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Are U.S. growers losing their competitive edge because of regulatory hurdles?

By Sara Wyant

With the challenges of feeding a rapidly growing global population, farmers are looking for new seed traits that can improve yields, withstand extreme weather, and provide greater end-user value. Brazil, where regulators are steadily approving new biotech seed traits, has signaled that it is open for biotech business.

That's unlike the United States, where the regulatory approval process has slowed to a snail's pace. Brazilian regulators approved eight new genetically engineered traits for corn, soybeans and cotton in 2010 and two more this year, bringing their total to 30 since 2005. U.S. regulators deregulated a paltry three new traits last year and only two new traits in 2011. Twenty-four petitions are currently pending a determination by USDA's Animal and Plant Health Inspection Service, a process that often takes three to four years.

What's the holdup?

"The time frame for completion depends on the complexity of the genetically engineered traits and the type and number of public comments," explained a USDA spokesperson. Just last week, APHIS gave the public another month to comment on Monsanto's petition to deregulate corn that has been genetically engineered for drought tolerance. Most of the public docket is filled with comments from anti-GMO activists, who want all biotech traits banned, although a few farmers also weighed in to support biotech benefits.

Large biotechnology companies like Monsanto, Pioneer and Syngenta aren't ready to export their research and development to South America or other developing countries, but "it could become a real problem if we don't get things fixed here in the U.S.," says Val Giddings, a senior fellow with the Information Technology and Innovation Foundation.

Giddings worked for APHIS when biotech companies first started filing petitions for the non-regulated status of specific biotech traits in the early 1990s. He says that deadlines for decisions on regulatory status, which are required by statute to be made within 120 days, were "routinely met or beaten" at that time. "That is definitely not the case today. Lately, petitions have taken years, not months.

"The main effect has been to disadvantage academic researchers and drive them away from biotechnology because they believe they can't get stuff through the regulatory process," explained Giddings. "The big companies still have the boots on the ground to navigate through the regulatory process. It's the little guys, the academic researchers, who have really been disadvantaged so far."

Giddings said "minor" crops, like almonds, grapes, stone fruits and other crops important to California agriculture, have really great biotech solutions that could be employed, but they are not being pursued the way they were 15 years ago because researchers are discouraged and think the regulatory hurdles are insurmountable.

"The difference is not that the regulators have become incompetent," he said. "The real problem is that we have seen a multiplication of harassment lawsuits from career opponents of biotechnology." For example, Giddings pointed to the Center for Food Safety, which routinely files lawsuits in the Ninth Circuit Court in California to stop biotech approvals, even though most challenges are eventually overturned on appeal.

"You've had a series of highly dubious judicial decisions that have ignored the facts and put biotech sugar beets and alfalfa in a state of uncertainty, casting a pall over the entire regulatory process because now APHIS is worried about how this will play out when they are sued."

Giddings suggests APHIS has been poorly served by USDA's Office of General Counsel and the Justice Department, who opted to take a defensive posture, similar to physicians worried about malpractice lawsuits. "They order additional tests--even though they know they aren't necessary--just to document a paper trail for use in the courts when you have a lawsuit arising," he added.

"What we've got now is a situation where the degree of regulatory scrutiny applied to biotech products is grossly out of proportion to the potential hazards of those products," said Giddings.

Agricultural biotechnology is actually bringing to life the vision Rachel Carson articulated in the last chapter of her book "Silent Spring," where she sees agricultural research being poised to follow a new path, he said. Carson's vision "is one that relies not on conquering nature with synthetic chemistry, but by harnessing our increasing understanding of the principles of biology to make natural selection and biological phenomena, physiology and everything like that work for us in producing the food, feed and fiber that a growing population demands," said Giddings.

"But we won't continue on that path," he added, "unless regulatory decisions can be based on their merits and not on the basis of paranoid lawsuit management strategies."

Editor's Note: Sara Wyant publishes Agri-Pulse, a national electronic newsletter focused on farm and rural policy. For more four-week free trial, go to www.Agri-Pulse.com.

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