Genetically
 Manipulated 


 

 
 
 Food


 News

15 November 99

Table of Contents

List of Approved GE foods in Canada
Farmers Delay Buying Canola Seed
Biotech Companies Take on Critics of Gene-Altered Food
Cotton-Seed Firm's Stock Drops on Market Concern of Monsanto Deal
Monsanto Co. Reportedly Expects Sale or Merger
US bill would require labels on biotech foods
Corn Growers Endorse Labeling for Foods Containing Genetically Altered Products
Merger rumour: Monsanto and Novarits?
Monsanto faces its many options
Beyond 'Substantial Equivalence'
The failings of the principle of substantial equivalence in regulating transgenic foods
Proposal for Biotech Incubator: To be Paid by Municipality
GM chickens could be drug factories
Pfizer interested in Monsanto's Searle
Delta and Pine-Monsanto link up still not together
EU says U.S. interested in beef compensation

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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

List of Approved GE foods in Canada

List of approved GE foods in Canada is at the website http://www.cfia-acia.agr.ca/english/plant/pbo/okays.html

This list of approved GE foods in Canada shows 13 canola, 3 tomato, 5 potato, 13 corn, 1 soybean, 1 flax, 4 cotton, 2 squash.

There is also 1 GE wheat variety on the list, but it is not fully approved. Initial approved for animal feed has been done for the GE wheat, but it is not approved for human consumption. And even for animal use, it has not been fully registered yet.

For the squash and tomato, it appears they may not be approved for growing in Canada, but are approved for import and sale in Canada.


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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

Farmers Delay Buying Canola Seed

by Michael Raine, Saskatoon newsroom
The Western Producer, November 11, 1999

WINNIPEG – According to this story, the debate over genetically modified organisms has made the choices of canola more confusing and has resulted in a lower than normal demand for canola seed this fall. " Craig Evans, Monsanto Canada's general manager for biotechnology, was quoted as saying, "I can understand why farmers haven't been rushing out to order their seed yet. Many are confused by all the talk about the future of (GMO) canola and other varieties with novel traits." Evans said the late fall has had an impact on farmer decisions, but the controversy over the future of GM canola and the question about whether there will be a market for it is also a factor.


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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

Biotech Companies Take on Critics of Gene-Altered Food

By DAVID BARBOZA, New York Times, November 12, 1999

CHICAGO – Worried about growing resistance to genetically modified foods, some of the world's biggest biotechnology companies are mounting a huge lobbying and marketing campaign to counter their critics and combat what they call a rising wave of anti-biotech hysteria.

Makers of genetically modified seeds have taken a beating this year in Europe, where critics have sabotaged test plots of altered crops and have fostered widespread distrust of what they call Frankenstein foods.


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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

Cotton-Seed Firm's Stock Drops on Market Concern of Monsanto Deal

St. Louis Post-Dispatch, Missouri via NewsEdge Corporation, Nov. 11

As Monsanto Co. gets battered by rumors about its fate, one of its partners is getting battered on Wall Street.

Shares of Delta & Pine Land Co. dropped $1.25 a share Wednesday, closing at $26. The stock plunged $5.25 a share Tuesday, as investors apparently fear Monsanto's effort to buy the world's largest cotton seed company will be delayed or even killed.

"The market is saying this deal is in trouble," said Tom Burnett, founder of Merger Insight, a New York investment research firm.

"I don't know whether the deal will go through," said one person familiar with Monsanto and Delta. "It's frustrating."


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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

Monsanto Co. Reportedly Expects Sale or Merger

St. Louis Post-Dispatch, Missouri via NewsEdge Corporation, Nov. 10

Monsanto Co. will probably be sold or merged by year's end or early next year, a source close to the company's senior management and board of directors said Tuesday.

"People came away from the last two (monthly) board meetings saying it's not a question of whether but (of) when," said the source who requested anonymity.

The source said Monsanto Chairman Robert B. Shapiro, stung by the company's depressed stock and strong overseas protests against crop biotechnology, appears ready to make a deal.

"The guy does not want his legacy to be the failed merger with American Home Products," said the source, referring to Monsanto's attempt last year to merge with a company twice its size. Now that concern is beginning to grow in the United States. Environmental groups are stoking opposition through lobbying and full-page advertisements; federal lawmakers on Wednesday introduced legislation that would require labeling of food made with genetically modified crops, and regulators are re-evaluating everything from food safety to the effects bioengineered crops may have on the monarch butterfly.

At stake in this contest for American public opinion are billions of dollars in investments by the biotechnology industry and American farmers who have rapidly adopted products like corn, potatoes and soybeans that have been engineered to resist pests or producer higher yields.

Until recently, the leading biotechnology companies were reluctant to respond to criticism in this country for fear of making the novel foods an issue. But some biotech executives now say that there is a sense that the tide may be turning against genetically modified foods and that urgent action is needed.


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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

US bill would require labels on biotech foods

WASHINGTON, Reuters [WN] via NewsEdge Corporation, Nov 11, 1999

U.S. lawmakers introduced on Wednesday a bill calling for labels on foods with bioengineered ingredients, just three weeks before Clinton Administration negotiators must defend the safety of biotech foods at international trade talks.

http://www.cnn.com/FOOD/news/9911/11/bioengineered.foods.ap/index.html

Lawmakers seek special labeling for genetically engineered food

November 11, 1999

WASHINGTON (AP) – Everybody who eats food made in America deserves to know what's in it, a bipartisan group of lawmakers said as they offered legislation to create special food labels.

"Today's limited scientific knowledge warrants allowing consumers to make a better, more informed choice," said Rep. Dennis Kucinich, D-Ohio, leader of an effort to identify for the marketplace all genetically altered food.

His bill would require a label that says "United States government notice: This product contains genetically engineered material, or was produced with a genetically engineered material."

Labeling supporter Rep. Bernard Sanders, I-Vermont, said such labeling would help people make informed choices, just as current labels let customers decide whether they want to buy foods containing artificial colors and flavors.

