Gaping holes in US regulation - Seeds of Doubt part 4 (9/6/2004)

California capital's daily paper has published part four of its excellent series on GM: SEEDS OF DOUBT.

Part four looks at regulation US-style in a Californian context:


Confidential business information - CBI - is a common refrain in the biotech industry...

Barbara Hass, now retired, recalls her days as California's only biotech plant regulator. By 1990, the applications had become cryptic because of trade secrets.

Her opponent was formidable: CBI, short for "confidential business information," a federal protection for trade secrets that allows private companies to withhold information from the public.

Hass remembers thinking, "How would a sensible applicant think that it was possible for a government scientist to review their proposal?"

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.

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.

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.

LOOK OUT ALSO FOR THE SECTION: 'Congress sees biotech largesse'

Scattered efforts

California plays little part in the patchwork that oversees biotech crops http://www.sacbee.com/static/live/news/projects/biotech/c4_1.html

Bryce Lundberg and his dog, Chief, get pelted with rice and barley sown by a plane on his organic rice farm in Butte County. Lundberg has asked neighboring farmers not to plant genetically modified crops next to his fields. "If that was GMO rice," he said, "you could see how they could miss exact targets."

By Mike Lee and Edie Lau -- Bee Staff Writers
Published Wednesday, June 9, 2004 --
Fourth of five parts

Dig deep into state files to see just how closely genetically modified agriculture is regulated in California and you'll find an unsettling memo, part of a federal sign-off that is supposed to occur a week before some experimental crops are planted.

The memo is dated April 24, 2001 - five days after insect-resistant corn was planted on about 8 acres near Woodland.

"The weather was right, so we put it in the ground," seed giant Pioneer Hi-Bred informed government regulators.

No federal fine followed. No state alarm sounded.

California is home to the nation's most diverse and valuable agricultural industry and a center of organic farming. Its cornucopia of crops can be bound for biotech-wary markets in Japan or Europe. The smallest genetic mistake could send customers fleeing.

Yet California takes almost no role in regulating genetically engineered crops or food. It does little to manage the economic, environmental or trade implications of biotech farming on the state's $28 billion agricultural industry, despite several calls for action during the past five years.

None of the 1,791 employees at the California Department of Food and Agriculture is dedicated full time to crop biotechnology, one of history's largest agricultural revolutions, and one now budding in California.

Instead,  like every other state, California relies almost entirely on a decision made nearly a decade before the first genetically engineered foods arrived in supermarkets - that such products need no special state attention.

California defers to a three-agency system of federal oversight that has been widely criticized for failing in many of the areas that matter most to this state: contamination of other crops, foreign trade barriers to biotech products and the long-term environmental and health implications of genetic engineering.

The U.S. Department of Agriculture oversees crops being tested in fields, the Environmental Protection Agency regulates plants engineered to contain pesticides, and the Food and Drug Administration monitors food safety. But there are overlaps and yawning gaps.

Without the state filling in, farmers like Bryce Lundberg of Butte County are left to come up with their own system of self-protection, which for Lundberg includes writing letters to neighbors asking them not to plant genetically engineered crops next to his fields.

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Organic farmer Juli Brussell waits at 5 a.m. for a train in Casey, Ill., to take her to a meeting in Chicago. She spends much of her time as an activist on biotech issues.

Organic ideal becomes her mission

Just about every week, Juli Brussell charges from her lush organic farm in the gentle hills of southern Illinois to distant meetings in Wisconsin, Texas and California.

er mission: to preserve the organic ideal in a world overrun by genetically engineered crops.

She's passionate, articulate and linked to like-minded groups nationwide, including the Organic Farming Research Foundation in Santa Cruz.

 Her concerns - shared by a small minority in the Corn Belt - are that biotechnology mostly benefits big companies and that their products are spreading quickly into places where they aren't welcome, such as conventional seed.

"We can't measure the impact, we can't control the technology in the field and we have no way to know there is a problem until we have a train wreck. Then it will be too late, because the stuff will be pervasive in the environment," she said.

