2 November 2000

Table of Contents

Key StarLink Documents now available & Daily Exposure to Cry9c
On the Human Genome: Moments of Shocked Silence About Biotech
New Orleans Patients Exposed to Rare Brain Disease (CJD / human BSE)
A Potential Alternative to GM
Sales of Milk Hormone rBGH Must be Suspended:
The Power of genetic Recombination
Suppressed Information about the Real Hazards of GE Foods
Monsanto Shows Third Quarter Loss
Approval of GM crops for animal feed not for human
"No proof" is not the same as "no evidence"
The Thalidomide of Genetic Engineering
biotech missinformation on star link
Transgenic Plants as Factories for Biopharmaceuticals

Top NextFront Page

Date: 27 Oct 2000 16:30:58 +0100
From: Mark Gold

Key StarLink Documents now available & Daily Exposure to Cry9c

Ag BioTech InfoNet is pleased to offer a complete copy of the 74 page submission from Aventis to EPA, dated Oct. 25, 2000, asking for a four-year temporary tolerance for Cry9c endotoxins in corn. The submission, in a PDF file, contains the results of a new, rushed allergenicity risk assessment.


Thanks for the link. The math and logic looks quite creative.

Using their own figures providing of 0.0129% Cry9c in corn and a per capita daily corn consumption of 292.7 grams/day at the 99th percentile (meaning 2.5 million people), the daily exposure to Cry9c in products using solely Starlink corn would be:

292.7 grams/day * 0.000129 = 0.03717 grams/day = 37.17 mg/day

If 2.5 million people are ingesting 292.7 grams/day of corn, there might be many thousands who are ingesting quite a bit more than that.

Of course, it is not likely that most corn-containing products will be 100% Starlink. Also, there is also no guarantee that in products Starlink is used in, the normal maxiumum of 10% protein is still present. However, if the EPA approves it, even on a temporary basis, one has to assume that there *might* be Starlink purchased (unmixed with other corn), made into some corn product (e.g., chips, cereal) and then sold to consumers.

Aventis seems comfortable with a maximum likely daily intake of 8.6 ug (micrograms) per day of Cry9c. That level can be achieved if corn products contain less than 0.0232% Starlink corn. Therefore, if the EPA grants temporary approval, it should do so with the provision that corn in products cannot contain any more than 0.0232% Starlink corn. After all, we should be certain that the intake of Cry3c doesn't have a chance of rising above the levels that Aventis *claims* we'd be exposed to.


Mark D. Gold

Top PreviousNextFront Page

Date: 27 Oct 2000 23:59:44 +0100

On the Human Genome: Moments of Shocked Silence About Biotech

By Donella Meadows' The Global Citizen, March 16, 2000

Biotech stocks plummeted this week as President Clinton and British Prime Minister Tony Blair requested that companies make their data on the human genome public.

Private firms are racing madly to read and patent the genetic code that makes you you and me me. They are trying to beat publicly funded labs, which are required as a condition of their grants to publish the gene sequences they unravel. One company, Celera Genomics, is funded by drug companies with the understanding that the funders will see the code before anyone else does.

If it strikes you as alarming that private investors can patent and keep secret and sell something that sits within every cell of your body, you ought to pay much closer attention to the new, jaw-dropping biotech industry. I have just spent several weeks with my students listening to biotech enthusiasts, critics, and a lot of folks in between. There were three particular moments I'd like to tell you about, all of them moments of stunned silence.

The first came when we heard from an ecologist who sits on a USDA panel that approves the release of genetically engineered crop plants. Of the 71 applications currently pending, one is for the implantation of the gene by which scorpions make their toxin. Splice that gene into a plant, and anything that nibbles on a leaf, from woodchucks to bugs, falls down dead. Of course people who eat the plant fall down dead too, so there must also be a package of genes to turn the scorpion gene on and off. Turn it on in the roots and leaves and stems, turn it off in the flower and fruit.

But what happens to the poison, the students asked, when roots or leaves decompose in the soil? What happens if the turn-off gene doesn't work infallibly? Would we have to check every fruit or grain for traces of scorpion poison?

Don't know, said the ecologist.


The second moment came when a geneticist described a new rice with a pasted-in gene that allows the plant to make and store beta-carotene, the yellow pigment from which our bodies make vitamin A. Thousands of poor children in Asia, who eat little but rice, go blind or die for lack of vitamin A. The "golden rice" could solve that problem.

A hand went up, and one of the students asked, "Why not just splice the beta-carotene gene into the child?"

Silence. Finally another visiting expert said, "Within five years that could be possible. Fasten your seat belts."

More silence. I guess everyone's mind was racing as mine was. I was picturing golden children. Then I thought, why not splice in the gene for chlorophyll while we're at it, and just send the kids out in the sun to photosynthesize their lunch? Gold-green children.

Moment number three came when I showed the students a documentary called "The Day After Trinity." It's the story of J. Robert Oppenheimer, the developer of the atomic bomb, told through interviews with some of the great physicists who worked with him at Los Alamos during the Second World War.

The cause was compelling: to stop Hitler. The science was thrilling. The effort was tremendous. The bomb was nearing completion when Hitler surrendered in May, 1945.

That surrender did not cause any slowdown in the work at Los Alamos. There was too much excitement. It was nearly time for the first test, called Trinity, which took place at Alamagordo, New Mexico, on July 16. The scientists said that on that day, as they watched the first atom bomb explosion in history, their reaction was joyous. "It worked!"

Less than a month later, when a similar bomb incinerated 100,000 people at Hiroshima, one scientist said his first thought was, "Thank goodness it wasn't a dud." His second thought was, "Oh my God, what have we done?"

The film ends with Oppenheimer testifying in Washington two decades later. When asked by a senator how to contain the nuclear arms race, Oppenheimer answered, "It's 20 years too late. We should have done it the day after Trinity."

I turned on the lights. The students just sat there. Didn't move. Didn't say a word. I couldn't either.

Geneticists are already cloning sheep and cows and mice and pigs. They can pick out a trait from almost any creature and paste it into any other, and they are on the verge of being able to turn a gene on or off at will. We already plant gene-spliced crops on tens of millions of acres. We can order genes from catalogs. Within a few years we will be able to read the code for our very selves and reach in and tinker with it. It is only a matter of time before hackers appear who think it might be fun, as computer hackers do, to create and release their own viruses.

The stock market is speculating on this stuff. National leaders ask companies, politely, to make their knowledge available to all. We need to do much more that, more than just fasten our seatbelts and go along for the ride. We need to slow down and think together about where this technology is going and who should own it and who should decide.

For genomics it is still the day after Trinity. We don't want or need to have to ask, helplessly, "Oh my God, what have we done?"

Top PreviousNextFront Page

Date: 29 Oct 2000 12:55:40 U

Not G/E this one but very interesting all the same. A lot of folks have been wondering just HOW infectious CJD/BSE is among humans.

New Orleans Patients Exposed to Rare Brain Disease (CJD / human BSE)

28 Oct 2000 11:29 GMT (Reuters)

Creutzfeldt-Jakob Disease
Routine Washing Of Instruments

Creutzfeldt-Jakob Disease

NEW ORLEANS (Reuters) – Eight patients may have been exposed to a rare and fatal brain ailment after they were operated on with the same instruments that had been used on a person who died of the illness, officials at Tulane University Hospital say.

