WASHINGTON, Feb. 20, 2013 - There’s no crystal ball for the agricultural biotechnology industry, a number of insiders divulged during a Resources for the Future panel on Tuesday in Washington, D.C. – but a lot of decisions are going to be made, and soon.

“We find ourselves at a precipice for FDA approval” for genetically engineered livestock, said William McConagha, longtime former counsel at the Food and Drug Administration and now a partner in Sidley Austin LLP’s food practice. Concurrently, issues of genetic engineering (GE) will rear their heads during upcoming hearings on the reauthorization of the Animal Drug User Fee Act (ADUFA). “What always happens in these authorizations that they’re a vehicle…for policy discussions,” he said.

Panelists were, however, divided on what sorts of decisions will take shape – and what the right ones will be.

“We have been carrying out research for now about 30 years now, (and) there is no evidence that genetic modifications that are in the food and feed supply have any effect on human health,” said Nina Federoff, distinguished visiting professor at King Abdullah University of Science and Technology (KAUST) and an Evan Pugh Professor at Pennsylvania State University. But Federoff warned that “urban myths” about GE technology “get to market faster than the crops do.” “They’re cheaper,” she joked.

Federoff argued that the “hypothetical risks” associated with genetic engineering – risks, she said, that have yet to be realized – were vastly outweighed by the benefits of the technology.

Those benefits could include the use of golden rice – a crop engineered to produce beta-carotene, a precursor to vitamin A – in malnourished populations. Legislative embrace of biotech could also hasten the development of the Enviropig, a genetically modified line of pigs that produce less phosphorus in their excrement than their non-engineered brothers and sisters – a change that could dramatically reduce phosphorus pollution in waterways.

But Doug Gurion-Sherman, the senior scientist in the food and environment program at the Union of Concerned Scientists, said GE products have been favored to the detriment of other, more beneficial technologies – and that the world will ultimately be harmed by unsustainable GE crops.

Gurion-Sherman said that farmers have been “going out of business” because of the resurgence of crop resistant weeds, sometimes produced when purposefully engineered crops are introduced into natural environments. And weed-resistant plants lead the increased use of herbicides, he said – exactly the opposite of what GE crops are intended to do.

“My contention is not that we get rid of genetic engineering,” Gurion-Sherman said. Instead, scientists should focus on the “huge, untapped genetic potential in conventional breeding,” techniques he says are often underfunded because money goes to GE work instead.

“We focus too much on GE at the expense of these other approaches,” he concluded.

James Murray, a professor in the Departments of Animal Science and Population and Reproduction at the University of California, Davis, cautioned against dismissing GE because of the efforts of a few wrong-headed demagogues. “To not use (GE) is throwing the baby out with the bathwater,” he said.

Murray slammed the current regulatory process, which has left a number of GE products – livestock included – in the pipe even though they have undergone rigorous testing. He quoted Stanford policy expert Henry Miller when he argued, “Current regulatory regimes are unscientific, process-based, and require case-by-case review for virtually all genetically engineered plants and microorganisms, no matter how obviously trivial the modification or benign the product might be.”

Though the world will need GE technology to feed the world, Murray said, the process of product approval is unnecessarily burdensome under the current regulatory regime. “If we decide we're going to use the technology in 10 to 15 years, we can't use it for another 10 to 15 years after that” because of regulatory processes, he said.

Today’s regulatory process, Federoff concluded, unfairly favors large companies over smaller start-ups and land grant universities. “It costs millions of dollars to bring an event (or GE product) to market, and that's not all that innovators have to pay,” she said. “The only crops that can bear that cost are crops that grown all over the world. Today, most GE crops are cotton or feed crops, just (so companies can) stay as far out of the controversy (surrounding GE products) as possible.”

So while GE has promise – especially for those developing countries that struggle to close the gap between what they can produce and what their people need to survive – Federoff contends that current system makes it difficult.

Even Gurion-Sherman, the most clearly pro-regulation of the bunch, acknowledged that the process needs work. “I think the key is how to regulate smartly,” he said.



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