The label wouldn't suggest the product inside is unsafe, Sanders said.

"There continues to be unanswered questions about these products that science is still in the process of answering," he said, and in the meantime people "should be able to expect a clear label that indicates whether their food has been genetically altered."


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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

For Immediate Release
News From the American Corn Growers Association

Corn Growers Endorse Labeling for Foods Containing Genetically Altered Products

Contact: Gary Goldberg, 918-488-1829 or David Senter, 202-331-4348
WASHINGTON, DC. November 10, 1999

Farmer Liability Legislation Must be Next Step to Protect Agricultural Producers

The American Corn Growers Association (ACGA) has endorsed legislation that will require the Food and Drug Administration to label all food products produced from genetically modified foods. The bill, "Genetically Engineered Food Right to Know Act," is introduced by Congressman Dennis Kucinich (D-OH). "This legislation goes a long way towards providing the consumer the rights they deserve in knowing how their food was produced and what kinds of foods are contained in what they buy," said Gary Goldberg, Chief Executive Officer of the ACGA.


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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

Merger rumour: Monsanto and Novarits?

ZURICH, Nov. 9 (Reuters) - Novartis's reported interest in life sciences rival Monsanto faces serious anti-trust problems given the companies' big agribusinesses, equity analysts said today.

This could kill any deal unless the firms find a creative way to handle the problem, they said, but the report fuelled talk that Novartis is hunting for a takeover to prevent being shunted from center stage in a fast-consolidating drugs sector. Novartis said today it had no comment on a newspaper report that it was interested in buying all or part of U.S.-based Monsanto Co.

The Wall Street Journal, in an article published today, said Monsanto had been holding talks about a sale of all or part of the company, and Novartis had emerged as a serious suitor.


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Date: Sun, 14 Nov 1999 21:43:51 -0500
From: Richard Wolfson GEN11-14

Monsanto faces its many options

By Robert Steyer, Of The St. Louis Post-Dispatch
Sunday, November 14, 1999 | 6:14 a.m.

It's becoming clear that Robert B. Shapiro's vision exceeded his company's coffers and Wall Street's patience.

Investors, analysts and some Monsanto Co. insiders believe Monsanto's chairman soon will make a deal that will dramatically alter his goal of engineering a life sciences company. A deal could come within a few weeks or a few months.

Shapiro didn't invent the term "life sciences company," which describes the melding of nutrition, biotechnology, crop protection and medicine under one corporate roof.

But he has been the most passionate proponent, even as more well-heeled competitors have vacillated.

Now, it appears Shapiro may wave the white flag with some transaction -- merger, sale, spin-off, joint venture – that will cut back on Monsanto's ambition.

"I think the old concept of life sciences is on life support," said William Fiala, an analyst for the Edward Jones brokerage.

Fiala and other analysts, who have followed Monsanto's transformation from a traditional chemical company, said Shapiro is being pressured by some events beyond his control.

He is being roughed up by the quick-score behavior of big- time money managers who control about 80 percent of Monsanto's stock. "Once that pressure starts, you can't afford to have the institutional investors dumping their stock," said a former Monsanto executive who requested anonymity.

"Many people look at life sciences as providing some sort of short-term dividend, but that's never been the case," said Sano Shimoda, president of BioScience Securities, in Orinda, Calif., an agribusiness research firm. "Life sciences is a long-term strategy."

Several bigger companies – such as DuPont and Novartis – have the money to carry on the life sciences concept if Monsanto gets carved up. But these companies still view life sciences as a collection of components rather than as a unified business that weaves together all of the units.

"Monsanto is the professor; the other companies are the students," Shimoda said. "Monsanto is the leader in creating this vision, and it put its money where its mouth was."

But Monsanto gagged on its heavy spending – about $8 billion worth of transactions between 1996 and 1998, including one deal still pending.

Shapiro's desire to buy seed companies stretched Monsanto's balance sheet and weakened its stock price, despite big revenue infusions from the herbicide Roundup and, this year, from the arthritis drug Celebrex.

Seeking to finance his vision, Shapiro talked to many drug and chemical companies before embarking on an ill-fated merger plan with American Home Products Corp. last year.

Monsanto is talking to many companies now, and Shapiro has often said that everybody in this business talks to everybody else.

"This time, it's for real," said a former Monsanto executive. After the American Home merger collapsed 13 months ago, Monsanto moved quickly to create a financial recovery strategy. It issued stock and debt and started divesting assets. Monsanto's credit ratings barely budged downward, but investors continued to snipe.

Meanwhile, Shapiro failed to build the enhanced-nutrition component of his life sciences dream. While Monsanto's president, he was the point man for the $1 billion purchase in late 1995 of Kelco, a maker of food ingredients.

Kelco never blossomed. Monsanto almost shut down its alginate business - food ingredients derived from brown seaweed - before selling it at a bargain price. The bigger part of Kelco, the biogums ingredient business, is for sale. So is the rest of the consumer products division, including the artificial sweetener NutraSweet.

Monsanto's stock price has never reached the levels it enjoyed during the American Home courtship.

The stock has climbed about 20 percent in little more than a week thanks to rumors of impending deals and to a three-way slugfest among giant drug companies.

Investors are betting on a new round of drug industry consolidation, figuring Monsanto will be engulfed by it. Monsanto has been urged by some analysts to sell or spin off its drug subsidiary, G.D. Searle & Co. in the name of shareholder value.

At the same time, several Monsanto peers are pulling back on the agricultural part of their life sciences strategy.

Novartis, DuPont and American Home are firing employees in their crop protection divisions. American Home, Novartis and AstraZeneca are hinting at sales or spinoffs of their crop units.

As competitors struggle, Monsanto's farm products division is outperforming them during a worldwide agriculture slump.

Given the complications in the food and farm arenas, analysts can't agree on what Monsanto will do next. What deal makes economic sense, supports research and rewards shareholders?

