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Date:

September 9, 2003

Subject:

Precaution without Principle; Cancun Delusions; Italy Must Prove

 

Today in AgBioView: September 10, 2003:

* PRECAUTION WITHOUT PRINCIPLE
* New Issue of Economic Perspectives on Agricultural Biotechnology
* Request for corrections
* Cancun Delusions - Subsidizing the poor to death
* GMO import ban caught in crossfire
* Italy Loses Ruling on Modified Food
* Italy must prove health risk to keep GMO ban
* Judgment of the Court in Case C-236/01
* Cartagena Protocol on Biosafety takes effect
* Avestha Gengraine gets US patents for multiple use technology
* Crop geneticist wins Minister's Prize

http://www.washingtontimes.com/commentary/20030909-085538-2448r.htm

PRECAUTION WITHOUT PRINCIPLE

Washington Times
September 10, 2003
By Henry I. Miller and Gregory Conko

The European Parliament voted earlier this summer to change the way it
regulates gene-splicing, or genetic modification (GM) technology, possibly
opening the way for the lifting of the EU's 5-year-old moratorium on
approvals of new gene-spliced crops and foods. The EU's spin is that this
"progress" should induce the United States and other complainants to drop
their World Trade Organization grievance against EU regulation.

This is no more than a negotiating ploy: The legislation makes the EU an
even less hospitable environment for gene-splicing, not a better one.

While literally thousands of studies show the risks of gene-splicing
plants and foods to be minimal, their benefits are legion and their
potential extraordinary. Globally, the adoption of gene-spliced crops has
reduced pesticide use by tens of millions of pounds annually (resulting in
less occupational exposure and less runoff into waterways) and saved
millions of tons of topsoil from erosion. In less developed countries,
gene-spliced crops have increased yields and raised the incomes of
resource-poor farmers. Future advances promise to improve human nutrition,
reduce the land and water needed to produce food, and save ecosystems from
fragmentation and development. Standing in the way is the precautionary
principle, which holds that while the evidence about a product, technology
or activity is in any way incomplete, it should be prohibited, or at least
heavily regulated.

This principle forces government to ignore benefits of innovation in a
costly effort to avoid hypothetical risks. The precautionary principle
often has been used in Europe as justification for egregious regulatory
abuses of gene-spliced products. The highest French court invoked the
principle in 1998, when it suspended commercialization of three
gene-spliced corn varieties, even though the French government had
endorsed approval of those same varieties at the EU level just two years
earlier.

In 2000, the Italian government suspended the commercialization of four
gene-spliced corn varieties, allegedly over the concerns about potential
health risks, even after a report from the Italian National Institute of
Health had found "there is no reason to believe that a risk for human or
animal health could ensue from the consumption of products derived from
the [gene-spliced] plants in question." The list of baseless and
anti-innovation actions by European regulators is endless. The
Parliament's action does not actually repeal Europe's moratorium, nor does
it change the voting structure that allows a minority of European
countries to refuse registration of new gene-spliced products.

The new legislation does, however, contain Draconian new requirements,
including a strict labeling regime that requires gene-spliced foods to be
identified, the segregation of gene-spliced from conventional products,
and "traceability," so gene-spliced ingredients can be traced through
every step of the food chain all the way back to the farm where they were
grown.

The labeling and traceability rules have nothing to do with protecting
consumer health or the natural environment, a fact acknowledged even by
officials such as EU Minister for Health and Consumer Protection David
Byrne.

A recent report summarizing the conclusions of 81 different EU-funded
research projects spanning 15 years shows that, because gene-spliced
plants and foods are made with highly precise and predictable scientific
techniques, they are at least as safe, and often safer, than their
conventional counterparts. Moreover, the technology has been given a clean
bill of health by dozens of scientific bodies around the world, including
the French Academies of Science and Medicine, U.K. Royal Society, U.S.
National Academy of Sciences and the American Medical Association.

A revealing aspect of the new legislation is the distinction made by the
EU between foods and animal feeds produced with and produced from a
gene-spliced organism, a bizarre bureaucratic distinction that favors
certain classes of products widely made in Europe.

For example, products made with the aid of gene-spliced enzymes (such as
chymosin for cheese production) or with gene-spliced yeasts to make beer
and wine are exempted from the new labeling and traceability rules, while
a food like cornflakes made from gene-spliced Iowa corn would be captured
by the new regulations.

Thus European regulators find it necessary to protect consumers from foods
developed with certain production methods, but only when the foods come
primarily from other countries.

The new labeling and traceability regime does no more than the old to
promote consumer choice. It will, however, make it prohibitively expensive
and complicated for growers of gene-spliced crops to comply with the
rules.

