A critical assessment of regulatory triggers for products of biotechnology: Product vs. process

McHughen, Alan

doi:10.1080/21645698.2016.1228516

Cited by 49 publications

(37 citation statements)

References 17 publications

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“…Moving towards genetic homogeneity can lead to a greater susceptibility of plants to many pests, diseases or other negative environmental impacts, problems that are the scourge of monoculture agriculture. There are also ethical problems associated with transformation and introduction of genes of one species of plants or animals into the genetic apparatus of another species [16].…”

Section: Development Of Modern Biotechnologies and Risks Of Implementmentioning

confidence: 99%

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Risks of modern biotechnologies and legal aspects of their implementation in agriculture

et al. 2020

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The main purpose of this study is to determine the best practices of social regulation of negative consequences for modern biotechnology use based on a comparative review of European and Russian legal regulations on food safety. The paper gives original classification of risks of biotechnologies introduction in agriculture, namely: food, agricultural, environmental, patent, social and ethical ones. Although risk assessment systems have been in use for some time, consumers do not always trust the results. One explanation for this is that in the past many national food safety systems had problems with timely notification of certain products' potential hazards. In many countries, social and ethical views can be the reason for rejection of certain products, manipulation of genetically modified organisms (GMOs). Such conflicts often reflect deeper issues about the interaction of human society and natureissues that must be fully taken into account in any attempt at social communication. Authors offer a mode of social control and consensus in the form of agrobioethics, similar to bioethics in biomedical technologies.

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Section: Development Of Modern Biotechnologies and Risks Of Implementmentioning

confidence: 99%

“…➢ there are ethical problems associated with transformation and introduction of genes of one species of plants or animals into the genetic apparatus of another species [16].…”

Section: Ethical Risksmentioning

confidence: 99%

Risks of modern biotechnologies and legal aspects of their implementation in agriculture

et al. 2020

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“…Early GMO frameworks developed in the 1990s for products of then new recombinant DNA technologies have the objective of ensuring that such products are of comparable level of risk to the human health and the environment as products developed with earlier methods with history of safe use. As noted above, most regulatory frameworks use process triggers to conduct risk assessment and, where necessary, apply risk management measures (McHughen, ) to mitigate any identified risks. In particular, process‐based triggers prevail in the GMO regulatory frameworks of countries that are members of the United Nations Cartagena Protocol on Biosafety , including major agricultural producers such as the European Union and Brazil.…”

Section: Gmo Regulations and Plant Breeding Innovationmentioning

confidence: 99%

Plant breeding innovation: A global regulatory perspective

Atanassova

Keiper

2018

Cereal Chem

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Background and objectives While there has been continued improvement and increasing accessibility of enabling biotechnological tools, their ultimate deployment and range of applications in support of plant breeding will largely depend on how the resulting products are regulated and the extent of premarket assessment required. The features of GMO regulatory systems throughout the world are reviewed, with a focus on recent developments aimed at clarifying their application to biotechnological tools used for targeted mutagenesis and transfer of genetic material between crossable species. Findings To date, regulatory clarity for biotechnological innovations in plant breeding is limited to a small number of countries; the few countries with product‐based regulatory systems are generally able to continue using exiting regulatory provisions, and others have provided timely solutions that can result in the exclusion of some types of plant products from the scope of GMO regulations. However, the majority of countries are yet to take decisions on the topic. Their challenge is to achieve proportionate risk regulation for products developed using recent biotechnological tools that can result in a range of products, from transgenic plants to plants that are indistinguishable from conventionally bred plants. Conclusions The challenges for providing clarity on the regulation of plant breeding innovations are strongly linked to the features of the existing GMO regulations. Countries that regulate product risks are better equipped to adapt to technological change; conversely, countries that use process‐based regulatory triggers face the challenge of continuously adjusting to technological development and will lag behind unless they can timely develop criteria for regulatory exclusions. As a consequence of these different approaches, adopters of plant breeding innovations are faced with an uncertain and complex global regulatory situation that is unlikely to be resolved in the near future. Significance and novelty This review of the global regulatory status of plant breeding innovations demonstrates that to date, few countries have provided regulatory clarity. However, regulatory clarity, including consistent and predictable legislation with clear scope, triggers, and technical criteria, is required to facilitate technology adoption. The current uncertain and complex global regulatory situation is stifling innovation and the realization of the full potential of these technologies.

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“…In the US one of the regulatory triggers used by USDA-APHIS is the involvement of a plant pest [24]. The use of disarmed Agrobacterium tumefaciens has always been considered to constitute such a regulatory trigger, even though the disarmed bacterium is no longer able to cause disease.…”

Section: Can Cisgenic Lbr Potatoes Not Be a Gmo?mentioning

confidence: 99%

“…Agrobacterium tumefaciens is being used to introduce the LBR genes, thereby triggering the need for deregulation by USDA-APHIS [24]. So far, such cisgenic potatoes are also considered to trigger the European GMO legislation, and as a consequence, a battery of safety testing, a market authorization, and labeling of the potatoes and derived food and feed are required [3].…”

Section: What If Cisgenic Lbr Potatoes Are Considered a Gmo?mentioning

confidence: 99%

Why Organic Farming Should Embrace Co-Existence with Cisgenic Late Blight–Resistant Potato

Gheysen

Custers²

2017

Sustainability

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Abstract:The EU regulation on organic farming does not allow the use of genetically modified organisms (GMOs) which are subject to Directive 2001/18/EC. Mutagenesis using irradiation or chemicals is genetic modification, but the organisms obtained through these techniques are not subject to the provisions of the GMO directive. Such mutants can therefore be used in organic agriculture. Derived from its basic principles, organic farming can only use natural substances to control disease and crops should be resilient, which, in the case of disease resistance, means that durable (horizontal) resistance is preferred to vertical (single gene) resistance. Cisgenesis can achieve such a durable resistance by introducing multiple resistance genes in one step. These multiple-resistant plants only contain natural genes that can also be introduced by breeding. In case cisgenic plants are not subject to the provisions of the GMO legislation, they can even be legally used in organic agriculture. In case they are not exempted from the GMO regulation, the question is: why obstruct a cisgenic potato crop that can hardly be distinguished from a potato crop that is the result of conventional breeding? Among the reasons why organic agriculture does not allow the use of GMOs it is mentioned that genetic engineering is unpredictable, it causes genome disruption and it is unnatural. However, our knowledge of plant genome evolution and breeding has increased dramatically. We now know that breeding is more unpredictable and causes more genome disruption than genetic engineering. Recent field trials have shown the efficacy of cisgenic late blight-resistant potatoes carrying multiple resistance genes. Large-scale growing of such durably resistant potatoes would not only be environmentally beneficial by it would strongly reducing the need for fungicide sprays in conventional potato cultivation and it would also reduce the disease pressure in organic potato cultivation.

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A critical assessment of regulatory triggers for products of biotechnology: Product vs. process

Cited by 49 publications

References 17 publications

Risks of modern biotechnologies and legal aspects of their implementation in agriculture

Risks of modern biotechnologies and legal aspects of their implementation in agriculture

Plant breeding innovation: A global regulatory perspective

Why Organic Farming Should Embrace Co-Existence with Cisgenic Late Blight–Resistant Potato

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