Plants Developed by New Genetic Modification Techniques—Comparison of Existing Regulatory Frameworks in the EU and Non-EU Countries

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.

Shotguns vs Lasers: Identifying barriers and facilitators to scaling-up plant molecular farming for high-value health products

“…In the EU, NPBTs have fallen under the umbrella of existing (first-generation, transgenic) GM legislation (2001/18/EC) [39,40]; the decision of the European Court of Justice (ECJ) in 2018 that directed mutagenesis is covered by this regulation has caused concern amongst the European scientific community over the impact to biotechnology investment and commercialisation prospects [41,42]. In the United States and other countries in the Americas, crops bred with NPBTs have found relatively quick routes to market where regulation is no stricter than for conventionally-bred crops [43].…”

“…These have included crops with targeted gene 'knockouts', such as a non-browning mushroom with reduced polyphenol oxidase production [44]. The alternate regulatory 'triggers' in the EU and in the USA represent the two broad pathways to regulating modified crops [39]: process-and product-based regulation. A process-based regulatory trigger responds to crops produced by specific technologies, as in the EU [39].…”

“…The alternate regulatory 'triggers' in the EU and in the USA represent the two broad pathways to regulating modified crops [39]: process-and product-based regulation. A process-based regulatory trigger responds to crops produced by specific technologies, as in the EU [39]. A productbased regulatory trigger responds to products with specific, often "novel" characteristics, such as transgenes.…”

“…A productbased regulatory trigger responds to products with specific, often "novel" characteristics, such as transgenes. In practice, the two pathways are both subject to considerable local variations and exemptions, which Eckerstorfer et al [39] argue will prevent international harmonisation in the near future.…”

Detección del promotor 35S mediante PCR tiempo-real: indicador de transgenicidad en alimentos y Gossypium sp.

“…Estados Unidos lidera la producción de CGM, los cuales abarcan actualmente alrededor de 75 millones de ha de la producción global; seguido por Brasil y Argentina (51,3 y 23,9 millones de ha respectivamente). En el 2018 se cultivaron doce CGM en veintiséis países (ISAAA, 2018).Como consecuencia del incremento global del área dedicada a CGM y sus derivados, los organismos reguladores de distintos países han promovido la necesidad de monitorear su presencia mediante técnicas eficientes a nivel de laboratorio (Pierboni et al, 2016;Eckerstorfer et al, 2019). Aproximadamente sesenta países poseen normativas para el etiquetado de productos que contienen trazas de organismos genéticamente modificados (OGM) que excedan los estándares establecidos por su propia legislación (Leão-Buchir et al, 2018).…”