The only winners from such wrongheaded public policy will be the unelected
apparatchiks in Brussels, who will enjoy additional power and resources;
and anti-science activists, who will have succeeded in erecting yet
another barrier to a superior technology. The biggest losers will be
consumers, who systematically will be denied access to safer, more
nutritious, and affordable products.

Henry I. Miller is a fellow at the Hoover Institution at Stanford
University and an adjunct scholar with the National Center for Policy
Analysis. Gregory Conko is director of food safety policy at the
Competitive Enterprise Institute.
+++++++++++++++++++++++++++++++++++++++++

http://usinfo.state.gov/journals/ites/0903/ijee/ijee0903.htm

New Issue of Economic Perspectives on Agricultural Biotechnology

The latest issue of Economic Perspectives highlights how advances in
biotechnology can be adapted to benefit the world in the 21st century,
particularly developing countries.

Contributors to this journal include Under Secretary of State Alan Larson,
Under Secretary of Agriculture J.B. Penn, Deputy Food and Drug
Administration Commissioner Lester Crawford, and Ambassador Tony Hall,
U.S. Representative to the U.N. Agencies for Food and Agriculture, who
address a broad range of topics from the basic science of biotechnology to
food safety and labeling issues. Their articles are complemented by essays
from an internationally respected group of researchers and academics, a
State Department fact sheet on the Cartagena Biosafety Protocol and
additional resource information.

Should you wish to read it, it is available in both HTML and .pdf formats
at:

http://usinfo.state.gov/journals/ites/0903/ijee/ijee0903.htm

This document will also be available in multiple languages at a future
date.
+++++++++++++++++++++++++++++++++

Date: Tue, 9 Sep 2003 13:29:38 -0500
From: "Nill, Kim"
Subject: A Request

Dear AgBioView:

In today's issue of AgBioView, there was an article titled "GHANA IN A
FIX" from a Ghanian newspaper. The final sentence within that article
stated that "... Australia,.. and China... have refused to use GM
technology".

May I request that, when AgBioview publishes such a (reprinted) article in
the future--- which contains such a patently false statement--- that you
insert a short note beneath the (reprinted) article... which makes clear
the inaccuracy?

For example, I am sure that the below decision recently made in Canada
will be incorrectly reported by some newspapers as mandatory GMO labeling.
However, as the below article makes clear, Canada did not mandate GMO
labeling.


Kim Nill

-------------------------------

Canada to label some genetically modified food

Reuters
2003-09-08
By Roberta Rampton

WINNIPEG, Manitoba, Sept 8 (Reuters) - After spending thousands of hours
over four years discussing how best to label foods that contain
genetically modified ingredients, a Canadian committee said on Monday it
has agreed on voluntary rules.

Canadian food makers will not be forced to indicate whether or not their
products contain GM ingredients, but if they want to make claims on the
subject, they have to be able to prove them, said a spokeswoman for the
Canadian Council of Grocery Distributors.

"I think it would be incorrect to think that suddenly there's going to be
a proliferation of labels, but when there are labels, you can know that
they are truthful, and they are based on some consistent set of rules,"
said Jeanne Cruikshank, who has been part of the committee since it began
in 1999.

The rules are controversial in part because food containing less than 5
percent GM content can have a label stating it does not contain GM
material.

Canadian farmers widely grow GM canola, corn and soybeans, and do not have
to keep the product segregated, meaning small amounts of the GM crops can
get into shipments that growers intend to be GM-free, Cruikshank
explained.

About 70 percent of processed food in Canada may contain some GM
ingredients, she said.

"It is more likely the 'does not contain' products that are going to be
labeled first, because we can do those with the most accuracy," she said.

The committee comprised academics, regulators, food and agriculture
companies as well as consumer and activist groups, which made it
challenging to reach a consensus, Cruikshank said.

"I really think a very sincere effort was made to get it right," she said.

But activists who oppose GM food slammed the voluntary labeling scheme,
noting many consumer groups dropped out of the process because they
believe food makers won't have an incentive to label food that contains GM
ingredients.

"When they say they have consensus, they're really saying they have
consensus between industry and government," said Patrick Venditti of
Greenpeace, a group that boycotted the process because it wanted mandatory
labels.

The logistics of the labeling rules will now be reviewed by the Canadian
General Standards Board, and should be finalized by early in 2004,
Cruikshank said.

However, she noted the consensus-building process was originally expected
to last 18 months, and instead took 10 days short of four years.

"In this process, I guess I would say, 'never say never,' because it has
had its share of quirks," Cruikshank said.
++++++++++++++++++++++++++++++++++++++

http://www.reason.com/rb/rb091003.shtml

Cancun Delusions - Subsidizing the poor to death

Reason Magazine
September 10, 2003
By Ronald Bailey

Cancun, MexicoųThe World Trade Organization's fifth ministerial meeting
will get under way tomorrow here in this Caribbean resort fringed with
white sand beaches. Hopping off of the airplane, I immediately rushed
through police blockades to get to the anti-globalization "teach-in" being
run by the International Forum on Globalization (IFG). I was anxious to
hear what these passionate anti-globalizers would have to say about
agricultural subsidies. Why?

