[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: 02 May 2003 10:10
To: 'biotech-room1@mailserv.fao.org'
Subject: 12: Re: Regulation of GMOs: issues to be addressed in developing countries

This is Kelebohile Lekoape. I am a short-term professional staff member at the World Health Organization (WHO). I am currently working on a study 'Modern food biotechnology, human health and development'. The primary objective of the study is to give WHO Member States, as well as stakeholders in this area, the basis for an evidence-based description of the broad area of the use of biotechnology in food production, including both potential advantages and problems.

While I largely agree with the comments made by Vasanthi Siruguri (Message 8, April 30), my concerns are that international regulatory systems are intended to bring about harmonization of the divergent national systems presuming an equal knowledge base. In most developed countries, regulatory expertise was built almost simultaneously with advances in biotechnology. Developing countries, on the other hand, do not have sophisticated biotechnology research programmes from which to gain knowledge and experience.

Within the framework of international obligations, developing countries therefore must be in a position to clearly articulate:

1. What it is they hope to regulate i.e. R&D (including field trials) and/or imports (commercial releases; processed foods);
2. How they hope to regulate;
3. Do they have the basic competencies, and what constitutes the core/minimum skills;
4. Consider sharing and maximising resources as subregions/regions with similar agro-ecological zones in order to build regulatory capacity that cuts across all the required scientific sectors.

Kelebohile Lekoape
WHO,
Food Safety Department
Avenue Appia 20
1211 Geneva 27
Switzerland,
lekoapek (at) who.int

-----Original Message-----
From: Biotech-Mod1
Sent: 05 May 2003 10:06
To: 'biotech-room1@mailserv.fao.org'
Subject: 13: Regulation in developing countries - costs and requirements

This is from Jane Morris, Director of the African Centre for Gene Technologies (ACGT), based in South Africa. The ACGT is a joint initiative between the Council for Scientific and Industrial Research (CSIR) and the University of Pretoria to build a platform for gene discovery (including genomics, proteomics etc). I also have extensive experience of regulatory issues related to GMOs in South Africa (it was good to see the contribution from Kele Lekoape (Message 12, May 2) who played a valuable role in the SA regulatory environment).

I would like to comment on a few of the excellent contributions made so far in this discussion:

Hector Quemada (Message 4, April 28) rightly points to the cost of regulatory processes, with particular regard to the cost of obtaining sufficient data to provide the regulators with adequate information to make an informed decision. This is becoming a critical issue not only for major agricultural commodities, but also in developing countries for crops which have their centre of origin on the continent, and where the potential for cross-pollination with wild relatives is not well documented. In Africa there is enormous potential for improvement of crops such as sorghum and millet using GM technology, but who will carry the cost of undertaking the biosafety research to ensure their safe introduction? Moreover, will the regulators in developing countries have the confidence to go ahead and recommend their use and release?

Tracey McCowen (Message 10, April 30) urges developing countries not to repeat some of the North American mistakes with regard to e.g. inadequate planting of refugia, or implementation of multiple herbicide tolerance leaving farmers with limited herbicide options. In developing countries where small scale farmers are rapidly adopting GM technology this is already an issue that requires further discussion. Bt cotton is rapidly being adopted by South African small scale farmers and the evidence shows that, at present, there are sufficient adjacent uncultivated areas with natural vegetation to serve as insect refugia. However, this situation will need to be monitored as it is unlikely that the small scale farmers will plant adequate refugia of the non-GM variety. Adoption of GM crops will no doubt increase with the introduction of stacked traits and the impact of this will need to be carefully considered. In the case of crops such as maize, the introduction of glyphosate tolerance at least provides an alternative to the use of herbicides such as atrazine, which are still used due to the lack of any cost-effective alternative [For more information on atrazine, see e.g. http://www.epa.gov/oppsrrd1/reregistration/atrazine/ ...Moderator].

Dick Richardson (Message 11, April 30) mentions the applications of genomics, proteomics and related technologies as tools in the regulatory process. While we are building capacity in these technologies in South Africa through the ACGT, many developing countries unfortunately do not have the basic tools of molecular biology in place, let alone sophisticated techniques such as gene expression analysis using DNA microarray, proteomics (involving expensive matrix-assisted laser desorption/ionisation-time of flight (MALDI-TOF) mass spectometry etc) or metabolomics (using nuclear magnetic resonance, gas chromatography/mass spectrometry, liquid chromatography/mass spectrometry etc). [Proteomics aims to identify and characterise complete sets of proteins and protein-protein interactions in a given species; metabolomics is the large-scale study of the full complement of secondary metabolites produced by a given species in all its tissues and growth stages...Moderator]. While these tools undoubtedly have a valuable role to play in understanding possible unintended consequences of genetic modification, we should not lead developing countries to think that they need to have expertise in these areas before they can safely introduce GM crops.

E Jane Morris PhD
Director
African Centre for Gene Technologies
P O Box 75011
Lynnwood Ridge
Pretoria 0040
South Africa
Tel: +27 12 841 2642
Fax: +27 12 841 3105
Cellular: +27 82 566 2210
e-mail: jmorris (at) csir.co.za

-----Original Message-----
From: Biotech-Mod1
Sent: 05 May 2003 10:56
To: 'biotech-room1@mailserv.fao.org'
Subject: 14: Experience of regulating GMOs in developing countries - India

I am Ramesh V. Bhat, Deputy Director of the Food and Drug Toxicology Research Centre, National Institute of Nutrition, Indian Council of Medical Research, Hyderabad, India. I have been working in the area of food safety/quality and foodborne diseases for over the last 3 decades. Basically a research scientist, my official responsibilities include providing suggestions/advice to food regulatory bodies of the Ministry of Health of the Government of India.

A) The current regulatory system in India:

1. Environment Protection Act 1986 and rules 1989 in the draft Notification of 2001 deals with rule and procedure for handling GM organisms/food. The Genetic Engineering Approval Committee (GEAC) of the Ministry [of Environment and Forests...Moderator] is the key agency dealing with GM issues.
2. The Review Committee on Genetic Manipulation (RCGM) under the Department of Biotechnology, Ministry of Science and Technology, monitors safety aspects of research involving GMOs and issues guidelines. The Recombinant DNA Advisory Committee (RDAC) and Institutional Biosafety Committee (IBSC) implements these guidelines at national and institutional levels respectively.

Other ministries, like Agriculture, Health, Commerce, although they have a direct interest in the subject, have no definite regulatory role but may have their representatives included in the CEAG. When constituting other committees, like the RCGM and the RDAC, the Department of Biotechnology in the Ministry of Science and Technology includes representatives from other Ministries, like Agriculture and Health.

India is following the policy of a "case-by-case approach" regarding GM foods/crops. So far, only Bt cotton has been permitted for commercial cultivation. Applications for clearance of other crops, like mustard, are pending and are undergoing field trials. Though no formal regulation regarding labeling of GM food exists in India, it has been officially advocating comprehensive labeling provisions at international meetings. Recently, a discussion paper on GM foods has been prepared by the Ministry of Health and circulated to various ministries. An official policy in GM crop/foods is likely to be adopted soon by a high level inter-ministerial committee. Recently, the import of corn soy blend was stopped since clarification regarding presence of the Starlink variety of maize in the consignment was not forthcoming from the importing aid agencies like CARE and Catholic Relief Services.

B) Capacity Building:

India has a large base of well qualified technical manpower having sufficient expertise in the field of biotechnology. It also has several well equipped scientific laboratory infrastructure. Research on developing several new GM crops like GM basmati rice, GM coffee, GM potato (potato rich in proteins), GM lathyrus and adaptive trials like those on GM mustard either by government/private institutions are in progress. Research on detection methods for GM foods are in progress in at least six internationally reputed laboratories.

C) Problems in adopting GM food/crop technology:

- Dumping of GM food by agriculturally advanced other countries, either as food aid or as commercial transaction.
- Lack of regulatory mechanism - Regulation and implementation mechanism, inspection, laboratory detection system.
- Restrictions on agricultural exports of GM foods by importing European Union countries
- Subsistence farming, small holding, non-access to high-tech farming methodology, lack of resources to make heavy investments.

As could be evidenced by the limited response for this e-mail conference from developing countries, even awareness among regulatory authorities about GM is minimal. The regulation should take into consideration of the above.

D) The way ahead:

Regulations on GMOs in developing countries should be primarily based on considerations of human health and environmental safety. The expertise and infrastructure needed to undertake a critical, transparent, valid scientific assessment of the food and environmental safety are either not existing or are in a rudimentary state of development in most of the countries. The issues of GM food/feed/crop cannot be tackled by a single ministry and coordination between ministries of Agriculture, Health, Environment, Science and Technology, Commerce are essential. There needs to be a single apex agency, Biotechnology Regulatory Commission, to act as a single window for interacting with the risk Assessors, risk managers and risk communicators and all the stakeholders, including the industry, farmers and consumers. Appropriate risk communication strategies need to be evolved.

Ramesh V. Bhat
Deputy Director (Sr.Gr.)
Food & Drug Toxicology Research Centre
National Institute of Nutrition
Indian Council of Medical Research
Hyderabad-500007,
India
Telephone: 91-40-27008921 to 27 Extn.281
Fax; 01-40-27019074
Email: rameshvbhat (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 05 May 2003 11:20
To: 'biotech-room1@mailserv.fao.org'
Subject: 15: Capacity building

I am Olusanya Olutogun, a lecturer at the University of Ibadan, Faculty of Agriculture, Nigeria but currently at Michigan State University (MSU), East Lansing in the United States of America with another 30 Africans undergoing Agricultural Biotechnology Short Course organized by the MSU in collaboration with the United States Department of Agriculture Foreign Agricultural Service (USDA-FAS).

One of the objectives of this short course is to expose Africans to the subject raised in this e-mail conference. And this is in aid of developing countries, particularly Africans, developing the capacity to regulate and utilize the tremendous opportunities, and to stem the tide of poverty and hunger in Africa. Most of the points raised earlier by contributors are relevant to most developing countries, but for me capacity building takes the pride of place. Also, there is the urgent need to educate the people of these developing countries about the beneficial effects of GM crops. There is really no zero risk in any human endeveavour and informed and educated people will mitigate the risks associated with any human activty. This is why the developed world will help the developing world by way of capacity building in all ramifications of agricultural biotechnology. And the earlier this is pursued the better it will be for the developing countries to recognise the immense advantages inherent in agricultural biotechnology. Any technology is harmful in the hands of the uneducated man.

Olusanya Olutogun, Ph.D.
Department of Animal Science
University of Ibadan
Ibadan.
Nigeria
Mobile:234-803-322-3784
saolutogun (at) yahoo.co.uk
olutogun (at) hotmail.com

-----Original Message-----
From: Biotech-Mod1
Sent: 05 May 2003 13:05
To: 'biotech-room1@mailserv.fao.org'
Subject: 16: Regulation of for-profit GMOs

This is Justin Mog, a recent graduate of the Gaylord Nelson Institute for Environmental Studies at the University of Wisconsin-Madison (USA), and a 2001 Fulbright scholar to the Philippines. My research is focused on the fundamental characteristics of sustainability and their implications for development programs in poor, rural communities, and the evaluation of such programs.

I've enjoyed the discussion to date, and would like to broaden the debate to include considerations of the potential role of GMOs in further increasing the dependency of poorer countries and farmers on wealthier foreign interests. Many have already mentioned the fact that -- despite a few examples such as India and South Africa -- most so-called "developing countries" lack the resources to adequately regulate GMOs, much less develop them on their own. It seems clear that most GMO development is occurring in nations which already have tremendous economic advantages over others; and, within these wealthier countries, the majority of advancements are being made by for-profit corporate interests (though, others - including many in this conference, I presume - are, of course, making important contributions as well).

Given that there is no reason to suspect that this situation will significantly change in the near future, I am concerned that certain GMOs may become another tool for the exploitation of the poor by those with the resources to control their development. It follows that this should be a predominant concern for regulators in poorer nations.

Painting all GMOs with the same brush is clearly not helpful, but it seems to me that regulators could make important steps in prioritizing areas of concern by distinguishing between GMOs sourced from those intending to profit from their sale, and GMOs from other sources. While the latter may also deserve attention from regulators for the reasons others have already mentioned, the former are particularly worthy of suspicion because they have the potential to make poor farmers dependent upon GMO products that have been designed to increase the profits of foreign corporations.

Two concrete examples of this which have already emerged are seeds with "terminator genes" and those, e.g. herbicide-resistant crops, which are designed as a part of a larger technological package. In both cases, poor farmers may enjoy certain advantages inherent to the GMO, but they do so at the cost of their independence -- i.e. with "terminator genes" they can no longer save seeds, and herbicide-resistant crops only increase the incentive to use expensive (often imported) herbicides. In such a context, rather than increasing the opportunities for poor farmers, for-profit GMOs seem likely to drag them into a cycle of dependency and further subjugate them to powerful foreign interests, well beyond the reach of their government's control.

As I have seen in my research in the southern Philippines, affordable access to agricultural inputs such as quality germplasm and agrichemicals is a key concern for many small-scale farmers. If such inputs become the exclusive domain of foreign for-profit interests, I fear that it is the poor and most vulnerable farmers who will suffer. In such a scenario, not only would poor cash-crop farmers be further disadvantaged by having to compete with GMO crops on the global marketplace, but the prices all farmers would pay to access GMO germplasm (and associated agrichemicals) would be beyond the control of domestic regulators and undoubtedly inflated by some degree to increase foreign profits.

Thus, along with the reasons already mentioned in this conference, for the purposes of protecting the interests of the most vulnerable members of their agricultural populations, regulators in poorer nations might do well to restrict the access granted for-profit GMOs to domestic agricultural input markets. And to briefly respond to Olusanya Olutogun's (Message 15, May 5) important call for capacity-building in poorer countries, I would hope the focus of such efforts would not simply be on improving poor farmers' ability to make use of the technologies developed by foreigners, but on improving the capacity of domestic institutions to develop not-for-profit technologies of their own.

Justin Mog, PhD
Gaylord Nelson Institute for Environmental Studies
University of Wisconsin-Madison
315 N. Ingersoll St.
Madison, WI 53703-1611
U.S.A.
E-mail: jmmog (at) wisc.edu

-----Original Message-----
From: Biotech-Mod1
Sent: 05 May 2003 14:41
To: 'biotech-room1@mailserv.fao.org'
Subject: 17: Credibility - Stacked GMOs - Biosecurity

I am Gert Willemse from South Africa, past member of SAGENE (South African Genetic Experimentation Committee; advisory body on GMOs before promulgation of SA's GMO Act) and currently member of the national GMO Executive Council.

The issue of how strict regulatory frameworks should be in developing countries is not a simple one to answer and would mostly be determined by each country's specific needs and circumstances.

While agreeing with Kelebohile Lekoape (Message 12, May 2) on the international harmonization of regulatory regimes, I believe some latitude for individual country needs should be provided for. One of the most important (if not THE most important) aspects of a national regulatory framework is the credibility that the implementation of such a framework would enjoy at national level. To this end, regulatory frameworks in developing countries would need to be (in all probability), at least initially, more strict than in developed countries to ensure acceptance not only of the framework, but also of subsequent approvals and/or refusals. The natural evolution of a stricter framework evolving into a less strict and more streamlined framework is not unique to developing countries, but is generally a feature also of initial regulatory frameworks in developed countries.

A further proviso for international harmonization of regulatory frameworks is the need to recognize two-way fertilization of framework development and evolution. In our experience, many aspects, especially with regard to environmental safety, are not adequately addressed in existing regulatory frameworks and need to be attended to during the development and trial phases of GMOs in order to provide a more factual scientific basis for risk-based decision making. An example here is the requirement of approval of a "stacked" GMO as a "new" GMO (in a more strict regime) or no requirement for approval (less strict regime) based on substantial equivalence and the means of "development" through natural breeding. The issue here is really whether the risks posed (if any) by the "stacked" GMO would necessarily be the numerical sum of the parent stock or whether existing risks resulting from genetic manipulation in parent stock (e.g. elevated gossypol in cotton) could be enhanced in the "stacked" event. ["Stacked" genes refer to the insertion of two or more genes into the genome of an organism. An example would be a plant carrying a Bt transgene giving insect resistance, and a bar transgene giving resistance to a specific herbicide (see http://www.fao.org/DOCREP/004/Y2775E/Y2775E00.HTM); Gossypol is a yellow pigment found in cotton seeds that is toxic to monogastric animals (http://www.fao.org/ag/aga/agap/frg/afris/Data/541.HTM) ...Moderator].

Finally, the Biosecurity concept could be a very useful basis for framework development or even reform of existing frameworks. [This concept was discussed in Section 4.d of the Background Document to this conference...Moderator]. A large degree of overlap exists with respect to resource capacity and expertise required for risk analysis of biological risks in the agricultural, health and environmental fields. A "one-stop-shop", such as envisaged in the Biosecurity concept, could provide a solution to the issue of capacity constraints but would require extensive cross-sectoral integration of the regulatory framework at all levels and spheres, including that of policy, legislation and institutional frameworks.

Dr Gert Willemse
Private Bag X447
Pretoria 0001
South Africa
Tel: +27 12 3103836
Fax: +27 12 3207026
bioconsult2002 (at) yahoo.co.uk

-----Original Message-----
From: Biotech-Mod1
Sent: 05 May 2003 15:06
To: 'biotech-room1@mailserv.fao.org'
Subject: 18: Re: Regulation of for-profit GMOs

This is from Farida Dollie, a Senior Researcher at the South African Human Rights Commission.

Justin Mog (Message 16, May 5) raises some very important issues for developing countries. He mentions South Africa as one of those countries which has the resources to regulate GMOs. I would be interested to know if indeed South Africa does regulate GMOs and if so, whether relevant documents or literature are available.

Farida Dollie,
South African Human Rights Commission
South Africa
fdollie (at) sahrc.org.za

[FAO has been putting together biotechnology policy documents from FAO members. Here, a document of potential interest to Farida, "A National Biotechnology Strategy for South Africa" (June 2001), which considers national and international policy and legal instruments in Section 3.5, is available...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 05 May 2003 16:53
To: 'biotech-room1@mailserv.fao.org'
Subject: 19: South African regulation of GMOs

This is from Jane Morris, South Africa.

Farida Dollie (Message 18, May 5) should refer to the South African Genetically Modified Organisms Act, 1997 (Act No.15 of 1997), which is administered by the National Department of Agriculture. In terms of the Act, there is an Executive Council comprised of representatives from each of the interested government departments, and an Advisory Committee consisting of technical experts. So South Africa does indeed have the regulatory processes in place to ensure the safe use and release of GMOs. [This Act is freely available on the Department of Health's website, at http://www.doh.gov.za/docs/legislation/acts/1997/act15.pdf ...Moderator].

E Jane Morris PhD
Director
African Centre for Gene Technologies
P O Box 75011
Lynnwood Ridge
Pretoria 0040
South Africa
Tel: +27 12 841 2642
Fax: +27 12 841 3105
Cellular: +27 82 566 2210
e-mail: jmorris (at) csir.co.za

-----Original Message-----
From: Biotech-Mod1
Sent: 06 May 2003 08:44
To: 'biotech-room1@mailserv.fao.org'
Subject: 20: Re: Experience of regulating GMOs in developing countries - India

I am Debasmita, doing my M.A. in sociology in the University of Hyderabad.

I just wanted to know about the Genetic Engineering Approval Committee's (GEAC) recent stance about granting permission to the GMOs in India.

