[For further information on the Electronic Forum on Biotechnology in Food and Agriculture see Forum website.
Note, participants are assumed to be speaking on their own behalf, unless they state otherwise.]

-----Original Message-----
From: Biotech-Mod1
Sent: 28 April 2003 11:51
To: 'biotech-room1@mailserv.fao.org'
Subject: 1: Regulation of GMOs with homologous or native inserted genes

This is from Professor Steven Strauss in the Department of Forest Science at Oregon State University, United States. I have served on a number of panels at the US National Research Council, National Science Foundation, and Department of Agriculture. My current research focuses on genomic analysis and genetic engineering methods for trees, and I direct a university-industry consortium that is developing genetic engineering solutions to mitigate concerns of gene flow from transgenic plantations.

I think it is the developing world and poor people worldwide that will be the big losers if the current pan-GMO regulations on field tests and commercial release persist (i.e., if laws are not passed, and internationally recognized, that distinguish and deregulate research field trials, and eventually commercial uses, of native/homologous and domestication transgenes).

We already know what extraordinary gains in productivity have been enabled by simple genetic changes such as semi-dwarfism in cereal crops. There is no question in my mind that there is plenty of room for additional gains of similar magnitude powered by genomics. Genomics and genetic engineering also allows the insertion of homologous or native genes based on genomics progress in model and well-studied crop plants to radically speed domestication of poorly known and slowly bred crops, including perennials important in the developing world.

The traits that can certainly be modified given sufficient research include yield based on changes in stature, inflorescence/fruit structure, and ability to tolerate and absorb nutrients from soil; nutrition, based on changes in plant proteins, lipids, and reduced production of selected allergens and toxins; and increased tolerance of various biotic and abiotic stresses, such as salt and cold tolerance. None of these are easy to do, and will be greatly slowed, and prevented altogether in many cases, if field trials and subsequent commercial uses continue to be so difficult due to excessive regulation.

Progress will occur at a snail's pace if each test of a transgenic crop requires bureaucratic red tape, government approvals, and risks trade impacts or simple stigmatization due to its scary "GMO nature". Leaders in the UN/FAO and elsewhere need to stand up and say clearly that the likely benefits to the poor are too great and the risks too familiar (compared to traditional breeding) to regulate GMOs with native/homologous genes as though they were potential environmental menaces. It is absurd and ethically repugnant, and I believe that humanitarian leaders and NGOs need to say so in the clearest terms. That is one of the challenges implicit to my essay. I am not asking that they endorse all GMOs as good or bad, but I do think they can clearly endorse this class as familiar in risk and of enormous potential benefit.

Generic regulation of all GMOs is a major obstacle to the "democratization" of biotechnology needed for the developing world. Until we regulate this class of transgenic crops in a manner proportional to their risk, biotechnology is likely to continue to be dominated by large corporations and focused only on major crops and traits. By reducing regulation-associated risks and costs, we will empower modestly funded public sector researchers at all levels to do what is needed based on local and regional problems, not corporate priorities.

If the GMO regulatory logjam could be broken for this one sector of biotechnology, it could go a long way to starting to resolve the world controversy over GMOs. I believe that the public might agree that "common sense" regulations that distinguish modifications to native genes from the expression of novel proteins and anti-pest toxins is appropriate. Nature and breeders modify the expression of hundreds of native genes continuously...all that is needed is some hybridization and inbreeding. When biotechnologists do this with a very clear idea of the mechanisms involved, and then test plants carefully, it should reduce, not increase, concern. But regulations, and the social unrest they encourage, do the opposite. The stakes for the poor are too high to continue this way.

