USDA Told To Disclose 'Biopharm' Locations

By Sean Hao, Advertiser Staff Writer
August 5, 2004

The federal government must reveal where companies grow genetically modified pharmaceutical crops in Hawai'i, a judge ruled yesterday.

Public interest groups are seeking the information to force the government to study the environmental impact of the crops they see as potentially dangerous. The government and industry contend public disclosure could lead to crop vandalism and corporate espionage of trade secrets.

After weighing the arguments, U.S. District Judge David Ezra ordered the U.S. Department of Agriculture to identify where four companies have received permits for open-field testing of pharmaceutical crops in Hawai'i and to reveal the locations to the environmental watchdog group Earthjustice and the Center for Food Safety, a nonprofit that challenges food production technologies.

"It's definitely a victory," said Isaac Moriwake, an attorney for Earthjustice. "It's basically an affirmation that the defendants haven't been able to show that this kind of information is confidential."

Ezra gave the USDA another 90 days to prove that releasing the locations to the public would cause irreparable damage to the biotech industry. That step could force biotech companies to look elsewhere to conduct their pharmaceutical crop tests, a biotech industry representative said yesterday.

"It's disappointing," said Lisa Dry, a spokeswoman for the Biotechnology Industry Organization. If crop locations were made public, it would be "a real detriment for continuing to do business in that area. Basically it would be viewed as an unfriendly business environment for technology of any sort."

Earthjustice sought the locations of so-called biopharms to force the USDA to conduct environmental impact statements before allowing open-field crop research. Biopharming is a relatively new area of research where plants are engineered to produce nonfood items, such as drugs or industrial chemicals. Without confirmation of the locations, Earthjustice would have difficulty making the case for an environmental impact statement.

Ezra said yesterday that the locations of such tests don't constitute confidential business information. He also said the government and the Biotechnology Industry Organization failed to provide sufficient evidence that such crops would be damaged if their locations were revealed.

Representatives for both sides of the issue said this would be the first time in the United States that locations of biopharm tests would be revealed to an outside party. That could set a precedent for similar disclosures in other states and could pave the way for disclosing the locations of all genetically modified crop research.

In Hawai'i, Monsanto Co., the Hawaii Agriculture Research Center, ProdiGene Inc. and Garst Seed Co. have been granted permits to test biopharm crops. Under Ezra's order, the locations of the testing will be disclosed to Earthjustice, but they must keep the information confidential for at least 90 days.

Environmental groups and food processors contend that open-field testing of biopharm crops is racing ahead of what is known about potential risks to the environment, people and the food supply. Industry officials contend that government regulations sufficiently minimize such risks.

Dry said research into using plants to produce drugs or industrial chemicals holds promise for producing compounds cheaper and faster than in factories. The seed-crop industry employs an estimated 1,190 people in Hawai'i in relatively high-wage jobs. In the past decade, the value of the state's seed-crop industry, 40 percent of which is estimated to involve genetically engineered crops, has grown fivefold, to a record $50.5 million. The amount spent on biopharm crop tests is unknown, but represents a small fraction of the industry in Hawai'i.

Hawai'i leads all states in open-air test sites of genetically engineered crops.

Michael Rodemeyer, executive director for the independent Pew Initiative on Food and Biotechnology, said there are strong arguments on both sides of the disclosure issue.

"Certainly there are ways to make more information available to consumers," he said. "It's not clear that crop location information is really going to help people understand more about what these safety issues are.

"It may give them a greater sense of confidence, but that has to in turn be weighed against the potential that these crops could end up being destroyed which may end up spreading some of these crops around."

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Review Of Tenure Refusal Uncovers Conflicts Of Interest

By Rex Dalton
Nature 430, 598
August 5, 2004

[SAN DIEGO] The academic rights of an ecologist at the University of California, Berkeley, may have been violated when he was denied tenure last year, according to a report from the academic senate.

Ignacio Chapela was an outspoken critic of Berkeley's controversial academic?industrial partnership with the Swiss agribiotech firm Syngenta, which ended last year (see right). He was also the lead author of a disputed paper in Nature in which he asserted that genes from genetically modified crops had flowed into Mexican maize, and had become scattered throughout the genome (D. Quist and I. H. Chapela Nature 414, 541?543; 2001). After a storm of criticism about the paper, Nature withdrew its support for the article, but the authors stand by their research.

Against this background, Chapela was denied tenure at Berkeley's College of Natural Resources in November 2003 (see Nature 426, 591; 2003). He appealed.