Debasmita Patra,
University of Hyderabad
India
debasmitapatra (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 06 May 2003 14:14
To: 'biotech-room1@mailserv.fao.org'
Subject: 21: A dynamic interdependent network

This is again Gert Willemse from South Africa. In my previous message (nr. 17, May 5), I referred to the need for two-way fertilization of regulatory framework development and evolution between developed and developing countries. To provide more clarity on this issue, it is necessary to view the current global situation in GMO regulation.

In the past, technological capacity for GMO development resided primarily in developed countries with regulatory or biosafety frameworks developing in tandem. Kele Lekoape (Message 12, May 2) alluded to the benefits of such parallel development, which was mostly not the case in developing countries. This situation is, at least in some developing countries, rapidly changing. Firstly, some developing countries, as part of a focused strategy, are developing capacity at national level in gene technologies and, secondly, developing countries are more frequently the site of field trials or bulking-up operations for GMOs developed elsewhere. Consequentially, technological capacity and regulatory framework development more frequently follow the same developmental path in developing countries as was historically the case in developed countries.

One important advantage the developing countries had was that they could rely substantially on the past experience and lessons from developed countries to guide the regulatory framework development. Currently, this is mostly still the case with capacity building initiatives modelling development of regulatory frameworks on the existing frameworks in developed countries.

Experiences and developments in developing countries with existing regulatory frameworks have, however, provided some important lessons that could, equally well, benefit, not only regulatory framework development in other developing countries, but also the review end evolution of existing frameworks in developed countries. A case in point is the example of stacked events, which I referred to in my previous message, where the notion that the stacked event should not be subject to regulation because the development was through a process of natural breeding and the risk assessment of parent stock suffices on the basis of substantial equivalence. This argument is, of course, contrary to the principle of regulating the product and not the process and bases the acceptable level of risk on the basis of assumption rather than scientific fact.

Similarly, the Mexican landrace debacle provides ample experience to influence, not only development of regulatory frameworks in countries of endemism or origin of biodiversity, but also revision of existing frameworks in countries of export to minimize risk of genetic pollution in such recipient countries.

In summary then, the global GMO regulatory scenario is evolving into a dynamic interdependent network that could only benefit from cross-fertilization of all experiences and lessons learnt.

Dr Gert Willemse
Private Bag X447
Pretoria 0001
South Africa
Tel: +27 12 3103836
Fax: +27 12 3207026
bioconsult2002 (at) yahoo.co.uk

-----Original Message-----
From: Biotech-Mod1
Sent: 06 May 2003 16:48
To: 'biotech-room1@mailserv.fao.org'
Subject: 22: The meaning of "regulatory framework"

This is Jessica Vapnek, a legal officer in the Development Law Service of FAO, at FAO headquarters in Rome.

I don't want to divert the "thread", but I can't resist asking whether, in our various postings, we have all been meaning the same thing when we've used the term "regulatory frameworks", or even "regulation", with reference to GMOs. The reason I ask is that I think to lawyers the term "regulatory framework" has a fairly specific meaning, but I have been finding it interesting that in many of the messages posted to the list, the term as it is being used does not *seem* to have the same meaning which we legal types assume it to mean. That is, when lawyers talk about the "regulatory framework for GMOs" or the "regulation of GMOs" in a particular country, we would be talking about what legislation there is which governs the subject matter, and then we would specify whether each piece of legislation in the universe of applicable legislation is binding or not binding (and we would also want to know who issued it). For example, one country might have two parliamentary-level acts that address the topic, plus a variety of implementing regulations (issued, say, by a relevant Minister), whereas another country might have no enacted legislation as such, but might have only policy statements, guidelines or other "soft law" instruments which are hortatory but not binding. To lawyers, these would be two examples of "regulatory frameworks for GMOs" at national level.

It may be that my question is off the thread, in which case maybe one or two of you non-lawyers out there could just write to me individually to satisfy my curiosity. It seems that many of you have been using the term "regulatory framework" to refer to the universe of specific rules that govern the use and release of GMOs at national level -- whether such rules are binding or not, and without any indication of who issued them. So does that mean that when you all think about these issues you don't focus on the legal status of the rules? Or have you only been referring to binding rules, wherever and by whomever issued?

I suppose the reason I've asked is that I obviously had the "lawyer's" understanding of the term when I signed up for the conference, and was therefore thinking that some of the conference submissions would illuminate the question of how GMOs are being "regulated" at national level -- i.e., how various governments and legislatures in developing and transition countries are choosing to address GMOs. For instance, are they regulating them through food legislation? Through phytosanitary legislation? Through both? Or through specific and targeted "GMO" legislation? Or, not through legislation at all? In several recent trips to FAO member countries, government representatives have expressed to me their interest in "regulating" GMOs (i.e., in preparing legislation), and since this is a new topic to me, I am interested in best practices, if there are any out there to be shared. (I know of the specific legislation in South Africa, for example.)

Jessica Vapnek
Legal Officer
United Nations Food and Agriculture Organization
Viale delle Terme di Caracalla
00153 Rome RM Italy
(+39-06) 5705-6605
(+39-06) 5705-4408 fax
Jessica.Vapnek (at) fao.org
www.fao.org/Legal

-----Original Message-----
From: Biotech-Mod1
Sent: 06 May 2003 16:56
To: 'biotech-room1@mailserv.fao.org'
Subject: 23: Re: A dynamic interdependent network

This is Kelebohile Lekoape, from the World Health Organization.

While I concur with Gert Willemse's notion (Message 21, May 6) of the regulatory evolution in some developing countries having similarities with the developed countries, it is important to point out that the majority do not have the resources, or perhaps the need, to establish similar frameworks. It is therefore imperative that capacity building initiatives are demand-driven. Developing countries should not feel obliged to follow in the footprints of the developed nations. Each country has a unique set of circumstances (level of development, capabilities, aspirations, cultures and traditions) that ought to influence its road map in the adoption and regulation of any technology.

Having forerunners certainly does mean there are lessons to be learnt from their experiences and, in my view, the most important is engaging the public at all levels, from drawing up a research policy to decision making of approvals. This bottom-up approach means consumers are not only a part of the process, they identify with it and assume responsibility for the end result, thus endorsing the credibility of a regulatory framework.

Kelebohile Lekoape
WHO,
Food Safety Department
Avenue Appia 20
1211 Geneva 27
Switzerland,
lekoapek (at) who.int

-----Original Message-----
From: Biotech-Mod1
Sent: 07 May 2003 10:59
To: 'biotech-room1@mailserv.fao.org'
Subject: 24: Regulating "process" versus "product"

This is Donald MacKenzie from AGBIOS in Canada.

In a previous contribution, Gert Willemse (Message 21, May 6) has used the example of stacked events to emphasize that regulatory systems should focus on the risks inherent in a product, rather than the process by which that product was made.

The implication was that countries which do not regulate stacked events to the same extent as the parental lines were doing so "contrary to the principle of regulating the product and not the process." For those countries, the line of reasoning may be summed up as "safe apart, safe together." Essentially, that bringing together two traits, which have been previously assessed and determined to be safe, by "traditional breeding" should not imply additional regulatory oversight. Although this example usually involves the cross-breeding of two independent transgenic lines, what about other examples?

To pose a hypothetical case, how does the crossing of insect-resistant maize (event MON 810) with glyphosate-herbicide tolerant maize (event GA21) differ from the same cross performed where imidazolinone-herbicide tolerant maize (EXP1910IT, produced by chemical mutagenesis) replaces GA21? What if the glyphosate-herbicide tolerant parental line had been produced by accelerated mutagenesis instead of recombinant-DNA technology?

In fact, all countries (except Canada, which regulates "novelty") have chosen to regulate "process" not "product". Even in countries employing a product-focused risk assessment process, the regulatory trigger is the process of genetic engineering. The situation is the same for the Cartagena Protocol on Biosafety. The development of biosafety regulations consistent with the philosophy of the Cartagena Protocol implies a trigger for regulatory oversight based on the process of genetic engineering rather than on the risks associated with the expression of any novel traits.

Certainly, focusing regulation on the process of recombinant-DNA technology and modern biotechnology goes a long way to addressing public fears, and is eminently more practical for regulators to manage from the compliance and enforcement perspective. For countries with "process-based" regulatory systems to invoke the "product risk" argument only for the special case of stacked events, is confusing at the least.

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: 07 May 2003 11:23
To: 'biotech-room1@mailserv.fao.org'
Subject: 25: Codex food safety guidelines

This is from Héctor Villaverde, Consumers International, Chile.

I cannot agree with Kelebohile Lekoape (Message 23, May 6) that frameworks could be different, or more flexible.

One of the great advances in relation to regulatory frameworks is the Guidelines for food safety evaluation of GM foods, at Codex level, probably approved in the next session of the Codex Alimentarius Commission, guidelines that account with the support of all stakeholders, including consumer movement. This is a reference framework that, in my opinion, should be implemented in all countries of the world. The consumer movement has the opinion that all consumers should have the same degree of consumer protection. We battled for a lot of time to obtain such a reference framework, with the participation of all our worldwide membership, and now it is not realistic to think that our membership is willing to accept a regulatory framework less protective of consumer rights. Something similar could be said of environmental regulations raised by the Cartagena Protocol.

If a developing country wishes to export their GM food to the developed world, it must accomplish this with the regulatory framework of the importing country: In the case of the European Union, regulatory frameworks in food safety and environment risks, tracability and labelling; but also in the United States, the regulatory framework is increasingly less flexible. Therefore, the regulatory framework in a developing country does not have much degree of freedom in relation to the regulatory framework of the importing country, if that country wishes to export its products.

If their priority is not export, and their regulatory framework is weak or inexistent, its consumers could be exposed to potential risks, and this is inacceptable. We need to understand that this discussion on GM foods is global, and therefore need to have global solutions. The several cases of food contamination by GMOs intended for feed or pharmaceuticals highlight the importance of having a wide regulatory framework in place.

Héctor Villaverde
Food Programme Co-ordinator
Consumers International
Office for Latin America and the Caribbean
Las Hortensias 2371
Providencia, Santiago
CHILE
Phone: (56-2) 335-1695
Fax: (56-2) 231-0773
Email: programalimentario (at) consint.cl
www.consumidoresint.cl

[The Joint FAO/WHO Codex Alimentarius Commission is an intergovernmental body set up to establish international standards on foods. The Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology has just held its 4th and final scheduled session on 11-14 March 2003 in Yokohama, Japan. At the session, the Task Force advanced the "Draft Guideline for the Conduct of Food Safety Assessment on Foods Produced Using Recombinant-DNA Microorganisms" to the 26th session of the Codex Alimentarius Commission (CAC), to be held 30 June - 7 July 2003, Rome, Italy, for its adoption at Step 8. The Task Force previously agreed, at its 3rd session held on 4-8 March 2002 in Yokohama Japan, to advance the following texts to the 26th Session of the CAC for adoption at Step 8: "Draft Principles for the Risk Analysis of Foods derived from Modern Biotechnology", "Draft Guideline for the Conduct of Food Safety Assessment of Foods derived from Recombinant-DNA Plants" and "Proposed Draft Annex on the Assessment of Possible Allegenicity" (an Annex of the previous guideline). All these texts and reports/agendas of different sessions of the Task Force are available at www.codexalimentarius.net/reports.asp (or contact codex@fao.org for further information)...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 07 May 2003 11:26
To: 'biotech-room1@mailserv.fao.org'
Subject: 26: Local control vs. one-size-fits-all

This is Justin Mog, from the University of Wisconsin-Madison, United States, again.

I just wanted to concur with the emphasis Kelebohile Lekoape (Message 23, May 6) has placed on GMO regulatory capacity-building initiatives being locally-controlled and demand-driven, rather than one-size-fits-all. Of course, nations which have yet to develop a regulatory framework for GMOs would do well to learn what they can from the experience of other countries; but this is no reason to expect them to follow the model of their predecessors (either in process or product).

My research on sustainable rural development and experience in the southern Philippines has demonstrated the central importance of intimately involving local people in the process of researching and developing both technologies (like GMOs) and the policy measures necessary to regulate them. As Kelebohile Lekoape has already noted, this is vital because:
1. it helps make them more effective and appropriate by tailoring them to local circumstances; and
2. it helps locals identify with, invest in, and take responsibility for them -- thereby increasing local credibility.

I would just add that such a participatory process will also better prepare a country to face unknown future challenges. With an issue as dynamic as the regulation of GMOs, what locals really need is help learning how to learn, innovate and adapt to the type of evolving concerns that GMOs raise. Simply "telling them how to do it" may solve some immediate crises, but it will be of little help in the long-run.

Justin Mog, PhD
Gaylord Nelson Institute for Environmental Studies
University of Wisconsin-Madison
315 N. Ingersoll St.
Madison, WI 53703-1611
U.S.A.
E-mail: jmmog (at) wisc.edu

-----Original Message-----
From: Biotech-Mod1
Sent: 07 May 2003 14:09
To: 'biotech-room1@mailserv.fao.org'
Subject: 27: Re: A dynamic interdependent network

Gert Willemse from South Africa again.

Having read Kelebohile Lekoape's response (No. 23, May 6) to my second message (No. 21, May 6) it seems that I have been interpreted as having proposed that developing countries should follow developed countries in the adoption and regulation of technologies. In actual fact, I am in total accord with the sentiments expressed by Kelebohile. Adoption of technologies (or their products) and regulation should always be driven by domestic demand and influenced by domestic circumstances, and no country (whether developed or developing) should be obliged to follow in the footsteps of any other. This was exactly the point I was making in suggesting that what informs the substantive content and structure of regulatory frameworks during development should not necessarily only be based on the experience of developed countries only, but that developing countries also have a significant contribution to make. Indeed, many developing countries may not have the resources or the need for either the technology or the products and consequently also no need for a domestic regulatory framework. Even in this instance, trade relations between such a country and another country that has adopted the technology may be positively influenced if the regulatory framework of the latter takes cognisance of the needs and requirements of the former.

As to the process of development and adoption of frameworks, again I am in agreement with Kelebohile, recognizing of course that this would again be determined by domestic demand and circumstances.

Perhaps a clearer distinction between process (framework development and evolution) and substance (framework nature and content) would serve to prevent confusion or misunderstanding. This returns also to the question posed by Jessica Vapnek (No. 22, May 6). I believe she is quite correct in that we may not all have the same understanding of what a regulatory framework constitutes. I can only give my own understanding of a regulatory framework and it may not necessarily be the correct one. In my understanding, a regulatory framework has two main components, namely a legislative component (any number of relevant domestic legislative instruments) and an institutional component (one or more institutional structures responsible for enforcement). It is my view that the effectiveness and credibility of regulatory frameworks in the long term depend on the effective and efficient functioning of the institutional component.

One should not, however, confuse policy and strategy instruments to be part of the regulatory frameworks. Although these instruments, together with regulatory frameworks, constitute the broader enabling environment, their functions are determinant of the direction and process of regulatory framework development and evolution, not necessarily of regulatory framework content and structure.

Dr Gert Willemse
Private Bag X447
Pretoria 0001
South Africa
Tel: +27 12 3103836
Fax: +27 12 3207026
bioconsult2002 (at) yahoo.co.uk

-----Original Message-----
From: Biotech-Mod1
Sent: 07 May 2003 14:13
To: 'biotech-room1@mailserv.fao.org'
Subject: 28: Re: Experience of regulating GMOs in developing countries - India

This is from Professor C Kameswara Rao, Executive Secretary, Foundation for Biotechnology Awareness and Education, Bangalore, India.

In response to Message 14 (May 5) concerning the regulatory system in India:

The Genetic Engineering Approval Committee (GEAC), Government of India, is expected to accord approval for controlled trials or commercial release of genetically engineered products. Since most of the products have a direct or an indirect impact on the environment, the GEAC is attached to the Ministry of Forests and Environment, Government of India. The GEAC has so far taken a relatively cautious approach to granting approval of GE crops.

However, the policy of the Government of India and that of the general public is not anti-biotechnology. The Government established the Department of Biotechnology in 1985, one of the earliest such departments in the world. The Department of Biotechnology, the Indian Council of Agricultural Research, the Department of Science and Technology, the Council for Scientific and Industrial Research, the research and educational institutions of the Central Government and those of the States, are all actively engaged in research in biotechnology. It would take some years for any marketable products to come out of these efforts. While the policy of the Government is pro-technology, the climate of the regulatory processes in India is not conducive to promote biotechnology. Though the products of conventional agriculture through hybridisation and induced mutation can pose as serious risks as attributed to products of genetic engineering, stringent regulatory processes are applicable only to the latter.

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

-----Original Message-----
From: Biotech-Mod1
Sent: 07 May 2003 15:30
To: 'biotech-room1@mailserv.fao.org'
Subject: 29: Using GMO registrants to informally regulate

This is Mark Kuhn, a graduate student in the field of biotechnology management at the University of Maryland in the United States. The following are some personal observations of mine.

I tend to agree that there is some truth to a common assertion that industry will only regulate itself when forced to. This probably applies to industry watching over itself with regard to GMOs, too. But portions of a report issued last month by the Pew Charitable Trusts' Initiative on Food & Biotechnology may illuminate a potential answer--at least a starting point--to solving the problem of how developing and transition nations that lack resources and expertise might regulate the global GM food trade, or other GMO-based products and services. That answer is industry self-policing. [This report, entitled "Post-Market Oversight of Biotech Foods: Is the System Prepared?" and co-authored by Michael Taylor and Jody Tick of Resources for the Future was released last month and is available from http://pewagbiotech.org/newsroom/releases/042403.php3 ...Moderator].

The Pew study, unintentionally no doubt, raises a possibility that one way of approaching global GM food regulation might be through GM crop registrants-companies that sponsor GM food products--much as the U.S. Environmental Protection Agency (EPA) presently does with plant-incorporated protectants (PIPs). The EPA considers it the responsibility of registrants to monitor the proper use of PIPs in the field. This includes registrants overseeing post-market use of GM crops by farmers. Thus, biotech companies selling GM food crops must keep an eye on those who grow them, including growers in foreign markets. Such an oversight system, regardless of its obvious imperfections, could provide regulatory penetration into developing counties' use of PIPs, or any other GM crop for that matter. In other words, relying on private-sector monitoring could accomplish some degree of GM food regulation in developing and transitions countries without a significant intrusion into those nations' governance or placing too great a burden on nations' government resources and bureaucracies. That is to say, oversight of a certain degree could be accomplished via the private sector through post-market monitoring by GM crop registrants, at least until a developing or transition nation's government matures enough to assume a greater oversight role of its own.

A similar model might be appropriate for other GMOs. For instance, an initial registrant-policing model may be appropriate for transgenic animals and microbes. The Pew report raises important questions about imposing testing and traceability requirements on registrants. Such tools, I believe, should be used to make registrant monitoring more effective. Indeed, such requirements might be unavoidable where nations lack governmental capacity to watch over the GM crop trade. I would also shorten the period of registrant recertification required by the EPA to once every two or three years instead of the current five years.

Mark Kuhn
CD Publications,
8404 Fenton St.,
Silver Spring,
MD 20910
United States.
mkuhn (at) cdpublications.com

-----Original Message-----
From: Biotech-Mod1
Sent: 07 May 2003 16:26
To: 'biotech-room1@mailserv.fao.org'
Subject: 30: Re: Regulating "process" versus "product"

This is again Gert Willemse from South Africa.

In response to the message of Donald MacKenzie (No. 24, May 7), I would like to correct some misconceptions contained in his message. It is not correct that "all countries (except Canada...) have chosen to regulate "process" not "product"." In the case of South Africa, both process (genetic modification of organisms) and product (GMOs) are regulated. The genetic modification of organisms is also regulated whether achieved by means of recombinant DNA technology, chemical mutagenesis or any other means of genetic modification.

