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<rachel (AT) rachel (DOT) org>

<rachel-weekly (AT) europe (DOT) std.com>

Thursday, February 03, 2000 6:37 PM

Rachel #685: TROUBLE IN THE GARDEN

 

 

> =======================Electronic Edition========================

> . .

> . RACHEL'S ENVIRONMENT & HEALTH WEEKLY #685 .

> . ---February 3, 2000--- .

> . HEADLINES: .

> . TROUBLE IN THE GARDEN .

> . ========== .

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> =================================================================

>

>

> TROUBLE IN THE GARDEN

>

> Wall Street investors lost confidence in agricultural

> biotechnology during 1999.[1,2,3] Agricultural biotechnology is

> by no means dead, but investors drove down stock prices of ag

> biotech companies during 1999 in a stunning reversal for the

> industry. The WALL STREET JOURNAL said Jan. 7, 2000, "With the

> controversy over genetically modified foods spreading across the

> globe and taking a toll on the stocks of companies with

> agricultural-biotechnology businesses, it's hard to see those

> companies as a good investment, even in the long term."[2]

>

> Hardest hit was Monsanto, the St. Louis chemical giant that had

> spent 5 years and billions of dollars morphing itself into a

> "life sciences" company, betting its future on biotechnology in

> pharmaceutical drugs and agricultural crops. As the WALL STREET

> JOURNAL wrote December 21, 1999, "Billions of dollars later, that

> concept of a unified 'life sciences' company -- using technology

> to improve both medicines and foods -- has become an affliction

> itself for Monsanto. The crop-biotechnology half of the program

> has grown so controversial that Monsanto has agreed to a deal

> that is likely not only to push biotech to the back burner, but

> also to cost Monsanto its independence. And investors are

> reacting harshly."[3]

>

> Monsanto agreed late in 1999 to merge with Pharmacia & Upjohn,

> Inc. and the combined company will be run not from St. Louis but

> from Pharmacia headquarters in Peapack, New Jersey. Monsanto's ag

> biotech business will be spun off into a separate company and as

> much as 19.9% of it will be sold.

>

> Two other leaders in ag biotech, the Swiss pharmaceutical giant

> Novartis AG, and the Anglo-Swiss drug firm AstroZeneca PLC,

> announced during 1999 that they will combine their ag biotech

> divisions into one and sell it off, "effectively washing their

> hands of crop biotechnology," the WALL STREET JOURNAL said.[3]

>

> Thus by the end of 1999, ag biotech companies found themselves in

> trouble, worldwide, for the first time. Here is a short list of

> reasons why:

>

> ** A lawsuit against the U.S. Food and Drug Administration (FDA)

> forced the release of government documents showing that FDA

> scientists had expressed grave doubts about the safety of

> genetically modified foods even as the agency was publicly

> declaring such foods "substantially equivalent" to traditional

> crops.[4] It seems clear from these documents that the scientific

> integrity of the U.S. regulatory system has been compromised for

> political purposes, to provide a "fast track" for the rapid,

> large-scale introduction of genetically modified foods.

>

> ** The insurance industry has consistently refused to write

> policies covering liability for harm caused by genetically

> modified organisms. Steven Suppan, research director at the

> Institute for Agriculture and Trade Policy (IATP) in Minneapolis,

> said last June, "It is worth asking what kind of regulatory

> system approves for commercialization a technology whose risks

> are so undetermined that the products developed from the

> technology have not been insur- ed? An intuitive response is that

> the U.S. rejection of liability suggests that U.S. agribusiness

> and the U.S. government have less confidence than is proclaimed

> publicly in the safety of the products approved and in the

> integrity of the product review process," Dr. Suppan said.[5]

>

> ** A growing body of literature has begun to show that

> genetically modified crops are creating new kinds of

> environmental problems for farmers, and that genetically modified

> crops are exacerbating already-severe economic problems on

> American farms.[6]

>

> ** Europeans and others overseas have continued to insist that

> the safety of genetically modified foods has not been

> sufficiently documented and that import of such foods must be

> prohibited, or they must be labeled. The doubts expressed by FDA

> scientists, and the growing list of economic and environmental

> problems are likely to stiffen European resistance to

> genetically-modified seeds, crops, and foods.

