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The Regulatory Landscape for Genome-edited Plants is Rapidly Changing, Experts Say
Saturday, 2021/05/15 | 05:48:22

Developments in regulations of genome-edited plants are rapidly changing and continue to evolve as more countries firm up their regulatory policies. This is according to the Transgenic Research article authored by international biotech experts.


The article presents the latest legal and regulatory developments in various jurisdictions including CanadaArgentinaBrazil, the USA, Kenya, Nigeria, South Africa, Australia, New Zealand, Japan, and the Philippines. Some of the key points in the article are as follows:

  • - Genome editing has the potential to contribute to saving several challenges in health, food, and agricultural production.
  • - The regulatory policy cannot keep pace with the fast-moving scientific advances.
  • - Scientific societies, regulatory agencies, and other relevant organizations have investigated the issues surrounding genome editing and concluded that imposing regulatory scrutiny based on documented risks of the product, rather than on the process and that products of genome editing, may not need additional regulation required for conventional plants.
  • - Common approaches in regulation are emerging in many countries, including the use of the "case-by-case" approach and "novel combination of genetic material" as GMO regulatory threshold. 


The authors, including Jon Entine, Martin Lema, Wayne Parrot, Carl Ramage, Reynante Ordonio, and Diane Wray-Cahen, hope for increased collaboration to better align regulatory processes and improve coordination of approaches worldwide.


Download the open-access article in Transgenic Research.


Fig. 1 Decision tree for NBT products from the Ad Hoc TWG of the National Committee on Biosafety of Philippines (NCBP), with minor modifications. *Includes insertion using the new CRISPR-CAS with Prime Editing (Anzalone et al. 2019), ** Not to be confused with Synthetic Biology, which specializes on sequences/genetic elements (e.g. unnatural base pairs) in the genome that are not found in nature (beyond novel combination), ***Pertains to a largely synthetic assembled genome.

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