What safety studies were done for ensuring that GM Mustard is safe and were they done according to relevant guidelines

The following safety studies were done for GM Mustard and they were as per prescribed guidelines developed by Government of India from time to time

Category

Tests Done

Relevant Guidelines

Molecular characterization ·      Gene sequences, constructs and molecular characterization

·      Expression studies of the three inserted genes – bar, barnaseand barstar

·      Cloning, expression, purification and production of three expressed proteins

·   Recombinant DNA Safety Guidelines, 1990

 

·   Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 prepared by Indian Council of Medical Research (ICMR), Ministry of Health and Family Welfare, Government of India

 

Food safety

Studies

·      Equivalence of the Bar, Barnase and Barstar recombinant proteins produced in bacteria with that expressed in GE plants

·      Bioinformatics analysis of the three proteins

·      Pepsin digestibility of the three proteins

·      Heat stability of the three proteins

·      Acute oral toxicity of the three proteins in mice

·      Sub-chronic toxicity of leaves and seeds containing the three proteins in rats

·      Compositional analysis

 

·   Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 prepared by Indian Council of Medical Research (ICMR), Ministry of Health and Family Welfare, Government of India

 

Environmental

safety studies

·           Research & Development Phase including primary field trials 2004-2007.

·           BRLI trials for two growing seasons (2010-11, 2011-12)

·           BRLII trials for one growing season (2014-15)

·           Weediness potential and aggressiveness parameters

·           Impact on soil microflora during BRLI and BRLII trials

·           Crossability and pollen flow studies

·           Pollination behavior, pollen morphology and physiology

·   Revised Guidelines for Research in Transgenic Plants, 1998 (DBT)

 

·   Guidelines for the monitoring of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008 (DBT & MoEF&CC)

Detection

Protocols

· Protocol for testing at a level of detection (LOD) of 0.01{b9cca8aede1995d450ecbb7cabdd9c806c66ba8f7afe5985dcdbcb8cb5055004}

· Development of ELISA kits for Bar, Barnase and Barstar

·      Tests and Detection methods developed