Merging with DuPont or Novartis would trigger anti-trust alarms; the deals would put a lot of seeds in few hands. Spinning off Searle would fetch a nice price, but would leave Monsanto vulnerable as long as the farm economy remains depressed and biotechnology is controversial.

Merging with a drug company would not solve the farm or biotech issues. Pfizer, for example, likes Searle but has no interest in agriculture. Resurrecting an American Home-type deal is always possible. The merged company could then spin off the agriculture units as a separate entity - but it might not yield much of a price.

There are plenty of reasons - unrelated to drugs or crops - why analysts expect Monsanto to make a big deal soon. Accounting rules are expected to be revised by the end of 2000, repealing or scaling back existing rules that offer tax advantages for mergers.

Analysts also believe that Shapiro, 61, doesn't have a successor to forcefully promote his vision. They say Monsanto's president Hendrik Verfaillie is a competent manager with strong agriculture expertise, but they say he is not the ringmaster for the multi-faceted life sciences show.

"An independent Monsanto is gone because the former vision as we knew it is gone," said a long-time Monsanto watcher on Wall Street. "There's not enough glue to hold life sciences together under one company. You can expect more alliances in the future for pieces of life sciences."

Still, some people cling to the notion of Monsanto as an independent company. "Sure, it could happen but there would be tremendous risk," said Shimoda, the agribusiness analyst. The risk is a depressed stock price and prospects of shareholder suits. The risk will remain as long as protests against biotech crops create uncertainty among consumers, farmers and investors.

Monsanto has been staggered by the virulent reaction of European consumers, politicians and, ultimately, food company customers against genetically engineered foods.

Overseas protests, foreign food labeling laws and Europeans' vows to avoid bioengineered foods have worked their way back to the United States. American farmers, who have embraced biotech crops, now wonder how much cotton, soybeans, canola and corn they should buy for the next planting season.

Even if biotech crops help them cut costs of using chemicals to kill weeds and insects, they don't know if they can find adequate markets for these crops. Despite efforts by trade groups and companies to alleviate these fears, experts say many farmers will wait longer than usual to make seed-buying decisions this year.

Right now, Shapiro's vision is in the hands of the highest bidder. Analysts expect Monsanto could fetch a price of at best $55 a share, or about $10 a share better than Friday's closing price.

Many people who question some of Monsanto's tactics and fret about its stock price still find time to praise Shapiro's vision.

"The manipulation of food and the work with genetics just may be way too early (for investors to embrace)," said Alex Hittle, who follows the life sciences industry for A.G. Edwards & Sons. "Twenty years down the road, we might take the pieces of Monsanto and put them back together again."

** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed for research and educational purposes only. **


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Date: Mon, 15 Nov 1999 22:03:48 -0500
From: Richard Wolfson GEN11-15 Substantial Equivalence

Here are two articles on the failings of the principle of substancial equivalence Thanks to Bob Phelps of the Australian GeneEthics Network geneethics@acfonline.org.au for posting this

Beyond 'Substantial Equivalence'

By Erik Millstone, Eric Brunner & Sue Mayer
Nature 401, 525 - 526 (1999), 7 October 1999

Showing that a genetically modified food is chemically similar to its natural counterpart is not adequate evidence that it is safe for human consumption.

Sections:
Insubstantially equivalent?
Acceptable daily intake
Trying to have it both ways
'Substantial equivalence' ill-defined
An anti-scientific test
References
About the Authors

Insubstantially equivalent?

A GM food's toxicity cannot be predicted from its chemical composition.

Whenever official approval for the introduction of genetically modified (GM) foods has been given in Europe or the United States, regulatory committees have invoked the concept of 'substantial equivalence'. This means that if a GM food can be characterized as substantially equivalent to its 'natural' antecedent, it can be assumed to pose no new health risks and hence to be acceptable for commercial use. At first sight, the approach might seem plausible and attractively simple, but we believe that it is misguided, and should be abandoned in favour of one that includes biological, toxicological and immunological tests rather than merely chemical ones.

The concept of substantial equivalence has never been properly defined; the degree of difference between a natural food and its GM alternative before its 'substance' ceases to be acceptably 'equivalent' is not defined anywhere, nor has an exact definition been agreed by legislators. It is exactly this vagueness that makes the concept useful to industry but unacceptable to the consumer. Moreover, the reliance by policymakers on the concept of substantial equivalence acts as a barrier to further research into the possible risks of eating GM foods.

Acceptable daily intake

The concept of substantial equivalence emerged in response to the challenge confronting regulatory authorities in the early 1990s. Biotechnology companies had developed several GM foods and, to reassure their customers, wanted official approval for their introduction. But government statutes did not cover GM foods, nor did they provide the authority to regulate these innovations. Legislation could be amended, but that would not address the core problem of how to assess the risks. One obvious solution at that time would have been for legislators to have treated GM foods in the same way as novel chemical compounds, such as pharmaceuticals, pesticides and food additives, and to have required companies to conduct a range of toxicological tests, the evidence from which could be used to set 'acceptable daily intakes' (ADIs). Regulations could then have been introduced to ensure that ADIs are never, or rarely, exceeded.

From the point of view of the biotechnology industry, this approach would have had two main drawbacks. First, companies did not want to have to conduct toxicological experiments, which would delay access to the marketplace by at least five years, and would add approximately US$25 million per product to the cost of research and development. Second, by definition, using ADIs would have restricted the use of GM foods to a marginal role in the diet. An ADI is usually defined as one-hundredth of the highest dose shown to be harmless to laboratory animals. Thus, even if the animals show no adverse effects on a diet consisting exclusively of a test material, human intake would still be restricted to 1% of the human diet. The biotechnology companies want to market GM staples, such as grains, beans and potatoes, which individually might account for as much as 10% of the human diet, and collectively might provide more than half of a person's food intake.

The adoption of the concept of substantial equivalence by the governments of the industrialized countries signalled to the GM food industry that, as long as companies did not try to market GM foods that had a grossly different chemical composition from those of foods already on the market, their new GM products would be permitted without any safety or toxicological tests. The substantial-equivalence concept was also intended to reassure consumers, but it is not clear that it has served, or can serve, that purpose. Although toxicological and biochemical tests, and their interpretation, are notoriously problematic and contested, and are slow and expensive, they canprovide information vital to consumer protection1.