It is also incorrect that the philosophy of the Cartagena Protocol on Biosafety implies triggering of "regulatory oversight based on the process of genetic engineering rather than on the risks associated with the expression of any novel traits". Article 8(g) of the Convention on Biological Diversity, which forms the basis for the Cartagena Protocol negotiated in response to Article 19(3), is very clear on the measures to be taken to "regulate, manage or control the risks associated with the use and release of LMOs..." (=GMOs). Refer also to the scope of the Cartagena Protocol (Article 4) which specifies "transboundary movement...handling and use" of GMOs. The trigger for obligations under the Protocol is therefore not the process of genetic modification, but activities involving the product or GMO. [Multi-lingual versions of the texts of the Convention on Biological Diversity and of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity are available at http://www.biodiv.org/convention/articles.asp and http://www.biodiv.org/biosafety/protocol.asp respectively...Moderator].

Coming back to the stacked gene example, I would argue that the line of reasoning of "safe apart, safe together" is inherently flawed. It is based on the assumption that previously assessed novel traits in subsequent breeding would not have any further pleiotropic or other unforeseen effects. I reiterate that this assumption is no more than an assumption and is not based on any scientific fact. I concede that, from a regulatory viewpoint, no distinction should be made between a stacked event bred from parental lines where the genetic modification have been achieved by different means, and I am certainly not proposing that any regulatory framework should make exceptions to include/exclude any given ad hoc case. To do so would only lead to major confusion, as Donald MacKenzie has pointed out. It would be far less complex to set (depending on the individual country needs and circumstances) basic principles and parameters within which the flexibility of the regulatory framework would then ensure the required safety and efficiency. In this context, as I have earlier pointed out, it may be of benefit to address the needs and requirements of intended recipient countries in the approval process if transfer of GMOs is contemplated, in order to prevent unneccesary delays in the approval process of the recipient country. One principle that should not be negotiable is the right of the recipient country to decide its own criteria and level of biosafety.

Dr GT Willemse
Private Bag X447
Pretoria 0001
Tel: +27 12 3103836
Fax: +27 12 3207026
bioconsult2002 (at) yahoo.co.uk

-----Original Message-----
From: Biotech-Mod1
Sent: 07 May 2003 16:52
To: 'biotech-room1@mailserv.fao.org'
Subject: 31: The importance of having a regulatory framework

My name is Tamala Tonga Kambikambi. I am an agronomist and I lecture at the University of Zambia.

I guess most of you had heard about the saga of my country refusing to take the GMO food maize. I suppose that underscores the importance of having a regulatory framework because what really happened is that we did not know how to handle that product in the absence of appropriate legislation. We have hence moved on and are on the way to ensuring that we are ready for any such eventuality in future.

Jessica Vapnek (Message 22, May 7) brings in an important aspect. I totally agree that we need to know what type of regulatory framework we need to adopt i.e an Act of Parliament or a Policy statement. My belief is that both are important, especially for developing countries like ours. Why do I say so? I think that the Policy gives the direction which the country should be going. Given that a number of our countries rely on donors for support, that sort of gives them a guideline on what to do and also helps the nation to have a focused direction. I speak from experience in some other sectors where we went straight to enact Acts of Parliament without a Policy guideline. We have had donors coming in with their own 'agendas' for lack of a better term. So I seriously think a Policy should be the first step and we are in the process of putting one in place.

The Legislation is of course vital because it sets standards. What we are doing in our case is coming up with one specifically on Biotechnology and Biosafety because when we looked at the other existing legislation, we found that there were gaps and that even if we were to amend some to them, some gaps would not be covered. Hence, we felt that it is better to have a totally new piece of legislation to cover that. However, we shall have to relook at the other complimentary pieces like the Food and Drug Act, the Plant Varieties and Seeds Act and the Plant Quarantine and Phytosanitary Act, to mention but a few, and amend where possible to take into account issues of Biotechnology and Biosafety.

Before I end, I want to comment on Message 16 (by Justin Mog, May 7) where it said "herbicide-resistant crops only increase the incentive to use expensive (often) imported herbicides" and I think this was in reference to Bt cotton. [In Message 16, the comments about herbicide-resistant crops were made without referring to any specific crop...Moderator]. Cotton growers in our part of the world still use expensive, definitely imported, herbicides because if they do not, the result is zero yield. In Zambia, this is a crop grown solely by small scale farmers. They have to spray mostly by knapsack sprayer and the water to mix the chemical is normally drawn several km away from the field it is used in. To me, it therefore makes a lot of sense if the number of sprays can be reduced because of the inherent resistance the Bt cotton provides because this certainly reduces the labour burden of these poor and vulnerable farmers and I would like to believe that that saving can be used for other ventures.

Tamala Tonga Kambikambi
Crop Science Department,
School of Agricultural Sciences,
University of Zambia,
P.O. Box 32379, Lusaka.
Zambia.
Telefax: 260-1-295655
tkambikambi (at) agric.unza.zm

-----Original Message-----
From: Biotech-Mod1
Sent: 08 May 2003 09:45
To: 'biotech-room1@mailserv.fao.org'
Subject: 32: Independent and individual regulatory systems

This is from Tracey McCowen in Canada.

Regarding Message 23 (May 6) from Kelebohile Lekoape, in response to Message 21 (May 6) by Gert Willemse:

How independent and individual can a nation's regulatory system be, given WTO restrictions? Even developing countries rely on trade in order to generate currency. [In Message 23, Kelebohile wrote "Each country has a unique set of circumstances (level of development, capabilities, aspirations, cultures and traditions) that ought to influence its road map in the adoption and regulation of any technology"...Moderator].

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

-----Original Message-----
From: Biotech-Mod1
Sent: 08 May 2003 09:45
To: 'biotech-room1@mailserv.fao.org'
Subject: 33: Regulatory enforcement and market access

This is from Lee Ann Jackson. I am a Research Fellow at the Centre for International Economic Studies at the University of Adelaide, South Australia.

Jessica Vapnek's message (nr. 22, May 6) relating to the meaning of "regulatory framework" raised an interesting point about the binding nature of GM regulations that also has relevance to the issue of enforceability. Having legal regulations that stipulate conditions for production or marketing of GM technologies is obviously important. However, if these conditions are unenforceable then the regulatory framework has only limited relevance to what is occurring on the ground.

I'm thinking in particular of two issues: the regulation of refugias for GMO production and the setting of standards for tolerable limits for GM material in products identified as "non-GM".

In the first case, scientists may have a clear vision of how refugia should be structured in order to control for development of pest resistance, for example. However, the lack of a quick mechanism for distinguishing GM from non-GM products makes the actual monitoring of implementation of refugia at the farm level burdensome. Mark Kuhn (Message 29, May 7) suggests one approach that places the burden on the private sector. Do other participants have examples of how (if?) these types of production regulations are being enforced in developing countries?

The second issue, GM content standards, relates to domestic regulatory frameworks and how these frameworks interact in the international trade arena. In many cases, the choice of a single standard for allowable GM content in "non-GM" products is a political choice and cannot be enforced given the diversity of products that contain GM material. For example, testing a shipment of soybeans for the presence of GM material is categorically different from testing a product like bread, which may contain soybean material within a complex matrix of other ingredients. Yet these standards determine international market access for products and there may be pressure to adopt strict controls in order to maintain market access. I'd be interested in the response from other participants regarding the influence of these types of foreign regulatory standards on development of domestic regulations. How do these market access issues bias domestic regulations in developing countries? And, how do they influence the regulatory approval process for new products?

Lee Ann Jackson
Centre for International Economic Studies
School of Economics
Adelaide University,
AUSTRALIA 5005
Ph : +61 8 8303 4927
Fax : +61 8 8223 1460
e-mail: leeann.jackson (at) adelaide.edu.au
CRICOS Provider Code: 00123M

-----Original Message-----
From: Biotech-Mod1
Sent: 08 May 2003 12:55
To: 'biotech-room1@mailserv.fao.org'
Subject: 34: Need for regulations - developing model regulations

This is from Ramesh V. Bhat, Hyderabad, India.

Necessity of Regulations on Biotechnology in Developing Countries and Ways of Framing

Necessity:

1. It is claimed that GM crops benefit developing countries by
i) increasing productivity;
ii) reducing vulnerability to the whims of nature, e.g. development of drought/saline tolerant varieties;
iii) improving nutritional qualities of food.

Regulations are needed in developing countries to check these claims. The companies that produce and market the GM seeds have invested amounts in research and they are eager to get maximum profit. These claims cannot be checked by resource-poor farmers. Careful analysis, to find out the likely impact of the improved varieties on the society, is also a responsibility of the Government. Recent experience in India indicates that the first GM crop to be permitted for commercialization in 2002, cultivated on 72,682 acres in South India, did not live up to expectations as claimed. (For details, see Suman Sahai. "The Bt Cotton Story: The ethics of science and its reportage", Current Science 84:(8) 974-975, 25th April 2003, www.ias.ac.in/currsci/apr252003/974.pdf ).

2. GM crops pose environment risk by inadvertent crossing with local crops or with wild flora. To safeguard this, the Montreal 2000 Biosafety Convention provided tools for making regulations. [Presumably referring to the meeting in Montreal where the Cartagena Protocol on Biosafety to the Convention on Biological Diversity was adopted on 29 January 2000...Moderator]. Rules governing cultivation, such as providing refuges to prevent a rapid escalation in pest resistance, are also needed.

3. The recent refusal of Government of India, backed by appropriate regulations, to allow the import of Corn Soy blend by the aid agencies CARE and Catholic Relief Services of USA, because of a specific guarantee that the imported product does not contain Starlink variety of corn, a GM variety not permitted in its own country of origin (USA) is a good example for the need of appropriate regulation to safeguard human health.

4. The State must evaluate the risks to consumers and take responsibility for labeling products having ingredients that could be damaging to health. Labelling of commodities for export was recognized as universal requirement at the 2000 Montreal Biodiversity Convention.

5. Long term effect of GM crops/foods are currently not known. Appropriate post market surveillance mechanism to find out the impact on health is needed.

Ways of Framing:

It is generally recognized that accepted risk levels are greatly affected by their income levels. The perspective on GM foods varies, even within the developed countries. As far as GM crop/food issues are concerned, the developing countries could be placed in two categories viz.,
i) Countries with infrastructure for biotechnology (e.g. Brazil, China, Egypt, India, South Africa, Malaysia, Mexico) and
ii) Other developing countries with practically no work or expertise in the area of biotechnology within the country.

Model regulations could be evolved by international agencies, after appropriate consultations with as many countries as possible. FAO/WHO/IAEA/UNEP need to jointly set up an International Biotechnology Development and Regulatory Committee or a Consultative Forum or a Regular Task Force on Foods derived from Biotechnology, which could be entrusted with this responsibility along with other issues. [IAEA = International Atomic Energy Agency; UNEP = United Nations Environment Programme; WHO = World Health Organization...Moderator]. Countries, depending on their need and level of expertise, could modify them to suit their requirements, such as import, export, domestic need, etc. It would be ideal to have a single regulatory agency to deal with modern biotoechnology issues. Dr. M.S. Swaminathan, in "The Chennai Declaration: Bridging the genetic divide" (Current Science 84 (4) 494-496, 25 February 2003, www.ias.ac.in/currsci//feb252003/494.pdf) had suggested setting up of an autonomous and professional Biotechnology Regulatory and Advancement Commission.

RAMESH V. BHAT
Deputy Director (Sr.Gr.)
Food & Drug Toxicology Research Centre
National Institute of Nutrition
Indian Council of Medical Research
Hyderabad-500007,
India
Telephone: 91-40-27008921 to 27 Extn.281
Fax; 01-40-27019074
Email: rameshvbhat (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 08 May 2003 17:06
To: 'biotech-room1@mailserv.fao.org'
Subject: 35: Towards effective practical regulation

This is from Glenn Ashton. Presently I am the interim co-ordinator of SAFeAGE, the South Africa (SA) Freeze Alliance on GE, an organisation I helped found. SAFeAGE represents over 250,000 people and organisations in South Africa who are calling for a moritorium on the growing, import, export of GE food and crops until such time as an adequate and transparent regulatory regime is in place and until the technology has been clearly shown to be safe and desirable. More information is at www.safeage.org . I am also director of the Ekogaia Foundation, a non-profit, non-aligned think tank examining evolving technologies, amongst other things.

It is pointless having a practically ineffectual regulatory framework. It has been implied, whilst not stated directly, that the SA GMO Act is adequate. Instead, it fails to regulate GMOs by rubber stamping after secret review of 'confidential' information. The Government, now joined by Monsanto, is contesting a court case for disclosure of such information, with no resolution in sight.

The Regulator has thrice admitted in parliamentary fora that we possess insufficient capacity to properly monitor or regulate all trials and general releases of transgenic crops, instead relying heavily on information from participating parties. Independent oversight is clearly lacking. What is happening with refugia? We have information that farmers simply ignore this essential requirement.

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.

Given that there is presently a "college" being held by the United States Department of Agriculture (USDA) in order to build capacity in biosafety and security amongst developing nations (funded by the US$100 million pledged to promote 'biotech' at the FAO Rome food summit of 2002?) and given the situation in my nation, what hope is there for the developing world to maintain both a transparent and an objective regulatory regime if such anti-democratic forces are brought to bear? The USDA and The United States Agency for International Development have both been active in this region, pushing unwanted transgenic products when it was known full well that there was no regulatory framework or capacity.

The SA GMO Act and its implementing regulations were introduced with no debate, token public consultation and stands in sharp contrast in its manner of introduction compared to almost every other piece of legislation introduced since SA freedom in 1994. Additionally, it is in conflict with related local and international legislative and regulatory frameworks.

Another issue is the high expense of proper regulation. This cost is borne by governments pressurised into establishing a regulatory framework, whilst other state infrastructure is simultaneously being eroded by international agreements. No attempt is made to offset these direct costs, let alone the costs in repatriated profits, segregation and other hidden costs, that are intrinsic to the introduction of transgenic crops. In SA, a general release of a transgenic crop costs the applicant around a thousand US dollars. This amount does not even cover the meeting costs of the committee, let alone administration. Who pays inspectors, transport, lab costs, consultation? Taxpayers. Who pays if anything goes wrong? Same again. Is this right or cost effective? I think not, especially when agricultural extension officers are disappearing in Africa at a time when they are more needed than ever. These fiscal drags are not properly calculated into the whole. This amounts to public subsidisation of introduction of an unwelcome and unpopular technology. The regulation of this must be made paid by the introducer of the technology.

If SA, as an advanced developing nation, has a supposedly good regulatory structure that has failed to work in any practical, accountable or transparent manner, what is the plan for the rest of Africa, or the world? Does a closed and secretive process constitute regulation? Who oversees the regulators? Who pays?

Glenn Ashton
Box 222
Noordhoek
Cape Town
South Africa
+0027+21-789-1751
ekogaia (at) iafrica.com

-----Original Message-----
From: Biotech-Mod1
Sent: 09 May 2003 10:56
To: 'biotech-room1@mailserv.fao.org'
Subject: 36: Re: Experience of regulating GMOs in developing countries - India

This is from Ramesh V. Bhat, in response to Debasmita Patra's (Message 20, May 6) request: "I just wanted to know about the Genetic Engineering Approval Committee's (GEAC) recent stance about granting permission to the GMOs in India".

The Government of India's Genetic Engineers Approval Committee (GEAC), in its 36th meeting on 25 April 2003, rejected the proposal of commercial cultivation of a Bt cotton variety, Mech 915, in North India mainly because it is highly sensitive to leaf curl virus disease.

It called for more field trial data for GM mustard seeds to assess the agronomic superiority, effects of crossability and pollen transfer and resistance to herbicides, under the supervision of the Indian Council of Agriculture Research. The panel was also of the view that, as mustard seeds and leaves were used in food, there was a need to assess the possible health hazards.

RAMESH V. BHAT
Deputy Director (Sr.Gr.)
Food & Drug Toxicology Research Centre
National Institute of Nutrition
Indian Council of Medical Research
Hyderabad-500007,
India
Telephone: 91-40-27008921 to 27 Extn.281
Fax; 01-40-27019074
Email: rameshvbhat (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 09 May 2003 11:09
To: 'biotech-room1@mailserv.fao.org'
Subject: 37: Financial/time costs of GE crops

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

Financial and time costs of commercialising transgenic crops and the need to reduce trial phase duration for repeated transgenic events.

It takes about 11-13 years for a specific transgenic variety to get into commercial cultivation. Five years to develop the transgenic event, such as pest resistance or herbicide resistance, 2 or 3 years of controlled greenhouse trials on approval by a regulatory agency, and 3 or more years of controlled field trials. This would cost US$ 5-7 million in the United States and 8-12 million in Europe. It takes some 5 years of commercial cultivation before it is de-regulated.

The regulatory authorities should have a rational and science based approach to giving or denying approval for a transgenic crop. For a number of crops there is only one annual growing season. If for any reason the trial phase is extended, as has just been done in India for 2 years each for GE mustard and Mech 915 Bt cotton meant for the north Indian States, the time lost would increase costs in terms of expense on the extended trials or maintenance, and interest on investment to date. This burden would fall on the cultivator/consumer.

Mahyco's Mech 915 variety has gone into a second deferment, after three other varieties containing the same gene for Cry 1Ac were approved last year, and this on the basis of a factor unrelated to Bt technology. Bt technology in cotton is meant to protect the cotton crop from the American bollworm and has nothing to do with the leaf curl virus. If susceptibility to the leaf curl virus makes Mech 915 unsuitable for cultivation now, one more year of field trial is not going to remedy that. GE or non-GE, no cotton variety in India is resistant to leaf curl virus and so none should be grown at all.

Transgenic technology for pest resistance and herbicide resistance have proved their merits and are being under increased acreage year by year, in increasing number of countries. Both their stability in the recipient genomes and their biosecurity have been proven beyond a reasonable doubt. The incidents related to Starlink or Prodigene were issues of human management errors and not technology lacunae.

If a particular transgenic event, like Cry 1Ac in cotton in India, is approved for commercial cultivation, the same event put into another cotton variety in India should not be required to pass through the entire 5-7 year trial phases. For example, Mahyco used Monsanto's Bt technology with Cry 1 Ac and the same is being used by Rasi Seeds. Under this scenario, the trial phase before commercialisation can be reduced for the gene construct with Cry 1 Ac, inserted into whatever variety of cotton in India. When a product developer introduces the same genetic event, as was used earlier, into a better variety, one year of controlled greenhouse trials and one year of controlled field trials should be adequate. It would be a different matter if the gene construct involves Cry 1 Ab or stacking of Cry 1 Ab and Cry 1 Ac.

Extended trial periods create another problem. The variety into which an event is introduced may be overtaken by other non-transgenic varieties, which results in an endless race and disadvantage to the transgenic varieties, benefiting no one. Mahyco's cotton varieties were among the best in the country when chosen for developing Bt varieties five or six years ago, but by the time they were allowed for commercial cultivation, they were overtaken in field performance by other non-Bt varieties.

Reduced time schedules will break monopolies in transgenic trade and provide the farmers with a wider choice of varieties of the same crop with a particular genetic event, from different developers.

