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Who and when to consult with internationally? [#168]
Stoats (Mustela erminea) were introduced from Britain to New Zealand in the 1880s in an attempt to control rabbits, but were quickly implicated in the decline of native birds.  Stoats are an ongoing major conservation problem in NZ - but an integral and valued part of the fauna of North America & Europe. Current techniques for controlling stoats in NZ can generally only be implemented over relatively small areas and it is likely that unless we can improve on this, a number of threatened bird species could become extinct. Some form of virally vectored fertility control would help with the stoat problem in NZ, and some preliminary research has been undertaken in this area.

A specification for any stoat biocontrol product is that it meets international obligations. This raises some interesting questions. If you are developing a new pest control technique that could adversely affect the biodiversity of another country, at what point to you consult with that country? Who do you consult? The process is not that clear.

I am interested in the question of what sort of framework should be in place to enable communication with potentially affected parties. New Zealand is a signatory to the Convention on Biological Diversity, and Article 14 (c) of the Convention text states that each Contracting Party shall promote notification, exchange of information and consultation on activities under their jurisdiction or control which are likely to significantly adversely affect the biological diversity of other States or areas beyond the limits of national jurisdiction. A supplementary agreement to the Convention, the Cartagena Protocol on Biosafety, came into force in September 2003. This protocol seeks to protect biological diversity from the potential risks resulting from transboundary/international movements of GMOs. However, this protocol deals mainly with intentional movements, rather than with unintentional ones. It does call for a risk assessment to be carried out prior to the first release of a GMO, but ideally, communication should be happening long before a release is being planned. Other agreements are likely to be applicable for example, the World Trade Organisation Agreement of Sanitary and Phytosanitary Measures (WTO/SPS). The WTO/SPS recognises two international technical organisations that could provide guidance – the International Plant Protection Convention (IPPC) and the Office International des Epizooties (OIE). However, none of these deal with assessing risks in the development phase, and the application of these agreements to transmissible forms of genetically modified animal-control agents is unlikely to have been tested.

It would be really useful to have some sort of agreed consultative framework that could be followed - comments/suggestions welcome!!

Elaine Murphy
Department of Conservation
New Zealand
posted on 2004-10-18 22:19 UTC by Elaine Carmel Murphy, Department of Conservation
Who and when to consult with internationally? [#347]
I agree with Elaine Murphy’s post, but am perhaps less hopeful that consultation can resolve the problems inherent in the technology to everyone’s satisfaction.

Some of the GMOs currently being developed in several countries to manage wild animals are disseminating (self-replicating and self-spreading). The countries developing them have good reasons for doing so, but they need to take into account the risks posed by the spread of their GMOs to other countries with different management objectives for susceptible species. For example, if the Spanish GMO designed to protect native European rabbits against myxomatosis and rabbit haemorrhagic disease got into rabbits in Australia, the result could be disastrous. And if Australia ever releases an immunocontraceptive GMO based on myxomavirus to control European rabbits, what would happen if it got into rabbits in Spain or into Sylvilagus brasiliensis (the natural host for myxomatosis) in America?

Can we manage these risks effectively, or is this just too big an ask? It does not seem good enough that each country goes its own way, regardless of the consequences for others. As Elaine points out in her post, the CBD requires each country to consult with others who may be affected by such activities, but it is easy to consult with someone and then disregard what they have to say (“My needs are greater than yours”). In any case, such consultation should start when the project is being planned, long before a country has spent millions of dollars developing a GMO and the momentum to release it becomes difficult to stop for all sorts of reasons. The difficulty is that the countries developing the GMOs would need to cede some of their sovereignty to allow other countries a say in what they let go inside their own borders, but the trade-off would be that they would minimise their risk of receiving another country’s undesirable GMOs.

I believe the primary need is to make the GMOs inherently safe (see thread “How can we make disseminating GMOs safer?”), but in addition we need to combine this with effective international consultation. The OIE deals with animal health matters that really make a difference to the countries involved. Would member countries agree to extend its remit to cover GMOs used to manage wild animals?

Robert Henzell
Animal and Plant Control Commission
South Australia
posted on 2004-10-18 23:55 UTC by Robert Henzell, Department of Water, Land and Biodiversity Conservation
RE: Who and when to consult with internationally? [#348]
Dear Elaine,

I find it an intriguing question, that you raise. I think there are
parallels with other transboundary pollution (oil-spills, nuclear waste etc
and the development of those things). Therefore I have send your message to
some jurists in our department. I will let you know when or what we can
think of this problem.

With kind regards,

Folchert


Dr. F.R. van Dijken
Senior Staff-officer
Department of Nature
Ministry of Agriculture, Nature and Food Quality
P.O.Box 20401, 2500 EK The Hague
The Netherlands
Phone:+31703785509
Fax: +31703786100
(edited on 2004-10-19 08:17 UTC by Ryan Hill)
posted on 2004-10-19 07:50 UTC by Folchert van Dijken, ministry of agriculture, nature and food quality
RE: Who and when to consult with internationally? [#349]
Dear Murphy,

I read your and consider it very interesting and if solutions are not found to these from the begining, then it will pose a problem in future as you have staed above concernig NZ.

I think the problem should first be approached from the particular country where the problem is

2. when the country is involved in the preparation of the modified organism the end - product should not pose a big problem because  all stakeholders such as the scientists,customs,phytosanitary, immigration and all accessories will the cooperate effectively towards the monitoring.

hope you will consider this as the point of entry.

E. ODJAM-AKUMATEY

ECOLOGICAL RESTORATIONS

GHANA
posted on 2004-10-19 07:56 UTC by EMMANUEL ODJAM-AKUMATEY, ECOLOGICAL RESTORATIONS
RE: Who and when to consult with internationally? [#350]
As pointed out, the issue of international sanctions or approvals for GMs used in biocontrol (or for other purposes) is not unique to this field.  Several years ago, we were (and to an extent still are) considering the release of a sterilising parasite to control populations of an invasive marine crab.  The issue was raised as to with whom and how one would consult other countries that border on the same ocean and hence might receive the parasite (on the unjustified assumption that oceans are boundary-less and that anything released at one point will inevitably show up everywhere).  The same issue arose several years earlier, when French scientists were considering release of an exotic herbivore to control an invasive exotic algae in the Med.  What was the process, if any, for getting all of the countries bordering the Med to agree to the release, particularly gven that a number of the relevant countries have a history of not talking directly with one another about anything.

Two issues are germane.  First, it was clear the opponents to any release of a biocontrol agent in the "pristine" ocean, saw and quickly siezed on the lack of an international consultation processes and purported need for uniform agreement as a means of stopping the process of marine biocontrol from ever happening.  This is a real risk for GM applications, as well.  Second, we all recognised the lack of and need for an international deliberative forum of some kind to vet proposals and develop agreed upon protocols, etc.  At the time, the best we could come up with was a UN body (specifically, the UN Group of Expert Scientists on Aspects of Marine Pollution [GESAMP], an ad hoc body previously used to make recommendations to the UN on a variety of issues, including control of marine pests).  Proposal got kicked around some, but never went anywhere.  I suggest a similar body, acting under the auspices of the Biodiversity Convention, would be appropriate.  It is, perhaps, something that one of the signatory countries could propose?

A final point is that with the industrialisation and potential profit generating power of GMs in, particularly, agriculture, I suspect any international body that is seen to infringe on big busnesses ability to make profits will have difficulty getting support from some countries.  An advisory body that focussed on GMs developed for pest management and other environmental applications would seem to be an easier first step to get up.
(edited on 2004-10-19 19:28 UTC by Kirsty Galloway McLean)
posted on 2004-10-19 18:47 UTC by Ronald Thresher, Commonwealth Scientific and Industrial Research Organaisation (CSIRO)
RE: RE: Who and when to consult with internationally? [#399]
I'd like to pick up on the issues raised by Ron Thresher in his experience with marine pest control. (Quite valuable experience, thankyou for sharing it).

1. The political expediency of a consensus. True, demands for "uniform agreement" (ie., a consensus) will always play into the hands of a proposal's opposition - consensus is notoriously difficult to achieve, and often then only at a level of compromise that so weakens the proposal to be almost meaningless, ineffective, or worst, counter-productive. This compromise-to-uselessness issue may be very important when dealing with quickly evolving systems like many pest-pesticidal situations. For instance, one can easily image a scenario where a political need to compromise that leads to a highly restricted application of pesticide – not enough to wipe a population out, but enough to create a selective force for resistance to evolve. We should be mindful of such dynamics here, doubly so when one considers the 'pesticide' (GMO biocontrol agent) is a component capable of evolution too.

2. Making decisions without a consensus. We need not acquiesce to demands for uniform agreement. It is worth noting that there are many decision-making systems in our societies that do not require consensus, yet are well respected. Democracy is one example. For another, civil suits in the British legal system use majority judgements of juries, and turn on balance of probabilities, the concepts of "reasonable", evidentiary thresholds, etc. Such systems often work very well, and do not seem to produce large injustices in society even though some disagree with the outcomes. It must be noted, however, that they aren't perfect, and are vulnerable to accusations of institutionalised bias - despite some great arguments, Western courts have a patchy record on defending environmental values, for instance. The “establishment” can have an uncomfortably large hold on negotiating power in these systems. As Thresher notes in his post, economic incentives in GM will be a powerful sector to work with/around.