Steven H. Strauss,
Department of Forest Science, Richardson Hall
Oregon State University,
Corvallis, OR 97331-5752
United States
Phone: 541 737 6578,
Cell: 541 760 7357,
Fax: 541 737 1393
Steve.Strauss (at) orst.edu

[Thanks to Professor Strauss for the first message of this 4-week long conference. His contribution echoes his recent reflections published in a "Policy Forum" article in Science (4 April 2003, 300, pages 61-62, entitled "Genetics, genetic engineering, and domestication of crops" (available through http://www.scidev.net/topopinions.asp) where he argues that genomics "is allowing breeders to generate similar kinds of traits to those sought conventionally by targeting the underlying genes. These kinds of GGT [genomics-guided transgenes] traits--particularly those that impart obvious domestication phenotypes or utilize native or homologous genes--should require far less oversight by government regulators, especially at the field-testing stage"...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 28 April 2003 13:32
To: 'biotech-room1@mailserv.fao.org'
Subject: 2: Farmer perspective - Including economics in risk assessment/management

I am Julie Newman. My husband and I conventionally farm 8,000ha and have a seed grading factory in Newdegate, West Australia.

I would like to respond to the section regarding risk analysis and risk management in the regulatory framework and priorities in legislation. [Refers to Section 4.b, entitled "key elements in developing a regulatory framework", of the Background Document to this conference...Moderator].

Any country establishing a GMO regulatory framework should have economic assessment as a priority in regulatory framework. The supposed reason for introduction of this crop is based on economics and if there is low economic advantage and high economic risk, the legislation should be based on how to manage this problem with the least economic risk to the industry.

As an Australian farmer, I feel it is an absolutely essential requirement to include a comprehensive, unbiased economic assessment as part of the risk analysis process. This risk assessment must include the impact on the non-GM grower and associated industries that may be affected. This assessment should be based on different management plans to enable legislation to be formulated along the "least risk" framework.

I am appalled that the legislation of developed countries has excluded economics in the legislated risk assessment. Due to consumer rejection, market loss will have serious economic ramifications within the agricultural industry and yet the drive for the commercial introduction of GM crops appears far greater than the concern for the agricultural industry.

Basically, it is too expensive and too difficult to segregate GM crops and if a country introduces GM crops their non-GM produce will be effectively labelled "GM" unless proven otherwise. There is serious market rejection which causes concern for all sectors of the industry. For example, the Canadian Wheat Board has surveyed their customers and 82% of their customers will not accept GM wheat. Because of this, marketers, farmers, storage and handlers and many other associated industries are pushing to reject the commercial introduction of Monsanto's Roundup Ready wheat. Due to the fact that economics is not part of the risk assessment, this crop may be introduced and 82% of this country's wheat markets may be lost. With any legislative process, it must be paramount that rights are taken into account. Consumers are demanding the right to choose NOT to consume GM foods and farmers demand the right to market unhindered to this market.

We have found the estimated costs to the non-GM grower for segregation to a contamination level of 1% are at least 10% of the product value if GM product is introduced to Australia. Contamination is expected and yet due to the Trade Practises Act [1974, which applies to trade and commercial activities in Australia...Moderator], it will be the non-GM grower that will be liable for not delivering the product under the product specifications required, such as "non-GM" which legally means NO GM content. Introduce GM into the cropping systems and non-GM produce will be contaminated and will be impossible to guarantee. Why should the non-GM growers be legally responsible for a product that they do not want? It is further complicated by the unique major patent of GM crops allowing the GM product provider the right to threaten non-GM growers that may have contamination. It is legislation that promotes the GM industry over the non-GM industry and should not be permitted.

If economics was considered in the risk management, the logical solution would be to ensure the GM production chain was legally responsible for all costs and liabilities for the control of their product. This will enable the protection of the existing cropping systems and hence economic security. Considering the GM promoters are claiming that contamination and segregation is not an issue, they should not object to this obligation. There should be no change between the precautionary principle (trials) guidelines and substantial equivalence (commercial release) guidelines for growing GM crops. The GM grower should keep GM crops contained (as is expected in trials) and not expect the non-GM grower to try to keep them out of their crops (as is expected in commercial release).

If there is no commercial advantage in growing a GM crop in these circumstances, this is an indication that the variety is not ready for commercialisation. When a GM crop offers consumer benefits and possibly consumer preference, or the variety offers significant yield advantages, the advantages will then outweigh the risks involved.