The patients were notified of the danger after it was discovered the instruments may have been tainted with Creutzfeldt-Jakob disease, a variant of which is linked to "mad cow" disease.

The instruments received routine washing and sterilization after being used earlier on a patient later found to have died of Creutzfeldt-Jakob disease, but the hospital said Friday that the risk of spreading the brain-wasting ailment may not have been eliminated.

The Wall Street Journal said the incident began in March when the original patient underwent surgery, but the hospital in New Orleans did not tell the other eight patients about the problem until this week.

The hospital, in a statement by its vice president Alan Miller, said only that the "the eight patients who potentially have been exposed have been contacted, and we are providing counseling and the related medical care they need." Miller said the names of the people would not be released.

Medical experts said it was impossible to know if the patients, all of whom underwent brain surgery, would contract the mysterious disease. Symptoms may not develop for years and its presence is detected only through autopsy, they said.

Autopsy results on the original patient, which the Journal said were known in May, found that the patient had Creutzfeldt-Jakob disease, which leaves the brain with holes and a sponge-like consistency. It causes progressive dementia, loss of physical functions and death.

Routine Washing Of Instruments

Before the autopsy, the surgical tools that had been used on the infected patient were used on the eight people now at risk.

"After the patient was treated, the surgical instruments used were put through normal washing and sterilization procedures and used in operations involving eight other patients," Miller said in a statement.

"The Creutzfeldt-Jakob disease risk is reduced by washing, but not eliminated by normal sterilization protocols. The eight patients who may have been exposed ... might have some risk of contracting the disease," he said.

Miller said the tainted tools had been "taken out of service" and that the federal Centers for Disease Control and Prevention had been notified.

Creutzfeldt-Jakob disease is related to bovine spongiform encephalopathy, better known as mad cow disease, which is thought to be transmitted to humans through the eating of infected beef. At least 70 people in Great Britain have died from the bovine-related illness.

The disease is thought to be transmitted through infected proteins called "prions."

The CDC estimates the annual incidence of Creutzfeldt-Jakob is about one case per million people.

The Tulane hospital is a unit of HCA-Healthcare Corp. HCA.N , whose stock closed down 7/16 to 39 9/16 on Friday.

Top PreviousNextFront Page

Date: 29 Oct 2000 14:13:17 U
From: "jcummins"

The abstract below shows that oils from medicinal plants can prevent fungus disease in plants.This provides an alternative to expensive GM products.

A Potential Alternative to GM

Journal of Phytopathology 148 (7/8) 483-487 © Blackwell Wissenschafts-Verlag, Berlin

Antifungal Activity of Leaf Extracts and Essential Oils of some Medicinal Plants against Didymella bryoniae

A. C. G. Fiori1, K. R. F. Schwan-Estrada1, J. R. Stangarlin1, J. B. Vida1, C. A. Scapim1, M. E. S. Cruz1 and S. F. Pascholati2

The fungitoxicity of crude extracts and essential oils of Achillea millefolium, Cymbopogon citratus, Eucalyptus citriodora and Ageratum conyzoides on the fungus Didymella bryoniae was verified in vitro by means of germination of spores and mycelial growth. In addition, some observations were made using scanning electron microscopy (SEM) to detect possible alterations on the hyphae of Didymella bryoniae.

The results revealed that crude extracts of E. citriodora and A. conyzoides were more effective in inhibiting the mycelial growth of D. bryoniae whereas in the germination of spores A. conyzoides and A. millefolium were responsible for most of the inhibition, namely, 52 and 46%, respectively. The essential oils of C. citratus, A. conyzoides and E. citriodora provided 100% inhibition of the mycelial growth and germination of spores of D. bryoniae. SEM observations revealed alterations in the growth pattern of hyphae of D. bryoniae when the essential oil of A. millefolium was present.

Top PreviousNextFront Page

Date: 30 Oct 2000 05:12:57 U

Please read the comment from Prof. Robert Mann to this article! (The general trend is right, but some scientific references are wonky)

Sales of Milk Hormone rBGH Must be Suspended: Diabetes Risk

SOURCE Fairview Industries, Inc.
CONTACT: Dr. William von Meyer for Fairview Industries, Inc., 608-437-6700

The Fairview Industries Press Release
Letter to FDA (May 30, 1997)
Letter to FDA (Feb 18, 1998)
rBGH Milk on the market without any health data
Federal inquiry required
Expect no help from Wisconsin.
Fixed Reviews
Monsanto disrupts talk

Fairview Industries: Sales of Milk Hormone rBGH Must be Suspended: Diabetes Risk; A Comment on Forbes '8/21/00 Stepping in It'

October 30, 2000

The Fairview Industries Press Release

BLUE MOUNDS, Wis., Oct. 27 /PRNewswire/ via NewsEdge Corporation -

The following was released today by Fairview Industries, Inc.:

Our laboratory and Dr. Bill von Meyer, mentioned by Forbes, concluded early in the 1990's that rBGH (recombinant bovine growth hormone) and the resultant rBGH milk (Monsanto milk!) were not tested properly thus posed serious risk.

We presented data to the Senate of Wisconsin 1992 showing lack of chronic health data and mis-calculated heat effects, FDA Food Advisory Panel of 1993, New York City Hearing ##194, the Governor of Wisconsin, Senator R. Kasten, Representative D. Obey, Senator H. Kohl, State Senator Feingold, Congressman S. Klug, The Senate of Canada, Canadian Health toxicologists, European Union, FDA Hearing 11/18/99, and recently State of California and other states. None of our concerns have been refuted by data from FDA or any officer of government.

The use of the milk hormone rBGH has produced milk which has more cow blood serum protein in it. For certain human children this protein is that which has been found to enhance diabetes. The protein acts to cause the formation of antibodies which then attack the human pancreas. We discovered this risk after we had earlier found major discrepancies in the testing data covering many years of study. (See comment from Prof. Robert Mann)

In our presentation before the Senate of Canada investigative committee on Evidence In Agriculture we established the diabetes concerns with supporting data (4/26/99). The data on the increased serum protein can be found in Dairy Science vol 72 (no. 6) by Baer et al 1989. Also untested protein changes can be found in the Freedom of Information Documents released by FDA (cg Table 25 showing statistically significant protein quantities). The direct adverse effect of fragments of bovine growth hormone in humans was published by Sonenberg (Journ Metabolism 14:1189. 1965). This finding was ignored by NIH and FDA reviews.

Of the Congressional people we contacted only Representative Klug's office acted to pursue the matter with FDA. We disclose today Representative Klug's letters to FDA which FDA tried to skirt and ignore.

They are as follows:

Letter to FDA (May 30, 1997)

Dr. Michael Friedman,
Lead Deputy Commissioner, Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857 May 30, 1997

Dear Dr. Friedman:

I am writing today on behalf of my constituent, Dr. William von Meyer, Ph.D. Fairview Industries, Inc. For your reference I have included a copy of our original correspondence of Oct 31, 1996. FDA Responded to our letter Feb 26, 1997 (note four months).

