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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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When Monsanto buys into a market they buy in big.

In 2005 Monsanto’s seed/genetic trait holdings were primarily in corn, cotton, soybean, and canola. That year they purchased Seminis, the world’s largest vegetable seed company (see And We Have the Seed) specializing in seed for vegetable field crops.

Now their takeover of the vegetable seed sector continues, as they have announced the intent to purchase the Dutch breeding and seed company, De Ruiter Seeds. This purchase diversifies Monsanto’s seed holdings in vegetable field crops (Seminis) to “protected culture” fruits and vegetables (primarily tomatoes and cucurbits produced greenhouse, hothouse, etc). Analysts from Bank of America say that this gives Monsanto 25% of the world vegetable seed market, but I believe that this is a low estimate. (I contacted both Monsanto and the BofA analysts to ask for their data but they did not respond to my emails.)

In 1998, according to their own figures, Seminis already controlled 26% of the overall global market in vegetable seeds, 39% of the US market, and 24% of the European market (Seminis. 2000. Seminis Annual Report—Fiscal Year 1999. Saticoy, CA: Seminis, Inc.). This is ALL vegetable seeds, but in their specialties – tomatoes, peppers, cucurbits, the percentage market share is much higher. A case filed by the US Government against Seminis in 2000 stated that they controlled 70% of the US fresh tomato seed market (the case was regarding an anticompetition agreement that kept a Israeli company from competing in the US tomato seed market. Syngenta initially lost in the federal district court case, but won in the Court of Appeals for the Ninth Circuit) And in 2005, at the time of the Monsanto acquisition of Seminis, I spoke with a tomato breeder for Seminis who estimated that they had 75% control of the overall US market.

With the De Ruiter protected-culture varieties they may hit 85% control of the total market, and that could increase considering the trend in expansion of hot house tomato production.

Hello, Department of Justice, do we have an antitrust case now?

I know it’s not corn, but fresh market tomatoes (FRESH, not including processing) was an industry worth over $4 billion (again, according to US Attorney General Documents). Tomatoes were the 9th most important agricultural food products in 2005 (and this against animal products) and the 4th (after corn, soybeans, and wheat) of food crops (non-animal).

De Ruiters is a Dutch company, so I believe the sale is outside of US DOJ jurisdiction. The Directorate General for Competition of the EU will likely not interfere, as Monsanto doesn’t own enough of the EU vegetable seed sector. There remains no cohesive international method for regulation on a global scale, which is wonderful for these global corporate firms.

One company with this much control in one of the largest agricultural markets in the US? Some economists use “The Rule of 3” – that a monopoly exists in a market if there are not a  minimum of 3 competing companies . There are certainly more than two other tomato seed companies out there, but with what kind of market share? Do any of them have 10%? What about 5%? Scale is a requirement for competition. So who is competing with Monsanto on tomato seed? The rest of the market is a quilt work of tiny companies in comparison to what Monsanto has created in under three years with a handful of quick and unregulated acquisitions.  Added to their seed concentrations in other crops, and given that food production starts with the seed, there should be no question of who controls our food supply. The only question is – will we do something about it?

I have to hope that the right administrative change will usher in the potential for a stronger Justice Department. At this point Obama has had the strongest voice in calling for greater government regulation of industry (primarily in reference to tightening up Wall Street). Regardless of who wins, we need to get farmers, food companies, and citizens working in concert to make congress, the executive branch, and Justice to hear our concerns about unregulated agricultural mergers. 

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?

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/.

Hillary and Monsanto

There have been two recent public letters to Hillary Clinton from an old college alum that point to her historical ties with large scale corporate food – Tyson, Walmart, and Monsanto. They’re very informative. Here they are:

Letter One

Letter Two

Catching up

I haven’t had much time to write given my workload with the Organic Seed Growers Conference. I’ll give an update from the conference tomorrow, after I get some sleep.

Two things now:

1) Here’s the beet sugar industry response to the lawsuit. As a litigation liaison for one of the plaintiffs I’m going to avoid making any comments. But I welcome yours.

2) I saw this quote in today’s NY Times in regards to the beef recall, from (senator, democrat, Iowa) Tom Harkin, chairman of the Chairman of the Senate Committee on Agriculture, Nutrition and Forestry, ”This begs the question: how much longer will we continue to test our luck with weak enforcement of federal food safety regulations?”

Thanks Tom.

