Heinemann Jack A, Clark Katrin, Hiscox Tessa C, McCabe Andrew W, Agapito-Tenfen Sarah Z
Centre for Integrated Research in Biosafety and School of Biological Sciences, University of Canterbury, Christchurch, New Zealand.
Climate and Environment Division, NORCE Norwegian Research Centre AS, Tromsø, Norway.
Front Genome Ed. 2023 Jan 10;4:1064103. doi: 10.3389/fgeed.2022.1064103. eCollection 2022.
Through genome editing and other techniques of gene technology, it is possible to create a class of organism called null segregants. These genetically modified organisms (GMOs) are products of gene technology but are argued to have no lingering vestige of the technology after the segregation of chromosomes or deletion of insertions. From that viewpoint regulations are redundant because any unique potential for the use of gene technology to cause harm has also been removed. We tackle this question of international interest by reviewing the early history of the purpose of gene technology regulation. The active ingredients of techniques used for guided mutagenesis, e.g., site-directed nucleases, such as CRISPR/Cas, are promoted for having a lower potential per reaction to create a hazard. However, others see this as a desirable industrial property of the reagents that will lead to genome editing being used more and nullifying the promised hazard mitigation. The contest between views revolves around whether regulations could alter the risks in the responsible use of gene technology. We conclude that gene technology, even when used to make null segregants, has characteristics that make regulation a reasonable option for mitigating potential harm. Those characteristics are that it allows people to create more harm faster, even if it creates benefits as well; the potential for harm increases with increased use of the technique, but safety does not; and regulations can control harm scaling.
通过基因组编辑和基因技术的其他技术,可以创造出一类被称为无效分离体的生物体。这些转基因生物(GMOs)是基因技术的产物,但有人认为,在染色体分离或插入片段缺失后,这些生物体不会留下该技术的任何痕迹。从这个角度来看,监管是多余的,因为利用基因技术造成危害的任何独特可能性也已消除。我们通过回顾基因技术监管目的的早期历史来探讨这个具有国际意义的问题。用于定向诱变的技术,例如定点核酸酶(如CRISPR/Cas)的活性成分,因其每次反应产生危害的可能性较低而得到推广。然而,其他人则认为这是这些试剂理想的工业特性,这将导致基因组编辑的更多使用,并使承诺的危害减轻失效。两种观点之间的争论围绕着监管是否能够改变基因技术合理使用中的风险。我们的结论是,基因技术即使用于制造无效分离体,也具有一些特性,使得监管成为减轻潜在危害的合理选择。这些特性是,它使人们能够更快地造成更多危害,即使它也能带来益处;危害的可能性随着该技术使用的增加而增加,但安全性却不会;而且监管可以控制危害的扩大。