Julie Newman
Network of Concerned Farmers
P.O. Box 6
Newdegate
West Australia
08 98711562
newseeds (at) treko.net.au
www.non-gm-farmers.com

-----Original Message-----
From: Biotech-Mod1
Sent: 28 April 2003 13:53
To: 'biotech-room1@mailserv.fao.org'
Subject: 3: Re: Regulation of GMOs with homologous or native inserted genes

This is from Craig Harris in the Department of Sociology at Michigan State University, United States. I have done research on consumer and citizen perceptions of agrifood biotechnology, and on policy discourse about agrifood biotechnology in developing countries.

This is in response to Message 1 (28 April) from Steven Strauss. If I were to summarize the message, he was arguing that excessive and unwarranted regulation of native/homologous genetic events is inhibiting the realization of the potential benefits of this type of genetic engineering. It would help me if Professor Strauss could be more specific about current regulation. I would like to start with the case of the United States. Specifically for the United States, what would be the regulatory process for a native/homologous genetic event of the type mentioned in the fourth paragraph (yield, nutrition, stress tolerance)? Would a change directed toward nutrition (e.g., "changes in plant proteins, lipids, and reduced production of selected allergens and toxins"), be regulated differently than a change directed toward yield or stress tolerance?

I think it would help the discussion to be clear about what exactly is the process before we discuss whether the process is unnecessarily stringent.

craig k harris
department of sociology
center for integrated plant systems
national food safety and toxicology center
institute for food and agricultural standards
michigan agricultural experiment station
michigan state university
429b berkey hall
east lansing michigan 48824-1111
United States
tel: 517-355-5048
fax: 517-432-2856
Craig.Harris (at) ssc.msu.edu

-----Original Message-----
From: Biotech-Mod1
Sent: 28 April 2003 16:18
To: 'biotech-room1@mailserv.fao.org'
Subject: 4: Re: Regulation of GMOs with homologous or native inserted genes

This message is from Hector Quemada. I am an agricultural biotechnology consultant. I've worked in the area of commercial development of transgenic crops in the U.S., and have experience in regulatory issues.

I would like to reinforce Dr. Steven Strauss' comment (Message 1, April 28) about the regulatory cost and its effect on the development of this technology. First of all, in the U.S., the cost of regulatory data collection and compliance has driven most small players out of transgenic crop work. I know of no major transgenic crop development being done any more by vegetable seed companies, for example. Universities, have been an important source of new conventionally-bred varieties, are not developing transgenic crops themselves. They simply don't have the money to do that. The net result has been that the technology is now being pursued by the major companies who can afford to spend the money and who have the appropriate staff to deal with the regulatory requirements. Because of the cost, these companies have to focus on only a few technologies, (for example herbicide tolerance, insect resistance) and in a few crops (for example soybeans, corn, cotton and maybe wheat) that can recover the cost.

This will leave a lot of needs not met, especially in developing countries. Transgenic disease resistance, for example, hasn't proven to be a big commercial success in any commercialized crop so far, and isn't likely to be a major commercial trait in the future, at least in the developed world (if the pattern of major company activity in this area is any indication). However, it is an important trait in developing countries. Who will develop crops with these traits? I compare the majority of crops and traits being developed now to "orphan drugs" in the drug industry. These are developments that would be beneficial but will not be developed because of cost.

I think it is critical that developing countries come to realize this issue as a major obstacle in developing biotech crops of their own. Regulations that are put in place as a defense against multinationals will, I believe, stifle the application of the research now taking place throughout the developing world and, in the next few years, these researchers will reach the point where they will want to go beyond the point of field trials. However, if the situation doesn't change, that is where most of the work will stop.

I do not suggest that regulations be abandoned entirely. I agree with Dr. Strauss' suggestion of streamlining the process for traits that can be considered low risk. Furthermore, streamlining the process for crops with traits that will solve major problems might also be considered. This approach is not new and has a good history of use by regulatory agencies overseeing the development of technologies other than transgenic crops (drugs and agricultural chemicals, for example).