Because the most important achievement of this WTO ministerial would be
substantial progress toward truly free trade in agricultural goods. This
is the central commitment of the so-called Development Round that was
launched in Doha, Qatar two years ago. Freeing up global agricultural
trade is vital because the majority of people living in the poorest
countries are still farmers. Bringing these poor farmers into the world
trading system will enable them to take the first steps up the ladder of
economic development. Of the 2 billion or so of the world's people who
live on less than $2 per day, most live in rural communities.

However, access to world markets is blocked by the protectionist policies
of the world's richest countries, the European Union, the United States
and Japan. These countries shovel out over $300 billion per year in
subsidies to their farmers. Such largesse means that the average European
cow receives an infamous subsidy averaging $2.50 per day. Consequently,
farmers in developing countries and least-developed countries suffer a
double whammyųrich country subsidies keep world prices artificially low so
poor farmers can't compete in world markets; rich countries then turn
around and dump their subsidized agricultural surpluses in the poor
farmers' local markets. The New York Times recently and correctly
editorialized that this situation is not only unfair, it is also
"immoral".

It is indeed immoral. Lack of free trade and developed country
agricultural subsidies are literally killing people, according to a recent
report by the Brussels-based Center for a New Europe (CNE). The CNE finds,
"6,600 people die every day in the world because of the trading rules of
the European Union (EU). That is 275 people every hour." Think of it like
crashing a Boeing 747 filled with people every hour, 24 hours per day.

The EU is far from alone in deserving blame for this trade tragedy. When
crop prices sank, the Bush Administration dumped the Freedom to Farm
program that was eliminating most US agricultural subsidies. To satisfy
the electorally important US farm lobby, Bush bumped up farm subsidies by
$175 billion over the next ten years.

The Washington, DC-based International Food Policy Research Institute
recently concluded, "Protectionism and subsidies by industrialized nations
cost developing countries about $24 billion annually in lost agricultural
and agro-industrial income." To put this figure in perspective, WTO
figures show that the world's 40 or so least developed countries exported
a total of only $38 billion worth of all goods in 2002. This is a drop in
the bucket; in 2002, total world merchandise exports were $6,240 billion
(or $6.24 trillion in American English).

The CNE report concludes that Africa in particular suffers from the
developed countries' agricultural subsidies. Just how desperate the
situation is in sub-Saharan Africa is made clear by British demographer
Angus Maddison's calculation that the average annual gross domestic
product in the region is just $450 per person. Maddison points out that
that was the average income of a citizen of the Roman Empire. In other
words, sub-Saharan Africa has made essentially no economic progress in the
past 2000 years.

Given this background, one would think that the environmental activists at
the IFG meeting would join together with free trade activists in
advocating that the trade ministers gathering in Cancun work to eliminate
these harmful rich country subsidies. Instead, several participants in the
IFG conference urged that the world move back toward low technology and
subsistence farming. Indian political environmentalist Vandana Shiva
insightfully told the IFG activists, "Domestic agriculture in India has
been destroyed by developed country farm subsidies and dumping." Then she
quickly veered from this reasonable observation to unthinking
environmentalist dogma. Her solution is not to eliminate the subsidies and
open up food trade. Instead she wants Indian farmers to reject the Green
Revolution which boosted Indian grain production four-fold over the past
four decades and move back toward small-scale agricultural production.
This is a recipe for famine.

Will Allen, an American organic farmer, noted at the IFG meeting that in
the United States, only 9 percent of the farmers receive nearly 80 percent
of the subsidies, so the subsidies aren't really helping small farmers in
the U.S. either. But instead of calling for the end of subsidies, Allen
declared, "We advocate there be subsidies all over the world to convert
agriculture into sustainable agriculture." Sustainable agriculture for
Allen is organic agriculture, which is less productive than conventional
or biotech farming. Lower productivity means more food insecurity and more
natural lands like forests chopped down to create farm fields. According
to the Consultative Group on International Agricultural Research, the
chief factor that drives deforestation in developing countries is "poor
farmers who have no other option to feeding their families other than
slashing and burning a patch of forest... Slash-and-burn agriculture
results in the loss or degradation of some 25 million acres of land per
year."

