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Note, participants are assumed to be speaking on their own behalf, unless they state otherwise.]

-----Original Message-----
From: Biotech-Mod1
Sent: 10 May 2003 18:14
To: 'biotech-room1@mailserv.fao.org'
Subject: 39: Re: Towards effective practical regulation

This is from Humberto Peralta Diaz, graduate student in the Nitrogen Fixation Research Center of the National University of Mexico, Mexico.

To comment on Message 35 (May 8) from Glenn Ashton who wrote: "Our Act also claims that 'the user' shall bear responsibility for impacts (financial, environmental) of transgenic organisms. This devolves responsibility to farmers, retailers and consumers, whilst absolving the party responsible for introducing the organisms in the first place. This is legally and ethically questionable."

I attended the first Latin America subregional workshop for biosafety framework stablishment based in the Cartagena Protocol (Dec. 2002, Mexico City, UNEP-GEF, UN). [The Latin America Subregional Workshop on "Risk Assessment and Management, and Public Awareness and Participation" was held 10-13 December 2002 and was convened by the UNEP/GEF Biosafety Project Team, in collaboration with the Government of Mexico. The report of the workshop is available in English and Spanish from http://www.unep.ch/biosafety/documents.htm ...Moderator]. One of the main concerns was: what about legal responsibilities of GMO introduction for companies, government or users? Who pays for environmental events (for example, undesirable crossings) or health damages? The national solution must be given in the corresponding regulatory framework, but certainly, the question is important to assign, clearly, responsibilities before events occur.

In Mexico, as known, there is a legal moratorium for GM maize introduction. However, that material was authorized to enter for forage use, and spilled out to traditional parcels in center-south of the country and contaminated autochtonous maize lines. Of course, national legal framework (in process) does not set responsibilities for an event like this. But, possibly, this experience will be useful for other countries.

The confidential information management is an additional concern. I think that information must be freely handled by specialized personnel, either from government or NGO, with adequate prudency, i.e. revisors must not have conflict of interests with other companies or groups. It is important to mention that inclusive key information about GMOs construction, use and effects is publicly available in the patent applications. A GMO introduction request contains information according to that presented in patents. The public has the right to know, as much as possible, important information in respect to GMO introduction, type of genetic modification (is it transferrable to other organisms in nature?), environment effects (known and theoretical) and health effects for consumption.

Humberto Peralta Diaz
Metabolic Engineering Program,
Nitrogen Fixation Research Center,
National University of Mexico,
Cuernavaca, Morelos,
Mexico
PO Box 565-A, CP 62210.
peralta (at) cifn.unam.mx

-----Original Message-----
From: Biotech-Mod1
Sent: 10 May 2003 18:20
To: 'biotech-room1@mailserv.fao.org'
Subject: 40: Re: Using GMO registrants to informally regulate

This is Tracey McCowen.

I would like to comment on Mark Kuhn's suggestion (Message 29, May 7) of self policing regulatory standards. My response is that if this system is a good system, it is only suited to the US legal system. Class action suits and trial lawyers are (as far as I know) unique to the US. As a result, a self policing regulatory system in countries with few resources for legal action would largely be no regulation at all, or at least regulation with no accountability. I would think that a self policing regulatory system can only work in a litigious society.

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

-----Original Message-----
From: Biotech-Mod1
Sent: 10 May 2003 18:23
To: 'biotech-room1@mailserv.fao.org'
Subject: 41: Re: Financial/time costs of GE crops

This is Tracey McCowen again.

I would like to comment on message 37 (May 9) by Dr. Rao. If I understand Dr. Rao correctly, he is suggesting that "reduce[d] trial phase duration for repeated transgenic events" are needed. I can see two problems with this point of view.

The first is economical, if the pioneering product must undergo a more lengthy trial phase it will deter companies seeking to be the first with a novel trait. The first regulated GE product on the US market, the Flavr Savr tomato, proved this.

The second point I take issue with is if the professor is suggesting that a repeated transgenic event is the same across different species, I would answer that they most certainly are not. Take for instance different pollen weights, canola (mustard or rape) and maize (corn) are vastly different, thus creating very different scenarios for risks associated with pollination.

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

-----Original Message-----
From: Biotech-Mod1
Sent: 10 May 2003 18:27
To: 'biotech-room1@mailserv.fao.org'
Subject: 42: Sharing of propagation materials

I'm Raymond Ramsaroop from the University of Guyana and do extension work in food security issues.

I'm not sure if this issue has been raised but in a developing country like Guyana, regulatory control of crops is made so much harder by the prolific sharing of propagation materials among farmers. It has obviously benefited the local farmers in preserving genetic biodiversity. But, on the other hand, it makes it difficult to control the likely spread of a gene-type e.g. GM crops, from an area where planting is done. The sharing is at the level even where prior permission needs not be sought in many instances.

