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Genetic Modification: Testing and Legalities in Biotechnology

Explore the testing methods and legal aspects of genetically modified organisms (GMOs) including regulatory issues, dangers, and societal concerns. Understand the protocols for GM microbe safety and environmental release regulations.

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Genetic Modification: Testing and Legalities in Biotechnology

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  1. TESTINGGENETICALLY MODIFIED ORGANISMS & LEGALITIES DR.K.S.MANJA

  2. GMO- Plants created for food • Desired traits • Genes – CaMV 35S Promoter • NOS Terminator • Bar gene • Pat gene • 45% Soya • 50% cotton • 60% Super Market

  3. U.K. -- Resist • Regulatory mistakes • Mistrust • Gene flow • Threat to biodiversity • Allergens • Antibiotic resistance transfer • Labelling ?

  4. What to test for ? • Introduced DNA • Expressed product • Protein based product • Use western blot technique • Immunoassay • Sensitivity 1%

  5. ELISA • Highly sensitive (0.25%) • Limitation if protein not expressed • DNA - PCR/Southern Blot • 20 pg. to 10 ng. • Quantitative PCR • Real time PCR

  6. Non-destructive testing • Near infrared spectroscopy • Less than 1 min. • PCR – Protein • Both negative • Undetectable level

  7. Problems • Not all products have DNA • Oil / Denature • Societal resistance for GMO • Fear of unknown • Terminator Gene • Gene flow • Allergens • Brazil nut methionine

  8. LEGAL ASPECTS OF BIOTECHNOLOGY HAZRDOUS & GE MICROBES MIN.OF ENV & FORESTS, 1989 RECOMBINENT DNA SAFETY MIN OF S & T / DBT NATIONAL BT STRATEGY DBT / MIN. S & T FOOD SAFETY & STD. BILL MIN.OF FOOD PROSS. INDUSTRIES

  9. RULES FOR HAZARDOUS & GE MICROBES • SALE STORAGE AND HANDLING • IMPORT / EXPORT • PRODUCTION / PACKAGING • AUTHORITIES • RECOMBINANT DNA ADV COMMITTE • DBT • REVIEW COMMITTEE – GEN MANUP.

  10. DBT,ICMR, ICAR, CSIR • INSTITUTIONAL BIOSAFETY COMM. • GEN ENGG APPROVAL COMM. • DEPT ENV & FORESTS • STATE BT CO-ORD.COMM. • DIST.LEVEL COMM. • DC/PCB/CMO/AGRI OFFICER/MB • BACTERIA,FUNGI,PARASITES,VIRUS

  11. APPROVAL/PROHIBITION • NO WORK- HAZ / GE MICROBES • WITHOUT GEAC. APPROVAL • PERMITTED IN RES / MIN ENV FOREST • EDUCATION /I. BIO. SAFETY COMM • NO DELIBERATE RELEASE • SPECIC PERIOD (4 YEARS) • SUPERVISION.GEAC/SBCC/PCB/DLC

  12. PENALTIES • DLC / SBCC – USER EXPENCE • URGENCY /STATE ACTION / RECOVER • SEEK GOVT-IMPLEMENTATION • ACCIDENTS TO BE NOTIFIED. • APPEAL NEXT AUTHORITY • 30 DAYS • POLICE OR FOREST DEPT HELP

  13. RISK GROUP • II ORD BACTERIAL PATHOGENS • III Cl botulinum/Plague. • II.FUNGI. CRYPTOCOCCUS • III HISTOPLASMA CAP. • II VIRUSES. HEPATITIS. DENGUE. • III MONKEY POX / RABIES • IV KFD / RSSE • SPECIAL-LASSA / S.POX / YF / MARBERG

  14. PLANTS • ALL VIRUSES • BACTERIA – XANTHOMONAS • FUNGI - 50 FAMILIES • PARASITIC WEEDS • PROTOZA. PHYTOMONAS • NEMATODES. 23 FAMILIES. • ARTHROPOD PESTS

  15. R. DNA SAFETY REGULATION • DBT. GE ORGANISMS • G. TRA. GREEN PLANTS / ANIMALS • R-DNA TECH – VACCINES • LARGE SCALE PDN PROHIBITED • EXEMPT(SELF CLONING) • COMPETENT AUTH(NON PATH) • APPROVAL(TOXIN GENE / DRUG RES)

  16. CONTAINMENT-LEVAL 3 - 4 • GOOD LAB PRACTICE • BIOLOGICAL CONTAINMENT • VECTOR SPECIFIC • SUVIVAL IN ENVIRONMENT • GREEN HOUSE CONTAINMENT • NEGATIVE PRESSURE • POSITIVE PRESSURE

  17. GREEN HOUSE • NON PATHOGEN VECTOR GH (A) • PATHOGEN VECTOR GH (B) • 20Lit AND ABOVE – LARGE SCALE • GE ORG SHOULD NOT BE PATHOGEN • RELEASE TO ENVIRONMENT • GENETIC MARKERS / HOST RANGE • STABILITY FOR 4 YEARS

  18. BIOWASTES TO BE DESTROYED • RESEARCH – DEPT.BIOTECH. • CGO COMPLEX NEW DELHI 110003 • ENV RELEASE – MIN ENV & FORESTS • PARYAVARAN BN. NEW DELHI.110003 • SUPPORTING ORGGANISATIONS • I C M R (AIIMS COMPLEX) • I C A R (KRISHI BN ) • C S I R (RAFI MARG)

  19. BIOHAZARD • GREEN HOUSE – A • TRAINING BIOHAZARD • I B S C • GREEN HOUSE - B • NEGATIVE PRESSURE • DOUBLE DOOR - POLLEN CONTROL • EFFLUENT TREATMENT

  20. EMPOWERING JUDICIARY • TRAING FOR JUDICIARY • CENTRE FOR FINGER PRINTING • TRG CENTRE FOR BIO – SAFETY • NATIONAL BIOTECH. AWARENESS FUND • HUMAN TISSUE ACT 2005 • IPR IN COLLEGE CURRICULUM • PUBLIC PARTICIPATION

  21. MULTIPLICITY OF FOOD LAWS • GROUP OF MINISTERS • INTEGRATED FOOD LAWS • FOOD SAFETY & STANDARD ACT 2005 • GENETICALLY MODIFIED FOODS • LABELLING OF FOOD PRODUCTS • CODEX ALIMENTARIOUS • P F A ACT. LABEL. WTS & MEASURES

  22. FOOD AUTHORITY NEW DELHI • AGRICULTURE / COMMERCE / HEALTH • FOOD PROC / LAW / A FOOD TECH • SCIENTIFIC COMMITTEE • FRADULENT PRACTICE.ADULTERATION • GM FOODS • STATE COMMISSIONER FOR F. SAFETY • SPCIAL APPELLATE TRIBUNAL • SPECIAL COURT (GAS TRAGEDY)

  23. Thank you

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