Genetically
 Manipulated 


 

 
 
 Food


 News

18 October 99

Table of Contents

South Africa: GE Call For Action 2
AfricaBio -- A Repeat of EuropaBio ?
SA Pro-GM Lobby launch...help call their bluff!!
GM food crops & World Trade Org bully tactics
GM Hormones: Codex Alimentarius voted in favor for EU ban on rBST
Initial paper on GM "substantial equivalence"
GM Foods: "substantial equivalence" questioned - Monsanto's reply

Top NextFront Page

Date: Thu, 21 Oct 1999 13:19:23 +0200
From: "Angus Durran" durran@mweb.co.za

South Africa: GE Call For Action 2

By Angus Durran, Safe Food Coalition, Johannesburg

Things are really hotting up in the Monsanto camp. They are now lauching 'Africabio' to help convince South Africans that GE is "fast becoming the topic of choice in South Africa".

The proponents of GE started getting concerned about the anti GE camp from a consumer meeting held at SABS earlier this year when Glenda, myself and Kolbe responded to Muffy Koch's talk which was extremely pro GE.

Since then the Safe Food Coalition held a peaceful protest outside the Department of Health's office in Pretoria at the labelling meeting.

Andrew Taynton recently advised me that Muffy Koch has been lobbying MP's, saying that this beneficial GE technology shouldn't be stopped because of a few fanatical opponents. Muffy also enclosed an article which was published in The Star captioned 'Future fantastic' written by Prof Jennifer Thompson from UCT (University of Cape Town). The article, needless to say, stated how wonderful this new technology is. (We've heard it all before!)

As you may be aware, Monsanto ran a PR campaign in the UK captioned 'Let the harvest begin'. This campaign backfired and made consumers more aware of GE and its dangers. Monsanto have obviously learnt their lesson and are not likely to repeat this type of publicity.

The Safe Food Coalition, as you are no doubt aware, has invited Dr Fagan to SA to help publicise the flip side of the GE coin. Dr Fagan will be arriving on the 27 October and will be holding talks throughout the country. Please advise all your friends who may be interested in this important visit. For more information, contact Kerry on 011 784 8711.

Africabio is an organisation which has been formed by 40 vested interests to convince South Africans of the benefits of GE. They are holding their launch on Wednesday 27 October at the Hilton Hotel, Sandton, 10am to 1pm (the day Fagan arrives!) We encourage anybody who can attend this meeting to do so. You can contact:

Tanya-Lisa Elston before Monday 25 October on Tel. (011) 784 1008 or email tanyae@meropa.co.za

If you can't attend, Tanya will send you information so please contact her.

This is the start of something big and we need to urgently prepare a strategy. Any suggestions please phone myself or Glenda at 011 803 5656.

Here's hoping we can keep SA GE free.

Kindest regards,
Angus
Safe Food Coalition


Top PreviousNextFront Page

Date: Thu, 21 Oct 1999 13:19:23 +0200
From: Franz Beck fb@intekom.co.za

AfricaBio – A Repeat of EuropaBio ?

By Franz Beck

EuropaBio didn't have a good start: The strategy paper behind the drive leaked out and started to defeat the objective of EuropaBio.

From the strategy paper it is evident that the authors (Burson Marsteller) as well as the client (the founders of EuropaBio) knew that they are in the wrong. They are up against public oppinion. It is all about introducing something new and untested to the suspicious public using all tricks of persuasion, miss-information and lobying.

Since the fathers of AfricaBio are the same as those of EuropaBio it is easy to conclude that the strategy and purpose is the same. Lets hope that it has the same fate as well, like in the UK.


Top PreviousNextFront Page

Date: Fri, 22 Oct 1999 10:13:07 +0200
From: Glenda Lindsay glenda@global.co.za

SA Pro-GM Lobby launch...help call their bluff!!

Dear Fellow NON-genetically manipulated citizens

An 'AFRICABIO' consortium of 40 pro-biotech companies has formed and is doing a press launch next week:

10am to 1pm Wed 27th October at the Hilton Hotel, Rivonia Road, Sandown (Johannesburg)

(Sorry its short notice - I just received this info from Angus late last night)

This is also an opportunity to raise GM concerns....

FOR EXAMPLE the fact that rBst (genetically modified hormone given to cows to increase milk production) is LICENSED FOR USE HERE - it's BANNED IN CANADA, EUROPE, NEW ZEALAND for its animal & human health risks (including increased risk of breast and prostrate cancer to humans drinking milk from cows who've been injected with it.) On August 19th this year Codex Alimentarius, the UN FOOD SAFETY COMMISSION REPRESENTING 101 NATIONS worldwide ruled unanimously in favour of the European ban on milk produced in this way.

I have flyers on this situation available if you can help distribute them to the media covering the event....

I also have t-shirts printed (cost me R50 each if you want to buy) with the circular 'zip' logo on the back reading: "Say NO to Genetic Engineering, Say YES to Food Labelling" and various other useful GM-info handouts....contact me ASAP if you're able to help get public concern info out to the media....or print out the (virus-free) attachment and circulate it.