Dr. von Meyer has asked me to submit the enclosed additional material to you on the safety issues involving rBGH milk. Of particular interest and concern is the information provided on the relationship between rBGH and diabetes, especially in children. I would ask FDA to provide me with detailed information on the testing and research done in this area. (they had none)

Dr. von Meyer also submitted a list of specific questions to which he would like a response from the agency. ... I would ask that the agency provide succinct response to each of these questions, a number of which relate to the diabetes questions above. A response within thirty days would be appreciated ...


Scott Klug
Member of Congress

Letter to FDA (Feb 18, 1998)

Ms. Diane Thomson Associate Commissioner for Legislative Affairs FDA Rockville, MD 20857

Feb 18, 1998

Dear Ms. Thompson:

I write again etc etc ...

In our May 30, 1997, letter I asked FDA to answer a number of specific questions Dr. von Meyer posed on the safety of rBGH milk. While I appreciate the agency responding to me on October 31, and offering to share Dr. von Meyer's letter with JEFCA, your letter failed to answer in sufficient in detail Dr. von Meyer's questions as they relate to FDA. Since the agency had several months, we were hoping that the response would have been more extensive.

The following is a list of questions provided that he has asked me to pass along for a thorough response:

  1. Is it true to say that no health testing of whole milk was done in the USA on milk from rBGH cows? (we mean health tests not chemical analyses)

  2. rBGH increases bovine serum protein levels in treated cow including lacto-albumin. Is it true that several chemicals including pieces of lacto-albumins from milk have been implicated in the promotion of childhood diabetes through an antibody mechanism? Isn't it also true that mastitis bacteria are a potential source of the enzyme glutamic acid decarboxylase, an antigen associated with auto-immune diabetes in human?

  3. The incubation period for diabetes in children is 8-11 years. How would you be certain that no testing of rBGH as a pure protein, no health testing of the whole milk, and only 14 days testing of pure IGF-I and no chronic testing of IGF-I as it occurs in rBGH milk is a safe procedure to protect our children from an unexpected immune reaction over a period of years ... ?

  4. In rats treated orally with rBST (WHO Series 31), Dr. von Meyer quotes Dr. Miller of FDA as follows: "antibody titers were slightly higher than background levels in several of the orally treated rats, but these were not detected by RIA (radio immune assay) These data suggest that the immune system (insert, of children) has access to the antigenic portion of the rBGH" Based on the formation of antibody to the orally delivered protein in a short period of time, why would you then terminate all chronic tests of milk derived from rBGH cows? Is not childhood diabetes an antigen promoted disease?

    And does it not have an incubation period of several years while the child's immune system is developing a response?

  5. Why would all diabetes references be omitted from public scrutiny in the NIH and Science 249:875 reviews of rBGH? This is my third letter to FDA on Dr. von Meyer's concerns.

While I have never prejudged what the answers to Dr von Meyer's questions should be, I do believe he is entitled to on-point and thorough responses to his questions. In addition to answering the above questions in a timely fashion, I would also appreciate an update from JEFCA as the previous information FDA submitted to the organization on Dr. von Meyer's behalf.


Scott Klug
Member of Congress

rBGH Milk on the market without any health data

Klug, in frustration and under continued pressure from our lab, went to FDA in June 1998 and demanded our lab interview FDA on 7/2/98. On that date we learned FDA placed the milk from rBGH cows on the market without any health data on the milk and no chronic diabetes data. No analyses were done of potential diabetes causing materials in rBGH milk. In fact no health data were collected on rBGH derived milk in the USA (If you disagree send us the data you can find).

In 1965, Dr. Martin Sonenberg found fragments of BGH were active in enhancing diabetes in humans. Fairview Industries found reports on cow serum leakage into the milk in several experiments employing rBGH derivatives. These proteins have a history of increasing diabetes in children as defined by the Toronto Hospital for Sick Children and government labs in Sweden. The European Union is thus fully justified in preventing use of rBGH and milk/cheese from entering Europe.

In 1998, a Compliance Officer of FDA under pressure of the Klug inquiry, Kim Bell, called Dr. von Meyer of Fairview Industries, Inc. and advised FDA lacked references on diabetes and milk proteins and asked for references. We sent those which were handy in the lab, but not all.

Later using references we supplied which were dated between the date of approval of rBGH and the inquiry date, FDA excused their lark of testing of the milk by saying the references were after FDA approval of rBGH thus they were excusing their faulty review. They offered no action at all. The first diabetes reference on bovine growth hormone was in 1965 (J. Metabolism 14:1189, Sonenberg), 20 years before Monsanto's petition. Naturally little action would be taken, the deputy director of FDA is the former office mate of the research director of Monsanto!

Federal inquiry required

A federal inquiry into the testing of GM foods is urgently required, and specifically into the diabetes data, handling and personnel involved in rBGH milk. 70% of large dairies in Wisconsin use rBGH and the milk is now contacting everyone yet lacks any chronic health or diabetes data what-so-ever. This information was provided to the Senate of Canada by Dr. von Meyer 4/26/99. Their concerns were immediate, their actions were swift in favor of their people. Senator Eugene Whelen stated, "These data are not good enough for Canada!"

Monsanto refused to attend the 4/26/99 hearing on rBGH in Canada. Mute testimony to their fear of direct contact with Dr. Bill von Meyer. Dr. von Meyer is a scientist who conducts genetic and biological research. He has conducted millions of dollars of health studies on chemical residues found in foods and reviewed the toxicity profile of dozens of chemicals prior to their manufacture and development. Monsanto formerly used the statements by the American Medical Association on rBGH with Senators and Congress and against Dr. von Meyer's review. The public should know that the officials at the A.M.A. who endorsed rBGH were subsequently fired for cause.

The senators in Canada who heard the data and blocked rBGH were not vying for campaign contributions from drug firms or milk price unionists who have encouraged hiding health data in the past in Wisconsin. Canadian senators are appointed until age 75. Many Canadian senators made outstanding contributions to Canada during their life to gain an appointment.

Expect no help from Wisconsin.

Wisconsin senators have ignored the health issues surrounding rBGH milk and are negligent in disclosing the problems revealed to them and by the Canadian Senate. They have made a policy decision to pander the farm vote and public, on milk price problems, but to actively hide all the milk risk problems which have been sent to them in spite of the risk to children.

The Governor of Wisconsin has been heavily lobbied by Monsanto and biotechnologists whose grants are viewed at risk if the health risks are revealed. The milk label law on rBGH in Wisconsin is voluntary. Violations are not enforced by the attorney general as evidenced by lack of checks on dairies claiming no rBGH is used. Meanwhile 70% of large dairies use rBGH in Wisconsin; none have facilities for separation of rBGH milk from natural milk. We make 30% of the USA dairy products.

A federal investigation is needed in the USA on the proper testing of GM foods and particularly diabetes risks.

The public needs to stay focused on rBGH because of the following:

  1. adverse human data exist on fragments of BGH;
  2. there is a direct diabetes risk to children;
  3. the review omitted all chronic toxicology data and WHO/FDA omitted all prior short term work involving feeding of whole rBGH milk.

If such reviews are repeated, GM foods may cause a broadly increased risk to the public due to lack of appropriate chronic health data. FDA has tried to stonewall public inquiry, "fix" reviews, ignore pertinent data, lobby the public with ads, cut hearings short, use DHHS to make ads and load panels with poorly informed people and hire people connected with Monsanto ...

