[To contribute to this conference, send your message to biotech-room1@mailserv.fao.org. 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: 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