Here's a copy of AFROBIO's PR blurb/media release sent to newspapers/magazines on 19/10/99:

"The promotion and use of biotechnology and genetic engineering to increase the yied and quality of food production on a global scale is fast becoming the topic of choice in Sth Africa..

It is vital that South Africans understand the current information and are fully informed about the benefits of biotechnology. To acheive this goal and facilitate informed choice, members of the food, feed and fibre sectors" ( IE VESTED INTERESTS)"have formed an autonomous biotechnology association.

The association will provide current and accurate information to all South Africans with an interest in biotechnology and genetic engineering. We invite you to join our panel og guests at the launch"

(Details as I've given above)
RSVP Tanya-Lisa Elston before Mon 25th Oct
on (011) 784 1008 or email tanyae@meroa.co.za

Light snacks and refreshments wil be served"

Can you attend –

Placards etc to greet arriving media would be useful too. Please help in any way you can.

Yours for a GM-Free future!
Glenda


Top PreviousNextFront Page

Date: Fri, 22 Oct 1999 12:36:26 +0200
From: Glenda Lindsay glenda@global.co.za
SOURCE: Five Year Freeze Campaign, UK, gealliance@dial.pipex.com
DATE: October 1999
archive: http://www.gene.ch

FIVE YEAR FREEZE CAMPAIGN
94 White Lion Street, London Nl 9PF
Tel: 0171 837 0642    Fax: 0171 837 1141    email: gealliance@dial.pipex.com

GM food crops & World Trade Org bully tactics

BRIEFING: GM food and crops - the right to choose Implications of the World Trade Organisation

Sections:
1 What is the WTO?
2 What is the 'Millennium Round' and what is happening in Seattle in November?
3 Why is the WTO important to the Five Year Freeze campaign?
4 What is a Biosafety Protocol and bow does it fit in to all this?
5 What impact does the WTO have on poorer countries?
6 What key messages should we be getting to the Government?
7 How do we get this message across most effectively?

1 What is the WTO?

The World Trade Organisation (WTO) is responsible for monitoring and enforcing the global trade rules which are agreed by over 130 countries in its membership. The WTO is probably the most powerful of all intergovernmental institutions, having the ability to authorise trade sanctions against governments contravening its agreed rules.

Yet it is unaccountable to the public and its negotiations are increasingly seen as a threat to local, national and international efforts to protect health and the environment. The main goal of the WTO is to increase economic growth through trade liberalisation. The WTO considers many laws designed to protect the environment, health and safety to be 'trade barriers' and member governments periodically negotiate with each other to remove these 'barriers'.

The richest are able to exert the most influence within the WTO and they are strongly lobbied by large corporations. Poorer nations tend to lose out. Poorer countries have yet to complete implementation of the last 'Uruguay' round of negotiations and the full results of that round, good or bad, are, as yet unknown. For this reason there is a general lack of enthusiasm amongst these countries and civil society groups for any new negotiations. However, a number of the richest countries in the world are keen to start another extensive round on negotiations in November 1999, known as the 'Millennium Round'.

Example: Hormone treated beef – WTO puts trade before health.

There has been a European Union (EU) ban on hormone treated beef for eleven years due to concerns about the threats to human health. The EU's Scientific Committee has highlighted that one of the hormones used is a known carcinogen, and has listed many other potential health risks.

The US and Canada challenged the ban through the WTO which ruled that the ban was incompatible with its Agreement relating to food safety (the Agreement on Sanitary and Phytosanitary Measures - see Box 2). The European Commission appealed against the ruling but the WTO concluded that the arguments on the harmfulness of hormone residues in meat were not sufficient.

The EU has continued to impose the ban. The US and Canada have responded by imposing tariffs on goods from the EU. The WTO awarded the US and Canada a total of US$124 million. This example shows the weak position of the precautionary principle in trade disputes.

2 What is the 'Millennium Round' and what is happening in Seattle in November?

The Millenium Round proposal was initiated and is being promoted primarily by the EU which wants to see a 'comprehensive' round of negotiations adding new issues and negotiations to the existing agenda. This could include pushing for the removal of health and environmental "barriers" to trade. Yet already the various agreements of the WTO work against health and environmental protection (see Box 2).

The EU wants Trade and the Environment included as an issue for the negotiations in the 'Millennium Round' including whether or not the use of ecolabels and the precautionary principle are acceptable. Given the overall emphasis on trade liberalisation such talks are unlikely to result in any improvement on the existing situation.

Many of the organisations signed up to the Five Year Freeze campaign, together with over 1,100 other organisations from over 87 countries, are campaigning to stop the Millennium Round altogether. They believe that this Round could further restrict the right of individual states to promote sustainable societies and protect their environment from the effects of unregulated free trade. They also believe that the economic power of the United States will be increased at the expense of smaller, less developed countries.

3 Why is the WTO important to the Five Year Freeze campaign?

The primary objective of the UK Five Year Freeze campaign is a moratorium on the import of GM food and farm crops, the commercial growing of GM crops and the patenting of genetic resources for food and farming. It would seem reasonable to assume that with the potential risks to human health and our wildlife, and the likely contamination of organic crops, the Government would be able to justify taking such action. However, if the Government were to respond positively to our demands, it would almost certainly face a challenge through the WTO.

