b'Regulatory and Political Challenges of New Breeding TechniquesHOW TO FIND THE RIGHT EU REGULATION FOR GENOME EDITING PRODUCTS. I n November 2020, the Nobel Prize in Chemistrywhere goods circulate will necessarily be impor-was awarded to Emmanuelle Charpentier andtant, not only in terms of competition but also for a Jennifer Doudna, co-inventors of the CRISPR- given country in terms of national agri-food inde-Cas, a genome editing technique published inpendence.Science 2012, for this major discovery that revolu-tionized genome modification techniques. A REGULATED WORLDEarly on, the question arose to examine the risks A BIOTECH BREAKTHROUGH REQUIRES of the genome changes developed in the laboratory. NEW REGULATION The Asilomar International Conference was organ-The genome modification techniques, developedized in 1975 by Paul Berg (Nobel Prize in Chemistry as early as the 1940s, reproduce in a research lab- 1980) to examine the assessment of these risks, and oratory, phenomena which exist naturally Theyas a result, regulations on the use of biotechnology CATHERINEallow us to free ourselves from the vagaries ofwere put in place in many countries. In the United REGNAULT-ROGERnature by selecting the changes to be induced.States, the Coordinated Framework for Regulation is Professor ofRandom mutagenesis and transgenesis, whichof Biotechnology was published in 1986. Universities Emeritus at the University ofrequire heavy experimental manipulations areIn Europe, the implementation of GMO regu-Pau and the Adournow taken over by the NBTs (New Breedinglations was a multi-step process.It concerns both Countries (E2S),Techniques). Some of these new techniques usegene therapies for humans or animals and trans-Member of theenzymes, directed nucleases to change the nucleicgenic crops. European regulations are applied to French Academybases of DNA. They edit the genome. These latestproducts obtained by the technique of transgen-of Agriculture andtechniques are more powerful because they areesis, while those obtained by random (classical) the French Nationalmore accurate and less expensive. The CRISPR- mutagenesis, a technique used since the 1940s, Academy of Pharmacy and Member of theCas technique (CRISPR for Clustered Regularlywere exempt.Scientific CommitteeInterspaced Short Palindromic Repeats, which of the High Council ofinvolves a guide ribonucleic acid associated with Biotechnologies. the CAS enzyme), has been called "molecular scis-sors" to emphasize its accuracy and also "garageEU-27 GMO REGULATIONSbiology" to emphasize the ease of implementing it. Two directives articulated together were The applications of these new genome-edit- published in 1989 and 1990, Directives ing techniques are multiple and concern human,89/219/EEC and 90/220/EEC on the use of animal and plant health. The range of applicationsGMOs in confined or open environments, is wide, from the production of pharmaceutical pro- followed 10 years later, in 2001, by the teins by plants or human gene therapy to the GeneDirective 2001/18/EC on the deliberate drive associated with CRISPR, against mosquitorelease into the environment of genetically vectors of tropical infectious diseases (dengue,modified organisms which is still in force. malaria, chikungunya, zika). Broad perspectivesIt was amended in 2015 by the Directive EU are now opened up in veterinary medicine (African2015/412 amending Directive 2001/18/EC swine fever as example) or to improve animal wel- as regards the possibility for the Member fare (by reducing the cold sensitivity of piglets, orStates to restrict or prohibit the cultivation creating hornless cows to avoid dehorning, a pain- of genetically modified organisms (GMOs) ful operation). In the field of plant health, numer- in their territory, which is in fact focused on ous patents based on the CRISPR-Cas techniquethe societal acceptability of transgenesis. have been filed to control pest insects and diseasesFinally, in 2018, the Directive 2018/350/or to adapt to climate change (water deficiency,EC amending Directive 2001/18/EC of the soil salinity)European Parliament and of the Council as Today the regulation that must be applied toregards the environmental risk assessment NBTs is the key question. Should genome-editingof genetically modified organisms updates products be considered as GMOs and subjected tothe regulatory framework for environmental the same regulations as transgenesis products?risk assessment. The Regulation (EU) There is no unanimous consensus across the world2015/2283 on novel foods completes these depending on countries policy. For agriculturalrules and guidelines.products, the consequences in a globalized world 30IEUROPEAN SEEDIEUROPEAN-SEED.COM'