Genetically
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6 February 2000

Table of Contents

EU Commission adopts Communication on Precautionary Principle
New page on the myth of E.Coli / Faecal Contamination
Re: GE Soydiesel
scientific conventions
Measles Vaccine In GM Food
GTM clowns at Guelph
Frankenfish or Salmon Saviour? (original article)
A Sweeter Deal than Expected from Transgenic Sugar Beets
GM crops to poison rain with mercury
Re: they're watching us!!!
Re: mercury GE plants
New York Times exposes Dennis Avery
Monsanto to sell sweetener unit for $570 million
Full text of Biosafety Protocol

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Date: 3 Feb 2000 07:06:41 U
From: wytze geno@zap.a2000.nl

Steve Emmott is Advisor-Genetic Engineering Greens/European Free Alliance Group
European Parliament, 1047 Brussels
Tel/fax +32 2 284 2026

Stephen Emmott wrote:

Here for your enjoyment is the text of the European Commission's Communication on the PP (Precautionary Principle). Critical evaluations will be gratefully received.

EU Commission adopts Communication on Precautionary Principle

Brussels, 2 February 2000

Sections:
Communication From The Commission on the Precautionary Principle
Summary

The European Commission has today adopted a Communication on the use of the precautionary principle. The objective of the Communication is to inform all interested parties how the Commission intends to apply the principle and to establish guidelines for its application. The aim is also to provide input to the on-going debate on this issue both at EU and international level. The Communication underlines that the precautionary principle forms part of a structured approach to the analysis of risk, as well as being relevant to risk management. It covers cases where scientific evidence is insufficient, inconclusive or uncertain and preliminary scientific evaluation indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen by the EU.

Today's Communication complements the recently adopted White Paper on Food Safety and the agreement reached in Montreal this week-end on the Cartagena Protocol on Bio-safety. The Communication also qualifies the measures that may be taken under the precautionary principle. Where action is deemed necessary, measures should be proportionate to the chosen level of protection, non-discriminatory in their application and consistent with similar measures already taken. They should also be based on an examination of the potential benefits and costs of action or lack of action and subject to review in the light of new scientific data and should thus be maintained as long as the scientific data remain incomplete, imprecise or inconclusive and as long as the risk is considered too high to be imposed on society.

Finally, they may assign responsibility or the burden of proof – for producing the scientific evidence necessary for a comprehensive risk assessment. These guidelines guard against unwarranted recourse to the precautionary principle as a disguised form of protectionism. Today's Communication was presented to the Commission by Mr Erkki Liikanen, Enterprise and the Information Society Commissioner, Mr David Byrne, Health and Consumer Protection Commissioner, and Ms Margot Wallstrom, Environment Commissioner. It is a follow-up to President Romano Prodi's speech to the European Parliament on 5 October 1999.

The Communication recalls that a number of recent events have undermined the confidence of public opinion and consumers because decisions or absence of decisions were not supported by full scientific evidence and the legitimacy of such decisions was questionable.

The Commission has consistently striven to achieve a high level of protection, inter alia in the environmental and human, animal and plant health fields. It is the Commission's policy to take decisions aimed to achieve this high level of protection on a sound and sufficient scientific basis. However, where there are reasonable grounds for concern that potential hazards may affect the environment or human, animal or plant health, and when at the same time the lack of scientific information precludes a detailed scientific evaluation, the precautionary principle has been the politically accepted risk management strategy in several fields. Although the precautionary principle is not explicitly mentioned in the EC Treaty except in the environment field, the Commission considers that this principle has a scope far wider than the environment field and that it also covers the protection of human, animal and plant health.

The Communication makes it clear that the precautionary principle is neither a politicisation of science or the acceptance of zero-risk but that it provides a basis for action when science is unable to give a clear answer.

The Communication also makes it clear that determining what is an acceptable level of risk for the EU is a political responsibility. It provides a reasoned and structured framework for action in the face of scientific uncertainty and shows that the precautionary principle is not a justification for ignoring scientific evidence and taking protectionist decisions.

The horizontal guidelines established in this Communication will provide a useful tool in the future for taking political decisions in this regard and will contribute to legitimate decisions taken when science is unable to assess completely the risk rather than decisions based on irrational fears or perceptions. Thus, one of the objectives of the Communication is to clearly describe the situations in which the precautionary principle could be applied and determining the scope of measures taken in this respect. It will therefore help ensuring the proper functioning of the Internal Market as well as a high level of protection and predictability for consumers and economic operators located in the EU and elsewhere.

-------------- Annex ------------------

Communication From The Commission on the Precautionary Principle

Summary

The issue of when and how to use the precautionary principle, both within the European Union and internationally, is giving rise to much debate, and to mixed, and sometimes contradictory views. Thus, decision-makers are constantly faced with the dilemma of balancing the freedom and rights of individuals, industry and organisations with the need to reduce the risk of adverse effects to the environment, human, animal or plant health. Therefore, finding the correct balance so that the proportionate, non-discriminatory, transparent and coherent actions can be taken, requires a structured decision-making process with detailed scientific and other objective information.

The Communication's fourfold aim is to:

  1. outline the Commission's approach to using the precautionary principle, establish Commission guidelines for applying it, build a common understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluate fully, and

  2. avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism. It also seeks to provide an input to the ongoing debate on this issue, both within the Community and internationally.

  3. The precautionary principle is not defined in the Treaty, which prescribes it only once – to protect the environment. But in practice, its scope is much wider, and specifically where preliminary objective scientific evaluation, indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community.

    The Commission considers that the Community, like other WTO members, has the right to establish the level of protection – particularly of the environment, human, animal and plant health, – that it deems appropriate. Applying the precautionary principle is a key tenet of its policy, and the choices it makes to this end will continue to affect the views it defends internationally, on how this principle should be applied.

  4. The precautionary principle should be considered within a structured approach to the analysis of risk which comprises three elements: risk assessment, risk management, risk communication. The precautionary principle is particularly relevant to the management of risk. The precautionary principle, which is essentially used by decision-makers in the management of risk, should not be confused with the element of caution that scientists apply in their assessment of scientific data.

    Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty.

    The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty.

  5. Decision-makers need to be aware of the degree of uncertainty attached to the results of the evaluation of the available scientific information. Judging what is an "acceptable" level of risk for society is an eminently political responsibility. Decision-makers faced with an unacceptable risk, scientific uncertainty and public concerns have a duty to find answers. Therefore, all these factors have to be taken into consideration.

    In some cases, the right answer may be not to act or at least not to introduce a binding legal measure. A wide range of initiatives is available in the case of action, going from a legally binding measure to a research project or a recommendation. The decision-making procedure should be transparent and should involve as early as possible and to the extent reasonably possible all interested parties.

  6. Where action is deemed necessary, measures based on the precautionary principle should be, inter alia: proportional to the chosen level of protection, non-discriminatory in their application, consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis), subject to review, in the light of new scientific data, and capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

    Proportionality means tailoring measures to the chosen level of protection. Risk can rarely be reduced to zero, but incomplete risk assessments may greatly reduce the range of options open to risk managers. A total ban may not be a proportional response to a potential risk in all cases. However, in certain cases, it is the sole possible response to a given risk.

    Non-discrimination means that comparable situations should not be treated differently, and that different situations should not be treated in the same way, unless there are objective grounds for doing so. Consistency means that measures should be of comparable scope and nature to those already taken in equivalent areas in which all scientific data are available.

    Examining costs and benefits entails comparing the overall cost to the Community of action and lack of action, in both the short and long term.

This is not simply an economic cost-benefit analysis: its scope is much broader, and includes non-economic considerations, such as the efficacy of possible options and their acceptability to the public. In the conduct of such an examination, account should be taken of the general principle and the case law of the Court that the protection of health takes precedence over economic considerations.

Subject to review in the light of new scientific data, means measures based on the precautionary principle should be maintained so long as scientific information is incomplete or inconclusive, and the risk is still considered too high to be imposed on society, in view of chosen level of protection. Measures should be periodically reviewed in the light of scientific progress, and amended as necessary. Assigning responsibility for producing scientific evidence is already a common consequence of these measures. Countries that impose a prior approval (marketing authorisation) requirement on products that they deem dangerous a priori reverse the burden of proving injury, by treating them as dangerous unless and until businesses do the scientific work necessary to demonstrate that they are safe.

Where there is no prior authorisation procedure, it may be up to the user or to public authorities to demonstrate the nature of a danger and the level of risk of a product or process. In such cases, a specific precautionary measure might be taken to place the burden of proof upon the producer, manufacturer or importer, but this cannot be made a general rule.


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Date: 3 Feb 2000 07:51:00 U
From: Marcus Williamson marcus_williamson@ibm.net

New page on the myth of E.Coli / Faecal Contamination

I've just posted a new page about the myth of E.Coli / Faecal Contamination in Organic food on my site at :

http://www.connectotel.com/gmfood/gmfaec.html

This includes an expose on the links between two proponents of this myth, Professor John Hillman / Dennis T Avery, and the biotechnology industry.

regards
Marcus


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Date: 3 Feb 2000 14:29:08 U
From: Paul & Katrin Davis devatalk@mcmail.com

Re: GE Soydiesel

Also it is not neccessary to grow new. Here in Europe, paticularly in Germany, recycled rapeseed oil is being used successfully. Emmissions are low and no change to the engine is needed (works only with diesel engines).

The person who 'refined' the sysytem buys waste oil and puryfies it. I have met taxi drivers who have used it exclusively for years with no damage to the engine and not mixed with other fuel....

I am sure there is enough waste from verious oils that could be adapted in this way. And conventially grown crops would suffice. Sorry - a bit off topic, but another example of what can be done.


