Genetically
 Manipulated 


 

 
 
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29 February 2000

Table of Contents

Pharmacia&UpJohn in payment for organs scandal
Stealth Virus And Viteria
BAN literature, pamphlets, articles, videos and bumperstickers
European Patent Office Admits Genetic Patent Error
GMO fish and extinction
Anything for a Buck.
US: The Genetically Engineered Food Right-to-know Act, S. 2080
new Bt corn with no refuge
The Thalidomide Of Genetic Engineering

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Date: 21 Feb 2000 10:18:40 U
From: "Genetic Concern" geneticconcern@eircom.net
-----Original Message-----
From: Genetwork geneticconcern@eircom.net
Date: 12 February 2000 11:14
Subject: TNC-Pharmacia&UpJohn in payment for organs scandal

Pharmacia&UpJohn in payment for organs scandal

By Eamon Timmins, Irish Times February 10th 2000

Pharmaceutical firm confirms it got glands

A pharmaceutical company, Pharmacia & Upjohn, confirmed last night that it had removed glands from dead children and adults in Irish hospitals for 11 years, until 1985. The practice of removing pituitary glands came to light as part of an investigation into organ removal and retention procedures at Our Lady's Hospital for Sick Children in Dublin.

The multinational firm confirmed yesterday that the glands were provided by a number of hospitals in Ireland between 1974 and 1985, and it did not confine its search to children's glands.

Then called Kabi Vitrum, the company used the pituitary glands to produce a growth hormone for children of short stature. They were flown by the firm to its parent company in Sweden, which processed them to manufacture the drug, which was then sold globally.

The Minister for Health and Children, Mr Martin, could only confirm in reply to a written Dail question by Mr John Browne (FG, Carlow-Kilkenny), that Our Lady's Hospital received a contribution of £109.50 towards the hospital's research centre for the period between 1980 and 1981.

However, Pharmacia & Upjohn was unable to confirm yesterday how much it had paid for the glands over the 11 years. Neither could it confirm the identity of the hospitals which provided glands or even how many there were.

"We cannot be specific at this stage. We are in the early days of an investigation," a spokeswoman said. "We need to look into this in a lot more detail."

The firm insisted that the pituitary glands were the only known source of the hormone at the time. "This was the only method worldwide of producing human growth hormone for the treatment of children with growth hormone deficiency, which at that time was an area of significant unmet medical need.

"Human growth hormone is used for the treatment of children with growth hormone deficiency, who may otherwise suffer from severe growth defects."

The practice of using pituitary glands ceased in 1985 when a synthetic was developed.

Mr Martin said Our Lady's Hospital had confirmed that in the early 1960s a growth hormone was developed in the US using human pituitary gland as a source, and a National Pituitary Agency was established there to manufacture the growth hormone and prepare it for injection.

"In Ireland, hospitals were involved in the effort to avail of this growth hormone product, there being no other way to treat children with this condition other than the pituitary gland-derived product at that time," he said.

He added that he was informed by Our Lady's Hospital that it was an established practice among hospitals to transfer organs to other hospitals' laboratories. This commonly arose where a second opinion was required or when technical or professional expertise available in a different institution was required.


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Date: 21 Feb 2000 15:43:17 U
From: "j.e. cummins" jcummins@julian.uwo.ca

Stealth Virus And Viteria

By Prof. Joe Cummins, e-mail: jcummins@julian.uwo.ca , 21 February 2000

Stealth Viruses and Viteria

There has been a great deal of recent interest in the concept of stealth virus and a related phenomenon viteria. The basic concept is that certain viruses can avoid elimination by the immune system by deleting the genes in the virus that are readily recognized by the immune system. The first stealth virus was cultured from a patient with chronic fatigue system. The virus was found to be related to simian cytomegalovirus from the African green monkey and their was distinct homology to gene sequences expressed in human cells (Martin, W. ,1998 and 1999a).

The human stealth virus had gene sequences resembling genes in human cells and had originated from the African green monkey. A stealth virus was also identified in a child with a behavioral problem but with no other overt neurological signs in a virus epidemic in the Mohave Valley, the author suggests that stealth virus infection may contribute to children with behavioral problems (Martin and Anderson 1999). The Epstein-Barr virus is implicated in lymphoma and carcinoma cancers even though most adult humans are infected benignly and for life with the virus. That virus has been found to be the stealth virus of human B cells of the immune system and is dormant in resting human B memory cells (Thorely-Lawson and Babcock 1999). The authors believe that the stealth virus achieves its life cycle by using B cell biology not by disrupting it.

DNA sequences from cytomegalovirus stealth virus were also found homologous to genes from bacteria. The virus acquired bacterial sequences. The findings highlight the dynamic interface between viral and bacterial genomes and the interaction in emergence and spread of novel pathogens. The term viteria was proposed for microorganisms that contain both eukaryotic-viral and prokaryotic-bacterial sequences (Martin 1999b).

