[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: 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