[To contribute to this conference, send your message to biotech-room1@mailserv.fao.org. For further information on the Electronic Forum on Biotechnology in Food and Agriculture see Forum website.
Note, participants are assumed to be speaking on their own behalf, unless they state otherwise.]

-----Original Message-----
From: Biotech-Mod1
Sent: 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