The discovery of stealth virus with a mixture of gene sequences some related to human genes and others to bacterial genes has prompted a great deal of discussion about the possibility that the bacterial sequences in the stealth virus originated from the gene cloning process in which virus DNA is amplified and identified using bacterial cloning vehicles. Viteria seem to have been discovered after the introduction of gene cloning but studies of virus and tissue samples frozen prior to 1972 should clear up that question of origin.

Stealth viruses are different from the endogenous (sleeping) viruses that are built into the genomes of animals and plants and the gene sequences derived from them. Such virus and transposon sequences make up a large part of most genomes. As genetics advances it grows clearer that the view that chromosomes are not just ribbons with codes for active gene sequences but they are jungles alive with sleeping viruses and mobile genes. Stealth viruses have learned to thrive by imitating chromosomal genes without joining the chromosome.

Taming the genome jungle greedily to benefit entrepreneurs is posing unforeseen pitfalls and dangers.

References

  1. Martin,W. Cellular sequences in stealth viruses Pathobiology 1998,66, 53-8

  2. Martin,W. Stealth adaptation of an African green monkey simian cytomegalovirus Exp Mol Pathol 1999 a ,66,3-7

  3. Martin,W. Bacteria-related sequences in a simian cytomegalovirus-derived stealth virus culture Exp. Mol Pathol 1999b, 66,8-14

  4. Martin,W. and Anderson,D. Stealth virus epidemic in the Mohave Valley: severe vacuolating encephalopathy in a child presenting with a behavioral disorder Exo Mol Pathol 1999,66,19-30

  5. Thorely-Lawson,D and Babcock,G. A model for persistent infection with Epstein-Barr virus: the stealth virus of human B cells Life Sci 1999,65,1433-53

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Date: 21 Feb 2000 20:04:53 U
From: Judy_Kew@greenbuilder.com (Judy Kew)

From now on, please send orders to BAN distro to us at the BAN account: ban@tao.ca

Thanx!

BAN literature, pamphlets, articles, videos and bumperstickers

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Date: 22 Feb 2000 17:50:17 U
From: Vegetarian Resource Center vrc@tiac.net

European Patent Office Admits Genetic Patent Error

The Associated Press, February 22 2000 4:53PM ET

Office Admits Genetic Patent Error

BERLIN (AP) - The European Patent Office on Tuesday admitted it made a mistake in granting a patent that critics claim would allow genetic manipulation of human organs and cells.

Facing protests from European governments and environmentalists, the Munich-based Patent Office said in a statement that the patent for research at Scotland's University of Edinburgh was flawed. non-human," which would make clear the approval does not apply to humans.

"We made a mistake," said Rainer Osterwalder, a spokesman for office established in 1977 to centralize the patent grant system, which currently includes 19 member countries. "This should not have been granted in the present form."

The environmental group Greenpeace, which discovered the mistake and led protests outside the Patent Office Tuesday, said the omission could be misinterpreted and used to support genetic cloning.

The Patent Office denied, however, that the patent could be extended to human cloning.

The patent refers to "a method of preparing a transgenic animal," but the non-human" should have been included because can also refer to humans.

The patent technically violates EU guidelines that take effect July 31 banning "processes that would change the genetic identity of human organisms."

Osterwalder said the office was investigating how the mistake got through, but he said inattention and a high volume of applications were likely to blame.

The patent, granted in December on a 1994 application, was sought for human cell research leading to possible replacement of diseased human tissue, such as that found in people suffering from Parkinson's disease, a spokeswoman at Edinburgh University said.

"The patent does not relate in any sense to the cloning of human beings," the spokeswoman said, speaking on condition of anonymity.

German and Italian politicians led protests Tuesday, pledging to file a challenge, the only remedy available. The Patent Office said it could not unilaterally undo the error.

German Health Minister Andrea Fischer said she would recommend Wednesday error. Justice Minister Herta Daeubler-Gmelin said the decision "cannot be reconciled with law and ethics."

Italy's EU policy minister, Patrizia Toia, said the Italian government may likewise take legal action to intervene against what she called a disastrous decision."


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Date: 23 Feb 2000 21:15:45 U
From: "Renu Namjoshi" renu@ispchannel.com

GMO fish and extinction

New Scientist magazine has an article on the dangers of a GM fish escaping to the wild. The link is
http://www.newscientist.com/ns/19991204/newsstory1.html

Extinction point

By Matt Walker, From New Scientist, 4 December 1999

It only takes one fish with the Trojan gene to invade a population and wipe it out

A SINGLE genetically modified fish could turn Darwinian evolution upside down and wipe out local populations of the species if released into the wild, biologists warn. They add that other organisms could face the same risk from transgenic relatives.

William Muir and Richard Howard of Purdue University in West Lafayette, Indiana, made the discovery while modelling ecological risks associated with genetically modified organisms (GMOs). They have dubbed their idea the "Trojan gene" hypothesis. "This resembles the Trojan horse," says Muir. "It gets into the population looking like something good and it ends up destroying the population.".

The researchers studied fish carrying the human growth hormone gene hGH, which increases growth rate and final size. Biologists in the US and Britain are experimenting with salmon engineered in a similar way, although no one has yet begun commercial production.

