U.S. biotech trait approval lags in world market

By Sara Wyant

© Copyright Agri-Pulse Communications, Inc.

WASHINGTON, April 11, 2012 -The rate at which Brazil approves genetically engineered plant traits for deregulated status is increasing due to its recent government commitment, while approval rates in the United States are lagging due to legal concerns and public awareness. Brazil identified biotechnology as an economic opportunity for its farmers and since then, the government's process for trait approval increased exponentially and is a competitive concern for U.S. companies, said Biotechnology Industry Organization (BIO) Food and Agriculture Executive Vice President, Cathy Enright.

Brazil added 19% to its biotech crop area last year to reach 30.3 million hectares, outpacing every other country for the third straight year, noted Clive James, author of the annual biotech crop report from the International Society for the Advancement of Agri-Biotech Applications (ISAAA). James wrote that the Brazil's government approved eight products in 2010 and six more last year. He noted this rate contrasts to other parts of the world, such as the European Union, which approved only two biotech crops in the last 15 years.

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According to sources with Dow AgroSciences, Brazil approved thirty new biotechnology traits since 2005, keeping on track with its commitment to the industry. The approval process conducted through Brazil's government is “more streamlined, more predictable, obviously cheaper and less risky,” than before its commitment, said University of Missouri MSMC Endowed Professor of Agribusiness, Nicholas Kalaitzandonakes.

While the ISAAA report noted the U.S. still leads the world in biotechnology adoption, the pace of approval has decreased significantly since the 1990s. Of the 50 deregulations granted from 1992 to 1999, only five took longer than eight months, explained Competitive Enterprise Institute Senior Fellow, Gregory Conko. The average time for USDA's Animal and Plant Health Inspection Service (APHIS) to approve the seven deregulations granted from 2008 to 2010 was more than 30 months, he said. APHIS granted 30 deregulations from 2000 to 2010, most of which took more than one year.

The U.S. government approved three traits in 2010, but boosted approvals last year with ten new deregulated traits. APHIS data shows twenty GE traits currently pending.

USDA recently responded to concerns about the length of their approval process with a commitment to be more efficient. Once the agency implements the changes, APHIS anticipates cutting the length of the petition process by more than half. According to APHIS, the agency “believes it can deliver to its customers and the public a more predictable process for considering and acting on product deregulations.”

APHIS published a notice in the March 6 Federal Register that it is implementing changes to the way it solicits public comment when considering nonregulated status for genetically engineered crops. APHIS will publish two separate notices in the register for each petition, with one announcing the availability of the petition, and the second detailing the availability of APHIS' decision making documents.

“Clearly, getting the average approval time down from over two years to just 18 months would be laudable,” said Conko. “Still, even if APHIS could do that, it'd have a long way to go before it got back to the pace it was on in the first decade of approvals. They're currently holding these products at a higher standard than is scientifically necessary.”

Sarah Gallo, director of public policy for the National Corn Growers Association (NCGA), said the deregulation process in South America is something her growers pay attention to. Typically, the less time it takes to approve a technology trait, the less expensive it is for the seed company. While compliance costs significantly vary according to crop, location and several other mitigating factors, a University of Missouri study indicated compliance costs to approve insect resistant maize range anywhere from $7 million to more than $15 million.

“The fact that farmers in Brazil would have access to technology before U.S. growers would put us at a competitive disadvantage,” said Gallo. “In countries like Brazil and Argentina, their approval time is decreasing as ours is increasing.” However, she added that USDA's plan to accelerate trait registration in the United States “shows the department has heard the concerns of growers and technology companies.”

Critics of a faster approval system include the Center for Food Safety (CFS). The group, which challenged approvals of Monsanto's Roundup Ready sugar-beet and alfalfa crops, believes the APHIS rule change employs a “rubber stamp” process.

Along with 19 other pending applications, USDA is currently considering an application by Dow Chemical for its genetically engineered corn crop that is resistant to the 2,4-D herbicide. CFS vowed to challenge USDA's decision in court if the crop is approved and requested that the comment period be extended. USDA granted the extension until the end of April.



Original story printed in April 11th, 2012 Agri-Pulse Newsletter.

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