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-----Original Message-----
From: Biotech-Mod1
Sent: 26 May 2003 11:01
To: 'biotech-room1@mailserv.fao.org'
Subject: 78: Re: Methodology for risk assessment

[Dear Participants, We are now at the beginning of the final week of this e-mail conference on "Regulating GMOs in developing and transition countries". The last day for receiving messages is Sunday 1st June. These final messages will then be posted on 2nd June and the conference officially closed. We encourage you all, especially those who have not yet done so, to participate actively in the conference in this remaining, final week. Messages 78 (below) and 79 (by Dick Richardson, upcoming) continue the thread of risk assessment of GMOs, a topic that was also well covered (regarding the ecological context) in Conference 7 of this Forum. We especially urge participants in this final week to focus on the GMO regulation subjects that have not yet received much attention in the conference (listed in Message 70, May 21)...Moderator].

This is Prof J Ralph Blanchfield responding to Clark Efaw (Message 67, May 21).

Repeating an elaborated version of Dr Doebel's claim (Message 62, May 20) does not make it so, particularly as the outcomes of the random insertion of unspecified and unknown numbers of genes resulting from "conventional" breeding are not subjected to the intense food safety scrutiny accorded (and rightly so) to GM.

The introduction of the purposes and economic motives of "biotech companies" and assertion of their "deliberate ... avoiding any responsibility for economic or environmental consequences that can occur on release" has no relevance whatever to the point under discussion and no bearing on the intrinsic risk or otherwise of any particular GM instance. I have no axe to grind for or against biotech companies, but since Clark Efaw has raised the issue, unless we blind ourselves by antipathy in general to companies, we should note the acceptance of full liability for the Starlink incident by the company concerned and the donation of royalty-free licences of patents to help the development of the "golden rice" and other rice varieties with enhanced pro-vitamin A. In any event, I think the future pattern of research and development will be much more by government agencies, charitable foundations and international research institutes and far less by the biotech companies.

Risk assessment of any course of action should necessarily include assessing the risks of all alternative courses of action, include doing nothing -- itself a course of action. Of course I agree with Mr Efaw that "the price of caution in the use of any new technology like biotech should be weighed against the benefit"; but caution should not be exercised on ideological or commercial grounds, and benefit should be measured primarily in terms of potential benefit to those suffering hunger and malnutrition, rather than to those of us taking part in this discussion.

Prof J Ralph Blanchfield, MBE
Food Science, Food Technology and Food Law Consultant
Chair, External Affairs, Institute of Food Science and Technology
Webmaster / Web Editor, Institute of Food Science and Technology
Vice President, European Food Law Association of the UK
Immediate Past Chair, IFT Committee for Global Interests
Adjunct Professor, Michigan State University
IFST Web address www.ifst.org
Personal Web address www.jralphb.co.uk
jralphb (at) easynet.co.uk

-----Original Message-----
From: Biotech-Mod1
Sent: 26 May 2003 11:01
To: 'biotech-room1@mailserv.fao.org'
Subject: 79: Testing systemic genetic effects and risk management

This is from Dick Richardson, United States.

While the new genetic technology potentially is capable of profoundly changing the way we live, the hazards of developing it are qualitatively different in potential harm, and potential benefit, compared to the 19th and 20th century technologies.

Scientifically, the comparison with medicinal, mechanical or electrical technology (antibiotics, airplanes, TV, etc.) is inappropriate to the genetic technology being discussed. Risks and personal choices in medical innovations are contained in an individual and risks agreed upon by the individual. Those being discussed are introduced into the ecosystem and can replicate and expand in the community of species. Once a novel gene cassette is released into the biosphere, recovery ("cleanup") is impossible if it turns out to be "invasive" or otherwise detrimental, including lateral transfer to other species. Everyone is affected, in perpetuity. Therefore, introduction of organisms modified with new gene combinations requires more conservative regulation than either novel pesticides or novel medical treatments, including those using similar genetic techniques.

Medical risk of acute effects that appear quickly differs from those appearing slowly. Even occasional lethality in developing early embryos may be undetected, but still have other delayed effects among those affected that survive the early crisis. For example (thanks to a colleague), mammals have a gene associated with formation of melanin (pigment). However, a mutant of this gene also produces dysfunctional neuronal apparatus for a visual image comparison between the brain hemispheres, eliminating 3D vision. (Siamese cats with a variant of this gene often are cross-eyed and must judge distance by a mechanism different than seeing in three dimensions.) Furthermore, the gene's coded product is more functional (stable) when cool. Judging from the coat color (darker nose, ears, legs and tail), we might consider this gene to be uncritical, but the impaired brain development is extreme. If analogous effects were caused by a new silencing RNA from a genetically engineered insertion, the effects might be missed, depending on the expression timing and our ability to detect a malfunction. Fortunately, a protein or RNA screen for novel molecules using a large array would help us detect this change early, and testing could continue for research depth of understanding. We don't need to know "everything" but we need to know what fits our present understanding of complexity. (assuming we agree on action based on rational decisions)

For agricultural regulatory purposes, initially (pre-release) an extensive assay is essential fundamental information, and should be repeated when growing conditions change from area to area, defined biologically rather than politically. The technology is developing rapidly, and is readily scaled to meet a regulatory demand market as needed. Implementation details may change from country to country, depending on political and biological variables. The testing procedures are being automated and one expects them to become inexpensive. Obviously, tests should be performed in independent bonded/certified laboratories. The regulatory agencies should be responsible for enforcement, but charge back to the seller the costs of testing and enforcement. This internalizes the costs, avoiding further economic stress on the country and allows proper economic forces to work effectively. When risks are internalized, then these precautions become "good business" to minimize potential catastrophic losses, in my judgement.

