THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Regulation of Plants Developed by New Genetic Modification Techniques
Existing regulatory frameworks for genetically modified organisms (GMO) cover new genetic modification techniques (nGMs), also referred to as “new (breeding) techniques”, to varying degrees. Coverage of nGMs depends mostly on the regulatory trigger. In general, two different trigger systems can be distinguished, taking into account either the process applied during development or the characteristics of the resulting product. The overarching question is which trigger would be better suited to address new developments in the field of biotechnology, including different nGMs.
A study analyzed GMO regulatory frameworks of different countries, covering both trigger systems, with a focus on their applicability to plants developed by various nGMs. In practice, both systems show features of the other, and neither system could be generally regarded as superior when addressing the challenges posed by nGMs. The specific trigger definitions and their implementation are more important when defining the range of covered products, than an initial choice of a either a process- or a product-oriented trigger system.
Sectoral regulation which applies to all agricultural- and food-products does not provide for a comparable breadth and standard of risk assessment as compared with the requirements of biosafety frameworks, which aim to identify and assess environmental and health risks associated with a given product generated by biotechnology. The decision as to whether certain nGM applications should fall under the respective biosafety frameworks is therefore critical for the scope and the quality of risk assessment which is provided for these applications.
The current lack of harmonization at the global level concerning regulatory approaches for nGM products may lead to situations that identical applications/products are assigned different regulatory status in different jurisdictions. This will result in a serious challenge for international trade between such countries. To address this, the authors recommend a public international registry listing all biotechnology products commercially used in agriculture. This transparency is essential in ensuring that all countries can identify products developed by nGMs, if their respective legislation requires them to do so. The Biosafety Clearing-House (BCH), set up under the Cartagena Protocol on Biosafety, is an existing registry for GMO applications at the international level that also contains information voluntarily submitted by non-Parties to the Protocol; it may thus provide an appropriate framework for the purpose of sharing relevant information on nGM applications.
With best wishes,
Third World Network
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PLANTS DEVELOPED BY NEW GENETIC MODIFICATION TECHNIQUES-COMPARISON OF EXISTING REGULATORY FRAMEWORKS IN THE EU AND NON-EU COUNTRIES
Eckerstorfer, M. F., Engelhard, M., Heissenberger, A., Simon, S., & Teichmann, H.
Frontiers in Bioengineering and Biotechnology, 7, 26
https://doi.org/10.3389/fbioe.2019.00026
19 Feb 2019
https://www.frontiersin.org/articles/10.3389/fbioe.2019.00026/full
Abstract
The development of new genetic modification techniques (nGMs), also referred to as “new (breeding) techniques” in other sources, has raised worldwide discussions regarding their regulation. Different existing regulatory frameworks for genetically modified organisms (GMO) cover nGMs to varying degrees. Coverage of nGMs depends mostly on the regulatory trigger. In general two different trigger systems can be distinguished, taking into account either the process applied during development or the characteristics of the resulting product. A key question is whether regulatory frameworks either based on process- or product-oriented triggers are more advantageous for the regulation of nGM applications. We analyzed regulatory frameworks for GMO from different countries covering both trigger systems with a focus on their applicability to plants developed by various nGMs. The study is based on a literature analysis and qualitative interviews with regulatory experts and risk assessors of GMO in the respective countries. The applied principles of risk assessment are very similar in all investigated countries independent of the applied trigger for regulation. Even though the regulatory trigger is either process- or product-oriented, both triggers systems show features of the respective other in practice. In addition our analysis shows that both trigger systems have a number of generic advantages and disadvantages, but neither system can be regarded as superior at a general level. More decisive for the regulation of organisms or products, especially nGM applications, are the variable criteria and exceptions used to implement the triggers in the different regulatory frameworks. There are discussions and consultations in some countries about whether changes in legislation are necessary to establish a desired level of regulation of nGMs. We identified five strategies for countries that desire to regulate nGM applications for biosafety–ranging from applying existing biosafety frameworks without further amendments to establishing new stand-alone legislation. Due to varying degrees of nGM regulation, international harmonization will supposedly not be achieved in the near future. In the context of international trade, transparency of the regulatory status of individual nGM products is a crucial issue. We therefore propose to introduce an international public registry listing all biotechnology products commercially used in agriculture.