Hector Quemada, Ph.D.
Crop Technology Consulting, Inc.
2524 East G Avenue
Kalamazoo, MI 49004-1941
United States
phone 269 387 5869
fax 269 387 5609
mobile 269 370 2358
hdquemada (at) croptechnology.com
http://www.croptechnology.com

-----Original Message-----
From: Biotech-Mod1
Sent: 29 April 2003 10:51
To: 'biotech-room1@mailserv.fao.org'
Subject: 5: Experimental trials vs. unconfined releases

This message is from Donald MacKenzie, Agriculture and Biotechnology Strategies (AGBIOS). We are a consulting firm specializing in providing public policy, regulatory, and risk assessment expertise for products of biotechnology.

This point addresses the development of biosafety regulatory systems in developing countries and specifically the importance of clearly differentiating experimental trials from unconfined (general) releases into the environment.

While it is certainly the case that regulatory systems from the developed world can rarely, if ever, be directly applied to developing regions, there are some important lessons worth noting. The commercial success of plant biotechnology in Canada and the United States would not have been possible without having systems in place to permit the routine and safe conduct of confined (experimental) field trials of plants of uncertain risk.

In this context, a confined field trial is a small-scale experimental field trial of a genetically modified plant species carried out to collect the data necessary for a complete environmental risk assessment, and is performed under terms and conditions (e.g., reproductive isolation, physical security as necessary, safe transportation, planting, monitoring, harvesting, storage, disposition, and reporting) that mitigate any impact on the surrounding environment.

The necessity of being able to safely evaluate plants of uncertain risk cannot be overemphasized. There is a crucial distinction between general (commercial) environmental releases and confined trials that has not been sufficiently well appreciated in developing countries (or, for that matter, in some developed countries), either by regulators, national biosafety committees, or capacity builders and trainers. At the level of a general release, the focus must be on rigorous risk assessment as the intent is widespread introduction of the modified plant into agriculture, usually with few or no provisions for risk mitigation. Conversely, for confined trials, the risks are not likely to be fully appreciated without data collected during the trial, hence the focus must be on risk management - the terms and conditions that are necessary to permit safe trial conduct.

Much of the current focus on developing country regulatory systems is on Africa, which risks being bypassed by the current "gene revolution" because it lacks the stable and predictable regulatory regimes necessary to create an enabling environment for the application of agricultural biotechnology. In Africa, only South Africa has successfully commercialized plant biotechnology products (insect resistant maize and cotton, and glyphosate herbicide tolerant soya) and has a working system in place for the conduct of experimental field trials of genetically modified plants. In Central and Eastern Africa, Kenya is the only country where a field trial has taken place but its process for the approval of new trials appears stalled. Uganda has reviewed an application for the trial of insect resistant cotton but it was rejected.

The capability to safely perform confined trials is crucially important in developing countries. There must be a system whereby locally developed plant biotechnology products can be assessed in experimental trials, and equally where foreign applications can be evaluated for potential biosafety impacts, prior to their release into local agriculture. The existence of a permissive environment for the conduct of experimental trials is key to continued local research and development (R&D) investment and it is equally important in providing biosafety committees and regulatory officials with experience and expertise. Again, drawing from North American experience, regulators benefited from seven years of experience with confined field trial applications prior to the first unconfined release approvals in 1995.

To date, the activities of national biosafety committees and donor organizations have focused on risk assessment and in building the scientific knowledge capacity to carry out risk assessment. While very important, these activities have failed to address the key limiting factors to conducting confined field trials. With their focus on risk assessment, biosafety committees can become paralyzed into indecision in cases where a complete assessment is not possible because of information gaps, as is often the case when product development is at the trial stage.

For confined field trials, the focus must be on the implementation of effective risk mitigation strategies rather than on exhaustive prior risk assessment. In countries with no, or limited, experience in the design and implementation of audit, inspection, and enforcement systems in other areas, such as food safety or plant and animal health, there is limited risk management capacity. At an operational level, these critical institutional and infrastructure deficiencies in basic inspection services are limiting trial approvals and cannot be overlooked during the design/implementation of a biosafety regulatory framework.

