Deregulation of LL601 was aboveboard, says USDA

The undersecretary of marketing and regulatory programs for USDA/APHIS says the agency did nothing out of the ordinary when it pushed through an approval for the genetically engineered rice line LL601.

In August 2006, trace amounts of LL601 were found in commercial rice supplies. Subsequently, Bayer CropScience, which developed the variety, filed a petition to deregulate it. Prior to that, Bayer CropScience had not sought deregulation of the genetically-engineered strain because the company did not intend to market it.

USDA requested public comment of the process and received nearly 16,000 comments, most of which were form letters from individuals or groups who were largely opposed to biotechnology products, according to Bruce Knight, speaking at the USA Rice Outlook Conference in Las Vegas.

On Dec. 1, 2006, APHIS announced the deregulation of LL601 “because a review of the scientific evidence showed that this variety is as safe as its traditionally-bred counterparts.”

There were subsequent reports in national and international media that the agency took shortcuts in pushing through the approval. Not so, says Knight.

“When a crop strain is very similar to other strains that have already been deregulated, APHIS procedures permit a company to seek an extension of deregulation. This means we consider the scientific evidence that has already been submitted as sufficient to support the earlier deregulation as right for the newest consideration.

“That’s what we did for LL601. We did not create a special shortcut for LL601, nor was there a compromise in the terms of the safety evaluation. Rather, the extension option enables companies requesting deregulation to build upon the scientific base that’s already been established and add it to the information that the APHIS staff had already analyzed and evaluated.

“This same process has been used at least a dozen times in the last 20 years. In this specific case, APHIS deregulated two similar Bayer rice lines in 1999. These contained the same proteins designed to make them resistant to Liberty.

“This protein has been approved for use in many of the foods we already eat. Bayer has commercialized those strains in corn, cotton and canola. This protein has been thoroughly and scientifically approved and the foods including it have been approved for use in the United States and a dozen other countries around the world. Our recent actions in extending non-regulated status to LL601 was thorough and rigorous and based on earlier scientific evaluation.”

Knight also brought U.S. rice producers up to date on an ongoing investigation to determine how grains of LL601 ended up in commercial rice supplies, “despite our best efforts not to do so.”

“Normally, we don’t release results at this stage, but growers need to be making key decisions for the 2007 year. Furthermore, our trading partners deserve full transparency. So we chose to release a limited amount of information that may be helpful.

“The good news is that the only foundation seed that tested positive for LL601 was contained in one rice line, Cheniere. Trace amounts of LL62, one of the strains previously deregulated in 1999, were also found in 2003 Cheniere foundation seed. Since LL62 was already deregulated and had undergone a full safety evaluation by USDA, this rice line was not the focus of the USDA investigation.

“All other tests of foundation seed have been negative for LL601. So the scope of this unintended release is limited to the foundation seed of one variety of long grain rice. Medium and short grain rice are not affected.

“At this point, I can’t say any more about the investigation or how much longer it will take. But as soon as it is complete we will share the outcome of that investigation with the public.”

Knight also emphasized the importance of getting U.S. rice trade back up to speed. “U.S. growers supply about 13 percent of the world rice trade and 80 percent of those exports are long grain. In a world where two-thirds of the people depend in some part on rice for their daily food, that is an incredible contribution. Toward that end, USDA and other agencies have been involved in a broad-based effort to address the international concerns raised about LL601.

“We are working hard to reopen markets affected by the finding of LL601. We’ve hosted delegations from other countries and traveled abroad to assure your customers that U.S. rice is safe and healthful.

“Unfortunately, the market in the EU remains problematic to this day. But there is some good news. Mexico and Canada are continuing to purchase U.S. rice. More Latin American countries are moving forward with U.S. rice imports, including Honduras, Nicaragua, Costa Rica and Panama.”

At the time of the meeting in early December, the rice industry knew of the rejection of at least 30 LASH barges of U.S. long-grain rice due to the presence of trace amounts of LL601. Each LASH barge has a cargo capacity of 385 tons.

Bob Cummings, USA Rice Federation’s vice president for international trade policy, said rice trade is continuing as usual for 59 percent of the $1.3 billion U.S. rice export market. The biggest of those importing countries are Mexico with $165 million in export value, followed by Haiti, $102 million, Ghana, $49 million, Saudi Arabia, $41 million and Nicaragua, $40 million.

Trade has been disrupted to some extent for the remaining 41 percent of the U.S. export market, including Japan’s $160 million market, where testing of rice will be required. Testing will also be required in Iraq, a $102 million market, Canada, a $95 million market, and Korea, a $7 million market.

Trade in long grain rice has stopped in the European Union, $87 million, and Taiwan, $17 million, and the Philippines, $18 million.

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