Fixed Reviews

One case of a fixed review is the recent WHO technical report 888 where the FDA people present managed to have omitted all data in the only previous health test of rBGH milk ever done (see J. Nutrition 120:514, 1990 by Groenewegn et al). This is a 14 day test of whole milk from rBGH cows done in Canada which showed liver effects. Had this omission been done by a corporation it would be equivalent to the Firestone Tire incident, i.e. "reckless endangerment." Diabetes costs now amount to 15-20% of all USA medical expense.

The purveyors of rBGH and their lobbyists such as the Am. Grocery Manufacturers etc. know that careful review of this matter broadly endangers other uses of biotechnology as to its image. We should not flush useful bio-technical cancer fighting technologies over rBGH, we should simply correct this matter. There are also many anti-biology lobbyists who will try to use rBGH as an umbrella of problems. However, each product must be taken on a case by case basis.

Monsanto disrupts talk

On Sept 7, 1994, Monsanto veterinarians traveled over 200 miles to disrupt a talk given by Dr Bill von Meyer to local farmers in a small town in Wisconsin. By 1995, Monsanto had previously interfered with programs intended by CBS and CNN. Years later similar events occurred with Fox news.

A federal hearing is now required on rBGH and testing GM foods. The probable diabetes effects are of prime concern.

Fairview Industries, Inc.
2836 Jefferson Dr., Blue Mounds, WI 53517

SOURCE Fairview Industries, Inc.
CONTACT: Dr. William von Meyer for Fairview Industries, Inc., 608-437-6700

Date: 4 Nov 2000 03:53:23 U
From: Robert Mann

oppose rBGH - for sound reasons (Fairview article)

The case against Monsanto rBGH (syn. rBST) is overwhelming, as summarised by the superb articles in The Ecologist by Prof S Epstein. Canada rejected this product on the main ground of cruelty to the cows - and the threats to human health are also quite sufficient to reject this GM product.

The application to sell it in my country (NZ) has been withdrawn.

This is one of the more straightforward duds of the GM products. It does not need much more discussion, for practical purposes.

Unfortunately it has been latched onto by the raver who produces the overheated crude sloppy polemical The Konformist (possibly funded by the CIA to spread confusion).

I repeat, rBGH hardly needs discussion - but wrong technologies should be opposed for the right reasons, if right is to prevail, so I make some corrections to a recent msg on this list. As it happens, Auckland is a pocket of expertise on some aspects of diabetes, so I can assure you what we say is correct.

Our comments are inserted after the respective quotes from Fairview Industries.

Fairview Industries: Sales of Milk Hormone rBGH Must be Suspended: Diabetes Risk; A Comment on Forbes '8/21/00 Stepping in It'

October 30, 2000

BLUE MOUNDS, Wis., Oct. 27 /PRNewswire/ via NewsEdge Corporation -

The following was released today by Fairview Industries, Inc.:

Our laboratory and Dr. Bill von Meyer, mentioned by Forbes, concluded early in the 1990's that rBGH (recombinant bovine growth hormone) and the resultant rBGH milk (Monsanto milk!) were not tested properly thus posed serious risk.


The use of the milk hormone rBGH has produced milk which has more cow blood serum protein in it. For certain human children this protein is that which has been found to enhance diabetes.

This work by H M Dosch has been discredited. In any event the amount of extra serum protein was really quite small - and would be insignificant compared with the amount in for instance a sausage or patty

The protein acts to cause the formation of antibodies which then attack the human pancreas.

Not true

We discovered this risk after we had earlier found major discrepancies in the testing data covering many years of study.


The direct adverse effect of fragments of bovine growth hormone in humans was published by Sonenberg (Journ Metabolism 14:1189. 1965). This finding was ignored by NIH and FDA reviews.

These diabetogenic fragments were given by injection - not by mouth; though it is conceivable that some fragments of small size may evade intestinal digestion and the powerful peptidyl peptidases present in blood.


The science upon which this Fairview Industries hypothesis relies is not nearly as strong as those summarised by Epstein - incr IGF1 in the milk of the rBGH-injected cows, and in the blood of those who drink the milk, likely to cause incr risk of cancers notably prostate and breast.


---------------- Robt Mann
consultant ecologist, P O Box 28878 Remuera, Auckland 1005, New Zealand, (9) 524 2949

Top PreviousNextFront Page

Date: 31 Oct 2000 08:23:41 U
From: "jcummins"

The Power of genetic Recombination

The vast majority of GM crops use virus components such as cauliflower mosaic virus promoter while others use virus components as virus pesticides.The proposed terminator technology uses virus components known to cause chromosome damage in humans.

The article below shows the power of genetic recombination. Potent viruses are recovered frame sewage in water these viruses originated from recombination involving "inactivated" viruses in oral vaccine.

Characterisation of vaccine-derived polioviruses isolated from sewage and river water in Japan

Hiromu Yoshida, Hitoshi Horie, Kumiko Matsuura, Tatsuo Miyamura

Department of Virology ll, National Institute of Infectious Diseases, Gakuen 4-7-1, Musashimurayama, Tokyo, 208-0011, Japan (H Yoshida MMedSci, T Miyamura MD);
Japan Poliomyelitis Research Institute (H Horie PhD); and Department of Virology, Toyama Institute of Health (K Matsuura BS)

Correspondence to: Dr Hiromu Yoshida (e-mail:


Background A nucleotide change from U to C at position 472 in the 59 non-coding region of the type 3 poliovirus is associated with increased neurovirulence. Moreover, the proportion of type 3 polioviruses containing this mutation (472-C revertants) correlates with the neurovirulence of a particular sample. We used mutant analysis by PCR and restriction-enzyme cleavage (MAPREC) to estimate the neurovirulence of environmental samples obtained from Toyama prefecture, Japan.

Methods Sewage and river water were collected between October, 1993, and September, 1995, and concentrated samples were inoculated into three different cell types. Isolated type 3 viruses were analysed to determine whether they were derived from the live oral poliovirus vaccine strain; they were then tested for neurovirulence by MAPREC.

Results 29 type 3 strains were isolated –ll of which were vaccine-derived. 16 (55%) comprised between 2% and 91% 472-C revertants by MAPREC and were expected to have high neurovirulence. The remaining strains included less than 0á25% revertants, and were regarded as attenuated viruses. Both types were isolated about 3 months after routine oral poliovirus vaccine administrations in May and October. Three strains isolated from river water were of the virulent type.

Interpretation Our results emphasise that there is an environmental risk of vaccine-associated paralytic poliomyelitis as long as live oral poliovirus vaccine is not replaced by inactivated polio vaccine.

Lancet 2000: 356: 1461-63

Top PreviousNextFront Page

Date: 31 Oct 2000 09:48:06 U
Originated from: "Robert Sterling" Reply-To:

Suppressed Information about the Real Hazards of GE Foods

Date: Mon, 30 Oct 2000 15:15:01 -0000

Please send as far and wide as possible.


