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Got hormones?; Ag Canada to withdraw from plant breeding; other stories

(Friday, Dec. 3, 2004 -- CropChoice news) -- Below are 6 information pieces dealing with agricultural biotechnology

1. Got hormones? The controversial milk drug that refuses to die
2. UCD cleared in seed mix-up: Researchers unknowingly sent out altered tomato seeds for seven years.
3. Agriculture Canada to Withdraw From Plant Breeding
4. Warning exports could be hit
5. German researchers and industry decry a new crop law as being detrimental to innovation
6. Europe votes to keep GM crop bans

1. Got Hormones? The Controversial Milk Drug that Refuses to Die

By Jeffrey M. Smith, author of Seeds of Deception
Institute for Responsible Technology, Spilling the Beans, Dec. 1, 2004

"Effective December 1, 2004, as a current customer, you will have access to an increased supply of POSILAC."1 This news from Monsanto to its customers was disappointing for those around the world who understood its consequences. Back in January, the company announced that they would reduce their supply of the drug by 50%, after FDA inspectors discovered unacceptable levels of contamination. Many people hoped that Posilac would quietly disappear altogether. "If Monsanto gives this stuff up, it would be a godsend to both cows and people,"2 said Rick North who heads up the campaign by Oregon Physicians for Social Responsibility to fight the drug. But on October 8, 2004, Monsanto announced it would be increasing its supply back up to "at least 70%."

Posilac is a genetically engineered drug that increases milk production in cows by 10-15%. It is also known as recombinant bovine growth hormone, rbGH, Bovine Somatotropin, BST, and "Crack for Cows." Its controversial history has left fifteen years of frustrated whistleblowers strewn in its wake.

Early casualties were scientists at the Food and Drug Administration (FDA) during the drug's evaluation. Chemist Joseph Settepani, in charge of quality control for the approval process of veterinary drugs at the Center for Veterinary Medicine (CVM), testified at a public hearing about threats to human safety. Soon after, he was reprimanded, threatened, stripped of responsibilities, and relocated a trailer at an experimental farm. In later testimony before a congressional subcommittee, Settepani said, "Dissent [atCVM] is not tolerated if it could seriously threaten industry profits."3

Division director Alexander Apostolou wrote in an affidavit, "Sound scientific procedures for evaluating human food safety of veterinary drugs have been disregarded. I have faced continuous pressure from my CVM superiors to reach scientific conclusions favorable to the drug industry. . . . In my time at CVM I have witnessed drug manufacturer sponsors improperly influence the agency's scientific analysis, decision-making, and fundamental mission."4 Apostolou was forced out after he began to express his concerns.

FDA Veterinarian Richard Burroughs said that agency officials "suppressed and manipulated data to cover up their own ignorance and incompetence."5 He also described how industry researchers would often drop sick cows from studies, to make the drug appear safer. Burroughs had ordered more tests than the industry wanted and was told by superiors he was slowing down the approval. He was fired and his tests canceled.

The remaining whistle-blowers in the FDA had to write an anonymous letter to Congress, complaining of fraud and conflict of interest in the agency. They described one FDA scientist who arbitrarily increased the allowable levels of antibiotics in milk 100-fold. This was necessary before approving rbGH. Since the drug increases the chance of udder infections, farmers inject cows with more antibiotics. This leads to a higher risk of antibiotic resistant diseases in cows and humans. According to the letter, Margaret Miller authorized the increased levels. She had formerly conducted research on rbGH while with Monsanto and then moved into the FDA department that evaluated her own research.

Dr. Samuel Epstein, Professor at the University Of Illinois School Of Public Health, cited numerous potential or theoretical health dangers from rbGH, including "hormonal and allergic effects . . . premature growth and breast stimulation in infants," and possibly cancer in adults.6 Epstein also received an anonymous box of stolen files from the FDA. Documents revealed that in order to show that rbGH injections did not interfere with fertility, industry researchers allegedly added cows to the study that were pregnant prior to injection. Also, blood hormone levels skyrocketed by as much as a thousand-fold after injections.7

Monsanto tried to silence Epstein. Their public relations firm created a group called the Dairy Coalition, which included university researchers whose work was funded by Monsanto, and selected "third party" experts and organizations. Representatives of the Dairy Coalition pressured editors of the USA Today, Boston Globe, New York Times and others, to limit coverage of Epstein.