Trying to have it both ways

The challenge of how to deal with the issue of risk from consuming GM foods was first confronted in 1990 at an international meeting, consisting of officials and industrialists but no consumer representatives, of the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO)2. The FAO/WHO panel report makes intriguing reading, because what it fails to mention is as important as what is discussed. It does not use the term 'substantial equivalence' or mention ADIs. It implies that GM foods are in some important respects novel, but it then argues that they are not really novel at all – just marginal extensions of traditional techniques. These inconsistencies are inevitable, given that the industry wanted to argue both that GM foods were sufficiently novel to require new legislation – and a major overhaul of the rules governing intellectual property rights – to allow them to be patented, yet not so novel that they could introduce new risks to public or environmental health.

The biotechnology companies wanted government regulators to help persuade consumers that their products were safe, yet they also wanted the regulatory hurdles to be set as low as possible. Governments wanted an approach to the regulation of GM foods that could be agreed internationally, and that would not inhibit the development of their domestic biotechnology companies. The FAO/WHO committee recommended, therefore, that GM foods should be treated by analogy with their non-GM antecedents, and evaluated primarily by comparing their composition with that of their natural antecedents, so that they could be presumed to be similarly acceptable. Only if there were glaring and important compositional differences might it be appropriate to require further tests, to be decided on a case-bycase basis.

Unfortunately, scientists are not yet able reliably to predict the biochemical or toxicological effects of a GM food from a knowledge of its chemical composition. For example, recent work on the genetics of commercial grape varieties shows that, despite detailed knowledge, going back for centuries, of the chemistry and flavour of grapes and wines, the relationship between the genetics of grapes and their flavour is not understood3. Similarly, the relationship between genetics, chemical composition and toxicological risk remains unknown. Relying on the concept of substantial equivalence is therefore merely wishful thinking: it is tantamount to pretending to have adequate grounds on which to judge whether or not products are safe.

The results of Arpad Pusztai's experiments with GM potatoes and their interpretation remain a matter of controversy4, but his starting hypothesis was that GM potatoes would be substantially equivalent to non-GM potatoes. Pusztai interpreted his still unpublished results as indicating that the GM potatoes exerted adverse biochemical and immunological effects, which could not have been predicted from what was known of their chemical composition. The experiments he conducted are not legally required and are therefore not routinely conducted before GM foods are introduced into the food chain.

'Substantial equivalence' ill-defined

The concept of substantial equivalence was first introduced in 1993 by the Organization for Economic Cooperation and Development (OECD)5, and was endorsed in 1996 by the FAO and WHO. Given the weight the concept has been required to carry, it is remarkable how ill-defined it remains, and how little attention has been devoted to it. The OECD document states:

"For foods and food components from organisms developed by the application of modern biotechnology, the most practical approach to the determination is to consider whether they are substantially equivalent to analogous food product(s) if such exist. ... The concept of substantial equivalence embodies the idea that existing organisms used as foods, or as a source of food, can be used as the basis for comparison when assessing the safety of human consumption of a food or food component that has been modified or is new." That is the closest there has been to an official definition of substantial equivalence, but the definition is too vague to serve as a benchmark for public-health policy.

GM glyphosate-tolerant soya beans (GTSBs) illustrate how the concept has been used in practice. The chemical composition of GTSBs is, of course, different from all antecedent varieties, otherwise they would not be patentable, and would not withstand the application of the herbicide glyphosate. It is quite straightforward to distinguish, in a laboratory, the particular biochemical characteristics that make them different. GTSBs have, nonetheless, been deemed to be substantially equivalent to non-GM soya beans by assuming that the known genetic and biochemical differences are toxicologically insignificant, and by focusing instead on a restricted set of compositional variables, such as the amounts of protein, carbohydrate, vitamins and minerals, amino acids, fatty acids, fibre, ash, isoflavones and lecithins. GTSBs have been deemed to be substantially equivalent because sufficient similarities appear for those selected variables.

But this judgement is unreliable. Although we have known for about ten years that the application of glyphosate to soya beans significantly changes their chemical composition (for example, the level of phenolic compounds such as isoflavones6), the GTSBs on which the compositional tests were conducted were grown without the application of glyphosate7. This is despite the fact that commercial GTSB crops would always be treated with glyphosate to destroy surrounding weeds. The beans that were tested were, therefore, of a type that would never be consumed, while those that are being consumed were not evaluated. If the GTSBs had been treated with glyphosate before their composition was analysed, it would have been harder to sustain their claim to substantial equivalence. There is a debate in the research community on whether such changes to the chemical composition are desirable or undesirable, but it is an issue that remains unresolved, and which has been neglected by those who have deemed GTSBs and non-GM soya beans to be substantially equivalent.

Only one official organization has recognized some of the limitations of the concept of substantial equivalence. A Dutch government team has acknowledged that "compositional analysis ... as a screening method for unintended effects ... of the genetic modification has its limitations ... in particular regarding unknown anti-nutrients and natural toxins", and it has given a lead by exploring some alternatives.

The Dutch team accepts that comparisons of relatively crude compositional data provide a very weak screen against the introduction of novel genetic, biochemical, immunological or toxicological hazards, and they have suggested a finer-grained screen to test for differences in some of the relevant biological variables, such as DNA analysis, protein fingerprinting, secondary-metabolite profiling and in vitro toxicity testing. If such a finer screen revealed that a GM food contained a relevant novelty, the case for further studies would be far stronger, and those studies might benefit from having some clues as to which end-points should be investigated.

An anti-scientific test

Substantial equivalence is a pseudo-scientific concept because it is a commercial and political judgement masquerading as if it were scientific. It is, moreover, inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit potentially informative scientific research. The case of GTSBs shows, moreover, that the concept of substantial equivalence is being misapplied, even on its own terms, within the regulatory process.