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Date: 3 Feb 2000 14:51:46 U
From: Robert Mann robt_m@talk.co.nz

scientific conventions

Hello fellow stirrers

Biologists will think less of you if you don't name species by the convention. The whole species name is italicised, or failing that is underlined; in the depauperate character-set of email, the usual way is exemplified by the species name

_Escherichia coli_ .

The name of the genus is capitalised; except in some cases which don't concern us here, the specific epithet is NOT. Thus, 'Coli' is wrong – and a biologist will definitely think you ignorant if you continue to use it.

Even if you haven't directly experienced the importance of these rules, or can't imagine why they matter, I hope you will accept my assurance that they do matter, and I urge you to follow them for the sake of the general credibility of the movement to control GE.

This does all matter, because as you know the gene-jockeys pretend that our reservations about GE are due to ignorance of the science. If we write like scientific illiterates, they will surely use that as 'evidence' in support of that dismissive attitude - and with a degree of justice.

It should also be a matter of simple self-respect for us to get scientific conventions right.

In case anyone feels "it's only a convention so I'll show I'm liberated by disregarding it", the above arguments should suffice to over-ride that rebel attitude; and I wonder whether you take that attitude to the 'mere convention' of which side of the road to drive on.

While I'm at it, could I expand on the issue of our attitudes to science?

There are those who don't care if scientists think less of them; indeed, like Norman Mailer, they ascribe many of today's social ills to science which they suspect & despise.

This is a tragic confusion. Science is not inherently antisocial! We have to use science for social benefit, as has been done in a very big way and could be done much more. In order to expand benefits from science, we will have to deal with it on its own conventions. People like Dr Ann Clark do so, and as a result they increase the effectiveness of the movement to control GE. Those who are not scientists can and should learn its conventions insofar as they apply to their writing. This species name convention is a simple case, but not a trivial one. Let's get it right, for our own credibility.

R

----------------------
Robt Mann
Mulgoon Professor emeritus of Environmental Studies, U of Auckland consultant stirrer & motorcyclist
P O Box 28878, Remuera, Auckland 1005, New Zealand (9) 524 2949


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Date: 3 Feb 2000 22:57:17 U
From: Judy_Kew@greenbuilder.com (Judy Kew)

Measles Vaccine In GM Food

It's curious that the rationale for creating a GE measles vaccine in lettuce is that it could be used in developing countries where conventional vaccines can't be refrigerated:

"The modified food would be treated as a medical product and would not be available for mass consumption. These crops wouldn't be generally released. You would make them in special areas and then distribute

Lettuce is a vegetable which doesn't grow vigorously in hot climates, and once picked, it wilts quickly without refrigeration. It would seem that if a GE vaccine in lettuce were distributed "in the same way" as other vaccines, you'd have the same problem with lack of refrigeration.

----------------
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Date: 4 Feb 2000 08:21:37 U
From: "j.e. cummins" jcummins@julian.uwo.ca

GTM clowns at Guelph

By Prof. Joe Cummins, February 4, 2000, e-mail: jcummins@julian.uwo.ca

I am commenting on the article University dismisses modified food study Feb. 4,2000. The article was about some criticism of Prof. Ann Clark, of Guelph University (in Ontario near my home University) for criticizing government reports on the safety of GM foods. Her critics were Dean of Agriculture McLaughlin and his sidekick, Doug Powell, who seem to have put themselves forward as expressing the view of the University. I should point out that a real University does not have a single view but puts forward all views freely(that is why it is called a university).

Dean claimed Ann Clark lacked expertise in GM safety , but even though he seemed to have pretended to have expertise he is not a recognized expert in genetics . Doug claimed that Ann's report was silly and superficial. Doug is not recognized as an authority in genetics, his training was mainly in journalism. Dean seems to believe that training in journalism is more valuable than expert knowledge in genetics. Doug seems to have led Dean to put forward his ill informed views in the tabloids. Both seem to consider that move a class act.

However, the article spared us one painful experience. The gruesome twosome, Doug and Dean, usually include a long and tedious presentation on their personal superiority.


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Date: 4 Feb 2000 08:47:12 U
From: "Nancy Allen" nallen@acadia.net
From: "Herb Hoche" herbh@acadia.net
From: Peter Panek ppanek@SFU.CA
From: fishnet@island.net

===== A message from the 'fishfarm' discussion list =====

The following is the basis of the article which appeared in the National Post on Saturday, September 4th – this is the unedited version:

Frankenfish or Salmon Saviour? (original article)

By Sarah Schmidt

Canada has a lot at stake in the debate over whether transgenic salmon should come to market

Behind the chain link fence, electronic alarm system, security guard and yet another lock, the caged fish live out their lives in double-screened tanks, custom-made to keep them from slipping down the drain and wreaking environmental havoc in the wild waters.

Fish don't usually warrant such tight security, but the ones at the federal Department of Ocean and Fisheries laboratory in West Vancouver aren't like other fish that wind up on the dinner table – yet. The silver-bodied coho, hand-feed as often as 20 times a day to satiated their extraordinary appetites, may not be able to swim as well as their siblings in the wild.

Their value lies elsewhere. The designer salmon, or super salmon, are genetically programmed to grow about eight times faster - and as much as 37 times larger - than normal during the first year of their lives.

The thousands of transgenic fish quietly tucked away for nearly a decade in Canada's own Fort-Knox for fish could soon swim into the public spotlight, as commercial interests are on the brink of taking their own superfish to market. By year's end, A/F Protein Canada Inc. of St. John's, Newfoundland, plans to seek Health Canada permission to provide local kitchens with its own trademarked AquAdvantage fish, rearranged bits of flounder and salmon genes designed to speed up salmon growth by 400 per cent.

The stamp of approval could come as early as 2001, according to the company, a subsidiary of A/F Protein Inc. of Waltham, Massachusetts and headed by fish biologist Garth Fletcher, affiliated with Memorial University.

Talk of a "blue revolution" sweeping the fishing industry – the commercial quest to conquer the last wild frontier in the food chain – couldn't come at a more explosive time. Nor could mention of a genetically modified "saviour" to dwindling wild salmon stocks, as mounting controversy over genetic tinkering with the food supply sweeps across Canada and abroad.

At home, scientist Robert Devlin, creator of the genetically modified fish at the government lab in West Vancouver, is anxious about industry's push to commercialize the technology. The world authority on breeding super salmon wants to see exhaustive environmental risk-assessment research before Health Canada considers health risks associated with science's latest aquacreation.

Cautious and independent, Dr. Devlin has refused multiple offers to work with industry on his transgenic fish project. He prefers not to have deal with the pressures of making a profit.

"There's a real life pressure when you take the commercial route," says Dr. Devlin. "I'm not here to make money."

At home, salmon farmers, the net beneficiaries from any technology that shortens the long production cycles, are already on the defensive. Local fishermen and environmentalists, including the well-respected David Suzuki Foundation, blame fish farms for financial and environmental ruin. Mix genetically modified salmon into the toxic pot and the result would be an unmitigated environmental disaster, they say.

"They'd be Ben Johnson fish. The effects could be untoward," says Joe Cummins, genetics professor of emeritus at the University of Western Ontario. "They'll invade the natural population and pollute the gene pool."

Research shows that transgenic fish are much more aggressive and and out-eat wild stocks. "They've got a revved-up metabolism. They're hungry all the time,' says Dr. Devlin.

If placed in fish farms today, "they'd escape. There's no doubt about that," he admits. Regulators currently prohibit open-water tests of transgenic fish.

Already, farmed-raised Atlantic salmon, referred to "fugitive fish," have escaped in B.C. waters and spawned in the wild, raising questions about the impacts on the runs of wild Pacific salmon. The B.C. government has refused to lift its moratorium on fish farming.

In the United States, foreign marine life invading waters where it is not usually found costs government and industry $123-billion (US) a year. Exotic species, bacteria and viruses can alter the food chain and change whole ecosystems.

In Canada, fish farming disasters alone are costly. For example, Ottawa provided New Brunswick with a $13-million grant last December for the management and control of Infectious Salmon Anemia disease in the salmon aquaculture industry in the Bay of Fundy.

"The real doomsayers are the DFO and industry aquaculturalists that tell us that wild salmon are doomed and should be preserved only in DNA banks while they transform the oceans into a giant cultivation zone," says Howard Breen of the Georgia Strait Alliance.

***

Although nearly every other food group has already undergone genetic manipulation, fish stocks remain the last frontier with which to tinker. And playing with fish evolution is proving difficult for many to swallow.

"Canada was and still is a leader. Technically, we're ready. We can produce transgenic fish. The problem now is the public acceptance," says Shao Jun Du, a geneticist who undertook revolutionary transgenic fish research with world-renown scientist Choy Hew at the University of Toronto in the first half of the decade. Today, he is stationed at University of Maryland's Center for Marine Biotechnology, where the first successful transgenic fish in the United States was created.

Chris Baker, a vice-president with Environics Research Group, says any talk of the intertransfer of genes still stirs up negative emotions among Canadians.

"That's when the red flags are raised," says Mr. Baker, who conducted an attitudinal survey last November for the Canadian Biotechnology Strategy Take Force.

In the case of transgenic fish, even natural allies – members the aquaculture industry, the commercial target of the trials – are busy distancing itself from the technology that could send their profits into the stratosphere.

The B.C. Salmon Farmers Association, for example, identifies reducing production cost as one of its top priorities. Yet, the association is officially opposed to the fast-growing superfish.

"Scientists are always at the forefront of research. It's up to the public, the market, to determine whether they want it," says executive director Anne McMullin.

The association certainly doesn't want to be caught in a situation akin to their New Zealand colleagues. The local Green Party wrecked havoc in April when it released documents from Communications Trumps, a public relations firm hired by New Zealand King Salmon, currently conducting trials on transgenic fish.