Hormones in Your Milk

Several claims made by FDA scientists in defense of rbGH have not held up under scrutiny. For example, they said that bovine growth hormone does not increase substantially in milk from treated cows. The study they cited, however, shows a 26% increase in the hormone. Furthermore, researchers injected cows with only a 10.6 mg daily dose of rbGH compared to the normal 500 mg bi-weekly dose used by farmers. In fact, they didn't even use Monsanto's rbGH, but rather another version that was never approved. They then pasteurized the milk 120 times longer than normal in an apparent attempt to show that the hormone was destroyed during the process. They only destroyed 19% of the hormone.8 They then spiked the milk with powdered hormone-146 times the naturally occurring levels-heated that 120 times longer than normal, and were then able to destroy 90% of the hormone. FDA scientists reported that 90% of the hormone was destroyed during pasteurization.9

The hormone most critics are concerned about, however, is insulin-like growth factor 1 (IGF-1). Natural milk contains IGF-1. Milk drinkers increase their levels of IGF-1.10 Studies suggest that pre-menopausal women below 50 year old with high levels of IGF-1 are seven times more likely to develop breast cancer.11 Men are four times more likely to develop prostate cancer.12 IGF-1 is also implicated in lung and colon cancer. Milk from cows treated with rbGH has significantly higher levels of IGF-1.13 (No comprehensive study has evaluated a direct link between rbGH and human cancer.)

This potential link between rbGH and cancer was one of the many controversial topics to be covered in a four-part investigative news series at a Tampa-based Fox TV station. But four days before the series was to air, Fox received a threatening letter from Monsanto's attorney. They pulled the show. The station manager reviewed it, approved the content, and scheduled it for the following week. A second letter arrived from Monsanto's attorney, this time threatening "dire consequences for Fox News."14 The show was postponed indefinitely. Jane Akre and Steve Wilson, the award winning investigative reporters who had created the report for Fox, say that they were offered hush money to leave the station and never speak about the story again. They declined. So Fox's corporate attorney led them in a series of rewrites, attempting to soften the language and apparently appease Monsanto. Six months and 83 rewrites later, the reporters were ultimately fired for refusing to write in the script that the milk from treated cows was the same as normal milk. The reporters argued that that Monsanto's own research showed a difference, such as the increased IGF-1 levels, and even the FDA scientists had acknowledged this.

The reporters sued. Akre was awarded $425,000 by a jury that agreed that Fox "acted intentionally and deliberately to falsify or distort the plaintiffs' news reporting on BGH,"15 and that Akre's threat to blow the whistle was the reason she was fired. But an appeals court overturned the verdict on the grounds that the whistle-blower's statute only protects people who threaten to report a violation of a law, rule, or regulation. Distorting TV news, evidently, is not technically illegal. Akre and Wilson now have to pay a combined $196,500 to cover some of Fox's legal costs. This is on top of the $200,000 - $300,000 they already spent on their case.

Attacks on rbGH whistleblowers are not limited to the US. In 1998, six Canadian government scientists testified before the Senate that they were being pressured by superiors to approve rbGH, even though they believed it was unsafe for the public. Their detailed critique of the FDA's evaluation of the drug showed how the US approval process was flawed and superficial. They also testified that documents were stolen from a locked file cabinet in a government office, and that Monsanto offered them a bribe of $1-2 million to approve the drug without further tests. (A Monsanto representative went on national Canadian television claiming that the scientists had obviously misunderstood an offer for research money.) The Canadian scientists later described how their superiors retaliated against them for testifying. They were passed over for promotions, given impossible tasks or no assignments at all, one was suspended without pay. Three of the whistleblowers, who also spoke out on such controversial topics as mad cow disease, were ultimately fired on July 14, 2004.

