[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: 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