Viewpoint: India should create the proposed biotechnology regulatory agency, despite its serious flaws

This article originally ran at Forbes and has been republished here with permission of the author.

India should appreciate the importance of genetically improved varieties of crops. The nation’s farmers have been among the greatest beneficiaries of the introduction of high-yielding wheat varieties, thanks to the “Father of the Green Revolution,” Nobel Laureate Norman Borlaug.

In pre-Borlaug 1963, wheat grew in India in sparse, irregular strands, was harvested by hand, and was susceptible to rust disease. The maximum yield was 800 pounds per acre. By 1968, after the introduction of Borlaug’s varieties and improved agronomic practices, the wheat grew densely packed, was resistant to rust, and the maximum yield had risen to 6,000 pounds per acre.

More recently, India has also benefited from the application of molecular techniques to the genetic engineering of crop plants. During the past decade, widespread adoption of an insect-resistant, genetically engineered crop called Bt-cotton, which contains a bacterial protein toxic to certain insect pests, has drastically reduced the use of chemical pesticides in cotton fields and improved farmers’ income and food security. Economists Graham Brookes and Peter Barfoot estimate that Bt-cotton boosted India’s economy by $9.4 billion from 2002 to 2010, and by $2.5 billion in 2010 alone.
Complementing the Brookes and Barfoot data, a just-published study by Matin Qaim and Shahzad Kouser of the University of Goettingen “proves that these income gains from Bt adoption have also improved household access to food, leading to higher calorie consumption and better dietary quality,” and that “the introduction of Bt technology has reduced food insecurity by 15 – 20% among Indian cotton growers.”

But the nation’s relationship with this critical technology is fragile. In June, a Technical Expert Committee (TEC) recommended to the Supreme Court an indefinite moratorium on field trials of genetically engineered (also known as “genetically modified,” or “GM”) crops until alleged deficiencies in the government’s regulatory and safety systems have been addressed. The “deficiencies”cited by the TEC are, however, arguably imaginary.

Genetic modification – considered broadly – has long been with us. Whenever plant breeders have exhausted the genetic resources (germplasm) within their crops’ species, they have used several techniques to introduce new genes or alleles into their cultivars. A genetic modification technique in use since the 1950s, for example, is induced-mutation breeding, which involves exposing seeds or cells to ionizing radiation or toxic chemicals to induce random, desirable genetic mutations (but which are accompanied by innumerable, other, uncharacterized genetic changes).

Thousands of such mutation-bred crop varieties have been commercialized in North America and Europe and are integral parts of our diet, and two varieties of desperately needed, rust-resistant wheat created this way have just been approved for distribution in Kenya. In addition, since the 1930s plant breeders have performed “wide cross” hybridizations, in which large numbers of “alien” genes are moved across what used to be thought of as “natural breeding boundaries” to create plant varieties that cannot and do not exist in nature. In these hybridizations, which are performed between organisms of different species or genera, the parental plants may be sufficiently compatible to produce a viable zygote but not compatible enough to permit normal embryo or endosperm development that results in a mature plant. Scientists devised mechanical and biochemical ways to “rescue” the embryos and make them viable. Common commercial crops derived from wide crosses include tomato, potato, oat, rice, wheat, corn and pumpkin, among others.

The results of wide-cross hybridizations and radiation-induced mutagenesis represent far more drastic “tinkering with Nature” than the modern molecular techniques, but it is only the latter that have been subjected to onerous government regulation and the opprobrium of activists.

The regulation of plants engineered with modern molecular techniques arguably has been a largely gratuitous exercise worldwide. The cultivation of these plants in 2012 on a record 170.3 million hectares worldwide (by more than 17 million farmers) caused not a single mishap – not an ecosystem disrupted or a person given a tummy ache. That might seem like an admirable accomplishment of regulation – except when one considers that virtually every one of the thousands of genetic “transformation events” submitted to regulators over two decades obviously posed negligible risk. As my old microbiology professor, Nobel Laureate Salvador Luria, used to say, something that isn’t worth doing at all isn’t worth doing well. And regulation that captures for case-by-case review only the most precisely crafted and most predictable organisms – virtually all of which are of negligible risk – isn’t worth doing at all.

Those facts notwithstanding, political reality intrudes: If Indian agricultural biotechnology is to survive – let alone thrive – in the short-term, the country needs a mechanism to satisfy the TEC and the Supreme Court. One has been proposed – in the form of draft legislation by the government that would establish a Biotechnology Regulatory Authority of India (BRAI) as an autonomous and statutory agency to regulate the research, transport, import, manufacture and use of organisms and products of “modern biotechnology.”

The current conception of the new BRAI regulator is far from ideal. As discussed above, the scope of what the new regulatory agency will review – only “new modern biotechnology” – makes no sense scientifically, and more logical and more risk-based approaches are available (see here for an for example), but the new regulator is necessary in the short term for the progress of agricultural biotechnology in India. For that reason alone, the legislation creating it should be passed without delay. There should, however, be a “sunset provision,” so that the BRAI will automatically terminate after a few years, necessitating reconsideration of its terms of reference.

 

Henry I. Miller, a physician, is the Robert Wesson Fellow in Scientific Philosophy & Public Policy at Stanford University’s Hoover Institution.  He was the founding director of the FDA’s Office of Biotechnology. Follow him on Twitter @henryimiller.

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