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Science The Codex Alimentarius distinguishes two types of unintended effects those predictable on the basis of knowledge of the inserted trait and its metabolic connections or of the site of insertion and those unexpected on the basis of current level of understanding Trends in Biotechnology September 2018 Vol 36 No 9873 Concluding Remarks No one questions the occurrence of unin tended effects during the development of plant varieties which is considered a nat ural fact The experience gained over the past 20 years is a valuable basis to improve the risk assessment approach forfood feedproductsderivedfrom GMOs and beyond A solid internationally agreed defi nition of the intuitively simple concept of history of safe use is a need not be overlooked anymore We need moreprecisecriteriaforselectingconven tional counterparts and an internationally agreed upon strategy to estimate natural variation To this end we encourage the scientifi c community to contribute to the development of an independent interna tional database with defi ned criteria for data insertion 113 TD DIFF warranting its quality to set reliable estimates of natural variability Box 2 The number and nature of OECD endpoints analyzed on a crop by crop basis should be prioritized on the basis of their representativeness relevance and variability Over the past 20 years this community developed a risk assessment strategy that has proven itself adequate but that could be further optimized in the interest of global harmonization The develop ment of alternatives to the current para digmestablishedbytheCodex Alimentarius can only start once interna tional consensus on the issues described here is achieved so that risk assessors and managers can rely on a common platform to outline strategies and set priorities Disclaimer Statement The authors are employed by the European Food Safety Authority EFSA The positions and opinions presented in this article are those of the authors alone Box 2 International Database Development The development of a high quality database requires international cooperation among different stakeholders to ensure the necessary reliability credibility and transparency The diffi culty of reaching these goals is probably not so much linked to the production of the database as such but rather to the setting of inclusion criteria warranting its quality This database should provide unbiased data on natural variation essential for the safety assessment The international community should take the responsibility of developing guidelines on the inclusion criteria addressing for example selection of plant varieties sampling of such varieties to produce representative data methodology of measurement used relative versus absolute measurements and comparability of results handling of errors and uncertainties A possible schematic logic fl ow is illustrated in Figure I Star ng point Public risk assessment bodies to dra guideliness for database inclusion criteria Final product Database publicly available evolving tool Stakeholders to provide feedback individual countries industry NGOs consumer organiza on Interna onal agreement on the dra guidelines Interna onally agreed guidelines on inclusion criteria publicly avialable Data producers e g industry associa on to build the database considering the established criteria Public risk assessement bodies to check the database against the established criteria Updated and curated following same logic fl ow Feedback for development Feedback for maintenance Figure I Possible Flow for Establishing an International Database NGO nongovernmental organization 874Trends in Biotechnology September 2018 Vol 36 No 9 and do not necessarily represent the views or scien tifi c works of EFSA The authors declare that they have no confl ict of interest Resources ihttp www fao org food food safety quality gm foods platform en iihttps www canada ca en health canada html iiihttp www oecd org science biotrack ivhttps www canada ca en health canada services food nutrition legislation guidelines guidance documents guidelines safety assessment novel foods derived plants microorganisms guidelines safety assessment novel foods 2006 html vhttp www efsa europa eu en events event 180424 0 1European Food Safety Authority EFSA Via Carlo Magno 1A 43126 Parma Italy Correspondence antonio fernandezdumont efsa europa eu A Fernandez https doi org 10 1016 j tibtech 2018 03 005 References 1 Haslberger A G 2003 Codex guidelines for GM foods include the analysis of unintended effects Nat Biotech 21 739 741 2 Ladics G S et al 2015 Genetic basis and detection of unintended effects in genetically modifi ed crop plants Transgenic Res 24 587 603 3 National Academies of Sciences Engineering and Medi cine 2016 Genetically Engineered Crops Experiences and Prospects The National Academies Press 4 Schnell J et al 2015 A comparative analysis of insertional effects in genetically engineered plants considerations for pre market assessments Transgenic Res 24 1 17 5 Organisation for Economic Co operation and Develop ment 1993 Safety Evaluations of Foods Derived by Mod ern Biotechnology Concept and Principles OECD 6 Food and Agriculture Organization World Health Organi zation 2000 Report of a Joint FAO WHO Expert Consul tation on Foods Derived from Biotechnology Safety Aspects of Genetically Modifi ed Foods of Plant Origin FAO WHO 7 Codex AlimentariusCommission 2003 2009 Codex Prin ciples and Guidelines on Foods Derived from Modern Biotechnology Foods Derived from Modern Biotechnol ogy 2nd ed FAO WHO 8 EuropeanCommission 2015 Regulation EU 2015 2283of theEuropeanParliamentandoftheCouncilof25November 2015 on novel foods amending Regulation EU No 1169 2011 of the European Parliament and of the Council and repealing Regulation EC No 258 97 of the European Par liament and oftheCouncil andCommissionRegulation EC No 1852 2001 Off J Eur Union L327 1 22 9 European Food Safety Authority 2011 Guidance docu ment on selection of comparators for the risk assessment of GM plants EFSA J 9 2149 10 European Food Safety Authority 2011 Guidance for risk assessment of food and feed from genetically modifi ed plants EFSA J 9 2150 11 European Commission 2003 Commission Implementation Regulation EU 503 2013onapplicationsforauthorisationof genetically modifi ed food and feed in accordance with Reg ulation EC 1829 2003 Off J Eur Union 1 48 L157 1 12 Privalle L S et al 2012 Development of an agricultural biotechnologycropproduct testingfrom discoverytocom mercialization J Agric Food Chem 60 10179 10187 13 Van Emon M J 2016 The omics revolution in agricultural research J Agric Food Chem 64 36 44 14 Van Dijk P J 2014 Safety assessment of plant varieties using transcriptomics profi ling and a one class classifi er Regul Toxocol Pharmacol 70 297 303 Forum Phage Aggregation Dispersion by Ions Striving beyond Antibacterial Therapy Marek Drab1 Bacteriophagessensealkaline cations in their immediate extra cellular environment which regu lates virion virion interactions An ion steerable aggregation disper sion A D phenomenon among virions is a recently discovered step in group behavior in the phage life cycle When powered bytheoctanol basedwater immisciblelipopolysaccharide LPS trap oWILT purifi cation approach A D promises break throughs for a plethora of biotech nologicalapplicationsbeyond phage therapy A Brief Introduction to Phage Therapy and Its Limitations Due to the paramount impact of bacter iophages on science and biotechnology including the use of phages for therapy the period since the beginning of the 20th century has sometimes been called the era of phages Beginning with d Her elle s letter on the fi rst use of antibacterial phages in 1917 2017 marked a century of phage antibacterial therapy and a 100 year long effort to reach a level of purity that would enable intravenous adminis tration of phages Sincebacteriophagesdonotinfect human cells they have emerged as an effi cient means to treat bacterial infec tions particularly those caused by antibi otic resistantbacteriaknownas superbugs 1 2 The success rate for pathogeneradicationinexperienced phage therapy centers usually reaches 50 which for otherwise incurable cases is an impressive feat Phage therapy is worth considering particularly in view of the mass emergence of bacterial strains possessing multidrug resistance Three issues currently limit the broader application of phagesin antibacterialther apy i the fi t of the phage to the targeted bacterium ii the medical purity of the phage and iii low phage vitality A few specialized centers are dedicated t
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