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Pre-Emptive Strike

The April 6th edition of the New York Times reports that the Supreme Court is leaning towards a legal argument called “pre-emption” that would prevent companies from being sued for product liability once that product is deregulated by a government agency, in this case the FDA. Excerpt from article:

“For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.”

Full Article

The courts leaning this direction will have obvious ramifications in the world of GMO’s as well. Transgenic crops are regulated by a ragged, moth-eaten quilt comprised of the EPA, FDA, and USDA – with all agencies acting separately and no interdepartmental communications. Each agency, as in the case with the FDA in this Johnson & Johnson suit before the Supreme Court, depends only on REPORTED testing from the companies seeking deregulation. If Monsanto or Bayer or J&J say their evaluations are positive it gets a gold star and the product goes out to the public. Not surprising with the revolving door between government agencies, the university community, and corporations. The regulatory agencies require no independent studies. “We’ll take your word for it.”

Now, when a product turns out to have a negative ramification, for example contaminating a neighbor’s crops with transgenic pollen and making them non-marketable, the companies can say – “Hey, the government approved it. Tough luck.” Even if you believe that there are useful biotech applications in crops, what ethical person can support a zero liability approach to any product, one in which we take the word of corporations as the gold standard? We as a public deserve better than this. Or maybe we should manage other public entities in the same manner. The DOT will just ask you to sign a statement saying you read the rule book and know how to drive. And do we really need contractors to get building permits and have inspections? I mean who would really build a substandard apartment complex for low-income persons just for the money?

Have we really gone this far towards a pro-corporate, anti-public, perilous and unethical regulatory climate? Undoubtedly. Paranoia? No. How many cases do we need to read about before we recognize the FDA, EPA and USDA are not doing their job? Do we allow our local institutions to behave so poorly? We need to demand that senate and congressional representatives investigate the irresponsible behavior of our federal agencies. If the courts back the agencies with pre-emption, the only way to protect ourselves is with complete reform of the agencies. As my Sicilian grandmother used to say when I tossed my toys about the living room without concern for her tripping on them: BASTA! You make the mess – you clean it up! Now!

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There have been several sugarbeet industry responses to the RR lawsuit filed by Organic Seed Alliance, Center For Food Safety, and Sierra Club.

First, an interview: Five Minutes With Luther Markwart, American Sugarbeet Growers
And along the same lines these comments from the American Association of Subarbeet.Please read the excellent public comments at the end of that article.

The one thing that I continue to see is a denial of how this technology impacts pre-existing rural economies/farmers/companies. These large commodity groups and their gene giant partners refuse to see that their acts/products can result in the loss of “freedom to operate” for farmers with an already existing market(non-gmo Beta vulgaris seed crops). They don’t want to pay for contamination testing, losses due to contamination, or even recognize that these seed grower’s products have value. And with seed the value is exponential – not only a value to the seed growers, but to the farmers who rely on seed free of contamination.

But then we get called “selfish”?

That was one of the nasty labels thrown out in a posting on Truth About Trade & Technology. It’s difficult to not respond with a volley of schoolyard name calling and an emotional rant such as was done by the TATT poster Noel Kjesbo. I’m not sure calling people “dishonest” and “selfish” without backing it up is an indicator of “truth” as much as it is juvenile and slanderous.

For the record Noel, Organic Seed Alliance has no links to Greenpeace (as you claim), nor are we an activist group. And, I challenge you to logically prove your slanderous statements (“fradulent”, “dishonest”, “hiding behind misleading names”, etc)

In any case, I would like to point my dear readers to Frank Morton’s (Wild Garden Seed) well reasoned response. Well done Frank.


FRANK’S RESPONSE:

As a farmer, seedsman, plant breeder, and member of the Isolation Pinning Rules Committee of Oregon’s Willamette Valley Specialty Seeds Association, I have another agricultural perspective to offer this author and his audience.

Our Valley produces virtually all of the sugar beet seed for our United States. It also produces some table beet seed and a huge percentage of the Swiss chard seed that ends up in the fresh salad trade from California to Maine and other markets overseas. We also grow seed for much of the world’s Brassica veg crops, cabbage, kale, broccoli, turnips and their kin. We think we matter as much as your sugar beet farmers in the Red River Valley, and we think our high value specialty seed trade with the Pacific Rim and the EU is a big deal. But this is all dependent on seed quality, and for us in our sensitive markets, seed quality means genetic purity–both for trueness to type, and freedom from transgenic contamination. Our buyers do not want GMOs in our seed whether you care (or we care) or not. Transgenes from Roundup Ready sugar beets or oilseed canola in our Swiss chard or Chinese cabbage will not be accepted by our overseas customers any more than they will by our organic seed customers in California. That’s the truth about trade that is obvious from my window.

