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Scattered efforts

California plays little part in the patchwork that oversees biotech crops

Cloak of secrecy

Confidential business information - CBI - is a common refrain in the biotech industry, used, it says, not just to keep competitors in the dark, but also to prevent destruction of controversial crops by environmental activists.

When Dow Chemical Co. wanted to plant up to 200 acres of corn engineered with “synthetic genes sourced from mammalian species” in Corcoran two years ago, the details of its experiment in state files included six mostly blank pages.

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Click image to see more about the Dow Chemical Co. application to plant biotech corn in California.

Click here to read a complete copy of this redacted report

Want to know what mammal the genes came from? CBI.

Want to know what drug components the company hoped to grow in corn plants? CBI.

Wonder whether the fields might be next to your family's corn farm? CBI.

The public might want to know that information. Just a few months before Dow's application to the federal government arrived in California, federal agents in Hawaii discovered the company had failed to plant the right trees to create a buffer zone to prevent genes from an experimental biotech corn plot from spreading to other corn on the island of Molokai.

Despite that lapse, in the end the EPA did not find evidence that genes had escaped. But concern increased when a second company, Pioneer Hi-Bred, had a similar problem on the island of Kauai.

The cloak of secrecy is reinforced by federal law, which can mete out harsher penalties for an employee who discloses trade secrets than for a company that breaks the rules for experimental plantings. Secrecy is closely protected by federal officials, who delayed The Bee's requests for information while they consulted with the companies involved - and then denied large chunks of information on the basis of confidential business information - CBI.

Such secrecy is not just a problem for reporters, either. Months after the Hawaii incidents, Sen. Daniel Inouye, D-Hawaii, wrote to then-EPA Administrator Christie Whitman, asking her to clear up widespread public confusion about what had happened.

Whitman wrote back that the ongoing investigation made it impossible for her to answer his questions.

The lack of transparency about biotechnology is so pervasive that the august National Academy of Sciences - commissioned by the USDA to critique biotech regulations - warned in 2002 that public confidence in federal oversight could be undermined by the companies' ability to withhold vast amounts of information.

Who's in charge

“Indeed, the committee often found it difficult to gather the information needed to write this report due to inaccessible CBI,” the scientists wrote.

Verbal compromise

Those difficulties are compounded when public-interest groups or government watchdogs want to investigate. They don't even know where to look for trouble, because locations of experimental fields are secret.

“It makes it virtually impossible for concerned citizens to know if regulations are being followed,” said Noli Hoye at GMO Free Kauai, a consumer group formed to oppose the expansion of biotech field experiments in Hawaii.

Such public concern increases the pressure on government agents to cobble together ways to do their jobs with limited authority and sometimes-skimpy data.

Hass, for instance, didn't want to bar the public from the state's files, nor did she want to reject company applications that posed no risk. So, she called companies and asked for deleted information over the phone, assuring them that nothing they told her would end up in the public files.

“We worked on a verbal basis,” Hass said. “It was sort of a compromise position. It was one of those things that I worked out to conduct business, to meet our responsibilities and keep the applications moving.”

Hass retired two years ago, and it's not clear whether her makeshift system remains in place today. The state Department of Food and Agriculture's written responses to questions from The Bee failed to address how the agency handles trade secrets.

Instead, state officials said simply that it's not their job.

“There really isn't much to discuss,” said agency spokesman Steve Lyle. “The regulatory authority rests with the federal government.”

Inspections rare

On the windblown west side of Kauai, federal inspectors showed up in March 2002 to look at land where farmers once turned swamps into sugar cane plantations. Now, it's used by one of the world's largest seed companies to test genetically engineered crops.

During that rare field visit by the Environmental Protection Agency, regulators realized that Pioneer Hi-Bred had planted experimental corn engineered to kill bugs in an unapproved location, too close to other corn. To make matters worse, the company had indications that genes were indeed migrating, but had failed to immediately tell the EPA.

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EPA soon may have eye in the sky

A biotech spy plane will swoop over a few Midwest fields this summer as the federal government tries to get an unusual pilot program off the ground.

Eventually, the Environmental Protection Agency hopes to be able to monitor millions of acres for the presence of insects that survived after eating plants that produce their own pesticides. The goal is to issue an early warning about the biotech plants before farmers face large populations of beefed-up bugs.

The EPA loves the idea of insect-resistant plants because they can reduce the use of chemical sprays. So, with the help of NASA, it's sending up an airplane equipped with a special computer-linked camera that can detect subtle differences between biotech crops and their conventional counterparts.

To most observers, the two types of crops look exactly the same on the ground - let alone from 10,000 feet - but agency tests in 2003 showed that a highly precise photography called “hyperspectral imaging” can discern differences between them.

By first locating biotech fields, analysts will be able to take the next step, zeroing in on insect “hot spots” based on relative crop health as observed from the air.