Dick Richardson
Professor
The University of Texas at Austin
Phone 512-471-4128
Integrative Biology
FAX 512-471-3878
1 University Station C0930
Austin, Texas 78712-0253
United States
d.richardson (at) mail.utexas.edu

-----Original Message-----
From: Biotech-Mod1
Sent: 26 May 2003 15:54
To: 'biotech-room1@mailserv.fao.org'
Subject: 80: Setting up a regulatory framework

This is Muhunthan Rajaratnam from Australia. My country of origin is Sri Lanka and I recently have migrated to Australia. I am a PhD research student at the Faculty of Agriculture, Food and Natural Resources, University of Sydney, and my research involves GM crops agricultural biotechnology in the Commonwealth Scientific & Industrial Research Organisation- Plant Industry (CSIRO PI), Canberra.

I think this conference is a timely initiative by FAO. I am keenly following this conference and by the end of message 52, the participants from developing countries accounted for about 60% of messages (refer FAO-BiotechNews: 6-2003), which is a healthy status as far as this conference is concerned. Regulating GMOs is very essential, concerned to human health and for the environment. Regulation of GMOs has to be carried out at different levels. [FAO-BiotechNews is an e-mail newsletter, launched in January 2002, providing updates of news and events relevant to applications of biotechnology in food and agriculture in developing countries. The items focus on FAO's work and the work of its main United Nations (UN) and non-UN partners and cover the crop, forestry, animal, fishery and agro-industrial sectors. To subscribe, send an e-mail message to mailserv@mailserv.fao.org with the following one-line text:
subscribe FAO-BiotechNews-L
...Moderator].

Some participants in the conference refer to regulation for biotechnology. But I think the word regulation has become very much significant with GMOs only, as in the past no one talked about regulation of other biotechnological applications such as biofertilizers or biogas, for example.

Even though already some, or many, developing countries (e.g. Sri Lanka) have begun setting up biosafety and regulatory frameworks for GMOs, setting up the framework for a developing country is not an easy task, as it is time consuming and needs expertise, finance and other resources. As stated by Ramesh V. Bhat (Message 34, May 8), organizations like FAO/WHO/IAEA/UNEP should come together to set up a common biosafety and regulatory framework for GMOs for developing countries and which could be used by those countries with modifications when and where needed, according to their necessity. Actually, I feel those international bodies should have done it much earlier, so it would have enabled the developing nations to use it with or without amendments according to their requirements. It could also have saved their time and resources. Never mind. Those international bodies should come forward now to draft a common, but special, regulatory framework specifically for GMOs, irrespective if it is crop or forestry or fishery or other GMO-agro industries, which could serve greatly for many developing countries.

Muhunthan Rajaratnam
CSIRO Pant Industry (Bdg 1)
GPO Box 1600
Canberra, ACT 2601
Australia
muhunthan.rajaratnam (at) csiro.au

-----Original Message-----
From: Biotech-Mod1
Sent: 26 May 2003 16:17
To: 'biotech-room1@mailserv.fao.org'
Subject: 81: How strict should the regulatory framework be in developing countries?

This is Muhunthan Rajaratnam again.

Thanks to the Moderator (Message 70, May 21) for reminding the participants about the core issues to be addressed in this conference.

All countries must have a regulatory framework in place for dealing with GMOs. First of all, each developing state should prioritize what GMOs (agro-industry, crop, fisheries, forestry and livestock) they need immediately and in time to come.

All the developing nations are facing many common problems, irrespective of their regional origin.

Many developing countries are holding rich biodiversity while many of those species are already under immense threat due to many reasons. Environmental pollution in these countries remains also very worrisome. Also, the populations in these counties are suffering from malnourishment and hunger and the economy of many of these states is in very bad shape. In this background, the emergence of new GM technology promises to deliver many good results, even though it is not going to be a silver bullet to solve all of their problems. While dealing with GMOs it needs regulation, as it cannot bring any new threat to the already threatened biodiversity, health risk in these countries while that regulation, by itself, should not prevent the benefits as well.

I think importation or marketing of any processed food based on GMOs from another country (most of them are developed countries or in sound technological background than the importer) into a developing country should not be prohibited as those products would already be in use and approved by the competent authorities in the country of manufacture. Alternatively, FAO/WHO/IAEA/UNEP-like organizations should set up a certification system so the importing nation or the exporter could verify the authenticity of those GMO-based foods before importation or exportation.

If it is going to be items such as GM seeds (in the case of crops) or GM seedlings (in the case of forestry) or GM microorganisms, the parties who bring those material into the states should take responsibility for setting up a monitoring system at various levels as the governments in these developing countries should make it mandatory. If those governments (genuinely) suspect that there is any infringement or lapse on the part of the monitoring system enforced by the party it could take that party to an international hearing panel or court (that could be set up by FAO/WHO/IAEA/UNEP-like organizations), where justice could be brought in the form of compensation/penalty/cancellation of license of those parties involved etc.

Muhunthan Rajaratnam
CSIRO Pant Industry (Bdg 1)
GPO Box 1600
Canberra, ACT 2601
Australia
muhunthan.rajaratnam (at) csiro.au