Fw: #685: TROUBLE IN THE GARDEN

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>=======================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. 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 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@....

>Telephone (612) 870-3413.

>

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

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

>

>[3] Kilman and 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 n Burros,

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

>TIMES December 1, 1999, pg. A15.

>

>[5] 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 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;

>

>

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