3. There's more than just science here. I would submit that a purely science-based decision process would be the wrong way to proceed. Science is important - grounded truths are essential! - but not the whole of the picture. Consider: How would we handle the demands for restorative justice if our new "council" makes a demonstrable mistake? How could we define "a mistake" for that matter? How could we handle a situation where a "pest" is used as a resource in one country, but not in others? Is this an economic or ecological pest, anyway? Clearly, these are issues of justice (a concept whose nature varies in different parts of the world), values, culture and worldview. They fall outside the remit of science. A decision-making process that does not explicitly negotiate these matters will fail. That matters a lot if you consider that a disaffected party might decide to go ahead and release its agent regardless (ie. defection). Science is immensely valuable, but these decisions are irreversibly political and negotiable.

4. Consult the experts. The situation in front of us is of course problematic, but we aren't alone here. Comparable issues have come and gone, or are still with us, yet they have been resolved. In regards GM biocontrol, there is so far a strong bias towards letting the scientist talk out the issues. (With a nod of credit to the few but influential govt. agency/ policy workers that have participated so far). Scientific expertise is essential, but it is not adequate on its own. There is significant expertise in departments of political science, institutional and regulatory design, international treaty law, etc in universities across the globe. That's just the universities - what about those who do this for a living – bureaucrats, diplomats, lawyers, etc.? We should get these people involved in this discussion and profit from these years of learning. We should actively recruit these people to this online conference, and whatever conversation continues afterwards.

5. A final point – when to consult. Once a GM biocontrol R&D program is established, it has a strong internal political momentum towards release. Consider again the problem of defection – a nation, agency, research group etc. ignores a recommendation from this “council” and releases something anyway. This scenario throws the idea of WHEN to consult (E. Murphy and replies) into sharp focus. It suggests that it is better for all (the world) to consult early, before a technology is ready for release. Once a biocontrol agent is developed – sitting and waiting to be used - it is much easier and perhaps more tempting to defect. Note the tension here between innovating nation and the rest of the world. Within a nation: i) The careers of scientists are advanced by such work as developing GM biocontrol; ii) While many research budgets are assigned without a guarantee of the final product being deployed, they do need to be justified in some way – delivering a working product is a good way to do that; iii) Political capital can be gained by throwing money at such technological solutions, but even more can be gained when a nationalist cause is fulfilled by their release (eg. “we’re defending our farmers’ livelihoods”, etc). These factors create a strong incentive for the innovating nation to push for international consultation later, rather than earlier. This will be at the point where it is harder for other nations to satisfactorily suppress a release, should they wish to do so. From other nations’ point of view, it is strategically better (less risky) to prevent a product being developed in the first place – hence, better to consult early. (This seems like another version of Game Theory’s ‘Prisoners’ Dilemma). I suspect this tension will be felt quite strongly. We must discuss it openly and candidly.

Regards

Ben Gilna
Researcher
Centre for Resource and Environmental Studies
Australian National University
(edited on 2004-10-21 06:09 UTC by Ben Gilna)
posted on 2004-10-21 03:25 UTC by Ben Gilna, Australian National University
RE: RE: Who and when to consult with internationally? [#438]
After reading Ben's comments, a few thoughts came to mind.

1.  The principal that a decision to release requires a majority or balance of probability process, rather than a consensus, is an important point, but one that may founder on the rocks of nationalism and infringement on perceived national rights.  This is not an issue, usually, at the individual level, as in a jury system, but is a large issue for international agreements.  Nonetheless, it would appear to be a crucial element of any internationally agreed upon process to vet GM proposals.

2.  A number of respondents comment on risk analyses and inadequacy of available evidence regarding unplanned effects of GM releases.  In some respects, this is currently counter-balanced in environmental applications at least (as opposed to $-driven agricultural applications) by a strong conservatism among decision makers, including the public.  To my knowledge, no GM is close to being released on purely environmental grounds, but our experience in Australia, where several are being developed, is that when and if we get to the serious "we're ready to release" stage, the proponents will have a major selling job on their hands before approval is granted even by existing bureaucracies.  In part this reflects inherent conservatism among bureaucrats and politicians, but also it reflects pervasive unease over the technology throughout society in general.  Although the 'defection' scenario is a real one, in its absence I strongly suspect that prior to approval for release, the level of evidence with regard to risks required for the first sets of environmentally-targeted GM will be substantial.  This does not preclude the need for an agreed upon process to vet such applications, but suggests that there is hope that the scientific, economic, cultural and other voices will be involved in the decision making in any case, and that there may be scope to learn from these experiences in designing formal systems to vet subsequent applications.

3.  As was suggested to me some time ago, with regard to these technologies we should be aiming for an approach that is safe when it fails, rather than one that is fail-safe.  I propose this as a useful starting point for implementation planning.
(edited on 2004-10-21 20:00 UTC by Kirsty Galloway McLean)
posted on 2004-10-21 19:51 UTC by Ronald Thresher, Commonwealth Scientific and Industrial Research Organaisation (CSIRO)
RE: RE: RE: Who and when to consult with internationally? [#468]
Thanks Ron –

1. Good point about the needs of sovereignty vs. legitimacy of a majority. Doesn’t majority decision happen at the UN, at least its security council? What about the EU Parliament? I suspect compliance in these situations is a question of leverage – it is often in the participating country’s interest to abide by rulings that go against its interests on a particular issue, because non-compliance brings either sanctions, or reduces negotiating power for the country in other matters before the ‘council’. Which implies, if we were to go down this route of majority-rules, that the council would have to be more than just a vetting agency for proposals – there would have to be clear streams of benefit to participating. One option I’m thinking of would be to make it clear that membership of the group would make the joining nation’s pest problems everybody’s problems – so Europe would be a ‘co-owner’ of Australia’s rabbit problem, and Australia of Europe’s RHD and myxomatosis problem. Each member nation would then support each other’s efforts in finding solutions in real and material ways – exchange visits of scientists, data sharing, common technological platforms, etc.

This is ambitious. At its worst I can foresee a bureaucracy groaning under its own weight (perhaps vulnerable to capture from special interests). At its best, though, it may provide really innovative solutions and a strong foundation for other, yet-to-emerge issues that biotech is likely to bring. I note that both Australia (Australian Research Council’s International Linkage program and various MoUs; http://www.arc.gov.au/int_activities/default.htm) and Europe (eg. Forum for European-Australian Science and Technology (FEAST; http://www.feast.org)) have formally signalled international collaboration as a priority area. Not saying it would be easy, but there may be pathways we can explore that could increase the effectiveness of solutions, foster a collaborative spirit, and make the costs of defection a bit higher.

I’d really like to consult some international policy experts on this one, but I haven’t managed to grab anyone in the past 24 h.

2. On the issue of evidence of risk. I’m not sure there is a universal ‘default’ risk-adverse attitude to such GMOs. Many countries seem very comfortable with the notion of new technologies. Even if, in the first instance, there is a cautious attitude to releasing these agents, I think it only buys us a measure of time that may be shorter than we’d like to imagine. It’s a matter of balancing risks. One can easily imagine a situation where there is such a terrible calamity in one country that caution becomes less important in making a release-decision (eg., a plague and associated famine, disease vector, etc.). I’ll return to this point in a minute.

In this political context, where claims of risk will be instrumental to approval or opposition, the question of evidentiary threshold is critical. It will have strong implications for the way such a council would be designed. It could take a stance similar to the World Trade Organisation (WTO), where all trade is permissible unless there is a ‘scientifically valid’ (I’m paraphrasing) quarantine risk. Asking other nations to effectively prove a high level of risk will be problematic. Which nation has the final say on when sufficient evidence has been reached? Could we really negotiate a standard threshold in advance? The history of using science in this way has a poor track record, and usually leaves science looking pretty suspect as a whole – something probably not in anyone’s long-term interest. In response has been the push to the Precautionary Principle (PP). The idea is roughly that absence of definitive proof of harm does not constitute evidence of harmlessness – the burden is now on the proposer to argue something is safe, not opponents to argue it is unsafe. The PP is now in so many treaties and statutes that, although a concept still in search of a precise operational definition, it would likely form a key plank of our proposed council. 

Perhaps a productive way forward would not be to have a WTO model or a PP model, but a middle way? Its been noted before in this country at least (Tony Peacock, CEO of the Pest Animal Control Cooperative Research Centre; http://www.pestanimal.crc.org.au) that with pest animals it’s a question of a balance of risks. The risks of a GM biocontrol agent should be compared explicitly against the risks of doing nothing. Leaving aside just how that is done for the moment (how quantitative? how commensurable? etc.), it would offer a much more informed way of looking at the issues, less vulnerable to capture by special interests or ideologies, but still open to contribution from a wide variety of perspectives.

3. Safe-when-failing seems like a pretty good strategy/perspective to me.


Elaine, you kicked off this thread – I’d be curious to hear your thoughts on the posts so far, and perhaps your colleagues as well?

Ben Gilna
Centre for Resource and Environmental Studies
Australian National University
(edited on 2004-10-22 01:37 UTC by Ben Gilna)
posted on 2004-10-22 01:29 UTC by Ben Gilna, Australian National University
Re: RE: RE: Who and when to consult with internationally? [#485]
Dear all,

- On the issue of evidence of risk. I think that countries where new
technologies are welcome have to be informed through health education (both
the environment and the human being) or at least, as in medical treatments,
where the doctor has to explain the cure risks and the patient gives his
consensus ("informed consensus", that's the case in Italy, but I don't know if that
is the case in other countries - let me know.). Maybe this is  valid everywhere, Italy included of course ("informed consensus" there is only in
medical treatments). I agree with Gilna that "The risks of a GM biocontrol agent
should be compared explicitly against the risks of doing nothing." This
necessitates an education too. The different mental structure of  human
beings, among various peoples, is the real difficulty. The mental skill on
the contrary helps to resolve the issue.

