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February 2007 Updates

Leading Advocates Against Genetically Modified RBGH Milk File Citizen's Petition With FDA

Medical News Today
February 22, 2007

Petition Seeks Withdrawal of Approval for Posilac - Recombinant Bovine Growth Hormone (rBGH)

Tuesday morning February 20, three major advocacy organizations representing consumers, family farmers, and cancer prevention advocates filed a citizen's petition to the FDA, seeking the Withdrawal of Approval for Posilac -- Recombinant Bovine Growth Hormone (rBGH).

The petition is based on scientific evidence of increased risks of cancer, particularly breast, colon, and prostate, from the consumption of milk from cows injected with Posilac(R), the genetically modified recombinant bovine growth hormone (also known as rBGH, or rbST), with increased levels of IGF-1. Posilac is the trademark for Monsanto's rBGH product, registered with the U.S. Patent and Trademark Office, and is approved for marketing by the Food and Drug Administration (FDA). This petition is also based on other abnormalities in the composition of rBGH milk, resulting from the recognized veterinary toxicity of rBGH.

The petition requests the immediate suspension of approval of Posilac(R) based on imminent hazard; and citing a section of the Federal Food, Drug, and Cosmetic Act to request the Commissioner of the Food and Drug Administration to label milk and other dairy products produced with the use of Posilac(R) with a cancer risk warning.

The petition was submitted on behalf of the Cancer Prevention Coalition, Samuel S. Epstein, M.D., Chair; the Organic Consumers Association, Ronnie Cummins, Executive Director; and Family Farm Defenders, John Kinsman, President.

Samuel S. Epstein, M.D., Chair of the Cancer Prevention Coalition Professor emeritus of Environmental and Occupational Medicine at the School of Public Health, University of Illinois at Chicago, is an internationally recognized authority on the causes and prevention of cancer, including carcinogenic ingredients and contaminants in food and other consumer products. He is the author of the new book "What's in Your Milk? An expose of Industry and Government Cover-Up on the Dangers of the Genetically Engineered (rBGH) Milk You're Drinking." Epstein's trailblazing scientific publications, editorials, national and international conferences, and legislative interventions, since 1989, have played a major role in influencing 27 nations, including Europe, Canada, Australia, New Zealand, and Japan to ban rBGH milk. Dr. Epstein is available for interviews regarding this petition, and to speak to health risks associated with rBGH milk.



Bill Would Hold Makers Of Engineered Crops Liable For Damage

By Steve Lawrence, AP
San Diego Union-Tribune
February 27, 2007

SACRAMENTO - Stepping into the middle of a growing debate, a freshman assemblyman has introduced legislation that would make companies developing genetically engineered crops liable for damages if their work results in contamination of other fields.

The bill by Assemblyman Jared Huffman also would ban open-field production of genetically engineered crops used in the development of medications. And it would require growers to give county agriculture commissioners at least 30 days notice before engaging in open-field development of other genetically modified plants.

Huffman, D-San Rafael, said the measure is needed to protect California farmers against significant losses if their conventional or organic crops are contaminated by genetically engineered plants, seeds or pollen.

His bill would cover cases in which a grower claimed annual losses of at least $3,500.

He said an incident last year in which an experimental form of rice being developed by a German company showed up in grain elevators in Arkansas and Missouri should serve as a wake-up call for California.

Hundreds of rice farmers in Arkansas, Missouri and Louisiana have filed lawsuits claiming losses because of that contamination.

"It certainly underscores the urgency of taking action before things like that happen here," Huffman said.

The bill would clarify who would be responsible for damages if there was contamination. With some limited exceptions, it would be the seed producer, chemical company or other manufacturer paying for the genetically altered crop rather than the farmer growing it under contract.

"I'm not interested in farmers suing farmers...," Huffman said. "The kind of damage that can occur when cross-contamination does happen can be of a scale where you're not going to be able to make farmers whole unless they can hold the manufacturer responsible."

The measure also would identify who was involved in genetically modified crop production. Right now, no one seems to have a clear idea of how much of that activity is taking place in California.

The bill would prevent the mixing of pharmaceutical plants with other crops by preventing those projects from being conducted in open fields.