It could force the UK to grow and import GM food and crops The Government has already used the possibility of a WTO challenge as an excuse for not imposing a moratorium on the commercial planting of GM crops. It has said that a moratorium would be illegal and would therefore face a challenge through the WTO. However an expert legal opinion commissioned by Friends of the Earth (FOE) and the Royal Society for the Protection of Birds (RSPB) has concluded that "good arguments can be made to support the view that a moratorium on the commercial growing of GM seeds would not be contrary to EU and WTO law". The Freeze campaign takes the view that a moratorium would be legal, but any further trade liberalisation would make it much harder for the Government to respond positively to our demands. The US has already threatened a trade war over GM food and crops.

Abbr.Key WTO Agreements
GATT The General Agreement on Tariffs and Trade provides the backbone to the WTO. This includes some of the basic provisions. For example member countries must treat "like" products from a WTO member as favourably as it does from any other member and as favourably as it treats its own domestic products. This makes it difficult for a country to stop importing products from a country which is not living up to their obligations under environmental agreements or to favour goods on the grounds that they are produced in a more humane or sustainable way.
TBT Agreement on Technical Barriers to Trade In international trade law, health and environmental standards and regulations, and even labelling, can be considered as technical barriers to trade. Under pressure from the US it is possible that the existing labelling of GM ingredients in the UK could be threatened. Before the current labelling legislation was introduced the US had made continual threats to the EU for 'restraint of trade' if they required mandatory segregation and labelling of US agricultural exports containing GMOs. The TBT Agreement is due to be reviewed whether or not the 'Millennium Round' goes ahead.
SPS Agreement on Sanitary and Phytosanitary Standards This Agreement is very important in terms of GMOs as it deals with laws and regulations that at concern food and food safety, and animal and plant health. Generally under this agreement member countries would have to produce scientific evidence to justify any restriction to trade. For example in the case of hormone treated beef (see Box 1) the WTO concluded that the EU's evidence of harm was insufficient. However, the SPS does allow measures to be taken "on the basis of available pertinent information", pending a fuller evaluation of the risks. This would seem to provide justification for a moratorium on GM food and crops pending further research into the environmental impact.
TRIPS Agreements on Trade Related Intellectual Property Rights Like the TBT Agreement, the TRIPS Agreement is due to be reviewed whether or not the 'Millennium Round' takes place. The US allows patents on life forms, many other countries do not. Currently the WTO rules allow plants and animals to be excluded from patent laws but there are concerns that all WTO member nations will be compelled to adopt and implement US-style patent-protection regimes. Patenting of seeds allows companies to stop farmers saving seeds so the extension of US type patent legislation into poorer countries could have a devastating effect on the ability of people in those countries to feed themselves. The rights of indigenous communities to genetic and biological resources that are held in common are also ignored in patent legislation. It could threaten consumer choice by stopping segregation and labelling of GM foods.

Another major concern is that the US has made it clear that it regards the EU system of labelling GM ingredients as a barrier to trade. A more comprehensive labelling system is needed but new WTO negotiations could undermine even the existing, flawed, system. It is possible that even labelling systems for certified organic food and fairly traded products will be threatened. In order to provide consumer choice GM and non-GM crops must be segregated along the whole food chain. The lack of segregation in the US has made this difficult, but not impossible. The wholefood trade, and now most UK supermarkets, are developing 'identity preserved' systems to ensure that they can offer GM-free products to consumers. However the onus should not be on companies offering GM-free choices to ensure that segregation takes place.

The Government should ensure that segregation takes place before import, and the exporting company should bear the cost. The UK Government has taken a very weak position on this, stating that it cannot insist on segregation of imports due to WTO rules. It could force all countries to adopt US style patents on life The effects of patenting genetic resources, especially from developing countries, may have severe consequences for food security. A significant proportion of people in poorer countries are dependent on traditional practices such as saving seeds from one year to the next. The patenting of the plants they rely on will mean they have to stop saving seed or pay the company holding the patent for the seed every year. Developing countries are concerned that a review of the agreement relating to patents (TRIPS) will increase pressure on them to adopt US style patents on life (see Box 2).

4 What is a Biosafety Protocol and bow does it fit in to all this?

In February 1999 at Cartegena, Columbia, signatories to the UN Convention on Biological Diversity (CBD) met to negotiate a Biosafety Protocol to regulate the movement of GMOs and their products between countries. The negotiations in Cartegena followed three years of meetings. Poorer countries and NGOs want a strong Biosafety Protocol which would allow countries to make their own decisions about the import and use of GMOs and their products, without these measures being undermined by the rules of the WTO.

Such a Protocol would include :

However a group of countries now known as the 'Miami Group' (the US, Canada, Australia, Argentina, Chile and Uruguay) were pushing for a 'Trade Protocol' (excluding liability and the precautionary principle and omitting GM crops which make up some 90% of trade in GMOs). The conflict between the Miami Group and countries from Africa and Asia which were demanding a stronger Protocol, could not be resolved and the negotiations at Cartegena collapsed.