- The principle that a decision to release requires a majority is the basis
of the democracy. I hope this doesn't necessitate information and
education.

- It is difficult to understand that possible irreversible damage can come from
risk, for those who are not scientists, to know that there is a
connection among every organisms and environment, man included. For this
reason I refer to the "information" and "education" linked to ecology,
two tools that can introduce the concepts of "reasonable", evidentiary
thresholds, as stated from Ben.
The "information" and "education" help to schedule an awareness and early consultation,
to answer the question "When to consult?, before throwing money at such technologies.

- I agree with an approach safe when it fails.

- I think that also the escaped GMOs have to be safe, otherwise that can
become an alibi at the mercy of economic interests. It is also necessary to have
professional ethics for researchers, because that contributes to safety.
I think an ethics onto which one swears an oath.

Regards

Pietro

*************
Dr. Pietro Demarchi
Naturalist
Via Gramsci 8
13037 Serravalle Sesia (VC)
Italy
pietrodemarchi@tele2.it
(edited on 2004-10-25 15:19 UTC by Elena Angulo)
posted on 2004-10-23 20:11 UTC by Pietro Demarchi
RE: Who and when to consult with internationally? [#352]
Dear friends,

Ben has a good point.

It is worse in most of the less-developed countries. The general people
know very little about GMO and the pros and cons with it. The educated
too had very fuzzy idea about this. So, the players in the National
Level, the bureaucracy and the (so-called) civil society are taking
their time, moving to and fro, not taking any decision. We do not have
rules-regulations; we do not know what the government had signed; there
is no discussion in the Parliament. We hear the time is up, we see GMO
is flooding market in disguise, coming cross the border, coming with the
big NGOs and seed companies, in the trials by research organizations.

There is no declaration, no labels, no listing.

So, yes. We are under the mainstream 'international', under the 'big
copntrols' of the UN, EU, GATT; actually they decide what we do.

That's why the ' big majority decision' is important for the world - now
the question is who controls it ?

Is GMO so important that we have to go for it even under all these
uncertainties ?

M.I.Zuberi, University of Rajshahi, Bangladesh
=========================================================
(edited on 2004-10-25 15:19 UTC by Elena Angulo)
posted on 2004-10-24 22:38 UTC by m.i.zuberi, university of rajshahi
Re: Who and when to consult with internationally? [#405]
Let me just answer the last question.
GMOs are not that important to us and the less developed nations as well as
the EU and many countries.They want organic food.
They are important to the proponents,the GMO giants
TNC/MNC.They need to make us accept it to survive
as a corporation.
We do not need it. And you are correct no one understands it,even the smart
people/governments.
So why are we being pushed to accept it.
It is new and not proven safe beyond reasonable doubt.
Let us go for a moratorium until such time that it is proven
safe beyond reasonable doubt.
(edited on 2004-10-25 15:18 UTC by Elena Angulo)
posted on 2004-10-25 06:48 UTC by Antonio M. Claparols, Ecological Society of the Philippines
RE: Who and when to consult with internationally? [#353]
Where to begin?

Important points were raised by Elaine and Ron. However, what approach
shall we take? It is definitely important to look at this issue in
"case-by-case" basis - some people argue it it the best way tackle with
this problem - and focus on the risks and effects of a particular event.
Moreover, it is also important to look from above, and start addressing
the GMO issue with a particular thinking trend, such as the PP. What
could be the implications of leaving the burden of proof (to be safe) to
the GMO proponents and assume that transgenics are "harmful"? (Opposite
thinking of traditional legal procedures).

I think that one of the few paths we have, at least try, to solve this
problem, is to start looking at the implications of the use of GMOs in
different countries where have been more exensively utilized (mostly
developed countries) and start searching for particular trends
associated with the use of GMOs, i.e. the statistical relation of GMOs
utilization and a particular disease, a particular specie population,
etc. Start more from the big picture, instead of an isolated case, and
evaluate past experiences (at least to the present), in order to give us
a better direction.

Some things are certain, less-developed countries do not have strong
legislation or infrastructure to deal with the movement of Living
Modified Organisms, and yet they are subject to importations by
international laws, and already receiving GMOs into their countries.

Comments?

Guillermo Castillo
Risk Assessment, Biosafety
Mexico


Este mail esta libre de virus!!
posted on 2004-10-25 19:51 UTC by Guillermo Castillo, Instituto Nacional de Ecologia
RE: Who and when to consult with internationally? [#406]
Yes, Guillermo is right. We should look at the problem
on a case by case basis. It must be known that the
problem is more complicated with animals than it is
with plants. So the management has a lot to learn from
animal production geneticists who have devised ways to
manage gene flow in farm animal populations. Extension
of the methods of animal geneticists to GMOs will
generally involve more rigour in breeding management.
David A. Mbah
Biosafety Support Project, Cameroon
(edited on 2004-10-27 10:54 UTC by Ryan Hill)
posted on 2004-10-27 06:19 UTC by David A. Mbah, Cameroon
Case-by-case will not be simple, or even really case-by-case. [#354]
Let me draw from the Australian experience. In Australia (2001), we created the Office of the Gene Technology Regulator (OGTR), an agency answerable to a council of Commonwealth (federal/national-level) ministers, who reviews all dealings with GMOs in this country. It grants licenses - or rejects them - on a "scientific" basis, with a view to human health and environmental concerns. (There are also other agencies that may be involved in a GMO approval, depending on how/where it is to be used).

The OGTR has 3 categories of dealings with GMOs. More interesting for us is the category it has for GMOs designed explicitly to be released into the real world. These “Direct Intentional Release” (DIR) applications – crops make up almost all of the applications, but also recently have been a couple of transgenic veterinary vaccines (attenuated viruses, I think from memory). DIR applications are:

· dealt with on a case-by-case basis
· big, detailed documents
· have a high reliance on information supplied by the applicant

So far, many GM crops have been approved, but only the vaccines really stand out as something different. There have been one or maybe more (not many) rejections. No-one is really testing the boundaries with a really radical proposal* – yet.  Some groups (pro and con) are unhappy, and some more than others, but the OGTR seems safe – there’s no threat to reform it. So far, we might say, so good.

So case-by-case might be a good way to go. We should keep in mind though, that this is not an easy system to administer, and almost nothing is really case-by-case. There is unquestionably an accumulated body of ‘corporate knowledge’ that the OGTR uses in making decisions – crops are pretty similar in many ways. Yes, they are complex, especially including distribution chains, etc., but I would suggest that there is a lot more in common between tropical cotton farming and temperate-climate canola farming systems than there is between, say, the dynamics of a cool temperate rainforest and a hot sandy desert. The implication is that “case-by-case” will take a LOT of work.

And then of course is the question of where we get our information from – do we believe the ecological data supplied by the nation that is proposing the GM biocontrol? Will all agencies/groups in that nation say the same thing? Who do we listen to? Would we accept information about an organism’s endogenous ecology from a nation that has the same organism as a pest? If we decide to trust no-one, would our ‘council’ have the budget and authority to commission its own studies? How long would that take?

I’m not arguing against a careful, detailed and specific review of each proposal that comes along – quite the opposite. What I AM saying is that we should be careful to go into this with our eyes open, and that “case-by-case” is not as simple, rational and foolproof as we might hope.

We also have to figure out how to rigorously and appropriately include lessons learnt from past experience. I think comparisons with GM crops might have very limited lessons for the issues before us, although not completely without value. As has been mentioned by others, we should also draw insight from standard biocontrol, introgression of farmed/stocked genetics into wild populations, hybridisation, etc. However, comparisons can trick us (or politicians, publics, etc) into a false sense of security - these issues may be similar in some ways, but not ALL ways. There are some things here that are fundamentally new, and that we fundamentally don't understand. Partial knowledge cuts both ways (an advantage and disadvantage).

*(Yes, on a long-term basis, GM crops may be considered radical, but they have been the subject of concerted critical focus for a little while now. We can't have answered all the questions about them, but we certainly have developed ways of thinking about them).

Ben Gilna
Centre for Resource and Environmental Studies
Australian National University
(edited on 2004-10-28 00:23 UTC by Ben Gilna)
posted on 2004-10-27 21:02 UTC by Ben Gilna, Australian National University
RE: Case-by-case will not be simple, or even really case-by-case. [#407]
Hello Everybody,

Ben Gilna is absolutely correct in his comments about case by case
studies. In dealing with initial cases the authorities who regulate gene
technology will develop a corporate knowledge and so will tend to group
similar applications instead of being absolutely objective and treating
each case as a new entity. Nevertheless, is this actually a bad thing?
It can be a two way process and where excellent, well researched cases
are made for introducing a new GMO these will also raise standards and
expectations for future applications. This was certainly my experience
with the Australian Quarantine Inspection Service when making
applications for introductions of biological control agents into
Australia.