Muir and Howard included hGH in embryos of a fish called the Japanese medaka (Oryzias latipes), a common aquarium fish that is widely used in research. They found that modified individuals became sexually mature faster than normal fish and produced more eggs.

Other experiments using non-modified fish also showed that larger males attracted four times as many mates as their smaller rivals. This effect is also known in salmon. Muir predicts that bigger, engineered fish would enjoy the same advantages. So the hGH gene would quickly spread through a fish population.

But Muir and Howard also found that only two-thirds of engineered medaka survived to reproductive age compared with wild medakas. So the spread of the growth hormone gene could make populations dwindle and eventually become extinct.

To quantify this, the researchers plugged their results into a computer model to find out what would happen if 60 transgenic individuals joined a wild population of 60 000 fish. The population became extinct within just 40 generations. Even a single transgenic animal could have the same effect, they found, although extinction would take longer.

"You have the very strange situation where the least fit individual in the population is getting all the matings –his is the reverse of Darwin's model," says Muir. "The sexual selection drives the gene into the population and the reduced viability drives the population to extinction." The researchers say their results are the first evidence that GMOs could have catastrophic consequences on their own species.

David Penman, a fish geneticist at the University of Stirling, welcomes the discovery. But he says there is evidence that some transgenic fish modified with growth hormone have reduced sperm production and mating success. "If large males tend to mate with large females, this would often result in matings between transgenics," he adds. This would decrease rather than increase the spread of the gene.

But John Beringer of Bristol University, a former chairman of the British committee that advises the government on GMOs, says the research is a warning. "It would make it very difficult for anyone at the moment to approve the release of GM fish carrying growth hormone," he says. "I would have to give a great deal of consideration about whether that's an intelligent route to go down."

Muir says that the model may prove an invaluable tool in assessing the dangers of GMOs. He hopes to test its predictions in tightly controlled fish farm ponds.

Source: Proceedings of the National Academy of Sciences (vol 96, p 13 853)


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Date: 24 Feb 2000 00:40:03 U
From: RickVed@bellsouth.net

This is my letter to Dale Wilson of Lumens Foods who had an interchange with "Greg". Their discourse appears in full at the end of my comments.

-----Gerard Owmby

Anything for a Buck.

From: "Wilson, Dale" WILSONDO@phibred.com
To: sanet sanet-mg@ces.ncsu.edu
Subject: RE: Lumen Foods goes pro-GMO (& contact info.)
Date: Wed, Feb 23, 2000, 8:56 AM

Wilson: < Greg, I am by no means a spokesperson for the "evil empire", but I will try to answer your questions. >

Contrary to your opening assertion, you most certainly are a spokesman for the genetic engineering industry.

Wilson: < 99% of the genetics that feeds the world are in the public domain. We may have assembled [these corn varieties] into "cadillac" varieties, but the building blocks are there for everyone to use. >

In that case, Monsanto's trespassing, crop damage, and lawsuits against farmers whose traditional fields have been contaminated by patented, wind-born GM pollens should be of interest to you.

Wilson: < Where do you draw the line? In an edenic sense, all agriculture is probably unnatural. I think that if you follow this line of reasoning carefully, you will see that appeal to natural law cannot provide a firm foundation for these judgements.... GMO's are insignificant compared to the domestication of crops and livestock. >

Indeed, where DO you draw the line? I think that if you follow this line of reasoning carefully, you will see that only an appeal to natural law can provide a firm foundation for life. You are talking about the beauty of giving nature a place to grow, and Greg is talking about the dangers of violating the barriers that nature has put into place.

This outdated science of genetic reductionism, as opposed to the recent discoveries of the Fluid Genome, is non-systematic and imprecise. It is not science. Using viruses and bacteria as penetrators to carry genes of one specie into the genome of another creates lifeforms not possible in nature. Furthermore, those involved in propagating this so-called iengineeringi do not understand the long-term consequences of these imprecise tamperings. By its very identity, genetic engineering makes use of the invasion of viruses into genes.

This principle of horizontal gene transfer allows the soil, earthworms, insects, pollens, other plants, animals, and humans to take up those viruses and bacteria used as vectors in these invasive practices, thus weakening our own immune systems and altering our own genes. This not only makes humans susceptible to disease, but alters our own consciousness and our identities as human beings. You have volunteered for this experiment.

Greg: < How about explaining when or even why the crops would ever produce a genetically manipulated product that will actually benefit the hungry of the world? >

Wilson: < I personally know of many, many people with genuinely good motives in the seed industry, who really do want to help feed the world. But of course the reason this is in the private sector is because people will pay money to buy food. Not very much of the money actually gets to the seed companies, but a little does. And the market for seed is very, very competitive. Tiny differences in service, performance or flexibility cause major shifts in market share. We are striving for excellence (so we can have a job in 5 years). >

OK. Now how about explaining when or even why the crops would ever produce a genetically manipulated product that will actually benefit the hungry of the world? And while you are at it, tell us why the world needs more food when it already produces one and a half times the amount food required to feed the world. I suppose your reasons are humanitarian. Perhaps industry wants to keep more people alive so that the population bomb will grow into mass starvation so that industry can make more profits which will be used to feed those who can afford to survive. Or something like that.

