GMO and coexistence between conventional,
organic and GM crop production in Italy*
Dr. A. Chiarabolli
1. INTRODUCTION
A Genetically
Modified Organism (GMO) is “an organism,
with the exception of human beings, in which the genetic material has been
altered in a way that does not occur naturally by mating and/or natural
recombination”[1]. The technologies employed
to produce a GMO belongs to the field known as biotechnology, and in particular
the modern use of similar methods includes genetic engineering. The genes of an
organism are changed during the genetic modification process and the DNA of the
organism is recombined. The application of this technology in the European
Union is strictly regulated.
EU
legislation on GMOs, since the early 1990s, has two main objectives: to protect human health and environment[2]
and to ensure free movement of safe gm products in the European Union. Today EU
gm crop rules are probably the
strictest[3]
in the world and in particular the following conditions must be respected:
·
All gm
products to be admitted to the EU market must be
authorised using a centralised
European Commission authorisation procedure[4]
based on an independent risk assessment carried out by the European Food Safety
Authority – EFSA[5].
Consequently all gm seeds must pass through the EU authorization process before
cultivation[6];
·
Authorised gm food and feed are labelled[7]
(threshold 0,9%) and traced in order to guarantee freedom of choice for
consumers (informed choice). The labelling rules cover all authorised GMOs for
their placing on the market, that is all products, including food and feed,
containing or consisting of GMOs[8];
·
For non-approved GMOs the threshold is zero (zero tolerance)[9].
Agricultural
systems can be divided into three general categories: a conventional production
system, a biotech production system and an organic production system. The three
agricultural models can coexist in the same geographical area, but it is
largely accepted that a total isolation of gm material is impossible[10].
Consequently, in order to prevent an economic loss[11],
conventional and organic growers aim to avoid a gm admixture in their production[12].
·
Two GM maize products, of which only the
insect-resistant Bt maize MON810 is cultivated in the EU area[16];
·
One GM potato[17].
Today
coexistence is the weak point in European biotechnology legislation[18] and the coexistence debate is wide
and difficult[19]. The starting point of the analysis is the view of the
European Commission: coexistence is an
economic problem and refers to the ability of growers to make a practical and
free choice between conventional, organic and GM crop production, in compliance
with the legal obligations for labelling and/or purity standards[20].
European growers should have the possibility to choose
their preferred agricultural system because “no form of agriculture, be it conventional, organic or agriculture
using genetically modified organisms (GMOs), should be excluded in the European
Union” (Whereas 1 - Recommendation No.556/2003). On the basis of the choice of the
European Commission an authorized
GM seed is
considered a safe seed[21]
and therefore it can
be grown throughout the EU. The coexistence rules should implement the necessary
measures to avoid a GM admixture
and consequently an economic loss for
conventional or organic growers. The policy objective is to preserve the choice for producers to grow
their preferred crops and for consumers to buy freely conventional, organic or GM
products.
In the European Union the goal of avoiding GM
admixture is particularly important. GM admixture must be adventitious[22]
if the presence results from natural processes,
like pollen transfer or cross pollination, and technically unavoidable[23]
if the techniques to protect against admixture during certain farm activities
do not exist or if the application of these techniques goes beyond economic
flexibility. The EU “accepts” an
adventitious or technically unavoidable presence of authorized GM material in
non-GM food: it is established under the 0.9% level[24].
For EU unapproved GMOs, a zero tolerance is applied.
The European Commission adopted a conceptualization of
coexistence relating to the economic consequences of the introduction of GM
crops[25],
and even then only when those economic consequences are directly linked with
the de minimis non-GMO purity threshold
which has been established for the labelling of products[26].
Coexistence
measures have their focus on the economic impact, on the technical segregation measures and on the possible
economic consequences of admixing GM and non-GM crops because
environmental and health aspects of GM crop cultivation are to be addressed
during the EU authorisation procedure. The European Commission coexistence approach on the
one hand balances the freedom of economic initiative[27]
and on the other tries to ensure a high level of protection of human and
animal health and of the environment. In the European Union, coexistence regulation is a Member State
In next paragraph
the Italian approach to coexistence between conventional, organic and GM crops
productions is described.