"Issues such as deformities, lumps on heads etc. should not be mentioned at any point to anyone outside – comments about those would create ghastly Frankenstein images and would be whipped up into a frenzy by Greenpeace," reads the document.

Says David Conley, spokesman for Canada's Office of the Commission of Aquaculture, created in December to facilitate industry development, including transgenics: "It's just such a pit, a public relations nightmare."

***

A nightmare, perhaps. But it's also lucrative.

In 1997, for example, farmed salmon became the dominant force in the world market for the first time, supplying more than half of the world production. And according to the International Salmon Farmers Association, increases in Atlantic salmon production among the seven largest producers (including Canada) is expected to increase more than three-fold between 1997 to 2010.

In British Columbia, where dwindling wild salmon stocks continue to devastate coastal communities, the landed value of farmed salmon production totalled $229.2-million in 1998, compared to $55-million worth of wild production. These numbers represent a reversal of roles from 10 years prior, when wild production of salmon equalled $410.4 million, compared to $52.1-million in farmed production.

The East Coast is even a step ahead. Six Prince Edward Island fish farmers recently formed OvaTech, a company to distribute A/F Protein's genetically modified fish as soon as they are available.

Meanwhile, Ottawa funds transgenic research through the Canadian Biotechnology Strategy and the National Science Engineering Research Council.

"There is the recognition that other people are doing this kind of work and Canada needs to be ready," says Don Noakes, director of DFO's Pacific Biological Station and head of the Aquaculture Division.

Already, numerous applications for international patents for growth acceleration in fish and other aquatic organisms have been made to the Canadian government, including the Crown itself (its patent applications in Canada, the U.S., Britain, Chile and Norway are for the growth factor genes and gene construct for the salmon developed by Dr. Devlin in the West Vancouver lab).

"We're not licensing it, at least not at the moment," says Ialo Price of DFO's Aquaculture and Oceans Science Branch.

Approximately a dozen industry players have approached the federal government for rights to the technology. The commercialization of biotechnology discoveries and products now in the pipeline is a key to boosting industry revenues by a factor of five (from $1.1-billion to $5-billion) between 1998 and 2005, a goal of Industry Canada's National Biotechnology Advisory Committee.

At the same time, Ottawa is currently in negotiations with the private sector and aquaculture agencies over its West Vancouver lab. One of the options being considered is handing over operations to the private sector.

***

Environmentalists, who argue that Canada is leading the international charge on the transgenic fish front, say that Ottawa's behaviour could result in a nasty showdown abroad.

Canada, the third larger producers of genetically modified crops, is already on a collision course over GMOs with the European Union, where any reference to transgenic fish usually includes a highly charged quip about "Frankenfish."

And as Canada prepares to walk into World Trade Organization talks in Seattle this fall with an aggressive plan to push for the removal of trade barriers for these high-tech crops, any overzealous public cheerleading for transgenic fish will raise international eye brows, says Jo Dufay, campaigns coordinator for the Council of Canadians.

Adds Mark Ritchie, president of the U.S.-based Institute for Agriculture and Trade Policy. "Canada is blowing it's image as a bottle of pure water."

The most powerful reservations, however, may come from the creator of the West Vancouver creatures. Dr. Devlin, internationally renown for his work on risk-assessment of superfish, has much respect for the East Coast geneticists and fish biologists working to bring their transgenic AquAdvantage fish to market.

The pioneers of transgenic fish promise to introduce precautions to prevent genetically altered fish from upsetting the biosystem, including neutering the fish.

Like A/F Protein Inc., Dr. Devlin is working on sterilization solutions to solve the potential gene-pollution problem. However, he says even more risk-assessment work needs to undertaken.

Unaffected by commercial pressures, Dr. Devlin is the first to admit that the thousands of transgenic fish (10 strains) tucked away in his secured tanks look much better than they did a few years back, when the first batch of growth enhanced fish were "quite deformed."

"Commercial people don't like when I show the ugly fish [at conferences]," he says.

Today, after tweaking with the growth stimulation, the fish look normal. However, Dr. Devlin is now observing some abnormal behaviour in his genetically modified coho salmon (he used to work with chinook salmon).

"It's much much more aggressive. It was one of the things that made me wake up," he says.

"How do you take all that data, multiply it and come up with a risk statistic? I can't do that now."

And until he can, Dr. Devlin wants to keep his fish under lock and key while Health Canada wrestles with its first transgenic fish application.

Canadians, meanwhile, will have to decide whether they want to eat designer salmon.

-------------------------------------------------------

Peter Panek, Graduate student
Simon Fraser University, Institute of Fisheries Analysis
Burnaby, V5A 1S6
e-mail ppanek@sfu.ca    P(604) 291-3062    P(604) 291-5801    F(604) 291-5716


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Date: 4 Feb 2000 11:05:17 U
From: wytze geno@zap.a2000.nl

A Sweeter Deal than Expected from Transgenic Sugar Beets

By Claire Granger, Carnegie Institution of Washington
Department of Plant Biology    claire@Andrew2.Stanford.edu

The technical feasibility of producing novel products in traditional crops has been demonstrated many times, but in very few cases have these discoveries been put into commercial use. This is due to a number of factors, largely economic in nature. Few transgenic plants produce the compound of interest at a high enough level to offset the cost of processing, and in many cases the infrastructure necessary for processing the novel product simply does not exist. Now, recent experiments describing fructan production in transgenic sugar beet seem to satisfy all the demands for commercial production along with the possible side benefit of enhanced agronomic performance under conditions of drought stress.

Fructans are fructose polymers of commercial interest due to their promise as replacements for high calorie sweeteners and fats. Short chain fructans have the same sweet taste as sucrose, but provide no calories as humans lack the fructan-degrading enzymes necessary to digest them. The same is true for the longer chain fructans, which form emulsions having fat-like textures. Humans may not be able to utilize fructans, but the natural bacterial flora of the human gut can, resulting in a stimulation of their growth and leading to an increase in overall digestive health.

Currently, commercial production of small fructans from sucrose is carried out enzymatically in bioreacters using a fructosyl transferase isolated from Aspergillus niger. This production method is extremely expensive, resulting in a final cost for the compound that is too high for use in general foodstuffs. However, fructans accumulate naturally in about 15% of flowering plant species, including a number of traditional crop species such as wheat, onion, chicory, and Jerusalem artichoke, where they function primarily as a storage carbohydrate. The latter two species have been used for commercial extraction of fructans, but poor yield and complications with processing and product quality have ultimately rendered both plants economically unfeasible as sources.

Part of the problem with using natural sources for fructan extraction lies in the enzymes that control the synthesis and accumulation of these molecules. In plants, fructan synthesis occurs in the vacuole and begins with the conversion of sucrose to short fructose polymers through the action of 1-sucrose:sucrose fructosyl transferase (1-SST). A second enzyme, 1-fructan:fructan fructosyl transferase (1-FFT), is responsible for producing the longer chain forms of fructan by transferring fructosyl residues from one fructan molecule to another or to sucrose.

The combined action of these two enzymes results in a mix of fructans of different lengths, and additional enzymes cause branching or hydrolyze the chains to varying degrees. This mix of fructan end products causes problems for commercial manufacturers because a fairly homogeneous product is desirable. Consequently, additional processing is often necessary with fructans obtained from endogenous sources, driving up the cost of production.

With the cloning of cDNAs for 1-FFT and 1-SST from plant and bacterial sources, interest has grown in introducing these enzymes into plant backgrounds that do not normally synthesize fructans. The rationale behind this is that by introducing a single fructosyl transferase into a plant species devoid of fructan biosynthetic enzymes, it should be possible to produce a particular class of fructan molecules. The feasibility of this approach has been demonstrated by the introduction of fructosyl transferases from both bacterial and plant sources into tobacco, corn, and potato plants. However, in all these cases, the levels of fructan produced were not high enough to be economically useful or had deleterious effects on plant growth and development.

All photosynthetic plants synthesize sucrose, so any crop plant potentially could be engineered to produce fructan. However, sugar beet has several features that make it a logical choice. Sugar beet is bred to produce and store large amounts of sucrose, the precursor of fructan, and the majority of the sugar produced is stored in taproot cell vacuoles, the site of fructan synthesis. From a processing standpoint, the infrastructure already exists to extract and purify sugar compounds from beets. On the other hand, sugar beets are notoriously difficult to transform, a feature that has dissuaded a number of researchers from working with this species.

In an article in Nature Biotechnology, Koops and his colleagues described how they were able to overcome this hurdle by creating a transgenic line of sugar beet in which 40% of the taproot dry weight was converted to short chain fructans without discernible impact on plant growth or phenotype(1). They utilized a stomatal guard cell-based method of transformation to introduce a construct containing a cDNA encoding 1-SST from Jerusalem artichoke. After regeneration of intact plants, eight independently transformed lines were recovered and demonstrated to contain between one and greater than eight copies of the transgene.

Biochemical analysis confirmed that the inserted gene was expressed and functional in six of the eight lines. To verify that the plants were producing fructans, Koops and his colleagues performed both thin layer chromatography and high pressure anion exchange chromatography on extracts from taproot, the site of maximal sucrose production in wild type plants. They found that over 90% of the endogenous sucrose had been converted to small fructan molecules when compared with wild type lines, resulting in a yield of 110 umol/g fresh weight. This impressive yield has led the authors to refer to their transgenic plants as "fructan beets" instead of sugar beets.

In a recent paper in Plant Physiology and Biochemistry, Pilon-Smits and her colleagues described a related set of experiments that point to a possible added agronomic benefit of these plants(2). They also created fructan-producing sugar beets, this time using a bacterial fructosyl transferase instead of a plant fructosyl transferase. This enzyme, SacB, obtained from Bacillus subtilis, successfully catalyzed the production of long chain fructans in the transgenic plants. Though these plants displayed a relatively low level of fructan accumulation (0.5% dry weight in the highest-producing lines), they performed significantly better under conditions of drought stress when compared to wild type plants.