Apparently, many environmental activists prefer that poor farmers and
their families remain doing the backbreaking, mind-numbing labor of
subsistence farming. U.S. organic farmer Allen recounted with evident
nostalgia the fact that in 1848, when chemists had finally learned how to
use fertilizers to boost crop production, 90 percent of Americans lived on
farms. According to Allen, a century later, 37 percent of Americans still
worked on farms. Today, only 1 percent of Americans are farmers. Did
Americans become poorer because they fled the farm? Hardly. They moved up
from farming to become the richest, most technologically sophisticated
economy in history. It is past time that the richest countries remove the
barriers that block the poorest countries from following this same
trajectory to prosperity. The Cancun WTO conference is the place to begin.

++++++++++++++++++++++++++++

http://www.newscientist.com/news/news.jsp?id=ns99994147

GMO import ban caught in crossfire

New Scientist
10 September 03

From tomorrow, countries will have a right under international law to ban
imports of food containing genetically modified organisms (GMOs) that they
think could be unsafe. Or maybe not.

The UN's Biosafety Protocol - which allows bans where governments fear
imported GMOs in food may have an "adverse effect" on biological diversity
or human health - comes into force on Thursday. But as it does, the right
to impose bans is being attacked by a US action launched in August against
the European Union.

The US claims a five-year-old European ban on food containing GMOs is a
breach of another set of international rules - the World Trade
Organization's requirements for free trade.

The dispute, which will be decided by the WTO's dispute panel, is shaping
up to be a face-off between the competing goals of free trade and
safeguarding the environment. Friends of the Earth campaigns director
Liana Staples condemns the US action: "It is just the latest Bush
government-led attempt to bulldoze over other countries' rights to protect
their people and the environment."

But US trade representative Robert Zoellick says the EU ban is
"unsupported even by the EU's own scientific studies". The dispute
promises to be a major talking point at the WTO meeting starting today in
Cancun, Mexico.

Collision course

The Biosafety Protocol, agreed between most of the world's governments in
2000, formed an addition to the 1992 Biodiversity Convention. It seemed to
legitimise a five-year-old EU ban on imports of GM foods from the US and
elsewhere.

But the US never signed the convention, and so is not a party to the
protocol. It called the EU ban an illegal infringement of trade and began
the WTO action. In so doing, say environmentalists, it is setting the two
treaties on a collision course.

The EU says the US complaint is now irrelevant. In August, EU ministers
set new rules that should allow imports of products containing GM
material, provided they are properly labelled and the sources of the GMOs
are fully traceable. But the US disagrees, saying that in practice the
rules would be impossible to meet.

Hunger and poverty

The controversy will be further inflamed on Thursday when Tewolde
Egziabher, one of the architects of the Biosafety Protocol, marks its
coming into force by speaking at the upper house of the British
parliament.

Egziabher, director of Ethiopia's Environmental Protection Authority, will
argue that the US action is designed to intimidate African countries. They
want to use the protocol to set up their own systems for regulating
imports of GM food, including US food aid.

Before leaving Addis Ababa, Egziabher said: "We resent the way that the
image of the hungry in developing countries has been used to force a style
of agriculture that will only exacerbate problems of hunger and poverty."

And he added that Ethiopia, as a centre for the natural genetic diversity
of the world's grain crops, has special reason to oppose "the hasty
introduction of GM crops". His fear is that GMOs might contaminate the
country's wild grains, from which early food crops were bred.
++++++++++++++++++++++++++++++++++++++

http://www.nytimes.com/2003/09/10/business/worldbusiness/10food.html?ex=1063857600&en=5eba9e0c362b261c&ei=5062&partner=GOOGLE


Italy Loses Ruling on Modified Food

New York Times
By PAUL MELLER
September 10, 2003

BRUSSELS, Sept. 9 - In a judgment that appeared to offer ammunition to
both sides in the debate on genetically modified foods, the European Court
of Justice ruled today that Italy's grounds for banning foods derived from
certain genetically altered corn seeds were unjustified.

Europe's highest court was asked to intervene by an Italian court, which
was handling an appeal of a ban on foods containing four strains of
genetically modified corn that had been submitted by the biotechnology
companies Monsanto, Syngenta and Pioneer Hi-Bred International shortly
after the ban was introduced in 2000.

The Italian government imposed the ban because it feared that the presence
of a synthetic protein in the foods might be a risk to human health. The
biotechnology companies argued that the protein was so unimportant that
the foods ultimately made from the corn would be virtually identical to
foods made from conventional corn strains.

The companies also argued that the Italian ban breached European Union
laws, which permit the trade in foods containing genetically modified
elements if the food is "substantially equivalent" to conventional foods.

British food authorities had already decided that the strains of corn in
question were safe well before Italy imposed its ban. And the European
Union's executive branch, the European Commission, circulated the British
position to all 15 member countries to use as grounds for appraising the
corn.

Today's judgment is not the final word on the matter. The case must now go
back to Italian courts for a final ruling, but the European court's
opinion will guide the Italian judges when they reassess the case.