 

SuperCarrot – addendum

Frank Morton posted this comment on the SuperCarrot piece. His additions to the story need to be front and center:

Thanks for bringing this up to where the sun shines, Matthew.

I second everything that you are breathing fire about, but particularly to the uncritical praise from the hi-tech set. After actually reading the paper, as you must have done, several big issues jumped out at me that must have flown past a Wired reporter.

Starting at the top of the paper, “Nutritional impacts of elevated calcium transport in carrots,” we see that this is a paper about the impact of GM-tech on food and human health. We also see that it comes from the Vegetable and Fruit Improvement Center at Texas A&M. Riddle me this–Is this Center the result of Monsanto largess? Many new “crop improvement facilities” at our land grant universities come directly from the biotech industry (eg. a new biotech crop science building at WSU in Pullman, WA), and one can only assume that such investments expect affirmative results.

Directly under the the names of the researchers we find the names of the editors of the paper, who are associated with the Plant Science Center, St. Louis, MO. Is it just a coincidence that this the home address for the Monsanto corperation, Matthew?

The abstract begins with a discussion of calcium deficiencies “worldwide” that results from “Nutritional recommendations (that) emphesize ingestion of plant-based diets rather than…animal products. However, this plant based diet could limit the intake of essential nutrients such as calcium.” The abstract donates the first third of it’s space to justifying the use of novel technology for the prevention of osteoporosis caused by a lack of calcium in carrots…Never is it mentioned that carrots and other members of the Carrot Family of vegetables are not particularly good sources of this mineral. Nor that the Cabbage Family would be the appropriate source for getting ample calcium in the vegetable diet–which is what people commonly do in the real world. Kale, cabbage, broccoli, Chinese cabbage, turnips, radish, or leaves of any wild or domestic member of this crop family would easily supply more calcium AND more vitamin A and C, than any carrot–transgenic or natural. This seems easy to overlook amid all the science jabber.

In the body of the paper we learn that these crops are being grown in hydroponic solution, not in soil, which at first passes as a simply scientific means to control the availability of calcium isotopes in the test carrots. There is a passing reference in the Results section to the fact that the test carrots did not absorb extra heavy metals, but the significance of this observation cannot be found until we get to the very last paragraphs in the Discussion section. Here we learn that the genetic transformation that allows the absorption of extra calcium by the carrot (”overexpression” of sCAX1 transporter gene) ALSO ALLOWS THE ENHANCED ABSOPTION OF HEAVY METAL IONS, INCLUDING CADMIUM, COPPER, MANGANESE, IRON, AND ZINC…

The reason that the test carrots had a “2-fold increase in Ca++ and no increase in the content of other minerals” (cadmium, copper, iron, manganese, and zinc) as noted in the Results, is because these minerals were not included in the hydroponic solution! That is some result! The researchers note that the ionic radius of cadmiun is “almost identical” to that of calcium, “…so we used cadmium-free hydroponic solutions to avoid any adverse metal accumulation in the carrots.”

The concentrations of other metals in the solution is not mentioned, but we are left to assume that these were present at some level (because all except cadmium are essential trace nutrients), but likely were not available to the test crops in overabundance, as was the calcium. In other words, if these transgenic carrots were grown in real agricultural soils, we may find that they absorb toxic levels of whatever heavy metals or normal trace nutrients are available in those soils.

In the final paragraph of Discussion, we are informed that the real significance of this work is the finding that “overexpression of a gene found in all plants”–the CAX-transporter gene–could lead us into a new era of enhanced nutrition founded on plant-based diets.

Could be a hard sell to the vegetarians I know.

My Final Comment:
The cruciferous vegetables (which are related to Arabidopsis, the experimental source of the CAX1-gene used to transform the “super-carrot”), especially Brassica juncea, are well-known bioaccumulators of heavy metals. Brassica juncea is used in bioremediation as a lead absorber for heavily tainted soils. Using this genetic trait to create “overexpression” of large metal ion transport systems in a wide array of crops my have unintended consequences for agriculture and nutrition in the real world where soils vary widely in their native concentrations of potentially toxic metals. It just may be that ‘modulated expression’ of such transport systems in crops–as opposed to “overexpression” of these absorptive mechanisms–is nature’s way of keeping both plants and animals healthy in real life.

We are evolved to eat many things to be healthy…not just “super-carrots” and “golden rice.”

–Frank Morton
Wild Garden Seed