scholarly journals Biosafety considerations of open air genetic engineering. An analysis of the New Zealand Environmental Protection Authority’s reasons for not classifying organisms treated with double-stranded RNA as genetically modified or new organisms

Author(s):  
Jack A Heinemann

The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. The Decision rests on the EPA’s conclusion that dsRNA is not heritable and therefore treatments using dsRNA do not modify genes or other genetic material. I found from an independent review of the literature on the topic that each of the major scientific justifications relied upon by the EPA to conclude that exposures to exogenous sources of dsRNA were out of legislative scope was based on either an inaccurate interpretation or failure to consult the research literature on all types of eukaryotes. The Decision also has not taken into account the unique eukaryotic biodiversity of the country. The safe use of RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation. However, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes by failing to restrict the source or means of modifying the dsRNA.

2019 ◽  
Author(s):  
Jack A Heinemann

The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. The Decision rests on the EPA’s conclusion that dsRNA is not heritable and therefore treatments using dsRNA do not modify genes or other genetic material. I found from an independent review of the literature on the topic that each of the major scientific justifications relied upon by the EPA to conclude that exposures to exogenous sources of dsRNA were out of legislative scope was based on either an inaccurate interpretation or failure to consult the research literature on all types of eukaryotes. The Decision also has not taken into account the unique eukaryotic biodiversity of the country. The safe use of RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation. However, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes by failing to restrict the source or means of modifying the dsRNA.


2018 ◽  
Author(s):  
Jack A Heinemann

The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. dsRNA molecules can be potent gene regulators in eukaryotes, causing what is known as RNA interference. RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation but also raises the threat of unintended consequences. The Decision rests on their conclusion that dsRNA treatments do not modify genes or other genetic material and are therefore not heritable. The EPA conclusion is not consistent with the totality of peer-reviewed research on dsRNA or industry claims. The Decision applies to nearly all eukaryotes, however, the EPA relied upon knowledge of relatively few eukaryotes and its analysis neglected known exceptions. The Decision also has not taken into account the unique eukaryotic biodiversity of the country, much of which is still to be described. The regulator has potentially created precedent-setting definitions of previously undefined or alternatively defined key terms that trigger obligations under binding international agreements, in addition to domestic legislation. Finally, by placing no restriction on the source or means of modifying the dsRNA, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes. This article examines the scientific evidence, conclusions and recommendations of the EPA and also presents some additional options.


2018 ◽  
Author(s):  
Jack A Heinemann

The New Zealand Environmental Protection Authority (EPA) issued a Decision that makes the use of externally applied double-stranded (ds)RNA molecules on eukaryotic cells or organisms technically out of scope of legislation on new organisms, because in its view the treatment does not create new or genetically modified organisms. dsRNA molecules can be potent gene regulators in eukaryotes, causing what is known as RNA interference. RNA-based technology holds promise for addressing complex and persistent challenges in public health, agriculture and conservation but also raises the threat of unintended consequences. The Decision rests on their conclusion that dsRNA treatments do not modify genes or other genetic material and are therefore not heritable. The EPA conclusion is not consistent with the totality of peer-reviewed research on dsRNA or industry claims. The Decision applies to nearly all eukaryotes, however, the EPA relied upon knowledge of relatively few eukaryotes and its analysis neglected known exceptions. The Decision also has not taken into account the unique eukaryotic biodiversity of the country, much of which is still to be described. The regulator has potentially created precedent-setting definitions of previously undefined or alternatively defined key terms that trigger obligations under binding international agreements, in addition to domestic legislation. Finally, by placing no restriction on the source or means of modifying the dsRNA, the EPA removed regulatory oversight that could prevent the accidental release of viral genes or genomes. This article examines the scientific evidence, conclusions and recommendations of the EPA and also presents some additional options.


Author(s):  
M.J. Willocks

Commercialisation of genetically modified organisms creates new challenges for marketers and developers of this technology. The cost of development is high, and the need to gain a return on investment that reflects this cost is critical to ensure that this technology is brought to New Zealand agriculture. A further challenge is that the regulatory requirements differ from those required for non-transgenic crops. Once introduced into the market, it is important to develop a product stewardship programme to ensure continued trait performance and prevent factors arising that will negate the value of these traits such as pest resistance. Keywords: genetically modified organisms, market analysis, product stewardship, regulatory process, return on investment


2017 ◽  
Vol 1 (1) ◽  
pp. 1-8
Author(s):  
Sarah Edwards

New Zealand is known around the world as a country that is clean, green and “100% Pure.” The existence of genetically modified organisms in New Zealand is generally viewed as inconsistent with this identity, and there is therefore considerable public controversy surrounding research that utilises genetic modification techniques. In this paper, I examine the variety of interacting factors that are serving to shape this controversy, the influence it is having on research practices, and the implications for future risk management policy.