Brussell has made it her mission to force such issues into the public debate, and she's got a federal grant to create something she calls the Illinois Sustainable Food Policy Council. Its job is to lobby for legislation that supports healthy farms and healthy food from the perspective of small farmers and others who typically don't get asked about farm policy.

Like Brussell, the group will raise questions about the economic, social and health impacts of biotech foods, questions that Brussell fears often are ignored because of the biotech industry's influence.

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Lundberg hopes for something better someday soon - perhaps a tracking program for genetically modified crops, like the one that allows him to get information about farm chemical use across the state.

"That system is already in place," said Lundberg, who exports rice to notoriously picky buyers in Japan. "Why not put GM (genetically modified crops) in there so we are not letting this stuff just go all over the place and potentially impact ... customers and companies that haven't accepted biotech?"

More than 110 biotech field tests    were slated for California this spring alone - experiments in growing everything from rice to peas - and the volume of commercial plantings of biotech corn and cotton continues to grow.

Yet state oversight does not grow with them. Former state Sen. Tom Hayden, who in 2000 tried - and failed - to get California to require labeling of genetically modified food, finds that surprising for a state that generally takes pride in setting stricter environmental standards than the federal government.

"We have the lead in anti-smoking legislation, we take the lead in trying to protect the coast against offshore drilling, we take the lead in trying to establish standards higher than the norm for pesticides," said Hayden, who now teaches at Occidental College. "With respect to biotech, (the state) took the complete reverse position. ... We are just going to pass on it. I found that really astounding."

With a flood of ever more novel genetically engineered plants on company drawing boards, but only a few in commercial fields, Hayden and others say there's still time for California to protect itself from the unintended consequences of biotechnology.

Missing pieces

Barbara Hass became California's first line of defense against biotech mistakes in 1986, when she started part time as its sole biotech plant regulator.

Hass, a biologist, was charged by CDFA with preventing the experimental plots from introducing diseases or insect infestations into the state's farms.

Glossy FedEx packets of proposed experiments for California fields landed almost daily in Hass' third-floor office downtown, competing with her raft of nonbiotech duties.

First, she'd look to see what type of plant was being engineered, then what novel trait had been created. In the early days, she remembers, that initial review went relatively smoothly.

But by 1990, Hass hit a bump. Nitty-gritty scientific descriptions were missing from many pages; others lacked information as basic as the variety of plants.

Hass puzzled over the increasingly blank documents. "What is going on?" she asked herself.

"You look at application after application with skimpy data and manage to figure it out," Hass said. "Then you would finally come to one that was basically an application form with 'CBI' deleted on just about everything."

Barbara Hass, now retired, recalls her days as California's only biotech plant regulator. By 1990, the applications had become cryptic because of trade secrets.

Her opponent was formidable: CBI, short for "confidential business information," a federal protection for trade secrets that allows private companies to withhold information from the public. Biotechnology companies, increasingly aware of how accessible state files were to the public and competitors alike, had begun removing as much information as they legally could.

Hass remembers thinking, "How would a sensible applicant think that it was possible for a government scientist to review their proposal?"

She questioned the U.S. Department of Agriculture about the deleted data, only to be told that the state couldn't have the missing information unless she promised to keep it from public view.

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.

[Related Document

Click [] to see more about the Dow Chemical Co. application to plant biotech corn in California. http://www.sacbee.com/static/live/news/projects/biotech/imgs/grfx_c4_2.pdf - 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.

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."

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.

States' concern grows

As biotechnology spreads farther into California, Richvale rice farmer Bryce Lundberg wants to make sure things are done better.

He peeled away from his job as organic certification director at Lundberg Family Farms during the heat of the summer growing season last year to urge a state Senate committee to protect farmers from the unintentional spread of genetically engineered crops.

"I don't want them on our farm and ... right now there's nothing that says it's wrong for those genes to be moving across farm borders," Lundberg told Sen. Nell Soto, D-Ontario.

"I'll be glad to introduce that legislation," Soto replied.

"I think that would be fantastic," Lundberg said.

Though Soto has yet to follow through, her interest may be part of a small, but growing, awareness in Sacramento. Similar concerns are being voiced in statehouses and county offices from Vermont to Hawaii.