Most industrialized nations have banned rbGH. Within the US, many school systems have also banned it and several dairies refuse to use it. Oakhurst Dairy of Portland, Maine, for example, requires its suppliers to sign a notarized affidavit every six months. The Oakhurst label stated, "Our Farmers' Pledge: No Artificial Growth Hormones." But on July 3, 2003, Monsanto sued the dairy over their labels. Oakhurst eventually settled with Monsanto, agreeing to include a sentence on their cartons saying that according to the FDA no significant difference has been shown between milk derived from rbGH-treated and non-rbGH-treated cows. The statement is not true. FDA scientists had acknowledged the increase of IGF-1 in milk from treated cows. Nonetheless, the misleading sentence had been written years earlier by the FDA's deputy commissioner of policy, Michael Taylor. Prior to becoming an FDA official, Taylor was Monsanto's outside attorney. He later worked at the USDA on biotech issues, and later became vice president of Monsanto.

Visit www.seedsofdeception.com for a list of non-rbGH dairies, article references, and a free newsletter.

2. UCD cleared in seed mix-up: Researchers unknowingly sent out altered tomato seeds for seven years. By Mike Lee -- Bee Staff Writer Sac Bee, Wednesday, December 1, 2004 http://www.sacbee.com/content/business/story/11624353p12513897c.html

Two West Coast mix-ups involving genetically engineered seeds ended with modest fines for two companies and no fault for the University of California, Davis, according to federal records made public Tuesday.

Oxnard-based Seminis Inc., the world's largest fruit and vegetable seed company, and The Scotts Co. of Marysville, Ohio, a grass seed giant, are on the hook for penalties totaling $5,625 for violations of rules set to contain biotech genes.

The fines are toward the low end of the scale for the U.S. Department of Agriculture, which oversees biotech crop field tests and movement of plants between states. In 2002, for instance, the USDA fined Texas-based ProdiGene Inc. $250,000 after federal inspectors found biotech corn that had been engineered to produce a pharmaceutical compound growing among Nebraska soybeans.

The USDA's most recent penalties indicate a much lower level of agency concern, although the incidents do illustrate the difficulty of containing genetically engineered plants.

Joseph Mendelson, legal director of the consumer watchdog group Center for Food Safety in Washington, D.C., had mixed opinions about the USDA's actions.

"It's good that (USDA is) actually doing some investigations," he said. "But is it window dressing when a company like Scotts gets ... slapped on the wrist and essentially rewarded for their bad actions?"

Seminis was fined $2,500 for shipping biotech tomato seeds to UC Davis, which runs one of the world's top tomato seed banks, without properly identifying the seeds.

Davis researchers, unaware that the seeds were genetically engineered, shipped them to scientists around the world who had requested conventional seeds.

Last December, embarrassed university officials said the mistake had been going on for seven years.

On Tuesday, they said that new protocols have been put in place to assure research samples are properly tagged. For instance, the university checked its other tomato seed varieties obtained from seed companies and found them negative for biotech genes. It now requires documentation on how donated seeds were developed.

"We are satisfied that the protocols that are now in place for labeling, storing and shipping of seeds will serve to prevent future errors when seeds are distributed to researchers around the world," Agriculture Dean Neal Van Alfen said in an e-mail.

USDA spokesman Jim Rogers said agency files indicate Davis was cleared of wrongdoing. "It doesn't look like anything was pursued there," he said.

Instead, USDA focused on a 1996 mix-up by Petoseed Co., one of the predecessors of Seminis.

A statement by Seminis called the penalty "fair and proportional to the nature of the incident." It said the problem appears to have been an administrative error that confused a conventional tomato with a similar biotech variety.

The biotech tomatoes, which had been cleared for human consumption by the FDA, were engineered to alter the thickness of tomato paste.

"While our handling procedures are more strict today ... we have used this case to review our current quality controls," the company said.

In the other case, USDA levied a $6,250 fine against Scotts for failing to notify federal officials immediately after an accidental release of biotech grass seed in Oregon in 2003. USDA said half of that penalty was suspended.

The investigation centered on creeping bentgrass, popular on golf courses, developed by Scotts and St. Louis-based biotech giant Monsanto Co. Their product is engineered to withstand sprays of Monsanto's signature herbicide Roundup.

That genetic trick, also common in soybeans, allows for easier weed control because the weedkiller doesn't damage the biotech plants.

Monsanto, which commonly licenses its technology to other companies, was not penalized.

Scotts spokesman Jim King said the penalty was related to a wind storm that swept across Scotts' fields and scattered grass seeds outside the test plot.

