one could agree if we could sell it to other countries or not. It was a public perception issue.”
In the past there have been rumblings that regulatory agencies are to blame for slowing down new trait commercialization. According to a team of agricultural economists and biotechnology experts, regulatory changes enacted a decade ago appear to be responsible for dramatically slowing the flow of biotech innovations to a mere trickle. Findings from the study were published in the August issue of the journal Nature Biotechnology.
“One of the great frustrations in the agricultural biotechnology community has been the failure of many new products with enhanced quality traits – such as nutritional content, ripening control and processing attributes – to reach consumers and processors,” said Gregory Graff, an Agricultural Economist at Colorado State University. Graff led the study as a postdoctoral researcher while at UC Davis, working with Alan Bennett, a UC Davis Plant Science Professor and Executive Director of the Public Intellectual Property Resource for Agriculture, and David Zilberman, a Professor of Agricultural and Resource Economics at UC Berkeley.
“While biotech innovations with on-farm production traits – such as insect resistance and herbicide tolerance – moved through the research and development pipeline relatively quickly, commercialization of product-quality innovations failed to materialize,” Bennett said. “It had been hoped that these products would directly benefit the general public and change public perception of agricultural biotechnology.”
To investigate the cause for the delay, the researchers conducted two surveys, one looking back on the history of 558 product-quality innovations and another looking forward at 49 quality-innovations expected to be developed by the year 2015. The retrospective study found that many research breakthroughs related to flower color and fruit ripening occurred in the 1980s, when agricultural biotechnology was in its infancy. It was expected that research and development in these areas would have grown during the 1990s as new products entered the market. Instead, innovation in product-quality innovation leveled off around 1998 and then declined.
“That drop-off seems to be most closely linked to the halting of regulatory approvals for ag biotech products in Europe in 1998 and the repercussions that had for regulators in other countries,” said Zilberman. “While those regulatory responses were largely directed at controlling the risks of early pest-control biotechnologies, it may have contributed to a slowdown in the commercialization of product-quality innovations.”
However, others in the industry argue that it’s not a regulatory issue at all, but a matter of lack of resources at regulatory agencies due to more submissions for increasingly complex products. “There is no regulatory agency better than the USDA; it is top-notch,” says Jerry Hjelle, Regulatory Lead for Monsanto. “However, there are more companies and submissions and the complexity of the products is greater than ever before.”
Jeff Rowe, Vice-President of Biotechnology Affairs at Pioneer, concurs. “Our position is that the current model is working, but approvals haven’t been as quick as we’d like to see,” he says. “We’re moving into the next generation of traits
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