Robert Sterling Editor, The Konformist

Starlink Is Not The Problem! Suppressed Information About The Real Hazards Of Genetically Engineered Foods

by Barbara Keeler and Robert Sterling

Getting into the Media
FDA's response
Monsanto tries to silence critics
Not reporting Data
Missing supplementary data
The missing information
Introduce "substantial equivalence"
Suppress opposing research
Fund and recruit Notable Scientists

Getting into the Media

It took Starlink biocorn to get the media's attention on genetically engineered foods. Dragging their footsteps, our government agencies gradually followed in the media's wake. Starlink only made the news because the form of corn involved had not yet been approved for use in human food. Not that it had been disapproved. The EPA had said only that it needed more and better scientific information.

And who discovered the widespread presence of the unapproved corn product? Not the people we pay to protect us or safeguard the food supply, but a band of underfunded, underrespected, and at times scorned food safety activists.

In spite of its high media profile, Starlink is not the major problem. Government agencies are tracking it down, and food companies are way ahead of them, recalling their products. Most significant, everybody knows about Starlink. The problem lies with the more serious issues and hazards being ignored.

FDA's response

For example, what was the response when Monsanto researchers notified FDA that the most widely used genetically engineered product, Roundup Ready soybeans, contained a surprise package-some unintended and unsuspected gene fragments? Apparently when Monsanto enabled soybean plants to survive spraying with their weed killer, Roundup, by splicing a gene into the bean's DNA, they tossed in a little extra.

FDA's response: a big yawn. Media response: UK papers carried the story. A newswire service reported it in the US. Maybe some newspapers and news stations picked it up, but we did not see it anywhere except in the July News column of Whole Life Times.

Although this story should have smeared egg on the faces of biotech cheerleaders who claim that genetic engineering is more precise than conventional breeding techniques, scientist to this day publish high-profile opinion pieces making this now-disproved assertion.

What might explain the absence of the spotlight on these genetic hitchhikers in soy that pervades a majority of processed foods on the market? In soy on the market with FDA blessing? Possibly apathy. However, a document posted on GeneWatch UK website: , offers another possible explanation. In what Genewatch says is a leaked internal document from Monsanto, the writer brags that "The [Monsanto] Scientific Outreach network and the Technology Issues Team averted attacks on recently emerging biotechnology issues. The team developed rapid responses to avoid over-reaction to claims regarding...the characterization of additional non-functional DNA in Roundup Ready soybeans."

Monsanto tries to silence critics

Not to worry, says Monsanto's letter to the UK government. According to Monsanto spokesman Jeff Bergau the gene fragments were in RR beans when they passed safety assessments by US authorities in 1994. What else was in the beans when they passed safety assessments? Well, not Roundup. Unlike the beans on the market and in the food supply, the beans Monsanto researchers analyzed had not been treated with weed killer.

Monsanto tried valiantly to silence one of the first critics to point out this discrepancy, Dr. Marc Lappe, Formerly head of the State of California's Hazard Evaluation System and a former tenured professor in Health Policy & Ethics at the Univ of Illinois at Chicago College of Medicine. His book, AGAINST THE GRAIN, was the topic of a threatening letter from Monsanto to its original publisher in 1998. After the first publisher backed down, Common Courage Press published the book.

Not reporting Data

If not Roundup, what DID the Roundup Ready soybeans contain when they were reviewed by FDA in 1994? For starters, higher levels of a known allergen. Apparently, Monsanto managed to keep some troubling information from becoming an issue. They just didn't report the data in their published study or the report they sent to the EPA. What information the published study and FDA report did reveal was camouflaged in a place readers were least likely to look for it. Sandwiched between lists of macronutrients (protein, carbohydrates, etc.) were levels of trypsin-inhibiter, an allergen which inhibits protein digestion and has been associated with enlarge cells in rat pancreases. Table 9 shows trypsin-inhibiter, levels that are 26.7 percent higher in the untoasted RR soybeans than in the conventional controls.

The authors' discussion of table 9 did not mention trypsin-inhibiter levels, which meant no mention was made in the online text version, sans tables, available in most libraries. In fact, we missed it the first few times through the tables, and we were looking for it.

An 1996 article describing Monsanto's research was published in the JOURNAL OF NUTRITION. It's title is "The composition of glyphosate-tolerant soybean seeds is equivalent to that of conventional soybeans," but statistically significant differences were measured in content of ash, fat carbohydrate and some fatty acids. The brain-boosting vitamin choline was 29% lower in Roundup Ready lecithin. Go figure.

In the text, the authors acknowledge "higher than expected" levels of trypsin inhibitor in Experiment 1, which was conducted on conventional and RR beans grown in Puerto Rico. The authors contend that the processing caused the elevated levels, but they noted elsewhere in the study that "processing soybean protein significantly inactivates TI." Moreover, processing was identical for Roundup ready beans and controls.

The did not report the data about the Puerto Rico beans in their published tables, calculations, or discussion. Their rationale: the beans were grown in a single Puerto Rico site, and the beans in Experiment 2 and 3, from several US sites, were "more representative of the wide geographical area in which soybeans are grown." They did not explain why they grew the Puerto Rico beans for the study in the first place. Nor did they explain why a comparison between batches of beans grown at the same site under identical conditions is less valid than comparisons among beans grown in different geographical areas under widely varying conditions.

Missing supplementary data

A footnote in the journal said that supplementary information on the Puerto Rico beans had been deposited with American Society for Information Science, National Auxiliary Publication Service under Doc. 04949. For a price, the data could be ordered.

Contrary to the authors' statement, the data filed under Doc. 04949 pertains to an unrelated study be a different author. The National Auxiliary Publication Service confirmed that the data was never deposited.

The missing information

The JOURNAL OF NUTRITION supplied the missing information. What did it reveal? It does indeed show higher levels of the allergen trypsin inhibitor in toasted RR soy meal thaN in the controls. In fact, by one measure the levels of trypsin inhibitor in toasted Roundup Ready meal were over the top of the literature range –he highest and lowest levels measured for soybeans by other researchers.

Roundup Ready beans were also significantly lower in protein and the aromatic amino acid phenylalanine. Drops in aromatic amino acid levels are of particular importance, because Roundup kills weeds by inhibiting an enzyme that helps the body make the aromatic amino acids. There were also significantly different levels of the amino acid cysteine and one fatty acid.

Data omitted from the published study also show that after a second toasting, the levels of an allergen called lectin in Roundup Ready meal nearly doubled the levels of the conventional control beans.

Besides possible allergic reactions, what might be expected from higher levels of trypsin-inhibitor and lectin? Well, animals would be expected to grow more slowly and gain less weight, and that is exactly what happened to male rats fed unprocessed meal from Roundup Ready soybeans.

Cows fed the RR soya meal showed higher levels of fat in their milk. Yet the title of the study is "The feeding value of soybeans fed to rats, chickens, catfish and dairy cattle is not altered by genetic incorporation of glyphosate tolerance," and the abstract makes no mention of the data that challenges their conclusion.

Introduce "substantial equivalence"

Don't research findings such as these point to the need for more testing, rather than immediate FDA blessing? EPA busted the suppliers of Starlink for similar shoddy research, and that is the reason Starlink is not approved for human consumption. EPA said, essentially, that the data in these studies did not support the authors conclusion and invited them to submit better studies. Ironically, the safety studies for foods now ubiquitous in the food supply also fail to support the authors' conclusions, according to Dr. Lappe and Dr. Joe Cummins. As Dr. Cummins puts it, "The concept of substantial equivalence has been introduced to commercialize genetically modified (GM) crops without extensive testing or labeling in the marketplace. The concept assumes that GM crops are equivalent seems to be being used as a license to distribute GM crops which are unsubstantially equivalent."