King said Scotts properly alerted neighbors and the state, but that it took nearly a month to tell USDA about the wind-blown seeds. "We had a communication shortfall on our side," he said. "We should have notified (USDA) within a few days."

King said the penalty was not related to a report by U.S. Environmental Protection Agency scientists in September that documented genes from Scotts' Oregon bentgrass plots in related grasses 13 miles away.

The USDA said Scotts faces an ongoing investigation. Industry watchers speculate the investigation is related to EPA's findings.

Norm Ellstrand, a genetics professor at the University of California, Riverside, said EPA's report raises questions about whether Scotts followed rules to contain grass pollen. "It seems to me that there is a serious compliance violation," he said.

Biotech fines

$2,500 Company: Seminis Inc. of Oxnard

Why: Shipped biotech tomato seeds to the University of California, Davis, without properly identifying the seeds.

$3,125 Company: The Scotts Co. of Marysville, Ohio Why: Failed to notify officials immediately after the accidental release of biotech grass seed in Oregon in 2003.

The Bee's Mike Lee can be reached at (916) 321-1102 or mailto:mflee@sacbee.com

3. Agriculture Canada to Withdraw From Plant Breeding

by Paul Beingessner
Canadian farmer, writer

As farmers in western Canada recover from a very difficult year, they will begin to think about the crops that must be planted next spring. For some, it may be a struggle just to find seed that will grow.

While farmers are contemplating this, they will also find themselves confronted with much larger questions concerning seeds. One of these revolves around suggested changes to the regime governing Plant Breeders Rights and the patenting of plants. The Canadian Food Inspection Agency is currently asking for comments on suggested changes to the legislation governing the seeds farmers plant each spring.

It is worth remembering that the notion plant breeding should be done for profit by private companies is a relatively recent one. A mere 30 years ago, almost all plant breeding was done by government research stations and universities. Given the central role agriculture played (and still plays) in the economy, it was seen as a benefit to the whole society when farmers were able to grow new and better varieties. It was also clear that the expertise to produce new varieties and the concern for the public welfare existed in these government departments and research institutions.

In the 1990s, in the frenzy of cost cutting that followed large budget deficits, the Canadian government began to withdraw dollars from research and spout the line that private sector companies would take up the slack if we would make it sufficiently profitable for them. Along came Plant Breeders Rights (PBRs), with the idea that companies could charge farmers royalties on seed sales. These royalties were to be the incentive to fund further varietal development.

Many farm groups criticized plant Breeders Rights, but they passed anyway. At that time, the federal government promised there would be no reduction in public plant breeding under the new regime.

Now the government says Plant Breeders Rights do not go far enough. The many changes proposed by the Canadian Food Inspection Agency include allowing for a longer term for PBRs, allowing varieties to be protected both by PBRs and by patents, restricting the use of protected varieties in further breeding, and much more. The CFIA claims the new legislation will protect the farmers' right (they call it a privilege) to save seed, but with patents and PBRs allowed on plants, this is an illusion.

While this alone is worth looking at, the icing on this cake hasn't even been discussed publicly. Along with the proposed changes to PBRs, the government is also privately and quietly plotting to remove itself from plant variety research. It will focus instead on "genetic enhancement and germplasm". The implication is clear. Government will do the background research on germplasm, and then turn this over to companies like Monsanto to do the final development and to charge farmers for the seeds.

What will the loss of government plant breeding mean to farmers? Will private industry pick up the slack?

The CWB recently released its survey of the varieties of wheat and barley farmers planted in 2004. Prairie-wide, about 70 percent of acres planted to hard red spring wheat were to varieties that came from Agriculture Canada. Barrie and Superb were the leading ones. Another 8 percent came from the University of Saskatchewan. For durum wheat, 97 percent of acres were seeded to Agriculture Canada varieties. For hard white spring what it was 100 percent. In hard red winter wheat, varieties from Agriculture Canada and the University of Saskatchewan accounted for over 99 percent of seeded acres.

In barley, the situation is much the same. For two-row malting barley, nearly half the acres in the west were seeded to a single Agriculture Canada variety. Most of the rest were seeded to varieties from prairie universities.