2017 ◽  
Vol 41 (2) ◽  
pp. 110
Author(s):  
Gabriele Borges Rodrigues ◽  
Leonardo Da Rocha de Souza

Resumo: O objetivo deste artigo é analisar o princípio da precaução como critério utilizado pela Administração Pública para a liberação de organismos geneticamente modificados (OGMs). Para isso, realiza-se um estudo a respeito da importância do princípio da precaução para a realização da proteção ambiental, trazendo-se um enfoque da sua regulação em instrumentos internacionais. A seguir, trabalha-se com os problemas provenientes da incerteza científica e como eles afetam o dever que o Estado tem de evitar danos, incertezas essas que geram dificuldades para a aplicação do princípio da precaução. Esse contexto leva este texto a algumas propostas de soluções para Administração Pública aplicar o princípio da precaução apesar (e em virtude) das incertezas científicas. Permeia o texto, e enfatiza-se ao final, uma aplicação do princípio da precaução na liberação de organismos geneticamente modificados. A abordagem é realizada utilizando-se o método hipotético-dedutivo, levantando-se hipóteses e possibilidades para aplicação prática do princípio da precaução na atuação da Administração Pública. Utiliza-se a técnica de pesquisa de documentação indireta, com a revisão bibliográfica de obras nacionais e estrangeiras, incluindo periódicos e textos normativos. Como resultado, pretende-se que este artigo subsidie o aperfeiçoamento de políticas públicas de proteção ambiental, de forma a evitar que as incertezas científicas gerem danos ambientais e propondo-se maior cautela na inserção dos OGMs no meio ambiente.Abstract: The purpose of this article is to analyze the precautionary principle as a criterion used by public authorities for the release of genetically modified organisms (GMOs). For this, we carried out a study about the importance of the precautionary principle for the realization of environmental protection, bringing a focus of its regulation on international rules. Next, we work with problems arising from scientific uncertainty and how they affect the duty that the state has to prevent damage, such uncertainties that generate difficulties for the application of the precautionary principle. This context leads this text to some proposed solutions for Public Administration apply the precautionary principle despite (and because) of scientific uncertainty. During the text, with an emphasis on end, we carry out an application of the precautionary principle in the release of genetically modified organisms. The approach is performed using the hypothetical-deductive method, rising hypotheses and possibilities for practical application of the precautionary principle in the operation of Public Administration. We use the indirect documentation search technique, the literature review of national and foreign works, including periodicals and normative texts. As a result, we intend this article to subsidize the improvement of public policies for environmental protection, in order to prevent the scientific uncertainties, generate environmental damage and proposing greater caution in the insertion of GMOs into the environment.


2008 ◽  
Vol 35 (6) ◽  
pp. 573 ◽  
Author(s):  
P. E. Cowan ◽  
W. N. Grant ◽  
M. Ralston

The suitability of the nematode Parastrongyloides trichosuri (Nematoda: Strongyloididae) as a genetically modified vector for transmissible fertility control of introduced brushtail possums (Trichosurus vulpecula) is being explored in New Zealand. This review of progress in assessing the ecological and epidemiological characteristics of P. trichosuri against a set of essential properties for a suitable transmissible vector indicates that the parasite appears to have all the attributes of a highly effective vector, although additional information on persistence at low host density and on the outcome of competition between existing infection and new (recombinant) strains is needed to confirm this. Concerns have been raised about risks to possums and other marsupials in Australia from a genetically modified form of P. trichosuri. An international body with responsibility for managing consultation and debate about issues arising from the proposed use of genetically modified organisms for vertebrate pest management has been suggested as a way of addressing such concerns. A key issue remains as to which agency or group of agencies would take responsibility for such a body. A joint meeting of relevant agencies and researchers is needed urgently to begin the process of moving this issue forward.


2015 ◽  
Vol 15 (3) ◽  
pp. 309
Author(s):  
Živko Gacovski ◽  
Goce Cilev ◽  
Biljana Petrovska

Genetically modified organisms (GMO) are organisms whose genetic modification of heritable genetic material (DNA) is a planned amendment to the unnatural way by applying modern techniques of genetic engineering, or, a gene or genes from one organism are inserted into another organism,what in nature with a natural breeding would never be created. GMOs are a source of modified laboratory food, supplements and various additives.The subject of this research paper is to see the impact of GM food as a threat or a benefit on the health of humans and animals, as well as its application in the Republic of Macedonia. Comparative analysis of scientific research in the field of modern biotechnology science using the technique of genetic engineering has been used in this paper. From the analysis of previous research, there are no official data on possible effects on human health, and animal tests have shown negative effects on their health.


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