What your folks see as a great blessing (may improve yields 10% I hear from the company that stands to gain the most) could hereabouts destroy the value of conventional seedsmen’s crops downwind of GMO plantings of sugar beets, canola, corn, or whatever the next transgenic specialty crop may be. BT-broccoli, RR-radish, onion, spinach–all of these are potential trade disasters waiting to happen to my happy valley, now 95% stocked with Roundup Ready sugar beets, brought in secretly over three years without any notification to neighbors, fellow seedfolks, or the seed association, until after planting of the third year.

This valley isn’t big enough to provide certainty of genetic isolation between GE-sugar beets and conventional beets and Swiss chard. Such certainty would require more than 6 miles of isolation distance between transgenic and conventional fields, according to the sugar beet industry’s own research. The Pinning Isolation Rules of the seed association provide for 3 miles of isolation, and these are the new rules, made in full cognizance (for the first time) that GMOs were among us. To provide the 6 miles necessary to keep conventional beets and Swiss chard transgene-free, sugar beet isolations would need to expand against their conventional neighbors, and due to production seniority, would push other producers out of the valley entirely. In other words, to protect the conventional beet/chard industry, it would be disappeared. That might seem fair in someone’s version of the truth, but not the guys I know.

None of these issues related to genetic contamination of world class seed production zones like ours were taken into account by USDA/APHIS, the Oregon Dept. of Agriculture, or my own WVSSA members that visited this suprise upon us about one year ago. Since these would have been the guardians of the public and commercial intrests at hand, and since none of this was in fact considered when USDA/APHIS deregulated GE-beets (nor when they began to planted in Oregon), it seems entirely reasonable to me that we specialty seedfolk have been infringed upon in more ways than one, and a Judge ought to have a look at the situation. Maybe our author and “the company that has the most to gain” would prefer to have their day in a Missouri Court to argue before a Judge, but my grief is happening well west of there, and I’m happy with our justice system in this regard.

This is no different than the Roundup Ready Alfalfa case. One company assumed it could ride in and transgenically contaminate everyone producing alfalfa–regardless of the market consequences–and get away with it. Alfalfa seed and forage farmers showed them different, and that company is paying a price for assuming it can push its heavy weight around any farming sector. RR-Alfalfa is a flawed technology put back in its box where it belongs. RR-beets are the same kind of buffalo bull, likely to cross the fence and make little beefalos where they are not the intended kind of cow.

I would think any farmer that knows the truth when he sees it would be able to understand this; milking beefalos will not do for the dairyman.

When biotech can manage to keep its pretties at home where they have a value to someone, and when biotech is proud enough of its work that it will label it, then maybe they will have a place in free and fair trade. As long as biotechnology has the potential to destroy the neighborhood’s product values by blowing on the wind, I think biotech has offered up a flawed device.

You think mine is a dangerous idea?

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This just in, release from USDA on a new “event”. It once again points to the lax regulation, poor handling, and inevitable escape of transgenic products into the greater agricultural and ecological community. Here is the joint statement from APHIS, EPA, FDA:

Cindy Ragin, APHIS (301) 734-7280
Dale Kemery, EPA (202) 564-7839
Stephanie Kwisnek, FDA (301) 436-1408

USDA, EPA AND FDA STATEMENT ON GENETICALLY ENGINEERED CORN “EVENT 32”

 

February 22, 2008

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the U.S. Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) are coordinating efforts following notification by Dow AgroSciences that the company detected extremely low levels of an unregistered genetically engineered (GE) pesticide product known as a plant-incorporated protectant (PIP) in 3 of its commercial GE hybrid corn seed lines. The unregistered product produces proteins that are identical to a registered product. USDA, EPA and FDA have concluded that there are no public health, food or feed safety concerns. Additionally, USDA and EPA have determined that the unregistered GE corn PIP poses no plant pest or environmental concerns.