"We're seeing food crops being engineered to grow chemicals as an alternative way of producing things like vaccines and antibiotics," Huffman said. "That is fascinating stuff, but obviously you don't want those crops getting into the food supply."

Huffman's bill might go too far for some segments of California's agriculture industry and not far enough for others.

Greg Massa, co-chairman of the Rice Producers of California, said he welcomes Huffman's bill but added, "I don't really know if it's enough."

His group of 200 farmers wants a moratorium on genetically modified rice experimentation and production. A study it commissioned found that California growers could lose about 40 percent of their rice market if Japan, China and several other nations imposed trade embargoes to keep out genetically modified crops.

"We can't take the risk," Massa said. "The report we just put out said pretty clearly that our customers don't want (genetically engineered crops) and that contamination in California would be much more severe than in the South."

A California law adopted in 2000 might give farmers enough protection already, said Tim Johnson, president and chief executive officer of the California Rice Commission, which represents growers and marketers.

That statute, the California Rice Certification Act, provides for a committee representing growers, handlers, warehouses and researchers to suggest regulations designed to prevent the intermingling of different varieties of rice.

"That really has provided us, at least up to this point, the tools we need to manage customers' response to genetically modified crops," Johnson said. "That said, the industry will take as deliberative a review of Mr. Huffman's legislation as we did in developing the California Rice Certification Act of 2000."

The California Farm Bureau Federation opposes the bill "as it stands now," said Cynthia Cory, the bureau's director of environmental affairs.

But she said her group of 91,000 farmers and others in the agriculture industry, including companies engaged in genetic engineering, is willing to work with Huffman.

"Biotechnology across the board is very important to this state," she said. "I don't think the bill acknowledges that."

The bill's ban on open-field production of corn and other crops for use in medications could curtail "a cheap and effective way to produce the drugs," Cory said.

Huffman's bill may be unnecessary because legal remedies already exist, said Richard Matteis, executive vice president of the California Seed Association, which also represents some companies involved in genetic engineering.

"In California, I'm not aware of any growers being damaged because of the presence of biological crops in their crops," he said. "I think the system is working."

Huffman's bill is similar to legislation introduced in 2005 by Assemblyman John Laird. That measure passed the Assembly Judiciary Committee but died in the Assembly Agriculture Committee.

Laird, D-Santa Cruz, said his bill ran into "big fears that (it) would get in the way of certain agriculture production."

"I think those fears are misplaced," he said. "I think it's an issue of markets. There are potentially markets that will close themselves to American crops if they believe there is (a genetically modified crop) involved."

Huffman's bill might have a better chance of passing because of increased concern about the potential threat posed by the inadvertent spread of genetically modified grasses and crops since his bill failed, Laird said.

Several federal court rulings in the last six months have found that the U.S. Department of Agriculture has been lax in enforcing environmental protections on genetically modified crop projects, Laird said.

In one case, a judge ordered the department to conduct more detailed reviews of genetically engineered plant projects after studies found that pollen from weed killer-resistant grass had drifted more than 12 miles from plots in Madras, Ore., and bred with conventional plants.

"Two things are inevitable on this issue," Huffman said. "One is genetic engineering is here to stay. We're going to see it more and more.

"But the second is there is going to be some regulation of this, and hopefully we can put a coherent policy in place before California experiences a cross-contamination disaster like the one that happened in Arkansas."


U.S. Courts Say Transgenic Crops Need Tighter Scrutiny

By Dan Charles
February 26, 2007

Citing a broad range of risks, U.S. federal judges in three separate cases have asked the USDA to examine genetically engineered crops more closely. The courts said the department had violated the National Environmental Protection Act (NEPA) in approving commercial sales of transgenic alfalfa and field trials of turf grass and plants engineered to produce pharmaceuticals.

Critics of genetically engineered crops say the decisions, two issued this month and one last August, will compel tighter regulation of transgenic crops. Will Rostov, an attorney for the Center for Food Safety in Washington, D.C., which filed all three lawsuits, called the alfalfa decision, rendered 12 February by U.S. District Judge Charles Breyer in San Francisco, California, "another nail in the coffin for USDA's hands-off approach to regulation." But Stanley Abramson, a lawyer who represents several biotech companies, pointed out that the courts raised questions about USDA's procedures, not its substantive decisions. He predicted that USDA's final judgments would hold up in court.