Professor C Kameswara Rao,
Executive Secretary,
Foundation for Biotechnology Awareness and Education,
Bangalore,
India
e-mail: krao (at) vsnl.com

-----Original Message-----
From: Biotech-Mod1
Sent: 09 May 2003 11:13
To: 'biotech-room1@mailserv.fao.org'
Subject: 38: Re: A dynamic interdependent network

This is from Dr Aisha, A. Badr, Tropical fruit division, Sabahia Horticultural Research Station, Alexandria, Egypt.

In response to Message 21 (May 6) of Dr Gert Willemse: "In summary then, the global GMO regulatory scenario is evolving into a dynamic interdependent network that could only benefit from cross-fertilization of all experiences and lessons learnt".

It is evident that network is important to help in regulating GMO in agriculture and related industries and other areas. This lead to my opinion, in the previous FAO conference [entitled "What should be the role and focus of biotechnology in the agricultural research agendas of developing countries?", held 13 November to 11 December 2002...Moderator] to regulating team work of all specializations for doing research and here to encourage developing counties to build its own base of GMOs in all areas of studies, including the most worried field of health and safety. Each developing country has its priorities in the way of development; its own culture, which is one of the factors needed to accept new technological techniques; its own customs, citizens who play great part in acceptance of GMOs. Even inside the same country we will find differences.

In my opinion, regulation of GMOs needs to be in regulated steps in both developed and developing countries including: certificated GMOs (I mentioned it in the previous FAO conference), similar to ISO, to be given for safe GMOs, because trust is the first effective factor. [International Organization for Standardization (ISO) Standards are voluntary and are used in a wide range of fields, such as agriculture and construction or information technology...Moderator]. This can be followed by guiding people to the importance of the certified GMOs. The developed countries can support by funding, according to priorities of each country. I agree with Dr Gert Willemse about the benefits from cross-fertilization of all experiences and lessons learnt.

Dr Aisha, A. Badr,
Tropical fruit division,
Sabahia Horticultural Research Station,
Alexandria
Egypt.
momidic (at) hotmail.com

-----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

-----Original Message-----
From: Biotech-Mod1
Sent: 12 May 2003 10:15
To: 'biotech-room1@mailserv.fao.org'
Subject: 45: Regulatory structures for GE-products in Nigeria

My name is Danladi Dada Kuta, a plant biotechnologist with the National Cereals Research Institute of the Federal Ministry of Agriculture, Nigeria. I have been involved in the development of research and development agenda for biotechnology in Nigeria, and also in public awareness campaigns on the potential benefits and risks of agricultural biotechnology. I am currently on a scientific study visit to the Biotechnology Research Unit of the International Institute of Tropical Agriculture (IITA), Ibadan, where I am improving my knowledge on different aspects of biotechnology, including biosafety. This Visiting Fellowship program was funded by the United States Department of Agriculture Foreign Agricultural Service (USDA/FAS).

REGULATORY STRUCTURES FOR GE-PRODUCTS IN NIGERIA

A) Introduction:

Growing enough food to feed the teeming population of Nigerians is a very challenging task, especially when left in the hands of resource-poor rural farmers. Weeds, drought, soil-related stress factors, insect pests and diseases continue to rob the farmers of valuable yields. Recent advances in agricultural biotechnology have made it possible for crops to be genetically engineered to tolerate drought, herbicides, insect pests and diseases.

The Federal Government of Nigeria has taken necessary steps to join the rest of the world in reaping the benefits of agricultural biotechnology. It has already put in place a Nigerian Biotechnology Policy, with the following Mission Statement: "Nigeria should as a matter of priority initiate appropriate steps to explore the use of biotechnology for the benefits of Nigerians and thus ensures that Nigeria becomes one of the international leaders in biotechnology".

B) Status of regulation of GE crops in Nigeria:

Nigeria is yet to introduce any GE product, but it is putting the necessary structures on ground to accommodate such products in the near future.Nigeria is a signatory to the Convention on Biological Diversity and the Cartagena Protocol on Biosafety. The Federal Government has recently taken a giant stride by approving a National Biosafety Policy to regulate the impact and safety of GE products.

The major Federal Agencies that would be actively involved in the implementation of the National Biosafety regulations include the following:

1. National Agency for Food and Drug Administration and Control, a parastatal of the Federal Ministry of Health. [A parastatal is a state-owned company or enterprise...Moderator].

2. Federal Ministry of Environment

3. Federal Ministry of Agriculture and Rural Development

4. National Biotechnology Development Agency, a parastatal of the Federal Ministry of Science and Technology

5. SHESTCO (Sheda Science and Technology Complex) Biotechnology Advance Laboratory, also a parastatal of the Federal Ministry of Science and Technology

The Federal Government of Nigeria has therefore demonstrated the interest to establish an efficient regulatory system for GE-products. What Nigeria lacks now is the required quantity and quality of human capacity for scientific assessment of possible environmental and health risks associated with GE-products. Expertise in handling of containment facilities is also urgently required.

Danladi Dada Kuta, Ph.D
Senior Research Scientist,
Plant biotechnologist,
National Cereals Research Institute (NCRI),
Badeggi,
PMB 8 Bida, Niger State,
Nigeria
E-mail: drkuta2002 (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 12 May 2003 10:21
To: 'biotech-room1@mailserv.fao.org'
Subject: 46: Re: Financial/time costs of GE crops

This is from Professor C Kameswara Rao, India, responding to Tracey McCowen (Message 41, May 10).

The pioneering product must undergo the required length of, or even extended, trial phases. Even this should have a reasonable timeframe, with reasons explained for extended periods. Repeated events in the same crop need not necessarily be subjected to the same lengthy process. If it is Cry 1Ac in cotton, whoever is producing the same event in the same crop, is my point. It is not necessary to repeat every experiment on biosecurity in every country.

I have worked on pollen for a considerable period of time and I am aware of the dynamics of pollen drift and that this is not the same for every crop and gene flow considerations are not the same in every country.

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

-----Original Message-----
From: Biotech-Mod1
Sent: 12 May 2003 10:29
To: 'biotech-room1@mailserv.fao.org'
Subject: 47: Re: Use of terms GMO, GEO and application of regulatory

This is from Julie Newman, Australia.

In response to Professor Kameswara Rao's comment (Message 43, May 10), "All the organisms deployed in agriculture and animal husbandry today are the products of Genetic Modification for over 10,000 years.":

It is very unfortunate that the misleading terminology of "genetic modification" was ever given, much less adopted, in reference to transgenics or the processes explained as GEO. "Modification" means change and hence the term does not specify how the genetic change took place. While Professor Rao is technically correct with his definition clarification, it should be noted that governments around the world have adopted an incorrect term and the terms GMO and GEO are deemed to refer to "recombinant DNA" processes. [GMO = Genetically Modified Organism; GEO = Genetically Engineered Organism...Moderator].

Referring to the technically correct terminology is perhaps a very critical issue that should be addressed in the formulation of any legislation.

Julie Newman
Network of Concerned Farmers,
Newdegate, West Australia
www.non-gm-farmers.com
newseeds (at) treko.net.au

-----Original Message-----
From: Biotech-Mod1
Sent: 12 May 2003 15:23
To: 'biotech-room1@mailserv.fao.org'
Subject: 48: Types of regulations - Implementation

This is from Ramesh V. Bhat, India.

I wish to provide a continuation of my two earlier messages 14 (May 5) and 34 (May 8).

Types of regulations on biotechnology issues and how to implement them in developing countries.

1. Legislation requirement:

Use of modern biotechnology derived GM crops, GM foods, ingredients, additives, food supplements, pesticides, GM animals, medicine needs appropriate legislation in all developing countries. It should cover import, export, domestically grown and traded produce.

2. Implementing mechanism:

The implementation needs to be dovetailed to existing mechanisms, depending on the system in each country in the case of
i) Environment protection;
ii) Food safety implementation;
iii) Export/import inspection.

However, in the case of agricultural production systems and animal husbandry areas, new mechanisms need to be evolved since in these areas there has not been any regulation in the past. Agricultural technologies must be adopted to various agro-ecological conditions. They are more location-specific than other technologies. Lack of regulation would only help wealthy nations and multinational corporations follow their own narrow self-interest and profit objectives.

The legislation should be strictly implemented, with mechanisms of warning, fines, blacklisting of companies and, in extreme cases, punishments like even imprisonment.

3. Model:

Primarily, the USA model and the EU (European Union) models of regulations are available. In the EU model, GM foods and ingredients are novel foods that require safety assessment while in the US model they are not considered different from other technologies and are considered generally recognized as safe except
i) introduced foreign gene products may be considered as food additives as per FDA (Food and Drug Administration) regulations;
ii) pesticide products from foreign genes (Bt plants) requiring threshold level of tolerance from EPA.

Developing countries need general comprehensive regulations and a separate regulations evolved on a case-by-case basis depending on the need of each country.

4. Requirements:

i) Data to be generated by the technology developer
ii) Regulatory authorities to evaluate the data
iii) Adequate labelling procedure to be adopted
iv) Legal responsibility for adverse impact to be borne by companies (see Message 39 (May 10) by Humberto Peralta Diaz)

5. International infrastructure:

Individual developing countries may not have the resources, infrastructure and technical manpower to even to review the data. A central agency under the auspices of FAO/WHO, as I proposed earlier in message 34 (May 8), appropriately recognized by the World Trade Organization can do this job. In addition, an analytical laboratory service facility to evolve sampling procedure and detection of GM foods for developing countries needs to be provided by international agencies. The unique laboratory facility of the UN system existing with the Joint FAO/IAEA facilities at Sibendorf near Vienna could be considered for the purpose. [The FAO/IAEA Agriculture and Biotechnology Laboratory is part of the International Atomic Energy Agency's Laboratories at Seibersdorf, Austria. It plays a key role in supporting the Joint FAO/IAEA programme with Member Countries on Nuclear Techniques in Food and Agriculture - http://www.iaea.org/programmes/nafa/dx/html/labindex.html ...Moderator].

RAMESH V. BHAT
Deputy Director (Sr.Gr.)
Food & Drug Toxicology Research Centre
National Institute of Nutrition
Indian Council of Medical Research
Hyderabad-500007,
India
Telephone: 91-40-27008921 to 27 Extn.281
Fax; 01-40-27019074
Email: rameshvbhat (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 12 May 2003 17:08
To: 'biotech-room1@mailserv.fao.org'
Subject: 49: Re: Sharing of propagation materials

I am Jasper Buijs. I work as a socio-biotechnological researcher at the International Potato Center (CIP) in Lima, Peru. My work involves assessment of possible pathways for the deployment of transgenic insect resistant potato varieties, based on Bt-technology, in Peru and Colombia.

This message is somewhat in response to message 42 (May 10) from Raymond Ramsaroop.

Looking at GM-technology in a development perspective, I strongly believe that transgenic technology should be put to the benefit of small-scale agriculture in developing countries. To pursue this aim, one of the options is to develop new transgenic technology in species and varieties that are used specifically by small-scale farmers. There is an inherent problem with this strategy though, and that is what Mr. Ramsaroop already underlined by stating that the prolific sharing of propagation materials is a factor that makes spread of genetic types difficult to control.

The associated possible problems with this process are, to my opinion, mainly environmental. The questions are:
- Are transgenic varieties able to escape the agricultural context and survive in the wild?
- Given the agricultural practices, are plants able to outcross with related wild species?
- Are farmers likely to abandon the conservation of their landraces (and therewith lose out on a diversity conservation force) upon deployment of a GM variety with a dominant feature?

Speaking with a perspective from my work in Peru - with potato - I think one of the main questions is whether the deployment of transgenic varieties is done in, or near, an area of origin of diversity. For potato, for instance, the Andean regions of Peru are an origin of diversity.

It would require much additional research to determine whether there are possibilities to combine the interests of small-scale farmers (regarding their livelihood strategies), and the protection against possible environmental escape of transgenes, upon their deployment.

Transgenics regulation in developing countries should both recognise the importance of stimulating the tailoring of research towards small-scale agriculture, as well as bearing in mind the specific problems this raises.

Jasper Buijs
Crop Improvement and Genetic Resources Department
International Potato Center
Lima,
Peru
J.BUIJS (at) CGIAR.ORG

-----Original Message-----
From: Biotech-Mod1
Sent: 14 May 2003 16:12
To: 'biotech-room1@mailserv.fao.org'
Subject: 52: The Precautionary Principle

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

The Precautionary Principle (PP) vis-à-vis Genetically Engineered Organisms (GEOs) in agriculture:

The PP has become an important instrument in making decisions on the introduction of GEOs into the environment. Experience gained subsequent to the application of the PP to the evaluation of biosecurity issues related to GEOs, indicates the need to re-examine the issue, for a more meaningful application of the PP, which is good in intent, but faulted in implementation.

Originally applied to environmental issues (Earth Summit, 1992, Principle 15), long before GEOs were on the scene, the PP states that "where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation".

The Cartagena Protocol on Biosafety (2000, Articles 10.6 and 11.8) applied the PP to GEOs stating that "Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the Party of Import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism....., in order to avoid or minimize such potential adverse effects". The emphasis here is on conservation, sustainable use of biological diversity and human health. The PP is meant to exercise caution while importing GEOs or releasing them for commercialisation. The PP should be used with diligence, only when essential, not routinely and certainly not to prevent deployment of GEOs endlessly.

Products of agricultural biotechnology have been subjected to the PP, overtly or covertly, while pharmaceutical and industrial products of genetic engineering are not subjected to the same strict application of the PP. Scientific evidence on different aspects of biosecurity of release of GEOs into the environment, as well as the absence of evidence that such an act is harmful, is adequate to consider it safe. The World Trade Organization (WTO) stated, in the context of Sanitary and Phytosanitary Measures (1993, Article 5.7), that "in cases where relevant scientific evidence is insufficient, ...(the regulatory authority) may provisionally adopt measures on the basis of available pertinent information... (and) may seek to obtain the additional information necessary for a more objective assessment of risk and review...the measure accordingly within a reasonable period of time". In the face of pressure from anti-technology lobbies, regulatory authorities take shelter behind the PP and defer decisions on the deployment of GEOs, as is the case in India with GE mustard and some varieties of Bt cotton, by the Genetic Engineering Approval Committee (GEAC), ignoring the rider 'within a reasonable period of time'. The net result is confusion, suspicion and loss of time and money. It should be remembered that there is no technology with zero risk, and that positive evidence of safety of a product should weigh as much as the absence of evidence that it is unsafe. Given the complexities of gene function, it is not possible to prove experimentally that a particular technology is unsafe. It is possible that some un-anticipated effect may surface after a period of time, and they should be addressed, if and when the situation demands.

Whenever the PP is applied, the concerned authority has a moral responsibility to give reasons. It is the spirit of the principle that is more important than its application in letter. The PP should not be an instrument to deter or delay deployment of technology that is potentially beneficial, and it is not intended to be a means of appeasing anti-tech activists.

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

[Notes: - In 1992, more than 100 heads of state met in Rio de Janeiro, Brazil for the United Nations Conference on Environment and Development, also known as The Earth Summit. Among other things, the assembled leaders endorsed the Rio Declaration on Environment and Development. Principle 15 of the "Rio Declaration" states "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation". http://www.un.org/documents/ga/conf151/aconf15126-1annex1.htm
- The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is available at http://www.biodiv.org/biosafety/protocol.asp
- the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (1995)is available at http://www.wto.org/english/docs_e/legal_e/15sps_01_e.htm . Article 5.7 states "In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time"...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 16 May 2003 09:33
To: 'biotech-room1@mailserv.fao.org'
Subject: 53: Re: The Precautionary Principle

This is from Tracey McCowen, Canada.

Dr Rao (Message 52, May 14) writes, "In the face of pressure from anti-technology lobbies, regulatory authorities take shelter behind the PP and defer decisions on the deployment of GEOs, as is the case in India with GE mustard". [GEOs = Genetically Engineered Organisms...Moderator].

I would have thought that the use of the Precautionary Principle (PP) in the field trial phase of GE mustard would be an example of the necessity for the clause since GE mustard (canola or rape) has shown a propensity towards weediness in the countries where it has been approved. Furthermore, referring to "anti-technology lobbies" is a derogatory and offensive term used to describe those people in science questioning the way the technology is being applied. Is the professor then suggesting that there is no longer a need for peer review?

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

-----Original Message-----
From: Biotech-Mod1
Sent: 16 May 2003 11:56
To: 'biotech-room1@mailserv.fao.org'
Subject: 54: Re: The Precautionary Principle

This is from C Kameswara Rao, Bangalore, India, responding to Message 53, May 16, of Tracey McCowen.

Peer review is certainly very necessary. I know of technologists opposing some aspects of biotechnology. But most people who agitate against technology do not qualify to be called 'peers' since they have no background of scientific and technical aspects of the issues and implications. They have reasons other than the risks of technology, to oppose technology. Then, for peer review, the data should be made available to the scientific community and the interested public, and not considered only by a closeted committee, shrouded in secrecy, and not giving reaasons for deferring decisions or asking for extended trial periods.

I do not mean any offense to the scientific community that has reasons to oppose technology. I myself oppose a number of aspects of biotechnology.

I am surprised that Dr McCowen understands the term 'anti-tech lobbies' as being used to describe those people in science questioning the way the technology is being applied. This assumption is not correct. There are anti-tech lobbies throughout the world, constituted of people with no science background and they pressurise the governments and regulatory committees, directly or indirectly, at every step, from import of GE products, permitting for field trials and to release for commercial cultivation, when the safer option is deferrment.

I cited examples from the Indian situation to indicate the frequent and unwarranted use the Precautionary Principle. In the case of GE mustard in India, the Review Committee for Genetic Modification had no negative observations on the performance of GE variety but the approval for field trials was deferred twice. [Presumably, the reference is to the Review Committee on Genetic Manipulation under the Department of Biotechnology, Ministry of Science and Technology, see Message 14, May 5, by Ramesh V. Bhat...Moderator]. Factors such as gene flow, weediness, yield in terms of seed and oil content, have all been examined and nothing that warrants extended field trials was evident. The Bt cotton variety for north Indian states has been deferred twice, the second time on account of it being susceptible to leaf curl virus, which is the case with every variety of cotton grown in India, including the isogenic of the Bt variety in question. If the logic is extended, no variety of cotton should be grown in India. Bt technology has nothing to do with inducing or preventing the disease caused by the leaf curl virus.

I support the application of the Precautionary Principle during regulatory processes but not its overuse or misuse.

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: 19 May 2003 09:36
To: 'biotech-room1@mailserv.fao.org'
Subject: 55: Re: Codex food safety guidelines

[NB NB NB.....We are now entering the final week of this FAO e-mail conference on Regulation of GMOs in Developing and Transition Countries, as it is programmed to run from 28 April to 25 May. The vast majority of you who registered, have not yet sent a message to the conference. In the remaining time, we especially encourage you to share your views and experiences, seen from your country, with us on any of the issues involved in GMO regulation in developing or transition countries or to discuss points made in messages previously posted or to raise topics discussed in the Background Document to the conference. As the emphasis in the conference has, so far, been on regulation of GM crops, we also especially encourage inputs from people involved or interested in livestock, forest trees, agro-industry and fisheries to speak up and be heard..........

For those who joined the Forum and/or the conference late, we remind you that messages posted so far can be received by sending a message to mailserv@mailserv.fao.org with the following two-line text message:
send listlog/biotech-room1.apr2003
send listlog/biotech-room1.may2003

Similarly, to receive the Background Document for the conference by e-mail, send a message to mailserv@mailserv.fao.org with the following one-line text message:
send listlog/biotech-l.apr2003

...Moderator]

This is Héctor Villaverde, Chile, in response to S. Vasanthi (Message 44, May 10).