One of the main areas of dispute at Cartegena was whether the Protocol should be subject to WTO rules. The EU took the position that they should not. Negotiations for a Biosafety Protocol were resumed on 15 September 1999 and will culminate in May 2000. The debate over whether the Protocol would be subject to WTO rules persists. It is critical that negotiations take place within the Protocol and not the WTO where trade would most likely take precedence over other issues.

5 What impact does the WTO have on poorer countries?

Development charities like Action Aid, Christian Aid and the World Development Movement (WDM estimates that some 80% of crops in such countries are grown using seed saved by farmers previous years crops) are concerned that international trade rules will be used to force poor countries to accept GM crops and food, taking away their right to choose.

The patenting of genetic resources is a particular concern for poorer countries. Companies can claim ownership rights to indigenous plants which people have eaten and used for medicinal purposes for generations. Patented seeds will be expensive so small farmers will not be able to afford them. US patent laws also allow multinational companies like Monsanto to take farmers to court for saving seeds. This could be devastating to small farmers in developing countries who rely on the practice of seed saving.

6 What key messages should we be getting to the Government?

It is important that the Government is made aware of the level of concern about further trade liberalisation at the expense of human health, the environment and the rights of people in developing countries. We need stronger regulations governing the international movement of GMOs and a better system of segregation and labelling, not a weakening of the existing, flawed, systems. There are a number of key messages:

On this basis the Government should impose a Five Year Freeze on GM food and crops. The Government should also support a strong Biosafety Protocol to regulate the international movement of GMOs. This should take precedence over the provisions of the WTO. It should also support the right of all countries to exclude 'patents on life'.

7 How do we get this message across most effectively?

Over 100 organisations are signed up to the UK Five Year Freeze campaign. Many of them will be encouraging their members to lobby their MPs about the proposed 'Millennium Round'. These organisations will have a slightly different perspective e.g. some will be mainly concerned with the threat to labelling and others with the impact on developing countries. However they all share the objective of securing a Freeze on genetic engineering and patenting in food and farming and share the concern that increased trade liberalisation will make this objective more difficult to achieve. This provides an opportunity at the local level for a co-ordinated lobby of MPs, made more effective by the number and diversity of groups involved.

===================================================

Hartmut Meyer, Co-ordinator GENET, The European NGO Network on Genetic Engineering

Reinhäuser Landstr. 51
D - 37083 Göttingen
Germany

phone: #49-551-7700027    fax : #49-551-7701672    email: genet@agoranet.be


Top PreviousNextFront Page

Date: Mon, 18 Oct 1999 23:05:16 +0200
From: Glenda Lindsay glenda@global.co.za

GM Hormones: Codex Alimentarius voted in favor for EU ban on rBST

Hi All

In case you didn't know, Sth Africa's Dept of Agriculture has licensed the use of this substance in Sth Africa, despite these overseas bans.... Let me know if you want me to fax you a copy of the Dept of Ag's confirmation of this....meanwhile, cancel that milkshake!

Glenda
TITLEMonsantošs genetically modified milk ruled unsafe by the United Nations
SOURCEPR Newswire
DATEAugust 18, 1999
ARCHIVE http://www.gene.ch

Monsanto's genetically modified milk ruled unsafe by the United Nations

by Samuel S. Epstein, M.D., Professor of Environmental Medicine
University of Illinois School of Public Health, Chicago:

CHICAGO, Aug. 18 /PRNewswire/

The Codex Alimentarius Commission, the U.N. Food Safety Agency representing 101 nations worldwide, has ruled unanimously in favor of the 1993 European moratorium on Monsanto's genetically engineered hormonal milk (rBGH). This unexpected ruling, revealingly greeted by the U.S. press with deafening silence, is a powerful blow against U.S. global trade policies which are strongly influenced by powerful multi-national corporations, such as Monsanto. The Codex Commission ruling has also forced the U.S. to abandon its threats to challenge the European moratorium before the World Trade Organization later this year.

As importantly, the ruling represents the first large scale defeat of genetically modified foods on unarguable scientific grounds, apart from ethical and ideological concerns.

Since the Food and Drug Administration approved the sale of unlabeled rBGH milk in February 1994, the U.S. has exerted considerable pressure on Mexico and other trading partners to approve rBGH in efforts to increase pressure on Europe through the World Trade Organization. In this, they have been strongly supported by reports from the Food and Agriculture/World Health Organization's (FAO/WHO) Joint Expert Committees on Food Additives (JECFA), including its latest September 1998 report, which unequivocally absolved rBGH from any adverse veterinary and public health effects.

However, these JECFA committees, besides others such as those claiming the safety of meat from cattle treated with sex hormones, operate under conditions of non-transparency and conflicts of interest, and are predominantly staffed by unelected and unaccountable U.S. and Canadian regulatory officials and industry consultants with no expertise in public health, preventive medicine and carcinogenesis. The 1998 JECFA report on rBGH was then submitted to the Codex Committee on Residues of Veterinary Drugs in Foods, chaired by FDA's Director for Veterinary Medicine Dr. Stephen Sundloff who also played a prominent role in the 1998 JECFA Committee.