If policymakers are to provide consumers with adequate protection, and genuinely to reassure them, then the concept of substantial equivalence will need to be abandoned, rather than merely supplemented. It should be replaced with a practical approach that would actively investigate the safety and toxicity of GM foods rather than merely taking them for granted, and which could give due consideration to public-health principles as well as to industrial interests.

About the Authors

References

  1. Food Additives and the Consumer Appendix I, 41-43 (European Commission, Brussels, 1980). Links
  2. Strategies for Assessing the Safety of Foods Produced by Biotechnology (WHO, Geneva, 1991). Links
  3. Bowers, J. et al. Science 285, 1562-1565 (1999). Links
  4. Masood, E. Nature 398, 98 (1999). Links
  5. Lydon, J. Duke, S. O. Pestic. Sci. 25, 361-374 (1989). Links
  6. Padgette, S. R. et al. J. Nutr. 126, 702-716 (1996). Links
  7. Kuiper, H. A. et al. Food Safety Evaluation of Genetically Modified Foods as a Basis for Market Introduction (Ministry of Economic Affairs, The Hague, 1998).

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Date: Mon, 15 Nov 1999 22:03:48 -0500
From: Richard Wolfson GEN11-15 Substantial Equivalence

The failings of the principle of substantial equivalence in regulating transgenic foods

By John Fagan, Ph.D., Professor of Molecular Biology, Maharishi University of Management

Sections:
Introduction
Inadequate Testing
Unpredicted Side-Effects
Health Risks in Derivatives
Clinical Tests Needed
Need for Labeling
Literature Cited

Introduction

The concept of substantial equivalence has been used in Europe, North America, and elsewhere around the world as the basis of regulations designed to facilitate the rapid commercialization of genetically engineered foods. For instance, European Commission (EC) regulations concerning novel foods and food ingredients apply the concept of substantial equivalence to both the safety testing and to the labeling of genetically engineered foods. Genetically engineered foods classified as substantially equivalent are spared from extensive safety testing on the assumption that they are no more dangerous than the corresponding non-genetically engineered food (1). Using similar arguments, genetically engineered foods classified as substantially equivalent are not required to be labeled as genetically engineered (2). The effect of these regulations has been to allow genetically engineered foods to enter the market place without sufficient testing to assure safety and without sufficient labeling to allow consumers to decide for themselves whether or not to purchase and eat these novel foods. The health of the population of Europe is thus being placed at risk.

The fundamental inadequacies of this approach have been discussed previously. For instance, one article presented in the Proceedings of the Organization for Economic Cooperation and Development (OECD) Workshop on Food Safety Evaluation (3), came to the following conclusions:

  1. Because the concept of substantial equivalence has no dimensions, it cannot be used as a predictor of which novel foods will require substantial safety testing in animals.

  2. Depending on the nature of the novel food, the usefulness of the concept of substantial equivalence in determining the necessity for extensive safety testing ranges from useful to negligible.

  3. The number and range of safety tests required is best determined, not by the concept of substantial equivalence, but by the nature of the product under consideration.

At first glance the term substantially equivalent implies that two foods are equivalent in all characteristics that are of importance to the consumer-safety, nutrition, flavor, and texture. However, in actual practice the investigator compares only selected characteristics of the genetically engineered food to those of its non-genetically engineered counterpart. If that relatively restricted set of characteristics is not found to be significantly different in these two, the genetically engineered food is classified as substantially equivalent to the corresponding non-genetically engineered food and is required to be neither tested further nor labeled as genetically engineered.

The argument supporting this practice is that since most of the characteristics of a particular genetically engineered food are similar to those of its non-genetically engineered counterpart, it must be the case that the genetically engineered food is substantially equivalent to its non-genetically engineered counterpart with respect to all characteristics relevant to the consumer. This is obviously a fallacious argument, and should not be used as the basis for avoiding more extensive testing and for avoiding the labeling of genetically engineered foods. Most critically, if characteristics important to food safety are not evaluated directly, the safety of consumers will be in jeopardy.

Inadequate Testing

Any claim of substantial equivalence is only as good as the series of tests upon which that claim is based. In practical terms, if a genetically engineered food is different from its non-genetically engineered counterpart, that difference will be detected only if a test is carried out that is capable of measuring the specific characteristic which is different between the two. Therefore, if the tests prescribed for determining substantial equivalence do not include one or more tests capable of quantitating the characteristic which happens to be different in the genetically engineered food compared to its non-genetically engineered counterpart, the genetically engineered food will be wrongly classified as substantially equivalent to its non-genetically engineered counterpart.

Currently, the testing procedures required in Europe, North America and elsewhere consist almost exclusively of specific chemical and biochemical analytical procedures designed to quantitate a specific nutrient or a specific toxin or allergen. These tests focus on specific components of a food that are suspected to be altered in that particular genetically engineered food, based on the known characteristics of its non-genetically engineered counterpart, and based on the known characteristics of the genes introduced into that organism. For instance, in its assessment of Roundup Ready soybeans, Monsanto quantitated a few of the allergenic proteins known to be normally produced in soybeans, showing that genetic manipulations had not accidentally caused Roundup Ready soybeans to produce higher than normal levels of those allergens.

Unpredicted Side-Effects

Important as these studies are, however, they fail to even begin to assess one very substantial class of risks that are inherent in genetically engineered foods. That class of risks consists of health hazards resulting from the unanticipated side-effects of genetic engineering. Such testing schemes are completely incapable of detecting unsuspected or unanticipated health risks that are generated by the process of genetic engineering, itself.

It is a scientific fact that the process of genetic engineering often gives rise to unanticipated side-effects. These can-and have been shown to-introduce unforeseen allergens and toxins into foods and unexpectedly reduce nutritional value. Not every genetically engineered food will have these problems, but there is a finite probability that any given genetic modification will lead to unanticipated side-effects that result in food characteristics that threaten the health of consumers.

