Modern biotechnology, which utilizes recombinant DNA (rDNA) technology and genetic engineering, has revolutionized agricultural research by enabling the development of genetically engineered (GE) crops with improved traits. As these crops and their derived products become more widely cultivated, consumed, and traded globally, ensuring their safety for human health and the environment is of paramount importance. This approval is required for reporting safety studies of GE crops/plants intended for agricultural and environmental use. Researchers and Principal Investigators (PIs) planning to undertake safety assessments or related studies on genetically engineered crops must submit the required information to the Review Committee on Genetic Manipulation (RCGM) before conducting or reporting such studies.
REPORT OF RESEARCH TRIAL(S) AND/OR SAFETY STUDY(IES) FORM D7: SUBMISSION OF REPORT OF SAFETY STUDIES OF GENETICALLY ENGINEERED (GE) CROPS/PLANTS FOR AGRICULTURAL AND ENVIRONMENTAL USE
What is Application for REPORT OF RESEARCH TRIAL(S) AND/OR SAFETY STUDY(IES) FORM D7: SUBMISSION OF REPORT OF SAFETY STUDIES OF GENETICALLY ENGINEERED (GE) CROPS/PLANTS FOR AGRICULTURAL AND ENVIRONMENTAL USE
Who Can Apply for REPORT OF RESEARCH TRIAL(S) AND/OR SAFETY STUDY(IES) FORM D7: SUBMISSION OF REPORT OF SAFETY STUDIES OF GENETICALLY ENGINEERED (GE) CROPS/PLANTS FOR AGRICULTURAL AND ENVIRONMENTAL USE
Documents Required for this REPORT OF RESEARCH TRIAL(S) AND/OR SAFETY STUDY(IES) FORM D7: SUBMISSION OF REPORT OF SAFETY STUDIES OF GENETICALLY ENGINEERED (GE) CROPS/PLANTS FOR AGRICULTURAL AND ENVIRONMENTAL USE
- A combined colour photocopy of all the minutes and / or permit(s) issued earlier by IBSC / IAEC / RCGM / GEAC
- Crop biology document
- Agronomic performance
- Expression analysis study report
- Functional equivalence of transgenic protein(s) expressed in microbial system versus the transgenic protein(s) in the GE event
- Description of trait efficacy studies for each location
- Colour photographs of the severity of the damage with percentage / injury rating by non-target organisms along with ETL for all the non-target organisms with reference
- Compositional analysis raw data and statistically analysed data with appropriate data transformation wherever required
- Appropriate references and any other relevant information including IBSC minutes and trial recording formats such as Record of Harvest Termination etc.
Act and Rules
Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008
Environmental Risk Assessment of Genetically Engineered Plants: A Guide for Stakeholders, 2016
Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016
Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008
Environmental Risk Assessment of Genetically Engineered Plants: A Guide for Stakeholders, 2016
Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016
Role of Shamkris and Process of REPORT OF RESEARCH TRIAL(S) AND/OR SAFETY STUDY(IES) FORM D7: SUBMISSION OF REPORT OF SAFETY STUDIES OF GENETICALLY ENGINEERED (GE) CROPS/PLANTS FOR AGRICULTURAL AND ENVIRONMENTAL USE
Shamkris adopts a results-oriented approach to ensuring compliance with the mandatory requirements for obtaining the Application. With a simple and guided methodology, Shamkris helps organizations achieve the necessary application in a timely and cost-effective manner. Shamkris offers 100% support in advisory, guidance, and compliance, ensuring smooth processing for obtaining the application.
The Application acquisition process described below:
Advisory for the document required
Preparation of documents as per application & list of documents.
Certificate File
Inspection by the department if required
Certificate department
Certificate issued
Yearly Compliance if Applicable
Renewal when due
Who can issue Approval for REPORT OF RESEARCH TRIAL(S) AND/OR SAFETY STUDY(IES) FORM D7: SUBMISSION OF REPORT OF SAFETY STUDIES OF GENETICALLY ENGINEERED (GE) CROPS/PLANTS FOR AGRICULTURAL AND ENVIRONMENTAL USE
FAQ
This approval is for reporting safety studies of genetically engineered (GE) crops/plants intended for agricultural and environmental use.
Principal Investigators (PIs), research institutions, universities, biotechnology companies, and other organizations conducting safety studies of GE crops/plants.
Yes, applicants must submit the required information to the RCGM before reporting the safety studies.
Safety studies related to the agricultural and environmental use of genetically engineered crops/plants.
They help assess potential risks and ensure the safe use of GE crops for human health and the environment.