Conclusions
Our analysis investigated how regulatory systems determine the regulatory status of biotechnology applications. In general, two categories of regulatory triggers can be distinguished: process-oriented and product-oriented. The overarching question was which trigger would generally be better suited to address new developments in the field of biotechnology, including different nGMs.
Our review of available scientific literature and the results of the interviews conducted with regulatory experts allows us to draw the general conclusion that in practice neither trigger system can be generally regarded as superior when addressing the challenges posed by nGMs. We note that all existing triggers have generic advantages and disadvantages and that the specific trigger definitions and their implementation are more important when defining the range of covered products than an initial choice of a either a process- or a product-oriented trigger system. On the one hand none of the existing trigger systems allows for a straightforward, unambiguous denomination of regulated articles. In process-triggered systems administrative, legislative or court decisions (like in the EU or New Zealand) are necessary to clarify which categories of nGM applications fall under the respective legislation/GMO definition. In frameworks based on product-oriented triggers nGM applications are scrutinized individually to assign their regulatory status.
On the other hand most of the existing biosafety frameworks do not address newly developed products in a fully consistent manner. What all biosafety frameworks have in common is that they aim to identify and assess environmental and health risks associated with a given product generated by biotechnology. Ideally those frameworks should aim to regulate products with comparable risks in a similar manner. In practice many examples can be identified where products with comparable characteristics are subject to very different requirements. In frameworks with process-oriented triggers products generated with GM-technology need to be assessed for biosafety, whereas comparable products developed with conventional approaches are not required to undergo a similar premarket risk assessment. In the product-oriented framework operated in the USA similar products developed with different transformation methods are treated differently irrespective of similar characteristics of the final product. A higher degree of consistency is currently only achieved in the Canadian framework, which is based on a product-oriented trigger focusing on the novelty of products.
With the advent of nGMs coherent regulation of novel biotechnology products becomes even more challenging. The information gathered in our study indicates that sectoral regulation which applies for all agricultural- and food-products does not provide for a comparable breadth and standard of risk assessment as compared with the requirements according to the respective biosafety frameworks. The decision as to whether certain nGM applications should fall under the respective biosafety frameworks is therefore critical for the scope and the quality of risk assessment which is provided for these applications. This decision is ultimately a political one. With that in mind legislators have different options to regulate nGMs for biosafety purposes, if desired. Those options range from applying and/or adapting existing rules to developing a new overall framework for all biotechnology applications or additional biosafety regulations for nGM applications. The latter would amount to substantial changes of the existing frameworks, specifically for frameworks based on process-oriented triggers. According to the information collated in our study such major legislative changes are not likely to be implemented in any of the investigated countries.
The regulatory status of nGM applications is in the process of being resolved in a growing number of countries by administrative or judicial decisions based on the existing biosafety laws and by introducing supplementary regulations specifying concrete criteria for such decisions. However, the lack of harmonization at the global level concerning such approaches will lead to situations that identical biotechnological applications/products are assigned opposing different regulatory status in different jurisdictions. This will result in a serious challenge for international trade between such countries. To address this challenge transparency in decision-making for nGM applications is a crucial issue acknowledged by regulatory experts from all investigated frameworks. We consider a public international registry which includes all biotech products that are placed on the market, among them (nGM) applications exempted in certain countries from regulatory oversight and risk assessment prior to commercial use, to be essential. This would ensure that all countries are enabled to identify products developed by nGMs, if their respective legislation requires them to do so. Non-registered and undescribed products developed by certain nGMs, e.g., SDN-1 type genome editing, can be difficult to detect and keep track of. Shipment of agricultural products suspected to be of uncertain composition, i.e., containing nGM products, could provoke unwanted disruptions of international trade.
We note that the Biosafety Clearing House (BCH) according to the CPB is an existing registry for GMO applications at the international level that also contains information voluntarily submitted by non-parties to the Protocol. It may also provide an appropriate framework for the purpose of sharing relevant information on nGM applications. We are, however, aware of the fact that it will be a challenge to establish and maintain a registry including nGM applications, which are not subject to regulation according to some national biosafety frameworks, since active voluntary cooperation of country administrations and developers is required. Nevertheless stakeholders from all countries should be aware that sharing information on nGM products will be vital, since global harmonization of regulatory approaches toward applications of genome editing and other nGMs will not be easily achieved in the near future.