D.J. MacKenzie, Ph.D.
Exec VP/CFO, AGBIOS
106 St. John Street, P.O. Box 475
Merrickville, ON K0G1N0
CANADA
Tel : +1.613.269.7966
Fax : +1.613.269.4367
E-Mail: djmackenzie (at) agbios.com
URL : www.agbios.com
URL : www.essentialbiosafety.info

-----Original Message-----
From: Biotech-Mod1
Sent: 29 April 2003 11:03
To: 'biotech-room1@mailserv.fao.org'
Subject: 6: Re: Regulation of GMOs with homologous or native inserted genes

This is the second message from Donald MacKenzie, Agriculture and Biotechnology Strategies (AGBIOS), Canada.

This point is in response to Dr. Strauss' opening contribution (Message 1, April 28) on the regulation of GMOs with homologous or native inserted genes.

Incorporation of the "categories of risk" argument, as presented by Dr. Strauss, into regulatory systems requires a fundamental re-think of the existing approach to risk assessment of transgenic plants.

Existing regulatory systems attempt to evaluate not only the predictable consequences of inserting genes of known function into plants (or animals) but also the unintended consequences of genetic manipulation. This latter concern is related to the possibility that insertion of a genetic element into the host genome may give rise to unforeseen and/or pleiotropic effects, perhaps due to insertional inactivation or up- or down-regulating of a metabolically important host gene, or some other interaction. [Pleiotropy is the simultaneous effect of a given gene on more than one apparently unrelated trait - see the FAO Biotechnology Glossary...Moderator].

The adoption of a "categories of risk" approach to regulation, wherein certain introduced traits are judged to be less risky than others and, therefore, warranting less stringent oversight, would signal that so-called "pleiotropic effects" are not a serious concern.

The point of this response is not to make the case that "unintentional consequences" pose a significant new risk in plant breeding, as I don't believe that they do, but merely to highlight that this is a principal issue at the heart of unnecessary "regulatory cost" and complexity.

The regulatory preoccupation with "unintentional consequences" has, in large part, been the driving force behind increasingly complex data requirements for the molecular-genetic characterization of transgenic plants. It has resulted in a form of "molecular arms race", whereby developed-country regulators are in competition to develop the most stringent requirements possible, perhaps believing that increasing complexity equates to higher levels of safety. It doesn't, it's just more costly and more complex.

Not only do developers have to provide information on what genes have been introduced into the new plant, but also data on the number of copies of introduced genes and any rearrangements or deletions or truncations that have occurred. In some cases (Belgium, Japan), regulators are requiring the complete nucleotide sequence of the inserted DNA as well as the sequence of at least some of the surrounding host genome, as well as a thorough bioinformatics analysis to uncover any potential novel and/or chimeric open reading frames. While much of this information may be "nice to have", it provides little, if any, insight into environmental or food safety. There is, for example, no correlation between gene copy number and safety, or between evolutionary distance between the host and the introduced gene and safety. Elaborate molecular characterization is not a replacement for direct measurements of changes in the levels of nutrients and antinutrients, endogenous toxicants, or potential allergens in a new food product.

As was already alluded to in Dr. Strauss' contribution (and Dr. Quemada's response - Message 4, April 28), the implementation of elaborate data requirements that are not essential for determining safety plays to the strength of large multinational developers and unfairly prejudices small developers and developing countries. The push for developing "minimum necessary" standards for risk assessment must be led by the developed world. The standard should be, "has the developer effectively demonstrated safety?" and not, "has the developer used every technology available to characterize this product?".

D.J. MacKenzie, Ph.D.
Exec VP/CFO, AGBIOS
106 St. John Street, P.O. Box 475
Merrickville, ON K0G1N0
CANADA
Tel : +1.613.269.7966
Fax : +1.613.269.4367
E-Mail: djmackenzie (at) agbios.com
URL : www.agbios.com
URL : www.essentialbiosafety.info

-----Original Message-----
From: Biotech-Mod1
Sent: 29 April 2003 11:16
To: 'biotech-room1@mailserv.fao.org'
Subject: 7: Non-GM crop biotechnologies- Regulation

As a farmer I find it difficult to understand why non-GM genomics is not being hailed as the best of biotechnology. To be able to identify, mark and fast-track breeding traits such as drought, salt, frost and disease resistance is a breakthrough in our non-GM genomics plant breeding techniques and it is not weighed down by the regulatory process involved with GM crops as mentioned. Any legislation should be promoting biotechnology, but in the form of non-GM genomics, not recombinant DNA. Cell tissue selection, colchicine, protoplast fusion, grafting, plant regeneration, embryo rescue, tissue culture hybridisation, anther culture hybridisation and random mutagenesis have managed to produce consistent improvements in plant breeding to date.