The Codex Committee promptly rubber stamped JECFA's seal of approval for rBGH with the confident expectation that this would be subsequently endorsed by the parent Codex Commission. However, the best laid plans of Monsanto and the FDA were aborted by an unexpected turn of events. Bowing to growing pressure in 1998 by Canadian advocacy groups, "dissident" government scientists and the Senate Agriculture Committee. Health Canada convened expert committees on veterinary and human safety under the auspices of the Canadian Veterinary Medical Association and the Royal College of Physicians and Surgeons, respectively.

Based on conclusions on the adverse veterinary effects of rBGH, particularly an increased incidence of mastitis, lameness and reproductive problems, Health Canada reluctantly broke ranks with the U.S. in January 1999, and issued a formal "notice of non- compliance", disapproving future sales of rBGH.

Meanwhile, the European Commission had commissioned two independent committees of internationally recognized experts to undertake a comprehensive review of the scientific literature on both the veterinary and public health effects of rBGH. The veterinary committee fully confirmed and extended the Canadian warnings and conclusions. The public health committee confirmed earlier reports of excess levels of the naturally occurring Insulin-like-Growth Factor One (IGF-1), including its highly potent variants, in rBGH milk and concluded that these posed major risks of cancer, particularly of the breast and prostate, besides promoting the growth and invasiveness of cancer cells by inhibiting their programmed self-destruction (apoptosis).

Faced with this latest well documented scientific evidence from both Canada and Europe, the U.S. bowed to the inevitable and failed to challenge the Codex ruling in support of the European moratorium.

It is now 15 years since Monsanto embarked on a series of large scale veterinary trials on rBGH all over the U.S., and sold milk from these trials to an uninformed and unsuspecting public with the full approval of the FDA. Since then, Monsanto and the FDA, strongly supported by a network of indentured university academics, aggressive lobbying by the National Dairy Council and its well organized "hit squads" targeting rBGH opponents, and an overwhelmingly uncritical media, have ignored or trivialized substantial scientific evidence on the hazards of rBGH milk, including a series of publications over the last decade in the International Journal of Health Services, the most prestigious international public health publication.

Also ignored by the media have been charges in 1981 by Congressman John Conyers (then Chairman of the House Committee on Government Operations), on the basis of a leaked confidential Monsanto study revealing serious pathology in cows injected with rBGH, that "Monsanto and the FDA have chosen to suppress and manipulate animal health test data in efforts to approve commercial use of rBGH".

These considerations reinforce growing concerns on the extreme unreliability of Monsanto and other biotech industry claims of the safety of genetically modified soy and other foods, especially in the absence of comprehensive testing by independent scientific experts, who should be funded by industry and not consumers.

Contact:
Samuel S. Epstein, M.D.
Professor of Environmental Medicine at the University of Illinois
School of Public Health, Chicago
Chairman of the Cancer Prevention Coalition +1-312-996-2297

Web site: http://www.preventcancer.com

===================================================

Hartmut Meyer, Co-ordinator GENET, The European NGO Network on Genetic Engineering

Reinhäuser Landstr. 51
D - 37083 Göttingen
Germany

phone: #49-551-7700027    fax : #49-551-7701672    email: genet@agoranet.be


Top PreviousNextFront Page

Date: Mon, 18 Oct 1999 21:01:27 +0200
From: Glenda Lindsay glenda@global.co.za
From: GENETNL genetnl@xs4all.be
TITLE: Beyond "substantial equivalence"
SOURCE: Nature, by Erik Millstone, Eric Brunner and Sue Mayer DATE: October 7, 1999

Initial paper on GM "substantial equivalence"

Dear GENET-news readers,

today you will receive bigger than usual messages. The publication of the below attached article "Beyond 'substantial equivalence'" caused an massive outcry of GE proponents that is worthy of documentation.

The attack of Millstone and coauthors hit the Holy Grail of international GE food legislation: the Principle of Familiarity and the Principle of Substantial Equivalence. Both concepts were created by US industry and affiliated scientists in the preparatory phase of GE food introduction (Calgene's Flavr Savr, Monsanto's RR soybeans) and resulted in the corresponding US "novel food legislation" from 1992. Due to the dominance of proponents of these both principles amongst industrial and governmental experts, the US legislation served as basis for numerous recommendations of international organisations and legislation of a number of other countries.

All statements of GE proponents resemble remarkebly in one point: They all leave their readers unclear about the fact that the EU laws subordinate the concept of substantial equivalence to the Precautionary Principle as it is laid down in the EU Treaty and the various GE legislations with respect to the protection of the environment and human health.

For many years, critics promoted the idea that the sheer number of laws based on industry's instructions is not a good indicator for its scientific foundation and appropriate balance of contrasting viewpoints in the society. The rejection of GE food first by European, but now by a quickly expanding portion of the world's consumers illustrates that the Principle of Familiarity and the associated Corporate Science is not able to convince consumers of the harmlessness of GE food - not to speak from the usefulness.

