EXCERPT: Pharma crops are supposed to be rigorously regulated. But the Food and Drug Administration (FDA) does not review biopharmaceutical crops before planting, even though many of them have toxic or anti-nutritional effects on human health or the environment.

A recent audit by the U.S. Department of Agriculture's Inspector General found the USDA failed to inspect field trial sites as promised and didn't even know where some experiments were planted. The Inspector General also found that USDA didn't follow up to find out what happened to the biopharm harvests. Two tons of a drug-laden crop was stored for more than a year at two sites without USDA's knowledge or inspection.
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Are There Human Genes in Your Food?
by Trudy Bialic
The Seattle Post-Intelligencer, February 24, 2006 http://www.commondreams.org/views06/0224-28.htm

Ask the people around you if they want experimental drugs and industrial chemicals in their food or beer -- without their knowledge or consent. Chances are they'll say no. Then tell them experiments that could make that happen are occurring right here in Washington state.

As you read this, a professor at Washington State University and a private Canadian company, SemBioSys, have applied for permits to turn two common food crops -- barley and safflower -- into virtual factories for synthetic drugs or chemicals.

On its Web site, SemBioSys declares its plan to inject safflower with human genes to produce experimental insulin and a drug for heart attacks and strokes. WSU confirms that it plans to grow barley, injected with human genes, to produce artificial proteins with pharmaceutical properties. Where these fields will be is secret; nearby farmers and residents won't be notified.

Proponents say that injecting human genes into plants (or animals) will provide cheaper drugs -- someday. But this so-called "biopharming" has met with considerable opposition.

In California and Missouri, farmers protested and effectively stopped outdoor cultivation of "pharma rice," concerned that the drug-plants would contaminate their food-grade crops and make them unmarketable. Food companies such as Anheuser-Busch and Kraft Foods, as well as the Grocery Manufacturers of America and the Food Products Association, concur. The risks are more than hypothetical. Several cases of cross-contamination from GE crops have cost farmers and the food industry more than a billion dollars in recalls and lost export markets.

The National Academy of Sciences, a nongovernmental body of scientists and professionals, has warned in two reports that it's virtually impossible to keep biopharms out of the food supply if food crops are used to grow them. Insects, birds, animals, wind, storms, trucks, trains and human error see to that.

Pharma crops are supposed to be rigorously regulated. But the Food and Drug Administration (FDA) does not review biopharmaceutical crops before planting, even though many of them have toxic or anti-nutritional effects on human health or the environment.

A recent audit by the U.S. Department of Agriculture's Inspector General found the USDA failed to inspect field trial sites as promised and didn't even know where some experiments were planted. The Inspector General also found that USDA didn't follow up to find out what happened to the biopharm harvests. Two tons of a drug-laden crop was stored for more than a year at two sites without USDA's knowledge or inspection.

What's the risk of cross-contamination from these experiments? State legislators at least should order a thorough risk assessment and allow public comment.

Washington's Barley Commission is aware that WSU is biopharming barley and is strongly opposed. Administrator Mary Sullivan says, "Once those genetically altered genes are out there, there'll be GMOs in the beer."

No one's opposed to less expensive and effective drugs, but biopharming in food crops in open fields is a bad financial risk. Several leading biopharm companies have gone bankrupt. When Large Scale Biology went bankrupt -- it was the first to conduct a field trial in 1991 -- even biotech movers and shakers contemplated the demise of the biopharming concept.

Agriculture and the food industry are the largest employers and the greatest source of revenue in Washington state -- more than Microsoft and Boeing combined. WSU and SemBioSys should not be mixing drugs and food. They should cancel these risky experiments immediately.

If they want to produce plant-based drugs, they should follow the lead of Dow AgroScience, which just announced approval of a vaccine for chickens produced by tobacco cell cultures in a contained steel tank. Cell cultures are a proven way to generate pharmaceuticals under controlled laboratory conditions -- without the risk of untested drugs in our food.