Julie Newman
Network of Concerned Farmers
P.O. Box 6
Newdegate, 6355
West Australia
Ph 08 98711562
newseeds (at) treko.net.au
www.non-gm-farmers.com

-----Original Message-----
From: Biotech-Mod1
Sent: 30 April 2003 14:16
To: 'biotech-room1@mailserv.fao.org'
Subject: 8: Regulation of GMOs: issues to be addressed in developing countries

I am Vasanthi Siruguri, working as Research Officer in the Food and Drug Toxicology Research Centre of the National Institute of Nutrition, Hyderabad, India. I have been working on GM foods for the past 4 years in areas of method development for their detection and also actively involved in the establishment of infrastructure for the safety assessment and testing of GM foods at the Institute.

This e-mail conference on regulation of GMOs in transition and developing countries is very appropriate, particularly under the existing global scenario of uncertainties and controversies regarding the safety of GMOs and their release into the environment. In India, commercialization of GM crops has just begun with the introduction of Bt cotton. The existing regulatory framework for transgenic crops is being strengthened, especially in the area of risk assessment of GM foods. In this context, various policies are being made, keeping in view the international scenario of regulations and food use approvals for GM crops. The following are some of the issues that may be particularly relevant while developing regulations for GMOs in developing countries.

Much debate is going on as to what, how and when to regulate GMOs, in international circles. Under these circumstances, developing countries are faced with the challenge to put in place a regulatory system that can meet the changing context/developments in scientific and international fields as well as to build the capacity required to establish such a system. Regulations for GMOs have been established in many countries adopting these foods, but differences in the basic philosophy of regulation between these countries has created much difficulties in assessing the extent and type of regulation that is required for GM foods. Added to this, are the complexities of regulatory guidelines established by international bodies like WHO (World Health Organization), FAO, WTO (World Trade Organization), OECD (Organisation for Economic Co-operation and Development) and CBD (Convention on Biological Diversity) which are affecting international trade and the release of GMOs in individual countries. These developments are likely to have much influence on the acceptance and release of GMOs in developing countries, most of which are as yet to establish regulatory frameworks for GM foods. The following are some of the priority issues that need to be addressed from the point of developing countries' perspective on GMO impact on health and environment:

2. The extent of strictness/rigourness needed in the regulation would have to take into account the type of GMOs that are likely to enter into a particular country. In many developing countries, regulations for GMOs are yet to be framed. Under these circumstances, there is a potential for entry of unapproved varieties in the food chain as happened with Starlink maize. The regulatory framework needs to address the kind of approaches to be taken to prevent/guard against the entry of such varieties, particularly in food-aid channels.

3. The importance of post-market monitoring of GMOs, particularly in the field during and after cultivation, and during marketing needs to addressed. In this context, the kind of methods required, particularly approaches for preventing/checking clandestine cultivation of GM crops that may not have an approval status, and checking for compliance with cultivation procedures of GM crops, need to be discussed.

4. Methods for detection of GMOs are currently the most important requirements for controlling the movement of GMOs in the food chain. The extent of sensitivity, robustness, rapidity, and economy that is needed remains to be addressed, keeping in view the availability of infrastructure in developing countries.

5. Monitoring for long-term health effects in consuming populations is being emphasized in international circles. What approaches will be required for such monitoring, remains to be addressed.

6. International harmonization of risk assessment procedures appears to be an urgent requirement in view of the widely diverging views on the safety of GM foods. However, these need to be supplemented with risk assessment procedures that may be specifically important to a country in question. This aspect may assume much relevance in countries where some of the widely developed GM crops, like maize and probably rice, are consumed as staple cereals in populations. The food consumption patterns, method of preparation and the contribution of important nutrients through these foods are some important issues.