I understand that in the current processes to implement the Cartagena Biosafety Protocol, the guidelines for the food safety evaluation of GM foods should be main global regulatory reference in relation to the establishment of a public health system on GMOs. The Protocol implies import/export regulations in essence, and under the SPS agreement (the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures) the systems implemented should ensure equivalency of their regulatory measures. The use of the Codex standards related to GM foods as a starting point for national regulations would be the most effective and efficient way to save time, money and human resources (and eventually challenges in WTO), specially in this case, where there is agreement between all stakeholders, including NGOs.

Héctor Villaverde
Food Programme Co-ordinator
Consumers International
Office for Latin America and the Caribbean
Las Hortensias 2371
Providencia, Santiago
CHILE
Phone: (56-2) 335-1695
Fax: (56-2) 231-0773
Email: programalimentario (at) consint.cl
www.consumidoresint.cl

-----Original Message-----
From: Biotech-Mod1
Sent: 19 May 2003 10:38
To: 'biotech-room1@mailserv.fao.org'
Subject: 56: Regulations must regulate, not facilitate

This is Glenn Ashton again.

An interesting contradiction emerges in recent posts.

On the one hand. the argument is made that the precautionary principle (PP) is abused by opponents to technology, in reference to groups that have taken a strong regulatory line with transgenic products. (C Kameswara Rao; Messages 52 (May 14) and 54 (May 16)).

On the other hand, Dick Richardson (Message 51, May 13) makes an elegant case around insufficient genetic information, indirectly showing the need for the PP. Given this lack of information and indeed, if Richardson's submission is read alongside Barry Commoners article, "Unraveling the DNA Myth: The Spurious Foundation of Genetic Engineering", published in the February 2002 issue of Harper's Magazine (full references and background at http://www.criticalgenetics.org/), it is clear that opposition to pressure to introduce GE foods and crops - by an emphasis on substantial equivalence and other scientifically questionable assumptions - is indeed founded upon real scientific concerns. This aspect underlines the real need for the PP.

Moreover, concerns around poor regulation of transgenics are not only scientific; there are also economic (liability and intellectual property), political (responsibility), social (ownership and gender impacts), environmental (ecology) and other concerns that must be regulated. It is therefore insufficient to regulate this technology only by scientific criteria. Far more worryingly, in light of the above references it becomes increasingly clear that the dominant paradigm of the central dogma, coupled to Cricks' sequence hypothesis, each, jointly and separately, fail to stand up in practice. That these outdated concepts form a basis for present assumptions for claims of safety and testing, whilst using a model more suited to chemical safety than genomic safety, is unacceptable.

Certainly, we need to use certain scientific criteria to regulate transgenics, but we must move away from the present emphasis on flawed theoretical frameworks that are manipulated by powerful lobby groups to suit their own narrow ends. We all know that statistical analyses can easily be abused. Given the international scope of revolving door regulation, in which the de facto lead international regulators (The United States' Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) among others) are especially compromised by their close associations with industry and the implications of negative influences on meaningful regulation are highlighted.

Regulations must regulate, not facilitate. In most cases internationally (nations like Switzerland, Austria etc with highly developed agricultural inspection and research regimes are exceptions and have as a result taken a conservative view of the desirability of transgenic crops), regulations have become a one way street that facilitates introduction of transgenic crops with little counterbalance. Democratic regulatory interaction is undermined.

Also, the cost of rigorous regulation is clearly onerous, especially on developing nations and a principle of 'user pays' must be established. The user must be the party responsible for introducing the product into the market. However, it is difficult to divorce 'user pays' from buying or compromising objectivity in oversight practice. The cost of regulating transgenic crops bears closer examination. Segregation costs are passed on to consumers against a marked reluctance to introduce even a functional or meaningful international labelling regulatory framework. While consumers contribute directly to the cost of regulation and biosafety monitoring inspections, it appears that tails they loose, heads they pay.

Regulation of anything, be it guns, chemicals or transgenic organisms, must be meaningful and democratically consultative and accountable. The present international regulation of transgenic crops is neither.

The ironic tragedy is that the real potential of agricultural biotechnology is being marginalised by those who 'promote' it. Contrary to assertions made in this debate (C Kameswara Rao, Message 54, May 16) and elsewhere, most of those questioning the rationale and methodology governing existing GE crops are not opposed to biotechnology or technological innovation per se. On the contrary.

Glenn Ashton
Ekogaia Foundation
Box 222
Noordhoek
Cape Town
South Africa
+0027+21-789-1751
ekogaia (at) iafrica.com

-----Original Message-----
From: Biotech-Mod1
Sent: 19 May 2003 13:51
To: 'biotech-room1@mailserv.fao.org'
Subject: 57: Sundry comments

I am E.M. Muralidharan from India and I am involved in research into some aspects of the biotechnology of forest trees and medicinal plants.

The arguments for relaxing the regulations for well known and tested GM events is perfectly justified from a corporate point of view and, indeed, where a technology proven to be safe and useful is concerned. But that is perhaps stating the obvious. If a situation like the one Prof Rao (Message 37, May 9) writes about (where a GM event is repeated in the same crop but is forced into prolonged trials every time it is introduced by a different company or into a different country) then it is not a reasonable assessment of the risks involved. But again, is the concern actually about such familiar situations or is it more about the risks of an inadequately investigated event that might manage to pass through, if a less stringent regulatory regime was to be adopted?

The need for abundant precaution in regulations is clear in some of the postings, particularly the one by Budi Prakoso (Message 50, May 13), which points to the limitations that developing countries face technically. Effective implementation in the face of vested interests and unscrupulous elements has been shown to be difficult in several instances, including the case of Bt cotton that came into the hands of farmers, illegally, in India. I am also glad that the `classroom lecture' from Dick Richardson was posted (Message 51, May 13) which puts several things in perspective as far as the risks are concerned, for the non-technical reader. I hate to think of transgenic forest trees being deployed when not much of their genetics and phenology is known. [Phenology is the study of periodic biological phenomena, such as flowering in plants...Moderator].

It appears to me that most advocates of GMOs argue for the unique benefits that would come about through their rapid deployment (with minimum of regulatory hassles), by pointing to the dangers of continuing with more conventional technologies, namely use of chemical pesticides and fertilizers, the lack of essential nutrients in staple food, crops succumbing to natural stresses and so on. As I pointed out in the previous conference of the FAO Biotechnology Forum, entitled "What should be the role and focus of biotechnology in the agricultural research agendas of developing countries?", this anxiety is a bit misplaced if we are ready to consider alternative technologies which are rather conventional but simple, cheap and safe. These have unfortunately been eclipsed by the hard sell with which modern techniques like GM are promoted. We can therefore afford to wait a bit longer for GMOs to be field-tested to the satisfaction of all. [See Dr. Muralidharan's Message 55 in the previous conference...Moderator].

E. M. Muralidharan
Genetics Division
Kerala Forest Research Institute
Peechi - 680653,
Kerala,
India
emmurali (at) kfri.org

-----Original Message-----
From: Biotech-Mod1
Sent: 19 May 2003 17:11
To: 'biotech-room1@mailserv.fao.org'
Subject: 58: Regulations must regulate and facilitate

This is Professor J Ralph Blanchfield, a professional food scientist with no links with the biotechnology industry, and neither root-and-branch for GM nor root-and-branch against GM. A scientist should not be root-and-branch anything except for the methodology of science.

Dick Richardson's message (nr. 51, May 13) boiled down in essence to eight words -- "We don't know enough so don't do it". Despite his lengthy dissertation, his arguments apply with even more force to the relatively blind insertion of multiple genes in traditional breeding methods. "We don't know enough" is a euphemism for "Never". Of course, we can never know all there is to know about any subject. Thankfully our ancestors did not adopt that reason for rejecting progress; if they had we would still be in the Stone Age. In more recent times, there would be no electricity; the first passenger flight would not have taken place, so there would be no air travel; the first surgical operation would never have been carried out so there would be no surgery; the first anaesthesia would never have been used, so there would be no anaesthetics -- the list could be endlessly extended. Exactly the same arguments were used early in the 20th century to try to prevent the legalization of milk pasteurization. We can be thankful that it was eventually legalized and over several decades has saved untold numbers of lives that would otherwise have continued to be lost to milk-borne tuberculosis - second only to clean water as the most important public health measure ever adopted.

Properly used, the precautionary principle is not a device to block progress. It and risk assessment are not opposites but two sides of the same coin. Regulation should regulate but, contrary to Glenn Ashton (Message 56, May 19), it should also facilitate.

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: 20 May 2003 10:27
To: 'biotech-room1@mailserv.fao.org'
Subject: 59: Methodology for risk assessment

This is Bill Muir, Professor of Genetics. I conduct research on biotechnology risk assessment in aquaculture, produce transgenic fish, and examine impacts of transgenes on fitness components.

I totally agree with Professor Blanchfield's comments (Message 58, May 19). Because there are risks related to a technology, that does not mean we should abandon the technology until everything that is knowable is known, both of which are impossible. Rather there is an entire field of science devoted to methodology for risk assessment. The first fact is that there is no such thing as a zero risk of anything. Thus all risks must be put in terms of probabilities, such as there is an 80% chance of rain today (if rain were to be considered a hazard). Secondly, those risks must be weighed against, not only possible benefits, but also the alternatives, i.e. what is the cost in suffering etc. if we don't use this technology, or use a different technology. Finally, there are a number of ways to estimate risks of potential hazards in a safe secure setting such that a reasonable degree of safety can be determined before the technology is loosed on the world. This is how all new products, including pharmaceuticals, airplanes, cars, baby toys, etc. are evaluated before they hit the market. Biotechnology is no different.

Bill Muir, Ph.D.
Professor of Genetics
Department of Animal Sciences
Lilly Hall
915 W. State Street
Purdue University
W. Lafayette IN 47907-2054
United States
http://icdweb.cc.purdue.edu/~bmuir/
bmuir (at) purdue.edu

[Note, regarding risk assessment methodology, in Conference 7 of this Forum, held 31 May to 5 July 2002 and entitled "Gene flow from GM to non-GM populations in the crop, forestry, animal and fishery sectors", the main topic of discussion was the real or potential ecological impacts of gene flow and, in addition, how a science-based ecological risk assessment framework might be applied to gene flow. See the Summary Document from the conference...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 10:39
To: 'biotech-room1@mailserv.fao.org'
Subject: 60: Public understanding of biosafety issues in crops

This is from Danladi Dada Kuta, Nigeria.

Though the Federal Government of Nigeria has recently put in place the necessary policies and agencies for the advancement of biotechnology in the country, our recent independent survey shows that there is still low public awareness of issues concerning GE crops.

Many do not know the relevance of GE crops to Nigerian agriculture. Some are not sure whether GE crops will improve or degrade the environment. Several others doubt the ability of our scientists to predict the environmental impact of GE crops. Even among the national scientists/academicians, only few understand the issues concerning biosafety regulations of GE crops.

Those of us with good proposals on "educating the public about GE crops and its importance for Nigerian agriculture" are forced to shelf such proposals due to the lack of funds.

I think it is very important to take the public, especially the farmers, along in decision making concerning GE crops. With proper education, I believe the Nigerian farmers could be the ones demanding for the introduction of GE crops in Nigeria, and not just the agbiotech companies or scientists.

Danladi Dada Kuta,
Plant biotechnologist,
National Cereals Research Institute, Badeggi,
PMB 8 Bida,
Nigeria
drkuta2002 (at) yahoo.com

[The point made in the last paragraph of this message, about the importance of public participation in the regulatory process, was also made by Kelebohile Lekoape (Message 23, May 6). She argued that the most important lesson to be learnt from the experiences of countries that had already established GMO regulatory frameworks was "engaging the public at all levels, from drawing up a research policy to decision making of approvals. This bottom-up approach means consumers are not only a part of the process, they identify with it and assume responsibility for the end result, thus endorsing the credibility of a regulatory framework"...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 11:47
To: 'biotech-room1@mailserv.fao.org'
Subject: 61: Re: Methodology for risk assessment

This is from Julie Newman, Australia.

Regarding Bill Muir's comments (Message 59, May 20) on risk, I certainly agree with his final comment: "Finally, there are a number of ways to estimate risks of potential hazards in a safe secure setting such that a reasonable degree of safety can be determined before the technology is loosed on the world. This is how all new products, including pharmaceuticals, airplanes, cars, baby toys, etc. are evaluated before they hit the market. Biotechnology is no different."

Unfortunately, the risk management for transgenic products has assumed a management of it's own. It is unbelievable that in this day and age, our governments are allowing companies to form their own committees in the guise of misleading governments into thinking that risk is to be managed.

The current management plans imposed by the Australian government is to place unacceptable cost and liability onto those farmers not wanting to use the product for controlling uncontrollable contamination. Would we ever see this sort of imposition imposed on any other industry? Imagine releasing a pharmaceutical, airplane, car or baby toy that was known to have faults but accepting plans prepared by their manufacturers that the cost and liability for managing their problem is on anyone else except those that use or produce the product. For example, a car released without brakes and a management plan would have strict management codes for all concerned to avoid that sort of car and to accept liability if an accident did occur. I think not!

When formulating any legislation and management proposal, do not try to deal with the agricultural industry any differently than you would deal with any other industry. The GM product provider must be legally responsible for containing and controlling their product and for any economic damage that would occur.

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

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 12:00
To: 'biotech-room1@mailserv.fao.org'
Subject: 62: Re: Methodology for risk assessment

This is from Reinald Doebel, Germany

My concern for this whole discussion comes from my initial training as an agricultural engineer and the experiences with the notion of "development" in Malaysia, Zambia, and India. My comment concerns Prof. Muir's exposition of the technology of risk assessment (Message 59, May 20).

I commend Prof. Muir for explaining so clearly the requirement for a proper risk assessment: risk assessment is done on the basis of the likelihood (probability) of a certain outcome to happen. One must know whether the likelihood for obtaining a certain benefit is 1 percent, 10 percent or whatever. And equally, one must know whether the likelihood for a certain accident to occur is 1 percent, 10 per cent, or 65 percent. It is on this basis that not only risk assessment in the area of technology development is handled, but also the whole insurance business. In the insurance business this is developed to the fine art of being able to adjust the fees for car insurance to the type of the car, based on statistics about the frequency of accidents with that car type.

I mention the example of insurance companies to illustrate the basic requirement for proper risk assessment: the probability for the occurrence of a "risk" must be known. And it can be known only on the basis of what has really happened in the past. Everybody knew about the theoretical possibility that a nuclear accident can happen, but on the basis of probability, nobody predicted Chernobyl.

I do not mention Chernobyl to "subliminally" suggest that genetic engineering is even remotely as dangerous to living organisms as the technology of the fission of atoms. I mention it because of the similarity of these two technologies precisely with respect to statistics: to the extent that a technology is really new, there are no precedences on the basis of which the probabilities demanded by Prof. Muir for a proper risk assessment can be established. The conclusion is: if we know little about possible dangers, we are not in a position to establish possibilities - and hence simply cannot conduct proper risk assessment. Risk assessment with respect to car technologies, airplane technologies etc. is based on hundreds and thousands of cases of real experiences with similar items. There is no similar item to a gene into which an "alien" piece of DNA has been inserted in a place where it does not belong. There is no real similarity between genetic engineering and breeding: "breeding" leaves the chemical processes of adding a new piece of information to the interaction between the organism and the environment. Genetic engineering attempts to insert "information" without consideration of either the intra-molecular interaction (which is known to exist) between different parts of the DNA molecule, and also without consideration of the interaction between the environment and the information present in the chromosomes. Thus, there is no precedent for properly (i.e. "scientifically") assessing the risks connected with that technology - by the very standards which Prof. Muir has so clearly laid out.

I would appreciate if any of the participants of this conference could point out a flaw in the above argumentation - because if there is no flaw in it, then it turns that caution (taking into consideration some known dangers which have been mentioned) is the more appropriate attitude to regulation. Rather than the emotional appeal to the possible benefits and the equally emotional threat that we might fall back into the stone age if we did not explore this technology.

Dr. Reinald Doebel
Institut fuer Soziologie
Scharnhorststr. 121
48151 Muenster
Germany
dobel (at) uni-muenster.de

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 13:51
To: 'biotech-room1@mailserv.fao.org'
Subject: 63: Re: Methodology for risk assessment

This is Prof J Ralph Blanchfield again, responding to Dr Doebel (Message 62, May 20) who asks for the flaw in his argumentation.

A major flaw lies in his statement:' "breeding" leaves the chemical processes of adding a new piece of information to the interaction between the organism and the environment.' Instead of inserting specific known genes in a targeted way, "breeding" inserts an unknown collection of genes in an untargetted way. Whatever the problems of genetic modification, they are at least matched if not surpassed by those of "breeding". It is also overlooked that so-called "conventional" breeding has included polyploidisation and treatment with irradiation.

Dr Doebel refers to vast experience on which to base risk assessment in airplane technology. None of that experience existed at the time of the first Kitty Hawk flight of the Wright brothers in 1903. Without progressing from there in the face of the unknown we would not have today's intercontinental passenger and cargo flights. By the same token, we cannot expect today's early GM to deliver all the foreseeable potential benefits, but we need to be able to build on today's early GM technology.

The purpose of risk assessment does not end with carrying it out. We (society and scientists as part of society) are not disinterested bystanders merely trying try to assess problems. We should be doing so in order to address and solve those problems, so that the potential benefits that future GM can offer may contribute to help feeding the world's escalating population, especially in the poorest developing countries where most of that growth is expected to occur. If some dismiss that as "emotional appeal", I call it a scientific and social responsibility. [Conference 5 of this Forum, entitled "Can agricultural biotechnology help to reduce hunger and increase food security in developing countries?" (held from 1 November to 17 December 2000), discussed in detail the potential impacts of biotechnology (including GMOs) on hunger. Further messages on the subject will not be posted here...Moderator].

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: 20 May 2003 16:35
To: 'biotech-room1@mailserv.fao.org'
Subject: 64: Codex - Draft Food Safety Assessment Guideline

This is Héctor Villaverde, from Chile.

My apologizes for the big quotation, but this is what consumers wish to keep contained by regulations, not more and more marketing campaigns and rhetorics about benefits of biotechnology. The quotation is not extracted from a "luddite" pamphlet, but from Appendix III on the "Draft Guideline for the Conduct of Food Safety Assessment of Food derived from Recombinant-DNA Plants" in the Codex Alimentarius' report Alinorm 03/34. The following sentences are real risk assessment:

"UNINTENDED EFFECTS

14. In achieving the objective of conferring a specific target trait (intended effect) to a plant by the insertion of defined DNA sequences, additional traits could, in some cases, be acquired or existing traits could be lost or modified (unintended effects). The potential occurrence of unintended effects is not restricted to the use of in vitro nucleic acid techniques. Rather, it is an inherent and general phenomenon that can also occur in conventional breeding. Unintended effects may be deleterious, beneficial, or neutral with respect to the health of the plant or the safety of foods derived from the plant. Unintended effects in recombinant-DNA plants may also arise through the insertion of DNA sequences and/or they may arise through subsequent conventional breeding of the recombinant-DNA plant. Safety assessment should include data and information to reduce the possibility that a food derived from a recombinant-DNA plant would have an unexpected, adverse effect on human health.

15. Unintended effects can result from the random insertion of DNA sequences into the plant genome which may cause disruption or silencing of existing genes, activation of silent genes, or modifications in the expression of existing genes. Unintended effects may also result in the formation of new or changed patterns of metabolites. For example, the expression of enzymes at high levels may give rise to secondary biochemical effects or changes in the regulation of metabolic pathways and/or altered levels of metabolites.