The European Court of Justice said that the risk Italy used to justify its
ban "must not be purely hypothetical or be founded on mere suppositions
which are not yet verified," adding that Italy must base its action on
specific data and not on reasons of a general nature. "The mere presence
of residues of transgenic protein in novel foods does not prevent their
being placed on the market," the court said.

However, the court did uphold the right of governments to impose a ban on
substances that pose a threat to health.

"If a member state has detailed grounds to suspect such a risk," the court
said in a statement, "it may temporarily restrict or suspend the trade in
and use of the food in question in its territory."

The Italian government interpreted this as a victory. "I am very pleased
that Italy has won," the environment minister, Altero Matteoli, said today
in Brussels.

But Monsanto, the European Commission, the office of the United States
trade representative, as well as experts in European law reached a
different conclusion. "Based on today's judgment we should win when the
case goes back to the Italian court," said Tom McDermott, a Monsanto
spokesman.

"We have been saying for over two years that there is no justification for
Italy's ban on foods derived from the four corn types; the court confirmed
this," said Beate Gminder, a European Commission spokeswoman on health
matters.

"We are analyzing the decision closely," said Richard Mills, a spokesman
at the United States trade representative's office. "It appears to endorse
our view that science-based rules should be used."

Ian Forrester, a partner in the Brussels office of the law firm White &
Case, said, "This judgment appears to raise the bar for governments
seeking to ban novel foods." Mr. Forrester represented companies including
Pfizer in recent legal fights against bans of animal feed additives
containing antibiotics.

"It looks like the court is calling for higher standards of scientific
evidence" to justify a ban "than the standards required in the antibiotic
case," he said. "In this sense, the judgment is saying helpful things for
the industry."

Ms. Gminder said that bans like the Italian one were unlikely to be
imposed again because imminent new legislation will remove any grounds for
governments to act alone as Italy did. Next month, two unionwide
regulations come into force that will supercede the novel foods rule Italy
used to justify its ban on the four corn strains. One is a regulation
setting clear rules on how food containing genetically modified organisms
should be labeled and how such elements can be traced. The other will
regulate such organisms in human and animal food.

Mr. McDermott of Monsanto said that while his company took issue with some
aspects of these laws, it welcomed a legal framework that should allow for
the removal of the union's general moratorium on genetically modified
ingredients.

People close to the Bush administration doubt that the overall ban will be
lifted any time soon. "Promises, promises. We've heard it all before," one
person said.

The United States earlier this year filed a complaint against the European
Union's moratorium on genetically altered organisms with the World Trade
Organization.

Despite the moratorium, some countries in the union are already permitting
some genetically modified crops. Spanish farmers have been growing altered
corn for several years. The British government has also been supportive of
the new technologies, Mr. McDermott said.

"With the new rules on labeling, other member states might not be so
reluctant to accept biotech foods," Mr. McDermott added.
+++++++++++++++++++++++++++++++++++++

http://www.euobserver.com/index.phtml?sid=9&aid=12613

Italy must prove health risk to keep GMO ban

EU Observer
September 10, 2003

A national government in the European Union may temporarily restrict or
suspend the marketing of genetic modified foods.

This was the decision of the Judges in the European Court of Justice in
Luxembourg, today (9 September) ruling in a case brought to Court by the
biotech giant Monsanto against the Italian government.

The Italian government on 4 August 2000 suspended the trade in, and use
of, products derived from flour made from genetically modified maize
because of potential risks to human health.

Today, the Italian government was allowed to uphold the ban. However, it
must justify that health risks do exist, the Judges said.

The difficult task of proving risks to health in relation to Novel Foods
will be left with member states, wanting to restrict or suspend GM
products, the Judges said.

EuropaBio, representing European bio industries welcomed the decision and
said it upheld the right to free movement of goods including approved GM
products.

"In particular, we welcome the Court's clarification that Member States
must have reasons based on sound scientific evidence to invoke the
safeguard clause, and cannot be based on pure supposition or short term
political ends", the industries said in a press release.
++++++++++++++++++++++++++++++++++++++++++++

http://www.curia.eu.int/en/actu/communiques/cp03/aff/cp0367en.htm

Judgment of the Court in Case C-236/01
Monsanto Italia SpA and Others v Presidenza del Consiglio dei Ministri

9 September 2003

THE MERE PRESENCE OF RESIDUES OF TRANSGENIC PROTEIN IN NOVEL FOODS DOES
NOT PREVENT THEIR BEING PLACED ON THE MARKET UNDER A SIMPLIFIED PROCEDURE
PROVIDED THERE IS NO RISK TO HUMAN HEALTH

However, if a Member State has detailed grounds to suspect such a risk, it
may temporarily restrict or suspend the trade in and use of the food in
question in its territory

The Community regulation relating to novel foods1 provides that foods
which are produced from genetically modified organisms but no longer
contain them may be placed on the market within the Community under a
"simplified" procedure, which requires merely that a notification be made
to the Commission, if they are substantially equivalent to comparable
traditional foods: proof of which can be given by a national food
assessment body.

