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Dr. Shanthu Shantharam

“Biosafety”, a term widely used in the context of modern day Genetically Modified Organisms (GMOs) include factors related to the genetic stability, environmental, and food safety of organisms that have produced using modern recombinant DNA (rDNA) technology. A variety of scientific approaches are used to assess their genetic stability, reproductive ability, biochemical, morphological, physiological changes, their impacts on target and non-target organisms, and the surrounding environment in general.

One group of modern biotechnology products, the Genetically Modified Organisms (GMO), also knows as Genetically Engineered Organisms (GEO), Transgenic Organisms (TO) or Living Modified Organisms (LMO), have raised considerable concerns about their biosafety and environmental impacts in the minds of the public, mostly at the instigation of anti-technology activists. Most of these biosafety “concerns” have evolved into major “biosafety” issues of modern biotechnology, largely due to pernicious and persistent global anti-biotech campaign.


With the advent of modern biotechnology and recombinant DNA techniques, they have found rapid applications in improving human health, agriculture, as well as environmental protection in a sustainable manner. Since 1996, dozens of Genetically Modified (GM) crops are in commercial cultivation around the world, and in 2007, it topped one and a half billion acres in the world. More than 22 countries spread across all continents now grow GM crops.

Ever since the advent of GM crops, many anti-technology groups has consistently raised the biosafety, issues without accepting mounting scientific evidence to the contrary. This persistent anti-GMO campaign has resulted in a multi-million dollar global biotechnology regulatory enterprise so much so it is dubbed the “Greatest Biosafety Hoax”. There seems to be no end in sight for the demands to raise the regulatory bar around the world. If there is one single critical factor that is hampering the deployment of GMOs in the world, the constantly raising regulatory bar is becoming prohibitively expensive. However, for the unnecessary regulatory strictures on GMOs, there would be a thriving agricultural biotechnology industry around the world benefiting all, instead, there is a thriving regulatory enterprise in the world today.

The Science:

Whenever a plant breeder develops an improved variety, it is a normal practice to check for its agronomic performance and then carry out standardized tests to ensure that the new variety is the same in every other respect save for the desired change (trait) brought about by breeding. After a couple of years of multi-location trials for its reliable performance, the variety is released to farmers for cultivation. With GM crops, however, one cannot introduce them without undergoing a battery of sophisticated tests for five to ten years costing tens of million dollars to meet the regulatory requirements to make sure that it is “safe”.

The GMO safety tests include; biochemical and molecular characterization, and genetic stability testing including the determination of introduced gene’s copy number, followed by years of field-testing. In addition, food safety testing such as toxicological and allergenicity, nutritional and chemical composition analyses are required by conducting animal feeding studies for years. All purveyors of GM crops have been forced to carry out such expensive tests in spite of a preponderance of scientific evidence that GM crops are “substantially equivalent” to the non-GM counterparts. It has become a habit with many regulatory agencies asking for mostly the “nice to have data” as opposed to “need to have data”.

In almost 11 years of GM crops cultivation, there has not been a single proven instance of GM safety risk to the environment or human or animal health, and yet the “biosafety” issues still loom large over the development of GM crops technology. Other scientific concerns are gene transfer to non-target organisms, and threat to biodiversity, persistence of transgenes in the environment, and development of weediness or “super weeds”.

All the above scientific concerns of biosafety have been adequately addressed in thousands of environmental risk assessments, food safety reviews, and hundreds of research studies carried out in North America and the European Union. Moreover, highly respected scientific academies of the world and international organizations like UN-FAO and UN-WHO have all opined that GM crops are as safe as or even safer than any other crop variety that is on the market.

Position of FBAE:

FBAE promotes deployment of tools of modern biotechnology wherever appropriate and affordable.

FBAE believes in the deployment all tools of modern biotechnology to improve human welfare and for improving the environment.

FBAE is believes in the overwhelming scientific evidence, and proof to demonstrate that GM crops completely safe for large-scale cultivation, human and animal consumption.

FBAE believes that gm crops that are under commercial cultivation across the world are safe as none of them have shown to cause any deleterious effects on humans, animals or the environment.

FBAE believes that current regulatory reviews are unnecessariy tedious and repetitive without adding anything more to ensure safety or risk prevention.

FBAE believes that each GMO is unique and distinct that warrants a thorough safety and environemtnal risk assessment, and once so approved, they must be allowed for unfettered commercialization.

FBAE does not support any scientifically baseless fear or speculation to delay or stop the development of modern biotechnology.

FBAE champions the use of scientific criteria for technology assessment.

FBAE believes in scientific and empirical evidence to attest for biosafety.

There are some clearly discernible benefits from the no-till cultivation of GM crops and reduction in chemical inputs into agriculture and exposure of the same to farm laborers. There is demonstrable evidence of reduced fungal toxins in crops engineered with the Bt toxin genes, which is a bonus to avoid food toxicity.

FBAE believes that GM crops do not impact the environment significantly than any other crops that have been introduced in modern agriculture.

FBAE also believes that GM crops do not have any unique or significant negative impact on general biodiversity.

FBAE strongly supports the adoption of GM crops into Indian agriculture after a thorough scientific safety assessment and environmental risk assessment.