Traits and Germplasm Licensing

Bollgard® and Bollgard® II in-the-seed trait technologies provide cotton plants in-built insect protection against bollworms infestation with an insecticidal protein from a naturally occurring soil micro-organism, bacillus thuringiensis (Bt). It produces a protein that is toxic to bollworm insects which are known to cause maximum yield loss and economic damage to the cotton crop. When a bollworm ingests a portion of the plant (leaf or other tissue), the protein acts on the gut of the bollworm causing it to stop feeding immediately. 

Thus, in-the-seed Bollgard® and Bollgard® II insect protection Bt cotton technologies offer farmers the choice of in-built plant protection specifically to their target bollworm insects, resulting in lower insecticide use, better boll retention leading to potentially higher yields.

In 2002, the single-protein Bollgard® - was the first insect protection trait technology approved for commercialization in India by the Genetic Engineering Approval Committee (GEAC) – the Indian regulatory body for biotech crops.

In 2006, the GEAC approved the two-protein Bollgard® II insect protection cotton trait technology that offers farmers the choice of superior longer duration in-built plant protection from bollworm complex. Additionally, it also helps in increasing durability of technology due to superior Insect Resistance Management (IRM) properties.

It is critical to remember that Bollgard® and Bollgard® II in-the-seed insect protection cotton trait technologies work very well as a key component of Integrated Pest management (IPM). For insect pests including sucking pests and bollworms, farmer need to protect their cotton crop based on economic threshold levels (ETL) observations. We have been recommending ETLs established by CICR/ NCIPM.

In-the-seed Bollgard® and Bollgard® II insect protection Bt cotton technologies were introduced in India by Mahyco-Monsanto Biotech India Ltd. (MMB India) - a joint venture between Maharashtra Hybrid Seeds Co. Ltd. (Mahyco) and Monsanto Holdings Pvt. Ltd. (MHPL).

To offer farmers the choice of innovative technologies and in the preferred seeds of their choice, MMB India has partnered with 40+ seed companies in India in a broad-licensing model. Today Indian farmers choose from 800+ hybrid seeds sold by 40+ companies with five approved Bt technologies; plus non-Bt varietal seeds.

In-the-seed insect protection Bt cotton technologies are widely planted around the world as an environmentally friendly way of controlling bollworms. In 2011, seeds with biotechnologically derived cotton were cultivated on 370 million acres in 13 countries, i.e. 15 per cent of global biotech area and made a significant contribution to the income of farmers in 13 nations including USA, India, China, Pakistan, Australia, Argentina, Myanmar, Burkina Faso, Brazil, Mexico, Colombia, South Africa and Costa Rica.

Bollgard® and Bollgard® II logo designs are registered trademarks and under the license from Monsanto Company.

Roadmap to Obtaining Regulatory Approval for In-the-seed insect protection Bollgard® Bt cotton technologies

 

Governing law and approach towards safety evaluation:

  1. The environmental release of GM crops is regulated under The EPA 1986 through Rules for the Manufacture, Use/Import/ Export and Storage of Hazardous Micro organisms/ Genetically Engineered Organisms or Cells.
  2. Safety concerns focus whether environmental and ag application of organism modified by rDNA techniques pose an incremental risk.
  • Approval has to be sought under Rules 7-11 depending on the purpose i.e. production, deliberate release, approval for food use, etc.
  • Ref: Recombinant DNA Safety Guidelines 1990, Page 75 item 3