GUIDANCE FOR INFORMATION/DATA GENERATION AND DOCUMENTATION FOR SAFETY ASSESSMENT OF REGULATED, GE PLANTS

COMMENTS INVITED: GUIDANCE FOR INFORMATION/DATA GENERATION AND DOCUMENTATION FOR SAFETY ASSESSMENT OF REGULATED, GE PLANTS

Comments are invited by the Department of Biotechnology (DBT) on the “Guidance for information/data generation and documentation for safety assessment of regulated, genetically engineered (GE) plants” wherein indicative checklists have been provided to assist the applicants (product developers) as they undertake research including the confined field trials of regulated GE plants for addressing the food, feed and environmental safety requirements of regulated GE plants. These include:

I. Studies that should be completed before Biosafety Research Level I (BRL-I) trials are undertaken

II. Field studies that should be completed during BRL-I and/or Biosafety Research Level II (BRL-II) trials

III. Non-field studies that should be completed in parallel to BRL-I and BRL-II.

Comments may be sent by April 15, 2009 to:

Dr. K.K. Tripathi, Advisor, DBT and Member Secretary, RCGM