Michael Rodemeyer, executive director of the Pew Initiative on Food and Biotechnology, said the federal policy vacuum leaves states with the rubber-meets-the-road issues that accompany the expansion of any new technology.

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Congress sees biotech largesse

As the biotech industry matures, it's spreading more cash around Washington, D.C., and getting more favors in return.

Campaign contributions from biotech companies topped $7.7 million in the 2002 election cycle, up more than sixfold from $1.2 million in 1990, according to the Center for Responsive Politics, a nonpartisan campaign finance watchdog group. Its report includes biotech companies in agriculture and medicine.

The top donors are Dow Chemical Co., Aventis and Monsanto Co. - all of which have been big players in the agricultural biotech world - which gave nearly $13 million combined to congressional campaigns between 1990 and 2003. Not far behind are Bayer, DuPont and Syngenta, the other major players in biotech seeds, according to an analysis conducted by the center for The Bee.

One leading recipient of biotech largesse, Missouri Republican Sen. Christopher "Kit" Bond, boasts that he's been able to secure more than $40 million of federal money for biotech research in his home state, the corporate home for Monsanto. Since 1990, the biotech industry has given Bond more than $177,000, according to the center's analysis.

Sen. Chuck Grassley, an Iowa Republican and strong supporter of allowing drug compounds to be grown in corn, is among the heavyweights on the Senate Agriculture, Nutrition and Forestry Committee backed by biotech company dollars. He's gotten $123,000 since 1990. Other top recipients on the panel include Tom Harkin, D-Iowa, Richard Lugar, R-Ind., and Pat Roberts, R-Kan.

Few bills in Congress mention any risks associated with biotechnology. More typical is a June 2003 bill that would create a federal task force to promote the "benefits, safety and potential uses" of biotechnology around the world.

Mike Lee

Activists and legislators in dozens of states are trying to address problems such as what responsibility companies should have for preventing and cleaning up genetic contamination.

In 2003, legislators in 32 states introduced 130 biotech bills and resolutions, according to Pew research. Only 27 pieces of legislation passed and, of those, about 70 percent sided with industry - many of them aimed at boosting biotech businesses with research initiatives and tax breaks.

Virtually all attempts to restrict the industry have failed in recent years, including efforts to shift liability for environmental damage to biotech companies, give farmers the right to save genetically engineered seeds from year to year and allow states to ban the planting of biotech crops during a study period.

The biotechnology industry works hard to defeat such measures, saying state and county regulation is inappropriate because the federal government is in charge. Patchwork state-by-state legislation also would increase their cost of doing business.

"Consistent rules to the game would be good," said Doyle Karr, a spokesman for Pioneer.

Typically, gene giants don't invest much money directly in state candidates. Instead, they hire lobbyists in the major agricultural states. They also contribute to industry organizations, such as the Western Plant Health Association, which in turn support industry-friendly political candidates and oppose legislation that could undermine the industry.

Mendocino money

This spring, biotech interests turned their attention toward Mendocino County, where organic activists aimed to make their county the nation's first to swear off genetically modified plants. Under the banner of the industry organization CropLife America, biotechnology companies spent more than $600,000 to convince residents that the county had no business regulating biotechnology.

It bought them a blizzard of radio ads and countywide mailers, but not what they really wanted: a decisive defeat of the proposed ban. Measure H was approved, 56 percent to 44 percent, and already has spurred copycat measures in Humboldt and Sonoma counties.

The industry was more successful in North Dakota, where a bipartisan group of legislators in 2001 proposed a ban on growing biotech wheat, which farmers feared would scare away major export buyers.

The bill sailed through the state House but met stiff resistance in the Senate after CropLife and Monsanto lobbyists showed up.

At the time, Monsanto and the chairman of the state Senate Agriculture Committee said the bill sent a negative message about the acceptance of innovation in North Dakota. In May, the company succumbed to grower concerns about exports and said it would wait at least four years before putting its Roundup Ready wheat on the market.