Dr(Ms) S.Vasanthi
Research Officer
Food and Drug Toxicology Research Centre
National Institute of Nutrition
Indian Council of Medical Research
Hyderabad 500007
India
vasanthigm (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 30 April 2003 14:30
To: 'biotech-room1@mailserv.fao.org'
Subject: 9: Farmer perspective - Including economics in risk assessment/management

I am S. Vasanthi from National Institute of Nutrition, Hyderabad India.

I wish to respond to Julie Newman's message (nr. 2, April 28) on economic risk assessment of GMOs. I agree with her that it is important to include this aspect in regulations on GMOs. Economic risk assessment can be a part of post-market monitoring planning which is being included in the regulatory framework of many countries. Ideally, data on the economics of the entire process of cultivation, harvesting, marketing, traceability and consumption of GM crops would be needed for economic risk assessment. Since this may present a complex task perhaps categorizing various activities in the food chain that GM crops undergo may be helpful in assessing the economic risk. For e.g.:

Category I: Cultivation of GM crops (GM vs non-GM). Here, assessment can be in terms of cost of purchasing the seed, yield, cultivation methods, monetary returns to the farmer, etc.

Category II: Segregation of GM and non-GM produce. This would involve cost of analysis, labour, time spent etc.

Category III: Checking for adventitious contamination in the field, market, industry. The cost involved in recall (from market shelves, removal or destruction in the fields) may be important here.

Category IV: Cost of detection of GM foods moving in the food chain. (rapid versus sensitive methods like PCR). It is essential that each country works out such economics according to the resources available.

Dr (Ms) S. Vasanthi
Research Officer
Food and Drug Toxicology Research Centre
National Institute of Nutrition
Indian Council of Medical Research
Hyderabad 500007
India
vasanthigm (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 30 April 2003 14:53
To: 'biotech-room1@mailserv.fao.org'
Subject: 10: Gaps in current GMO regulations

This is Tracey McCowen. I am a bioethics consultant focusing in biotechnology agricultural developments. I am also a visiting professor in sustainable agriculture at Maharishi University of Management, Iowa, United States. I have previously worked on development projects in Peru. I currently divide my time between working on our family farm, research and consulting.

I do not dispute what has been said about the current laborious regulatory structure, but I think at this point it would be better to start this conference by discussing what we have learned so far about regulating GM products rather than articulating what various stake-holders would like changed.

So far North American regulations of GM crops undergo extensive scientific risk assessment analysis before being approved. However, this does not mean that the current regulations have prevented problems arising from GM crop cultivation. Looking at some of the problems current regulations do not account for is the best way to help nations integrate biotechnology safely into their agricultural systems.

There are two cases I think can add to this discussion. The first is glyphosate tolerant canola and the second is Bt-corn. Both these crops have a history in the regulatory system that can be reviewed, discussed, and improved upon. In doing so we can help other countries, even those within the European Union, develop regulatory strategies hopefully avoiding the problems we have faced.

Glyphosate tolerant canola seed, for instance has in some situations blown onto a neighbour's land and become a weed (a weed being any plant that is unwanted). The canola-weed, or volunteer as it is called, then must be controlled with another herbicide to which it is susceptible. This may not seem like a problem, but glyphosate will soon be the only herbicide that farmers can use without a license (2-4D is being banned), thus creating an additional expense and inconvenience to already cash strapped farmers. [2,4-dichlorophenoxyacetic acid is one of the first and most widely used selective herbicides...Moderator]. In North America there are strict regulations in place to protect farmers from the harmful effects of agri-chemicals, these include licensing and warning labels. However, in Peru, for instance, I saw herbicides that were banned in North America labeled in English, but not in Spanish. Compound this lower safety standard with the need to use more toxic and less biodegradable herbicides thus putting farmers and their families, especially children, at greater risk. Because herbicide resistant canola is not a direct risk, it is not considered in the current regulatory framework.