The articles in this GENET-news series will give a detailed overview on the current debate dealing with the very basic assumptions on GE food security. The different statements by GE proponents support very well the view of Millstone and coauthors that the concept of substantial equivalence is vague - vagueness is its very nature. Is it therefore that we can find three different statements on the date of its creation?

But the statements in support for substantial equivalence reveal more: Even the core persons and institutions in the GE food business have contrasting views on the character of their concept. While BIO and Monsanto defend the concept as scientific, H. I. Miller and the OECD deny this, supporting the view that it is a regulatory concept. That does not support credibility very much.

Yours,
Hartmut Meyer

Beyond "substantial equivalence"

Sections:
Acceptable daily intake
Trying to have it both ways
Failure to define 'substantial equivalence'
Acknowledged limitations
Authors:
References:

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

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 which 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 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 $25 million per product to R&D costs. 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 for laboratory animals. Thus, even if laboratory 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 toxicology 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 can provide information vital to consumer protection. (1)

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 UN Food and Agriculture Organisation (FAO) and the World Health Organisation (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 compositional data with those from 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-by-case 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 yet understood (3). Similarly, the relationship between genetics, chemical composition and toxicological risk remains unknown. Relying on the concept of 'substantial equivalence' is therefore just wishful thinking: it is tantamount to pretending to have adequate grounds 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 controversy (see Nature 398, 98;1999), 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 kinds of experiments which he conducted are not legally required and are therefore not routinely conducted before GM foods are introduced into the food chain.

Failure to define 'substantial equivalence'

The concept of 'substantial equivalence' was first introduced in 1993 by the OECD (4), and was subsequently 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 glyphosate. It is quite straightforward to distinguish, in a laboratory, the particular biochemical characteristics which 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 10 years that the application of glyphosate to soya beans significantly changes their chemical composition (for example the level of phenolic compounds such as isoflavones (5)), the GTSBs on which the compositional tests were conducted were grown without the application of glyphosate (6). This is despite the fact that commercial GTSB crops would always be treated with glyphosate to destroy surrounding weeds. The beans which were tested were, therefore, of a type which would never be consumed, while those which 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 which remains unresolved, and which has been neglected by those who have deemed GTSBs and non-GM soyabeans to be substantially equivalent.

Acknowledged limitations

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 trying to explore some alternatives (7). The Dutch team accepts that comparisons of relative 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, messenger-RNA fingerprinting, protein fingerprinting, secondary metabolite profiling and in vitro toxicity testing. If the use of such a finer screen revealed that a GM food contained a relevant novelty then the case for further studies would be far stronger, and those studies might benefit from having some clues as to which end-points might be most worthy of investigation.

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 therefore 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 which 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.

Authors:

  1. Erik Millstone, SPRU - Science and Technology Policy Research, Mantell Building, Sussex University, Brighton BN1 9RF (E-mail: e.p.millstone@sussex.ac.uk

  2. Eric Brunner, Department of Epidemiology and Public Health, University College, 1-19 Torrington Place, London WC1E 6BT

  3. Sue Mayer, GeneWatch UK, The Courtyard, Whitecross Road, Tideswell, Buxton, Derbyshire SK17 8NY

References:

  1. 'The ADI Debate', Appendix I of Food additives and the consumer', European Commission, 1980, pp. 41-3;

  2. Strategies for assessing the safety of foods produced by biotechnology, WHO, Geneva, 1991

  3. Bowers, J. et al. Science 285, 1562-1565 (1999)

  4. Safety Evaluation of Foods Derived by modern biotechnology OECD, Paris, 1993.

  5. Lydon, J. & Duke, S.O. Pesticide Science 25, 361-374 (1989)

  6. Padgette, S. R. et al. Journal of Nutrition 126, 702-716 (1996).

  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).

===================================================

Hartmut Meyer, Co-ordinator GENET, The European NGO Network on Genetic Engineering

Reinhäuser Landstr. 51
D - 37083 Göttingen
Germany

phone: #49-551-7700027    fax : #49-551-7701672    email: genet@agoranet.be


Top PreviousFront Page

Date: Mon, 18 Oct 1999 20:49:16 +0200
From: Glenda Lindsay glenda@global.co.za

TITLEGroup of Monsanto scientists response to the Millstone, Brunner and Mayer's letter to 'Nature' on applicability of substantial equivalence for assessing the safety of foods derived through biotechnology
SOURCEsent by AGNET, Canada
DATEOctober 5, 1999
ARCHIVE http://www.gene.ch

GM Foods: "substantial equivalence" questioned - Monsanto's reply

Sections:
BACKGROUND
Allegation 1
Response 1
Allegation 2
Response 2
Allegation 3
Response 3
References:

BACKGROUND

Erik Millstone, Eric Brunner and Sue Mayer are publishing a letter in Nature, Thursday, October 7, 1999 entitled "Beyond Substantial Equivalence". In this letter, these authors have reached the following conclusions: "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." "The case of GTSBs (glyphosate tolerance soybean) shows, moreover, that the concept of substantial equivalence is being misapplied, even on its own terms, within the regulatory process. If policymakers are therefore 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."