2. THE ITALIAN COEXISTENCE SYSTEM
As stated in the Special Eurobarometer Report “Attitudes of European citizens
towards the environment 2008”
the 55% of Italians are against GMOs and the USDA GAIN Report FR 9043 of 17 June 2010 placed Italy la Nutrizione
- INRAN) found that 82% of Italian farmers would refuse to grow GM crops on
their land while 80% of consumers describe GM products as “less natural”. The USDA GAIN Report IT 1006 of 2 February
2010 noted that the average Italian regularly uses products such as insulin and
cosmetics which are manufactured using biotechnology, because Italians
generally support the medical and industrial applications of biotechnology more
than agricultural biotechnology. According to this Report the Italian
inconsistency of agricultural biotechnology support is problematic, for the
USDA point of view, Italy
Italian consumers are sensitive to the potential risks
that GM food may pose to human health and environment, in 2004 a SWG research about the
Italian public opinion on GMOs showed
that 75% of Italian consumers is contrary to use GM
food and, in 2005, the percentage of Italians who perceive
GM products as positive for environment and human beings was about 12%[30].
In Italy there have been many initiatives
against GMOs[31] and among these
it is interesting to remember the “Italia
Europa – Liberi da Ogm” coalition,
which for the first time promoted and organised[32]
a National Consultation[33] on the question “Do you want the
agro-food sector, foodstuffs and their authenticity to be at the heart of development, which
includes people and regions, health and quality, and that it be sustainable and innovative, based on biodiversity
and GMO free?”. The poll was conducted via web or
directly at the local site member
organizations and the poll result was very clear[34]:
Yes (99,43%) and No
(0,57%)[35]. On April 2012 a group of 200 Italian
scientists wrote an appeal to President Napolitano and Prime
Minister Monti asking that Italy Italy
would not exist because Italy
In Italy
In Italy
a discussion about GM cultivation is purely theoretical because today in Italy
The only EU approved GM variety (for cultivation) of
interest to Italian farmers is GM maize[39]. EU Directive No.2001/18 has been implemented through
Legislative Decree[40]
No.244 of 8 July 2003 “Enforcement of
Directive 2001/18/EC on the deliberate release into the environment of genetically
modified organisms” (Attuazione della direttiva 2001/18/CE concernente
l'emissione deliberata nell'ambiente di organismi geneticamente modificati)[41]. In the coexistence scenario Italy was one of the
first Member States (after Denmark and Germany) to enact a coexistence
legislation: in November 2004 Italy issued Law Decree[42] No.279 of 22 November
2004 “Concerning control measures in
order to ensure the coexistence of genetically modified, conventional and
organic crops” (Disposizioni urgenti per assicurare la coesistenza tra le
forme di agricoltura transgenica, convenzionale e biologica)[43]
which became Law No.5/2005 of 28 January 2005 “Conversion into Law, with modifications, of Law Decree No. 279 of 22
November 2004”
(Conversione in legge, con modificazioni, del decreto-legge 22 novembre
2004, n. 279, recante disposizioni urgenti per assicurare la coesistenza tra le
forme di agricoltura transgenica, convenzionale e biologica)[44].
It was a framework law to be completed by Regional implementing regulations.
