Fifty years ago, scientists developed a regulatory framework for the safe use of recombinant DNA that focused on potential biosafety risks associated with the products of genetic engineering (GE). This morphed into an expensive and lengthy premarket risk assessment requirement for GE agricultural biotechnology products triggered solely by the fact that modern molecular technologies were involved in the development of those products. This has limited the commercialization of GE crop products primarily to multinational enterprises and precluded the development of GE animals at scale. Gene editing offers an opportunity to rethink the regulation of agricultural biotechnologies, and several countries have determined that gene-edited products lacking any โforeignโ DNA will be treated in the same way as products of conventional breeding.
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In February 1975, scientists involved in the initial recombinant DNA (rDNA) (see Glossary) experiments met in Asilomar, California engaging in a thorough discussion of this emerging technology. Research experts gathered to share concerns, evidence, insights, and best scientific practices. The Asilomar Conference created guidelines on safe rDNA experiment conduct, subsequently published by the American National Institutes of Health [1]. The science-basedrDNA regulations that evolved assessed the risks of products resulting from GEtechnologies, not the process used to create the product.
Some countries implemented science-based, product-based regulatory framework, successfully commercializing GE crop varieties for 30 years, such as Canada where 147 GE crop varieties have been approved since 1995. Other countries adopted process-triggered risk evaluation frameworks and unpredictable approval timeframes which have proven to stifle innovation. These effectively precluded the successful commercialization of GE crops, such as in the European Union (EU), which has only approved one GE crop variety for cultivation since 2000 [2]
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The mandatory premarket regulatory approval process for GE organisms, irrespective of product novelty or risk, has had an even more stifling effect on the development of GE animals. The first GE livestock were reported in 1985 [16] and several meritorious uses of the technology to improve livestock health [17., 18., 19.] and reduce environmental impacts (e.g., EnviroPig) [20] were reported. However, as of late 2024, only two applications for food use have been approved globally: the fast-growing AquAdvantage salmon [21], and the hypoallergenic GalSafe pig on a limited basis (1000 pigs/year on a single facility) in the USA [22].
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Recently, the development of gene editing (GnEd) offers an opportunity for some potential relief from this arbitrary GE process-based regulation trigger. GnEd technology allows for targeted inactivation of endogenous loci through site-directed nucleases (e.g., CRISPR/Cas9) [27], resulting in many plants [28] and animals [29] produced not containing any โtransgenicโ or foreign DNA. This has led some countries to reconsider their regulatory approach to simple edits, using a technique known as site directed nuclease 1 (SDN-1), where there is a targeted, non-specific genetic deletion mutation.
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Agricultural research over the past 40 years has clearly demonstrated science-based, product-risk focused regulatory frameworks are of fundamental importance to healthy, functioning innovation systems. Precaution-based and process-triggered regulatory approvals have consistently proven to be an innovation barrier.
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A better regulatory regime for plant and animal biotechnology would be guided by novel attributes of the product, if any, rather than triggered by the process used to develop that product. Currently, regulatory reviews concentrate only on risks associated with new varieties, ignoring both risks associated with existing varieties and the benefits ensuing from the primary purpose for the invention. Risk assessments should balance unique risks associated with new varieties against offsetting benefits (see Outstanding questions). Moreover, products that could have been achieved using conventional breeding should not be held to different standards or require regulatory studies beyond those required for products derived from conventional breeding.
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