During this year's "Two Sessions," one of my proposals is to formally release guidelines for the safety assessment of gene-edited animals as soon as possible, and to formulate and publish detailed review regulations for agricultural use of gene-edited animals, so that research and development units of gene-edited animals can have a clear expectation of the industrialization path." During the "Two Sessions," Cao Xiaofeng, a member of the National Committee of the Chinese People's Political Consultative Conference, an academician of the Chinese Academy of Sciences, and a researcher at the Institute of Genetics and Developmental Biology of the Chinese Academy of Sciences, said in an interview with the "China Science Daily."
In recent years, the application of international gene editing technology has developed rapidly. Among them, the industrial development of gene-edited plants started earlier, and many countries have introduced corresponding simplified regulatory policies, with a batch of gene-edited crops obtaining commercial approval. Internationally, although the industrialization of gene-edited animals started later, Japan, Argentina, Brazil, the United States, the United Kingdom, and other countries have introduced relevant simplified regulatory policies, and some products have obtained commercial approval, such as gene-edited tilapia in Argentina, gene-edited red sea bream, tiger puffer, and flounder in Japan, gene-edited cows in the United States, and gene-edited pigs in Colombia.
"These application trends fully demonstrate the potential of gene editing technology to lead revolutionary changes in agricultural breeding," Cao Xiaofeng said. As a frontline scientist in the field of biology, over the past three years, her proposals have consistently focused on this cutting-edge technology and have been approved by the National Committee of the Chinese People's Political Consultative Conference several times.
It is reported that China released the "Guidelines for the Safety Assessment of Gene-Edited Plants for Agricultural Use (Trial)" in 2022 and the "Regulations for the Review of Gene-Edited Plants for Agricultural Use" in 2023, providing clear policy and regulatory basis for safety assessment before the industrialization of gene-edited plants. From 2023 to the present, China has approved three gene-edited crop products, marking the successful first step in the industrialization of gene-edited crops.
Regarding the formulation of policies for gene-edited animals, the Ministry of Agriculture and Rural Affairs has initiated the formulation of the "Guidelines for the Safety Assessment of Gene-Edited Animals for Agricultural Use" and conducted opinions solicitation from relevant units and experts in June 2023. However, as the guidelines have not been formally released, research and development units of gene-edited animals can only conduct safety assessments and declarations based on transgenic animals.
"From the perspective of regulation, gene editing technology belongs to a kind of biotechnology, but some gene-edited products may not introduce exogenous gene fragments and cannot be distinguished from organisms obtained by traditional breeding," Cao Xiaofeng said. Therefore, in agricultural applications, reasonable and effective regulatory policies need to be formulated for this new technology according to its application characteristics, ensuring the safety of its application while tapping into its potential and fully applying it in the field of breeding to promote sustainable development of agriculture.
To this end, Cao Xiaofeng suggests formally releasing guidelines for the safety assessment of gene-edited animals as soon as possible to help enterprises plan relevant industrialization paths. At the same time, safety assessments of gene-edited animals should be based on the principle of case analysis, simplify the data requirements for safety assessments, and optimize the declaration process to reduce the burden on research and development units while ensuring safety. In addition, research and formulation of policies related to the industrial application process of safety assessment of gene-edited animals should be initiated to prepare for the industrialization of gene-edited animals, indicating the direction for the industrialization of gene-edited animals at the policy level and creating a favorable environment.
National Committee member of the Chinese People's Political Consultative Conference and Academician of the Chinese Academy of Sciences, Cao Xiaofeng. Photo by reporter Feng Lifei.