16. Unintended effects due to genetic modification may be subdivided into two groups: those that are "predictable" and those that are "unexpected". Many unintended effects are largely predictable based on knowledge of the inserted trait and its metabolic connections or of the site of insertion. Due to the expanding information on plant genome and the increased specificity in terms of genetic materials introduced through recombinant-DNA techniques compared with other forms of plant breeding, it may become easier to predict unintended effects of a particular modification. Molecular biological and biochemical techniques can also be used to analyse potential changes at the level of gene transcription and message translation that could lead to unintended effects.

17. The safety assessment of foods derived from recombinant-DNA plants involves methods to identify and detect such unintended effects and procedures to evaluate their biological relevance and potential impact on food safety. A variety of data and information are necessary to assess unintended effects because no individual test can detect all possible unintended effects or identify, with certainty, those relevant to human health. These data and information, when considered in total, provide assurance that the food is unlikely to have an adverse effect on human health. The assessment for unintended effects takes into account the agronomic/phenotypic characteristics of the plant that are typically observed by breeders in selecting new varieties for commercialization. These observations by breeders provide a first screen for plants that exhibit unintended traits. New varieties that pass this screen are subjected to safety assessment as described in Sections 4 and 5."

Héctor Villaverde
Food Programme Co-ordinator
Consumers International
Office for Latin America and the Caribbean
Las Hortensias 2371
Providencia, Santiago
CHILE
Phone: (56-2) 335-1695
Fax: (56-2) 231-0773
Email: programalimentario (at) consint.cl
www.consumidoresint.cl

[The quotation above is taken directly from paragraphs 14-17 of Section 3 (Introduction to Food Safety Assessment) of the "Draft Guideline for the Conduct of Food Safety Assessment of Food derived from Recombinant-DNA Plants" presented in pages 47-56 of report ALINORM 03/34, which is available towards the bottom of page http://www.codexalimentarius.net/reports.asp in English, French and Spanish. As explained at the bottom of Message 25 (May 7), the Joint FAO/WHO Codex Alimentarius Commission is an intergovernmental body set up to establish international standards on foods. The Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology agreed, at its 3rd session held on 4-8 March 2002 in Yokohama Japan, to advance the following texts to the 26th Session of the Codex Alimentarius Commission (to be held 30 June - 7 July 2003, Rome, Italy) for adoption:
1) The Draft Principles for the Risk Analysis of Foods derived from Modern Biotechnology
2) The Draft Guideline for the Conduct of Food Safety Assessment of Foods derived from Recombinant-DNA Plants
3) Proposed Draft Annex on the Assessment of Possible Allegenicity (an Annex of 2)).

ALINORM 03/34 is the report of this 3rd session. Reading from the Scope of the Draft Guideline, among other things it says that "This Guideline supports the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. It addresses safety and nutritional aspects of foods consisting of, or derived from, plants that have a history of safe use as sources of food, and that have been modified by modern biotechnology to exhibit new or altered expression of traits. This document does not address animal feed or animals fed with the feed. This document also does not address environmental risks". and "The Guideline describes the recommended approach to making safety assessments of foods derived from recombinant-DNA plants where a conventional counterpart exists, and identifies the data and information that are generally applicable to making such assessments"...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 17:21
To: 'biotech-room1@mailserv.fao.org'
Subject: 65: Regulation of GM versus conventionally bred plants

This is Professor Muir again. So sorry to get the list off on a divergent track already covered in Conference 7 of this Forum. However, in many aspects the regulatory framework and methodology for risk assessment cannot be separated. In the Background Document to this current conference, it states that "Regulation of GMOs has therefore always been a central part of the general GMO debate i.e. what kind of regulations they should be, what exactly they should regulate, how strict they should be, how GMOs should be regulated compared to their conventionally-bred counterparts etc.." .

The answer to the question posed was addressed by the National Academy of Sciences "Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation (2002)" viewed at http://books.nap.edu/books/0309082633/html/index.html [This publication by the Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants stems from the request by the United States Department of Agriculture (USDA) to the National Academy of Sciences to examine the scientific basis for and the operation of APHIS (Animal and Plant Health Inspection Service of the USDA) regulatory oversight...Moderator].

One of their main conclusions was that regulatory review should be the same for conventionally bred plants as for Genetically Modified (GM) plants. The basis for that conclusion was that specific traits introduced by both process can pose unique risks. In essence, they are saying the regulatory process is adequate for GM plants but inadequate for plants altered using conventional breeding techniques. It should be noted that one of the commonly used techniques in conventional breeding is mutagenesis induced using ionizing radiation.

While I believe that the range of traits that can be induced by transgenesis is much greater than that with mutagenesis, because mutagenesis is only inducing point mutations while transgenes are moving entire intact genes between species, I tend to agree with the basis logic of regulating the product not the process. In that regard, it is possible to evaluate risk of both types of plants (GM and Conventional) using the same methodology and that the regulatory framework could be the same. What that methodology is was the object of the Conference 7 of the Forum.

Bill Muir, Ph.D.
Professor of Genetics
Department of Animal Sciences
Lilly Hall
915 W. State Street
Purdue University
W. Lafayette IN 47907-2054
United States
http://icdweb.cc.purdue.edu/~bmuir/
bmuir (at) purdue.edu

[Professor Muir is correct about the difficulty of separating discussions of risk assessment and management from those of regulatory frameworks. In the Background Document to Conference 9, indeed, one of the questions we had asked people to discuss was
"- When addressing risk analysis and risk management in the regulatory framework, should
a) the risks associated with GMOs be compared with those from their conventionally-bred counterparts?
b) economic, social and ethical factors be included, in addition to potential human health and environmental impacts?"
Obviously, however, we don't want to go through exactly the same arguments as in Conference 7...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 21 May 2003 11:18
To: 'biotech-room1@mailserv.fao.org'
Subject: 66: U.S. regulatory experience may be instructive for developing countries

This is from Suzanne Wuerthele, United States.

While Bill Muir is correct (Message 59, May 20) that some products are evaluated "such that a reasonable degree of safety can be determined before they are loosed on the world," the automobile is a poor example. Automobiles were manufactured with no evaluation of future negative ramifications, while prospective benefits were highly advertised. Some countries have wrested incremental corrections at great expense from reluctant manufacturers, thanks to passenger injury and air pollution data. Other societal effects of automobiles, such as poor highway and city design will take centuries to reverse. [Bill Muir wrote "there are a number of ways to estimate risks of potential hazards in a safe secure setting such that a reasonable degree of safety can be determined before the technology is loosed on the world. This is how all new products, including pharmaceuticals, airplanes, cars, baby toys, etc. are evaluated before they hit the market. Biotechnology is no different"...Moderator].

Reinald Doebel pointed out (Message 62, May 20) that actuarial data allows accurate predictions of automobile accident risk, and because we have little experience with recombinant DNA (rDNA) technology, we have no basis for quantitative assessment of its risks. I would add that, like the automotive engineers of the 1920s, we don't yet even know all of the hazards of transgenic organisms.

Developing countries can nevertheless benefit from studying the regulatory experience in other countries. The following thoughts derive from observations in the United States:

1. rDNA technology will likely be used to create inventions which we cannot now imagine, but will want to regulate. For example, pharmaceutical companies are targeting developing countries for growing crops which make drugs and industrial chemicals. Thus, developing countries may want to consider legal frameworks which can regulate any future GMOs. Another example: In 1986 when the U.S. government set up its "Coordinated Framework" to regulate GMOs, it did not anticipate commercialization of transgenic animals. In 2001, when A/F Protein declared its intention to market the transgenic salmon, there still was no regulation which specifically covered that organism. But the Food and Drug Administration (FDA) claimed authority to regulate it by declaring the genes for accelerated growth a "new veterinary drug." Had the transgenic salmon been engineered for some other property, the government might not have had the legal authority to regulate it at all.

2. The U.S. experience also demonstrates the importance of determining in advance who will review the health, environmental, food safety, and social effects of GMOs, and how those reviews will be coordinated. Because coordination among U.S. regulatory agencies is still in flux, it is difficult for U.S. industry and consumers to determine how a product will be regulated or follow it through the regulatory process. For example, it is not clear which agency, if any, will review environmental hazards posed by the transgenic salmon. Likewise, most transgenic plants are reviewed under a law that limits the US Department of Agriculture (USDA) review to the plant's agronomic properties. If the USDA grants a plant "non-regulated status" then there is no legal mechanism for environmental reviews should problems be discovered in the future. And as GMOs go to market, many legal, ethical, and societal issues raised by GMOs are still unresolved. For example, there are no US regulations on liability for the consequences of gene flow to non-transgenic crops.

3. U.S. FDA policy states that GMOs are "substantially equivalent" to their non-engineered counterparts unless they are toxic, allergenic or have significant alterations in nutrient content. "Substantial equivalence" is a legal term. As a result, the transgenes and transgenic products in GM plants are considered "generally regarded as safe" under the law, and do not have to undergo long-term feeding studies or be labeled.

Adoption of a similar "substantial equivalence" policy by a developing country might prevent a food safety review of a GMO that could pose nutritional problems. It would be advantageous for developing countries to define in advance "significant" alteration of nutrients, especially in staple crops comprising a large percent of the diet or in people who have deficiencies. Likewise, developing countries should understand that because the "substantial equivalence" policy precludes long-term feeding tests, the U.S. has no data showing that transgenic foods do or do not create subtle adverse effects when ingested chronically or as a large part of the diet or in people with underlying nutritional problems.

4. Developing countries may want to consider laws which will allow regulation of the whole transgenic plant or animal, not simply its transgenic products. This is illustrated by the U.S. experience with transgenic plants that make pesticides. These plants contain several genes: those directing the pesticide production but also markers and promoters. However, as U.S. pesticide regulations are written, the regulated "pesticide" consists only of the pesticidal chemical and the genes necessary for its production, not other genes or the transgenic plant itself. Thus, if there is a need to regulate the way farmers use the transgenic plant (e.g., create insect refuges), this must be done indirectly. In the U.S., the pesticide manufacturer, rather than the government, inspects and enforces such requirements, then reports back to government regulators. This system was partly to blame for the fact that some farmers who planted StarLink didn't understand that they were required to segregate the corn from the human food supply. Another problem with this system is that it requires multiple reviews of the various genes by separate agencies.

Suzanne Wuerthele, Ph.D., D.A.B.T.
Regional Toxicologist
US Environmental Protection Agency Region 8
Denver, CO
United States
Wuerthele.Suzanne (at) epamail.epa.gov

-----Original Message-----
From: Biotech-Mod1
Sent: 21 May 2003 11:32
To: 'biotech-room1@mailserv.fao.org'
Subject: 67: Re: Methodology for risk assessment

This is from Clark Efaw, United States.

I have some problems with Dr. Blanchfield's (Message 63, May 20) argument in response to Dr. Doebel (Message 62, May 20).

Breeding randomly combines genes that already exist in the species being bred, and that have already gone through countless iterations of checks and balances to get there, both within the organism and in its environment. These checks and balances also decide whether mutations stay or go. The fact that inserted genes are targeted by biotech companies does not have any bearing on their suitability for release into the environment. They are targeted for reasons of economic benefit, and the producers seem to be very deliberate about avoiding any responsibility for economic or environmental consequences that can occur on release (see Julie Newman, Message 61, May 20).

Likewise, the analogy to airplane technology looks weak. The first flights at Kitty Hawk and in the following decades only exposed one human at a time to risk. Now, nearly a century later, most of us still have the option of avoiding it should we so choose, safe or not. Maybe a better analogy would be that of electricity distribution. Our great-grandparents were concerned that if all buildings were supplied with electricity, people would be dropping like flies. Today most homes and businesses in the developed world are flowing with juice, and, yes, it kills tens to hundreds of people every day. A great deal of environmental damage is caused in the production and distribution of elecric energy. Species are driven to extinction because of it. But we have made that trade-off because to a large extent we consider it worth the price. We minimize risk by isolating the hazard and holding product manufacturers responsible for product safety. We allow communities to have a say in how it is produced and distributed. We keep it contained, and label it clearly. We have government agencies dedicated to keeping it safe and to controlling monopolistic practices. We take advantage of the possibilities while going to great lengths to build redundancy into safety measures. These conventions have evolved over more than a century of use, and, yes, they use a different standard in Europe than in the US. I wouldn't take this analogy much farther, but the price of caution in the use of any new technology like biotech should be weighed against the benefit. If it's too expensive to internalize the costs of caution, then it's not yet worth it economically.

Clark Efaw,
CARE
Atlanta,
Georgia
United States
efaw (at) care.org

-----Original Message-----
From: Biotech-Mod1
Sent: 21 May 2003 11:48
To: 'biotech-room1@mailserv.fao.org'
Subject: 68: Substantial Equivalence

This is from C Kameswara Rao, Bangalore, India.

The Principle of Substantial Equivalence (SE) and Genetically Engineered Organisms (GEOs):

The Food and Drug Administration (FDA) of the US used the Principle of SE for decades to assure the public of the safety of foods (and drugs). The stringency of the regulatory oversight and safety standards of the FDA are regarded as high, and most other countries routinely approve drugs and pharmaceuticals on the basis of approval by the FDA. Subsequently, the Principle of SE has been applied to foods and other products from GEOs, to assure the consumer that the product is 'substantially equivalent' to its conventional counterpart and that it is safe for human consumption. This certification refers only to the product and not the process of its production.

The FDA has long considered GE plants to be substantially equivalent to conventional varieties and has published a policy statement to the effect that no other regulatory review to assure the safety of foods from GEOs is deemed necessary. However, taking advantage of the provision for voluntary consultation, biotech companies in the US seek independent certification by FDA of all GEO varieties and their products that are marketed in the US.

The policy of the FDA did not result in any health concerns but invited criticism on account of a) the FDA has a mandatory process for approving transgenic animals, and b) the United States Environment Protection Agency (EPA) and the United States Department of agriculture (USDA) have a mandatory and open process for evaluating the biosecurity of transgenic plants.

Foods from GEOs on the US markets have been tested extensively and judged substantially equivalent to their conventional counterparts. This is the case with many products from GEOs, such as cotton oil, tomato and corn from Bt varieties. Some products may contain miniscule quantities of one or two additional proteins, which are broken down during processing or digestion, or some others may contain some compounds not occurring in the counterparts that are present but below threshold levels. Such products are categorised as 'Generally Recognised As Safe' (GRAS). A factor that would cause a product to be considered otherwise is the presence of genes in the GEO or its product, which would code for fats, proteins or carbohydrates that may be toxic or may cause allergies or may change the nutritional value of the product. Bt potato is one such where the gene expresses in the tuber, but this has been tested and considered safe. For these reasons, a product can be certified as substantially equivalent to its counterpart only after an extensive analytical study.

Certifying a product as SE or GRAS is to assure the consumer that the food is safe to consume. While in the US, on account of the policy of the FDA, no labelling as SE or GRAS is mandatory, it is not so in several other parts of the world. This dichotomy causes considerable confusion in the global policy, and leads to needless controversies. There is a dire need for international harmonisation and uniform policy.

In recent times suggestions were made for the application of the Principle of SE to all products of genetic engineering, including livestock feed and GE crops, which raises certain questions.

When the principle of SE is applied to a GE crop variety, it should be substantially equivalent to its isogenic variety, in genotype, marked characters and performance, but for the transgenes and their anticipated characteristics and benefits. [Isogenic lines are genetically nearly identical, except with respect to identified genes...Moderator]. The objective is that, if the isogenic was safe, the transgenic would be equally safe, provided that the newly introduced transgenes do not exercise any adverse effects by themselves or through affecting the expression of any other genes of the isogenic counterpart. Such an assurance requires scientific evaluation of the crop variety first, and then of its products. This involves additional efforts, time and expense, raising costs to the consumer.

All US agricultural biotechnology companies submit to the FDA, voluminous dossiers on the safety and risk analysis of the GEOs and their derivatives produced by them before they go on the US markets. Such a voluntary mechanism should be global. However, like drugs and pharmaceuticals, what is considered safe in one country should be so in other countries, provided uniform testing procedures are adopted. There is no need to repeat every test in every country.

Another consideration is that transgenics would be substantially equivalent to their isogenics, up to a point in real time. Mutations occur naturally and randomly, affecting all genes. Members of the same population would be subjected to mutation of different genes and so would not be entirely identical with each other. Lethal mutations are naturally eliminated. If any genes related to the desired characteristics mutate, they are eliminated in the process of selection, but those that do not affect the desired characteristics escape attention and accumulate. After a certain number of generations, SE cannot be maintained for the entire genotype of all members of population. A critical genetic analysis at that point of time will contravene SE, although SE can be established for the genes of the desired characteristics. Such a situation would cause problems in some countries, where the regulatory authorities apply the principle in letter and a lot more strictly than in other countries.

On account of these reasons there is a need to re-examine the issue of SE and for re-defining its applicability to GE crop plants and their products, laying emphasis on a reasonable application of the principle, addressing only those genes and their products that are relevant to the objectives of developing a particular transgenic variety or product.

Since the objective of technology deployment is improvement of a product over what exists, the question should be 'is this better and safer than what is already there?'

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: 21 May 2003 14:28
To: 'biotech-room1@mailserv.fao.org'
Subject: 69: Re: Methodology for risk assessment

This is Dr. Doebel replying to Prof. Ralph Blanchfield's response (Message 63, May 20) to my earlier argument (Message 62, May 20).

I apologize to the participants for insisting on some seemingly minor details not directly related to regulation - but as Prof. Blanchfield clearly demonstrates with his repetition of an earlier message, nr. 58, May 19, (that time in response to Dick Richardson's message (nr. 51, May 13) on the molecular mechanics of genetic engineering versus the molecular mechanics of "traditional breeding"), it is the interpretation of such details which furnishes arguments for or against certain types of regulation. In particular: whether regulation should mean HOW to introduce a certain GMO or whether it should also be concerned with WHETHER a certain GMO should be introduced at all.

Prof. Blanchfield rejects the statement that: " 'breeding' leaves the chemical processes of adding a new piece of information to the interaction between the organism and the environment". He points to irradiation methods and polyploidisation as "conventional breeding" and writes "Instead of inserting specific known genes in a targeted way, "breeding" inserts an unknown collection of genes in an untargeted way. Whatever the problems of genetic modification, they are at least matched if not surpassed by those of "breeding"."

The scientific facts - as I see them - are that:

1) Irradiation methods are not part of "conventional breeding" but a rather recent introduction of forced mutation - leaving the response to the environmental (artificial) stimulation through irradiation to the DNA: not all mutations will survive and become part of the "real" breeding programmes which attempt to multiply those mutations producing particularly desirable traits.

2) Polyploidisation refers to stimulating the cell to produce an additional set of identical molecules of DNA - and therefore does not touch the internal structure of the DNA molecules. These are also rather recent methods and do not refer to "breeding" in the traditional sense of selecting plants with desired traits over plants with less desired traits.

3) The claim that the new methods consist of "inserting specific known genes in a TARGETED way" is simply not true: the truth is that snippets of the DNA molecule from one species (which are believed to result in a specific desired expression/action/trait of the whole organism - such as producing a chemical toxic for insects in the case of Bt cotton) are introduced into the sequence of nucleotides of the receiving organism (from another species) in a NON-TARGETED way. Non-targeted because (unless a new - and as yet little publicised - method has been found in the past two years) the specific location of insertion of the "alien" piece into the sequence of the receiving DNA cannot be determined in advance. This is problematic in an UNPRECEDENTED way, because the overall organismic reaction is determined not only by the chemical composition of the inserted snippet, but also by the interaction of this snippet with the rest of the molecule: the sequence of nucleotides determines the SHAPE of that molecule, and the shape in turn determines both the interaction within the molecule and the interaction between the molecule and the environment.