The alfalfa verdict could have the most significant impact. In 2005, USDA approved the sale of Roundup Ready alfalfa, jointly developed by Monsanto and Forage Genetics International, which can withstand the popular herbicide glyphosate. But last week, Breyer said that the department should have first prepared an environmental impact statement (EIS) as required under NEPA.

Joseph Mendelson of the Center for Food Safety said that his group may demand an end to sales of genetically engineered alfalfa or even a ban on planting transgenic seed already in farmers' hands. USDA officials declined to discuss the government's position or whether it plans to appeal. A spokesperson for Monsanto, which sells genetically engineered alfalfa but was not a party to the lawsuit, said he did not expect sales to be halted. Breyer gave both sides until next week to propose regulatory fixes.

The second verdict, handed down 5 February by a Washington, D.C., district judge, found that USDA should have carried out an EIS or a more modest environmental assessment before it allowed a 162-hectare field trial of transgenic turf grass near Madras, Oregon, in 2003. And last August, a federal court in Hawaii faulted USDA for approving field trials in Hawaii of corn and sugar cane engineered to produce experimental pharmaceuticals without considering the state's numerous endangered species.

In two of the cases, the judges expressed concerns about potential risks that USDA has dismissed as insignificant or outside its mandate. Breyer, for instance, complained that USDA ignored the cumulative impact of glyphosate tolerant alfalfa, corn, and soybeans. Greater use of glyphosate increases the odds that weeds will develop resistance to it.

Breyer also said USDA erred when it dismissed as not "significant" the concerns of organic farmers who don't want Roundup Ready pollen or seeds spreading to their alfalfa fields. The possible replacement of traditional varieties is itself significant, he noted. "An action which eliminates or greatly reduces the availability of a particular plant--here, nonengineered alfalfa--has a significant effect on the human environment," he wrote.

USDA argued that cross-pollination wasn't a serious problem in alfalfa, because farmers typically harvest their fields before the plants have a chance to flower, much less produce seeds. Producers of commercial alfalfa seed, however, would have to make sure their conventional and transgenic fields were widely separated. Alfalfa is pollinated by bees, which can carry pollen at least 3 kilometers.

In the turf grass case, Judge Henry Kennedy found that transgenic bentgrass from a large field trial in Oregon threatened a nearby area's "aesthetic and recreational" value. Pollen from the bentgrass spread up to 20 kilometers into the nearby Crooked River National Grassland.

Many scientists, including some critics of genetically engineered crops, say the bentgrass poses no real ecological threat in that area because it isn't well adapted to the region's arid climate. But the spread of this "confined" field trial proved embarrassing to the Scotts Co., which hopes eventually to sell bentgrass seed to golf courses.


Ex-FDA Chief Crawford Faces Sentencing

By Hope Yen
Associated Press
February 26, 2007

WASHINGTON — A judge wants attorneys to explain why former FDA chief Lester Crawford shouldn't receive stiffer punishment than a $50,000 fine and probation for lying about stocks he owned in companies regulated by his agency.

Crawford was to be sentenced Tuesday. His defense attorney and federal prosecutors worked out a deal that would spare jail time for the former head of the Food and Drug Administration.

However, Magistrate Judge Deborah A. Robinson wants to know why more stringent federal sentencing guidelines were not applied.

"Dr. Crawford has agreed to take responsibility for his actions," his lawyer, Barbara Van Gelder, wrote in court filings earlier this month. She noted that prosecutors acknowledged there was no evidence that Crawford had schemed to defraud or misuse his office for personal gain.

"The stigma of his conviction will follow him the rest of his life," Gelder wrote.

Crawford pleaded guilty last October to charges of having a conflict of interest and false reporting of information about stocks that he and his wife owned. Beginning in 2002, Crawford filed seven incorrect financial reports with a government ethics office and Congress.

Crawford did, however, pay taxes on the dividends and the options he exercised, according to prosecutors.