The law defined the minimum regulatory framework for coexistence of GM crops
with conventional and organic agriculture[45]
in order not to compromise the biodiversity
of the natural environment and to guarantee freedom of enterprise, consumers'
right of choice and the quality and genuineness of national agricultural
production (art.1 para.1 law No.5/2005). It is important to underline that the law indicated
that conventional, organic, and GM farming systems should coexist and the
practice of one does not compromise the practice of the others. The
introduction of GM crops must occur without the slightest prejudice to existing farms and without requiring changes
in normal farming techniques and the implementation of the coexistence rules
must ensure farmers, production chain operators and consumers the real
possibility to choose among conventional, organic and transgenic products[46];
therefore, transgenic farming must be practiced as part of production chains which are separate from those of
conventional and organic farming (art.2 law No.5/2005). The law established (art.7
Law No.5/2005) the creation of the “Advisory
Committee for the Coexistence of Transgenic crops with Conventional and Organic
crops” (Comitato consultivo in materia di
coesistenza tra colture transgeniche, convenzionali e biologiche)[47]
which should consist in coexistence qualified experts with documented
independence. The Committee should propose the coexistence guidelines within
120 days from the entry into force of the coexistence law. Following the
guidelines each Italian Region and Self
Governing Province Italy
In March 2006, after a Region Marche Appeal[52],
with Judgment No.116/2006 of 17 March 2006 the Italian Constitutional Court Self
Governing Provinces
Therefore
the Ministry of Agriculture enacted the Ministerial Circular Letter of 31 March
2006 (Circolare 31 Marzo 2006 del Ministero delle Politiche Agricole e
Forestali – “d.l. 279/2004, convertito con modificazioni in legge 5/2005 –
sentenza Corte Costituzionale n.116/2006 – Coesistenza – Moratoria – Semina
OGM), a kind of summary of coexistence legislation, establishing[58]:
·
a moratorium on GM crops planting until
definition of the Regional coexistence plans, which
have never been formally adopted;
·
the rules established with Ministerial Decree of the
Agricultural Ministry 27/11/2003[59]
will apply as to tolerance thresholds for seeds;
·
non compliance with the GM cultivation ban will be
punished with the penalties established at art.1 para.5 of Legislative Decree
No.212 of 24 April 2001[60],
(anyone who grows GM seeds without the authorization of the Ministry of
Agriculture, Food and Forestry Policies shall be punished with a penalty of
from six months to three years or a fine up to € 51,700. The same penalty
applies in case of revocation or suspension of the authorization).
In October 2006 the Ministry of Agriculture, Food and
Forestry Policies created a Technical Working Group[61]
within the State-Regions Conference (Conferenza Stato-Regioni)[62],
with the task to work out the general guidelines to be followed by the Regions
when establishing their coexistence rules[63].
On 18 October 2007 the group published the “Coexistence Technical Guideline as a baseline for Regional Coexistence
Measures” (Linee Guida per le
normative regionali di coesistenza tra colture convenzionali, biologiche e
geneticamente modificate) but the Region Presidents have not yet approved[64] the document creating a de facto moratorium on
GM crops commercial cultivation in Italy
a) Authorization and Information System
Authorised GM crops may be cultivated only by GM crop
growers who have previously received the official approval of the Region or Self Governing
Province
b) GM seed sale
The GM seed seller shall be approved by the Region
covering the area where the business is located.
c) Cultivation Measures
During GM crops
commercial cultivation GM crop growers have to respect the provisions of the Farm Management Coexistence Plan[78]. GM crop grower
must keep,
for each GM cultivation site, a Register containing the following
information[79]:
data of the GM seeds suppliers; data of the service providers; data of all
workers[80]; data of all vehicles, machineries, materials and stores used during GM
crops commercial cultivation; farming operations performed;
data of buyers of GM products. During GM crops
commercial cultivation a GM crop grower necessarily has to respect the segregation
measures: compulsory border rows with conventional/organic cultivation,
isolation distances and possible additional border rows with a consequent
reduction of the isolation distance. The
guidelines foresee the following cultivation distances[81]:
(for maize) 1000 meters
as a distance to minimize the risk of GM admixture with the objective of
ensuring an admixture rate
and 300 meters
as a distance to minimize the risk of admixture with the objective of ensuring
an admixture rate (0,9%)[82].
d) Control
Activity and Liability Measures
The Authorities must set up a
continuous monitoring activity to verify the effectiveness of measures and
instruments adopted in order to develop a continuous assessment. In the case of GM admixture, Civil Liability
rules will apply. A
grower is excluded from any
responsibility if he used certified non-GM seeds.
The guidelines foresee the
creation of a Regional Compensation Fund to compensate the damages resulting
from the presence of GM material in other products
or soils which cannot be compensated under civil liability rules[83].
The suffering farmer has to prove the
economic damage suffered by the presence of GM material[84]
and the Fund will compensate: the market price difference between conventional
or organic product and GM product; test costs and
indirect losses resulting from the change of market channels.
In January 2010 the State Council (Consiglio di
Stato)[85] with judgment No.183 of
19 January 2010[86] instructed the Ministry
of Agriculture, Food and Rural Policies to allow the planting of GM maize and
stated that the Ministry should issue procedures for GM maize cultivation within 90 days
from the communication of the decision or, if earlier, from the notification of the decision[87].