I do believe that arguments for more "enabling" regulations should respect known scientific facts, rather than referring to possible future benefits of the technology in question.

Dr. Reinald Doebel
Institut fuer Soziologie
Scharnhorststr. 121
48151 Muenster
Germany
personal e-mail: dobel (at) uni-muenster.de

-----Original Message-----
From: Biotech-Mod1
Sent: 21 May 2003 16:57
To: 'biotech-room1@mailserv.fao.org'
Subject: 70: GM regulations based on probability of spread

Professor Muir again.

The statement by Reinald Doebel (Message 62, May 20) "the probability for the occurrence of a 'risk' must be known. And it can be known only on the basis of what has really happened in the past" and reflected in other messages, implies that the regulatory process for GM products should be different from that of conventional breeding because the risk of harm (environmental) is unknowable for GM products because there is no past experience and cannot be determined until after the fact.

I differ with that conclusion on the basis that the longest running experiment in existence is evolution as a result of natural selection. We have studied the process of natural selection for decades and know how it works. Based on that knowledge we can develop regulations which restrict or prohibit release of GM organisms that appear to have some fitness advantage in a natural setting, e.g. forest trees that produce their own insecticide. It is clear that such a GM plant would have a survival advantage, it can be measured. Thus, regulations can be based on probability of spread of GM plants or animals into ecosystems. I feel we can easily quantify this risk of spread into categories of high versus low. Shifting the regulatory process to one that acknowledges the evolutionary process in an ecological context would help alleviate society concerns. This regulatory review could focus on the product and not the process, i.e. both domestically bred and GM plants and animals could be put through the same set of tests.

Bill Muir, Ph.D.
Professor of Genetics
Department of Animal Sciences
Lilly Hall
915 W. State Street
Purdue University
W. Lafayette IN 47907-2054
United States
http://icdweb.cc.purdue.edu/~bmuir/
bmuir (at) purdue.edu

-----Original Message-----
From: Biotech-Mod1
Sent: 22 May 2003 09:34
To: 'biotech-room1@mailserv.fao.org'
Subject: 71: Regulations for each sector? // Conference ends 1 June

[Thanks to Professor Muir (below) for raising for the first time one of several topics mentioned in Message 70 that we especially hoped to see discussed during this conference. It has now been decided to extend this conference on GMO regulation by 1 week, so the last day for receiving messages for posting in the conference will be Sunday 1st June. There will be no further extension past this date. We encourage you all to participate fully in the time remaining...Moderator].

Professor Muir again, I thank the moderator for getting us back on track again and setting out a number of very interesting but difficult questions in Message 70 (May 21). This message addresses the last question posed "Different issues are raised by the application of genetic modification in the agro-industry, crop, forestry, animal or fisheries sectors. Are different sets of regulations required for each sector?"

Again, risk assessment/management is tied in with regulatory issues. Human health risks differ depending on use of the product not the sector that produces it. Products that are consumed present more health risks than those that are not. For example, products from trees, cotton, and spider silk in goats milk are all associated with production of fiber for manifacturing fabric, tissue, paper, or lumber, but go across three sectors (forestry, crops, and animals). Thus, regulations related to human health should be associated with intended use rather than how the product is produced.

On the other hand, environmental risks can occur for all species regardless of intended use, i.e. any GM organism could potentially cause ecological harm through displacement or disruption if it can spread into the environment. Thus for environmental risks, regulations should be universal across all sectors. Having said that, there are certain species which pose more ecological risks than others. Those are species that can escape captivity, are mobile, and easily become feral. Thus maize, soybeans, and cows present a low degree of concern while trees, fish, pigs, and insects all present a higher degree of concern. However, those concerns can usually be addressed, but that is another story.

Bill Muir, Ph.D.
Professor of Genetics
Department of Animal Sciences
Lilly Hall
915 W. State Street
Purdue University
W. Lafayette IN 47907-2054
United States
http://icdweb.cc.purdue.edu/~bmuir/
bmuir (at) purdue.edu

-----Original Message-----
From: Biotech-Mod1
Sent: 22 May 2003 09:47
To: 'biotech-room1@mailserv.fao.org'
Subject: 72: Regulating for socio-economic risks

This is from Héctor Villaverde, Chile.

Maybe for developing countries the most important issue to address is the socio-economic risks from GM foods and organisms, and how to regulate to manage those risks. This is the main regulatory gap in developing countries.

The discussions are basically on food safety and environmental risks, but not at all on the seed monopoly by the transnational corporations (TNCs)(90% of the global area covered by GM crops benefits only one TNC), the lack of ompetition at national level due to the acquisition of national and local seed companies by TNCs, the lack of evalution of the costs/benefits of GM crops (for example, Mon 810 (Bt corn) fights a pest that doesn't exist in Chile or Uruguay; what are the benefits of growing such a crop in these countries? What are the benefits for its farmers, consumers, food manufacturers, and what are the costs?)

Héctor Villaverde
Food Programme Co-ordinator
Consumers International
Office for Latin America and the Caribbean
Las Hortensias 2371
Providencia, Santiago
CHILE
Phone: (56-2) 335-1695
Fax: (56-2) 231-0773
Email: programalimentario (at) consint.cl
www.consumidoresint.cl

-----Original Message-----
From: Biotech-Mod1
Sent: 23 May 2003 10:09
To: 'biotech-room1@mailserv.fao.org'
Subject: 73: Specific issues concerning regulatory frameworks

[Many thanks to Jane Morris for directly addressing some of the specific issues, listed in Section 5 of the Background Document and in Message 70, we wished to see raised in this conference...Moderator].

This is Jane Morris from South Africa

Let me try to address a few of the issues raised by the Moderator, although I do not pretend to have all the answers.

Firstly: regarding an appropriate regulatory framework for developing countries. In most developing countries the number of applications for use and release of GMOs is likely to be relatively small, at least in the early years. Therefore the regulatory framework should not be large and cumbersome, because this only introduces additional costs and there is no economy of scale. My colleague Muffy Koch contributed some interesting figures to a paper we published jointly at the end of last year on AgBiotechNet (December 2002, Vol 4, ABN102), which give some approximate costs for running a biosafety office and the cost per review. We make the point in the article that developing countries should not set up regulatory frameworks designed to "milk" the multinational companies of their funds. By doing so they will stifle the opportunity to grow the science base in their own countries and to develop GM products for public good rather than purely commercial gain. [The abstract of this paper, entitled "Biosafety of genetically modified crops - an African perspective", by Jane Morris and Muffy Koch is available at http://www.agbiotechnet.com/reviews/Abstract.asp?ID=188 ...Moderator].

It is, in my view, entirely appropriate for environmental and food safety data gathered in one country to be used as part of the input into the risk assessment process in another country. However, the risk assessment must of course take into account environmental differences (such as the possible presence of wild relatives of a crop in another country) as well as possible differences in food safety assessment (e.g. genetic predispositions to food intolerances in certain populations). There may be a need to gather additional data specific to the risk assessment for the country in question, but this should be determined on a case-by-case basis.

The question as to how much effort developing countries should put into developing a regulatory framework, given their limited resources, points to a number of issues:
1. If developing countries see potential benefit from the introduction of GM technology, then the effort will be worth it based on a cost:benefit analysis
2. The indirect impact of familiarization with GM technology can benefit science in the country as a whole
3. Developing countries should make maximum use of available resources internationally and in the developed world to assist them with risk assessment (it seems as though lack of familiarity with the technology is often the reason for indecision)
4. Developing countries should use regional organisations, where appropriate, as a means of pooling the resources and reducing the necessity for creating regulatory mechanisms in each country.

Costs of monitoring compliance with any legislation can be high, and GMOs are no exception (in fact, if monitoring may be needed even in the absence of legislation). Monitoring should therefore focus on the real safety issues rather than monitoring for non-compliance purely to catch people out for what may be fairly trivial issues. In the case of GM crops, most countries have some kind of existing agricultural inspection service, as well as extension officers, and these people can be trained in issues regarding GM technology in order to avoid duplicating functions and incurring additional costs.

In many developing countries there is a tendency to include social, ethical and economic factors in the decision making process as well as human health and environmental impacts. While these may not be safety issues per se, they are important, not only in looking at the cost:benefit equation, but also in ensuring the long term acceptance of introduced technology. The traditional decision making processes in Africa involve communities, and decisions made this way are more likely to achieve buy-in than a decision imposed only by scientists who are trained to deal specifically with safety issues.

E Jane Morris PhD
Director
African Centre for Gene Technologies
P O Box 75011
Lynnwood Ridge
Pretoria 0040
South Africa
Tel: +27 12 841 2642
Fax: +27 12 841 3105
Cellular: +27 82 566 2210
e-mail: jmorris (at) csir.co.za

-----Original Message-----
From: Biotech-Mod1
Sent: 23 May 2003 10:41
To: 'biotech-room1@mailserv.fao.org'
Subject: 74: Regional safety assessments - National agricultural decisions - Caution on novel traits

This is from Luca Bucchini, from Hylobates Consulting, Italy. Our firm provides consulting, training and laboratory services in biotechnology, food safety and risk analysis/management in Europe.

Three ideas for regulation: regional safety assessments, national agricultural decisions and caution on novel traits.

The discussion has been lively and interesting. Also, following the Moderator's recent remarks (Message 70, May 21), here are some ideas based on my work and research experience, and on analysis of trade and food safety trends.

In shaping regulatory frameworks for developing countries, it should be advantageous to consider the experience of countries that have extensively grown GM crops, especially the US and Canada (as Suzanne Wuerthele has pointed out in her message, number 66, May 21, listing some intriguing issues).

From my assessment of the US and Canadian experiences, at least two conclusions can be drawn with some confidence:

1. GM crops that have been planted on a large scale (Bt corn, herbicide tolerant soybean, herbicide tolerant canola, Bt cotton and perhaps virus resistant papaya) do not seem to cause significant adverse impacts on either the environment or on human health;

2. the ability to control gene flow and the movement of GM-derived material is, at best, limited (see the Starlink and the Oaxaca case, but also results from monitoring of soybean products in Europe). [The reference to Starlink is to the finding of Starlink corn, a variety approved for animal feed but not for human consumption, in products such as taco shells and chips in 2000. The reference to Oaxaca is to reports in 2001/2002 of transgenic material in maize landraces cultivated in Oaxaca in southern Mexico, part of the centre of origin and diversification of this crop...Moderator].

While these conclusions may not apply to other GMOs or to the more stringent regulatory system that the EU seems set to implement, they do carry to at least some inferences:

a) General approval of GM organisms should be granted at the global (or, at least, continent) level, taking into account regional differences.

If control of gene flow and movement of GM material, even across borders, is costly and extremely impractical in the US and Canada, it should be assumed that containing genes to certain restricted countries or parts of them is not feasible in other parts of the world.

Therefore, a useful distinction in regulations could be made between low level contamination (of seeds and/or food-feed), that may be considered acceptable, and planned, large-scale planting; I would leave the first in the international arena, and the second in the national one. Granted that low level presence of GM material may have serious environmental or sanitary consequences, and that it cannot be controlled at the national level, the appropriate level to determine its safety is at least that of a continent. This approach would also lessen trade disputes.

Even with a regional process, local differences in safety would be addressed, as risks of crops may vary in different countries (e.g., eating raw versus processed produce; centers of origin/diversity issues). It may be possible to put together international public funding to support such large-scale applications for few traits that may be urgently needed in some developing regions and cause reduced concerns (e.g., virus-resistant plants).

b) Permission to commercialize and use in agriculture GM plants or animals should be decided at the national level.

This is the level where social, economic and ethical issues should be debated and decisions made, probably more based on agricultural considerations than currently done, as safety issues have been resolved in international fora. In this case, additional data may be required that are useful to predict effects on agricultural practices.

In practice, one should note that, as pointed out in the Background Document to this conference, developing countries are facing increasing pressure to ensure the quality and safety of their agricultural products. It is doubtful that the efforts to enforce biotechnology regulations turn out to be effective and a good investment (especially, when complex management strategies or labeling thresholds are involved). Moreover, also under the hypothesis of national approvals, it is unclear whether any GM product approved only at the national level (especially in a developing country) could be effectively excluded from trade. In terms of forestry, there is little indication that GM wood may be acceptable to people who oppose GM foods.

c) Particular cautions should be taken with some modifications

The experience gained in the US and Canada and some other countries is limited to a few traits. Unless, in those countries, the approval process slows significantly, the number of traits and plants modified will expand dramatically to include biopharming-relevant modifications. It is not unreasonable to predict that some of these traits will cause some, possibly minimal, adverse events. However, even tiny adverse effects may elicit a very strong reaction from the public, in developed countries, especially when the hazard is new and not fully understood (witness, these days, the Mad Cow case in Canada).

It is extremely important, in my opinion, that developing countries take a cautionary approach to traits that go beyond the ones experimented in the countries mentioned above. In fact, even open-trade promoting countries may become extremely strict in matters of import when the public becomes sensitive to a safety issue. The future may be different, as genetic modifications is linked, in the public mind, to conventional breeding and the failure of a single event is not linked to a failure of the technology as a whole, but this future seems at least a decade away.

In summary, a science-based approach to ensure the human health and environmental safety of GMOs should be taken at the international or regional level, since low level flow of GMOs cannot be prevented. If such international determination is made, national decisions based on agroeconomic, social and ethical issues can really be made. Finally, developing countries should concentrate on few useful GM traits and exercise caution on novel, untested GM traits.

Luca Bucchini, PhD, MPH
President
Hylobates Consulting Srl
Via Gaggiano 42
00135 Rome
Italy
lucabucchini (at) hylobates.it

-----Original Message-----
From: Biotech-Mod1
Sent: 23 May 2003 10:44
To: 'biotech-room1@mailserv.fao.org'
Subject: 75: GM food crops and biosafety

I am Omwoyo Ombori from the Botany Department, Kenyatta University, Kenya.

Use of genetic engineering is a potential tool to produce transgenic plants of improved quality, hence this will increase production of food especially for the ever-increasing population in semi-arid areas. However, it requires that appropriate intensive biosafety measures are taken into consideration so as to avoid releasing food crops which can have negative effects on human beings. Strict regulations must be followed. All transgenic food released to the market must be labelled.

Omwoyo Ombori
Kenyatta University
P.O. Box 43844
Nairobi
Kenya
ombori (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 23 May 2003 11:09
To: 'biotech-room1@mailserv.fao.org'
Subject: 76: Economics - US regulation - Country data

This is from Budi Prakoso, Thailand.

I agree that we should regulate the products of GM organisms, not the process of how to modify the organisms. Breeders and biotechnologists, both try to combine desired traits and remove or repress the unwanted traits in their products. It is not economical to detect and know all unintended traits. In term of selecting a new crop line for example, greenhouse, field and multi-location trials are carried out to assess agronomic characters, including survival ability and weediness. In addition, proximate analysis is also carried out if the product will be consumed. [Proximate analysis is used to assess the relative content of water, fat, protein, ash etc. in the product...Moderator]. In certain cases, when a crop has been known to contain a toxic or harmful product (for example cyanide in cassava), the harmful concentration is also analyzed. In the present regulation, it is mandatory to do safety testing by assessing the effect of the new crop product on the growth of certain tested organisms. It is not economical to test the effect of that product on all organisms in the world. It is also not economical to do allergic tests for something that we do not know before (unintended proteins) to all sensitive persons (we do not know who will be sensitive to a new unknown antigen).

I think the present regulation on the release of GMOs applied in the USA is good enough to be applied in all countries. In addition, consumers should be informed and educated that GMOs that have been released are safe based on all tests that have been done. Then, labeling of GMO material in food will not have bad impact on its marketing. It is only a trademark. In some cases, it may inform the advantage of the GM product, for example if it has a better nutritional value.

The environmental and food safety data from one country may or may not be appropriate for commercialization in other country. For examples, proximate analysis data can be used everywhere, but survival ability and weediness are site specific. However, the data from one country can be used as a reference to carry out similar tests in the other country.

Budi Prakoso
Bioprocess Technology
Asian Institute of Technology
Pathumthani, Thailand
e-mail: bpd999870 (at) ait.ac.ath

-----Original Message-----
From: Biotech-Mod1
Sent: 23 May 2003 12:45
To: 'biotech-room1@mailserv.fao.org'
Subject: 77: GM crops regulations: End-user or affected party approach

I am Vikas Nath, Manager, global public goods Network (gpgNet.net) Forum.

My concern is that issue of regulations on GM crops cannot be dealt in a vacuum or in a blanket manner. Since end-users or affected parties of introduction of GM crops are heterogenous (implying, they will be affected to different degrees), we will have to design the regulations so that all affected parties are able to make an INFORMED choice on use of GM crops.

Some of the key affected parties are national governments, markets (including agro-intermediaries, retailers, stockers and wholesalers), farmers and the "public" which is the consumer of GM food crops.

When the affected party is the national governments, GM regulations should ensure that countries are fully aware of crops they are importing or trading or otherwise allowing for cultivation within their borders. This also implies that capacity-building of national agricultural research institutions should be undertaken so that they can better gauge the impact of GM crops introduction both ecologically and economically.

Where the affected party are the markets, then GM products should be clearly labelled so, rather than being sold surreptitiously through existing brand names. This has often been the case in many countries, and as a consequence of it, GM crops enter the markets without conscious decision of any of the agro-intermediaries.

Similar kind of regulations should exist, to ensure that farmers and the "public" at large are fully aware of the risks and prospects of GM crops. This implies that such information should be provided to them, not simply through GM firms but also through national research institutions and markets.

A chain reaction can therefore occur where weak GM regulations at one level may lead to potential disaster at another level. And in the absence of adequate funding for agricultural R&D to assess the risks and potential of new technologies, developing countries are certainly at the disadvantageous end, when it comes to GM crops introduction. Please feel free to share the concern on "Consequences of the shifting balance from public to private in agriculture R&D discussion forum", being run between 26 May and 9 June 2003 on the gpgNet.net platform. The complete background note is available at http://www.gpgnet.net/topic03.php. To subscribe, send a blank email to subscribe-gpgnet-agri@groups.undp.org

Vikas Nath
gpgNet.net Forum Manager
Office of Development Studies
United Nations Development Programme (UNDP)
336 East 45th Street, New York, NY 10017
USA
Email: info (at) gpgnet.net
URL: http://www.gpgnet.net
gpgNet.net intends to serve researchers, policymakers, business and civil society as a platform for information exchange and discussion on issues concerning the theory, policy design and practice of providing global public goods.

-----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

-----Original Message-----
From: Biotech-Mod1
Sent: 28 May 2003 10:03
To: 'biotech-room1@mailserv.fao.org'
Subject: 82: A few observations on the debate

These comments are from Dr. Peter W.B. Phillips, NSERC/SSHRC Chair in Knowledge-based Agri-food Development. Member of Canadian Biotechnology Advisory Committee and co-chair of the review of the Canadian regulatory system for GM foods (released Aug 2002) [Entitled "Improving the Regulation of Genetically Modified Foods and other Novel Foods in Canada", available from http://cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwGeneratedInterE/h_ah0009 4e.html ...Moderator].