Wilson: < Of course we want our varieties to be so good that people will buy them! Don't you try to produce the best hogs so people will pay a premium? I'll bet you bust your butt in the pursuit of excellence. I do too. >

By bust your butt, I presume you are referring to exploding cigarettes, since any such usage in inference to the human anatomy would be out of place in a discourse so refined as yours. Here's a tip: Producing better hogs means producing better blood. If you drink the blood right out of the pig as soon as you split it open, once you get past the smell, it is ever-so-tastey and much more full-bodied.

I foresee a looming boom market in Satanic rituals and Gothic festivals in the so-called iscientifici community – a boom so powerful and all-encompassing in its sweep that high-quality pig blood sold to millions and millions of comfortably-employed, eyes-glazed-over genetic-technicians-for-hire could make you even more money than genetically engineered crops. It's something to think about.


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Date: 24 Feb 2000 21:23:15 U
From: GMOStuff@aol.com

US: The Genetically Engineered Food Right-to-know Act, S. 2080

Sections:
Mrs. Boxer's speech in parliament
The text of the legislation follows:

Mrs. Boxer's speech in parliament

By Mrs. BOXER.
http://www.thecampaign.org/activities.htm#National

Mr. President, today I am pleased to introduce the Genetically Engineered Food Right-to-Know Act. This legislation requires that all foods containing or produced with genetically engineered material bear a neutral label stating that: `this product contains a genetically engineered material or was produced with a genetically engineered material.' The bill adds this labeling requirement to the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Meat Inspection Act, and the Poultry Products Inspection Act which contain the general standards for labeling foods.

Recent polls have demonstrated that Americans want to know if they are eating genetically engineered food. A January 1999 Time magazine poll revealed that 81% of respondents wanted genetically engineered food to be labeled. A January 2000 MSNBC poll showed identical results.

This pressure has already led some companies not to use genetically engineered materials in their foods. Gerber and Heinz have said they will no longer use genetically engineered material in their baby food. Whole Foods and Wild Oats Supermarkets also have said they will use no genetically engineered material in their own products.

Great Britain, France, Germany, the Netherlands, Belgium, Luxembourg, Denmark, Sweden, Finland, Ireland, Spain, Austria, Italy, Portugal, Greece, New Zealand, and Japan already require genetically engineered food to be labeled.

If the U.S. wants to sell its genetically engineered food to these countries, it will have to label the food for foreign consumers. It is only fair that American consumers be given similar information.

Why do I feel it's important for consumers to know that their food is genetically engineered?

First, we don't know whether genetically engineered food is harmful or whether it is safe. However, scientists have raised concerns about genetically engineered food. These concerns include the risks of increased exposure to allergens, decreased nutritional value, increased toxicity and increased antibiotic resistance.

In addition, scientists have raised concerns about the ecological risks associated with genetically engineered food. Some of those risks include the destruction of species, cross pollination that breeds new weeds that are resistant to herbicides, and increases in pesticide use over the long-term.

Earlier this year, for example, researchers at Cornell University reported that Monarch butterflies were either killed or developed abnormally when eating milkweed dusted with the pollen of Bt-corn, a genetically engineered food.

Second, the Food and Drug Administration does not require pre-market health and safety testing of genetically engineered foods. Therefore, it is only fair that consumers know they are eating products that have not been tested.

Third, the Environmental Protection Agency and the Department of Agriculture do not require substantive environmental review of genetically engineered materials under their jurisdiction.

My Genetically Engineered Food Right-to-Know Act not only mandates labels, but does something even more important: it authorizes $5 million in grants to conduct studies into the health and environmental risks raised by genetically engineered food.

Specifically, it directs the Secretary of HHS to make grants to individuals, organizations and institutions to study risks like increased toxicity, increased allergenicity, negative effects on soil ecology and on the environment in general.

What is the extent of genetically engineered crops today?

Last year, 98.6 million acres in the U.S. were planted with genetically engineered crops. More than one-third of the U.S. soybean crop and one-quarter of corn were genetically engineered. This represents a 23-fold increase in genetically engineered crop production from just four years ago.

And waiting to come into the marketplace are more than 60 different genetically engineered crops –rom apples and strawberries to potatoes and tomatoes.

Providing consumers with information about the foods they eat is hardly new.

For example, I was proud to be the author of the law to provide for the `dolphin safe' label on tuna. The label indicated that the tuna was harvested by methods that don't harm dolphins.

I was also proud to lead the fight in the Senate to make sure that chicken frozen as solid as a blowing ball could not be labeled fresh. At the time, USDA's position was that frozen chicken could be labeled `fresh.'

In 1996, I succeeded in amending the Safe Drinking Water Act to require that drinking water providers give their consumers annual reports concerning the quality of their water.

Others in Congress led the fight to tell consumers whether their products contain artificial colors or sweeteners, preservatives, additives, and whether they are from concentrate. I supported those labels as well.

Food manufacturers also label their products with information that is of little value to consumers. Certain brands of pretzels, for example, bear a label which states that the manufacturer is a `Member of the Snack Food Association: An International Trade Association.'