Similar results were also reported previously for tobacco transformed to express fructan. The discovery of the drought tolerance benefit is not surprising as it has long been suggested that fructans of all lengths have a role in defending plants against drought stress in species that naturally accumulate these compounds. However, in most cases, it has been difficult to correlate increased levels of fructans with drought tolerance.

With this in mind, it will be interesting to establish whether the "fructan beets" created by Koops and co-workers will display an increase in drought tolerance to accompany their altered biochemical makeup. If not, the findings by Pilon-Smits may provide important insights into the chemical requirements of fructan-mediated drought tolerance. Either way, it seems that transgenic sugar beet may hold the promise of finally making useful compounds such as fructans more economically available.

Sources

  1. Sevenier R, Hall RD, van der Meer IM, Hakkert HJC, van Tunen AJ, and Koops AJ. 1998. High level fructan accumulation in transgenic sugar beet. Nature Biotechnology 16:843-846

  2. Pilon-Smits EAH, Terry N, Sears T, and van Dun K. 1999. Enhanced drought resistance in fructan-producing sugar beet. Plant Physiology and Biochemistry 37:313-317

Information Systems For Biotechnology (ISB), News Report (from Agnet 3 Feb '00) February 2000


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Date: 4 Feb 2000 12:47:31 U
From: "j.e. cummins" jcummins@julian.uwo.ca

GM crops to poison rain with mercury

The advocates of putting genes into crops and trees so that the mercury in soil will be released to the atmosphere from the crops continue to ignore the deposition of mercury at high levels from atmosphere to rain in US cities (earlier I circulated the reports showing toxic levels in rain). The bulk of the mercury released by GM crops seems destined to be deposited in cities in rain and snow and in the arctic by cold condensation.I do not agree with the "science" writer from Nature that theGM mercury crops are a beneficial form of GM, in fact, it seems bad for cities! The abstract below is from Nature:

Wednesday 2 February 2000

biotechnology : GM mercury mop

By Sara Cross

The much-maligned science of genetic engineering may be invaluable in aiding otherwise intractable environmental problems. For example, researchers announce in Nature Biotechnology1 how the tiny weed, thale cress (Aribidopsis thaliana), can be genetically modified to remove the toxin 'methylmercury' from contaminated soil.

'Bioremediation', as the use of plants or bacteria to mop up human detritus is technically known, is attracting a lot of interest as a cheap and relatively simple method of dealing with contaminated soils or waters.

Unfortunately, the plants which naturally extract such poisons are slow growing and small, whereas the bacteria that can detoxify pollutants are generally less robust than the plants. Now Scott Bizily at the University of Georgia, Athens, Georgia, USA and colleagues get round these problems by putting a couple of bacterial genes into a plant.

Mercury occurs naturally at relatively safe levels. But industrial activities have produced vast quantities of a toxic, 'ionic' form of mercury that water-borne bacteria can easily convert into the even more deadly methylmercury.

Previous research has shown that plants engineered to contain the bacterial gene merB transform methylmercury to ionic mercury. Another bacterial gene, merA, when inserted into plants, causes plants to convert ionic mercury to elemental mercury that dissipates into the atmosphere. These genes cause plants to produce a protein that acts as a catalyst, converting one form of mercury to another.

Bizily's team developed a new variant of thale cress with both genes. These plants absorb methylmercury and convert it to ionic mercury through the action of proteins programmed for by the merB gene. The presence of the merA gene then enables the plant to convert this ionic mercury into the less harmful elemental mercury.

Unfortunately, outside the lab, things are more complicated. Elemental mercury is not as harmful as methylmercury but it is still a toxin and ideally should be destroyed. Also, contaminated land usually contains a mixture of pollutants requiring treatment. Many sites, used for the disposal of nuclear waste for example, are radioactive or may contain other noxious wastes that would kill the plants before they could extract any methylmercury.

Also, the conversion outlined above is likely to be a slow process simply because of the scale of methylmercury pollution. Further research into modifying large, fast-growing plants such as trees may be useful. Trees have a highly developed and extensive root system, which might extract toxins from the deeper parts of the soil, that the roots of thale cress cannot reach.

1.Bizily, S.P., Rugh, C.L. & Meagher, R.B. Phytodetoxification of hazardous organomercurials by genetically engineered plants. Nature Biotechnology 18, 213 - 217 (2000).

© Macmillan Magazines Ltd 2000 - NATURE NEWS SERVICE

Nature © Macmillan Publishers Ltd 2000 Reg. No. 785998 England.


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Date: 4 Feb 2000 14:28:31 U
From: Robert Mann robt_m@talk.co.nz

Re: they're watching us!!!

Laurel Hopwood wrote:

I recently posted Dr Michael Fox's piece MORE HELP OR MORE HARM? Genetically Engineered Crops and World Hunger

Somehow CAST saw his piece (which isn't a surprise because we know they're spying on us.) Here's what they sent Dr Fox:

For Michael Fox,

Having just read parts of your critical review of the Green Revolution and Doubly Green, I must ask if you:

  • travel by car?
  • travel by air?
  • eat more than the required number of calories to simply sustain life?
  • shower more than once a month?

    If the answer to any of these questions are "Yes" then I believe you are = guilty of a double standard and truly not putting the earth first!

    Richard E. Stuckey, Executive Vice President    rstuckey@cast-science.org
    Council for Agricultural Science and Technology
    4420 West Lincoln Way, Ames, IA 50014-3447
    Phone: 515-292-2125, ext. 25; fax: 515-292-4512
    World Wide Web: http://www.cast-science.org

  • The item is of psychological interest only - but, within that category, of considerable significance.

    This CAST has a history of distortions regarding pesticides and other chemical health hazards over at least two decades. That they now go on in such a silly fashion is evidence (like the would-be bovine engineer Phil l'Huiller claiming that the double helix was the start of GE) that the gene-jockeys and their venture-capitalist dupes are still riding along on the crest of an euphoric wave, thoroughly arrogant, supposing 'nothing can stop us now, 'cause we're the Dukes of Earl'.

    Time will tell.

    R

    ------------
    Robt Mann
    Mulgoon Professor emeritus of Environmental Studies, U of Auckland consultant stirrer & motorcyclist
    P O Box 28878, Remuera, Auckland 1005, New Zealand (9) 524 2949


    Top PreviousNextFront Page

    Date: 4 Feb 2000 20:06:57 U
    From: wytze geno@zap.a2000.nl

    Re: mercury GE plants

    This is the comment of Suzanne Wuerthele (from the US-EPA) on these mercury plants wytze

    Wuerthele.Suzanne@epamail.epa.gov wrote:

    4 Feb 2000 09:54:57 -0500 (EST) @

    The concept of engineering plants to take up chemical pollutants sounds great, and could be - theoretically. But, as always, one must consider hazards as well as benefits.

    One research project I read about (Univ. of Georgia) is creating GE trees which it is claimed will convert the mercury to "less toxic" elemental mercury, which will be transpired into the atmosphere. That could be a big problem. Of course, elemental mercury is well-absorbed, and quite toxic when inhaled, but the ecological effects of this scenario are more worrisome. Atmospheric transport (from power plants and incinerators) is the most likely source of mercury contamination in the Great Lakes. There the elemental mercury settles into sediments where bacteria convert it to the organic forms which cause reproductive effects in wildlife and make fish dangerous to eat. So a GE plant which simply transfers pollution from soil to air won't be desirable.

    Could GE plants concentrate the mercury, then be harvested, perhaps even be a profitable source of recoverable metal? That would be nice, if the plants aren't attractive to, and toxic to wildlife, and if they can't transfer the genes which allow them to concentrate the metal to native plants which in turn might make them toxic or otherwise alter ecological balance. Or if they don't escape to become exotic pests like water hyacinth in the Southern U.S.

    Because it's difficult to answer these questions, there is always value in asking if there is a native plant which might perform the same function. For some metals, there are plants which might be useful. The problem has been getting them to grow on tailings piles and other disturbed sites. This suggests that to get a GE plant to grow in such a site, it might have to be quite vigorous, perhaps have a selective advantage over other plants. And that raises the exotic weed question.

    None of this is brought up to suggest that people shouldn't try to solve problems, but rather as a reminder that every "problem-solving" technology presents its own problems, and the magnitude of those problems is a function of the power and nature of the technology. Genetic engineering is a powerful, and biologically-based technology. In the world of physics, every action has an equal and opposite reaction. In the world of biology, every action produces a reaction, but biological systems can multiply, magnifying and perpetuate effects.


    Top PreviousNextFront Page

    Date: 5 Feb 2000 01:17:05 U
    From: BluPiaf@aol.com

    Hello to all, please forgive me for cluttering your box if this has already made the rounds, but oh my, after Stossel's "acid trip" as one of you summed up so well, a reality check is needed.

    New York Times exposes Dennis Avery

    EATING WELL Anti-Organic, and Flawed

    By MARIAN BURROS, February 17, 1999 The New York Times

    Dennis T. Avery wants organic food to go away. And he doesn't care what it takes. Four years ago, he said that organic food could not feed the world without destroying the environment. Now, he says it's lethal.

    In an article in the fall issue of American Outlook magazine, published by his employer, the Hudson Institute, a conservative research group, Avery wrote, "Organic foods have clearly become the deadliest food choice." This is the case, he said, because organic farms use animal manure and do not use chemicals or permit pasteurization. The last assertion is untrue, as were several other statements in the article.

    The accusation might have gone unnoticed, but excerpts from the article were published in The Wall Street Journal and continue to be picked up around the country, by The Associated Press, The Tampa Tribune and trade industry publications.

    The simplest definition of "organic" is food grown without hormones, pesticides or synthetic fertilizers. Avery, however, used the terms "organic," "free-range," "natural" and "unpasteurized" interchangeably.