Let me start by suggesting that part of the difficulty of debating regulation is defining the rationale. As an economist, I tend to the view that governments should restrict their actions to areas where there are demonstrated market failures (which could mean inadequate private regulation, unacceptable market power, unacceptable distributional effects ...) and where the actions they take address and have some chance of ameliorating the market failure.

In that context, I am somewhat concerned about the view that regulation of biotechnologies in the food system should be expected to handle a wide range of posited market failures related to: health and environmental safety; industrial structure; economic and distributional impacts; social impacts; and moral aspects. I tend to the view that if we have multiple problems, we probably need multiple policy tools.

Now, let me relate this to the core of this discussion, which is what advice could we give to countries (mostly developing) which do not already have regulatory systems for GM foods.

1. Public health and safety should be the prime motivator for regulations specifically related to GM foods: In that context, I think that more discussion could be undertaken on what an appropriate distribution of local versus non-resident evaluation might be. Keep in mind that risks are examined in a methodical way and are commonly defined as hazard x exposure.

- In the first instance, I think there is a good base for common methodological assessments of risk. The methods of assessing food safety risk have been well articulated in the oft mentioned Codex Guidelines. Relying on and using those would be a wise first step.

- Second, I would argue that the characterization of the hazards related to GM food is unlikely to vary greatly by population or ecosystem, and as such is likely appropriately characterized well once and then incorporated into population or ecosystem analyses. Canada and the US, for instance, have Mutual Recognition Agreements on using some characterization data, while the Organisation for Economic Co-operation and Development (OECD) has developed consensus documents on the biology or characterization of certain events, which are then accepted and used by many regulators. On the food side, the critical hazards are toxicity, allergenicity and compositional change while invasiveness, outcrossing and potential hazard to non-target organisms (e.g. monarch butterflies) would be examples of the hazards that need to be characterized. In short, one good characterisation is undoubtedly better than many partial or poor efforts. Hence, international harmonization should be the standard here.

- Exposure levels, in contrast, are usually locationally specific. The challenge is to determine the critical level of exposure before a hazard can be observed to happen. Between populations, diets and susceptability to allergens can vary widely. Similarily, the impact of a new trait cultivar could vary widely depending on the indigenous flora and fauna and on the nature of the cultivated and uncultivated areas, and their interaction. In some cases, the structure of the industry and the institutions may influence exposure levels. All of these could be locally assessed or, perhaps more appropriately, health exposures should be assessed within a cultural/economic/social population (which in some areas of the world could be smaller than a state or in other areas encompass many states). Similarily, exposures and risks of release of organisms will seldom respect geopolitical boundaries and should be evaluated at the ecosystem level, which may be larger or smaller than a state.

This is a long exposition to simply argue that regulation of the health and safety aspects should rely fundamentally on internationally characterised hazards, generally accepted methods and locationally relevant assessments of exposure. To this end, developing countries should consider regional assessments (e.g. amazonian rain forest). In many cases there is pre-existing capacity to undertake some of the science in many of the Consultative Group on International Agricultural Research (CGIAR) centres located around the world. That would likely make assessments more effective (e.g. reduce type 1 errors, such as releasing a risky organism) at a lower resource costs. [In statistics, a type 1 error means we reject the null hypothesis when it is true; a type 2 error occurs when the null hypothesis is false but we fail to reject it...Moderator].

2. Most other aspects that concern people about GM foods--e.g. industrial structure; distribution of winners and losers; social impacts; moral aspects--while raised in the context of GM foods are not unique to GM foods and probably are better handled in the context of a broader development policy. Adding them to the health and safety regulations raises the risk that type 1 (risky) errors will be made (simply because the method is flawed or tradeoffs are undertaken by regulators), or alternatively, that type 2 errors (rejecting safe and possibly beneficial advances) may be compounded. Both are likely to be major problems for developing countries.

Professor Peter W.B. Phillips,
Department of Agricultural Economics
51 Campus Drive
University of Saskatchewan
Saskatoon, SK S7N 5A8
Canada
phillips (at) duke.usask.ca

-----Original Message-----
From: Biotech-Mod1
Sent: 29 May 2003 16:18
To: 'biotech-room1@mailserv.fao.org'
Subject: 83: GMO legislation and centers of genetic diversity

This is from Professor Nazimi Acikgoz, Seed Technology Center in Izmir - Turkey. I am also the editor of a monthly, bilingual (Turkish and English) electronic newsletter called Agbiyotek: http://www.agbiyotek.ege.edu.tr).

It seems that we have missed the main spirit of the GMO regulation issue. Before we deal with the technical or administrative aspects of biotechnology regulation, the general application of biotechnology in developing and transition countries should be discussed. So far, crosses cannot be prevented and are not negligible in commercial transgenic plantings (proved almost for every genus including autogamous (self-fertilising) species, but some tools like genetic use restriction technologies (GURTs), seed-lethal (SL) or similar systems are not put into practice yet (see e.g. J.P. Schernthaner et al. 2003. Control of seed germination in transgenic plants based on the segregation of a two-component genetic system. PNAS, 100, 6855-6859, abstract available at http://www.pnas.org/cgi/content/abstract/100/11/6855?maxtoshow=&HITS=10&hits =10&RESULTFORMAT=&author1=Schernthaner&searchid=1054214870161_2150&stored_se arch=&FIRSTINDEX=0&sortspec=relevance ).

The "centers of genetic diversity" concept should be considered as a key point for every GMO legislation initially. Being one of genetic diversity centers of wheat, Turkey, with over 9.3 million hectares wheat acreage (Acikgöz N. et al., Progresses in Turkish Seed Industry. In "Seed Policy and Legislation, Widening a Narrow Focus" The Haworth Press, New York 2002), might want to benefit from any transgenic wheat commercialization. Just a piece of information: wheat breeders know that there are more than 10 wheat cultivars in the world originating from Turkey. At this point, I ask myself:

1. Don't we need to protect all wild, landrace and cultivated genotypes (existing, or which can occur without any knowledge of human being) and present them to our future generations?
2. Assuming Turkey bans transgenic wheat cultivation, and transgenic wheat reflects a 10% benefit, will Turkey not be a loser of 1.8 million tons annually, with its 18 million tons of wheat production?
3. Who will pay the costs?

These statements reflect the fact that decisions cannot be easily made in plant biotechnology. I ask myself: "how will you explain the situation to those readers, with a background other than in life sciences". Maybe it will be logical to start in FAO's "Agricultural biotechnology: Meeting the needs of the poor?" with such fundamental issues. [This is the title of the upcoming The State of Food and Agriculture 2003, due to be published this Autumn. This annual SOFA report is one of FAO's main publications, providing an annual report on current developments affecting world agriculture...Moderator]. Preparing legislation, what kind of regulations, how strict they should be, how GMOs should be regulated etc. should be handled within local even ecological conditions. Regional cooperation and know-how exchange would bring a perfect solution to legislation. At the beginning, no one specific country can settle a perfect GMO regulation. A special experienced service provided by FAO seems to be a logical solution. Or a special training service for bureaucrats of mentioned countries might be also a start. Because "regulating for GMOs" is a job for a group of experts. Including "plant made pharmaceuticals or biopharmaceutical" issues, "regulating GMOs in any country" seems to be beyond the limits of a single country. Maybe such cases are the main reason for the existence of the United Nations and its sub-units. A similar brainstorming on "GMO and centers of genetic diversity" should be organized immadiately with FAO's initiative. For detailed resolutions, FAO should cooperate with the Organisation for Economic Co-operation and Development (OECD), the Consultative Group on International Agricultural Research (CGIAR), World Health Organization (WHO), United Nations Environment Programme (UNEP) and similar organizations. [FAO, WHO and UNEP are all part of the United Nations system, see http://www.un.org/aboutun/chart.html ...Moderator].

Prof. Dr. Nazimi Acikgoz
E.U. Seed Technology Center
35100 Bornova
Turkey
nacikgoz (at) ziraat.ege.edu.tr

-----Original Message-----
From: Biotech-Mod1
Sent: 30 May 2003 13:14
To: 'biotech-room1@mailserv.fao.org'
Subject: 84: Prioritizing the regulation of for-profit GMOs

This is Dr. Justin Mog from the University of Wisconsin-Madison, again.

Prof. Blanchfield's asserts (Message 78, May 26) that: "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." What is the basis for such an assertion, particularly in the context of the poorer nations that are the focus of this conference? Have government agencies, charitable foundations and international research institutes historically lead the way in the research and development (R&D) of many other such technologies introduced to 'Third World' communities? Isn't potential profitability a central driver of R&D investments for expensive, high-tech advances like GMOs? As I see it, experience to date and the fundamental nature of existing economic incentives suggest that, contrary to Prof. Blanchfield's assertion, it is for-profit biotech companies which are most likely to be leading the way in GMO R&D; while governments and others struggle to respond appropriately to the technologies introduced by these firms. I believe that this point is critically relevant to this conference's thematic question of how resource-strapped governments ought to prioritize GMO regulation.

In an earlier Message (nr. 16, May 5), I laid out an argument for prioritizing the regulation of for-profit GMOs vs. those not developed for profit, saying that: "for the purposes of protecting the interests of the most vulnerable members of their agricultural populations, regulators in poorer nations might do well to restrict the access granted for-profit GMOs to domestic agricultural input markets." Subsequent messages have tended to focus the debate about how to regulate on technical aspects of the technology itself, rather than the motivations behind its development and distribution. I won't restate my argument here, but I remain eager to know whether other participants agree that the for-profit vs. not-for-profit distinction is a useful one for prioritizing GMO regulation in the poorer, more vulnerable nations of the world.

Finally, I will just note that, perhaps, we may be blind to the importance of for-profit biotech firms because most of the participants of this conference seem to come from the not-for-profit side (myself included).

Justin Mog, PhD
Gaylord Nelson Institute for Environmental Studies
University of Wisconsin-Madison
315 N. Ingersoll St.
Madison, WI 53703-1611
U.S.A.
E-mail: jmmog (at) wisc.edu

-----Original Message-----
From: Biotech-Mod1
Sent: 30 May 2003 14:56
To: 'biotech-room1@mailserv.fao.org'
Subject: 85: Re: Prioritizing the regulation of for-profit GMOs

This is Prof J Ralph Blanchfield responding to Dr Justin Mog's (Message 84, may 30) request.

In referring to the future pattern I thought my context made clear that I was thinking not of more applications of current "first generation" GM (which were developed by the biotech companies primarily for their principal customers, the US farmers) but of the second and subsequent generations of GM, of the kind precisely for "the poorer nations that are the focus of this conference". The forerunner of these was Dr Ingo Potrykus's golden rice project, funded by the EU and the Rockefeller Foundation and now being further developed, with indigenous rice varieties, at the International Rice Research Institute and 13 other rice institutions across Asia. Yes, it has made use of a number of patents owned by biotech companies, but, as stated in my sentence immediately preceding the one quoted by Dr Mog, the patent owners have donated royalty-free licences for this purpose. The future is, of course, a matter of opinion, and in scientific matters rarely foreseeable merely by extrapolating from the past and present, but in my opinion this will be the main sort of pattern by which future GM crops will be developed that will provide such additional advantages as:
1. Ability to grow in inhospitable environments (conditions of drought, saline soils, aluminium-rich soils, extremes of temperature)
2. Improved nutrition attributes (especially of micronutrients) and addressing the major nutritional deficiency diseases that afflict such a large number of our fellow human beings, predominantly in the poorer countries - (Vitamin A deficiency disorders (VADD); nutritional anaemias (especially iron); and iodine deficiency disorders (IDD), the latter a desirable target for which no GM research strategy has yet been developed as far as I am aware).

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
IFST Web address www.ifst.org
Personal Web address www.jralphb.co.uk

[This discussion thread on the future pattern of GM research and development is now cut. Only messages directly dealing with the theme of "Regulating GMOs in developing and transition countries" will be posted...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 30 May 2003 16:32
To: 'biotech-room1@mailserv.fao.org'
Subject: 86: The objective and content of GMO regulatory frameworks

This is Gert Willemse from South Africa again.

Having made use of examples to make my point in the past, the discussions equating GMOs to planes and boats and trains (and motor cars) have convinced me not to use these examples any more. It really is a circular argument with some truth in any point of view held, not resolving anything.

What did become clear is that much disagreement exists as to the "what" (objective) and "how" (content) of regulatory frameworks for GMOs. I cannot agree with Justin Mog's view (Messages 16 and 84) that regulatory distinction should be made between for-profit and not-for-profit GMOs. If the point of departure in regulation of GMOs is a risk-based one (which it should be) such a distinction would automatically assume that the risk lies not with either the technology nor the product, but rather with the objective or purpose.

What the circular arguments do highlight is that serious consideration needs to be given to the content and institutional framework of regulatory systems during the design phase. When considering the arguments about plants produced through normal breeding and those that were genetically engineered, and the different approaches with regard to regulation, it becomes clear that the same regulatory criteria are not being applied for GMOs and for their non-GMO equivalents. And yet, the impacts through the "non-regulated" introduction of agricultural crops worldwide are enormous. The total global cost of common agricultural pests (introduced as aliens together with crop plants) would be enough to cover the development funding of several poor nations. The same holds true for invasive alien species of every taxonomic class imaginable, imported for purposes ranging from horticulture to the pet trade, resulting in huge losses due to, among others, diseases and decreased environmental services. The disaster that befell the European crayfish populations more than adequately illustrates this point. [The reference here is to an example of an introduced disease which severely impacted biodiversity - the crayfish plague (Aphanomyces astaci) which decimated European crayfish populations, see e.g. http://www.fao.org/DOCREP/003/AB412E/ab412e09.htm ...Moderator].

It is for this reason that I find the biosecurity concept such an attractive one, to deal with all risks on an even keel. [This concept was discussed in Section 4.d of the Background Document...Moderator]. If we continue to apply different criteria in risk assessment and risk management based on our perceptions and individual likes and dislikes, we will continue to generate disasters, while stifling development that is needed above all by developing countries.

Finally, in response to Nazimi Acikgoz's message (No. 83 of 29 May), the principle of not allowing a GMO into the species center of origin is one that should never be compromised. If an argument of costs is brought into the discussion to facilitate any decision where the principle is considered to be waived, such an argument should be based on full cost-benefit analysis taking into account potential costs to, and benefits of, the base genetic resources as well as the potential impacts on ecosystem goods and services, and heritage values. I believe in such an instance the cost-benefit equation would not be in favour of the GMO.

Dr Gert Willemse
Private Bag X447
Pretoria 0001
South Africa
Tel: +27 12 3103836
Fax: +27 12 3207026
bioconsult2002 (at) yahoo.co.uk

-----Original Message-----
From: Biotech-Mod1
Sent: 31 May 2003 10:55
To: 'biotech-room1@mailserv.fao.org'
Subject: 87: Regulation of GMOs in the livestock sector

This is a joint contribution from Dr Clemens B A Wollny (Animal Breeding and Husbandry in the Tropics, Georg-August University, Goettingen, Germany) and Dr Ronny R Noor (Animal Breeding and Genetics, Bogor Agricultural University, Indonesia).

We would like to highlight some aspects regarding livestock. We have to differentiate between use of GMOs as feed ingredient and use of genetically modified animals.

The current big issue in transition countries is the use of GM maize as a feed for poultry and pork or by-products of cash crops, which are fed to various species of farm animals. In general, trials conducted in developing countries are often poorly controlled and implementation of regulations is difficult to enforce. Also, monitoring and data analysis is rarely conducted by independent researchers but by governmental institutions. This may affect the credibility of reports or decisions taken by the general public and non-governmental organizations. The weakness is not the regulation policy as such but its implementation and control. Our experience from African and Asian developing countries is that the consumer perceives a risk, that products derived from livestock, which consumed GMOs-based diets, poses a hazard. We therefore recommend to analyse the food chain in regard to the prevailing production systems very carefully and to integrate the issue of any possibility of GMO products processed by farm animals. This is especially important in emerging large-scale peri-urban systems.

The second issue is the future existence of GM livestock. From historical data we know that indiscriminate crossbreeding threatens locally adapted farm animal populations resulting in the extinction of local breeds or strains. Loss of genetic diversity could be an irreversible result. At present, the debate and regulation regarding livestock is lacking far behind the scientific and public discussion in crops. Possible positive or negative effects of products derived from GM livestock on consumer health are not yet known - at least in most of the developing countries. On the other hand, a very strict policy, which would impose a ban on all GMO-related applied research in livestock would negatively affect the use of molecular genetics for, e.g., breed and trait characterisation. This area of research is very important to conserve and to utilize indigenous livestock. The exchange of genetic material for research between countries could also be negatively affected and is complicated further through the ongoing debate on property rights. Therefore, it is important that this area of research remains in the public and is regulated and controlled in a transparent way. Enforcement of objective regulation criteria can be easily set up between equal partners in developed countries but existing political dependencies between developed and developing countries require complementary measures. Strengthening of international public agricultural research is one important strategy to control and develop facts-based decision criteria for GM livestock.

Prof. Dr. Clemens B. A. Wollny
Animal Breeding and Husbandry in the Tropics and Subtropics
Institute of Animal Breeding and Genetics
Georg-August University Goettingen
Kellnerweg 6
37077 Goettingen,
Germany
phone: +49 551 39 3448
cell: + 49 171 907 1848
fax: +49 551 39 3099
email: cwollny (at) gwdg.de

-----Original Message-----
From: Biotech-Mod1
Sent: 31 May 2003 11:04
To: 'biotech-room1@mailserv.fao.org'
Subject: 88: Regulations in developing nations should be rigourous for some more time

I am E.M. Muralidharan from India again.

Since the conference is about to end, I would like to take the opportunity to make my position clear on the main issue. I believe that my position is somewhere in between the opposing groups in the debate on GMOs. In my view, GMO releases need to be rigorously regulated in the developing countries for some time to come and the regulatory systems need to be more transparent and should take into consideration the innumerable factors that don't fall within the purview of scientific research. In the angst concerning the developing world we should not prop up any fledgling technology (not all of GM) without having spent time and effort to understand all the implications. The comparison of recombinant DNA techniques with traditional breeding is not justified nor is the parallel drawn with the early efforts of the automobile or aircraft industry. On the other hand, I am sure GMOs are here to stay and indeed can offer specific solutions that cannot be achieved by any other way. Biotechnology itself is going to provide the tools for overcoming many of the features of GMOs that have given rise to the doubts among the anti-GMO lobby. For example, wound-induced promoters are an elegant way of ensuring that non-target insects are not affected by genes for insect toxins. We are sure to eventually find means of targeting the genes to specific locations in the host DNA and ensuring that non-intended effects are avoided. But this will take time. We are far too early in this technology to be claiming that a fairly good assessment of the risks has been done.

The regulatory system needs to be tailor-made for the developing countries since the chances of unanticipated outcome is greater. Most of such nations do not have, or cannot have in the near future, an appropriate regulatory system. GMOs and their products can be put to unintended uses and regulations breached unwittingly or for purely economic reasons. Examples that come to mind are cottonseed oil and oilcake being used as food and animal feed and illiterate or poor farmers with small plots of farmland ignoring the need for refuge crops. In a developed country the implementation of regulations can be ensured to a much greater extent and better guarantee provided for legal redress for any detrimental consequences resulting out of GMOs. The likelihood of entire communities being taken for a ride with false promises by the unscrupulous corporate interests is far greater in a developing country.

It appears feasible that the developing nations can pool their resources or institute a mechanism under the auspices of an international body like the FAO or CGIAR to take care of the risks of introducing GMOs.

E.M. Muralidharan
Genetics Division
Kerala Forest Research Institute
Peechi 680 653 Kerala,
India
emmurali (at) kfri.org