Center of Bioengineering, RAS The cooperation with EU in biotechnology Harmonization of approaches and principles for GMO detection in EU and Russia Konstantin Skryabin Center of Bioengineering, RAS

Centre Bioengineering, RAS Russia, Moscow, Prospekt 60-letiya Oktyabrya, 7/1 http://www.biengi.ac.ru

Centre «Bioengineering» RAS: main scientific tasks Development of transgenic plants, resistant to biotic and abiotic stresses Sequencing of microorganisms and plants genomes Mathematical analysis of DNA- and protein-sequences Computer modeling of development processes Cell engineering Bioengineering of biologically-active compounds (steroids, enzymes, antibiotics) Participation in the State control and regulation of GMO’s, GM foods and feeds

Evolution of the regulatory framework in Russia (genetic engineering) 1996 Jul 5 Federal act "On State regulation of genetic engineering activity" 2000 Jun Amendments in respect of gene therapy and genetic diagnostics to Federal act "On State regulation of genetic engineering activity" Nov Instruction by the Chief State Sanitary Physician of the Russian Federation: "On the order of hygienic expertise of food products, derived from genetically modified organisms” * 2001 Feb 16 The order by Government of Russian Federation «On state registration of genetically modified organisms» 2002 Jan “On state registration of feeds, derived from genetically modified organisms” 2003 Sep 16 The order by the Chief State Sanitary Physician of Russian Federation: “On the order of microbiology molecular-genetic expertise of genetically modified microorganisms, used in food production” * point 3. …Centre “Bioengineering” RAS performs medical-genetics assessment of novel foods. Collaborator is MGSC RAMS…

Guidance documents Novel Foods GM PLANTS

Biosafety Assessment GM Microorganisms GM Live vaccines

STATE STANDARD Russian Federation 52173-2003 The method of plant GMO detection RAW MATERIALS AND NOVEL FOODS

Workshops on GMO «Post-Registration Monitoring of GMO, Novel Foods and Feeds» with participation of OECD experts, Moscow - December 2003

Future workshops OECD Workshop on the Biology of the Atlantic Salmon «Transgenic fish: Biosafety problems» 29 Nov – 1 Dec 2004

Future workshops International meeting of the CIS Regional committee with participation of OECD experts) «Mutual platform in genetic engineering regulation in the frames of CIS protocol» 15-16 Dec 2004

OECD BIOSAFETY CONSENSUS DOCUMENTS Series on Harmonization of Regulatory Oversight in Biotechnology (12 documents)

Participation in EC Meetings WORKSHOP ORGANIZATION LOCATION TIME Workgroup on GMM-analysis OECD Bilthoven, Netherland September, 2002 Study in IRC-Courses for preparation of experts in GMO analysis in novel food ICR Ispra, Italy November, 2002 Introduction to bioscience communications in Europe EC, VIB, Belgium Praha,Chech Republic Meeting of the ENGL ENGL Varna, Bulgaria September, 2003 Measuring and Monitoring the Impacts of GMOs ESF Scientific Programme on assessment of the Impact of GM Plants (AIGM) University of Cambrige, UK March, 2004

Participation in EC Meetings WORKSHOP ORGANIZATION LOCATION TIME Visiting the Genome sequencing Centre Max Planck Molecular Biology Institute Berlin, Germany May, 2004 Discussion of the standardization problems of GMO detection CEN, Institut national de la recherche agronomique Paris, France November, 2004 Participation in the V-VII-th Meetings of the Task Force for Safety of Novel Foods and Feeds OECD Task Force for Safety of Novel Foods and Feeds 2001-2003 XI-XV –th Meetings of the Working Group for Harmonization of Regulatory Oversight in Biotechnology OECD Working Group for Harmonization of Regulatory Oversight in Biotechnology 2001 - 2004

RUSSIAN – FRENCH RESEARCH COOPERATION «The harmonization of approaches and principles for quantitative GMO detection in EU and Russia»

RUSSIAN – FRENCH RESEARCH COOPERATION «Perspectives of integration of the Russian laboratory into the ENGL»

YES !