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Sent: 23 May 2003 10:09
Subject: 73: Specific issues concerning regulatory frameworks
[Many thanks to Jane Morris for directly addressing some of the specific issues, listed in Section 5 of the Background Document and in Message 70, we wished to see raised in this conference...Moderator].
This is Jane Morris from South Africa
Let me try to address a few of the issues raised by the Moderator, although I do not pretend to have all the answers.
Firstly: regarding an appropriate regulatory framework for developing countries. In most developing countries the number of applications for use and release of GMOs is likely to be relatively small, at least in the early years. Therefore the regulatory framework should not be large and cumbersome, because this only introduces additional costs and there is no economy of scale. My colleague Muffy Koch contributed some interesting figures to a paper we published jointly at the end of last year on AgBiotechNet (December 2002, Vol 4, ABN102), which give some approximate costs for running a biosafety office and the cost per review. We make the point in the article that developing countries should not set up regulatory frameworks designed to "milk" the multinational companies of their funds. By doing so they will stifle the opportunity to grow the science base in their own countries and to develop GM products for public good rather than purely commercial gain. [The abstract of this paper, entitled "Biosafety of genetically modified crops - an African perspective", by Jane Morris and Muffy Koch is available at http://www.agbiotechnet.com/reviews/Abstract.asp?ID=188 ...Moderator].
It is, in my view, entirely appropriate for environmental and food safety data gathered in one country to be used as part of the input into the risk assessment process in another country. However, the risk assessment must of course take into account environmental differences (such as the possible presence of wild relatives of a crop in another country) as well as possible differences in food safety assessment (e.g. genetic predispositions to food intolerances in certain populations). There may be a need to gather additional data specific to the risk assessment for the country in question, but this should be determined on a case-by-case basis.
The question as to how much effort developing countries should put into
developing a regulatory framework, given their limited resources, points to
a number of issues:
1. If developing countries see potential benefit from the introduction of GM technology, then the effort will be worth it based on a cost:benefit analysis
2. The indirect impact of familiarization with GM technology can benefit science in the country as a whole
3. Developing countries should make maximum use of available resources internationally and in the developed world to assist them with risk assessment (it seems as though lack of familiarity with the technology is often the reason for indecision)
4. Developing countries should use regional organisations, where appropriate, as a means of pooling the resources and reducing the necessity for creating regulatory mechanisms in each country.
Costs of monitoring compliance with any legislation can be high, and GMOs are no exception (in fact, if monitoring may be needed even in the absence of legislation). Monitoring should therefore focus on the real safety issues rather than monitoring for non-compliance purely to catch people out for what may be fairly trivial issues. In the case of GM crops, most countries have some kind of existing agricultural inspection service, as well as extension officers, and these people can be trained in issues regarding GM technology in order to avoid duplicating functions and incurring additional costs.
In many developing countries there is a tendency to include social, ethical and economic factors in the decision making process as well as human health and environmental impacts. While these may not be safety issues per se, they are important, not only in looking at the cost:benefit equation, but also in ensuring the long term acceptance of introduced technology. The traditional decision making processes in Africa involve communities, and decisions made this way are more likely to achieve buy-in than a decision imposed only by scientists who are trained to deal specifically with safety issues.
E Jane Morris PhD
African Centre for Gene Technologies
P O Box 75011
Tel: +27 12 841 2642
Fax: +27 12 841 3105
Cellular: +27 82 566 2210
e-mail: jmorris (at) csir.co.za
Sent: 23 May 2003 10:41
Subject: 74: Regional safety assessments - National agricultural decisions - Caution on novel traits
This is from Luca Bucchini, from Hylobates Consulting, Italy. Our firm provides consulting, training and laboratory services in biotechnology, food safety and risk analysis/management in Europe.
Three ideas for regulation: regional safety assessments, national agricultural decisions and caution on novel traits.
The discussion has been lively and interesting. Also, following the Moderator's recent remarks (Message 70, May 21), here are some ideas based on my work and research experience, and on analysis of trade and food safety trends.
In shaping regulatory frameworks for developing countries, it should be advantageous to consider the experience of countries that have extensively grown GM crops, especially the US and Canada (as Suzanne Wuerthele has pointed out in her message, number 66, May 21, listing some intriguing issues).