For instance, in 1989 Showa Denko K.K. marketed tryptophan that had been produced in genetically engineered bacteria as a nutritional supplement in the USA. When this product was placed on the market, it made thousands of consumers ill. Of these, 1500 were permanently disabled and 37 died. Analysis by high pressure liquid chromatography indicated that this product was more than 99.6% pure tryptophan. However, these also contained traces of a highly toxic contaminant. This toxin accounted for less than 0.01% of the total mass of the product but this was sufficient to seriously threaten health.

According to the measurements made, the genetically engineered tryptophan was equal in purity, and thus substantially equivalent, to previous preparations that had been produced using natural bacteria. However it was clearly not substantially equivalent with regard to human safety. If other tests had been required, such as animal or human feeding tests, which are capable of screening broadly for harmful substances, the fact that this material was not substantially equivalent would have been obvious. However, those tests were not done.

Health Risks in Derivatives

Another example of how the concept of substantial equivalence can lead to abuses is the claim that is commonly made that corn oil from genetically engineered corn need not be labeled as genetically engineered because the process of oil production separates the oil from all potentially toxic or allergenic constituents of corn and that the composition of the oil itself is identical to that obtained from non-genetically engineered corn. Similar arguments have been used to justify the deregulation of oil from genetically engineered soybeans.

The problems with these arguments are two: First, corn oil is not chemically pure. It is well known that corn oil still contains sufficient corn proteins to elicit allergic reactions in individuals who are highly allergic to corn. Therefore it is highly likely that it will also contain small amounts of the genetically engineered proteins present in genetically engineered corn. An individual who is allergic to these proteins would be likely to react negatively to oil derived from genetically engineered corn. Second, only the major constituents of genetically engineered corn oil have been examined in assessing substantial equivalence. However, some of the minor constituents of this oil, which were ignored in this assessment, could be of substantial significance to the nutritional value or the safety of this product. For instance, genetic manipulations could unexpectedly alter oil metabolism by a number of mechanisms, generating a toxic fatty acid derivative. Thus, this claim of substantial equivalence is superficial and should not be used as an argument to justify avoidance of further testing and labeling.

Clinical Tests Needed

Given that genetic engineering can introduce unexpected health hazards into foods, it is logical that every genetically engineered food should be subjected to tests that are capable of detecting a wide range of unforeseen health threats. Yet, at present, the liberal use of the concept of substantial equivalence makes it possible to avoid such testing.

What additional tests are required? Tests are needed that are capable of screening for a wide range of diverse allergens and toxins. It is not possible within the scope of this document to discuss in detail the deficiencies in the current system and the measures required to rectify this situation. (This subject is discussed in Assessing the Safety of Genetically Engineered Foods, a Science-Based, Precautionary Approach, by the author) In short, what is missing in current testing programs is clinical tests in which humans are fed the genetically engineered food in question both short-term and long-term.

Human tests are of primary importance because animals are poor models for assessing the human health impacts of foods. In particular, animal tests provide virtually no useful information regarding the allergenicity of food to humans.

Only clinical tests have the broad specificity and relevance to human physiology needed to detect the wide range of allergens and toxins that might result from unexpected side-effects of the genetic engineering process. Without such tests, the full range of allergens and toxins that can be introduced via the process of genetic engineering cannot be detected, and without such tests, it is impossible to assure that a given genetically engineered food is in fact free from health-damaging characteristics.

Need for Labeling

Even if more stringent testing is implemented, it is essential that genetically engineered foods be labeled as genetically engineered. No testing scheme can ever be exhaustive. Therefore some residual risk of undetected health damaging characteristics will always remain with foods that have been produced using a technique, such as genetic engineering, that is capable of introducing into a food a wide range of unexpected side effects. For instance, if clinical experiments are carried out for 3 years, longer term health effects may be overlooked that take 5 or 10 years to manifest. Invariably, residual risk remains regardless of the tests carried out and regardless of the testing period chosen. Labeling these foods as genetically engineered allows consumers to choose for themselves whether or not to accept this residual risk.

Industry has stiffly opposed proposals that would have required genetically engineered foods to undergo clinical testing similar to that which is standard for novel food additives. The expense and time required for testing is perceived as a hindrance to commercialization of genetically engineered foods. However, in the long run, more rigorous testing will be good, not only for consumers, but also for industry.

Without such testing some genetically engineered foods that seriously damage the health of consumers will enter the market. Thus, this short-sighted approach to safety assessment clearly favors commercial interests while placing the health of the entire population at risk. Not only does this abrogate scientific responsibility and basic humanitarian values, but it is also bad business, because it will inevitably lead to loss of consumer confidence in genetically engineered foods.

Literature Cited

  1. Regulation EC /95 of the European Parliament and of the Council Concerning Novel Foods and Food Ingredients, Article 3.4.

  2. Regulation EC /95 of the European Parliament and of the Council Concerning Novel Foods and Food Ingredients, Article 8.1.

  3. OECD, DSTI/STP (95)18, Paris, 1995, pages 79-87.

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

  5. An Investigation of the Cause of the Eosinophilia-Myalgia Syndrome Associated with Tryptophan Use, New England Journal of Medicine, 323: 357-365, 1990.

  6. EMS and Tryptophan Production: A Cautionary Tale, TIBTECH, 12:346-352, 1994.

John B. Fagan, Ph.D.
Professor of Molecular Biology
Maharishi University of Management
(Maharishi International University 1971 to 1995) 1000 North Fourth Street
Fairfield, Iowa, 52557-1078
Phone(515) 472-8342    Fax (515) 472-5725    email jfagan@mum.edu

** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed for research and educational purposes only. **


Top PreviousNextFront Page

Date: 11 Nov 1999 07:45:22 -0600
From: joe cummins jcummins@julian.uwo.ca

Proposal for Biotech Incubator: To be Paid by Municipality

The letter below was in response to a proposal to tax the municipality for biotechnology research!