Suppress opposing research

The leaked Monsanto document also credits its response team for developing "rapid responses to avoid over-reaction to claims regarding...gene transfer by honey bees" referring to gene transfer from genetically engineered rapeseed to bacteria and fungi in the gut of honey bees detected by Professor Hans-Hinrich Kaatz from the Institut fur Bienenkunde (Institute for bee research) at the University of Jena. The story made its way into the Whole Life Times news column, but for the most part, the suppression was successful in the US. The document brags "Two op-eds on the honeybee issue by notable scientists were triggered to help avoid additional high profile press coverage."

Fund and recruit Notable Scientists

Monsanto and other producers of GE seeds fund plenty of research at universities around the world, making it easy to recruit "notable scientists" as mouthpieces. They also fund think tanks and similar organizations to spread their misleading messages.

An example of a widely published mouthpiece for big agribusiness is Dennis Avery, the author of SAVING THE PLANET WITH PESTICIDES AND PLASTICS, and currently is director of the Center for Global Food Issues for the Hudson Institute, a pro-corporate think tank with major funders such as Monsanto, DuPont, Novartis, Dow, and ConAgra. The biotech industry's PR firm, Burson-Marsteller, allegedly involved in a massive PR campaign to counteract the escalating global anti-GE movement in the US and abroad, is represented on Hudson Institute's board.

Herb London, President of the Hudson Institute, is a John M. Olin Professor of Humanities at New York University, a position funded by the John M. Olin Foundation. The Olin Foundation was created and is still controlled by the Olin Corporation, a leading North American chemical giant and top producer of agricultural chemicals, including sulfuric acid, fertilizers and pesticides.

Herb London also sits on the Board of Associates for the Palmer R. Chitester Fund – right-wing foundation which sells educational materials based on John Stossel's 20/20 reports on ABC, giving ABC a cut of the profits. Remember Stossel's 20/20 hatchet job on organic foods? Another major contributor to the Palmer R. Chitester Fund is the Olin Foundation. Is a picture beginning to emerge?

The corruptive inbreeding of interests does not end with the connections between agribusiness, a conservative foundation, a conservative think tank, a widely published media mouthpiece for agrigusniees, and a supposed independent journalist. We won't even start in on the well documented revolving door between Monsanto and FDA, or other US agencies that develop and implement biotech policy.

Is it any wonder that the American public does not hear about the real troubling issues in genetic engineering of foods, or that the pervasiveness of Starlink would be unsuspected but for the persistence of GE activists?

If you are interested in a free subscription to The Konformist Newswire, please visit and sign up. Or, e-mail with the subject: "I NEED 2 KONFORM!!!" (Okay, you can use something else, but it's a kool catch phrase.)

Top PreviousNextFront Page

Date: 31 Oct 2000 12:13:39 U
Biotech Activists
Posted: 10/31/2000 By

Monsanto Shows Third Quarter Loss


By Peter Shinkle; Of The Post-dispatch , St. Louis Post-Dispatch , October 31, 2000

In its first earnings report since being partly spun off to investors, Monsanto Co. said Monday that it has narrowed its losses and boosted sales of genetically altered seeds.

The company said it lost $ 66 million in the third quarter, or 25 cents a share, in contrast with the $ 127 million loss it reported in the same period of last year.

Monsanto, based in Creve Coeur, said its third-quarter loss would have dropped to $ 17 million from $ 56 million if one-time charges were excluded.

Monsanto President and Chief Executive Hendrik Verfaillie also said the agribusiness giant has seen strong growth in demand for genetically modified seeds, products that have come under steady protest this year from people concerned about their potential impact on health and the environment.

Verfaillie estimated that the total acreage planted with Monsanto's genetically modified seeds this year will reach 94 million acres worldwide, up by 9 percent from 1999.

"This 9 percent increase is testament to growers' continued very high satisfaction with these technologies, which improve their efficiency and reduce the quantity of chemicals they apply," he said in a conference call with securities analysts.

Despite the reported loss, Alex Hittle, an analyst with A.G. Edwards & Sons Inc., said the results are positive for Monsanto because they show that the company has not been derailed by the protests.

"The technology is really holding its own relative to the political atmosphere surrounding genetically modified crops," he said.

Monsanto's stock closed up 69 cents at $ 24.62 a share.

Meanwhile, Pharmacia Corp., the Swedish-U.S. drug maker that acquired Monsanto in April, said Thursday that strong sales of its Xalatan glaucoma drug and Celebrex arthritis drug helped push its earnings up 61 percent in the third quarter from the same period last year.

Pharmacia also revised expectations for its earnings for the fourth quarter, and its stock closed down $ 2 at $ 52.62.

Pharmacia merged Monsanto's Searle pharmaceutical business into its own drug businesses and on Oct. 18 spun off Monsanto's agricultural businesses into a separate company. Pharmacia owns 85 percent of Monsanto.

Monsanto employs 2,600 people in the St. Louis area, while Pharmacia employs about 800.

The third quarter is traditionally a weak one for Monsanto because of the cycle of sales of seeds and pesticides. But Monsanto also reported weak results for the first nine months of the year, earning $ 203 million, or 16 percent less than the same period last year.

However, if one-time charges are excluded, its first nine months show earnings of $ 430 million, or an increase of 17 percent.

Top PreviousNextFront Page

Date: 1 Nov 2000 09:21:54 U
From: "jcummins"

Approval of GM crops for animal feed not for human

Prof. Joe Cummins, November 1, 2000, e-mail:

In the debate over contamination of Starlink corn in humans destined for humans after the corn was approved as a biopesticide for animal consumption. The regimes for approving GM crops by government bureaucrats frequently employs the practice of approval for animal feed well before human should be allowed to face the dangerous food. Few of those discussing the problem of starlink pollution of human food have winced at the approval of a probably allergenic food product for animal feed.

Animals used for laboratory experimentation are said to be "sacrificed" on concluding an experiment. The experimental rabbits, sheep, chickens , ducks or other food animals would never be allowed to be used as food for humans or added to animal feed. The animals are normally burned with small ceremony. Using the animals as food crops to consume allergens seems both wasteful of information and rather unethical because the food animals may suffer unnecessary pain.

It is easy to see that farm animals do not have pockets for Kleenex when their noses run. Food allergy may cause chronic diarrhea or painful headaches. When sick animals fail to gain weight and obviously have low quality of life they are put down and sent for rendering, frequently as animal feed. No effort seems to have been taken to identify and record sick animals fed GM corn.

In the United States the polluted corn products were withdrawn from human consumption while in Canada the pollution seems to have been ignored. Canadian bureaucrats have a good deal more power over the population than those in the United States and appear to view them as substantially equivalent to farm animals. In Canada the human subjects of gene therapy experiments are considered "trade secrets" and information of their demise is considered company property.

Top PreviousNextFront Page

Date: 1 Nov 2000 16:48:00 U
From: Robert Mann

"No proof" is not the same as "no evidence"

By Dr Robt Mann, 00-11-2

I notice Elizabeth Whelan PhD, a long-time apologist for Big Chemicals, asserting in her recent essay mocking the Poms for their rejection of GEF "there is absolutely no evidence that GM foods will pose any unforeseen health hazards."