The two charges — conflict of interest and false reporting — are misdemeanors and each carries a maximum penalty of one year in prison and a $100,000 fine.

In filings, prosecutors say the proposed $50,000 fine was appropriate. They noted it would exceed the roughly $39,000 that Crawford and his wife, Cathy, made from exercising options and in dividends from illegally held stocks in food, beverage and medical companies, which included Embrex Inc. and Pepsico Inc.

Crawford also was cooperative once prosecutors began their criminal investigation in late 2005, said assistant U.S. Attorney Howard Sklamberg.

Crawford, a veterinarian and food-safety expert, abruptly resigned from the FDA in September 2005 but gave no reason for leaving. He had held the job for two months, following his confirmation by the Senate.


Synthetic Biology -- Genetic Engineering On Steroids

By Tim Montague
Rachel's Democracy & Health News #895
February 22, 2007

[Rachel's introduction: A new report from the ETC Group in Canada highlights the power of new genetic engineering techniques that are capable of creating new forms of life never seen on Earth before.]

In the past 5 years, the science of genetic engineering has made giant strides. Starting from scratch using lifeless chemicals, scientists are now able to create viruses, such as the polio virus. Technically, viruses are not "alive" because they require cells to survive. But soon -- perhaps some time this year -- scientists expect to create bacteria, which are definitely alive. From there, it will be a short step to manufacturing new forms of life that have never existed on Earth before. This startling new enterprise is called "synthetic biology."


Life begins as lifeless chemicals, called nucleotides. You can buy them off the shelf. Under some circumstances, these can combine into complicated chains to create DNA molecules. Long strands of DNA form genes, and genes give rise to proteins and eventually to cells and viruses. Cells metabolize, adapt to their environment, and reproduce themselves using the information packed away in their DNA -- thus fulfilling the definition of living things. The nucleotides are just ordinary lifeless chemicals, but by the time they combine into cells they have become the stuff of life itself.

Scientists have spent 300 years working backward from cells, trying to discover how all this works. Along the way they learned that genes can give creatures particular characteristics. Starting 30 years ago they began snipping genes from one creature and inserting them into a different creature, hoping to give the recipient some new characteristic that humans would find valuable. For example, trout can tolerate cold water, so perhaps a gene from a trout inserted into a tomato will help the tomato tolerate cold weather. This has become known as "gene splicing" or "genetic engineering."

All this activity can be described as "reading" the genetic code. But now scientists know enough to begin "writing" their own genetic code - -putting together chains of nucleotides into chunks of DNA, and pasting these together to create living things.

In 2002 a team of scientists at the State University of New York at Stony Brook took mail-ordered pieces of synthetic, lifeless DNA and pasted them together to create a polio virus -- a feat that took two years of hard work. It was the first time humans had ever created a functioning organism from scratch. Since then, things have speeded up.

In 2003 a team led by Craig Venter produced a second synthetic virus from scratch -- and they did it in 14 days. "Scientists predict that within 2-5 years it will be possible to synthesise any virus; the first de novo [meaning, "starting from scratch"] bacterium will make its debut in 2007," says a new report 1 Mbyte PDF{1} from the ETC Group in Canada. (pg. 1) Bacteria are definitely alive, so the creation of life from scratch, starting with simple chemicals, is upon us.

In 2005, researchers at Mount Sinai School of Medicine in New York and the U.S. Centers of Disease Control (CDC) in Atlanta announced that "They had resurrected the lethal [1918 flu] virus. They published details of the completed genome sequencing in Nature and details of the virus recreation in Science." (p. 24) The flu virus that swept the world in 1918 was especially adept at transmitting itself from one person to the next, and it was especially deadly, killing somewhere between 20 million and 50 million humans. Reconstructing the virus using gene-splicing techniques may help us avoid another pandemic like that of 1918 -- or it may give some "genetic hacker" an idea for creating mischief on a monumental scale.

Obviously the ability to create the polio virus, or the 1918 flu virus, is an extraordinary scientific accomplishment, but freighted with dark possibilities.

