There's more of them and nobody knows exactly where they are. Welcome to the regulation of potent pharmaceuticals in food crops, US-style.

EXCERPTS: The USDA has approved slightly more than 300 biopharming plantings throughout the country since 1995

The number of federal regulatory approvals and applications of these outdoor plantings -- often called "biopharming'' -- have nearly doubled in the last 12 months, compared to the previous year.

Most applications... don't specify how many acres are to be cultivated and exactly where the pharmaceutical crops are to be grown, making it impossible for nervous conventional farmers to know whether biotech varieties that could cross-pollinate with their harvest are growing nearby.
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'Pharming' experiments on rise a year after setback
Tue, Jun. 01, 2004
http://www.duluthsuperior.com/mld/duluthsuperior/business/technology/8811681.htm

SAN FRANCISCO(AP) - Biotechnology companies are quietly pushing to splice more human genes into growing numbers of food crops after the practice was nearly left for dead last year, a Washington-based advocacy group will report Wednesday.

The spike comes a little more than a year after a Texas company caused such uproar with its accidental mixing of its "pharma" crops with conventionally grown plants that giant food manufacturers called for tighter regulation of such experiments and biotech titan Monsanto Co. announced it was abandoning the field.

The number of federal regulatory approvals and applications of these outdoor plantings -- often called "biopharming'' -- have nearly doubled in the last 12 months, compared to the previous year, according to a study to be released by the Washington D.C.-based Center for Science in the Public Interest.

"The biopharming industry seems to be back in business,'' concluded the report, which is based on publicly available U.S. Department of Agriculture data.

The USDA has approved seven of the 16 applications it received between May 2003 and April. The nine applications pending were all submitted in the last four months, and the report's author Greg Jaffe expects those to be approved in the coming weeks. That's because the USDA has denied only two such applications since 2000, Jaffe said.

The USDA has approved slightly more than 300 biopharming plantings throughout the country since 1995. As late as June 2002, it approved about 25 annually before approvals fell to just four a year 12 months later.

No human drug made from genetically engineered crops has been approved for commercial use and most applications are for small outdoor plots of less than acre each, the USDA said.

Still, Jaffe and other critics complain that current USDA regulations are too lax and not open enough to the public.

Most applications, for instance, don't specify how many acres are to be cultivated and exactly where the pharmaceutical crops are to be grown, making it impossible for nervous conventional farmers to know whether biotech varieties that could cross-pollinated with their harvest are growing nearby.

Several small biotechnology companies and university researchers are attempting to make inexpensive human medicines such as insulin and vaccines by splicing protein-producing human genes into crops that include corn, rice and even tobacco.

The human genes coax the crops to produce proteins, which can be extracted from the plants and turned into medicines.

At Stanford University, 16 lymphoma patients last year were treated with an experimental cancer drug extracted from a genetically engineered tobacco created by Large Scale Biology Corp. -- the first human use of a pharmaceutical derived from a plant.

This biotechnology niche had been growing steadily for a decade despite continued attacks from genetic engineering foes who fear such work has not been studied enough to ensure the safety of the nation's food supply if accidental mixing occurs.

Pharming suffered a dramatic setback in late 2002 when the USDA fined College Station, Texas-based Prodigene Inc. $500,000 and ordered it to pay another $3 million to buy and destroy conventionally grown soy contaminated with its corn, which was genetically engineered to produce a pig vaccine.

Since then, Large Scale Biology has fallen on hard financial times and hasn't continued with expanded lymphoma experiments.

The Grocery Manufactures of America, which supports biotech crops approved for consumption and represents the Coca Cola Co., Nestle and dozens of others in the $500 billion food industry, has called on the USDA to tighten regulation of pharma crops and biotech companies to experiment exclusively with non-food crops.

Last year, Monsanto Co., the world's largest biotech farming company, announced it was abandoning the pharmaceutical field.

And in April, California regulators denied Sacramento-based Ventria BioScience's application to grow rice with human genes after California rice growers said they feared international customers would refuse to buy their conventionally grown crops out of contamination fears.

In response to the growing concern, the USDA plans to unveil a revised review process in the next three weeks that would make public more information on pharma applications and, for the first time since 1998, require detailed environmental assessments on large-scale projects near commercialization, said Cindy Smith, the deputy administrator of biotech regulation for the department.

Smith said Prodigene will be the first company to undergo the more stringent environmental review on the two applications it has pending to grow pharmaceutical corn in Texas this year.

A Prodigene spokeswoman didn't return a telephone call.

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