The brief article which I reproduce below for those who only recently joined this list shows considerable evidence for health hazards from one GM food. This evidence is not conclusive – it does not constitute *proof*; but it certainly is some evidence, as opposed to absolutely no evidence as Whelan claims.

Whelan reminds me of my govt's Agricultural Chemicals Board which in March 1980 announced solemnly "no scientific evidence from anywhere in the world has yet been presented to the Board to support the contention that 2,4,5-T has adverse effects on human reproduction".

My response is the same in each case: no proof? – correct; but "no evidence"? – you despicable liars.


Top PreviousNextFront Page

Dr Mann, a biochemist, served for its first dozen years on the Toxic Substances Board advising successive New Zealand ministers of health on poisons.
Dr Straton is a psychiatrist who has taken a special interest in therapeutic uses of tryptophan.
Mr Crist is a publicist who has interviewed researchers, victims, and lawyers involved with EMS.

The Thalidomide of Genetic Engineering

L R B Mann, D Straton & W E Crist
revised June 2000 from the GE issue of 'Soil & Health (NZ)' Aug '99:

By the end of the 1980s some millions of people, mostly in North America, were supplementing their diet with L-tryptophan, an essential amino-acid present in proteins of any normal diet. Amino-acids such as tryptophan are routinely produced in micro-breweries using suitable microbial cultures. One producer, Showa Denko K.K., artificially inserted genes into a bacterial species to increase its production of tryptophan.

Then in late 1989, some 5,000 – 10,000 in North America fell ill with a highly unusual illness, EMS (eosinophilia-myalgia syndrome) caused by Showa Denko tryptophan. Within months, dozens had been killed and thousands maimed. Today thousands continue to suffer permanent nasty effects, and a trickle of them continue to die early (at least 80 total by now). The epidemic ceased when over-the-counter tryptophan was severely restricted.

We emphasize that if thalidomide had happened to cause a type of birth defect that was already common, e.g. cleft palate or severe mental retardation, we would still not know about the harm, and pregnant women would have kept on taking it for its undoubted benefits. The fractional addition to figures which were already relatively large would not have been statistically significant. But as it turned out, the damage noticed was of a kind that most doctors never see in a whole career – drastic malformations of the arms & legs – so although the numbers were not huge these cases were picked up.

Similarly, impurities in the GE tryptophan happened to cause an illness (EMS) which was novel. The surge of numbers therefore stood out and got noticed. If Showa Denko's poison had caused the same numbers of a common illness instead, say asthma, we would still not know about it. Or if it had caused delayed harm, such as cancer 20 – 30 years later, or senile dementia in some whose mothers had taken it early in pregnancy, there would have been no way to attribute the harm to the cause.

This reminds us of the need for extreme caution with GE foods. They must be assumed guilty until lengthy tests have suggested they are, if not innocent, at worst guilty of only minor dangers. Such is nowhere near the case today as large companies rush to market their GE foods.

It is very disappointing to find a leading physician, Prof Sir John Scott, writing about this disaster thus: "Rare cases of EMS were known before the introduction of the genetically engineered bacterium, which further supports the hypothesis that EMS is not due to the genetic engineering event."

An exact analogue of that argument would run: "Rare cases of seal-limb were known before the introduction of thalidomide, which further supports the hypothesis that seal-limb is not due to thalidomide." But even more important is the fact that the trickle of about 100 early cases, years before the epidemic of late 1989, were due to (early versions of) Showa Denko GE microbial cultures. No other manufacturer's tryptophan caused EMS.

The contrast is startling with the elaborate procedure before registration of a new drug. It has taken a decade to get legal approval for supplementing humans with (a modified version of) the human hormone amylin, for treating diabetics. Yet GE foods are urged for legal distribution in great haste and with only extremely scanty testing, and the main discussion so far has been whether they should be labelled.

Labelling would not in itself be wrong, but can of course not substitute for the careful lengthy testing that would be needed before any GE food should be approved for human consumption. Labelling of GE food would imply acceptance by authorities, as does the ingredient list of any labelled food.

The Showa Denko disaster is crucial to understanding GE food. If a purified single chemical – the natural amino-acid L-tryptophan, better than 99% pure and definitely meeting the notorious 'substantial equivalence' test – can turn out when GEd to kill dozens and cripple thousands, what will it take to check properly a potato containing a synthetic 'exact' copy of a gene for a toxin from the African clawed toad?

And most urgently, the attempt to count as 'substantially equivalent' purified sugars, oils etc. is shown by the Showa Denko disaster to be a gamble. The assumption that soy oil from GE soybeans is exactly equivalent to ordinary soy oil requires the most careful scientific measurements to check it. Merely assuming 'substantial equivalence' will not do.

Those who search the internet on this topic will soon discover the claim by apologists for GE that the problem was only decreased purification of tryptophan. We disagree for several reasons – mainly, the first 3 GE strains had been causing EMS for years before this slackening of procedure in Jan 1989 when also the superproducer strain went into production and caused the epidemic. But this question cannot be settled with finality unless Showa Denko release the GE microbes for detailed examination.

Whether you believe the impurities were due to incompetent purification & monitoring, or to deviant metabolism in the GE-bugs, or both, you had better believe that the fabled 'substantially equivalent' assumption flopped in that epidemic of crippling & lethal illness.

The most menacing forms of biotechnology are genetically engineered foods and other uncontained GE organisms, but some other forms of biotechnology entail serious threats to public health which are under even less control than chemical poisons – and that's saying something.

If faulty filtering was indeed the problem, it follows that the production of amino-acids and other 'Health Food supplements' may be much more inherently hazardous than has been believed. Perhaps the Health Food Industry should be subject to controls on purity and safety comparable to those applied to the pharmaceutical industry.

Either way, biotechnology – which includes GE but also includes other processes such as purifying the mixture "lyprinol" from green-lipped mussels – requires much-enhanced scrutiny.

Good sources

  1. L-Tryptophan Puzzle Takes New Twist, Science 249 988, 31 August 1990

  2. Does Medical Mystery Threaten Biotech? Science 250 619, 2 November 1990

  3. EMS and Tryptophan Production: A Cautionary Tale, Trends in Biotech 12 346-352, September 1994.

  4. Eosinophilia-myalgia syndrome. Results of national surveillance. J Am Med Assoc 264 1698-703 1990


Robt Mann
consultant ecologist, P O Box 28878 Remuera, Auckland 1005, New Zealand, (9) 524 2949

Top PreviousNextFront Page

Date: 1 Nov 2000 17:29:22 U
From: "jcummins"

The information below is dated but shocking in its efforts to obfuscate the main finding and the problem area.The fact that the product was approved only for farm animals got obfuscated.

biotech missinformation on star link

Nature Biotechnology November 2000 Volume 18 Number 11 pp 1136 – 1137 Business and Regulatory News

Taco dispute underscores need for standardized tests

By Emma Dorey

On October 12, Safeway (Pleasanton, CA) removed its home-brand taco shells from supermarket shelves after Genetic Engineering Food Alert (GEFA; Washington, DC), a coalition of seven anti-biotechnology groups, said traces of a GM corn not yet approved for human consumption had been found in the shells.

