1. 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

2. Centre Bioengineering, RAS
Russia, Moscow, Prospekt 60-letiya Oktyabrya, 7/1

3. 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

4. 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»
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…

5. Guidance documents
Novel Foods
GM PLANTS

6. Biosafety Assessment
GM Microorganisms
GM Live vaccines

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

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

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

10. 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

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

12. 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

13. 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
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

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

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

17. YES !