From my assessment of the US and Canadian experiences, at least two conclusions can be drawn with some confidence:
1. GM crops that have been planted on a large scale (Bt corn, herbicide tolerant soybean, herbicide tolerant canola, Bt cotton and perhaps virus resistant papaya) do not seem to cause significant adverse impacts on either the environment or on human health;
2. the ability to control gene flow and the movement of GM-derived material is, at best, limited (see the Starlink and the Oaxaca case, but also results from monitoring of soybean products in Europe). [The reference to Starlink is to the finding of Starlink corn, a variety approved for animal feed but not for human consumption, in products such as taco shells and chips in 2000. The reference to Oaxaca is to reports in 2001/2002 of transgenic material in maize landraces cultivated in Oaxaca in southern Mexico, part of the centre of origin and diversification of this crop...Moderator].
While these conclusions may not apply to other GMOs or to the more stringent regulatory system that the EU seems set to implement, they do carry to at least some inferences:
a) General approval of GM organisms should be granted at the global (or, at least, continent) level, taking into account regional differences.
If control of gene flow and movement of GM material, even across borders, is costly and extremely impractical in the US and Canada, it should be assumed that containing genes to certain restricted countries or parts of them is not feasible in other parts of the world.
Therefore, a useful distinction in regulations could be made between low level contamination (of seeds and/or food-feed), that may be considered acceptable, and planned, large-scale planting; I would leave the first in the international arena, and the second in the national one. Granted that low level presence of GM material may have serious environmental or sanitary consequences, and that it cannot be controlled at the national level, the appropriate level to determine its safety is at least that of a continent. This approach would also lessen trade disputes.
Even with a regional process, local differences in safety would be addressed, as risks of crops may vary in different countries (e.g., eating raw versus processed produce; centers of origin/diversity issues). It may be possible to put together international public funding to support such large-scale applications for few traits that may be urgently needed in some developing regions and cause reduced concerns (e.g., virus-resistant plants).
b) Permission to commercialize and use in agriculture GM plants or animals should be decided at the national level.
This is the level where social, economic and ethical issues should be debated and decisions made, probably more based on agricultural considerations than currently done, as safety issues have been resolved in international fora. In this case, additional data may be required that are useful to predict effects on agricultural practices.
In practice, one should note that, as pointed out in the Background Document to this conference, developing countries are facing increasing pressure to ensure the quality and safety of their agricultural products. It is doubtful that the efforts to enforce biotechnology regulations turn out to be effective and a good investment (especially, when complex management strategies or labeling thresholds are involved). Moreover, also under the hypothesis of national approvals, it is unclear whether any GM product approved only at the national level (especially in a developing country) could be effectively excluded from trade. In terms of forestry, there is little indication that GM wood may be acceptable to people who oppose GM foods.
c) Particular cautions should be taken with some modifications
The experience gained in the US and Canada and some other countries is limited to a few traits. Unless, in those countries, the approval process slows significantly, the number of traits and plants modified will expand dramatically to include biopharming-relevant modifications. It is not unreasonable to predict that some of these traits will cause some, possibly minimal, adverse events. However, even tiny adverse effects may elicit a very strong reaction from the public, in developed countries, especially when the hazard is new and not fully understood (witness, these days, the Mad Cow case in Canada).
It is extremely important, in my opinion, that developing countries take a cautionary approach to traits that go beyond the ones experimented in the countries mentioned above. In fact, even open-trade promoting countries may become extremely strict in matters of import when the public becomes sensitive to a safety issue. The future may be different, as genetic modifications is linked, in the public mind, to conventional breeding and the failure of a single event is not linked to a failure of the technology as a whole, but this future seems at least a decade away.
In summary, a science-based approach to ensure the human health and environmental safety of GMOs should be taken at the international or regional level, since low level flow of GMOs cannot be prevented. If such international determination is made, national decisions based on agroeconomic, social and ethical issues can really be made. Finally, developing countries should concentrate on few useful GM traits and exercise caution on novel, untested GM traits.
Luca Bucchini, PhD, MPH
Hylobates Consulting Srl
Via Gaggiano 42
lucabucchini (at) hylobates.it
Sent: 23 May 2003 10:44
Subject: 75: GM food crops and biosafety
I am Omwoyo Ombori from the Botany Department, Kenyatta University, Kenya.