In response to recreation of the 1918 virus, technology gurus Bill Joy and Ray Kurzweil told the New York Times, "This is extremely foolish, the genome{2} [of the 1918 flu virus] is essentially the design of a weapon of mass destruction. No responsible scientist would advocate publishing precise designs for an atomic bomb... revealing the sequence for the flu virus is even more dangerous."(p. 24)

Despite such grim warnings, many new start-up firms are competing to find ways to profit from these new techniques.

Craig Venter -- the golden boy of synthetic biology -- and hundreds of other scientists are now trolling the depths of the oceans, the canopies of jungles and the far corners of earth to catalog and patent life's genetic heritage. A new report from the ETC Group titled "Extreme Genetic Engineering" 1 Mbyte PDF{3} says, "Venter claims that his expedition has discovered 3,995 new gene families not previously known, and 6-10 million new genes -- which he describes as 'design components' of the future."(p. 14)

The gold rush is on. Synthetic biology -- heralded as the next "big thing" to fuel economic growth{4} -- is genetic engineering on steroids. Cataloging our genetic heritage is just the beginning. Armed with desktop synthetic biology machines, scientists can now create DNA on demand, freely combining the best or worst characteristics of any known organism and inventing completely new life forms.

This is all very exciting for scientists and their financial backers who dream of making huge profits. "They hold growing patent portfolios and foresee industrial products for uses as diverse as energy production, climate change remediation, toxic cleanup, textiles and pharmaceutical production."(p.3) Huge sums of money are now pouring from private foundations, government programs and venture capital to invent new medical and chemical products.

As the synthetic biology industry hurtles into the future, civil society organizations are now asking if we shouldn't at least have widespread debate and legally-binding regulation before we rush into this great unknown?

Evidence is accumulating that we really don't know how to control this new technology. For example, Greenpeace just released a report{5} documenting the growing number of cases of unapproved GMO [genetically modified organisms] food crops showing up in regular food crops. GMO rice, corn, soy, cotton and other crops have now 'contaminated' the gene pools of their non-GMO cousins in 142 different incidents since the introduction of GMO crops 12 years ago in 1996.

If we can't control the spread of GMO crops -- relatively large, visible organisms -- how will we control microscopic viruses and bacteria?

Scientists at Berkeley University backed by a $42.5 million grant from the Bill and Melinda Gates Foundation, are developing synthetic drugs to combat malaria. This work gives synthetic biology the blessing of major philanthropy -- but the eventual outcomes for society are unpredictable. The Berkeley team says it will create unlimited and cheap production of the previously scarce drug Artemisinin to treat malaria in the developing world.(p. 20)

Artemisinin is naturally produced by the wormwood (artemisia) plant which is widely cultivated in Africa and Asia. Tea made from the plant is used as a natural medicine to prevent and cure malaria. Although synthetic biology may eventually yield an affordable synthetic alternative, it will likely disrupt indigenous agriculture that provides a livelihood for thousands of small-scale farmers.

And the ETC Group even questions whether the Berkeley work will produce a low-cost drug: "Pharmaceutical companies will accumulate control and power over the production process; artemisia producers will lose a source of income; and local production, extraction and (possibly) manufacturing of ACT [Artemisinin Combination Therapies] in regions where malaria is prevalent will shift to the main production sites of Western pharmaceutical companies."

The ETC Group report outlines six major areas where synthetic biology needs to be carefully watched and where it could undermine the public interest and local/regional economies.

  • Biological weapons -- more dangerous, more stealthy
  • Biofuels -- to replace petroleum with ethanol and other chemicals derived from genetically modified organisms -- instead of focusing on conservation and efficiency
  • Creating intellectual monopolies -- why not own the world? Companies are aiming to create new monopolies by patenting all manner of natural forms and substances
  • Conservation biology -- prevent and reverse extinction, thus introducing alien species into contemporary ecosystems
  • New commodities -- rubber, silk, you name it; will they interfere with existing crops? Can we anticipate the problems they will create?
  • Public health and safety -- trust us, we're experts. What will happen when new organisms enter ecosystems, evolve, and mutate?

The details of each are well worth reading (pgs. 23-48). The common theme is that corporate profits are the primary motivation for all of these innovations. When profit comes first, there is often little room for ethical and democratic exploration of better alternatives.