Monsanto Europe SA and other undertakings active in the development of
genetically modified food plants for use in agriculture had obtained
authorisations from France and the United Kingdom to market certain
genetically modified maize grain (Bt-11 and MON 810). Genetically modified
maize is resistant to certain insects and herbicides.

In 1997 and 1998 Monsanto and Others notified the Commission, under the
"simplified procedure", of their intention to market products derived from
genetically modified maize, such as cornflour.

The competent UK authority for food assessment had previously concluded
that those foods were substantially equivalent to conventional foods. The
Commission forwarded those notifications to the Member States.

In 2000, an Italian scientific institute noted the presence of residues of
transgenic protein (expressed by the inserted gene) in the flour in
question but did not consider that they posed any risk to human health.

The Italian Republic Ų in the light of the differing opinions put forward
by Italian scientific bodies Ų had concerns as regards the safety of the
products. It therefore adopted a decree on 4 August 2000 providing for the
precautionary suspension of the trade in and use of products derived from
those maize lines. Monsanto and Others subsequently challenged the Italian
decree, which they considered to be in breach of Community law.

The Administrative Court of Lazio accordingly asked the Court of Justice
of the European Communities whether novel foods which contain residues of
transgenic protein at certain levels can be considered substantially
equivalent to existing foods and may consequently be marketed under the
simplified procedure.

The Court of Justice first observes that the Community regulation
concerning novel foods has a twofold objective:

Ų to ensure the functioning of the internal market in novel foods, and

Ų to protect public health.

The Regulation characterises as "substantially equivalent to existing
foods" those foods which present differences in composition but have no
effect on public health.

Substantial equivalence is assessed by specialised bodies on the basis of
the scientific evidence available, prior to the novel food being placed on
the market: it does not require the risk assessment laid down under the
normal procedure. On the other hand, the absence of substantial
equivalence does not imply that the food is unsafe but merely that it
should be subject to risk assessment.

The Court considers that in no case should the simplified procedure lead
to a relaxation of the safety requirements that must be met by novel
foods.

The Court nevertheless points out that certain differences in the
composition of novel foods do not prevent their being deemed substantially
equivalent: on the contrary, they must be specifically mentioned on the
labelling.

It is for the Italian national court to decide whether the novel foods are
substantially equivalent to existing foods in the light, inter alia, of
the Court's ruling on the interpretation of Community law.

The Court finds that where use of the simplified procedure is not
warranted, a Member State can Ų as a preventive measure Ų temporarily
restrict or suspend the marketing of those foods in its territory (under
the "safeguard clause" laid down in the Regulation) without first being
required to challenge the lawfulness of the procedure.

Demonstration of the existence of a risk to health can justify the
adoption of such a measure: in that case, the risk must not be purely
hypothetical or be founded on mere suppositions which are not yet
verified; the State must base its action on detailed grounds and not on
reasons of a general nature.

The safeguard clause reflects the precautionary principle and allows
protective measures to be taken without having to wait until the reality
and seriousness of risks become fully apparent, even if a full risk
assessment proves impossible because of the inadequate nature of the
scientific data available.

In the framework of close cooperation between the Commission and the
Member States, the initial assessment of substantial equivalence by a
scientific body of a Member State is subject to verification at Community
level. Similarly, the protective measure adopted by the Member State under
the safeguard clause is subject to verification at Community level.
+++++++++++++++++++++++++++++++++++++++++

http://www.biodiv.org/doc/press/presskits/bs/pr-01-en.pdf

Cartagena Protocol on Biosafety takes effect

UNEP Press Release

Montreal, September 9, 2003 Ų The Cartagena Protocol on Biosafety, the
first legally binding international agreement governing the transboundary
movement of living modified organisms resulting from modern biotechnology
enters into force on Thursday, 11 September 2003.

The treaty, which aims at ensuring an adequate level of protection in the
field of the safe transfer, handling and use of living modified organisms
(LMOs) resulting from modern biotechnology, was adopted in January 2000 by
member countries to the Convention on Biological Diversity.

On 13 June this year, the Republic of Palau became the 50th State to
ratify the Protocol, which triggered the countdown to the entry into
force. To date, 57 States and the European Community have ratified it, the
Republic of South Africa being the most recent.

Underscoring the significance of the Protocol‚s entry into force, CBD
Executive Secretary Hamdallah Zedan said, „The Protocol has now become a
binding instrument for States (Parties) that have given their consent to
be bound by itš.