Raymond Ramsaroop
Department of Chemistry,
Faculty of Natural Sciences,
University of Guyana,
Turkeyen, Greater Georgetown,
P.O.Box 10-1110 Guyana
Tel:(592)222-4926 (or 6004); Fax: (592)222-3596
rayramsaroop (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 10 May 2003 18:35
To: 'biotech-room1@mailserv.fao.org'
Subject: 43: Use of terms GMO, GEO and application of regulatory processes

This is from Professor C Kameswara Rao, Bangalore, India.

On reading some of the messages posted, I felt a need to point out the loose use of terms GMO, GEO and LMO and the question of application of regulatory processes.

Genetic Modification:

All the organisms deployed in agriculture and animal husbandry today are the products of Genetic Modification for over 10,000 years. Initially, suitable varieties were 'selected' for the desirable characteristic from domesticated wild plants and animals. Some of the traits have surfaced in the genetic diversity of the concerned species through natural hybridisation and natural mutation, and were subjected to selection. Selection is the most important tool of both conventional and modern agricultural practice, both constituting biotechnology. Subsequently, artificial hybridisation has resulted in several crop plant varieties. Natural or artificial, hybridisation is possible only between organisms that are biologically closely related. Mutations induced by any one of several physical or chemical means were also a rich source of genetic diversity. Varieties of corn, wheat, sugarcane, cotton and several others involved hybridisation, while some like rice were based only on selection. This conventional means of producing Genetically Modified Organisms (GMOs) involves sexual reproduction. It constitutes vertical transfer of genes and the genes concerned express only in the next generation.

Genetic Engineering and Transgenic plants:

Under the conventional plant breeding procedures, genes from an organism can be introduced only into another biologically closely related organism, such as two varieties of the same crop and possibly, in exceptional circumstances between two species of the same genus. In nature such events do occur but are rare.

Exchange of genes between biologically totally unrelated organisms does not occur in nature. Using techniques of genetic engineering, now genes selected from a bacterium are inserted into the genome of a crop plant or human genes into bacteria. These are the Genetically Engineered Organisms (GEOs), also called transgenic organisms. Genetic engineering constitutes lateral (or horizontal) transfer of genes and the genes can express in the same generation.

Some examples of the transgenic technology are incorporation of
a) genes for the insecticidal proteins of bacteria into the genomes of several crop plants such as tobacco, corn, potato, rice, cotton, etc.,
b) genes for the synthesis of b-carotene from daffodil and a bacterium into rice,
c) genes for human milk proteins into rice,
d) genes for human insulin into bacteria and
e) genes for human haemoglobin into tobacco plants.

The term Living Modified Organisms (LMOs) is applicable to both GMOs and GEOs.

The fact that crop and animal varieties produced through the conventional means also involve genetic modification has not been appreciated with the degree of seriousness it deserves and the terms GMOs and LMOs have come to be applied only to Genetically Engineered Organisms (GEOs). In order to convey precisely, we should apply the term LMO to both conventionally induced genetic modification (GMO) and the transgenics induced through genetic engineering (GEO), and distinguish between the latter two.

Governmental Regulatory Processes:

There is no technology without risks. GMOs also are fraught with risks similar to those attributed to GEOs. A long time ago, I have seen with dismay, the kind and degree of variation that appeared on continued selfing and on exposure to gamma irradiation, in pearl millet. Some of the characters that surfaced throw overboard the taxonomic concepts of, not only Pennisetum americanum (= Pennisetum typhoideum), but even that of the family Poaceae. Some of this variation easily qualifies to be called monstrosities. No one ever considered that genetic modification by conventional means risky at all. Considering their potential risks of biosecurity, GMOs also should be subjected to the same rigorous regulatory processes as GEOs, but they are not.

Professor C Kameswara Rao
Executive Secretary
Foundation for Biotechnology Awareness and Education
Bangalore 560 004,
India
krao (at) vsnl.com

-----Original Message-----
From: Biotech-Mod1
Sent: 10 May 2003 18:45
To: 'biotech-room1@mailserv.fao.org'
Subject: 44: Re: Codex food safety guidelines

This is from S. Vasanthi from the National Institute of Nutrition, Hyderabad, India.

Codex guidelines for safety evaluation of GM foods will become important international standards for GM regulation. But how does such a reference framework, as mentioned by Héctor Villaverde (Message 25, May 7), fit into the import/export regulations of different countries? Can a specific framework of guidelines be created that will serve as a reference for regulating GMOs in import and export sectors? Although the WTO gives the international trade regulations for GM food safety under the SPS Agreement, conflicting agreements between various multilateral agreements, like the Cartegena Biosafety Protocol, are making the acceptance or rejection of GM foods difficult. This is of special relevance to developing countries where the GMO regulations are not yet established or fully functional. Thus, the potential for export rejections may be high if they cannot comply with the different GMO regulations of different importing countries (very often in the developed countries). On the other hand, they may be forced to accept imports under international rules like the WTO. To what extent can international harmonization of GM food safety standards help in reducing such conflicting situations?

Dr. 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

[The SPS Agreement refers to the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (1995)...Moderator].