>

> ** It became apparent in 1999 that the public rationale for

> promoting genetically modified foods -- that such foods would

> "feed the world" -- was based on wishful thinking, not economics.

> It is now clear that U.S. genetically modified crops are too

> expensive to "feed the world."[6]

>

> ** The rationale for refusing to label genetically modified foods

> came unraveled in 1999 as biotechnology companies began to

> announce new crops with special traits (rice with increased

> vitamin A, for example). For years, biotech companies, the U.S.

> Department of Agriculture (USDA), U.S. Environmental Protection

> Agency (EPA), and FDA have argued that labeling genetically

> modified foods was impossible because it would require food

> companies to segregate genetically modified crops from

> conventional crops and it simply couldn't be done. All the crops

> were mixed together in the grain elevator, so labeling would be

> impossible, they said.

>

> This silly and disingenuous argument evaporated in 1999. As soon

> as biotech firms announced specialty foods created by genetic

> engineering, the labeling problem miraculously disappeared.

> Labeling is suddenly easy -- indeed, required -- because

> consumer's can't be expected to pay premium prices for specialty

> foods if those foods aren't clearly identifiable on the grocery

> shelf.

>

> Polls have shown that more than 80% of American consumers want

> genetically modified foods labeled as such. Now that labeling is

> acknowledged as feasible, will the biotech industry, USDA, EPA,

> and FDA bend to the public will and start labeling ALL

> genetically modified foods? Not on your life. Government and

> industry argue with one voice that labeling is not necessary

> because genetically modified foods are "substantially equivalent"

> to the conventional foods they have replaced. They even say

> labeling would be "misleading" because it would imply that there

> are differences between biotech foods and conventional foods.

>

> Federal regulations governing biotech foods are founded on the

> premise that there are no "material differences" between

> genetically modified crops and conventional crops. This argument,

> it turns out, was thoroughly discredited by FDA scientists before

> the regulations were issued.

>

> The FDA spent 1989-1992 developing regulations governing

> genetically modified foods for humans and feed for animals. This

> was back when President Bush and Vice-President Quayle were

> advocating "regulatory relief" for industry.

>

> FDA's rules -- which were announced by Mr. Quayle in 1992 --

> allow a biotech company like Monsanto or DuPont to decide for

> itself whether its food products are "generally recognized as

> safe" (GRAS). If a company decides that its new genetically

> modified corn or soybean or potato or wheat is "generally

> recognized as safe" then no safety testing is required before the

> products are introduced into the food supply. FDA said these

> rules -- like all their rules -- are based on "sound science."

>

> However, during 1999 a lawsuit filed by the Alliance for

> Bio-Integrity in Fairfield, Iowa, forced the FDA to release some

> 44,000 pages of internal documents for the first time.[4] Among

> them was a series of memos from FDA scientists commenting on the

> FDA's proposed "substantially equivalent" policy for biotech

> foods.

>

> A key issue is whether "pleiotropic effects" will occur when new

> genes are inserted into plants to give the plants desirable new

> traits. Pleiotropy means that more than one change occurs in a

> plant as a result of the new gene. For example, a gene that

> allows a plant to grow better under drought conditions might also

> make the entire plant grow smaller. The smaller size would be an

> unexpected "pleiotropic" effect.

>

> FDA regulations assume that pleiotropic effects will not occur

> when new genes are inserted into conventional foods such as corn

> or potatoes or wheat or soybeans. Therefore, FDA says,

> genetically modified crops are "substantially equivalent" to

> conventional crops.

>

> Internal memos make it abundantly clear that FDA's scientific

> staff believes pleiotropic effects will occur when new genes are

> inserted into food crops. [in the following quotations, words

> inside square brackets have been added for clarity but words

> inside normal parentheses were in the original memos.--P.M.]

>

> Commenting on the FDA's proposed biotech regulations in early

> 1992, Louis Pribyl, an FDA microbiologist, wrote March 6, 1992,

> "It reads very pro-industry, especially in the area of unintended

> effects.... This is industry's pet idea, namely that there are no

> unintended effects that will raise the FDA's level of concern.