November 10, 1999
Prof. Joe Cummins
738 Wilkins Street
London, Ontario N6C4Z9 Canada
Telephone; 519 681 5477    e-mail: jcummins@julian.uwo.ca

Mayor Diane Haskett and Council
Attn: Jeff Malpass City Clerk
City of London
300 Dufferin Ave.
London, ON N6A4L9 Canada
e-mail: jmalpass@city.london.on.ca

re: The Biotechnology Incubator Proposal

The Biotechnology Incubator Proposal is a scheme to have the tax payers of the City of London contribute $5 million to provide buildings and facilities to underwrite researchers who hope to employ biotechnology (mainly genetic engineering) to create commercial products. The proposal for the project is truly an uncritical sales pitch for the project. The proposal presumes that such municipal tax support for research is the norm. I believe that such support is not the norm and is an unfair burden on London taxpayers.

The incubator proposal did not appear to delineate the various sources of government support for biotechnology available in Canada. The federal biotechnology committee has functioned for over a decade. That committee is dominated by officials from biotechnology firms along with a few devoted academic bureaucrats. That committee has functioned as a lobby for the industry and has repeatedly demanded trebling of government grants and extensive tax concession. Both those demands have been met and mainly seem to benefit the large multination chemical-pharmeceutical companies that dominate biotechnology. The committee has not yet produced a major breakthrough in any area of biotechnology.

Agriculture Canada has a "Matching Investment Initiative" a collaborative project in which the federal government match dollar for dollar contributions from multinational chemical companies to promote use of new chemical pesticides and gene tinkered crops. I understand that the program generates forty to fifty million dollars each year from each from industry and from tax. The research focuses on research benefiting industry and has not extensively dealt with safety issues.

The federal science and engineering research council and medical research council also contribute heavily to research in biotechnology.

Ontario has previously failed to participate in research involving biotechnology. However, the incubator proposal is mainly a provincial scheme.

The oral proposal from the proponents suggested that municipal tax dollars were a major contributor to development of biotechnology incubators in United States and that extensive biddings for such a facility is expected from Ontario municipalities. The comment that US municipalities contributed extensive tax dollars to biotechnology research facilities should have been documented. My reading of Biotechnology Trade Journals leads me to believe that support from the municipal tax base is very rare. However, it is clear that the burden of proof lies with the proponent. City council should require such documentation before squandering tax dollars from families.

Claims by a member of the Board of Control that the city has regularly provided support for research projects should be documented. I have not heard of research grants from city council and do not believe they have existed in the past.

There are real concerns related to the safety of biotechnology products that were not addressed in the proposal. For example, the pharmcrop tested near London last summer appears to have neglected the environmental impact of the the field test. The drug released in wounded plants and in decay of plant material is fully capable of polluting ground and surface water. The humanized pigs used in transplant experiments have been delayed by the finding that potentially hazardous viruses were being released from the pig cells. Pig-baboon transplants were conducted in London without without highest level security over virus release. The rush to commercialize products creates safety concerns recognized worldwide.

In the past council travel has been a topic of public concern. Frankly, I find municipal tax dollars squandered on travel to Israel for biotechnology should have been questioned in council. Israel is not a major player in the area of medical and agricultural biotechnology even though research is done. A serious investigation should have been made in centers of biotechnology , which would, at least save the taxpayer a few dollars. Real issues should be studied fully but I cannot understand what was achieved by travel to a distant medium sized center.

As a final point, I am concerned over the tax concessions provided large institutions and companies through reduced water and sewage fees. I seems as if the London demands family taxpayers subsidize large institutions and companies. Using municipal tax dollars to provide subsidy for research, which if successful will normally be snapped up by multinationals seems wrong. Council may find that spending like "drunken sailors" does not appeal to the public. Common sense says let the incubator be funded by private investment, or let it go to a gullible municipal bidder.


Top PreviousNextFront Page

Date: 11 Nov 1999 12:17:25 -0600
From: jim@niall7.demon.co.uk

GM chickens could be drug factories

LONDON, Reuters [WS] via NewsEdge Corporation

Genetically modified chickens could be the drug factories of the future, New Scientist magazine said on Wednesday.

Two U.S. biotechnology companies have already produced genetically modified birds that can lay eggs containing drugs, proteins and antibodies to ward off illness.

GeneWorks of Ann Arbor, Michigan, has up to 60 birds that carry genes which enable them to make human proteins or antibodies in their eggs. Although the company will not name the proteins, it says both have great potential for treating disease. According to its chief operating officer Steve Sensoli, GeneWorks has deals to make 14 proteins for six drug the magazine said.

Another company, AviGenics of Athens, Georgia is producing birds that carry a human interferon, or natural antibiotic, to treat cancer. The firm says the birds have already passed on the interferon gene to the next generation of birds. With hens producing an average of 200 eggs each year, and 100 milligrams or more of a drug in each egg, both companies believe the yields could be large and according to the magazine.

The companies insert the genes that make the proteins into harmless viruses to get them into the birds. Carl Marhaver, the president of AviGenics, told the magazine.

Neither company has published its achievements in the scientific press because they claim it is too commercially sensitive. said Sensoli.


Top PreviousNextFront Page

Date: 11 Nov 1999 12:27:52 -0600
From: jim@niall7.demon.co.uk

Pfizer interested in Monsanto's Searle

NEW YORK (Reuters) - Reuters [OL] via NewsEdge Corporation

Pfizer Inc., the No. 2 U.S. drug company, on Wednesday said it would be interested in acquiring Monsanto Co.'s Searle pharmaceutical unit, if it were available, to gain control of its arthritis drug Celebrex. the Pfizer spokesman said.

Pfizer, which has made a $75 billion unsolicited bid for Warner-Lambert, jointly markets Celebrex with Searle.

However, New York-based Pfizer, the maker of impotence drug Viagra, said it has no interest in acquiring all of Monsanto and said Searle may not be available separately.

The Wall Street Journal on Tuesday said St. Louis-based Monsanto has been in early-stage talks with several companies, including Pfizer, about a full or partial sale of the company.

The article said Swiss drug and chemical group Novartis has emerged as a serious suitor.

