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-----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