The second case in which there are gaps in the current regulations is Bt-corn. Bt-corn has been a wonderful asset in Ontario corn production where the European Corn Bore (ECB) is a major pest. However, it is known that ECB will eventually develop resistance to the toxic proteins in Bt corn. Because of this known risk, refuge strategies have been implemented in order to slow the rate of resistance development. This represents a regulation strategy to combat a known risk. However, the problem is not with the regulation, but how it can be implemented. Implementing refuge strategies is basically impossible. At present, seed dealers ensure that farmers purchase the correct ratio of Bt and conventional seed corn, but whether or not that ratio gets planted is an unknown. The refuge shape and size in the end is left up to the farmer. I know from conversations that farmers plant the internal rows to the Bt-variety and then plant around the outside of the field sowing the conventional corn that will be susceptible to ECB. This is not the refuge shape entomologists state is necessary to slow the rate of ECB resistance to Bt.

These two regulatory problems are not based upon scientific risk assessments, but they represent very real problems developing nations would do well to avoid.

Tracey McCowen MBE
Kingswood Farm
1314 King-Vaughan Rd
Maple, ON L6A 2A5
Canada
tmccowen (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 30 April 2003 15:03
To: 'biotech-room1@mailserv.fao.org'
Subject: 11: Introduction & perspective

Dick Richardson, here. I'm a professor of integrative biology at the University of Texas, Austin, United States. My graduate training is plant breeding, genetics and experimental statistics. My publications and books range from quantitative genetics in Drosophila to molecular diversity in evolving natural populations of insects (pest and non pest species), to grazing behavior in livestock. My current research is soil biodiversity and natural resource management. I grew up farming and ranching, and work with conservation and agriculture issues in government, NGO and private contexts. I teach graduate and undergraduate classes in genetics, ecology and management.

I have seen several advances in scientific techniques that are extremely important for research, only to be described as a "magic bullet" for production problems. Sometimes they turn into economic disappointments with negative social and environmental side effects. Effective marketing describes simple and effective benefits, whether known or imagined. However, the free services of the ecosystem have no marketing agents, leaving managers to recognize the options and identify those that are better alternatives. If the only tool we recognize is a hammer, then all our problems look like nails. Therefore, many new marketing claims for solutions of problems are suspect for increasing the costs of production and eventually displaying a dark side socially or environmentally. These negative results usually are externalized so the consumer does not see them in the purchase price of food, fiber and other agricultural products.

Regulation enters the picture to distribute risks and associated costs among the sellers and buyers. The use of regulation represents a patch for inadequate information to make better choices, and becomes a way to shift some of the risk expense of inadequate knowledge of risks and benefits to the public rather than having full accountability rest with the perpetrator. Some of the risks have no economically measurable cost since restitution is impossible when they affect future generations with no known moderation of effects. Such decisions need to be democratically addressed as a society.

Scientifically, I find the new techniques of genomics and proteonomics are comparable to the discovery of the microscope. They allow us to observe scales of interactions and regulation of complex systems most of us hardly dreamed of a decade or two ago. I am distressed that they are being circumvented in a rush to market new agricultural production modes before we can use them to understand the systems involved. Claims of benefits in the production context seems more like viewing the biological system linearly through new soda straws rather than gaining a wider integrated perspective of the massive and exciting flow of new information that allows us to understand the ecology of the genome-scale.

A risk-benefit analysis needs to include the full spectrum of options, from use of ecosystem services to the new technologies, so we can identify those options that are truly beneficial from social, economic and ecological perspectives. From my perspective, such an inclusive analysis is likely to reduce the need for, and costs of, regulation when the more complete picture is available. More specifically, we can view options systemically. Ecological systems approaches integrate with genomic systems approaches. We begin to view the genome as a micro-ecosystem, and is understood as a change of scale from the interspecific ecosystem. Understanding both of these is facilitated by development and use of the new molecular tools. In the meantime, we can use our experiences over the past few centuries with plant and animal introductions as a crude guide. The justification for proceeding with a breadth of understanding rather than simplistic assumptions is suspect. The models of the central dogma and Mendelian genes are rapidly becoming museum artifacts of genetics, included in textbooks as historical novelties. Any assumption based on them immediately is suspect. It cannot be substituted for solid evidence, PARTICULARILY when we have low risk, inexpensive and effective alternatives that are much better understood and tested by extensive experience.

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