6-Regulation: Syngenta's suggestions on protecting consumers fromtheir governments' GE decisions

[GENET <coordination@genet-info.org>]

Dear GENET-news readers,

this is one of the most interesting quotes I have seen in the last months
of GMO struggle in the EU:
"That really is the issue, that the regulation hasn't the power to act,
the regulation can only advise the government of the day. Put that
alongside the increasing power wielded by the consumer -- and
governments, of course, are made up of elected politicians -- then
elected politicians can be influenced by consumer opinion and attitude.
What you don't see is their best interest being protected by an
independent authority."

So consumers must be protected from their governments' actions which
reflect the influence by the consumers opinion and attitude? It is
difficult to follow this logic. As more simple appears the explanation
that EU governments do not follow the advice of Syngenta any longer but
EU and national agencies still do.

When we recall the opinion of Commissioner Lamy from 17 Mar 2004:
"'There will be new authorizations,' European Union Trade Commissioner
Pascal Lamy told Reuters. 'It has to be agreed by a majority of member
nations but, in the end, it's the (European) Commission that decides.'"
part of Syngenta's problems are already solved - by the possibility to
approve GMOs against the will of EU governments through the European
Commission as "independent authority".

Syngenta has a big influence in the Indian biotech discussion, so it is
not very surprisingly that we can find their ideas reflected in the
recent suggestions to streamline the Indian GMO approval system - see the
second news clipping.

regards,
Hartmut Meyer



                                  PART I
-------------------------------- GENET-news -------------------------------

TITLE:  Sygenta's Pragnell comments on biotech foods, EU regulation
SOURCE: Bloomberg, USA, by Peter McGill
        posted by checkbiotech / Syngenta
        http://www.checkbiotech.org/root/index.cfm?fuseaction=newsletter&
        topic_id=1&subtopic_id=8&doc_id=8115
DATE:   5 Jul 2004 

------------------- archive: http://www.genet-info.org/ -------------------



Sygenta's Pragnell comments on biotech foods, EU regulation

NEW YORK (Bloomberg) - Michael Pragnell, chief executive of Syngenta AG,
comments on the company's decision to end research on genetically
modified crops in the U.K. and discusses the European Union's need for an
independent regulator. Pragnell spoke at a conference on consumers,
farmers and food at the Royal Institute of International Affairs in London.
[<http://www.riia.org/index.php?id=5&cid=55>]
Syngenta, based in Basel, Switzerland, is the world's biggest maker of
crop chemicals.



On ending basic research on biotech crops in the U.K.:

"It was about the rationalization of our research activity around three
major laboratories, two in Europe and one in North America. We had four,
we wanted to reduce them to three, to get greater proximity of our
scientists, to accelerate the rate of innovation." "What we are doing is
investing some $40 million in new research facilities, and we had to
decide where we did what." "This was not a political decision about
saying 'Goodbye Europe, there is no future for biotechnology-based crops
here in Europe.' Not at all."


On European consumers' concerns about gene-altered foods:

"What we saw happening in the late 1990s here in Europe was where a
technology was launched on an unsuspecting consumer in the belief that
the consumer wanted the product and would therefore buy the product.
"What became abundantly clear was that the European consumer was not
prepared to be taken for granted. This was a consumerism point, not a
regulatory point."


On European Union regulation of biotech foods:

"Here in Europe, and this applies as much to the Commission as the
independent sovereign states, we have a situation in which regulators can
only advise the governments of the day, whereas in the U.S., the
regulatory obligation discharged by the Environmental Protection Agency
is enshrined in law, and the EPA is obliged to act independently in the
best interests of the consumer. "That is the fundamental challenge we
have here in Europe, and it's not one that is going to be quickly faced.
That really is the issue, that the regulation hasn't the power to act,
the regulation can only advise the government of the day. "Put that
alongside the increasing power wielded by the consumer -- and
governments, of course, are made up of elected politicians -- then
elected politicians can be influenced by consumer opinion and attitude.
What you don't see is their best interest being protected by an
independent authority. "That's really what underlay my point. Not a broad
swipe at regulators. Far from it."


On U.K. government policy toward genetically modified crops:

"I'm concerned that some of my competitors in the industry, who have been
submitting products for approval, appear not to have enjoyed the
wholehearted, enthusiastic support we had hoped for."


                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  Biotech Industry For Specialised Regulator
SOURCE: Financial Express, India, by Ashok B. Sharma
        http://www.financialexpress.com/fe_full_story.php?content_id=62956
DATE:   7 Jul 2004 

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Biotech Industry For Specialised Regulator

NEW DELHI: Not satisfied with the model of National Biotechnology
Regulatory Authority recommended by Dr MS Swaminathan panel, the industry
has proposed its own single window regulatory authority with three
specialised wings. The model is presented before the taskforce on
recombinant pharma sector - headed by Dr RA Mashelkar.

The industry has also demanded changes in the rules relating to
production, use, import, export, storage of genetically modified
organisms (GMOs), micro-organisms and cells and easy import of plant
tissue cultures. The Mashelkar panel is expected to submit its report shortly.

The Federation of Indian Chambers of Commerce and Industry (Ficci) has
suggested that the proposed Biotechnology Regulatory Authority should
have three wings incorporating the existing bodies like the Genetic
Engineering Approval Committee (GEAC), the Indian Council of Agricultural
Research (ICAR) and the Drugs Controller General of India (DCGI).

The role of DCGI should be redifined and reconstituted into Biotech
Controller General of India (BCGI).

There is no single regulatory authority for transgenic technology in the
US. In the US, approval and regulations are done by three different
bodies like the Environmental Protection Agency (US-EPA), the United
States Department of Agriculture (USDA) and the Food and Drug Agency (US-
FDA). In this context, Ficci has suggested that the three wings of the
proposed Biotechnology Regulatory Authority in India should should be
based on the US model.

According to Ficci, the GEAC in India should oversee not only testing of
genetically modified (GM) organisms but also the related containment,
hygiene and environmental protection. Like USDA, the ICAR in India should
oversee GM crop and animals. A nominee each from the Indian Council of
Medical Research (ICMR) and GEAC should be deputed to ICAR to monitor and
assess the impact of consumption of GM crops on humans. The GEAC nominee
should also assess the impact on environment and also determine the
pesticide levels in plants safe for human consumption.

Like the US-FDA, the existing DCGI in India should play the role of a
regulator for drugs, chemicals, intermediaries and bulk drugs. The
industry feels that the several provisions under the "Rules for
Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms,
Genetically Modified Organisms or Cell 1989 (Rules-1989)" are deterent to
the growth of the transgenic technology and, therefore, should be amended.

Also the "Plant Quarantine (Regulation of Import into India) Order 2004"
should be amended.

Ficci has also proposed that recombinant protiens (antigens) used by the
medical diagnostic industry should be exempted from the purview of the
GEAC as these are only synthetic dead protiens and not living modified
organisms or cells.

There should be harmonisation of recombinant pharma guidelines involving
the department of biotechnology (DBT), DCGI and GEAC.

Also, clinical trials and basic R&D should not come under the purview of GEAC.




--


GENET
European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
Kleine Wiese 6
D - 38116 Braunschweig
Germany

P: +49-531-5168746
F: +49-531-5168747
M: +49-162-1054755
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