We can certainly plan the best regulatory system possible, but in the
end, practical tests of the system are the only way of evaluating it and
subsequent adjustments must be made as things progress. This may not
simply mean progression in a technical sense (eg safeguards built into
GMOs); values and expectations can also change from one generation to
the next. People may become more relaxed about GMOs over time if there
were some obvious benefits to all or as needs change. On the other hand,
regulations would need to be tightened up or some kinds of research
forbidden if there were a major unforeseen problem. The management of
risk is both a technical and political process.

Regards

Dr Brian D. Cooke
Vertebrados introducidos y mamíferos endémicos
Estación Cientifica Charles Darwin
Puerto Ayora, Galapagos, Ecuador
Tel: (593) 05 2526 146 ext 228
Fax: (593) 05 2526 102
Postal address: Fundación Charles Darwin, Casilla 17-01-3891, Quito,
Ecuador
Email: bcooke@fcdarwin.org.ec
posted on 2004-10-28 10:36 UTC by Brian Cooke, Charles Darwin Foundation
Who and when to consult with internationally? [#409]
Hello everybody,
I agree that the problem is that less-developed countries do not have strong legislation or infrastructure to deal with the manipulation or release or movement of Living Modified Organisms, or a Regulator body for doing risk assessment and risk management.
In my country there is strong legislation, regulation and infrastructure for all biological risks such as LMO, or movement of LMO and now we are preparing the guideline for importations of LMO.
Comments?
Miguel Lorenzo
Biosafety risk analysis, Cuba
(edited on 2004-10-28 16:14 UTC by Ryan Hill)
posted on 2004-10-28 16:01 UTC by Miguel Lorenzo Hernandez, National Centre for Biological Safety
Re: Who and when to consult with internationally? [#446]
Dear friends,

Often we only discuss about problems, but we also have to give emphasis on solutions, on what we have to do. I raised the issue of Least Developed Countries (LDCs), in particular the lack of strong legislation or infrastructure to deal with the manipulation or release or movement of Living Modified Organisms, or an effective regulating body for risk assessment and management as also mentioned by our Cuban friend Miguel Lorenzo.

Now, the governments in these LDCs are not equipped and motivated to
take quick and proper steps; we have to involve the researchers from
universities and NGOs to collaborate and take this up. It is important that UN based efforts coordinate these because of the nature of the problem (transboundary spread etc).

In the process of risk assessment, proper weight on the higher chances of harm (due to unchecked and unnoticed release, or absence of means or delays in containment) in the LDCs due to weak monitoring and control should also be given.

Thanks,
Zuberi, Rajshahi University, Bangladesh; zuberimi@yahoo.com
<mailto:zuberimi@yahoo.com>
(edited on 2004-11-01 08:26 UTC by Ryan Hill)
posted on 2004-11-01 01:57 UTC by m.i.zuberi, university of rajshahi
Who and when to consult with internationally? [#472]
Dear friends,

Our Least Developed Countries (LDCs) have two big problems, the first is risk analysis (risk assessment and risk management, risk comunication, ...) the second is monitoring. For both the solutions are FINANCIAL support (money). I think that our friend Dr Zuberi says that the governments in these LDCs are not equipped and motivated to take quick and proper steps for implementing risk assessment, risk mangement and monitoring.

The developed countries and UN will give financial support to  Least Developed Countries (LDCs), in order to build infrastructure and strong legislation for the handling and release of LMOs under safe conditions and preventing any harm. The best treasure of the world are the people and regulators who will ensure this.

Thanks
Best regards
Miguel
(edited on 2004-11-01 11:39 UTC by Ryan Hill)
posted on 2004-11-01 11:07 UTC by Miguel Lorenzo, National Centre for Biological Safety
Resource for case-by-case risk assessment [#408]
Dear All,

My apologies for not finding the time to join your discussion sooner.

At the risk of seeming self-serving, may I point out the existence of a useful (and widely used) document published by the Edmonds Institute to assist case-by-case decision-making: a Manual for Assessing Ecological and Human Health Effects of Genetically Engineering Organisms. The Manual, especially helpul to those new to  ecological considerations in biosafety decision-making, was written by a group of scientists from a wide range of biological disciplines, including Mark Wheelis (University of California-Davis), Andrew Spielman (Harvard University), Philip Regal (University of Minnesota), Deborah Letourneau (University of California-Santa Cruz), Terrie Klinger (Friday Harbor Labs), Anne R. Kapuscinski (University of Minnesota), Conrad Istock (formerly of the University of Arizona), Elaine Ingham (formerly of Oregon State University), Norman Ellstrand (University of California-Riverside), Pushpa M. Bhargava (Anveshna Consultancy, India), and Sharon Akabas (Columbia University).

The two-volume manual was reviewed in a double blind peer review
managed by a former head of the Ecological Society of America. It is available in a free, downloadable PDF format version or, for
researchers and regulators in the Global South or in Central and
Eastern Europe, on CD (available on request by mail). The Manual is the second, much-expanded, and renamed edition of the DRAFT Assessment of Genetically Engineered Organisms in the Environment: The Puget Sound Workshop Biosafety Handbook, brought out in 1996 as a biosafety handbook accessible to the public and reflective of maximum concern for ecological and human health.

For more information, including information about other biosafety
publications and videos available from the Institute, see our website at <http://www.edmonds-institute.org>. There you also will find the web address of the government-sponsored Slovenian translation of the Manual. A Russian translation is expected out later this year.

With apologies for my late entrance into the discussion,
Beth Burrows

President/Director
Edmonds Institute
20319-92nd Avenue West
Edmonds, Washington 98020
USA
phone: (001) 425-775-5383
email: beb@igc.org
website: <http://www.edmonds-institute.org>
(edited on 2004-10-29 12:53 UTC by Ryan Hill)
posted on 2004-10-29 12:47 UTC by Beth Burrows, Institute for Global Communications (IGC)
What about case-by-case international workshops? [#355]
From the previous posted comments I think there is a clear opinion that internationally consultation should be done to help in taking decisions in each country. This is clear at least when there are international risks for the environment or the economy (see for example, the case of wild rabbit or stoats in different countries) or when there is potential of the new GMOs for escape (because there is no way to reduce this risk).

At the moment, it is difficult to develop effective international regulations. But, what we can do readily now is to encourage workshops for international consultation. These workshops could be based on the case-by-case basis discussed by Ben.

It would be really interesting that each group or groups wanting to make research on a GMO with the ultimate goal of releasing it in the field (for example, for the management of a species) could organize a workshop. This would be not difficult if an international body could promote and finance such workshops and be implicated in the organization (for example the Convention of Biological Diversity).

The goal of workshops would be to discuss internationally about the specific GMO, in a variety of aspects. Ideally, I think that this workshops could be done as a first step before the acceptation of a project on the research of GMOs, so to discuss for example on what research lines should be covered, how the research should be oriented to be safe and to discuss on the risks posed internationally by the expected results of the project.

Thus, as pointed out in previous posts this meetings should assemble not only researchers from all the countries interested, but also lawyers, political scientist, etc. The founding international body should supervise that the meeting assembles all this people, that the important concerns are discussed, and could act in the future accumulating and exchanging the experience from one case to another (the ‘corporate knowledge’ mentioned by Ben).

Would such workshops be an interesting and effective tool?
Post your comments please…

Elena Angulo
Université Paris XI
Lab. Ecologie Systematique et Evolution, Bat 362                         
F-91405  Orsay, France
posted on 2004-10-28 09:35 UTC by Elena Angulo
international workshops [#411]
From the previous posted comments I think there is a clear opinion that internationally consultation should be done to help in taking decisions in each country.
I think we need to do workshop with scientific finding and the practical experience in each country.
Each country will show the result of risk analysis (risk assessment, specific risk for environment and health and risk management and others).
Yes, it is difficult to develop effective international regulations. I agree that the goal of workshops would be to discuss internationally about the specific GMO, in a variety of aspects, ethical, ecological risk, health, results of public participation, results of risk assessment.
These workshops could be done as a first step before the acceptation of a project on the research of GMOs used to manage animal populations.

Miguel Lorenzo
Regulator on Biosafety in Cuba
(edited on 2004-10-28 12:38 UTC by Ryan Hill)
posted on 2004-10-28 12:32 UTC by Miguel Lorenzo, National Centre for Biological Safety
Case-by-case regulation [#412]
Hello Everybody,
Ben Gilna, Elena Angulo and others are absolutely correct in their comments about case by case studies. In dealing with initial cases the authorities who regulate gene  technology will develop a corporate knowledge and so will tend to group similar applications instead of being absolutely objective and treating each case as a new entity.  And each country must have strong regulation
in order to prevent associated risks from gene technology
and a strong regulating body for all activities in Biosafety (exotic, transgenic)
Best regards
Miguel Lorenzo
National Centre for Biological Safety
Havana, Cuba
(edited on 2004-10-28 14:29 UTC by Ryan Hill)
posted on 2004-10-28 13:35 UTC by Miguel Lorenzo, National Centre for Biological Safety
Re: What about case-by-case international workshops? [#410]
Dear all

I agree with the need for international consultation. With regard to the escape of GMOs I think things can be done: precautions improvement, biosafety protocol accuracy, more care in field trials, emergency plans like Lorenzo proposes.

Cooke traces distinctions between "treatment in a medical situation and use of something to help protect an ecosystem". I want only to point out that the idea that the damage we do to the environment will create problems for us, must be explained to the people (at public level) because they should be conscious of the consequences when they debate about GMOs. The parallels between a medical situation and ecosystem protection is in the manner in which we have to face the consultation aspect.