The resulting report, issued on 28 June, claims that Jasper Rine, a geneticist at the university who sat on a key committee reviewing Chapela's tenure, had conflicts of interest. It says that Rine had financial dealings with biotech firms, oversaw the Syngenta agreement and had cited Chapela's Nature paper as an example of poor science in one of his classes. Both the dean of Chapela's college and his department chair requested that Rine be taken from the committee four times; but Rine did not excuse himself nor did the committee chair ask him to leave. The report also says there was "unjustifiable" delay in the tenure-review process.

"I am glad the senate is able to rise to the occasion," says Chapela, whose contract has been extended while he appeals. Rine, Berkeley administrators and senate members would not comment on the report, citing its confidentiality. Such committee reports are rarely disclosed.

As the senate continues its inquiry, Chapela is hoping for a second tenure review. He has also filed two claims that may precede a lawsuit. In April, he accused the university of discrimination, saying that he was denied tenure because he is Hispanic. Early last month, he claimed he was victimized by the university for speaking out against the Syngenta deal.

Reflections On The Berkeley-Novartis Deal Review Report

By Andrew Paul Gutierrez, Professor
Miguel A. Altieri, Professor
UC Berkeley
August 6, 2004

We have read the report of the external review of the collaborative research agreement between Novartis Agricultural Discovery Institute, Inc. (NADI) and The Regents of the University of California. We were pleased to learn the history of the "bidding approach" suggested for selecting corporate partners for the University. We were also pleased to receive assurance from the reviewers that the UCB agreement (the UCB-N deal) had minimal direct impacts on the University, but not excluding the College of Natural Resources (CNR). This conclusion was reached without asking the question "what would have happen if the UBC-N deal had not been brought to light?" by a courageous CNR Executive Committee (EXCOM) ably chaired by a vulnerable untenured Assistant Professor Ignacio Chapela. EXCOM (one of us was a member, APG) who enabled a faculty review despite excessive pressure from the Dean's office to rapidly ratify the agreement. The report also assumes at Berkeley that the rise of biotechnology and the fall of applied agricultural fields such as biological control, plant pathology, soils and others is just part of the natural progress of science; a mere part of the process of modernization. In fact, according to the review, the "deal" appears consistent with the universities adjusting to the emerging norms of university-based economic development" and gives the impression that science at Berkeley is protected from the influence of politics and corporate power.

Although the reviewers identified the divide between faculty engaged in research in conventional agriculture and those who research alternative forms such as agroecology, sustainable agriculture and biological control, the report doesn't emphasize the clear fact that researchers working on alternative agriculture identify with goals congruent with the public mission of the University's Agricultural Experiment Station (AES) (e.g. protecting farmers, farm workers, the public and safeguarding the environment). This places them at odds with dominant forces in the University harnessed by the influences of big money. This is what happened to Professor Chapela whose findings on the genetic pollution of maize landraces threatened the biotechnology industry and we believe his tenure at the University.

The intrusion of private capital and its influence on shaping the research agenda and faculty composition is a major factor in the erosion of the public good mission of the AES from which CNR faculty receive most of their salary. The imposition of financial interests on the scientific process in CNR have begun to limit specific public good research (e.g. closing the Division of Biological Control and the use the FTE of retired faculty involved in applied agricultural research for biotechnology oriented positions), but also it changed the paths of inquiry in favor of private interests rather than in favor of the public. Just in California, we experience hundreds of millions in losses from invasive pest species, yet biocontrol and IPM positions in the agricultural experiment station are being closed down. Why is Berkeley so eager to develop the Gill Track in Albany into housing and commercial spaces - its only piece of land for agricultural research? Is it doing this without providing faculty; students and the general public involved in urban agriculture an alternative accessible site? Furthermore, not one cent of the $25 million from the UBC-N deal was spent on examining the ecological impacts of transgenic crops, this despite a growing number of scientists advocating the adoption of the precautionary principle on GMO adoption and despite the fact that the general public in California shows increasing mistrust of GMOs as indicated by the recent anti-GMO bills passed in Mendocino and Trinity counties. Similar anti-GMO bills are expected in at least 5 more counties by November of this year. Clearly, the public ("kept") University is so over-stretched by expanding into new research areas that corporate interests are willing to fund, that in the process it has forgotten it first mission is to serve the public good. So, when one looks deeply into the legacy of the UCB-N deal, some of the critic's worst fears did occur at Berkeley despite the reviewer's assertion to the contrary. Possibly such outcomes would have still occurred had the UBC-N deal never existed.

What is also interesting in the review is that the UCB-N deal did not produce any tangible benefit - overall nothing useful for California society at large came out. No options to negotiate an exclusive license that could have yielded patent rights or income to the Campus is active. So other than money for biotech researchers, post docs and graduate students, the returns on investment from Novartis were disastrous, but then $25 million is small compared to the public's investment in CNR infrastructure or the University and for NADI the money was likely pocket change. So what did Novartis really expect from such a deal, aside from obtaining an implied good house-keeping seal of approval by associating itself with UBC?