„This means that the transboundary movement of LMOs from one country to
another will have to be in conformity with the provisions of the Protocol
, in cases where both countries are Parties to the Protocol. However, in
cases where movement of LMOs involves a Party and a non Party, such
movement shall be consistent with the objective of the Protocol., said Mr.
Zedan.

„Because of the sensitivity and contention around some of the issues that
almost made it impossible to have agreement on the text of the Protocol
until the very last minute, some skeptics were wondering if the Protocol,
even though adopted, would ever enter into force. Well, they have been
proven wrongš, said Ambassador Philemon Yang of Cameroon.

The Protocol establishes a harmonized set of international rules and
procedures designed to ensure that countries are provided with the
relevant information to enable them to make informed decisions before
agreeing to the import of LMOs. It also ensures that LMO shipments are
accompanied by appropriate identification documentation. The adoption of
the Protocol in 2000 and now its entry into force have been significant
steps. However, the major challenge now is the practical implementation of
the provisions to enable the Protocol‚s objectives to be met. „All Parties
need to take appropriate legal, administrative and other measures at the
domestic level to translate the Protocol‚s provisions and objective into a
practical realityš, said Mr.Zedan.

Since the adoption of the Protocol, the Intergovernmental Committee on the
Cartagena Protocol on Biosafety (ICCP) has made considerable progress in
proposing possible implementation measures. ICCP is the interim body,
established to undertake preparatory work for the first meeting of the
Protocol‚s decision-making body. „The work done by ICCP has contributed
significantly to clarifying a number of issues thereby giving many
countries the confidence they needed to ratify the Protocol and get ready
for its implementationš, said Ambassador Yang, the ICCP Chair.

The decision-making body of all the member countrie s of the Protocol -
the Conference of the Parties serving as the meeting of the Parties to the
Protocol- will convene from 23 to 27 February 2004 in Kuala Lumpur,
Malaysia to address strategic and operational measures for the
implementation of the Protocol.

While the ultimate responsibility to ensure that the Protocol is
implemented lies with Parties, Mr. Zedan observed that „all relevant
stakeholders: business and industry, NGOs, scientists, researchers and the
media have a big role to playš. Their coope ration is essential for the
successful implementation of the Protocol. „I encourage all the players to
take on their respective responsibilities in support of the Protocolš.

„I strongly urge all countries that have not yet done so to ratify the
Protocol as soon as possible in order that they may participate as full
partners in the decision-making at the first meeting of Parties, which
will shape the future of the Protocolš.

Additional information for Journalists

(1) The Cartagena Protocol on Biosafety was negotiated under the
Convention on Biological Diversity in order to promote „the safe transfer,
handling and use of living modified organisms (LMOs) resulting from modern
biotechnology that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to
human health, and specifically focusing on transboundary movementsš.

(2) 103 countries signed the Protocol by the closing date for signature on
4 June 2001..

(3) The entry into force of the Protocol means, in practical terms, that a
number of things will change regarding the transboundary movement of LMOs,
involving countries that are Parties to the Protocol:

(a) Under what is known as the advance informed agreement (AIA) procedure,
any Party shipping LMOs for intentional introduction into the environment
for the first time shall have to give prior notification to the importing
country that is a party to the Protocol and provide sufficient information
to enable it to make an informed decision.

(b) On the other hand, if a Party approves for domestic use and marketing
LMOs intended for direct use as food, feed or processing and these may be
exported to other countries, that Party must communicate its decision and
details about the LMOs to the world community via the Biosafety
Clearing-House (BCH).

(c) Furthermore, exporters must ensure that all shipments are accompanied
by appropriate documentation required under the Protocol.

(d) Shipments of LMOs for intentional introduction into the environment
will have to be identified in accompanying documentation as LMOs, with a
specification of the LMO identity and characteristics and a declaration
that „the movement is in conformity with the requirements of the Protocol.

(e) The Biosafety Clearing-House is now operational. All decisio ns taken
by any Party regarding the importation or release of LMOs must now be made
available to the Biosafety Clearing-House. In addition, the information
specified in the Protocol, including: national laws for implementing the
Protocol; any bilateral, regional and multilateral agreements entered
regarding transboundary movement of LMOs and summaries of risk assessments
of LMOs must be provided through the BCH.

(f) Furthermore, Parties must ensure that risk assessments are carried out
for decisions taken under the AIA procedure and must adopt measures for
managing any risks identified by risk assessments. They must also monitor
and control any new risks that may emerge in the future.