The fact is private companies will take little interest in small acreage crops for the Canadian prairies like winter wheat, durum, and so on. Without the tremendous work done by Agriculture Canada scientists, Canadian farmers will fall behind their counterparts in other countries in terms of quality of our crops.

As you can see, the federal government's agenda for seeds is a one-two punch for farmers. Changes to PBRs will make it easier for private companies to make money off the seeds farmers grow. The federal government then proposes to phase out of plant variety development, to leave the door open to private companies to take total control of the seed industry.

The period for comments on the government's proposal ends on March 8, 2005. The proposals can be found at www.inspection.gc.ca/english/plaveg/pbrpov/ammende.shtml and there is more information on the National Farmers Union website at www.nfu.ca

(c) Paul Beingessner (306) 868-4734 phone 868-2009 fax beingessner@sasktel.net

4. Warning exports could be hit

Bangkok Post, 30 Nov 2004

The European Union's new regulation on labelling and traceability requirements on products containing genetically modified organisms was likely to have a huge impact on the Thai agricultural and food export industry, the National Centre for Genetic Engineering and Biotechnology (Biotec) warned yesterday.

"Food and animal feed products from Thailand will be rejected or destroyed if exporters fail to comply with the new regulation,'' said Biotect's deputy director Darunee Edwards.

"Reliable GMOs inspection and labelling process must be put in place urgently in order to protect the country's export industry,'' she said.

The EU is the fourth largest importer of Thai agricultural and food products.

Under the new regulation, which took effect in April, food and animal feed products which contain more than 0.9% of GM materials must be labelled.

Exporters must also identify the sources of GM materials even if the amount is less than 0.9% of overall ingredients.

The EU's regulation was much stricter than Japan, the second largest importer of Thai food products, which requires the products to be labelled if its overall ingredients or one of its three main ingredients contained more than 5% GM materials, said Mrs Darunee.

"Complying with the EC's labelling and traceability rules is a heavy burden for Thai exporters. The requirements would also force a sharp increase in production costs, considering that GMOs-testing costs about 2,000 baht a sample and a large number of samples are needed for one export shipment,'' she said.

Because of the absence of a reliable system in segregating GM from non-GM materials here, it was very likely that Thai food and animal feed products would be accidentally contaminated with transgenic materials.

Sunthorn Sritawee of the River Kwai International Food Industry, said the new regulation had had no significant impacts on food exported so far since the EU had listed Thailand as a "non-risk'' country.

5. German researchers and industry decry a new crop law as being detrimental to innovation

By Ned Stafford
The Scientist, December 1, 2004

The final passage of a highly restrictive genetically modified (GM) crops law is being hailed as a major victory by German Agriculture Minister Renate Künast, but the bioscience community and biotech sector see the new legislation as a blow to German science and industry.

Among the most controversial aspects of the new law are clauses holding planters of GM crops liable for economic damages to adjacent non-GM fields even if they followed planting instructions and other regulations. Opponents say this will create a financial risk some German universities, research organizations, and companies will not take.

Mark Stitt, managing director at the Max Planck Institute of Molecular Plant Physiology, told The Scientist: "I think the law, as it now stands, is going to have a very detrimental effect on innovation in Germany."

"Germany has potentially one of the most flourishing bioscience industries in the world," Stitt said. "But now, research will be leaving Germany. Firms will be leaving Germany."

"I have no problem with liability," Stitt said. "If you do something wrong, you should pay for it. But with this law, you have liability without blame. This is an absolutely impossible situation."

The new law had a rocky ride through the German legislative process. It was passed in June by the Bundestag, Germany's lower house, with strong backing of the Greens, a junior coalition partner of Chancellor Gerhard Schröder's SPD party. The law was then nullified in early November by the Bundesrat, or upper house, which is controlled by a slim majority of opposition parties. However, the opposition was not able to muster the two thirds vote needed to kill the law, throwing it back into the Bundestag for an ultimate vote.

In the decisive Bundestag vote on Friday (November 26), Schröder's SPD party held ranks with the Greens, with a slim majority voting to resuscitate the law. It will now take effect on January 1.