The unregistered GE corn PIP, known as Event 32, was found in some Herculex®RW andHerculex®XTRA Rootworm Protection products. Seed containing low levels of the unregistered Event 32 was inadvertently sold to farmers by Dow’s affiliate Mycogen Seeds and planted in 2006 and 2007. EPA and USDA previously approved Herculex®Rootworm Protection products containing a closely related PIP, Event 22. These products are also approved for use in several foreign countries.

Through careful analysis, EPA determined that the introduced proteins produced by Event 32 are identical to those approved for Event 22, and therefore they are covered by an existing tolerance exemption (EPA food safety clearance). FDA has concluded there are no food or feed safety concerns because EPA has determined that the introduced proteins in Event 32 are safe and because corn containing Event 32 is present in food or feed, if at all, only at low levels. In addition, APHIS’ scientific analysis concluded that Event 32 poses no plant pest or environmental concerns. The 2008 U.S. corn crop will not be affected. APHIS took steps to ensure Dow recalled all affected seed that was shipped to dealers for the 2008 planting season. APHIS and EPA are coordinating on the investigation of potential violations under their respective regulatory acts.

Corn Event 32 was found at extremely low levels—approximately 3 seeds per 1,000—in affected Herculex seed products. Dow reported that in 2007 approximately 53,000 acres of the affected products were planted in the United States. Total U.S. corn acreage in 2007 was more than 93 million acres. Taking into account, the low levels of Event 32 in the Herculex seed products as well as the very small proportion of these seeds that were planted, any amount of Event 32 in harvested corn would be negligible. It is estimated that no more than 0.0002 percent (two ten– thousandths of one percent) of the 2007 corn crop may have contained Event 32.

For more information on the respective roles of USDA APHIS, EPA, and FDA in the federal regulation of GE plants, see the United States Agencies Unified Biotechnology Web site at http://usbiotechreg.nbii.gov/.

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Obviously I need to be a bit careful on this, as Organic Seed Alliance is as plaintiff in the case, but I am working on an editorial piece that should be up next week. Press release below, actually complaint.

 

FARMERS, CONSUMER ADVOCATES, CONSERVATIONISTS CHALLENGE FEDERAL APPROVAL OF GENETICALLY ENGINEERED BEETS

Negative Impacts on Crops, Business, Environment, and Consumer Rights Cited

San Francisco, CA, January 23, 2008 – Today, farmers, food safety advocates, and conservation groups filed suit in federal court challenging the deregulation of herbicide-tolerant “Roundup Ready” sugar beets by the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA). Attorneys from the Center for Food Safety and Earthjustice are representing plaintiffs Organic Seed Alliance, Sierra Club, High Mowing Seeds, and the Center for Food Safety in the lawsuit, which seeks a thorough assessment of environmental, health, and associated economic impacts of the deregulation as required by federal law.

This spring, commercial sugar beet farmers in the western United States will begin planting Roundup Ready sugar beets, which are genetically engineered (GE) to be resistant to Monsanto’s herbicide Roundup. Sugar beet seeds are primarily grown in Oregon’s Willamette Valley, also an important seed growing area for crops closely related to sugar beets, such as organic chard and table beets. The wind-pollinated GE sugar beets will inevitably cross-pollinate with related crops being grown in close proximity, contaminating conventional sugar beets and organic chard and table beet crops.

Contamination from genetically engineered pollen is a major risk to both the conventional and organic seed farmers, who have a long history in the Willamette Valley,” said the Organic Seed Alliance’s Director of Advocacy, Matthew Dillon. “The economic impact of contamination affects not only these seed farmers, but the beet and chard farmers who rely on the genetic integrity of their varieties. The government is playing fast and loose with these farmers’ livelihoods.”

GE sugar beets are wind pollinated, and there is a strong possibility that pollen from Roundup Ready sugar beets could contaminate non-GE sugar beets and important food crops such as chard, and red and yellow beets (or “table beets”). Such biological contamination would also be devastating to organic farmers, who face debilitating market losses if their crops are contaminated by a GE variety. Contamination also reduces the ability of conventional farmers to decide what to grow, and limits consumer choice of natural foods.

According to Tom Stearns, President of High Mowing Seeds, “the issue of releasing GMO crops without serious research or oversight risks the security of our food supply and the economic viability of our nation’s non-GMO and organic farmers.”