    "I grant you that I've mixed together natural and organic," Avery, the author of "Saving the Planet With Pesticides and Plastic" (Hudson Institute, 1995), said in an interview last week. "But to me they are distinctions without significant difference in terms of public health."

    His most combative accusation is based, he said, on 1996 data compiled by the Centers for Disease Control and Prevention, showing that "people who eat organic and 'natural' foods are eight times as likely as the rest of the population to be attacked by a deadly new strain of E. coli bacteria (O157:H7)."

    Yet some of the foods that caused the outbreak, which he called organic, were not, like unpasteurized Odwalla apple juice.

    Avery's claim that "consumers of organic food are also more likely to be attacked by a relatively new, more virulent strain of the infamous salmonella bacteria" was based on a Consumers Union study in 1998 showing that "premium" chickens had higher levels of salmonella than regular supermarket chickens. But the premium chickens were not organic.

    In the article, Avery took the Food and Drug Administration to task for failing "to issue any warnings to consumers about the higher levels of natural toxins their researchers regularly find in organic foods." In the interview, he said that that assertion was based on a statement by Dr. Robert Lake, an official in the agency's Center for Food Safety and Nutrition.

    Lake denied making such a statement, saying, "We don't go out of our way to sample organic food, and hence I don't think we are in a position to say anything one way or another about it."

    Avery wrote that because "organic farmers use animal manure as the major source of fertilizer," there are higher levels of harmful bacteria in organic food. Katherine DiMatteo, the executive director of the Organic Trade Association, said that manure is not the major source of fertilizer on organic farms (it is also used in conventional farming) and that, when it is used, certain rules must be followed for safety.

    Avery said he had never "bothered that much about consumer safety aspects of organic food until O157:H7." His real goal, he said, is to prevent organic agriculture from becoming the norm. "My big concern is that we do not have room on the planet to feed ourselves organically," he said.

    The attack on organic food by a well-financed research organization suggests that, even though organic food accounts for only 1 percent of food sales in the country, the conventional food industry is worried.


    Top PreviousNextFront Page

    Date: 5 Feb 2000 02:56:36 U
    From: jim@niall7.demon.co.uk

    Monsanto to sell sweetener unit for $570 million

    Reuters Story - February 04, 2000 08:28
    http://www.marketwatch.newsalert.com/bin/story?StoryId=CojPC0b8ZtJa ...

    ST. LOUIS, Feb 4 (Reuters) - Life sciences firm Monsanto Co. said on Friday it agreed to sell its sweetener business, which includes the NutraSweet and Equal brands, to an investment group for $570 million in cash.

    Monsanto, which had said last year it was looking for a buyer for the unit as part of a restructuring plan aimed at reducing debt, said it signed a definitive agreement with Tabletop Acquisition Corp., whose institutional investors include Pegasus Capital Advisors and MSD Capital.

    Monsanto said proceeds from the sale of the sweetener business would be used to pay down debt and for other corporate purposes. All employees of the sweetener unit will be offered jobs with the new owners, Monsanto said.

    St. Louis-based Monsanto, which agreed in December to a merger with U.S.-Swedish drug group Pharmacia & Upjohn , incurred billions of dollars in debt after it acquired several seed companies in recent years. The purchases catapulted Monsanto into the No. 2 spot in the U.S. seed industry, but left it saddled with debt.

    "As we stated last year, the tabletop sweetener business, as well as the sweetener ingredients and biogums businesses, are excellent revenue-generating businesses that are not in line with Monsanto's strategic direction," Gary Crittenden, Monsanto's chief financial officer, said in a statement.

    Monsanto has chosen agricultural products and pharmaceuticals as its two key markets. Its arthritis treatment Celebrex became the best-selling new drug in 1999, and its Roundup herbicide is among the top selling crop inputs.

    Ahead of the news, shares in Monsanto closed Thursday at 42.


    Top PreviousFront Page

    Date: 5 Feb 2000 11:06:54 U
    From: wytze geno@zap.a2000.nl
    From List: Biotech Activists biotech_activists@iatp.org
    Posted by: farmer.to.farmer@sk.sympatico.ca

    Biotech Activists wrote:

    I found this on the web. It claims to be the Final Draft of the Protocol from Montreal.

    Full text of Biosafety Protocol

    Final Draft of Biosafety Protocol Approved at Montreal Meeting On Biological Diversity Convention, Released Jan. 29, 2000.

    Sections:
    The Parties to this Protocol
    Article 1: OBJECTIVE
    Article 2: GENERAL PROVISIONS
    Article 3: USE OF TERMS
    Article 4: SCOPE
    Article 5: PHARMACEUTICALS
    Article 6: TRANSIT AND CONTAINED USE
    Article 7: APPLICATION OF THE ADVANCE INFORMED AGREEMENT PROCEDURE
    Article 8: NOTIFICATION
    Article 9: ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION
    Article 10: DECISION PROCEDURE
    Article 11: PROCEDURE FOR LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING
    Article 12: REVIEW OF DECISIONS
    Article 13: SIMPLIFIED PROCEDURE
    Article 14: BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND ARRANGEMENTS
    Article 15: RISK ASSESSMENT
    Article 16: RISK MANAGEMENT
    Article 17: UNINTENTIONAL TRANSBOUNDARY MOVEMENTS AND EMERGENCY MEASURES
    Article 18: HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION
    Article 19: COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL POINTS
    Article 20: INFORMATION-SHARING AND THE BIOSAFETY CLEARING-HOUSE
    Article 21: CONFIDENTIAL INFORMATION
    Article 22: CAPACITY-BUILDING
    Article 23: PUBLIC AWARENESS AND PARTICIPATION
    Article 24: NON-PARTIES
    Article 25: ILLEGAL TRANSBOUNDARY MOVEMENTS
    Article 26: SOCIO-ECONOMIC CONSIDERATIONS
    Article 27: LIABILITY AND REDRESS
    Article 28: FINANCIAL MECHANISM AND RESOURCES
    Article 29: CONFERENCE OF THE PARTIES SERVING AS THE MEETING OF THE PARTIES
    Article 30: SUBSIDIARY BODIES
    Article 31: SECRETARIAT
    Article 32: RELATIONSHIP WITH THE CONVENTION
    Article 33: MONITORING AND REPORTING
    Article 34: COMPLIANCE
    Article 35: ASSESSMENT AND REVIEW
    Article 36: SIGNATURE
    Article 37: ENTRY INTO FORCE
    Article 38: RESERVATIONS
    Article 39: WITHDRAWAL
    Article 40: AUTHENTIC TEXTS
    Annex I: INFORMATION REQUIRED IN NOTIFICATIONS UNDER ARTICLES 8, 10 AND 13
    Annex II: RISK ASSESSMENT UNDER ARTICLE 15
    Annex III: INFORMATION REQUIRED FOR LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING UNDER ARTICLE 11

    The Parties to this Protocol, Being Parties to the Convention on Biological Diversity, hereinafter referred to as "the Convention"

  • Recalling Article 19, paragraphs 3 and 4, and Articles 8(g) and 17 of the Convention,
  • Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention to develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement,
  • Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on biological diversity, taking also into account risks to human health,
  • Recognizing that modern biotechnology has great potential for human well-being if developed and used with adequate safety measures for the environment and human health,
  • Recognizing also the crucial importance to humankind of centres of origin and centres of genetic diversity,
  • Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms,
  • Recognizing that trade environment agreements should be mutually supportive with a view to achieving sustainable development,
  • Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements,
  • Understanding that the above recital is not intended to subordinate this Protocol to other international agreements, Have agreed as follows:

     --- Article 1 ---

    OBJECTIVE

    In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.

     --- Article 2 ---

    GENERAL PROVISIONS

    1. Each Party shall take necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol.

    2. The Parties shall ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account risks to human health.

    3. Nothing in this Protocol shall affect in any way the sovereignty of States over their territorial sea established in accordance with international law, and the sovereign rights and the jurisdiction which States have in their exclusive economic zones and their contentional shelves in accordance with international law, and the exercise by ships and aircraft of all States of navigational rights and freedoms as provided for in international law and as reflected in relevant international instruments.

    4. Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for in this

      Protocol, provided that such action is consistent with the objective and the provisions of this Protocol and is in accordance with its other obligations under international law.

    5. The Parties are encouraged to take into account, as appropriate, available expertise, instruments and work undertaken in international fora with competence in the area of risks to human health.

     --- Article 3 ---

    USE OF TERMS

    For the purposes of this Protocol:

    1. "Conference of the Parties" means the Conference of the Parties to the Convention.
    2. "Contained use" means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment.
    3. "Export" means intentional transboundary movement from one Party to another Party.
    4. "Exporter" means any legal or natural person, under the jurisdiction to the Party of export, who arranges for a living modified organism to be exported.
    5. "Import" means intentional transboundary movement into one Party from another Party.
    6. "Importer" means any legal or natural person, under the jurisdiction of the Party of import, who arranges for a living modified organism to be imported.
    7. "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.
    8. "Living organism" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids.
    9. "Modern biotechnology" means the application of:
      1. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
      2. Fusion of cells beyond the taxonomic family that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.
    10. "Regional economic integration organization" means an organization constituted by sovereign States of a given region, to which its member States have transferred competence in respect of matters governed by this Protocol and which has been duly authorized, in accordance with its internal procedures, to sign, ratify, accept, approve or accede to it.
    11. "Transboundary movement" means the movement of a living modified organism from one Party to another Party, save that for the purposes of Article 17 and 24 transboundary movement extends to movement between Parties and non-Parties.

     --- Article 4 ---

    SCOPE

    The Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

     --- Article 5 ---

    PHARMACEUTICALS

    Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to the making of decisions on import, this Protocol shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organisations.

