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