The lawyers, politicians, lawgivers, and so on, must know the basics of ecology, at least, to be aware of what they discuss and decide, so as to not underestimate the problem. This is the analogy with "informed consensus" used in medical treatments.

'The Genie is out of the bottle' isn't a good reason for avoiding debating.

I agree with workshops on case-by-case basis and I think that we have to be careful with our eyes open, as says Gilna.

Regards

Pietro
*************
Dr. Pietro Demarchi
Naturalist
Via Gramsci 8
13037 Serravalle Sesia (VC)
Italy
pietrodemarchi@tele2.it
(edited on 2004-10-30 22:20 UTC by Ryan Hill)
posted on 2004-10-29 07:46 UTC by Pietro Demarchi
Re: What about case-by-case international workshops? [#450]
Dear Colleagues,
I wish to amplify the relevance/importance of ecosystem health and
consultation.

One of the core pillars of the biodiversity and development paradigm is
ecosystem diversity and health. This is the genesis of the new concept
of "Conservation Medicine" with an excellent compendium edited by
Aguirre, Ostfeld, Tabor, House & Pearl (2002) Conservation Medicine -
Ecological Health in Practice. Published by Oxford University Press. I
commend this as relevant reading.

At a conference on LMOs and the environment hosted by the US goverment
in late 2001 the rapporteurs - Professor Calestous Juma, Audia barnett
and Iain Gillespie - concluded in a report that there was "general
agreement that the case-by-case, step-by-step approaches are the best
available tools for managing risks associated with LMOs"

My concern though is that most of the studies on ecological and other
risks posed by GMOs have utilized temperate models. We must note that
tropical forest ecosystems are the most biologically complex and
fragile. We should endeavour to have simulated ecological studies
involving more tropical species/systems because we all appreciate the
importance of tropical forest ecosystems in other global issues such as
climate change.

Not very much is known about microbial and insect biodiversity in a
number of developing tropical countries. The Global Taxonomy Initiative
is yet to take root in several developing countries. We must be careful
not to eliminate what we don't even know as yet and their ecological and
biogeochemical importance in fragile ecosystems.

This raises the issue of "biocomplexity" concept as a new paradigm in
addressing risk assessement, analysis and management issues at another
level.

John Caesar
Guyana UNEP-GEF Biosafety Project
& University of Guyana
posted on 2004-11-14 14:31 UTC by John Cartey Caesar, University of Guyana/Environmental Protection Agency
RE: Who and when to consult with internationally? [#356]
While I think that case-by case analysis can offer the flexibility
necessary to respond to unique situations, it seems to me that there are
another layer of questions that need to be answered in a more universal
fashion.  Particularly, there need to be some standards about the sorts
of evidence will be acceptable to satisfy a risk analysis, who will bear
the burden of proof (does the proponent of an action have a burden to
show safety before taking an action that could have transboundary
impacts) and the possible effects that must be considered before making
a determination.  Unless there is some consistent framework that keeps
case-by-case analyses consistent, deciding to respond in that sort of a
fashion can be a proxy for not exerting any effective control.

Rebecca M. Bratspies
Associate Professor
CUNY School of Law
718-340-4505
(edited on 2004-11-09 12:39 UTC by Elena Angulo)
posted on 2004-11-01 14:08 UTC by Rebecca Bratspies
When to consult? [#357]
I would appreciate others views on at what stage international consultation should take place - e.g. when research is started on a potential vector? or when it has already been developed and is ready to be deployed? Also, should potentially affected countries have a say on the research directions undertaken?

Both Australia & New Zealand are spending considerable research $'s into trying to develop disseminating GM forms of biocontrol for animal pest species. Such solutions could be really beneficial from both a conservation and economic viewpoint. I don't think we should rule out GM at this stage but could there be some sort of agreed ground rules to guide whether certain research directions are followed or not? For example, sexually transmitted viruses may be safer as a GM disseminating vector than those that are transmissible without direct contact. But what happens if there are no suitable sexually transmitted viruses that could be used for your pest species?  Do you investigate whatever you can?

Brushtail possums were introduced to New Zealand from Australia to establish a fur trade but have since become a major conservation and economic threat.  One of the current research directions is aimed at genetically modifying the possum nematode Parastrongyloides trichosuri to make possums sterile. This parasite has a free-living life-cycle and eggs are passed out in possum faeces (where they remain viable for at least two months). It is also capable of completing an apparently indefinite number of free-living generations outside the host. This acts to sustain and amplify its presence in the environment once released. Although this makes it a good candidate for dissemination, it also makes it much more likely to be able to cross to Australia from contamination of food stuffs/camping gear/clothing etc. From a New Zealand perspective, the nematode is an ideal candidate but would appear to present a high risk to Australia. But who do you talk to in Australia to determine whether this type of GM vector would ever be acceptable, and at what stage?

I feel split when I consider the above type of research. It does cost a lot of money and it may never be used in the end – but will some of the things we learned on the way help us develop new controls that we can’t even imagine now? Who has the responsibility for deciding - the scientists? funding agencies? tax payer? – it is not clear to me whether anyone is taking the bigger picture into consideration. As Ben Gilna pointed out (#136), once a GM biocontrol R&D programme is established, it has a strong internal political momentum towards release - and international consultation currently seems to have been pushed to later, rather than sooner.

Elaine Murphy
posted on 2004-11-02 20:42 UTC by Elaine Carmel Murphy, Department of Conservation
RE: Who and when to consult with internationally? [#358]
Dear all,
My apology for joining the forum late. I'm coming from
the Lobeke National Park, cameroon and we do not have
the net there.
The problem outlined by Elaine is very crucial. As
someone said (Dr Ron Thresher I hope), the best that
can be done is the implementing of an ad hoc experts
group working in the auspices of the CBD which will
try to propose solutions for such a problem.A lso
workshops should be organised to inform the public in
the problem. For me, regional initiatives such as
european parliament are not suitable for this since
they cannot accept rulings that go against its
interests.
Dr Jean Lagarde BETTI
Department of Forestry,
University of Dschang,
Cameroon
(edited on 2004-11-04 09:14 UTC by Kirsty Galloway McLean)
posted on 2004-11-04 04:01 UTC by BETTI JEAN LAGARDE, UNIVERSITY OF DSCHANG
Where we stand so far [#359]
Okay, I’m going to be presumptuous here and make a rough summary of where we’re at, because we certainly have covered a lot of ground! I hope it’s useful. A note of caution: summaries have a tendency to recast ideas to suit the author’s bias – that is helpful in a complex exchange such as this, but it can also mean some voices/perspectives/priorities get left out. Please feel free to correct this as required!!

1. Consultation: We’re all agreed that we need to consult internationally.
2. Methodological Approach:
   a. Workshops would be an excellent way to start.
   b. A case-by-case approach would be very useful, providing flexibility and relevance, but;
   c. We need to be clear on how we develop and apply generalised principles and a consistent framework.
3. Institutional:
   a. A central co-ordinating body (“council”), perhaps the under the auspices of the UN, will be required to take this forwards.
   b. Several pre-existing bodies/treaties have been identified as possible hosts: Convention on Biodiversity (CBD), International Plant Protection Convention (IPPC) and the Office International des Epizooties (OIE) – have I left one out?
   c. It is unclear, even in countries pioneering these technologies, just who to consult.
   d. Less Developed Countries (LDCs) face special institutional challenges and will likely need support.
   e. We need be cautious that a series of case-by-case workshops is not used as an excuse by policy-makers to defer action (ie., its not okay to let the scientists talk on their own, but do nothing).
4. Evidence:
   a. We are working in an area of fairly high uncertainty (which will never be reduced to zero), although there are some similar issues from which we can learn.
   b. Good science is crucial.
   c. Just what constitutes “good science” is likely to be contested.
   d. Science will have to interface with a range of other expertise, and those experts may not necessarily be convinced by scientific argument alone.
   e. Scientific evidence will not be sufficient.
   f. The source and quality of evidence is unclear.
5. Action:
   a. Consulting early in the life of a research project is probably most effective.
   b. We are still unclear of what authority a council will have, nor how it will exercise it.
   c. Authority of the council’s recommendations will have to be negotiated politically before it has an effect.

So as I see it – and please feel free to disagree – the core areas we need to focus on are:

1. Our own nations’ institutional capacity:
   a. Who should someone overseas consult?
   b. Who has national jurisdiction?
   c. Who decides what projects get funded, and how? How would such a funding institution receive such international advice?
   d. Who would attend/host an international workshop?
2. International treaties/bodies:
   a. Do any existing treaties/bodies have a mandate that covers these technologies – does it fall within the legal definition of their jurisdiction?
   b. If not, who do we need to convince to design one and bring it into being, and;
   c. Where will the money come from to run this?
3. Evidence and Methods:
   a. Thresholds – what evidence qualifies?
   b. Who must produce what evidence?
   c. Different sources of expertise will have different limits of credibility – legal opinion will be different from science, and lay-community different again. How will we reconcile this? (This is a hard one).
   d. Establish a rigorous, transparent and critical process that develops general principles from case-by-case assessments.
4. Instruments:
   a. Where do the council’s operating resources come from?
   b. How do we gather evidence of different kinds, in our own and other nations?
   c. What inspection/monitoring and enforcement powers would this council have, if any at all?
   d. What incentives can we offer to encourage consultation, engagement and collaboration? Will we send workers, information, money to other nations? Will we accept another nation’s problem as our own for our common interest?
5. Biophysically (although this is probably more relevant to the biosafety thread), what recommendations can we give now to move to a ‘safe-when-fails’ design?
6. Immediate actions:
   a. Organise a face-to-face workshop.
   b. Convince the decision-makers that this is an issue that requires attention.