I don't think this is information consumers are clamoring for, yet the manufacturer is willing to go through the trouble of putting it on the bag.

My legislation builds on the existing food labeling system, and would be simple to implement. It would require that all foods containing or made with genetically engineered foods be labeled with this information: `this product contains a genetically engineered material or was produced with a genetically engineered material.'

For example, corn flakes made with genetically engineered corn would be a `product that contains' genetically engineered material. To take another example, milk from a cow treated with genetically engineered bovine growth hormone would be a product `produced with' genetically engineered material.

Specifically, my bill requires that food that contains or was produced with genetically engineered material be labeled at each stage of the food production process –rom seed company to farmer to manufacturer to retailer. The labeling requirement in my bill, however, does not to apply to drugs or to food sold in restaurants, bakeries, and other similar establishments.

Genetically engineered material is defined under the bill as material that `has been altered at the molecular or cellular level by means that are not possible under natural conditions or processes.' Food developed through traditional processes such as crossbreeding is not considered to be genetically engineered, and the legislation's labeling requirement would not apply to foods produced in that way.

Under the bill, persons need not label food if they obtain a written guaranty from the party from whom they received the food that the food does not contain and was not produced with genetically engineered material. Persons who obtain a valid guaranty are not subject to penalties under the bill if they are later found to have failed to label food that contains genetically engineered material.

For example, a farmer who plants genetically engineered corn must label that corn. Each person who then buys and then sells that corn, or food derived from it, will also be required to label it as genetically engineered.

Conversely, farmers who obtain a guaranty that the corn they are planting is not genetically engineered may issue a guaranty to purchasers that their corn is not genetically engineered. The purchaser then would not have to label that corn or product made with that corn.

If the corn or food is later found to have contained or been produced with genetically engineered material but was not labeled accordingly, the purchaser would not be subject to penalties under the bill.

This guaranty system is used today to enforce provisions of existing law concerning the distribution of adulterated or mislabeled foods. The system is much less expensive than a system which would require food to be tested at every phase of the food production process.

Failure to label food that contains or was produced with genetically engineered material carries a civil penalty of up to $1,000 amount for each violation.

Importantly, the bill provides that if a party fraudulently warrants that a product is not genetically engineered, no party further down the chain of custody may be held liable for mislabeling. This provision is particularly meant to protect small farmers from the possibility that their suppliers would by contract provide that any liability for mislabeling be borne by the farmer regardless of the suppliers' own actions.

The bill also provides another protection for farmers. Under the bill, a farmer who plants a non-genetically engineered crop, but whose crop came to contain genetically engineered material from natural causes such as wind carrying pollen from a genetically engineered plant is not subject to penalties under the bill. This is the case so long as the farmer did not intend or did not negligently permit this to occur.

And, finally, the bill directs the Secretary of HHS to make grants to study the possible health and environmental risks associated with genetically engineered foods. The bill authorizes $5 million for this purpose.

In closing, Mr. President, during the recent negotiations on the Biosafety Protocol, it was the United States' negotiating position that international shipments of seeds, grains and plants that may contain genetically engineered material be labeled accordingly.

If the United States took the position that it is appropriate to provide this information to its trading partners, shouldn't we make similar information available to American consumers?

I am hopeful that my House and Senate colleagues can act quickly to ensure the passage of my legislation to give American families the right-to-know whether their food contains or was produced with genetically engineered material.

I ask that the text of my legislation be printed in the Record.

The text of the legislation follows:

S. 2080 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.
This Act may be cited as the `Genetically Engineered Food Right-to-Know Act'.

SEC. 2. FINDINGS.
Congress finds the following:

(1) In 1999, 98,600,000 acres in the United States were planted with genetically engineered crops, and more than 1/3 of the soybean crop, and 1/4 of the corn crop, in the United States was genetically engineered.

(2) The process of genetically engineering foods results in the material change of such foods.

(3) The health and environmental effects of genetically engineered foods are not yet known.

(4) Individuals in the United States have the right to know whether food contains or has been produced with genetically engineered material.

(5) Federal law gives individuals in the United States the right to know whether food contains artificial colors and flavors, chemical preservatives, and artificial sweeteners by requiring the labeling of such food.

(6) Requirements that genetically engineered food be labeled as genetically engineered would increase consumer knowledge about, and consumer control over consumption of, genetically engineered food.

(7) Genetically engineered material can be detected in food at levels as low as 0.1 percent by reasonably available technology.

SEC. 3. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) In General: Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following paragraph: `(t)(1) If it contains a genetically engineered material, or was produced with a genetically engineered material, unless it bears a label (or labeling, in the case of a raw agricultural commodity) that provides notices in accordance with each of the following requirements:

`(A) The label or labeling bears the following notice: `GENETICALLY ENGINEERED'.

`(B) The label or labeling bears the following notice: `THIS PRODUCT CONTAINS A GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A GENETICALLY ENGINEERED MATERIAL'.

`(C) The notice required in clause (A) immediately precedes the notice required in clause (B) and the type for the notice required in clause (A) is not less than twice the size of the type for the notice required in clause (B).