> But time and time again, there is no data to backup their

> contention, while the scientific literature does contain many

> examples of naturally occurring pleiotropic effects. When the

> introduction of genes into [a] plant's genome randomly occurs, as

> is the case with the current [genetic modification] technology

> (but not traditional breeding), it seems apparent that many

> pleiotropic effects will occur," Dr. Pribyl wrote. "Many of these

> effects might not be seen by the breeder [meaning Monsanto or

> DuPont or other biotech firm] because of the more or less similar

> growing conditions in the limited trials that are performed.

> Until more of these experimental plants have a wider

> environmental distribution, it would be premature for FDA to

> summarily dismiss pleiotropy as is done here," Dr. Pribyl wrote.

>

> On the same subject, a memo from the Division of Contaminants

> Chemistry within FDA's Division of Food Chemistry and Technology

> said November 1, 1991, "Pleiotropic effects occur in genetically

> engineered plants... at frequencies up to 30%. Most of these

> effects can be managed by the subsequent breeding and selection

> procedures. Nevertheless, some undesirable effects such as

> increased levels of known naturally occurring toxicants,

> appearance of new, not previously identified toxicants, increased

> capability of concentrating toxic substances from the environment

> (e.g., pesticides or heavy metals), and undesirable alterations

> in the levels of nutrients may escape breeders' attention unless

> genetically engineered plants are evaluated specifically for

> these changes. Such evaluations should be performed on a

> case-by-case basis, i.e., every transformant should be evaluated

> before it enters the marketplace."

>

> Instead of heeding the concerns of its scientific staff, FDA

> issued biotech food rules that assume no pleiotropic effects will

> occur, therefore no safety testing is required. All biotech foods

> are assumed to be safe. The stage was thus set for confidence in

> biotech foods to plummet as soon as word leaked out that the

> scientific underpinnings of the regulatory system had been

> compromised.

>

> To be continued next week.

>

> ==============

>

> [1] I am indebted to Steven Suppan, research director at the

> Institute for Agriculture and Trade Policy (IATP) in Minneapolis,

> who provided me with several brief, thoughtful summaries of the

> state of agricultural biotechnology. Contact: ssuppan (AT) iatp (DOT) org.

> Telephone (612) 870-3413.

>

> [2] Christina Cheddar, "Tales of the Tape: Seed Co. May Yet Reap

> What They Sow," WALL STREET JOURNAL January 7, 2000, pg. unknown.

>

> [3] Scott Kilman and Thomas M. Burton, "Biotech Backlash is

> Battering Plan Shapiro Thought Was Enlightened," WALL STREET

> JOURNAL December 21, 1999, pg.A1.

>

> [4] The FDA documents are available at

> http://www.bio-integrity.org/list.html. And see Marian Burros,

> "Documents Show Officials Disagreed on Altered Foods," NEW YORK

> TIMES December 1, 1999, pg. A15.

>

> [5] Steven Suppan, unpublished paper, "National Summit on the

> Hazards of Genetically Engineered Foods, June 17, 1999, Capitol

> Hilton Hotel, Washington, D.C. 2 pgs.

>

> [6] Some of this literature is summarized in Charles M. Benbrook,

> "World Food System Challenges and Opportunities: GMOs,

> Biodiversity, and Lessons From America's Heartland," unpublished

> paper presented January 27, 1999, at University of Illinois.

> Available in PDF format at http://www.pmac.net/- IWFS.pdf .

>

> Descriptor terms: biotechnology; monsanto; dupont; novartis;

> pharmacia; astrozeneca; agriculture; hunger; fda; regulation;

> labeling; alliance for biointegrity; pleiotropy;

>

>

> ################################################################

> NOTICE

> In accordance with Title 17 U.S.C. Section 107 this material is

> distributed without profit to those who have expressed a prior

> interest in receiving it for research and educational purposes.

> Environmental Research Foundation provides this electronic

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> --Peter Montague, Editor

> ################################################################

>

>

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