What do you think?

Ben Gilna
Centre for Resource and Environmental Studies
Australian National University
(edited on 2004-11-04 20:11 UTC by Ben Gilna)
posted on 2004-11-04 20:09 UTC by Ben Gilna, Australian National University
Re: Where we stand so far [#422]
Dear All

I take the liberty of adding some lines to the summary made by Ben (post 217).

The added sentences are as follows (in capital letters):

Summary:
4. Evidence:
    G.)  ETHICAL EVIDENCE IS ALSO IMPORTANT.

Core Areas Need to Focus On:
4. Instruments:
    E.) ARE THE INCENTIVES SUFFICIENT OR ESSENTIAL? IS IT MAYBE MORE IMPORTANT WE DEBATE AND CONFRONT WITH DIFFERENT CULTURES, BEGGING LEAVE?

6. Immediate actions:
    C.) INFORM DECISION-MAKERS, BUT ALSO POLICY-MAKERS AND PEOPLE,
BECAUSE PERSONS CAN BIAS POLICY OPINIONS, ABOUT NECESSARY ATTENTION.

Dr. Pietro Demarchi
Naturalist
(edited on 2004-11-09 23:09 UTC by Ryan Hill)
posted on 2004-11-09 21:31 UTC by Pietro Demarchi
Re: Where we stand so far [#461]
Dear friends
I agree with Dr. Pietro (write in capital letter) and I added some comments

4. Instruments:
E.) ARE THE INCENTIVES SUFFICIENT OR ESSENTIAL? IS IT MAYBE MORE IMPORTANT WE DEBATE AND CONFRONT WITH DIFFERENT CULTURES,BEGGING LEAVE? This point is very interesting but it is neccesary to
improve and development

6. Immediate actions:
C.) INFORM DECISION-MAKERS, BUT ALSO POLICY-MAKERS AND PEOPLE, BECAUSE PERSONS CAN BIAS POLICY OPINIONS, ABOUT NECESSARY ATTENTION.
Policy-Makers needs to learn in many issues like ecological,
environmental issues , ethical, cultural ....and more

Miguel Lorenzo
(edited on 2004-11-11 09:41 UTC by Elena Angulo)
posted on 2004-11-11 07:49 UTC by Miguel Lorenzo, National Centre for Biological Safety
Addendum - the "when" question. [#360]
You know, on reflection, I don't know if I was fair to Elaine Murphys (#205) reiterated question:

"I would appreciate others views on at what stage international consultation should take place - e.g. when research is started on a potential vector? or when it has already been developed and is ready to be deployed? Also, should potentially affected countries have a say on the research directions undertaken?"

ARE we agreed that early consultation is best? Are we the participants the ones that really have to be convinced of this anyway?

I think this is going to be a big issue, and I wouldn't want to close off debate on it just yet.

Ben Gilna
Centre for Resource and Environmental Studies
Australian National University
posted on 2004-11-04 20:24 UTC by Ben Gilna, Australian National University
Re: Addendum - the "when" question. [#425]
Dear Colleagues,
Ben's worry  about when consultation should take place and the say of potentially affected countries is very legitimate. Today there are "no boundries" any more among countries.
When a vector is being developed, international consultation is necessary. This allows potential users/environments be "stakeholders" in the effort from the beginning. This should enable the development of a sound, relevent and easily adoptable technology.
Of course,the potential or target country/environment must have a say in the development of the
technology/vector.

David A. Mbah
Biosafety Support Project,Cameroon
(edited on 2004-11-05 06:06 UTC by Elena Angulo)
posted on 2004-11-05 05:16 UTC by David A. Mbah, Cameroon
Re: Addendum - the "when" question. [#457]
Dear Colleagues,

I agree withh David Mbah. Could this be the reason for the African
Model law on biosafety, particularly Articles 4 and 14, that are very specific on liability and redress, an issue that is a priority for potential importers?

Thanks,regards

Stanley.
(edited on 2004-11-05 09:43 UTC by Ryan Hill)
posted on 2004-11-05 09:40 UTC by Stanley Atsali
When to consult internationally, and where is the mandate [#424]
I'd like to respond in part to the issue about when international consultation should take place (posts 205 (Elaine), 218 (Ben), 220 (David)), and the question about what international agreements have a mandate for such consultation (Ben's post 217, point 2a under the suggested core areas that require focus).

The Biosafety Protocol, which now has 110 Parties, has an Article dedicated to Risk Management - Article 16. Within that Article, there are two specific paragraphs that are directly relevant:

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

16.5: Parties shall co-operate with a view to:
(a) 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
(b) Taking appropriate measures regarding the treatment of such living modified organisms or specific traits.

"Risk Assessment and Risk Management" is an item on the agenda of the meeting of the Parties to the Protocol, beginning at their second meeting (May or June 2005). Article 16.5 above is specifically mentioned in the medium-term programme of work as an issue to be considered by the Parties, but in fact the Parties could decide to look at any aspect of risk assessment or risk management that they wish.

There has been some criticism that scientific expertise was lacking at the first meeting of the Parties in February 2004, and during the preparatory process leading up to that first meeting. Consequently, all scientists with expertise relevant to risk assessment and/or risk management should be encouraged to become familiar with and contribute to Protocol-related processes to the extent possible.

The Protocol also contains Article 17 which deals in part with unintentional transboundary movements, but this Article is less about prevention and more about procedures for dealing with releases of GMOs after they occur.

Note: the term living modified organism (LMO) is usually considered to be equivalent to genetically modified organism (GMO) for general purposes. However, the term LMO, as well as the terms "living organism" and "modern biotechnology" are precisely defined in Article 3 of the Protocol, and may or may not be similar to the various definitions related to GMO and other terms. The text of the Protocol is available at <http://www.biodiv.org/biosafety/protocol.asp>.


Ryan Hill
Programme Officer, Scientific Assessments
Biosafety Programme
Secretariat of the Convention on Biological Diversity
Montreal, Canada
email: ryan.hill@biodiv.org
posted on 2004-11-05 09:55 UTC by Ryan Hill, Secretariat
RE: When to consult internationally, and where is the mandate [#458]
I would add another question who to consult and who has to consult.  The
Biosafety Protocol binds Parties but much of the work is not being done
by states or state-sponsored parties but by private entities.  Are there
any duties of private parties beyond those imposed by national law?
Many states do not have the resources, and others may not have the
inclination to force private actors into a Biosafety Protocol like
process? 



Rebecca M. Bratspies

Associate Professor

CUNY School of Law

718-340-4505
posted on 2004-11-09 10:27 UTC by Rebecca Bratspies
Addendum - the "when" question. [#426]
Dear friends
I agree that consultation will best be included in the early steps in a project because we would like to know very well our reality. If I know that my country doesn't have a safe facility in which research will be done, we will never approve the project. If our country doesn't have strong legislation on Biosafety, we need infrastructure and development of Biosafety issues before approval of any research or field trials. The way will be to include both research and biosafety legislation and more issues.

Miguel Lorenzo
Cuban Biosafety regulator
(edited on 2004-11-05 11:20 UTC by Ryan Hill)
posted on 2004-11-05 11:17 UTC by Miguel Lorenzo, National Centre for Biological Safety
RE: Addendum - the "when" question. [#423]
Further to Ben's post #218 and other's following. I suspect we are agreed that early consultation is best - but we are not the ones doing the research. I notice that none of the researchers that are directly involved have contributed so far to the debate - I would be very interested to hear from the Australian, New Zealand & Spanish researchers currently working in this area, as to whether they have considered the consultation problem.

Elaine Murphy
posted on 2004-11-09 23:52 UTC by Elaine Carmel Murphy, Department of Conservation
RE: Addendum - the "when" question. [#464]
In response to Elaine's request to the researchers to respond to the
"when" question, my answer is simple; early and often. The policy of the
Vertebrate Biocontrol CRC and the Pest Animal Control CRC which have
been exploring the use of viruses to immunosterilise pest animals has
always been to communicate what they were/are doing  as widely and as
often as possible to as many audiences as possible within the limits of
what can be disclosed without compromising IP.

Nationally, successive CRCs have regularly consulted with the Australian
regulatory authorities (OGTR and DAFF) and kept them informed of
strategies and progress. They have regular consultation with
conservation agencies, wildlife agencies and animal welfare groups.
There is a newsletter circulated internally on a weekly basis and one
externally to a wide range of stakeholders on a regular basis.

Internationally they have consulted with the relevant committee members
at OIE and WHO and presented seminars at scientific meetings and other
forums around the world. There is a PAC CRC web site which advertises
what the intentions of the CRC are and what they hope to achieve.

In other words, consultation at those levels by scientists was early and
has been, and continues to be, frequent and widespread.

The issue of consultation between government agencies, nationally and
internationally is a different one. All the researchers can do is inform
these agencies of progress and it is up to those agencies to consult
with each other through the appropriate channels.  I have no reason to
believe that this does not happen but it is likely that until they get a
specific proposal that may affect other jurisdictions their conversation
would be at a general policy level. The Biosaftey Protocol would seem a
reasonable mechanism to use for specific proposals but my understanding
is that Australia is currently not a signatory to that agreement so, at
the moment, would need work through other established channels.