Bankers told the Wall Street Journal that Searle alone could be worth $25 billion to $27 billion, much of Monsanto's value as a whole.

Monsanto and Novartis have both declined comment.

Pfizer said it would like to expand the marketing of Celebrex into Japan, where it is the largest non-Japanese pharmaceutical company.


Top PreviousNextFront Page

Date: 12 Nov 1999 18:25:55 -0600
From: jim@niall7.demon.co.uk

Delta and Pine-Monsanto link up still not together

by Laura Jacobs, Chicago Derivatives Desk(312)408-8750
chicago.derivatives.newsroom@reuters.com , Reuters [WN] via NewsEdge Corporation

Implied volatility and volume popped higher Wednesday in options on Delta and Pine Land Co. [DLPN] on continued concern about Delta's agreed-upon merger with Monsanto Co. [MTCN].

"(There are) huge volume and huge volatility spikes," said Paul Foster, investment strategist with 1010wallstreet.com, of Delta's options.

"Everything's pumped up big-time," said Randy Emer, designated primary market maker at the Chicago Board Options Exchange. "We're just seeing players who have an opinion on what's going to happen with the Monsanto deal."

Monsanto agreed to buy Delta in May 1998, but the deal has been mired in a lengthy antitrust review process.

Implied vols for the November 25s jumped to around 158 percent, with December at 133 percent, versus about 76 percent on Tuesday and 46 percent three weeks ago, Foster said.

Options volume also jumped again on Wednesday, with some 9,425 calls and 1,125 puts traded by 1432 CST/2032 GMT. On Tuesday, more than 3,200 options changed hands, well above the more-typical recent daily average of around 800 contracts.

The Wall Street Journal reported on Tuesday that Monsanto has been holding talks with several companies, including Pfizer Inc. , about a full or partial sale of the company. It said Swiss drug maker Novartis AG < NOVZn.S> had emerged as a serious suitor.

Monsanto and Novartis both have declined comment about about a possible merger.

The Mississippi-based cotton seed breeder Delta could not be reached for comment on Tuesday. A Monsanto spokeswoman said on Tuesday it remained committed to completing the Delta deal.

On Wednesday, Pfizer said it would be interested in acquiring Monsanto's Searle pharmaceutical unit, if that unit were available separately.

Foster also said stock arbitrageurs who are long Delta and short Monsanto shares have seen those spreads widen as Delta stock fell and Monsanto shares rose on concern about the fate or timing of the planned merger, and some of those arbs have covered their positions for now.

"Now spreads have widened on merger fears, of Pfizer buying out Monsanto and leaving Delta without a marriage partner," Foster added.

"This has probably been an arb's nightmare, and they are trying to protect themselves by buying the (Delta) puts the last few days" even though put premiums are high, said Emer.

Most active on Wednesday were Delta's December 25 calls, which fell 3/4 to 5-1/4 on volume of 3,957 and open interest of 10. On the put side, the November 30s rose 1/2 to 5-3/8 on volume of 509 and open interest of 2,909.

Delta and Pine Land shares on Wednesday ended down 1-1/4 at 26 on New York Stock Exchange volume of 855,800. Monsanto shares rose 1-11/16 to 46 on NYSE volume of 4.1 million. Pfizer shares lost 1/8 to 34-7/8 on NYSE volume of 12.2 million.


Top PreviousFront Page

Date: 12 Nov 1999 18:26:44 -0600
From: jim@niall7.demon.co.uk

EU says U.S. interested in beef compensation

BRUSSELS, Reuters [EB] via NewsEdge Corporation

The United States has expressed interest in negotiating compensation from the European Union to replace sanctions it imposed on EU exports over the bloc's ban on hormone-treated beef, an EU official said on Thursday.

"The American side is interested in compensation again," the official said, speaking on condition of anonymity. "We are open to exploring that avenue."

The proposal appeared to offer hope of reducing transatlantic tension over the EU's decade-old ban on imports of beef from cattle reared with artificial growth hormones.

U.S. trade officials in Brussels were not immediately available to comment.

The United States imposed $117 million of punitive duties on EU exports, including mustard, foie gras and pork, in July after winning a World Trade Organisation ruling against the EU's ban.

The EU had refused to lift its ban, citing cancer fears.

Compensation would take the form of expanded access to the EU market for U.S. products other than hormone-treated beef. The EU official said the " obvious area" for compensation, which would benefit the U.S. cattle industry, would be to increase imports of U.S. beef raised without growth hormones.

The two sides discussed this option before the United States imposed sanctions but could not reach agreement.

The U.S. government said at the time it was only prepared to discuss compensation as a temporary solution if the EU pledged to lift its import ban on hormone-treated beef in the future.

U.S. Cattlemen Interested In Compensation

In recent weeks, however, U.S. cattlemen have indicated interest in replacing U.S. sanctions with a temporary compensation package from the EU, possibly in the form of increased market access for U.S. hormone-free beef.

Another EU source said that allowing in thousands of tonnes more of U.S. hormone-free beef could meet resistance from some of the bloc's member states.

French Agriculture Minister Jean Glavany said during a visit to Washington this week that the EU would outline in "a few days" its proposal for resolving the beef hormone dispute. However, European Commission officials were not aware that a formal proposal was imminent.

The bloc has said repeatedly that it will not adopt a definitive policy on hormone-treated beef until it has the results of 17 scientific studies which are expected to be finished by the middle of next year. REUTERS


Richard Wolfson, PhD
Consumer Right to Know Campaign, for Mandatory Labelling and Long-term Testing of all Genetically Engineered Foods,
500 Wilbrod Street Ottawa, ON Canada K1N 6N2
tel. 613-565-8517 fax. 613-565-1596 email: rwolfson@concentric.net

Our website, http://www.natural-law.ca/genetic/geindex.html contains more information on genetic engineering as well as previous genetic engineering news items. Subscription fee to genetic engineering news is $35 (USD for those outside Canada) for 12 months, payable to "BanGEF" and mailed to the above address. Or see website for details.