(4) Additional information about the Protocol is available at the
following Web sites: CBD Web site: http://www.biodiv.org/biosafety and
Biosafety Clearing-House: http://bch.biodiv.org/Pilot/Home.aspx.
Frequently asked questions are also available at:
http://www.biodiv.org/biosafety/faqs.asp

For further information, please contact:

Diana Nicholson: Tel: +1 -514-287-7031, diana.nicholson@biodiv.org
Erie Tamale: Tel: +1 Ų514-287-7050, erie.tamale@biodiv.org
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http://economictimes.indiatimes.com/cms.dll/html/uncomp/articleshow?msid=174342


Avestha Gengraine gets US patents for multiple use technology

Economic Times (India)
September 10, 2003
By Nidhi Nath Srinavas

NEW DELHI: India can now boast of a genetically modified (GM) technology
even the big daddies in the US don‚t have. A top Indian biotech company
has invented a unique way to GM everything from basmati to bhindi for
breeding new hybrids, minus the labour, cost and time this usually takes.
What‚s more, the US has granted a patent for this truly transgenic,
cutting-edge technology last week. Patent rights are also on their way in
Europe, China, Africa, Australia, Canada, Thailand, Singapore and the
Philippines.

Avestha Gengraine Technologies, the Bangalore-based biotech major, has
modified genes in basmati to make breeding of new hybrids easier. Both the
transgenic plant and the process of its gene manipulation have been
patented by Avesthagen. The company has funding from ICICI, Global Trust
Bank and Tata Industries.

Transgenic rice sterile lines, like Avesthagen‚s new Basmati-370, spell
profits because seed companies can licence them to create new hybrids
cheaper and faster. Basmati-370 itself is commercially significant because
it is hugely popular with foreign consumers for its aroma and cooking
qualities.

Avesthagen says seeds based on its technology should be available within a
year, albeit bearing the őGM‚ tag. However, as only plant genes are being
used, the company does not expect farmer or consumer resistance. „We have
already received offers for a licensing contract from several leading seed
companies. They are excited because using it would lead to substantial
saving in time and cost. We are trying to work out the best deal now,š
said a source within the company.

„The technology works with all seeds ų rice, wheat, cotton, maize, oil
crops like mustard and sunflower, vegetables like okra, brinjals and
tomatoes, flowers. In other words, every plant which has a commercial
hybrid seed available in the market,š the source added.The technology uses
RNA editing as a molecular tool. „The invention relates to RNA editing for
expressing the unedited nad9 gene, thereby disenabling ATP production in
the mitochondria of plant, resulting in mitochondrial dysfunction in the
plant, thus leading to male sterility,š researchers said.

Here‚s how it works. Every hybrid needs a male sterile line, which is
crossed with a female line to get a new seed. But the process is beset
with several problems. There are very few sterile lines available
world-wide for every variety. So to get a basmati hybrid, for instance,
scientists would only use IRRI‚s sterile lines.

Even the undesirable characteristics of the male parent show up in the
progeny. In basmati, attributes like aroma and elongation become diluted
in hybrids.

Thirdly, the whole process is laborious, time-consuming and costly. Hence,
companies only produce hybrids with a commercial future.

Avesthagen‚s technology short-circuits the entire process. It can produce
sterility in the existing seed itself and thus saves back-crossing. When
you cross it with the female line, there is no danger of dilution of
attributes. Moreover, it is faster.

Hybrids have had an enormous impact on the country‚s rice productivity.
Basmati hybrids, for instance, have already given a new lease of life to
this traditional rice because they are high-yielding and
disease-resistant. However, they fall short when it comes to traditional
attributes like aroma. Using a transgenic Basmati-370 to create new seeds
could overcome these problems.

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Crop geneticist wins Minister's Prize

M2 Presswire
September 10, 2003

World-leading research to identify genes that control plant development
has won CSIRO Plant Industry's Dr Chris Helliwell the prestigious Science
Minister's Prize for Life Scientist of the Year.

Presented last night at Parliament House by Federal Science Minister, the
Hon Peter McGauran MP, the prize recognises a scientist under 35 whose
research in the life sciences advances, or has the potential to advance,
human welfare or society.

"It's fantastic to see plant science recognised and rewarded," says Dr
Helliwell.

"Plants are vitally important to life on earth and plant research is up
there with other areas such as medical research in its contribution to
health and well being."

Dr Helliwell has made breakthrough discoveries of plant genes that are
responsible for hormone production in plants. Plant hormones determine
plant height and lifespan, flowering and fruiting time, leaf and flower
development and structural arrangement.

"Using our understanding of plant genes and the hormones they regulate we
hope to breed crops that produce even better quality food," says Dr
Helliwell.

"For example currently some of our table grapes are sprayed with a natural
plant hormone, called gibberellin, to help produce large, juicy grapes."

"Our research could lead to the development of grapes that produce enough
gibberellin at the right time without the need for spraying, reducing
costs and management."

"It could also lead to more strategic application of plant hormones where
they are needed to maximise their effectiveness."

Other potential applications of Dr Helliwell's research could include
improving germination and early growth of dwarf cereal crops and improving
flowering and fruit production in citrus.

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