`(D) The notice required in clause (B) is the same size as would be required if the notice provided nutrition information that is required in paragraph (q)(1).

`(E) The notices required in clauses (A) and (B) are clearly legible and conspicuous.

`(2) This paragraph does not apply to food that –

`(A) is served in restaurants or other similar eating establishments, such as cafeterias and carryouts;

`(B) is a medical food as defined in section 5(b) of the Orphan Drug Act; or

`(C) was grown on a tree that was planted before the date of enactment of the Genetically Engineered Food Right-to-Know Act, in a case in which the producer of the food does not know if the food contains a genetically engineered material, or was produced with a genetically engineered material.

`(3) In this paragraph:

`(A) The term `genetically engineered material' means material derived from any part of a genetically engineered organism, without regard to whether the altered molecular or cellular characteristics of the organism are detectable in the material.

`(B) The term `genetically engineered organism' means –

`(i) an organism that has been altered at the molecular or cellular level by means that are not possible under natural conditions or processes (including recombinant DNA and RNA techniques, cell fusion, microencapsulation, macroencapsulation, gene deletion and doubling, introduction of a foreign gene, and a process that changes the positions of genes), other than a means consisting exclusively of breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture; and

`(ii) an organism made through sexual or asexual reproduction, or both, involving an organism described in subclause (i), if possessing any of the altered molecular or cellular characteristics of the organism so described.

`(C) The term `produced with a genetically engineered material', used with respect to a food, means a food if –

`(i) the organism from which the food is derived has been injected or otherwise treated with a genetically engineered material (except that the use of manure as a fertilizer for raw agricultural commodities may not be construed to be production with a genetically engineered material);

`(ii) the animal from which the food is derived has been fed genetically engineered material; or

`(iii) the food contains an ingredient that is a food to which subclause (i) or (ii) applies.'. (b) Guaranty:

(1) In general: Section 303(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(d)) is amended –

(A) by striking `(d)' and inserting `(d)(1)'; and

(B) by adding at the end the following paragraph:

`(2)(A) No person shall be subject to the penalties of subsection (a)(1) or (h) for a violation of section 301(a), 301(b), or 301(c) involving food that is misbranded within the meaning of section 403(t) if such person (referred to in this paragraph as the `recipient') establishes a guaranty or undertaking that –

`(i) is signed by, and contains the name and address of, a person residing in the United States from whom the recipient received in good faith the food (including the receipt of seeds to grow raw agricultural commodities); and

`(ii) contains a statement to the effect that the food does not contain a genetically engineered material or was not produced with a genetically engineered material.

`(B) In the case of a recipient who, with respect to a food, establishes a guaranty or undertaking in accordance with subparagraph (A), the exclusion under such subparagraph from being subject to penalties applies to the recipient without regard to the manner in which the recipient uses the food, including whether the recipient is –

`(i) processing the food;

`(ii) using the food as an ingredient in a food product;

`(iii) repacking the food; or

`(iv) growing, raising, or otherwise producing the food.

`(C) No person may avoid responsibility or liability for a violation of section 301(a), 301(b), or 301(c) involving food that is misbranded within the meaning of section 403(t) by entering into a contract or other agreement that specifies that another person shall bear such responsibility or liability, except that a recipient may require a guaranty or undertaking as described in this subsection.

`(D) In this paragraph, the terms `genetically engineered material' and `produced with a genetically engineered material' have the meanings given the terms in section 403(t).'.

(2) False guaranty: Section 301(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(h)) is amended by inserting `or 303(d)(2)' before `, which guaranty or undertaking is false' the first place it appears.

(c) Unintended Contamination: Section 303(d) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b)(1), is further amended by adding at the end the following paragraph:

`(3)(A) No person shall be subject to the penalties of subsection (a)(1) or (h) for a violation of section 301(a), 301(b), or 301(c) involving food that is misbranded within the meaning of section 403(t) if –

`(i) such person is an agricultural producer and the violation occurs because food that is grown, raised, or otherwise produced by such producer, which food does not contain a genetically engineered material and was not produced with a genetically engineered material, is contaminated with a food that contains a genetically engineered material or was produced with a genetically engineered material (including contamination by mingling the 2 foods); and

`(ii) such contamination is not intended by the agricultural producer. `(B) Subparagraph (A) does not apply to an agricultural producer to the extent that the contamination occurs as a result of the negligence of the producer.'.

(d) Civil Penalties: Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following subsection:

`(h)(1) With respect to a violation of section 301(a), 301(b), or 301(c) involving food that is misbranded within the meaning of section 403(t), any person engaging in such a violation shall be liable to the United States for a civil penalty in an amount not to exceed $1,000 for each such violation. `(2) Paragraphs (3) through (5) of subsection (g) apply with respect to a civil penalty assessed under paragraph (1) to the same extent and in the same manner as such paragraphs (3) through (5) apply with respect to a civil penalty assessed under paragraph (1) or (2) of subsection (g).'.

