CoReGMC: Computational Resources for Genetically Modified Crops
GMO Risk Assessment Guidelines

GMO Risk Assessment Guidelines

Genetically Modified Organisms (GMOs) have become an integral part of modern agriculture, food production, and biotechnology. To ensure the safety of GMOs for human consumption, animal health, and environmental protection, international organizations and individual countries have established comprehensive risk assessment guidelines. These guidelines serve as the foundation for evaluating the safety and impact of GMOs.

This webpage focuses on the GMO risk assessment guidelines from three key regulatory authorities:

Below, we outline the common characteristics of these guidelines, highlight differences in their approaches, and provide resources to access detailed documents.

Common Characteristics

The following categories represent detailed common elements across guidelines for GMO risk assessment:

Comparative analysis involves assessing differences between GMO plants and their conventional counterparts:
  • Evaluation of agronomic and phenotypic characteristics, excluding introduced traits.
  • Compositional differences in key nutrients and natural constituents.
  • Interactions in stacked transformation events via conventional crossing.

Toxicity studies focus on:
  • Potential adverse effects of new proteins or constituents.
  • Stability under digestion and processing conditions.
  • Sub-chronic and chronic toxicity, including dose-dependent effects.

Allergenicity assessments include:
  • Amino acid sequence homology checks for known allergens. (35 % sequence identity to a known allergen over a window of at least 80 amino acids)
  • Specific serum screening for allergenic potential.
  • Tests for pepsin resistance and digestibility.
  • Adjuvanticity potential in immune response enhancement.

Nutritional assessments ensure:
  • Nutritional equivalence to conventional counterparts.
  • Evaluation of nutrient and metabolite profiles under processing conditions.
  • Potential effects on bioavailability and safety of altered nutrients.

Differences in Guidelines

While commonalities exist, the guidelines vary across regions. Differences are highlighted below:

Download Guidelines

Access full guideline documents for each region:

Indian Specific Guidelines

Biosafety Guidelines for GM Crops in India

Contained Use (DBT)

  • Recombinant DNA Safety Guidelines, 1990
  • Recombinant DNA Safety Guidelines and Regulations, 1994
  • Revised Guidelines for Research in Transgenic Plants, 1998

Confined Field Trials (MoEFCC and DBT)

  • Guidelines for Conduct of Confined Field Trials of Regulated GE Plants, 2008
  • Standard Operating Procedures (SOPs) for CFTs of Regulated GE Plants, 2008
  • Guidelines for Monitoring of Confined Field Trials of Regulated GE Plants, 2008

Food Safety Assessment (DBT and ICMR)

  • Guidelines for the Safety Assessment of Foods Derived from GE Plants, 2008 (Updated in 2012)
  • Protocols for Food and Feed Safety Assessment of GE Crops, 2008

Environmental Safety Assessment (MoEFCC and DBT)

  • Guidelines for Environmental Risk Assessment (ERA) of GE Plants, 2016
  • Risk Analysis Framework, 2016
  • ERA of GE Plants: A Guide for Stakeholders, 2016