VANCOUVER – North America’s approval system for GM crops has become so cumbersome, overtaxed and subject to litigation that it is leading to long delays in getting new products to market, said Monsanto.
Approval systems are even worse elsewhere in the world, leading to the asynchronous approvals that are at the heart of the low level presence issue disrupting global trade of agricultural commodities.
“We need a course correction to deliver the promise of GM crops,” said Eric Sachs, Monsanto’s science and policy lead for regulatory issues.
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“There is an awful lot of opportunity in the technology coming and we have to do something to address these constraints.”
Regulatory approval has become longer because the traits being reviewed are becoming more complicated.
Some of the new traits, such as yield and stress tolerance, are unfamiliar to regulators, and the genetic manipulations are more complex. There are genes that regulate dozens of other genes and stacked traits to consider.
There are also more products to review, putting increased pressure on budget-constrained regulatory agencies. For instance, 24 traits are under review in the U.S. regulatory pipeline.
“That’s double the number of products that have been deregulated in the last five years, so there is clearly a constraint there,” said Sachs.
Cindy Smith, chief adviser for government, academia and industry partnership with the U.S. Department of Agriculture, said there were eight GM trial permits and notifications in 1987 compared to 700 in each of the last three years.
“The pace of our petition work has picked up considerably,” she said.
Meanwhile, the review and approval process has become less efficient in recent years.
“When we invite public comment on these petitions, they prompt many more comments than they used to,” she said.
Sachs said the public comment portion of the process has become a nightmare.
“One of the biggest problems we have through the regulatory process are questions that come that have absolutely nothing to do with the potential risks of these products.”
And then there are the lawsuits. The approval of Monsanto’s Roundup Ready alfalfa has been tied up in litigation since 2006.
The upshot is that the average time to achieve regulatory approval in the United States has grown to more than two years from six months in the early days of agricultural biotechnology.
There have been 11 deregulations in the U.S. during the last five years compared to 51 the previous five years.
“As the rate of deregulation slows, the backlog of products that is waiting to get into the market is growing,” said Sachs. “This bottleneck is only going to get worse.”
The U.S. system is streamlined compared to other regions.
The World Trade Organization slapped the European Union’s wrists in 2006 for its painfully slow approval process. Little has changed since then, although the EU said it is about to introduce new legislation that will streamline the process.
China’s approval process takes two to three years, but it can commence only once submitters have already received full regulatory approval in their home countries. As a result, China has approved only 11 of the 29 GM corn traits authorized in the U.S.
The difference in average approval times for a new trait is massive. It takes an average of 27 months from submission to approval in the U.S., but 45 months in the EU and 54 months in China.
Seed technology companies investing hundreds of millions of dollars developing a new trait don’t have the patience to wait for all the approvals to happen.
As a result, asynchronous approvals can lead to low level presence problems, where trace amounts of a GM crop approved in an exporting country but not approved in the importing country can cause a shipment to be rejected because of strict zero tolerance policies for unapproved GM traits that are common around the world.
Sachs said importers need to develop low level presence policies to keep trade flowing because the costs of not doing so can be substantial.
Charlotte Hebebrand, chief executive officer of the International Food and Agricultural Trade Policy Council, said tariffs and subsidies are decreasing in importance in terms of barriers to trade.
Tariffs have been lowered through multilateral trade deals and subsidies aren’t as big a deal as they once were because of high prices for agricultural commodities.
“When we look ahead and think about what are the key issues impacting international global food trade, it is this issue of so-called non-tariff measures,” she said.
And low level presence has become one of the biggest and costliest of those non-tariff impediments.
An American study estimated that the discovery of StarLink, a GM corn crop approved only for feed, in the food supply decreased U.S. corn prices by 6.8 percent for at least one year.
European studies estimate that a ban on soybean imports from the U.S., Argentina and Brazil because of low level GM presence would drive up feed costs by as much as 500 to 600 percent in the EU market.
And a study by the International Food and Agricultural Trade Policy Council estimates it would cost China $191 million a year by 2015 if 10 percent of its GM soybean imports were rejected because of low level presence issues.
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commercial
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in 2008
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commercial
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pipeline
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regulatory
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pipeline
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advanced
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devel.
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total by
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2015
