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US plan to tolerate unapproved GMOs in crops draws concern
February 5 2009 
By Bill Tomson
The U.S. Department of Agriculture wants to cement into law its authority to do nothing when unapproved biotech material is discovered in crops, and that has raised concerns by groups worried about the purity of food, U.S. exporters and foreign importers.

New authorities are needed to deal with the rapidly advancing field experiments of genetically modified crops, according the USDA's Animal and Plant Health Inspection Service's plan to control the industry. But the agency also made it clear there are plenty of conditions under which it will do nothing if those experiments end up in the food supply.

Biotech seed developers comply with "stringent regulations" to keep experiments from ending up in commercial grain supplies, according to a letter to USDA's Aphis from Penny Hunst, biotech regulatory leader for Dow AgroSciences, a wholly owned subsidiary of The Dow Chemical Company (DOW). But sometimes unapproved biotech material ends up as a "low-level presence" in public feed and grain.

How Low Is A "Low-Level Presence?"

When a "low level presence" of unapproved biotech material is discovered, it's likely not a problem, according to the Aphis plan, if there is no threat that it will lead to the creation of a widespread "plant pest" or "noxious weed."

Nowhere in the plan does the agency define what a "low level presence" is, and that has concerned people like Bill Freese, a senior policy analyst at the non-profit group Center for Food Safety.

"What might the actual level of unapproved [genetically engineered] crop contaminating commercial supplies be? Does 'low-level' mean 0.01% presence of the contaminant, 0.1%, 1% or 10%?" Freese said in a letter to USDA's Aphis. "The failure to provide any information whatsoever on quantity, measurement or procedures to determine quantity with respect to 'low level presence' undermines the legitimacy of this policy from the start."

But Aphis, in explaining why it needs to establish the authority to decide that "a low level presence of [genetically engineered] plant materials in seeds or grain may not be cause for agency remedial action," said it will "not predetermine a specific level that is considered non-actionable because this determination should always be made case-by-case."

No reason was given why it must be "case-by-case" and Aphis would not make available experts to discuss the logic.

Exporting Contaminated Grain

Japan, one of the largest importing markets for U.S. corn, told the USDA directly that the plan "may have a significant impact on international trade." In particular, Japan said it wanted to know if USDA's Aphis would take action if it found a "low level" of unapproved biotech traits in grains or oilseeds being exported.

Aphis has not yet answered Japan, one of the largest buyers of U.S. grains and oilseeds, said Aphis spokeswoman Rachel Iadicicco. But a Japanese government official, who asked not to be named in this story, said both governments continue to negotiate how to handle trade when unapproved biotech enters feed and food supplies. Japanese consumers, the official said, are extremely "sensitive" to the issue.

Concerns that unapproved biotech traits may be hidden among the millions of tons of corn, soybeans, wheat and rice imported from the U.S have been stoked in recent years by several occurrences where commercial seed and grain supplies here have been contaminated and some of that contamination has made it overseas.

Dow AgroSciences in February 2008 reported discovering traces of an unapproved biotech material in three lines of corn seeds. The USDA said the unapproved biotech seed was planted on about 53,000 acres of U.S. farm land in 2007.

In August 2006, an experimental rice developed by Bayer CropScience, a division of Bayer AG (BAYRY), somehow made it into supplies of non-biotech rice. Exports to Europe dried up immediately after traces of the unapproved rice were found in Germany, Italy and other countries.

In March 2007, another of Bayer's unapproved rice was found in BASF AG's (BASFY) non-biotech rice. Almost immediately, Mexico began detaining shipments of U.S. rice at its border.

Switzerland's Syngenta AG (SYT) revealed in March 2005 that it inadvertently sold unapproved Bt10 corn seed instead of the approved Bt11 to U.S. farmers who planted it on 37,000 acres from 2001 through 2004. In June 2005, Japan discovered corn it had bought from the U.S. was contaminated with the unapproved Bt10 trait.

Steve Hensley, regulatory affairs director for the USA Rice Federation, told the USDA in a letter that there should be stricter confinement rules for experimental biotech crop field trials. He also noted that foreign countries are far quicker to shut down imports because of a contamination than the U.S. is on imports.

USA Rice, Hensley said, "cannot fathom, under the restrictions imposed upon U.S. rice for the low-level presence of a GE event in our export supply, why the agency would suggest that we unilaterally allow those same countries to ship to the United States low-level amounts of traits that have not been rigorously tested and approved in the U.S."

Reason Not To Act

Often in recent years the USDA has sought to calm consumer and importer fears by insisting that the experimental biotech crops released into commerce were perfectly safe because they were very similar to GMOs that were already approved.

The USDA's Aphis, in its proposed rule, listed several "factors" that would allow it do nothing, but the first states that "a decision not to order ... remedial action" would be if a genetically engineered "plant of the same species expressing nearly identical proteins or substances has already been approved."

Biotech seed companies like Monsanto Co. (MON), Syngenta, and Dow AgroSciences lauded the Aphis plan. Monsanto pledged "strong support" in a letter to the agency and the company pledged "to continue to implement stewardship and quality management systems to avoid, to the extent possible, the presence of regulated material in commercial seed or grain."

The government considers unapproved biotech seed to be "regulated," whereas once they have been approved they become "unregulated."

Syngenta, in a separate letter from Nafta Regulatory Affairs Head Lawrence Zeph, said the company also supports the Aphis plan because it recognizes "that large-scale field testing of [genetically engineered] organisms" could cause unapproved material to end up "at low levels in the food supply." It's appropriate, Zeph said, "to establish science-based criteria by which regulated material would be considered 'not-actionable' by the agency."