Genome editing in agriculture and food is leading to new, improved crops and other products. Depending on the regulatory approach taken in each country or region, the commercialization of these crops and products may or may not require approval from the respective regulatory authorities.
Genome editing is a generic term used to describe a host of methods for altering the genetic information in a cell, as described in other articles in this issue. Briefly, GEd encompasses several distinct types of alterations generating different products: site-directed deletions, allele replacement, site-directed insertions, and base conversion.
Regulations, whether for conventional or biotech products, are intended to protect public health and safety, ensuring that products released into the market are as safe as possible for humans, animals, and the environment. Although all countries seek to promulgate regulatory approaches and processes to protect the common good of human, animal and environmental safety, the regulatory details in different jurisdictions can differ widely, and these differences and how they are implemented can have large impacts on the time required and cost of bringing new plant products of biotechnology to the global market place.
Different laws and regulations for products of technologies using rDNA are in place around the world. The regulatory triggers for these products are generally based on the techniques used to create them, rather than the identification of any specific or novel potential hazards that such products may pose. While these laws and regulations differ among countries and regions, there is general agreement in each regulatory regime as to what products and processes are covered by these regulations for rDNA-derived products.
Regulatory policy cannot keep pace with the fast-moving scientific advances. To name just some of the challenges: the speed at which new technologies are being developed, new technologies not fitting into old regulatory definitions and paradigms, difficulties with international coordination, lack of harmonized definitions and laws, lack of public understanding and trust, lack of regulatory certainty for developers, lack of political will, and regulatory policies taking longer to put in place than the uptake of breakthroughs in the global scientific community. Regulatory and policy officials are frequently tasked with the sometimes conflicting goals of ensuring public and environmental safety while addressing public perception and expectations and doing so without slowing down innovation.
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