Allegation 1

"Substantial equivalence is a pseudo-scientific concept because it is a commercial and political judgement masquerading as if it were scientific."

Response 1

International scientific and regulatory experts have carefully evaluated approaches to assess the safety of foods derived from crops developed through biotechnology and have included substantial equivalence as a key component of this safety assessment process. The concept of substantial equivalence was elaborated by international scientific and regulatory experts convened by the Organization for Economic Coordination and Development (OECD) in 1991, well before any biotechnology products were ready for market.

The detailed scientific principles which underpin the application of substantial equivalence for the safety evaluation of foods derived from crops produced through biotechnology were further defined by leading international food and regulatory bodies including the World Health Organization (WHO, 1991; 1995)), the United Nations Food and Agricultural Organization (FAO, 1996), OECD (1993; 1996) and the International Life Sciences Institute (ILSI, 1997).

Government authorities in Japan (MHW, 1996), Canada (Heath Protection Branch, 1994), United States (FDA, 1992), United Kingdom (ANCFP, 1991), the EU Novel Foods (Official Journal of the European Communities, 1997) and many other countries have adopted substantial equivalence as part of the basis for the safety assessment of food derived from crops developed through biotechnology and have approved numerous products based on this approach. These regulatory agencies have concluded that foods derived from crops developed through biotechnology, which have been approved, are as safe as foods derived from conventional plant varieties.

Therefore, substantial equivalence is a well-established, scientifically valid approach used to assess the safety of the foods derived from crops developed through biotechnology, an approach accepted and implemented by scientific and regulatory experts globally.

Allegation 2

"It is, moreover, inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests."

Response 2

The safety assessment of the food crop is based on a number of components, of which substantial equivalence is a key component. Substantial equivalence includes assessing both the biological (agronomic, morphological, disease susceptibility, etc.) aspects of the genetically modified crop as well as a detailed assessment of the key nutrients and anti-nutrients in the food. Each of the measured parameters provides an assessment of the cumulative result of numerous biochemical pathways and hence provides an assessment of a wide range of metabolic pathways.

Comparisons are made to both a closely related traditional counterpart as well as to the established published range for the specific component within that crop to compare the observed levels to the natural variation of that component in current plant varieties. Data are generated using the latest validated methods on plant materials grown under environments in which the crop will be produced commercially to obtain data from a number of different environmental conditions.

Foods derived from the currently available biotechnology modified crops have been shown to be substantially equivalent to their conventional counterpart except for the introduced or intended trait. Typically, the introduced trait is conferred by the production of one or a few proteins which are encoded by the introduced DNA. The analysis of the introduced trait involves a detailed molecular characterization of the introduced DNA and a thorough safety assessment of encoded proteins, including evaluation of the specificity and activity of the encoded protein(s) as well as toxicological and immunological testing, as appropriate. The introduced proteins must be well characterized and shown to cause no harm to human health or the environment. Typically, the proteins used in the initial commercial products have been obtained from or are very similar to proteins from sources with a history of safe use.

For example, the proteins from Bacillus thuringiensis which have been used to confer protection against insects, are from naturally occurring soil microorganisms which have been used in microbial formulations applied to crops for almost 40 years. These organisms and the insecticidal proteins have been extensively testing in long, medium and short term toxicology studies over the past 40 years.

The FAO/WHO expert consultation concluded, regarding substantial equivalence, that: "While there may be limitation to the application of the substantial equivalence approach to safety assessment, this approach provides equal or increased assurance of the safety of food produced derived from genetically modified organisms as compared to foods or food components derived by conventional methods". Therefore, foods derived from crops developed through biotechnology are tested extensively, including biochemical characterization and toxicological testing of the introduced protein(s).

Allegation 3

"The case of GTSBs (glyphosate tolerant soybean) shows, moreover, that the concept of substantial equivalence is being misapplied, even on its own terms, within the regulatory process. If policymakers are therefore 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."

Response 3

The safety assessment of glyphosate tolerant soyabeans (or Roundup Ready. soyabeans) has been conducted according to internationally established guidelines, which include substantial equivalence. The only material difference between Roundup Ready soyabeans and other soyabeans, which results from the genetic modification, is the introduced EPSPS (CP4 EPSPS) protein that confers tolerance to glyphosate. The CP4 EPSPS is very similar, structurally and biochemically, to the EPSPS protein which is already present in soyabean (Padgette et al., 1996a; Harrison et al., 1996). Toxicological and immunological studies were conducted which confirm the safety of the CP4 EPSPS protein (Harrison et al., 1996).

The composition of Roundup Ready soyabeans has been studied in detail and published in a landmark paper in the respected Journal of Nutrition (Padgette et al., 1996). Data were generated on both soyabeans which were treated with glyphosate, the active ingredient in Roundup. herbicide, during the growing season (Taylor et al., 1999) as well as soyabeans which were not treated (Padgette et al., 1996b). Over 1400 compositional analyses of Roundup Ready soyabeans were conducted which confirm that there are no significant differences in the key soyabean nutrients and anti-nutrients.

