)