SEC. 4. GRANTS FOR RESEARCH ON GENETICALLY ENGINEERED FOOD.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

`SEC. 908. GRANTS FOR RESEARCH ON GENETICALLY ENGINEERED FOOD.
`(a) In General: The Secretary may make grants to appropriate individuals, organizations, and institutions to conduct research into the public health and environmental risks associated with genetically engineered materials, food that contains a genetically engineered material, and food that is produced with a genetically engineered material, including risks related to –

`(1) increased allergenicity;

`(2) increased toxicity;

`(3) cross-pollination between genetically engineered materials and materials that are not genetically engineered materials; and

`(4) interference with the soil ecosystem and other impacts on the ecosystem. `(b) Authorization of Appropriations:

`(1) In general: There is authorized to be appropriated $5,000,000 for fiscal year 2001 to carry out the objectives of this section.

`(2) Availability: Any sums appropriated under the authorization contained in this subsection shall remain available, without fiscal year limitation, until expended. `(c) Definitions: The terms `genetically engineered material' and `produced with a genetically engineered material' have the meanings given the terms in section 403(t)(3) of the Federal Food, Drug, and Cosmetic Act.'.

SEC. 5. CONFORMING AMENDMENTS.
(a) Section 1(n) of Public Law 90-201 is amended –

(1) in paragraph (11), by striking `or' at the end;

(2) in paragraph (12), by striking the period at the end and inserting `; or'; and

(3) by adding at the end the following:

`(13) if –

`(A) it contains a genetically engineered material, or was produced with a genetically engineered material; and

`(B)(i) it does not bear a label or labeling, as appropriate, that provides the notices required under the terms and conditions of section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)); or

`(ii) it is the subject of a false guaranty or undertaking, subject to the terms and conditions of section 303(d) of that Act (21 U.S.C. 333(d)) and subject to the penalties described in section 303(h) of that Act (21 U.S.C. 333(h)) and remedies available under this Act.'.

(b) Section 4(h) of Public Law 85-172 is amended –

(1) in paragraph (11), by striking `or' at the end;

(2) in paragraph (12), by striking the period at the end and inserting `; or'; and

(3) by adding at the end the following:

`(13) if –

`(A) it contains a genetically engineered material, or was produced with a genetically engineered material; and

`(B)(i) it does not bear a label or labeling, as appropriate, that provides the notices required under the terms and conditions of section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)); or

`(ii) it is the subject of a false guaranty or undertaking,

subject to the terms and conditions of section 303(d) of that Act (21 U.S.C. 333(d)) and subject to the penalties described in section 303(h) of that Act (21 U.S.C. 333(h)) and remedies available under this Act.'.

SEC. 6. EFFECTIVE DATE.
This Act and the amendments made by this Act take effect 180 days after the date of enactment of this Act.


Top PreviousNextFront Page

Date: 25 Feb 2000 10:43:42 U
From: "j.e. cummins" jcummins@julian.uwo.ca

Dan Ferber is a writer in Urbana, Illinois.

new Bt corn with no refuge

ECOLOGY:

New Corn Plant Draws Fire From GM Food Opponents

By Dan Ferber, Science, Volume 287, Number 5457 Issue of 25 Feb 2000, p 1390
© 2000 by The American Association for the Advancement of Science.

Improved methods for controlling corn rootworms could help the farmer, but a novel corn strain genetically modified to do just that is raising safety concerns

The next battle in the war over genetically modified (GM) foods may be shaping up in Washington, D.C. In December, Monsanto Corp. applied to the U.S. Environmental Protection Agency (EPA) for approval to field-test and sell a new line of modified corn. The plant carries a bacterial gene that produces a toxin that kills one of the toughest insect pests of corn, the so-called corn rootworm complex, actually the larvae of three related beetle species.

A go-ahead for field tests could come as early as next month, and Monsanto says it hopes to be able to sell seeds to farmers in time for planting next year. But biotech watchdogs are urging EPA to reject Monsanto's applications unless a host of safety questions are answered.

Currently, corn rootworms, which infest virtually all of the 30 million hectares of corn planted annually in the United States, are controlled either by rotating corn with another crop, such as soybeans, whose roots are not palatable to the pests, or with chemical insecticides. For the most part, the insecticides are applied to the 5.7 million hectares where crop rotation isn't practiced. Even so, they cost farmers about $200 million each year –bout one-fifth of the total spent on insecticides for all crops in the United States.

The new GM corn could dramatically reduce this pesticide use, at least for a few years, experts say. "Farmers have been waiting for something like this for a long time," says Fred Yoder, a spokesperson for the National Corn Growers Association who farms about 400 hectares of corn, soybeans, and alfalfa near Plain City, Ohio. Indeed, finding a new rootworm control strategy is becoming increasingly important as rootworms are becoming resistant, not just to chemical pesticides but to the crop rotation strategy as well. In the past few years, some beetles have adapted to lay eggs in soybean fields that hatch to attack the next year's corn crop.

