Field Trials

Field Trials

Subject – Agriculture

Context – Rallis India seeks ‘no objection’ to hold GM cotton, maize trials

Concept –

• Field trials are an important component of the process for approval of a genetically engineered (GE) crop for commercial cultivation.
• These trials represent the first controlled introduction of a GE crop into the environment falling in between experiments in contained facilities and commercial release to farmers.
• “Guidelines for Research in Transgenic Crops, 1998” issued by the Department of Biotechnology (DBT) briefly describe the considerations for limited field experiments.
• In view of the enormous progress made during the last decade in the research and development of GE crops a need was felt to revisit these guidelines to streamline the procedures for the safe conduct of confined field trials and methodical evaluation of the same.
• In this context, the “Guidelines for the conduct of confined field trials of regulated, GE plants in India” have been prepared to provide instructions to help applicants meet requirements for the application and authorization/ approval of confined field trials of regulated, GE plants under Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells Rules, 1989 of the Environment (Protection) Act, 1986.
• These guidelines summarize the information requirements and procedures used by the two regulatory committees, the Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC), that are responsible for evaluating and approving applications for confined field trials.

Contained Conditions

• Contained conditions refer to work with GE organisms within contained facilities, such as a laboratory, a greenhouse, a nethouse, and areas used for the storage and handling of experimental GE organisms.

Confined Field Trial

• A confined field trial is a field experiment of growing a regulated, GE plant in the environment under specified terms and conditions that are intended to mitigate the establishment and spread of the plant.
• Experimental plant/species/varieties/hybrids grown in confined trials are those that have yet to receive regulatory approval for environmental release from GEAC.
• Embodied in this definition of confinement are three important considerations.
  • Firstly, confined field trials are typically carried out on a small scale, usually to a maximum of one hectare (ha). There may be exceptions to this.
  • Secondly, a confined trial is an experimental activity conducted to collect data on potential biosafety impacts. The collection of such field trial data is a prerequisite for safety assessment of the GE crop under evaluation.
  • Additionally, field trials are carried out to produce sufficient plant material so that the developer can undertake research to address the information and data requirements for livestock feed and human food safety assessments.
• Finally, the trial is conducted under conditions known to mitigate:
  • Pollen- or seed-mediated dissemination of the experimental plant;
  • Persistence of the GE plant or its progeny in the environment, and;
  • Introduction of the GE plant or plant products into the human food or livestock feed pathways.

Regulatory Authorities –

• The activities involving the use of GE organisms and products thereof are regulated under the “Rules for the manufacture, use/import/export and storage of hazardous microorganisms/genetically engineered organisms or cells” notified under the Environment (Protection) Act, 1986, commonly referred as Rules, 1989.
• These rules and regulations are implemented by the Ministry of Environment and Forests (MoEF) and Department of Biotechnology (DBT) and State Governments. S
• ix competent authorities and their composition have been provided for in the Rules to handle various aspects i.e.,
  • Recombinant DNA Advisory Committee (RDAC),
  • Review Committee on Genetic Manipulation (RCGM),
  • Genetic Engineering Approval Committee (GEAC),
  • Institutional Biosafety Committee (IBSC) attached to every organization engaged in rDNA research,
  • State Biotechnology Coordination Committee (SBCC)
  • District Level Committees (DLCs).
• While the RDAC is advisory in function, the IBSC, RCGM, and GEAC are of regulatory function. SBCC and DLC are for monitoring purposes.
• GEAC, functioning in the MoEF, is the Regulatory Authority for Biosafety Research Level II (BRLII) trials.