     --- Article 6 ---

    TRANSIT AND CONTAINED USE

    1. Notwithstanding Article 4 and without prejudice to any right of a Party of transit to regulate the transport of living modified organisms through its territory and make available to the Biosafety ClearingHouse, any decision of that Party, subject to Article 2, paragraph 3 of this Protocol, regarding the transit through its territory of a specific living modified organism, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to living modified organisms in transit.

    2. Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for contained use within its jurisdiction, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to the transboundary movement of living modified organisms destined for contained use undertaken in accordance with the standards of the Party of import.

     --- Article 7 ---

    APPLICATION OF THE ADVANCE INFORMED AGREEMENT PROCEDURE

    1. Subject to Articles 5 and 6, the advance informed agreement procedure in Articles 8-10 and 12 shall apply prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import.

    2. "Intentional introduction into the environment" in paragraph 1 above does not refer to living modified organisms intended for direct use as food or feed, or for processing.

    3. Article 11 shall apply prior to the first transboundary movement of living modified organisms intended for direct use as food or feed, or for processing.

    4. The advance informed agreement procedure shall not apply to the intentional transboundary movement of living modified organisms identified in a decision of the Conference of the Parties serving as the meeting of the Parties to this Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

     --- Article 8 ---

    NOTIFICATION

    1. The Party of export shall notify, or require the exporter to ensure notification in writing to, the competent national authority of the Party of import prior to the intentional transboundary movement of a living modified organism that falls within the scope of the Article 7, paragraph

    2. The notification shall contain, at a minimum, the information specified in Annex I.

    3. The Party of export shall ensure that there is legal requirement for the accuracy of information provided by the exporter.

     --- Article 9 ---

    ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION

    1. The Party of import shall acknowledge receipt of the notification, in writing, to the notifier within ninety days of its receipt.

    2. The acknowledgement shall state:
      1. The date of receipt of the notification;
      2. Whether the notification, prima facie, contains the information referred to in Article 8;
      3. Whether to proceed according to the domestic regulatory framework of the Party of import or according to the procedure specified in Article 10.

    3. The domestic regulatory framework referred to in paragraph 2 © above, shall be consistent with this Protocol.

    4. A failure by the Party of import to acknowledge receipt of a notification shall not imply its consent to an intentional transboundary movement.

     --- Article 10 ---

    DECISION PROCEDURE

    1. Decisions taken by the Party of import shall be in accordance with Article 15.

    2. The Party of import shall, within the period of time referred to in Article 9, inform the notifier, in writing, whether the intentional transboundary movement may proceed:
      1. Only after the Party of import has given its written consent; or
      2. After no less than ninety days without a subsequent written consent.

    3. Within two hundred and seventy days of the date of receipt of notification, the Party of import shall communicate, in writing, to the notifier and to the Biosafety Clearing-House the decision referred to in paragraph 2 (a) above:
      1. Approving the import, with or without conditions, including how the decision will apply to subsequent imports of the same living modified organism;
      2. Prohibiting the import;
      3. Requesting additional relevant information in accordance with its domestic regulatory framework or Annexes I and II; in calculating the time within which the Party of import is to respond, the number of days it has to wait for additional relevant information shall not be taken into account; or
      4. Informing the notifier that the period specified in this paragraph is extended by a defined period of time.

    4. Except in a case in which consent is unconditional, a decision under paragraph 3 above shall set out the reasons on which it is based.

    5. A failure by the Party of import to communicate its decision within two hundred and seventy days of the date of receipt of the notification shall not imply its consent to an intentional transboundary movement.

    6. Lack of scientific certainty due to insufficient relevant scientific information and acknowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects.

    7. The Conference of the Parties serving as the meeting of the Parties shall, at its first meeting, decide upon appropriate procedures and mechanisms to facilitate decision-making by Parties of import.

     --- Article 11 ---

    PROCEDURE FOR LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING

    1. A Party that makes a final decision regarding domestic use, including placing on the market, of a living modified organism that may be subject to transboundary movement for direct use as food or feed, or for processing shall, within fifteen days of making that decision, inform the Parties through the Biosafety Clearing-House. This information shall contain, at a minimum, the information specified in Annex III. The Party shall provide a written copy of the information to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the Biosafety Clearing-House. This provision shall not apply to decisions regarding field trials.

    2. The Party making a decision under paragraph 1 above shall ensure that there is a legal requirement for the accuracy of information provided by the applicant.

    3. Any Party may request additional information from the authority identified in paragraph (b) of Annex III.

    4. A Party may take a decision on the import of living modified organisms intended for direct use as food or feed, or for processing, under its domestic regulatory framework that is consistent with the objective of this Protocol.

    5. Each Party shall make available to the Biosafety Clearing-House copies of any national laws, regulations and guidelines applicable to the import of living modified organisms intended for direct use as food or feed, or for processing, if available.

    6. A developing country Party of a Party with an economy in transition may, in the absence of the domestic regulatory framework referred to in paragraph 4 above, and in exercise of its domestic jurisdiction, declare through the Biosafety Clearing-House that its decision prior to the first import of a living modified organism intended for direct use as food or feed, or for processing, on which information has been provided under paragraph 1 above, will be taken according to the following:
      1. A risk assessment undertaken in accordance with Annex II; and
      2. A decision made within a predictable timeframe, not exceeding two hundred and seventy days.

    7. Failure by a Party to communicate its decision according to paragraph 6 above, shall not imply its consent or refusal to the import of a living modified organism intended for direct use as food or feed, or for processing, unless otherwise specified by the Party.

    8. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of that living modified organism intended for direct use as food or feed, or for processing in order to avoid or minimize such potential adverse effects.

    9. A Party may indicate its needs for financial and technical assistance and capacity-building with respect to living modified organisms for direct use as food or feed, or for processing. Parties shall cooperate to meet these needs in accordance with Article 22 and 28.

     --- Article 12 ---

    REVIEW OF DECISIONS

    1. A Party of import may, at any time, in light of new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health, review and change a decision regarding an intentional transboundary movement. In such case, the Party shall, within thirty days, inform any notifier that has previously notified movements of the living modified organisms referred to in such decision, as well as the Biosafety Clearing-House, and shall set out the reasons for its decision.

    2. A Party of export or a notifier may request the Party of import to review a decision it has made in respect of it under Article 10 where the Party of export or the notifier considers that:
      1. A change in circumstances has occurred that may influence the outcome of the risk assessment upon which the decision was based; or
      2. Additional relevant scientific or technical information has become available.

    3. The Party of import shall respond to such a request in writing within ninety days and set out the reasons for its decision.

    4. The Party of import may, at its discretion, require a risk assessment for subsequent imports.

     --- Article 13 ---

    SIMPLIFIED PROCEDURE

    1. A Party of import may, provide that adequate measures are applied to ensure the safe intentional transboundary movement of living modified organisms in accordance with the objective of this Protocol, specify in advance to the Biosafety Clearing-House:
      1. Cases in which intentional transboundary movement to it may take place at the same time as the movement is notified to the Party of import: such notifications may apply to subsequent similar movements to the same Party; and
      2. Imports of living modified organisms to it to be exempted from the advance informed agreement procedure.

    2. The information relating to an intentional transboundary movement that is to be provided in the notifications referred to in paragraph 1(a) above shall be in the information specified in Annex I.

     --- Article 14 ---

    BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND ARRANGEMENTS

    1. Parties may enter into bilateral, regional and multilateral agreements and arrangements regarding intentional transboundary movements of living modified organisms, consistent with the objective of this Protocol and provided that such agreements and arrangements do not result in a lower level of protection than that provided for by the Protocol.

    2. The Parties shall inform each other, through the Biosafety Clearing-House, of any such bilateral, regional and multilateral agreements and arrangements that they have entered into before or after entry into force of this Protocol.

    3. The provisions of this Protocol shall not affect intentional transboundary movements that take place pursuant to such agreements and arrangements as between the parties to those agreements or arrangements.

    4. Any Party may determine that its domestic regulations shall apply with respect to specific imports to it and shall notify the Biosafety Clearing-House of its decision.

     --- Article 15 ---

    RISK ASSESSMENT

    1. Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex II and taking into account recognized risk assessment techniques. Such risk assessments shall be based at a minimum on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

    2. The Party of import shall ensure that risk assessments are carried out for decisions taken under Article 10. It may require the exporter to carry out the risk assessments.

    3. The cost of risk assessment shall be borne by the notifier if the Party of import so requires.

     --- Article 16 ---

    RISK MANAGEMENT

    1. The Parties shall, taking into account Article 8(g) of the Convention, establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment provisions of this Protocol associated with the use, handling and transboundary movement of living modified organisms.

    2. Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the living modified organism on the conservation and sustainable use of biological diversity, taking also into account risk to human health, within the territory of the Party of import.

    3. Each Party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including such measures as requiring risk assessments to be carried out prior to the first release of a living organism.

    4. Without prejudice to paragraph 2 above, each Party shall endeavour to ensure that any living modified organism, whether imported or locally developed, has undergone an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use.

    5. Parties shall cooperate with a view to:
      1. Identifying living modified organisms or specific traits of living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and
      2. Taking appropriate measures regarding the treatment of such living modified organisms or specific traits.

     --- Article 17 ---

    UNINTENTIONAL TRANSBOUNDARY MOVEMENTS AND EMERGENCY MEASURES

    1. Each Party shall take appropriate measures to notify affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations, when it knows of an occurrence under its jurisdiction resulting in a release that leads or may lead to an unintentional transboundary movements of a living modified organism that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health in such States. The notification shall be provided as soon as the Party knows of the above situation.

    2. Each Party shall, no later than the date of entry into force of the Protocol for it, make available to the Biosafety Clearing-House the relevant details setting out its point of contact for the purposes of receiving notifications under this Article.