Dr Tony (AJ) Robinson
Agriculture Landscapes Program
CSIRO Sustainable Ecosystems
GPO Box 284
Canberra
ACT 2601
Ph   +61 (02) 6242 1676
Fax  +61 (02) 6242 1556
Mobile 04 0977 6705
tony.robinson@csiro.au
posted on 2004-11-10 02:32 UTC by Tony Robinson
RE: Addendum - the "when" question. [#479]
Dear Dr. Robinson,

Your contribution is very important, particularly on Biosafety issues. It is already becoming apparent that trade between BSP Members and non members could be a problem. Is it possible to find an easier way of facilitating trade between Parties and non-Parties
without complications?

Regards
Stanley S Atsasli
(edited on 2004-11-11 13:03 UTC by Elena Angulo)
posted on 2004-11-10 09:42 UTC by Stanley Atsali
RE: Addendum - the "when" question. [#463]
Regarding consultation, I think it is worth noting that there are at least three levels of consultation, all of which are important, but each of which needs to be considered and facilitated in its own right.

The first level of consultation occurs when someone gets a good idea, and seeks funding/support for the work.  In doing so, we, like most researchers that are not indepenedently wealthy, have to tell someone (funding agency at least, even if it is the "bosses" in a private company) what and how we intend to proceed.  In most instances, initial results are required, and are often, if not always, reported in scientific forums of one sort or another, including international meetings.  Details may be omitted, due to patent issues and the like, but at least the basic approach is usually outlined.

The bottom line from this is that if the approach one proposes meets with strong negative responses, either from funding agencies or the scientific community, it is not likely to proceed.  I suspect that many "good" ideas fail this test, on the grounds of biosafety, ethics, or just practicality. 

The second level involves public consultation.  The public, politicians, NGOs deserve to be told about what is planned and being researched.  Again, a strong negative response by such groups is usually sufficient to stop R&D.

The third level, which we have discussed at some length to date, is the formal process required to ensure widespread approval prior to field release.  This could involve national mechanisms, and should involve international ones, for which we have had a few suggestions for possible mechanisms.

Tony Robinson has commented on the CRC's efforts to pursue principally the first two levels of consultation.  We (the "daughterless fish" project) have done much the same, telling everyone who will listen about our plans (including an article by a staff writer for New Scientist, which was broadly opposed to what we plan to do, for reasons we thought were pretty spurious).

In some countries, such as Australia and New Zealand, there are formal national processes to go through to get approval for laboratory, contained field trials and release.  This process requires some level of consultation at the first two levels, at least.  I do not think it would be possible to legislate scientific/funding agency consultation or public consultation, out side of such national frameworks that require evidence of consultation prior to approval to proceed to the next stage of the work.  In practice, it probably happens most of the time anyway, and only a particularly dedicated and independently funded group is likely to proceed without scientific and public support.

I suggest the best practice is 1) facilitating strengthening of national frameworks (perhaps by developing a model system) that does legislate for adequate public and scientific consultation prior at key decision points, and 2) facilitating a formal international process to vet all proprosals for field release prior to such release, on the basis that any self-propogating system has the potential for international ramifications.

Finally, I would note that what is not acceptable now might be a few years hence, and vice versa.  At the laboratory, biosecure stage, I think it is worth exploring genetic options even if they are unlikely to be approved for field release, on the basis that such work could lead to options that are safe and acceptable, and because further work may well show that what were thought to be unacceptably high risk levels was not correct.  Of course, there is always to alternative result - that what was thought safe proves not to be so.  That is what research is all about.
(edited on 2004-11-10 19:00 UTC by Kirsty Galloway McLean)
posted on 2004-11-10 17:57 UTC by Ronald Thresher, Commonwealth Scientific and Industrial Research Organaisation (CSIRO)
The ‘when’ question [#361]
I think the ‘when to consult’ question is very important if we want to have a certain degree of success in the consultation. As stated by others (Bob Henzell, Ben Gilna, etc) it should start when the project is being planned, and of course long before the money is expended or the GMO is ready to be released.

The case of the genetically modified myxoma virus in Spain is an example of the problems that appear when international consultation is not made in the early stages: myxoma virus was modified to immunize rabbits against two diseases, and financial support was provided by hunters. It is expected that most hunters and probably also Conservation Agencies will use it in the recovery of wild rabbit populations. The GMvirus is ready to be released, and was already released in a trial rabbit population in a little Mediterranean island, as described in:
- Angulo, E. & Cooke, B. (2002) First synthesize new viruses then regulate their release? The case of the wild rabbit. Molecular Biology 11, 2703–2710.
Or in the original work:
- Torres JM, Sánchez C, Ramírez MA et al. (2001) First field trial of a transmissible recombinant vaccine against myxomatosis and rabbit hemorrhagic disease. Vaccine, 19, 4536-4543.

Currently, the GMvirus cannot be used for commercialization or release before it is accepted by the European Union (as an alive recombinant vaccine virus). However, the publicity made by the supporting organism has created high expectation in hunters. Besides, there has been much money expended to support research. All these factors together have finally created an increasing pressure for the legal acceptation of the vaccine.
Here, we find that international consultation is done but only within European countries, and not with other countries that are interested (for example Australia).  In my opinion, the first financial support of a research program on GMO should be used to organize international consultation.

Some questions remain, for example:
- Tensions between innovating and no innovating countries (mentioned by Ben)
- What happens after international consultation: what tools should be used in the agreement between countries? This is just answered in part by Ryan Hill, with the Biosafety Protocol Article 16.5 about co-operation between countries (thanks Ryan for sharing this information).  It would be very interesting to discuss about specific tools to be implemented (especially if we choose a case-by-case international consultation). 

Elena Angulo
Université Paris XI
Lab. Ecologie Systematique et Evolution, Bat 362                         
F-91405  Orsay, France
posted on 2004-11-05 10:41 UTC by Elena Angulo
The balancing act of when to consult and the difficulty of knowing how to respond [#362]
I have followed the discussion with interest and make several observations/comments from my perspective of heading up the Pest Animal Control Cooperative Research Centre, the body doing work on immunocontraception in the mouse, rabbit, fox and daughterless technology in the common carp.

What technologies to consult about?
I do not believe there is much benefit in international consultation for non-disseminating GMOs for pest animal control.  Our fertility control virus for foxes is designed to e contained within the bait, affecting only the consuming animal.  The fact that it is GMO should not be the factor that requires international consultation - the Australian regulatory system is vigourous and thorough (this treatment would need approval of the Office of the Gene Technology Regulator, the Australian Pesticides and Veterinary Medicine Authority, the Department of environment and Heritage and then each state would need to approve its use).  In this regard, the proposed treatement is no different to the GM oral rabies vaccine used in 10s of millions of doses over an extended period in Europe and North America with great success.

I do believe there should be international consultation regarding any treatment that is potentially disseminating.  However, again I would not necessarily make the fact that the agent is GM the triggering factor for consultation, the issue is surely the risk of dissemination to somewhere where the agent is harmful, potentially harmful or just unwanted.  Our mouse, rabbit and carp treatment would fall into this category.  We have great concerns about the New Zealand research on use of a sterilising nematode on brushtail possums (you can be bushwalking out of Christchurch in the morning and Sydney in the afternoon - in one place the possums are a foreign pest in the other a native treasure) and the Spanish myxoma/RHDV vaccine (the prospect of a return to pre 1950 levels of rabbits in this country is frightening).

When to consult?
Early and often is a good policy, but there can be problems here.  After a decade of work we have decided to park our rabbit research for technical reasons, whereas we intend to press ahead with our mouse work to field testing stage.  Too much effort on early consultation would be wasted time, money and perhaps angst on the rabbit, but not on mouse, so when is a reasonable question to ask.  Having said this, it is my observation that the research itself almost always improves as a result of more consultation with wider groups, simply through peer analysis, so consultation is never a complete 'waste'.

Who to consult?
We obviously would prefer a clear-cut set of rules as to who we should consult.  OIE has shown a cautionary interest in our work for some years, and the BSP has on obvious interest - but Australia is not a signatory. 

I suspect in the case of Australian concerns about the NZ sterilising nematode there would be bilateral discussions if the research went into a serious development phase.   For myself, I am fairly relaxed that no release would go ahead because there would be enormous Australian concern if the work was likely to become a reality.  If I am right, the researchers in NZ would be better off working on other things, but who's too say useful information won't come out of the project anyway?

Reaction to consultation
If there is a negative reaction to our mouse control virus by one other country, do we stop?  My understanding is that Australian authorities can take account of trade implications in our regulatory system, giving a potential link between consultation and regulation for us - but this seems a tenuous link.  The Australian regulatory system for GM requires a consultation with the public and all applications are available on the Office of the Gene Technology Regulator website [url]http://www.ogtr.gov.au[url]. I don't know if the Regulator is required to take account of comments from non-Australian sources, but I can't imagine such comments would be ignored. One could argue that consultation without teeth is simply talk. Maybe ensuring international consideration is built into national systems is the way to go? I'd be interested in opinions on how to make the international consultation as effective as possible.
posted on 2004-11-11 19:44 UTC by Dr. Tony Peacock, Pest Animal Control Cooperative Research Centre
Re: The balancing act of when to consult and the difficulty of knowing how to respond [#431]
Dear friends,

I think there will be much benefit in undertaking international consultation for non-disseminating GMOs as well.  It will be useful for the regulatory bodies to be able to take these comments into consideration.  It may take many years before we observe adverse effects of GMOs, so regulators need to ensure good field trials, all conditions, strong regulation and to do a good risk analysis.  When?  Of course before.  Who?  The scientific community, environmental bodies, interested people and international consultation.  Why not?