So what is an ostensibly-democratic society supposed to do? The ETC Group suggests, " keeping with the Precautionary Principle, synthetic microbes should be treated as dangerous until proven harmless. At a minimum, environmental release of de novo synthetic organisms should be prohibited until wide societal debate and strong governance are in place, and until health, environmental and socioeconomic implications are thoroughly considered."(p. 50)

The synthetic biology industry has made some soft proposals of self- governance, as a preemptive measure. Most of these have focused on biological weapons. "One proposal was... to boycott gene synthesis companies that did not screen orders for dangerous pathogens, and the development of software that could check genetic code for sequences that could be used maliciously." And a second, "He [Stephen Maurer, a Berkeley attorney] also proposed a confidential hotline for synthetic biologists to check if their work, or the work of others, was ethically acceptable."

But even some synthetic biologists doubt that self-policing can work. Drew Endy{6} of MIT -- a synthetic biology leader and advocate of 'open-source' biology -- said, "I expect that this technology will be misapplied, actively misapplied.... I don't think [these proposals] will have a significant impact on the misuse of this technology."(p. 47)

In May of 2006, the synthetic biology 2.0 conference was held in Berkeley California. When the ETC Group tried to register to attend the event, they were turned away because of "limited space." So they submitted an open letter{7} signed by 38 civil society organizations calling on the synthetic biology industry to "participate in a process of open and democratic oversight of the technology."(p. 50)

"Scientists creating new life-forms cannot be allowed to act as judge and jury," explained Sue Mayer, director of GeneWatch. "The implications are too serious to be left to well-meaning but self interested scientists. Public debate and policing is needed."(p. 47)

The ETC Group report makes the following recommendations:(p. 50)

  • There must be a broad societal debate on synthetic biology's wider socioeconomic and ethical implications, including potential impacts on health, environment, human rights and security."
  • Civil society should meet at national, regional and international levels to evaluate and plan a coordinated response to the emergence of synthetic biology in the context of wider, converging technologies.
  • Governments should maintain zero tolerance for biowarfare agents, synthesised or otherwise, and adopt strong legal measures and enforcement to prevent the synthesis of biowarfare agents.
  • The building blocks of life must not be privatised: Despite earnest calls for "open source biology," exclusive monopoly patents are now being won on the smallest parts of life -- on gene fragments, codons{8} and even the molecules that make living organisms (i.e., novel amino acids{9} and novel base pairs{10}).
  • To facilitate coordinated global action, an international body should be established to monitor and assess societal impacts of emerging technologies, including synthetic biology.

Can regulation work?

If society does create rules for the development of synthetic biology it should remember that, "scientists are ill-equipped by their training to grapple with the ethical and moral dimensions of their work. Scientists have no equivalent of the Hippocratic Oath -- "First do no harm" -- that guides the behavior of physicians. The Hippocratic oath counsels restraint, humility, and caution. In science, on the other hand, wherever your curiosity takes you is the right place to go, even if it takes you into "a darker bioweapons future."(Rachel's News #835{11})

Even when industry accepts regulation we must be wary. First, history tells us that government regulation translates mostly into government approval. Furthermore, new products are invented so fast that government can't keep up with the onslaught. And when someone is harmed and sues, manufacturers will use regulation as an excuse to evade responsibility: "The government approved this so I'm not liable."(Rachel's News #834{12})

In addition, regulation gives big firms unfair advantage over their smaller competitors. Complicated regulations require armies of lawyers and engineers -- "compliance specialists" -- who "do nothing but read the regulations and fill out the burdensome paperwork, bellyaching all the way to the bank."(Rachel's News #834{13})

Let us remember these words, from the ETC group's open letter{14} to the 2006 synthetic biology 2.0 meetings: "We believe that this potentially powerful technology is being developed without proper societal debate concerning socioeconomic, security, health, environmental and human rights implications. We are alarmed that synthetic biologists meeting this weekend intend to vote on a scheme of voluntary self-regulation without consulting or involving broader social groups. We urge you to withdraw these self-governance proposals and participate in a process of open and inclusive oversight of this technology."

References available on request

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