Use of genetic engineering is a potential tool to produce transgenic plants of improved quality, hence this will increase production of food especially for the ever-increasing population in semi-arid areas. However, it requires that appropriate intensive biosafety measures are taken into consideration so as to avoid releasing food crops which can have negative effects on human beings. Strict regulations must be followed. All transgenic food released to the market must be labelled.
P.O. Box 43844
ombori (at) yahoo.com
Sent: 23 May 2003 11:09
Subject: 76: Economics - US regulation - Country data
This is from Budi Prakoso, Thailand.
I agree that we should regulate the products of GM organisms, not the process of how to modify the organisms. Breeders and biotechnologists, both try to combine desired traits and remove or repress the unwanted traits in their products. It is not economical to detect and know all unintended traits. In term of selecting a new crop line for example, greenhouse, field and multi-location trials are carried out to assess agronomic characters, including survival ability and weediness. In addition, proximate analysis is also carried out if the product will be consumed. [Proximate analysis is used to assess the relative content of water, fat, protein, ash etc. in the product...Moderator]. In certain cases, when a crop has been known to contain a toxic or harmful product (for example cyanide in cassava), the harmful concentration is also analyzed. In the present regulation, it is mandatory to do safety testing by assessing the effect of the new crop product on the growth of certain tested organisms. It is not economical to test the effect of that product on all organisms in the world. It is also not economical to do allergic tests for something that we do not know before (unintended proteins) to all sensitive persons (we do not know who will be sensitive to a new unknown antigen).
I think the present regulation on the release of GMOs applied in the USA is good enough to be applied in all countries. In addition, consumers should be informed and educated that GMOs that have been released are safe based on all tests that have been done. Then, labeling of GMO material in food will not have bad impact on its marketing. It is only a trademark. In some cases, it may inform the advantage of the GM product, for example if it has a better nutritional value.
The environmental and food safety data from one country may or may not be appropriate for commercialization in other country. For examples, proximate analysis data can be used everywhere, but survival ability and weediness are site specific. However, the data from one country can be used as a reference to carry out similar tests in the other country.
Asian Institute of Technology
e-mail: bpd999870 (at) ait.ac.ath
Sent: 23 May 2003 12:45
Subject: 77: GM crops regulations: End-user or affected party approach
I am Vikas Nath, Manager, global public goods Network (gpgNet.net) Forum.
My concern is that issue of regulations on GM crops cannot be dealt in a vacuum or in a blanket manner. Since end-users or affected parties of introduction of GM crops are heterogenous (implying, they will be affected to different degrees), we will have to design the regulations so that all affected parties are able to make an INFORMED choice on use of GM crops.
Some of the key affected parties are national governments, markets (including agro-intermediaries, retailers, stockers and wholesalers), farmers and the "public" which is the consumer of GM food crops.
When the affected party is the national governments, GM regulations should ensure that countries are fully aware of crops they are importing or trading or otherwise allowing for cultivation within their borders. This also implies that capacity-building of national agricultural research institutions should be undertaken so that they can better gauge the impact of GM crops introduction both ecologically and economically.
Where the affected party are the markets, then GM products should be clearly labelled so, rather than being sold surreptitiously through existing brand names. This has often been the case in many countries, and as a consequence of it, GM crops enter the markets without conscious decision of any of the agro-intermediaries.
Similar kind of regulations should exist, to ensure that farmers and the "public" at large are fully aware of the risks and prospects of GM crops. This implies that such information should be provided to them, not simply through GM firms but also through national research institutions and markets.
A chain reaction can therefore occur where weak GM regulations at one level may lead to potential disaster at another level. And in the absence of adequate funding for agricultural R&D to assess the risks and potential of new technologies, developing countries are certainly at the disadvantageous end, when it comes to GM crops introduction. Please feel free to share the concern on "Consequences of the shifting balance from public to private in agriculture R&D discussion forum", being run between 26 May and 9 June 2003 on the gpgNet.net platform. The complete background note is available at http://www.gpgnet.net/topic03.php. To subscribe, send a blank email to firstname.lastname@example.org
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