Stitt said the law goes far beyond EU GM law, which he called "sensible and reasonable." He noted that EU law allows non-GM plants to be "contaminated" with up to 0.9% of pollen from neighboring GM plants, while the German law is purposefully vague, saying that non-GM farmers who suffer a decline in the value of crops due to contamination can seek reimbursement. In Germany, so-called "bio" products must contain less than 0.1% GM contamination in order to obtain the bio stamp, Stitt said.

"This law has gone far beyond what is necessary," Stitt said. He noted that Syngenta, the world biggest agro-chemicals group, based in Basel, announced that it had halted all its European field trials of GM plants and seed material varieties because of public resistance and had moved the programs to the United States. Earlier this year, anti-GM activists in Germany destroyed GM wheat fields coordinated by Syngenta.

Jens A. Katzek, chief executive officer of BIO Mitteldeutschland GmbH, which promotes the biotechnological industry in central Germany, told The Scientist that any farmer, researcher, firm, or organization considering planting GM crops now must decide whether to risk the possible economic consequences.

"This law is going to have dramatic consequences," Katzek said. "Planting GM crops in Germany is now an economic risk. Simply an economic risk."

Katzek said that his home state, Saxony-Anhalt, has already announced it will challenge the new law in federal court. During the past year, Saxony-Anhalt has been promoting itself as a biotechnology center, which has included helping to coordinate a major GM corn project.

An aspect of the law Katzek finds especially worrying is a clause that requires GM crop planters to publicly register exact location of fields. Proponents of the clause said that non-GM farmers have the right to know if neighboring fields contain GM crops.

6. Europe votes to keep GM crop bans
Commission's position - unpopular and undemocratic

For immediate release: MONDAY 29 NOVEMBER 2004

Adrian Bebb, Friends of the Earth Europe +49 1609 490 1163
Geert Ritsema, Friends of the Earth Europe +31 62 90 05 908

Brussels, 29th November 2004 - Europe's member states today voted against proposals to overturn the bans of genetically modified (GM) crops in five countries. The GM position of the European Commission, who tabled the vote, has been described by Friends of the Earth as "deeply unpopular and clearly undemocratic".


On lifting the bans on Sygenta's Bt176 maize in German, Austria and Luxembourg In favour: 54 votes; Against: 221 votes; Abstained: 46 votes

On lifting the ban on Bayer's T25 maize in Austria In favour: 54 votes; Against: 221 votes; Abstained: 46 votes

On lifting the ban on Monsanto's MON810 maize in Austria In favour: 73 votes; Against: 178 votes; Abstained: 70 votes

On lifting the ban on Bayer's oilseed rape Topas 19/2 in France and Greece In favour: 54 votes; Against: 178 votes; Abstained: 89 votes

On lifting the ban on Bayer's oilseed rape MS1xRf1 in France In favour: 54 votes; Against: 178 votes; Abstained: 89 votes

The votes today took place in the Regulatory Committee meeting on the deliberate release of GMOs in the environment. Each of the Commission's proposals, calling on countries to repeal their bans within 20 days, failed to get the required "qualified majority" of 232 votes out of 321. For some of the bans the Commission narrowly escaped a qualified majority against them. The proposals will now go to a Council of Ministers meeting in the new year.

The Commission's proposals are seen as a direct result of the trade dispute in the World Trade Organisation (WTO) started last year by the United States, Argentina and Canada. The three countries claim that Europe's precautionary stance on GM food, including the national bans, are a barrier to free trade and harm their farmers. The WTO has set up a 3-person panel which is currently meeting in secret to judge the case. A final verdict is expected next year.

Adrian Bebb, GMO campaigner of Friends of the Earth Europe said:

"European countries should be congratulated for not supporting these outrageous proposals. The European Commission only survived today by a handful of votes. Their position on genetically modified foods is deeply unpopular and clearly undemocratic. This should serve as wake-up call for them to start fighting for the right of countries to ban genetically modified foods instead of caving in to the pressure of the World Trade Organisation and the Bush Administration."

A full briefing from Friends of the Earth on the national bans can be found at:


A new report published today by Friends of the Earth heavily criticises the European Food Safety Authority (EFSA) for its constant position in favour of the biotechnology industry. The advice from EFSA is used by the European Commission to justify the approval of new GM foods and also the lifting of the national bans. A press release and the report can be found at: http://www.foeeurope.org/press/2004/AB_29_Nov_EFSA.htm