I do not think all countries carry out full consultation.  In theory there are at least three levels of consultation or more - sometimes the regulatory bodies have many applications, and the consultation is very late at the first or second levels - what can the regulatory bodies do?  I think this is very interesting and important, but not easy!!!  Please, could others share their experiences in this field?


Miguel Lorenzo
Cuban specialist in risk analysis
(edited on 2004-11-13 12:25 UTC by Elena Angulo)
posted on 2004-11-12 08:26 UTC by Miguel Lorenzo Hernandez, National Centre for Biological Safety
Re: The balancing act of when to consult and the difficulty of knowing how to respond [#465]
Dear friends,
The discussion in the online conference assumes that the regulatory
bodies are in  a position to evolve and implement the regulatory norms efficiently and objectively. There is also another tendency to believe that all countries have competent and adequately staffed regulatory bodies. There is a need to do a cross-country study on the structure and functions of the regulatory bodies and the budgets of the bodies. This is an important task.
Haribabu Ejnavarzala.
(edited on 2004-11-14 07:42 UTC by Ryan Hill)
posted on 2004-11-14 02:12 UTC by Haribabu Ejnavarzala
Re: The balancing act of when to consult and the difficulty of knowing how to respond [#481]
Hi! Friends,
I agree with this.we have to consider this important task.

Thank you all,
Dr. paresh pandya
(edited on 2004-11-14 17:45 UTC by Elena Angulo)
posted on 2004-11-14 08:00 UTC by paresh pandya, kotak institute of science, GVP
Re: The balancing act of when to consult and the difficulty of knowing how to respond [#484]
Dear Colleagues,
I wish to commend participants for a very rewarding experience.
Dr. Haribabu Ejnavarzala has raised a very important point on the issue
of capacity of developing countries in the biosafety issues posed for
this conference. This was raised in a couple of other posts.
It is important to consider biosafety regulation capacity of developing
countries at three levels - human, organizational and societal. The
latter will definitely relate to cultural diversity aside from other
legal constructs.
The current global UNEP-GEF Biosafety framework projects are undoubtedly
geared precisely to the wisdom for capacity building at the national
level. However, there are likely constraints in actual sustainability of
implementation for many developing countries, some too small to
effectively have all the human resource base required for effective and
efficient regulatory regime. The UNEP biosafety project will reveal the
status of S&T, biotechnology and biosafety capacity which will be
available on the BCH. Evidently the paucity of capacity in some of our
developing countries will become pellucidly clear. We just do not have
the capacity!
Let us consider the case of the Caribbean region. Cuba is way ahead of
the pack. Most other Caribbean countries are just beginning to grapple
with the issues of biotechnology, biosafety and biosecurity. Most
Caribbean countries are members of the Caribbean Community (CARICOM), a
regional integration grouping on - trade, politics, legal, health, etc.
It will require harmonization of human resources and institutions for
effective biosafety regulation. The CARICOM charter would also require
regional consultation on such issues. Some relevant regional
institutions existing under the CARICOM purview are:

* Caribbean Court of Justice (CCJ)
* Caribbean Agricultural Research & Development Institute (CARDI);
* Caribbean Environmental Health Institute CEHI);
* Caribbean Food & Nutrition Institute (CFNI); and
* Caribbean Disaster Emergency Response Agency (CDERA).

Perhaps a sub-regional pool of capacity - human, institutional and
societal - would have to be structured along the lines of pre-existing
CARICOM institutions as many of the countries have populations less than
half a million with GDPs barely meeting development needs vis-a-vis the
threat of European Union banana and sugar export quota removal - banana
and sugar being key export commodities outside tourism for some
countries.
The issue of brain drain is also another aspect to consider. We can
train a cadre of GMO risk assessment and biosafety-related personnel but
what is the assurance that they will stay in the regions or developing
countries with the kind of salaries? The twin issues of human capacity
sustainability and brain drain in the developing countries will
inevitably be a looming threat to effective regulation unless we find
innovative answers - regional pools with reasonably/moderately
competitive salaries?

I believe there are other regional groupings which will require
membership consultations within a structured framework on such issues -
ASEAN, AU, ECOWAS, MERCOSUR, etc. following the communal example of the
EU.

John Caesar
Guyana UNEP-GEF National Biosafety Framework Project
& Senior Lecturer in Biology, University of Guyana
posted on 2004-11-14 13:11 UTC by John Cartey Caesar, University of Guyana/Environmental Protection Agency
RE: Re: The balancing act of when to consult and the difficulty of knowing how to respond [#491]
I agree with the issues raised by John.  Current processes initiated through the UNEP/GEF Biosafety Projects is to assist developing countries  develop national biosafety framework, assess existing capacity to implement such frameworks and try to address gaps through the implementation process.  One issue, which the project seeks to address is to assist in "teasing out" commonalities that will assist sub regions in the area of harmonisation and pooling of resources to address biosafety needs.  Through the CARICOM initiative a sub regional model could be evolved to assist the less endowed countries in terms of capacity and also in the areas of risk assessment and risk management on a case by case basis, reports of common products could be used as a baseline for national assessments.  Experts who have "hands on" experience could be called on to assist.  Similar initiatives on sub regional models for biosafety and biotechnology management have been initiated in East Africa through ASARECA.  An initiative have also started in West and Central Africa through CORAF which seeks to collaborate with ECOWAS in evolving a sub regional activities in biotechnology and biosafety.  The Roster of experts of the CBD and expected financial arrangements could aslo assist countries as we look for experts in risk assessment and management.

Actually the term risk assessment and risk management is not new to our world and have been used in sectors such as the insurance and banking industry for some time.  Developing countries could tap on the expertise of such local experts in evolving risk assessment and risk management programmes peculiar to modern biotechnology.

Shared resources and approaches seems to be a worthwhile approach in meeting national, regional and international obligations concerning the use of modern biotechnology as a tool for sustainable development.
posted on 2004-11-14 13:59 UTC by Alex Owusu-Biney, Ghana
The common thread [#363]
It is apparent that we are pushing ahead with a technology without
knowing how to avoid becoming victims of it and at same time are caught up in a morass of legal issues which are merely a smoke screen since in the final analysis, as has been pointed out, the law is only kept by those who respect it.

Briefly then, a few reflections on points raised in the various threads, in particular who and when to consult but also on Biocontrol and making GMOs safer.

1. Most of the proposed uses of GMOs appear to involve the use of this highly risky technology to "solve" problems caused by other
technologies. (such as trying to exterminate and then having to rescue rabbits!) Nevertheless, the experts propose using more of the same technology to make it "inherently" safe. (Biocontrol thread and Who and when Henzel #122)

2. As in the case of GMOs in agriculture, instead of adopting a systemic approach to problem solving, going to the root of the matter and thereby finding sustainable solutions, GMOs are too frequently offered as technological fixes to symptoms when the real problem may lie much deeper and beyond the narrow confines of their particular discipline. The patching up of symptoms becomes a never-ending, unsustainable vicious circle. ( Biocontrol thread)

3. The question is asked who and when (# 217 Gilna): What is good science? Let us remember what science itself is: the best theory available based on current state of knowledge. Genetics is in its infancy and undergoing paradigm shift. Good science humbly recognises its limitations. I would ask how, given this uncertainty, any genetic manipulator can feel so sure about the long-term outcomes of these experiments?

4. For under/least-developed countries, biosafety frameworks are not
just a question of financial support ( Who and when #193). Not only do they require enormous investments, but also the effort required detracts the nations´ resources away from solving more urgent problems of food, education, health etc. Such countries cannot rely on public awareness and pressure to avert the indiscriminate use of GMOs since most of their people are solving the next-meal problem. Given also the general lack of knowledge of these matters, high levels of corruption and weakly enforced legislation it is unlikely that coherent, rigorous and strictly enforced biosafety systems can be set up. Most of the world´s biodiversity lies within such countries. Hence, when serious risks from liberation of GMO cannot be prevented, the only responsible course of action is to apply the Precautionary Principle and prohibit their liberation. 

5. I have little confidence that we shall succeed in controlling the
population of any of these GMOs - we cannot even control our own!

6. On the issue of GMOs that could "potentially" affect the biodiversity of another country and the need for prior consent of affected nations: (Who when - Murphy 121, Gilna136, 141) in a globalised world and given the intricacy of ecosystems, it is difficult to imagine that, with our current state of knowledge, the usage of GMOs can be limited to any particular region. Hence we should assume this scenario, particularly in the case of microorganisms. Therefore the liberation of GMOs is everybody´s concern, no matter what, no matter where.  

Lorna Haynes
CENTINELA  -Environmental NGO
Retired lecturer : Universidad de los Andes
Mérida, Venezuela
(edited on 2004-11-15 12:29 UTC by Ryan Hill)
posted on 2004-11-15 12:23 UTC by Lorna Haynes, CENTINELA