In addition to the risk of crop contamination, scientific studies have shown that applications of Roundup, a glyphosate-based herbicide, increase significantly when Roundup Ready crops are grown. Increased use of this herbicide is instrumental in the creation of Roundup-resistant “super weeds”.

Contrary to the industry’s mantra that these plants reduce chemical use, studies have shown that herbicide use actually increases with the planting of Roundup Ready crops,” said Kevin Golden, of the Center for Food Safety. “Just as overuse of antibiotics eventually breeds drug resistant bacteria, overuse of Roundup eventually breeds Roundup-resistant weeds. When that happens, farmers are forced to rely on even more toxic herbicides to control those weeds.”

Crops that have been genetically engineered to withstand herbicides made up 81% of the GE crops planted globally in 2006. 99% of the herbicide tolerant crops grown in the U.S. are “Roundup Ready”. According to an independent analysis of USDA data by former Board of Agriculture Chair of the National Academy of Sciences, Dr. Charles Benbrook, GE crops increased herbicide use in the U.S. by 122 million pounds – a 15-fold increase – between 1994 (when GE herbicide-tolerant crops were introduced) to 2004.

The law requires the government to take a hard look at the impact that deregulating Roundup Ready sugar beets will have on human health, agriculture and the environment,” said Greg Loarie of Earthjustice. “The government cannot simply ignore the fact that deregulation will harm organic farmers and consumers, and exacerbate the growing epidemic of herbicide-resistant weeds.”

These herbicide-resistant weeds have spread rapidly over the past seven years, and experts agree that their proliferation is directly linked to the introduction of Roundup Ready crops, including soybeans, cotton and corn. As recently as 2000, there were no documented cases of weeds resistant to glyphosate in the Corn Belt. Today, marestail, common and giant ragweed, waterhemp and Palmer pigweed are weeds with confirmed resistance to glyphosate. Cocklebur, lambsquarters, morning glory, velvetleaf, and others are also proving tougher to kill. In total, Roundup-resistant weeds have been reported on 2.4 million acres of U.S. cropland.

The sugar produced by Roundup Ready beets, which may have greatly elevated levels of the herbicide glyphosphate, may be included in products ranging from candy to breakfast cereal to bread. At this point, none of those products will require labeling of any kind to indicate the presence of sugar derived from Roundup Ready sugar beets.

As a consumer, I’m very concerned about genetically-engineered sugar making its way into the products I eat, as well as genetic contamination of conventional and organically grown varieties of table beets and chard,” said the Sierra Club’s Neil Carman. “It’s unacceptable for consumers to be exposed to untested genetically engineered ingredients in foods that aren’t labeled. At a time when consumers are facing multiple food safety challenges, we don’t need more corporations messing with our food supply.”

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Warning – this is not objective reporting and contains cynicism and sarcasm. But then again, who needs objectivity, not our Federal agencies…read on….

On September 26th Monsanto announced the “Biotech Yield Endorsement Program”(BYE), a partnership with the Federal Crop Insurance Corporation (FCIC) which will give a 20% discount on crop insurance premiums to farmers who plant Monsanto varieties that feature YieldGard Plus with Roundup Ready Corn 2 or YieldGard VT Triple technologies. In recent days there have been a slew of new press releases and articles on this (it is time to be buying your spring seed you know).

Before I get into this and complete blow a gasket, let me first key you in on the mission of the FCIC. From the FCIC web page:

The Federal Crop Insurance Corporation (FCIC) promotes the economic stability of agriculture through a sound system of crop insurance and providing the means for the research and experience helpful in devising and establishing such insurance.”

Product not Practices, and Protocols without Public Oversight

The big news isn’t the USDA having a partnership with Monsanto, as they already hold a joint patent on Terminator Technology with the seed company, but rather that it is the first time that the FCIC has allowed a premium discount for a specific commercial product. Normally the FCIC supports farmers making good decisions in practices, that is minimizing risk by choosing the best strategies in irrigation practices, pest management, harvesting or processing, and so on. Product premiums are a bit odd. If John Deere makes a cultivator that leaves less of the harvest for the field mice (thus reducing risk of loss), should farmers get a discount on their crop insurance for using the new model? Is the FCIC really going to go into the product endorsement business?

