CHAMPAIGN, Ill. — Global inconsistencies in the biotechnology regulatory approval process is costly and negatively impacts agricultural innovation.

Nicholas Kalaitzandonakes, director of the University of Missouri’s Economics and Management of Agrobiotechnology Center, said the current asynchronous approval system of inconsistencies results in, for example, a new biotech trait approved in Asia, but disappears in the European regulatory process.

Looking back at the history of agricultural production developments provides context of the importance of a consistent regulatory process and its benefits to global food security, Kalaitzandonakes said at the International Biotechnology Symposium, hosted by the Illinois Soybean Association.

He said from 1866 through the 1930s corn yields basically were the same, ranging from 20 to 30 bushels per acre, followed by sustained yield growth, “which we have come to anticipate over time.”

The upward yield trend for all crops was not only a result of hybridization, but also the emergence of synthetic fertilizers, herbicides and insecticides and mechanization.

“It is very clear when we started getting those innovations in place. But it’s also very clear what impact the agricultural innovations have had when looking at land use,” Kalaitzandonakes said.

From the 1880s until the 1930s, land use was increased threefold. All of the production growth during those years was from expanding land use.

“As innovation kicks in, we actually go from the highest point in cropland that we’ve used in the U.S. now to giving back almost 100 million acres of forests, wetlands and other recreational lands, despite the fact that we have four times more production from the 1930s on,” Kalaitzandonakes said.

“So, as a society, we are benefiting from the ecological uses of all of this land, we take the carbon sequestration benefits and all of the environmental benefits that came from putting all of this land back into environmental uses.”

Labor also has changed to the point where it once took 180 hours of labor to produce 100 bushels of corn and it now only takes a few.

“All of this labor was transferred into the industrialization of the U.S.,” Kalaitzandonakes said.

“All of these economic gains and all of these environmental gains have come from the emergence of sustained innovation, which for decades we have come to anticipate from every crop that we’ve had.

“In addition to that we’ve done all of this by not only putting more food on the plate for people, but making them more food secure by enjoying and eightfold decrease in prices over that same period and all of this has come because we have had innovation to outpace the demand increase.”

Public and private investments in research and development also are components of agricultural innovation, increasing from $220 million in 1985 to $3.5 billion in 2012.

Kalaitzandonakes said the development of traits is a driver in productivity, “but it isn’t the whole story because biotech traits have to be put into genetics.”

“We have seen an increase in the number of new hybrids brought into the market,” he said.

“The variety of genetics has increased, but at the same time the product life cycle has decreased. The number of years a new hybrid stays in the market has fallen from 4.5 to 3.5 years. What that tells use is the accelerated pace of innovation and new product introduction, not just biotech products, but genetics, as well.”

Producers not only gain from new technologies, but also consumers in the form of lower prices. For example, from 1996 through 2006 Roundup Ready soybeans have resulted in $14 billion in economic benefit for consumers and $26 billion for U.S. farmers.

There also have been environmental gains through expanded no-till practices enabled by biotechnology.

“This is an industry that is dynamic, that we have dynamic innovation with new products coming into the market at an accelerated rate, investments have increased and the hybrid life cycle is shrinking,” Kalaitzandonakes said.

“This describes an industry where innovation is speeding up. The question is for a technology like biotech, which is regulated, how do you pair a dynamic innovation system with a regulation system that actually can keep up?”

Regulatory systems should be in place that promote innovation and reduce uncertainty.

“A key component of this is how do I put together regulatory systems that are not particularly expensive in meeting the demands of safety assessment and so on and then at the same time reducing uncertainty to promote innovation. That’s not what we have in the case of biotech,” Kalaitzandonakes said.

He referred to a 2005 study that found the cost of getting a new corn product approved costs between $7 million and $15 million, therefore limiting the process to large companies that have the financial resources.

Beyond the costs, issues of timeliness and predictability in the biotech regulatory process are worse.

For example, in the European Union on the production side, there have been 22 applications and of those two have been approved in the last 20 years. For importing transgenic products to the EU, the average regulatory approval for a trait is 3.5 years.

However, of the 100 applications for regulatory approval, 54 have not received a response from the EU Food Safety Authority nor has there been a review.

“More than half languish somewhere in the process, but no one knows where it’s at,” Kalaitzandonakes said.

He said the asynchronization that results from the piecemeal network of global regulatory procedures create a tremendous amount of uncertainty.

“Asynchronization is about all of the economic impacts, all of the economic benefits that we don’t get. It’s about the innovation that doesn’t happen. It’s about the product that doesn’t show up in time,” he said.

“The most important thing is it is about a regulatory system that is not predictable and, therefore, does not reduce, but increase uncertainty. It does exactly the opposite of what a proper regulatory system is all about.

“In addition to that, it’s about trade. Trade is equally important to innovation in terms of economic growth and in terms of food security for many countries.

“Regulatory asynchronization is not as big of a problem that it can be, but if it is not addressed today, it will be a significant problem in trade for many years to come.

“Countries that have had sustained commitment for agricultural innovation have seen their agriculture and overall economies flourish because innovation matters.

“They’ve used resources effectively and have contributed to the well-being of their people both in terms of lowering their cost of food, making them more food secure, but also advancing industrialization.

“Sometimes when you do innovation, it’s like riding a tiger. Sometimes it’s not going to be very pleasant, but you can’t come on and off the tiger at your own pace. Sustained is the key word because it takes a long time to bring innovation in place to create an ecosystem that makes innovation flow.”

“We, obviously, want responsible use of the technology. We, obviously, want to manage any issues around safety, but the issue is that at the same time something has to come out of the pipe.”

The system will require all stakeholders to come develop practical solutions to move the process along at an even place.

“Practical solutions are important as anything else because at the end of the day, not all systems, not all laws, not all bio-safety committees are going to be structured the same way,” Kalaitzandonakes said.

“So understanding each other and knowing how to manage in practical ways the regulatory system that we have in place is really important. Why? Because this is the closest thing we have to a free lunch.”