Over the summer, though, North Dakotans still plan to gather signatures for a ballot initiative that would give the state's agriculture commissioner some authority over the growing of biotech wheat.

If North Dakota adopts the initiative, it would follow in the steps of California's rice industry, which four years ago sponsored legislation to protect itself from the economic hazards of biotech rice.

Rice law unique

The California Rice Commission's president, Tim Johnson, worked out the legislative language as he and his wife flew to Kauai for their 10th anniversary in January 1999.

Biotechnology companies were creating a biotech rice for California, and the state's growers were agitated about how foreign buyers would react.

Concerned that companies were moving faster than public acceptance, Johnson spent his vacation in paradise on the phone with Rice Commission lawyers, hammering out what would eventually become the Rice Certification Act of 2000.

The legislation remains the only law of its kind in the nation. Although it never mentions biotechnology, it gives a 12-member committee of the Rice Commission an opportunity to set protocols for any new rice varieties that need to be kept separate from the main crop.

The Legislature approved it, biotech companies cringed - but they didn't mount a concerted campaign against the bill - and rice growers waited.

Four years later, a small Sacramento biotech company called Ventria Bioscience caught almost everyone off-guard with a proposal that gave Johnson's legislation its first big test.

Ventria asked to expand its test plots of rice engineered to inexpensively produce common human proteins for use in an anti-diarrhea medication - the first attempt in the nation to grow commercial-scale food crops as drug factories.

The rice industry collectively gasped, then debated for months about what conditions to set.

The main issue: how to assure that not a single biotech grain escaped from Ven.tria's transport trucks, farming machines or planted fields.

In early March, Maxwell rice farmer Joe Carrancho told the rice panel that he wouldn't hesitate to eat Ventria's rice. But he's so uncertain about how the rest of the world might react to the new product that he begged the panel not to allow it in California.

"If there is one kernel that gets out here somehow, it could ruin our entire industry," Carrancho said.

 Although Ventria worked toward compromise, privately the company bristled at the public scrutiny.

"We are less than happy with a completely open process," company official Stacey Roberts complained in a January e-mail to the California Rice Commission that was obtained by The Bee. In another, she wrote: "Under no circumstances is the location of our crop, its yield nor the amount processed 'public information.'"

Agreement stalled

At the end of March, the rice panel gave the go-ahead for a new era in California agriculture, but only after Ventria agreed to dozens of conditions on its crop - including to not plant it in the state's rice-growing region, the Sacramento Valley. Then, the California Department of Food and Agriculture rejected the Rice Commission's emergency agreement, saying the public needed time to comment. The issue is expected to come back to the state later this year.

The process illustrated the potential value of state review, which allowed Ventria and the rice industry to alleviate some major concerns.

Yet, besides the rice bill, California has done little else to put bounds on biotechnology. Instead, like other states, it's focused on promoting biotech business and its high-paying jobs.

"I do believe its success is going to drive our economy and hopefully push us out of the economic downturn we are in," said Assemblywoman Ellen Corbett, D-San Leandro, who recently introduced bills for biotech tax breaks and biotech job training.

When faced with the 2000 proposal from former Sen. Hayden to label genetically engineered foods, the Legislature instead created a task force to assess advantages and risks of biotech crops.

The task force's findings, issued three years later, proposed no new rules for genetically engineered agriculture, nor did the panel address whether the state's role was adequate.

An accompanying letter from the state Department of Food and Agriculture highlighted some weighty public-policy considerations for California: federal and state oversight, impacts to organic farming, implications for international marketing and issues that might arise if biotech traits were introduced into one of many crops that California grows almost exclusively.

It also expressed the need for long-term studies about the environmental and health effects of biotechnology.

The Legislature never responded, said Lourminia Sen, who was tracking biotechnology for the CDFA when she wrote the letter.

Since then, Sen's position has been eliminated. She does analytical chemistry for the agency instead. But the issues raised in her letter, she said, still merit state attention.

"It's huge - it's right here on our doorstep," Sen said. Referring to biotech mistakes such as StarLink corn that have rocked Midwest grain markets in recent years, she added, "To me, it's a wake-up call for California."

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