    3. Any notification arising from paragraph 1 above should include:
      1. Available relevant information on the estimated quantities and relevant characteristics and/or traits of the living modified organism;
      2. Information on the circumstances and estimated date of the release, and on the use of the living modified organism in the originating Party;
      3. Any available information about the possible adverse effects on the conversation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measures;
      4. Any other relevant information; and
      5. A point of contact for further information.

    4. In order to minimize any significant adverse effect on conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party, under whose jurisdiction the release of the living modified organism referred to in paragraph 1 above occurs, shall immediately consult the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures.

     --- Article 18 ---

    HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION

    1. In order to avoid adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party shall take necessary measures to require that living modified organisms that are subject to intentional transboundary movement within the scope of the Protocol are handled, packaged and transported under conditions of safety, taking into consideration relevant intentional rules and standards.

    2. Each Party shall take measures to require that at a minimum documentation accompanying;
      1. Living modified organism that are intended for direct use as food or feed, or for processing, clearly identifies them as "may contain" living modified organisms and as not intended for intentional introduction into the environment, as well as a contact point for further information. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall take a decision on the detailed requirements for this purpose, including specification of their identity and any unique identification, no later than two years after the entry into force of this Protocol.
      2. Living modified organisms that are destined for contained use clearly identifies them as living modified organisms; and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the living modified organisms are consigned; and
      3. Living modified organisms that are intended for intentional introduction into the environment of the Party of import and any other living modified organisms within the scope of the Protocol, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter.

    3. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall consider the need for and modalities of developing standards with regard to identification, handling, packaging and transport practices, in consultation with other relevant international bodies.

     --- Article 19 ---

    COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL POINTS

    1. Each Party shall designate one national focal point to be responsible on its behalf for liaison with the Secretariat. Each Party shall also designate one or more competent national authorities, which shall be responsible for performing the administrative functions required by this Protocol and which shall be authorized to act on its behalf with respect to those functions. A Party may designate a single entity to fulfill the functions of both focal point and competent national authority.

    2. Each Party shall, no later than the date of entry into force of this Protocol for it, notify the Secretariat of the names and addresses of its focal point and its competent national authority or authorities. Where a Party designates more than one competent national authority, it shall convey to the Secretariat, with its notification thereof, relevant information on the respective responsibilities of those authorities. Where applicable, such information shall, at a minimum, specify which competent authority is responsible for which type of living modified organism. Each Party shall forthwith notify the Secretariat of any changes in the designation of its national focal point or in the name and address or responsibilities of its competent national authority or authorities.

    3. The Secretariat shall forthwith inform the Parties of the notifications it receives under paragraph 2 above, and shall also make such information available through the Biosafety Clearing-House.

     --- Article 20 ---

    INFORMATION-SHARING AND THE BIOSAFETY CLEARING-HOUSE

    1. A Biosafety Clearing-House is hereby established as part of the clearing-house mechanism under Article 18, paragraph 3, of the Convention, in order to:
      1. Facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms; and
      2. Assist Parties to implement the Protocol, taking into account the special needs of developing country Parties, in particular the least developed and small island developing States among them, and countries with economies in transition as well as countries that are centres or origin and centres of genetic diversity.

    2. The Biosafety Clearing-House shall serve as a means through which information is made available for the purposes of paragraph 1 above. It shall also provide access to information made available by the Parties relevant to the implementation of the Protocol. It shall also provide access, where possible, to other international biosafety information exchange mechanisms.

    3. Without prejudice to the protection of confidential information, each Party shall make available to the Biosafety Clearing-House any information required to be made available to the Biosafety Clearing-House under this Protocol, and:
      1. Any existing laws, regulations and guidelines for implementation of the Protocol, as well as information required by the Parties for the advance informed agreement procedure;
      2. Any bilateral, regional and multilateral agreements and arrangements;
      3. Summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordance with Article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology;
      4. Its final decisions regarding the importation or release of living modified organisms; and
      5. Reports submitted by it pursuant to Article 33, including those on implementation of the advance informed agreement procedure.

    4. The modalities of the operation of the Biosafety Clearing-House, including reports on its activities, shall be considered and decided upon by the Conference of the Parties serving as the meeting of the Parties at its first meeting, and kept under review thereafter.

     --- Article 21 ---

    CONFIDENTIAL INFORMATION

    1. The Party of import shall permit the notifier to identify information submitted under the procedures of this Protocol or required by the Party of import as part of the advance informed agreement procedure of the Protocol that is to be treated as confidential. Justification shall be given in such cases upon request.

    2. The Party of import shall consult the notifier if it decides that information identified by the notifier as confidential does not qualify for such treatment and shall, prior to any disclosure, inform the notifier of its decision providing reasons on request as well as an opportunity for consultation and for an internal review of the decision prior to disclosure.

    3. Each Party shall protect confidential information received under this Protocol, including any confidential information received in the context of the advance informed agreement procedure of the Protocol. Each Party shall ensure that it has procedures to protect such information and shall protect the confidentiality of such information in a manner no less favourable than its treatment of confidential information in connection with domestically produced living modified organisms.

    4. The Party of import shall not use such information for a commercial purpose, except with the written consent of the notifier.

    5. If a notifier withdraws or has withdrawn a notification, the Party of import shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Party and the notifier disagree as to its confidentiality.

    6. Without prejudice to paragraph 5 above, the following information shall not be considered confidential:
      1. The name and address of the notifier;
      2. A general description of the living modified organism or organisms;
      3. A summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and
      4. Any methods and plans for emergency response.

     --- Article 22 ---

    CAPACITY-BUILDING

    1. The Parties shall cooperate in the development and/or strengthening of human resources and institutional capacities in biosafety, including biotechnology to the extent that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in developing country Parties, in particular the least developed and small island developing States among them, and in Parties with economies in transition, including through existing global, regional, subregional and national institutions and organizations and, as appropriate, through facilitating private sector involvement.

    2. For the purposes of implementing paragraph 1 above, in relation to cooperation, the needs of developing country Parties, in particular the least developed and small island developing States among them, for financial resources and access to and transfer of technology and know-how in accordance with the relevant provisions of the Convention, shall be taken fully into account for capacity-building in biosafety. Cooperation in capacity-building shall, subject to the different situation, capabilities and requirements of each Party, include scientific and technical training in the proper and safe management of biotechnology, and in the use of risk assessment and risk management for biosafety, and the enhancement of technological and institutional capacities in biosafety. The needs of Parties with economies in transition shall also be taken fully into account for such capacity-building in biosafety.

     --- Article 23 ---

    PUBLIC AWARENESS AND PARTICIPATION

    1. The Parties shall:
      1. Promote and facilitate public awareness, education and participating concerning the safe transfer, handling and use of living modified organisms in relation to the conservation and sustainable use of biological diversity, taking also into account risks to human health. In doing so, the Parties shall cooperate, as appropriate, with other States and international bodies;
      2. Endeavour to ensure that public awareness and education encompass access to information on living modified organisms identified in accordance with this Protocol that may be imported.

    2. The Parties shall, in accordance with their respective laws and regulations, consult the public in the decision-making process regarding living modified organisms and shall make the results of such decisions available to the public, while respecting confidential information in accordance with Article 21.

    3. Each Party shall endeavour to inform its public about the means of public access to the Biosafety Clearing-House.

     --- Article 24 ---

    NON-PARTIES

    1. Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol. The Parties may enter into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding such transboundary movements.

    2. The Parties shall encourage non-Parties to adhere to this Protocol and to contribute appropriate information to the Biosafety Clearing-House on living modified organisms released in, or moved into or out of, areas within their national jurisdictions.

     --- Article 25 ---

    ILLEGAL TRANSBOUNDARY MOVEMENTS

    1. Each Party shall adopt appropriate domestic measures aimed at preventing and, if appropriate, penalizing transboundary movements of living modified organisms carried out in contravention of its domestic measures to implement this Protocol. Such movements shall be deemed illegal transboundary movements.

    2. In the case of an illegal transboundary movement, the affected Party may request the Party of origin to dispose, at its own expense, of the living modified organism in question by repatriation or destruction, as appropriate.

    3. Each Party shall make available to the Biosafety Clearing-House information concerning cases of illegal transboundary movements pertaining to it.

     --- Article 26 ---

    SOCIO-ECONOMIC CONSIDERATIONS

    1. The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities.

    2. The Parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of living modified organisms, especially on indigenous and local communities.

     --- Article 27 ---

    LIABILITY AND REDRESS

    The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analysing and taking due account of the ongoing processes in international law on these matters, and shall endeavour to complete this process within four years.

     --- Article 28 ---

    FINANCIAL MECHANISM AND RESOURCES

    1. In considering financial resources for the implementation of this Protocol, the Parties shall take into account the provisions of Article 20 of the Convention.

    2. The financial mechanism established in Article 21 of the Convention shall, through the institutional structure entrusted with its operation, be the financial mechanism for this Protocol.

    3. Regarding the capacity-building referred to in Article 22 of this Protocol, the Conference of the Parties serving as the meeting of the Parties to this Protocol, in providing guidance with respect to the financial mechanism referred to in paragraph 2 above, for consideration by the Conference of the Parties, shall take into account the need for financial resources by developing country Parties, in particular the least developed and the shall island developing States among them.

    4. In the context of paragraph 1 above, the Parties shall also take into account the needs of the developing country Parties, in particular the least developed and the small island developing States among them, and of the Parties with economies in transition, in their efforts to identify and implement their capacity-building requirements for the purposes of the implementation of this Protocol.

    5. The guidance to the financial mechanism of the Convention in relevant decisions of the Conference of the Parties, including those agreed before the adoption of this Protocol, shall apply, mutatis mutandis, to the provisions of this Article.