On September 26th I called FCIC to confirm that this tax-payer funded, federal insurance program, administered under the US Department of Agriculture was indeed offering such a program. FCIC Board Executive Secretary, Brent Doanne, did confirm that this was a first for the organization, but noted that section 1523(D) of the Federal Crop Insurance Act allowed for the development of discount policies if a company could prove that their product clearly demonstrated reduced risk in the field. In this instance the FCIC board allowed for Monsanto’s field trial data to stand as sufficient evidence of clear demonstration; third party verification that the biotech products really reduce risk and maximize yield wasn’t necessary according to Mr. Doanne. But, as he said, “They have thousands and thousands of acres of data.” And hey, big numbers always means good science.

Let’s outsource regulation to the private sector!!

Yes, yes, the government has spent billions of dollars creating agencies to manage regulatory oversight of our environment, public health, economy, and so on. But people still get sick and rivers get polluted, so maybe they haven’t done such a good job. In fact, they’ve done such a bad job let’s go ahead and hire someone else to do it for us. Besides, we can’t afford to spend tax-payer money on regulatory testing – as we have the newly approved energy bill and the oil industry needs that $13.5 Billion in taxpayer funded incentives that the new Energy Bill provides because they only made $35 billion in NET profits last year. Let’s outsource regulatory oversight to people who know how to make money, not spend it, like those government bureaucrats.

Okay, enough sarcasm. The reality is that the FCIC trusts the Monsanto generated data, but they are going to keep their eyes open. Mr. Doanne did say that the FCIC will monitor yield for several years to determine if Monsanto’s products really do result in reduced yield risk. I find this to be an odd regulatory protocol, kind of like buying a mail order bride isn’t it? Not sure what you’ll get but boy they say she’s a beauty, so let’s trust em. Just as the FDA and other federal agencies are now trusting corporations to verify their products efficacy and safety (and isn’t Vioxx great? And nah, OxyContin isn’t addictive), so now another USDA agency continues to avoid regulatory responsibility. They ignore not only their public duty, but deny the immense economic benefit that unregulated approval of these products has for the corporations whose revolving doors they sashay in and out of like belles at the ball.

What? Benefit to Monsanto?

As states such as Iowa launch anti-trust investigation into Monsanto marketing practices the FCIC has in one fell swoop approved a policy that will result in an obvious marketing advantage to the company that already dominates the corn market. In addition to calling Mr. Doanne I also tracked down Curt Sindergard. Mr. Sindergard is a FCIC board member, and Iowas soybean and corn farmer, and seed dealer for DeKalb – which is of course owned by Monsanto. Mr. Sindergard told me that the FCIC board does not see this as favoritism to Monsanto in that other seed companies may petition for similar discount programs. “Monsanto invested a lot of money and time in getting this approved by the (FCIC) board. Other seed companies, competitors to Monsanto, will likely benefit from the precedent and put their own traits forward for similar programs.”

Mr. Sindergard also noted that this will benefit biotech usage, and that the usage of any technology that reduces risk of yield loss is a good thing for farmers. As he put it, “We (FCIC Board) see this as a way to support future enhancement of biotech traits.” Is this the FCIC mission? To support particular technologies? I thought they were in the insurance business. Oh yes, but the insurance business often colludes with the pharmaceutical sector in human health, why not in agricultural systems? Could it be that having a representative from the biotech seed sector on the FCIC board, such as Mr. Sindergard, is just a tad bit inappropriate? Just what does he know about insurance? Economics? Research? Here’s his bio: http://www.rma.usda.gov/fcic/sindergard.pdf

I suppose being a deacon he does have some insurance background. Plant your seeds and say your prayers.

But Hey, the FCIC gives Organic special treatment too

Meanwhile organic farmers are forced to pay an additional 5% surcharge for federal crop insurance, but are paid out on claims at conventional crop values as opposed to the higher, true, organic market value. When I asked Mr. Doane about this surcharge he said that it was, “Necessary because of the higher risk associated with organic farming.” When I pressed him to document that additional risk with research he said that the FCIC was still collecting data to determine just how high the level of risk was from growing organically. Well thank goodness they’re doing their regulatory homework and spending our dollars researching the dangers of organics. In other words organics is presumed guilty of being a substandard system of production with higher risk until proven innocent, whereas industry driven biotech claims are taken as the gold standard of acceptable research? Does the FCIC have an organic or low-input agricultural representative on their board? No. At least not until Monsanto goes organic.

 

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