Italian GMO ban could spread
URL: http://www.nature.com/cgi-taf/DynaPage.taf?file=/nbt/journal/v18/n11/full/nbt1100_1137.html
Anna Meldolesi
Anna Meldolesi is a freelance writer working in Rome.
The European Commission is under renewed pressure to
reverse unjustified bans on GM products following Italy's
rejection of GM maize produced by Monsanto, Novartis,
AgrEvo, and Pioneer. In the first case of its kind, Italy is
challenging the definition of "substantial equivalence" in
boycotting GM products. If the Commission fails to act and
unblock the regulatory impasse that has dogged the reversal of
previous unjustified bans, it could be opening the doors to a
new wave of embargoes that could be far more widespread.
The European Commission's Standing Committee on
Foodstuffs is currently reviewing Italy's ban of the GM maize.
The UK Advisory Committee on Novel Foods and Processes
found the products to be substantially equivalent to conventional
products between 1995 and 1997 and the Commission,
therefore, approved them for EU-wide commercialization
without the need for special safety testing. In a first for the EU,
the Instituto Superiore di Sanita (Italian National Institute of
Health) has challenged this ruling, claiming the products are not
substantially equivalent to unengineered products because they
contain traces of foreign Bt protein. As a result, the Italian
government has banned the products, citing article 12 of the
European regulation 258/97 covering novel foods and
ingredients. According to article 12, an EU member state may
ban a product if it has new reasons to believe the food
endangers human health or the environment.
Paola Picotto, who is a member of Italy's Committee on
Biotechnology, says "We have found [the products] present a
level of foreign proteins between 0.04 and 30 parts per million.
So according to a strict interpretation of the substantial
equivalence rule, they can't be commercialized without
undergoing a full authorization procedure."
Until now, the banning of the sale and use of GM products by
individual EU member states has focussed on article 16 of the
European directive 90/220 covering the deliberate release of
GMOs into the environment. This clause allows a country to
temporarily ban a product if there are "justifiable reasons" for
doing so—basically, new scientific evidence that the product
constitutes a risk to human health or the environment. Following
invocation of article 16, the European Commission's scientific
committees review the evidence. If the committees cannot
justify a ban scientifically, a reversal of the ban requires a
majority vote from the Regulatory Committee, which comprises
EU state representatives. If the Regulatory Committee fails to
reach a majority decision by a deadline set by the Chair, the
Commission is supposed to provide a draft of proposals (in line
with its scientific committees' findings) to the Council of
Ministers, which comprises environment ministers from EU
member states. If a majority decision by the Council of Ministers
is not reached within three months, then the Commission is
supposed to make a definitive ruling by adopting the proposals
it came up with after reviewing the scientific committees'
findings. This process is supposed to ensure the reversal of
unjustified bans.
However, the reality is very different. There are currently 8 such
bans (from 5 countries) outstanding (see Table 1). Countries
have cited such concerns as Bt-resistance, negative affects of
Bt pollen on non-target organisms, and outcrossing of GM
plants with wild relatives. While the two most recent
cases—Novartis's Bt corn in Germany and AgrEvo's GM maize
in Austria—are still under review, the European Commission's
scientific committees have found none of the others justifiable
(http://europa.eu.int/comm/food/fs/sc/scp/index_en.html). But
rather than being actively reversed, the bans remain; Austria's
and Luxemborg's ban of Novartis' Bt maize, for instance, are
still in place after three years.
The problem is that there is a political block at the points where
a majority vote is required from member states—at the
Regulatory Committee and at the Council of Ministers. For
instance, the environment ministers of France, Italy, Austria,
Luxembourg, and Denmark have agreed not to vote on matters
concerning GM products at least until 90/220 has been revised,
effectively preventing the Council of Ministers from being able to
gain a majority vote (Nat. Biotechnol. 18, 589;MEDLINE).
Moreover, the European Commission has made no attempt to
take charge of the situation, resulting in a regulatory impasse
whereby not only are unjustified bans not reversed, but there
have been no new approvals for GM products since October
1998. Article 16 of 90/220 has, in effect, become a political
instrument for arbitrary bans.
The fear now is that Italy's case will go the same way, opening
up article 12 of 258/97 to abuse. In September, the
Commissions' Scientific Committee on Food found Italy's
invocation of article 12 not scientifically justifiable. The
Commission's Standing Committee on Foodstuffs, like the
Regulatory Committee in the 90/220 cases, is now required to
come up with a majority vote. If it fails to do so, as in the 90/220
cases, the matter will fall to the Council of Ministers. Failure of
the Commission to act if there is a deadlock would be
particularly grave because banning of the four types of GM corn
would extend to thousands of food products that contain them
as ingredients.
Meanwhile, the Council of Ministers is currently considering a
revised 90/220 and is expected to vote by the end of this year.