The move follows that by Kraft Foods (Northfield, IL), which recalled all Taco Bell Home Originals taco shell products on September 22 after tests commissioned by GEFA suggested the presence of the same GM corn. It was the first time a product containing GM ingredients had been withdrawn in the US, and the episode sparked a flurry of demands for tightening of biotech regulations including discussions between members of congress and the FDA commissioner Jane Henney.

However, there has been no risk to human health, and the incident only illustrates the need for standardized tests and the importance that EPA set thresholds for the accidental mixing of ingredients.

The corn in question, StarLink, has been genetically modified by Aventis CropScience (Lyon, France) to express the insecticidal protein Cry9C from Bacillus thuringiensis. It is currently approved for animal consumption, but approval for human food use is pending.

Genetic ID (Fairfield, IA), which was commissioned by Friends of the Earth to test 23 products after the group "heard that genetically engineered corn is deadly to monarch butterflies", says it found 1% of corn DNA in the taco shells was StarLink. Kraft Foods subsequently withdrew the products from the market, and Aventis halted sales of StarLink seed, agreeing to pay the USDA to buy all StarLink corn grown this year (at least $90 million) to prevent it from "tainting" the US food supply.

Rep. Dennis Kucinich (D-OH) and 15 members of congress wrote to Henney reiterating calls for "stringent pre-approvals for ag and biotech products" and anti-biotech activists had a field day promoting the recall as a public health measure. The FDA subsequently announced it would test a wide range of food products for the presence of StarLink corn, and it is now likely food manufacturers, hoping to avoid a recall of their own, will begin specifying the use of conventional grain.

Lost in all this was that human health was not in jeopardy. StarLink is only pending approval for food use because it did not pass all of EPA's screens for allergenicity-Cry9C was not immediately broken down in digestion tests, which can be a sign of food allergens. "I do not believe there has been any risk to the public," says Steve Taylor of the department of Food Science and Technology at the University of Nebraska. He points out that Cry9C actually does not resemble known allergens, "so in fact may not be an allergen." In addition he adds that most allergenic proteins are present at levels of 1-40%, but that Aventis indicates that the Cry9C protein is present in corn kernels at 0.3% and that taco shells would contain far less.

In any event, it was not Cry9C but the gene encoding for its expression that was allegedly detected in the taco shells. "My understanding is that the protein has been looked for extensively and noone, but noone, has found any trace of the protein," says Val Giddings, vice president of food and agriculture at BIO. The gene is not suspected of having any health effects whatsoever.

Moreover, there is some debate that StarLink DNA has actually been detected. Jeffrey Smith, Genetic ID's vice president of marketing communications, says the test was run three times, each time in duplicate with a separate DNA extraction, and all PCR reactions were consistent. In addition, he says the result of the PCR reaction with the Starlink specific primer set was sent to another laboratory for sequencing to verify the sequence was StarLink. Genetic ID, he says, is "extremely confident in our procedures and in the result." In addition, Kucinich says that Kraft and the FDA have confirmed the presence of StarLink corn in the taco bell shells.

However, Aventis spokesperson Rick Rountree says Aventis has "not been able to re-confirm [Genetic ID's] results," and that "There is still a strong likelihood that another genetically modified ingredient in a corn that is approved for food use may have been there and could be triggering a false positive."

Richard Birkmeyer, president and CEO of Strategic Diagnostics (SDI; Newark, DE), which produces protein tests based on immunassay technology, explains: "The more processed the food," he says, "the less accurate and reliable the results, no matter what method, because you're destroying protein and DNA and you can get very erroneous results."

DNA tests based on PCR (like the one used by Genetic ID) are very reliable if done properly, says Giddings, but there are lots of ways to generate false positives, particularly if used on processed foods. "None of the tests [out there] are validated for use on processed foods," he adds. Indeed, Genetic ID, which was founded by anti-biotech proponent John Fagan, dean of Maharishi University of Management, has been involved in a false-alarm dispute in the past.

Although not necessary from a human-health standpoint, the controversy highlights the growing need for a reliable way to detect the presence of GMOs, and several groups, including Kraft, Kucinich, and BIO, advocate validated, standardized tests.

Addressing this, the Grain Inspection, Packers & Stockyards Administration (GIPSA; Washington, DC) is setting up the Biotechnology Reference Laboratory (BRL; Kansas City, MO). GIPSA deputy administrator David Shipman says the aim will be to facilitate the marketing of grains by providing standard testing references so that buyer and seller can have confidence that the results they're getting are accurate and consistent.

The voluntary program will accredit test kits and analytical laboratories on the basis of all sorts of criteria, including detection of GM ingredients. In addition, European authorities are in discussion with GIPSA about what form standardized tests should take as part of the new GMO traceability requirement of the European Council (Nat. Biotechnol. 18, 705;MEDLINE). Although not the aim of BRL, credible independent verification of the reliability of the tests being marketed may go some way to allaying irrational consumer fears, and Birkmeyer, Kucinich, and Giddings think the BRL will be good for the industry.

Meanwhile, much of the taco-shell palaver occurred because the EPA has not yet established the tolerance level of Cry9C for human food use. While the major risk to human health comes from living microbes, most food chains or processing systems have "aesthetic" limits for the accidental mixing of foreign material. For example, the FDA will allow 25 insect fragments and 2 rodent hairs or 1 "rodent excreta fragment" in 50 grams of cornmeal, and 5 fly eggs or 2 maggots in every 100 grams of tomato juice. The EPA must set a similar limit for Cry9C. "That absolutely has to take place," says Kucinich.

Top PreviousFront Page

Date: 1 Nov 2000 17:33:31 U
From: "jcummins"

The safety of producing such products in the field needs more discussion.

Transgenic Plants as Factories for Biopharmaceuticals

By Glynis Giddings, Gordon Allison, Douglas Brooks & Adrian Carter
Nature biotechnology November 2000 Volume 18 Number 11 pp 1151 – 1155, Review

Institute of Biological Sciences, University of Wales, Aberystwyth, Cledwyn Building, Aberystwyth Ceredigion SY23 3DD, UK. Correspondence should be addressed to G Giddings. e-mail:

Plants have considerable potential for the production of biopharmaceutical proteins and peptides because they are easily transformed and provide a cheap source of protein. Several biotechnology companies are now actively developing, field testing, and patenting plant expression systems, while clinical trials are proceeding on the first biopharmaceuticals derived from them. One transgenic plant-derived biopharmaceutical, hirudin, is now being commercially produced in Canada for the first time.

Product purification is potentially an expensive process, and various methods are currently being developed to overcome this problem, including oleosin-fusion technology, which allows extraction with oil bodies. In some cases, delivery of a biopharmaceutical product by direct ingestion of the modified plant potentially removes the need for purification. Such biopharmaceuticals and edible vaccines can be stored and distributed as seeds, tubers, or fruits, making immunization programs in developing countries cheaper and potentially easier to administer. Some of the most expensive biopharmaceuticals of restricted availability, such as glucocerebrosidase, could become much cheaper and more plentiful through production in transgenic plants.

Keywords: biopharmaceuticals, GM crops, edible vaccine, antibodies, production systems