From Cotton Grower Magazine – June 2014
There’s no denying it. Technological advances in seed traits and chemistries have done wonders for production agriculture over the last two decades.
It was only 20 years ago, in 1994, that the first genetically modified crop was commercialized. Since that time the concept has been rapidly adopted, becoming the preferred method of production agriculture in the United States. The end result has been significantly improved yield across the board.
But that doesn’t mean the process of bringing forth a new piece of trait technology is any easier today than it was 20 years ago. In fact, if a new trait were conceived and invented today, representatives at leading trait development companies say it would be at least another decade before farmers could see the product sold commercially. Often, half of those years are spent testing genetic traits in-house, before they are ever submitted for review to agencies like USDA and EPA.
“Initial work is done in our Discovery Groups – phase one and phase two. That takes approximately five years,” says Marianne Malven, Monsanto’s molecular characterization team lead in the regulatory group. “And then regulatory analysis and submissions are averaging approximately six years. So yes, it takes quite a while. And I think 10 years is probably a conservative time frame.”
Through the years, Malven has been heavily involved in product testing and regulation management at Monsanto – most recently with XtendFlex technology. In cotton, the product will be featured in varieties which are tolerant to dicamba, glyphosate and glufosinate. She says her company leaves no stone unturned when testing trait products in-house.
“We’re looking at the gene and the protein,” Malven says. “We’re looking for efficacy, we’re looking for safety. We’re making sure that there is a history of being exposed to this gene or protein previously. It’s making sure that the event that goes on for further testing is going to be safe.”
As of press time, XtendFlex was under review of a USDA environmental impact statement, although company representatives say they expect to receive approval to commercialize the product in time for the 2015 production season.
USDA won’t be the only regulatory organization Monsanto must satisfy with the company’s new technology. Key U.S. trade partners are granted authority to regulate products that may ultimately be consumed within their own borders. This is how American consumers occasionally hear of agriculturally-specific products being held up by regulators in, for instance, Japan.
“For cotton, the critical import countries are Mexico, Canada, Japan and others,” Malven says. “We still make submissions to all countries that have functioning regulatory processes in place. It’s just that we must have approval from those critical import countries before we can launch.”
To ease the regulatory process, companies like Monsanto have on-site staff to handle regulatory requests within the borders of the critical import countries. Oftentimes, these foreign regulatory processes are going on simultaneously with USDA and EPA regulatory reviews.
Recently, researchers like Malven have begun advocating for a uniform set of regulatory requirements from each of the foreign agencies from which they seek approval. The process of satisfying multiple, differing sets of requirement regulations can take a significant toll on time and resources, they say. Genetic researchers know that standardizing international regulations could take some time, however.
“We are speaking with different country regulators to about standardization of regulations across countries,” Malven says. “I don’t know if it will happen, but it would benefit farmers.”