Don't understand how it all works? Neither does John Glaser, leader of this year's $800,000 experiment for the EPA in Cincinnati, Ohio.

“The cause-and-effect relationship is not completely there,” he said. “We are still in the learning mode ... but our plans are going in the right direction, and we can see what we are looking for.”

- Mike Lee

 


The discovery and delay led to more than $80,000 in fines for Pioneer - among the highest ever in the world of agricultural biotechnology.

The problems that led to the penalties might have served as a warning to the EPA about the potential for problems elsewhere.

Yet California - the nation's fourth-most-popular testing ground for biotechnology, with more than 1,100 tests since 1987 - has never had an EPA field inspection, not even of the 169 of those experiments that involved bug-killing plants like those in Hawaii.

The EPA suggests states should take the lead on inspections. California's EPA counterpart - the Department of Pesticide Regulation - flatly denies responsibility and accuses the federal EPA of routinely issuing field-test permits without a follow-up plan.

One of those permits in 2004 was for insect-resistant tomatoes on nearly 200 acres in the Central Valley. In that instance, the EPA did approve a plan to prevent biotech tomato genes from spreading, but a critical section of the permit is vague. Biotech tomatoes were to be separated from conventional tomatoes by “alleys.” The plan gives no intended size or other description of those alleys.

Such murkiness stems from regulation of biotech being squeezed into rules developed before the technology was invented - before anyone ever considered the complexity of regulating a plant that produces its own pesticide.

“The federal regulatory system is a weak one,” said Margaret Mellon, director of the food and environment program at the Union of Concerned Scientists. “It should not be relied on as one that is doing all that needs to be done to make sure we are not taking unacceptable risks.”

Policing themselves

Big food companies recognize the shortcomings of the federal tag-team effort. “It's difficult to explain to people and it's difficult to look at it as a ... robust reassurance to consumers in the face of controversy about the safety of human use,” Keith Triebwasser, a top regulatory official at Procter & Gamble, told a federal committee on agriculture last fall.

Companies have a lot riding on public acceptance, however, and some spend time and money policing themselves.

Judging from the experience of Monsanto Co., the nation's biggest seed biotech company, most mistakes are caught by the companies. Last fall, Monsanto said it had found, and reported, three-fourths of its 44 infractions.

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Biotech terms

The USDA maintains that less than 2 percent of biotech test plots violate federal rules, based on agency inspections and company-reported problems. Yet even after a special enforcement unit was created last fall, the agency inspects only about 10 percent of test plots.

Sometimes biotech food trouble is discovered at the last minute by advocacy groups such as Friends of the Earth, which in 2000 found taco shells laced with the biotech corn StarLink, which had not been approved for humans.

Consumers may assume the FDA has a rigorous program to assess biotech foods. But it actually defers to companies to determine whether their products should be regulated. When a company wants to market a biotech product as food, the FDA sign-off is optional.

The FDA does review companies' summaries of human safety data, but such documents vary widely in detail and scope, ranging from a few dozen pages to a few hundred, according to a 2003 report for the Center for Science in the Public Interest in Washington, D.C., written by a former EPA biotech plant specialist.

At times, the center found, companies didn't provide regulators with enough statistical analysis for adequate safety evaluations and, in three of the six cases reviewed by the center, when the FDA asked for more information, companies ignored the request.

Filling the gaps

Lanky Illinois farmer Leon Corzine loves his biotech soybeans as much as the next guy, but he's sympathetic to calls for mandatory FDA review of biotech foods.

“If it helps the comfort level of the consumer,” he said as beans clattered into his combine last fall, “that is probably something we should do.”

A combine kicks up dust in a field A combine kicks up dust in a field of conventional soybeans in Assumption, Ill. Sacramento Bee/Renée C. Byer

From the seats of their giant machines, however, it's unlikely that farmers such as Corzine ever will see a federal agent checking out their biotech crops.

Once biotech seeds and plants are approved by the government, usually on the basis of a small-scale field test, it's almost like they never existed.

When the USDA allows a biotech crop to be put on the market, the agency usually gives up its authority to require companies to monitor the crop, and the manufacturer may not have a legal obligation to report problems, according to an analysis by the Pew Initiative on Food and Biotechnology. From then on, there's no coordinated national attempt to track questions about long-term environmental complications.

In 2002, the National Academy of Sciences told the USDA that there are “several compelling arguments for ... ecological monitoring” of commercial biotech crops, including the fact that approvals often are based on tests of just a few acres.

Two years later, the USDA has improved an array of in-house biotech risk and mitigation research projects, and the White House has ordered related federal work to be reviewed for research shortcomings. USDA officials say that is part of an effort to answer public questions about the technology. But they acknowledge it is not comprehensive.

“There is certainly some monitoring and research out there, but it is not coordinated through us in some sort of central ecological (review),” said John Turner, who heads a policy branch of USDA's Biotechnology Regulatory Services division.


 

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