    6. The developed country Parties may also provide, and the developing country Parties and the Parties with economies in transition avail themselves of, financial and technological resources for the implementation of the provisions of this Protocol through multilateral, bilateral and regional channels.

     --- Article 29 ---

    CONFERENCE OF THE PARTIES SERVING AS THE MEETING OF THE PARTIES

    1. The Conference of the Parties shall serve as the meeting of the Parties to this Protocol.

    2. Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, decisions under this Protocol shall be taken only by those that are Parties to it.

    3. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, any member of the bureau of Conference of the Parties representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from among the Parties to this Protocol.

    4. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall keep under regular review the implementation of this Protocol and shall make, within its mandate, the decisions necessary to promote its effective implementation. It shall perform the functions assigned to it by this Protocol and shall:
      1. Make recommendations on any matters necessary for the implementation of this Protocol;
      2. Establish such subsidiary bodies as are deemed necessary for the implementation of this Protocol;
      3. Seek and utilize, where appropriate, the services and cooperation of, and information provided by, competent international organizations and intergovernmental and non-governmental bodies;
      4. Establish the form and the intervals for transmitting the information to be submitted in accordance with Article 33 of this Protocol and consider such information as well as reports submitted by any subsidiary body;
      5. Consider and adopt, as required, amendments to this Protocol and its annexes, as well as any additional annexes to this Protocol, that are deemed necessary for the implementation of this Protocol; and
      6. Exercise such other functions as may be required for the implementation of this Protocol.

    5. The rules of procedure of the Conference of the Parties and financial rules of the Convention shall be applied, mutatis mutadis, under this Protocol, except as may be otherwise decided by consensus by the Conference of the Parties serving as the meeting of the Parties to this Protocol.

    6. The first meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be convened by the Secretariat in conjunction with the first meeting of the Conference of the Parties that is scheduled after the date of the entry into force of this Protocol. Subsequent ordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held in conjunction with ordinary meetings of the Conference of the Parties, unless otherwise decided by the Conference of the Parties serving as the meeting of the Parties to this Protocol.

    7. Extraordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held at such other times as may be deemed necessary by the Conference of the Parties serving as the meeting of the Parties to this Protocol, or at the written request of any Party, provided that, within six months of the request being communicated to the Parties by the Secretariat, it is supported by at least one third of the Parties.

    8. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any State member thereof or observers thereto not party to the Convention, may be represented as observers at meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol. Any body or agency, whether national or international, governmental or non-governmental, that is qualified in matters covered by this Protocol and that has informed the Secretariat of its wish to be represented at a meeting of the Convention of the Parties serving as a meeting of the Parties to this Protocol as an observer, may be so admitted, unless at least one third of the Parties present object. Except as otherwise provided in this Article, the admission and participation of observers shall be subject to the rules of procedure, as referred to in paragraph 5 above.

     --- Article 30 ---

    SUBSIDIARY BODIES

    1. Any subsidiary body established by or under the Convention may, upon a decision by the Conference of the Parties serving as the meeting of the Parties, serve the Protocol, in which case the meeting of the Parties shall specify which functions that body shall exercise.

    2. Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of any such subsidiary bodies. When a subsidiary body of the Convention serves as a subsidiary body to this Protocol, decisions under the Protocol shall be taken only by the Parties to the Protocol.

    3. When a subsidiary body of the Convention exercises its functions with regard to matters concerning this Protocol, any member of the bureau of that subsidiary body representing a Party to the Convention but, at that time, not a Party to the Protocol, shall be substituted by a member to be elected by and from among the Parties to the Protocol.

     --- Article 31 ---

    SECRETARIAT

    1. The Secretariat establish by Article 24 of the Conveniton shall serve as the secretariat to this Protocol.

    2. Article 24, paragraph 1, of the Convention on the functions of the Secretariat shall apply, mutatis mutandis, to this Protocol.

    3. To the extent that they are distinct, the costs of the secretariat services for this Protocol shall be met by the Parties hereto. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, decide on the necessary budgetary arrangements to this end.

     --- Article 32 ---

    RELATIONSHIP WITH THE CONVENTION

    Except as otherwise provided in this Protocol, the provisions of the Convention relating to its Protocols shall apply to this Protocol.

     --- Article 33 ---

    MONITORING AND REPORTING

    Each Party shall monitor the implementation of its obligations under this Protocol, and shall, at intervals to be determined by the Conference of the Parties serving as the meeting of the Parties to this Protocol, report to the Conference of the Parties serving as the meeting of the Parties to this Protocol on measures that it has taken to implement the Protocol.

     --- Article 34 ---

    COMPLIANCE

    The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, consider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and to address cases of non-compliance. These procedures and mechanisms shall include provisions to offer advice or assistance, where appropriate. They shall be separate from, and without prejudice to, the dispute settlement procedures and mechanisms established by Article 27 of the Convention.

     --- Article 35 ---

    ASSESSMENT AND REVIEW

    The Conference of the Parties serving as the meeting of the Parties to this Protocol shall undertake, five years after the entry into force of this Protocol and at least every five years thereafter, an evaluation of the effectiveness of the Protocol, including an assessment of its procedures and annexes.

     --- Article 36 ---

    SIGNATURE

    This Protocol shall be open for signature at Nairobi by States and regional economic integration organizations from 15 to 26 May 2000, and at United Nations Headquarters in New York from 5 June 2000 to 4 June 2001.

     --- Article 37 ---

    ENTRY INTO FORCE

    1. This Protocol shall enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations that are Parties to the Convention.

    2. This Protocol shall enter into force a State or regional economic integration organization that ratifies, accepts or approves this Protocol or accedes thereto after its entry into force pursuant to paragraph 1 above, on the ninetieth day after the date on which that State or regional economic integration organization deposits its instrument of ratification, acceptance, approval or accession, or on the date on which the Protocol enters into force for that State or regional economic integration organization, whichever shall be the later.

    3. For the purposes of paragraphs 1 and 2 above, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization.

     --- Article 38 ---

    RESERVATIONS

    No reservations may be made to this Protocol.

     --- Article 39 ---

    WITHDRAWAL

    1. At any time after two years from the date on which this Protocol has entered into force for a Party, that Party may withdraw from the Protocol by giving written notification to the Depository.

    2. Any such withdrawal shall take place upon expiry of one year after the date of its receipt by the Depositary, or on such later date as may be specified in the notification of the withdrawal.

     --- Article 40 ---

    AUTHENTIC TEXTS

    The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary-General of the United Nations.

     --- Annex I ---

    INFORMATION REQUIRED IN NOTIFICATIONS UNDER ARTICLES 8, 10 AND 13

    1. Name, address and contact details of the exporter.
    2. Name, address and contact details of the importer.
    3. Name and identity of the living modified organism, as well as the domestic classification, if any, of the biosafety level of the living modified organism in the State of export.
    4. Intended date or dates of the transboundary movement, if known.
    5. Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.
    6. Centres of origin and centers of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.
    7. Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.
    8. Descripton of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the living modified organism.
    9. Intended use of the living modified organism or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology.
    10. Quantity or volume of the living modified organism to be transferred.
    11. A previous and existing risk assessment report consistent with Annex II.
    12. Suggested methods for safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.
    13. Regulatory status of the living modified organism within the State of export (for example, whether it is prohibited in the State of export, whether there are other restrictions, or whether it has been approved for general release) and, if the living modified organism is banned in the State of export, the reason or reasons for the ban.
    14. Result and purpose of any notification by the exporter to other States regarding the living modified organism to be transferred. (o) A declaration that the above-mentioned information is factually correct.

     --- Annex II ---

    RISK ASSESSMENT UNDER ARTICLE 15

    Objective

    1. The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health.

      Use of risk assessment

    2. Risk assessment is, inter alia, used by competent authorities to make informed decisions regarding living modified organisms. General principles

    3. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.

    4. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk.

    5. Risks associated with living modified orgamisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.

    6. Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment. Methodology

    7. The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances.

    8. To fulfil its objective, risk assessment entails, as appropriate, the following steps:
      1. An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health;
      2. An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism;
      3. An evaluation of the consequences should these adverse effects be realized;
      4. An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized;
      5. A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks; and
      6. Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment. Points to consider

    9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following subjects:
      1. Recipient organism or parental organisms. The biological characteristics of the recipient organism or parental organisms, including information on taxonomic status, common name, origin, centres of origin and centres of genetic diversity, if known, and a description of the habitat where the organisms may persist or proliferate;
      2. Donor organism or organisms. Taxonomic status and common name, source, and the relevant biological characteristics of the donor organism;
      3. Vector. Characteristics of the vector, including its identity, if any, and its source or origin, and its host range;
      4. Insert or inserts and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the function it specifies, and/or characteristics of the modification introduced;
      5. Living modified organism. Identify of the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the recipient organism or parental organisms;
      6. Detection and identification of the living modified organism. Suggested detection and identification methods and their specificity, sensitivity and reliability;
      7. Information relating to the intended use. Information relating to the intended use of the living modified organism, including new or changed use compared to the recipient organism or parental organisms; and
      8. Receiving environment. Information on the location, geographical, climatic and ecological characteristics, including relevant information on biological diversity and centres of origin of the likely potential receiving environment.

     --- Annex III ---

    INFORMATION REQUIRED FOR LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING UNDER ARTICLE 11

    1. The name and contact details of the applicant for a decision for domestic use
    2. The name and contact details of the authority responsible for the decision.
    3. Name and identify of the living modified organism.
    4. Description of the gene modification, the technique used, and the resulting characteristics of the living modified organism.
    5. Any unique identification of the living modified organism.
    6. Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.
    7. Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.
    8. Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.
    9. Approved uses of the living modified organism.
    10. A risk assessment report consistent with Annex II of this Protocol.
    11. Suggested methods for safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.