These analyses included an assessment of phytoestrogen levels; no significant differences were observed in either case. Several animal studies were conducted which confirmed the Roundup Ready soyabeans are nutritionally equivalent to conventional soyabeans (Hammond et al., 1996). All these data were provided to and reviewed by the Advisory Committee on Novel Foods and Processes (ACNFP) in the United Kingdom and other European regulators.

These data clearly establish that Roundup Ready soyabeans are as safe as conventional soyabeans. This conclusion was reached after a thorough safety assessment, using substantial equivalence as a key safety assessment approach. This conclusion has been confirmed by regulatory agencies in thirteen countries around the world, including the UK and EU, all of which have approved Roundup Ready soyabeans. Four years of safe commercial use have confirmed these safety conclusions.

References:

  1. ACNFP (Advisory Committee on Novel Foods and Processes). 1991. Department of Health Report on Health and Social Subjects, No. 38. Guidelines on the Assessment of Novel Foods and Processes. London (HMSO).
  2. FAO/WHO. 1996. Biotechnology and Food Safety. Report of a Joint JAO/WHO Consultation. FAO, Food and Nutrition Paper 61.
  3. Food and Drug Administration. 1992. Statement of Policy: Foods Derived from New Plant Varieties: Notice, Federal Register 57:104; 22984-23005.
  4. Hammond, B.G., J.L. Vicini, G.F. Hartnell, M.W. Naylor, C.D. Knight, E. Robinson, R.L. Fuchs and S.R. Padgette. 1996. The Feeding Value of Soybeans Fed to Rats, Poultry, Catfish and Dairy Cattle is Not Altered by Incorporation of Glyphosate Tolerance. J. Nutrition 126:717-727.
  5. Harrison, L.A., M.R. Bailey, M. Naylor, J. Ream, B. Hammond, D.L. Nida, B. Burnette, T.E. Nickson, T. Mitsky, M.L. Taylor, R.L. Fuchs and S.R. Padgette. 1996. The Expressed Protein in Glyphosate-tolerance Soybean, 5-Enolpryruvyl-shikimate-3 phosphate Synthase from Agrobacteriuin sp. Strain CP4, is Rapidly Digested in vitro and is not Toxic to Acutely Gavaged Mice. J. Nutrition 126:728-740.
  6. Health Protection Branch. 1994. Guidelines for the Safety Assessment of Novel Foods. Vol. I and II. Health Canada, Ottawa.
  7. ILSI Europe Novel Foods Task Force. 1997. The Safety Assessment of Novel Foods. Food Chem. Toxicol. 34: 931-940.
  8. Ministry of Health and Welfare (MHW). 1996. Guidelines for Foods and Food Additives Produced by the Recombinant DNA Techniques.
  9. Japan. Official Journal of the European Communities. January, 27, 1997. Regulation (EC) No 258/97 Of The European Parliament And Of The Council. No L43. 1 p. 7.
  10. OECD (Organization for Economic Cooperation and Development). 1993. Safety Evaluation of Foods Produced by Modern Biotechnology: Concepts and Principles. OECD, Paris.
  11. OECD. 1996. OECD Documents: Food Safety Evaluation. OECD, Paris.
  12. Padgette, S.R., D.B. Re, G.F. Barry, D.E. Eichholtz, X. Delannay, R.L. Fuchs, G.M. Kishore and R.T. Fraley. 1996a. New Weed Control Opportunities: Development of Soybeans with a Roundup ReadyTM Gene. In Herbicide-Resistant Crops: Agricultural, Environmental, Economic, Regulatory and Technical Aspects. S.O. Duke, Ed. CRC Press, Boca Raton, pp 53-84.
  13. Padgette, S.R., N.B. Taylor, D.L. Nida, M.B. Bailey, J. MacDonald, L.R. Holden, and R.L. Fuchs. 1996b. The Compositio of Glyphosate-tolerant Soybean Seeds is Equivalent to Conventional Soybeans. J. Nutrition 126:702-716.
  14. Taylor, N. B., Fuchs, R. L., MacDonald, J., Shariff, A. R., Padgette, S. R. Compositional Analysis of Glyphosate-Tolerant Soybeans Treated with Glyphosate, Journal of Agricultural and Food Chemistry; 1999; ASAP Article
  15. WHO, 1991. Strategies for Assessing the Safety of Foods Produced by Biotechnology. Report of a Joint FAO/WHO Consultation. World Health Organization, Geneva.
  16. WHO. 1995. Application of the Principles of Substantial Equivalence to the Safety Evaluation of Foods and Food Components from Plants Derived by Modern Biotechnology. Report of a WHO Workshop. World Health Organization, Geneva. WHO/FNU FOS/95. 1.

===================================================

Hartmut Meyer, Co-ordinator GENET, The European NGO Network on Genetic Engineering

Reinhäuser Landstr. 51
D - 37083 Göttingen
Germany

phone: #49-551-7700027    fax : #49-551-7701672    email: genet@agoranet.be