Although we welcome the recommendation from the review team that UBC should avoid entering into such agreements in the future, we suggest that there is much more at stake than simply revealing and monitoring corporate ties to science at Berkeley. The public mission of the agricultural experiment station at Berkeley needs to be protected, revived and supported on behalf of the public, irrespective of private sector pressures and calculations of value added to profitability made by administrators in times of budget cuts. This is the only way that the principles of creativity, autonomy and diversity that the reviewers perceive as central to the ethical framework of the University can be restored at Berkeley.

Biotech Request Alarms Food Industry

By Philip Brasher
Des Moines Register Washington Bureau
August 6, 2004

Washington, D.C. - A biotech company is seeking federal approval to begin regular production of pharmaceutical corn crops, a move that has alarmed the U.S. food industry.

The Texas-based company, ProdiGene Inc., gave the biotech industry a black mark two years ago when it was caught mismanaging field trials of genetically modified crops in Iowa and Nebraska.

ProdiGene, which is commercializing two medical products made from bioengineered corn, has asked the U.S. Agriculture Department to allow cultivation of the crops in Frio County, Texas, a thinly populated area southwest of San Antonio.

The Grocery Manufacturers of America, which represents such brands as Kellogg, General Mills, Kraft and Gerber, opposes the application. In a letter July 28 to the USDA, the trade group said the government provides inadequate oversight of crops engineered for pharmaceutical and industrial purposes.

"We have long memories of the potential impact this can have on our companies," said Stephanie Childs, a group spokeswoman.

Some food companies were required to do nationwide recalls three years ago, after a variety of biotech feed corn not approved for human consumption, StarLink, was found mixed with supplies of food-grade grain.

ProdiGene officials did not return calls seeking comment.

ProdiGene was forced to pay the government about $3 million in penalties and cleanup costs for failing to prevent its pharmaceutical corn plants from getting mixed with crops intended for food or animal feed.

ProdiGene's problems, coupled with tighter planting rules imposed by the USDA in 2003, dealt a sharp setback to Iowa's hopes of developing bio-farming.

A taxpayer-financed Iowa investment fund bought into ProdiGene in 2001. Last year, a subsidiary of Iowa-based Stine Seed Co. purchased a majority ownership in ProdiGene.

However, the food companies' opposition to ProdiGene's Texas plans highlights the industry's concern about biotech crops.

There were no field trials of pharmaceutical crops in the state last year, and this year there is just one, which involves barley, not corn.

The Grocery Manufacturers of America said the Food and Drug Administration should evaluate the safety of pharmaceutical or industrial crops before they are approved for cultivation.

"Right now, as it stands, federal regulations say that if any of these plant-made pharmaceuticals make it into the food supply, we have an adulterated product," Childs said. "It's our brands that get damaged. We're not ready to take that risk for a product that we're not developing."

The USDA took the unusual step of writing environmental assessments for the ProdiGene crops because the company plans repeated plantings during the next several years.

USDA analysts concluded there would be little health or environmental risk from the corn crops, in part because little other corn is grown in Frio County. Although the location was not disclosed, the ProdiGene crops will be at least a mile away from any other corn with which they could cross-pollinate, the studies said.

The corn would be used to manufacture trypsin, used for insulin, vaccines and other products, and aprotinin, which also has a number of medical applications. Both products are now derived from cattle tissue.

The company will inspect the crops weekly at first and then daily during pollination, the USDA said. Several vegetable crops that will grow nearby, including onions and cabbage, will be picked by hand to ensure that no corn seeds are mixed with them.

Two trade groups representing companies that process and ship grain - the National Grain and Feed Association and the North American Export Grain Association - told the USDA they were pleased the Texas farm is "far removed from major corn producing areas."

But Gregory Jaffe, who follows the biotech industry for the Center for Science in the Public Interest, a consumer advocacy group, said the USDA released insufficient information about the site to judge whether the crop was a threat.

He also shares the food industry's concern about ProdiGene's plans.

"We should not engineer any food crop and allow it to be grown on a commercial scale without FDA determining that that crop is safe if it gets into the food supply," he said.

The USDA is taking public comment on the environmental assessments through Tuesday.

In 2003, the USDA increased isolation and inspection requirements for pharmaceutical crops to avoid a repeat of the ProdiGene incidents.

"We expected it would mean less pharmaceutical corn is grown in the Corn Belt," said Cindy Smith, who oversees biotech regulation for the USDA. "We leave it up to researchers to decide where they are going to grow."

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