But despite the potential benefits of a rootworm-resistant corn plant, the new strain is raising concerns among environmental and consumer groups. Monsanto scientists created the modified corn by putting in the gene encoding one of the Bt toxins, so called because they come from the soil bacterium Bacillus thuringiensis. But this toxin, from B. thuringiensis tenebrionis, is different from the ones previously used to produce corn resistant to the European corn borer, which don't deter rootworms. And because no transgenic crop expressing this toxin has ever been planted commercially, all sorts of safety questions should be addressed anew, says Charles Benbrook, an agricultural consultant in Sand Point, Idaho, who works with consumer and environmental groups.

He and representatives of three public-interest groups, including Consumers Union, the publisher of Consumer Reports, urged the EPA in written comments to reject the application to field-test the corn unless Monsanto proves that it is not toxic to other species, including beneficial beetles such as the pest-eating ladybird beetle. The company also needs to show, Benbrook says, that the toxin breaks down in soil and doesn't harm soil organisms, a particular concern given recent work showing that the roots of other Bt corn plants secrete their toxins into the soil (Nature, 2 December 1999, p. 480), where they can bind to soil particles and remain active for months. Finally, the groups opposing the new corn strain worry that it could lead to the development and spread of Bt-resistant corn rootworms, which could ultimately make the technology useless.

Entomologist Michael Gray of the University of Illinois, Urbana-Champaign, considers such resistance inevitable. He points out that the worms eat little else except corn roots, which means they can't escape to so-called refuges that are free of the toxin as European corn borers can, and that they've already demonstrated their adaptability by becoming resistant to chemical pesticides. "Any notion that they will not develop resistance to transgenic [corn] is foolhardy," Gray says.

But Randy Krotz, director of business and industry affairs for Monsanto, says that the company has been working for more than 2 years with corn-rootworm experts from midwestern universities to devise a plan to contain resistance to the Bt toxin should it develop. He also says that Monsanto has already conducted its own studies, some of which were submitted with the applications, showing that the corn does not secrete the Bt toxin into the soil. Even if it did, he adds, toxicity studies show that the new corn line does not harm nontarget organisms such as earthworms, ladybird beetles, lacewings, and more than nine other species. "The environmental profile is great," Krotz says.

Buoyed by these results, Monsanto is pushing the technology as fast as it can. The company applied in mid-December to conduct large-scale field tests, and they applied less than 2 weeks later for full commercialization, even though the field tests, if approved, would not be completed until late next summer. Other biotech companies say they are not far behind. Novartis Biotechnology is developing its own transgenic corn for corn rootworm control, and a joint effort by Dow Agrosciences and Pioneer Hi-Bred International has already yielded rootworm-resistant Bt corn lines.

EPA will take a hard look at the new technology before deciding whether to approve it, says Steve Johnson, associate deputy assistant administrator for the EPA's Office of Prevention, Pesticides, and Toxic Substances. "If we feel that there is additional research needed, we'll not grant the EUP [Experimental Use Permit for field trials] or the full license," he says. But under the most favorable scenario for Monsanto, the EUP could be granted as early as March, although the agency won't decide whether to let Monsanto commercialize the corn until after data are in from the field tests. Meanwhile, biotech watchdogs are getting ready to bark if EPA approves the crops quickly. "There will be a global reaction," Benbrook says.


Top PreviousFront Page

Date: 28 Feb 2000 15:15:38 U
From: Robert Mann robt_m@talk.co.nz

no evidence, huh?

INDEPENDENT (London)28 February 2000
Ian Gibson, MP for Norwich and a member of the Science and Technology Select Committee, said Americans had been eating GM foods for at least 15 years with no noticeable ill-effects.

"Unless Tony has been doing experiments in his spare time, there is no evidence, scientifically, that any GM food causes harm to human health," he said.

NO EVIDENCE says this MP.

For those who have joined this list recently, I copy a prevous note falsifying his claim.

-=-=-=-=-=-=-=-==-

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.

The Thalidomide Of Genetic Engineering

L R B Mann & D Straton
(slightly revised from the GE issue of 'Soil & Health (NZ)' July 99)

By the end of the 1980s some millions 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, thousands in North America fell ill with a highly unusual if not completely novel illness, EMS (eosinophilia-myalgia syndrome). 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 (around 75 total by now). Showa Denko has paid over U$2B to keep the resulting damages suits out of court.

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 GEd tryptophan happened to cause an illness (EMS) which is normally extremely rare. The surge of numbers therefore stood out and got noticed. If Showa Denko's poison had caused the same numbers but 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, presRSNZ - 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."

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 – and it is still not finally approved. 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 purported single chemical – the natural amino-acid tryptophan, better than 98.5% 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' or 'improved' 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 incompetent purification of one batch of tryptophan. We disagree for several reasons – for one thing, faulty filters had been used previously without apparently leading to epidemics like this. But this question of fact is unlikely to be settled with finality, if only because Showa Denko claim the GE microbe has been exterminated so that the experiment cannot be re-run.

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 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 additives' 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 some other unrelated processes such as purifying "lyprinol" from green-shell 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, TIBTECH 12 346-352, September 1994.

~~~~~~~

We are at pains to say there is not PROOF that GE caused this disaster; and to point out why there is no proof (destruction by the accused of the key material evidence); but the claim that these facts amount to NO EVIDENCE is false.

R