The Italian GM crop growers have the legitimate right to plant GM crops
authorised at European level and listed in the Common Catalogue of Varieties
and planting authorizations are not subject to the release of the coexistence
regulations[88]. Given the economic profiles to be
regulated by the regional coexistence plans and given that the coexistence
plans are not within the environmental and health aspects, the granting of
cultivation can not be conditioned by the prior adoption of the regional
coexistence plans.
Then, in
February 2010, the Regional Administrative
Court
of Lazio (Tribunale
Amministrativo Regionale del Lazio – TAR LAZIO) with judgment No.2378/2010
of 17 February 2010, following an appeal by “Monsanto Agricultura Italy Spa” sanctioned the GM maize hybrids cultivation ban and the failure, by the Ministry of Agriculture, Food and Rural
Policies, to register the GM maize applications in the National Register of
Varieties of Agricultural Species. The ruling denied the legitimacy of the
Ministry’s position that the issue of the permits would be conditional to the
implementation by the Regional Coexistence Laws[89]. The Administrative Court also stated that the Ministry has to
cover, even directly, the way to ensure, in the same territory, the coexistence
between the different cultivations, under the power granted to the State by
art.117 para.5 of the Italian Constitution[90] in the event of failure to implement the EU obligations
concerning not only the need to avoid restrictions on the use and movement of
GMOs, but also to safeguard biodiversity, to guarantee the freedom of private
economic initiative, the freedom of consumer choice and the quality and
uniqueness of the national food production.
Despite the ruling of the State Council, Italian GM
crop growers have not been able to start a GM crops commercial cultivation; in
fact, the joint Decree 19 March 2010 of the Ministry of Agriculture, Food and
Rural Policies, Ministry of Health and Ministry of Environment rejected the
authorisation for Silvano Dalla Libera to start a GM maize commercial
cultivation. The Decree is very simple and it consists in only one article “The request to plant GM corn hybrids,
including the Mon810 event, submitted by the Dalla Libera Silvano Farm on
08/14/2006 is rejected”[91]. For the Decree the coexistence
between conventional, organic and GM crops is not possible in Italy
Finally, in June 2011, the Regional Administrative
Court
of Lazio (TAR LAZIO)
with judgement No.5532/2011[93]
annulled the Decree 19 March 2010 for violating national law and the Court
noted that all GM cultivation regulations pending in the Ministry may not be
stopped or suspended for specific political reasons[94]
and consequently Italy, as others EU Member States, appears likely to invoke
the safeguard clause to prevent the GM crops commercial cultivations authorised
in the EU[95],
infact Italy, as EU Member State, in principle, may not prohibit the
cultivation of an authorised GM crops[96].
[*] Este artículo ha sido publicado como un adelanto del contenido del Liber Amicorum Luis González Vaqué, que se presentará en breve.
[1] Art.2
Directive No.2001/18/EC of the European Parliament and of the Council on the deliberate
release into the environment of genetically modified organisms.
[2] “The regulatory framework must provide for a high
level of protection for human health and the environment based on sound science
and at the same time should also allow society to profit from the benefits of
these new technologies…” (Source: European Commission MEMO/01/42,
16 February 2001, Commissioner for Consumer Protection and Health).
[3] See
Pollack M.A., Shaffer G.C., When Cooperation Fails, Oxford
University Press, 2009 where the author notes that the EU regulatory system,
despite its modifications over the past decade, remains a strict and
precautionary system and also McHughen A., Introduction to the GM crops special issue
on biosafety, food and GM regulation, in GM Crops and Food: Biotechnology
in Agriculture and the Food Chain 3:1, 1–3; January/February 2012, Landes
Bioscience.
[4] The EU rules
established two different authorisation procedures (for a short summary of the
procedures see the European Commission MEMO/10/58
of 13 July 2010):
1) Procedure
relating to GM food and feed if those GMOs are to be used as source material in
food and feed production (Under Regulation No.1829/2003 of the European
Parliament and of the Council of 22 September 2003 on genetically modified food
and feed). Reg. 1829 puts in place a centralised, uniform and transparent
procedure for all applications for placing on the market of GMOs, whether they
concern the genetic modified organisms or the food and feed derived therefrom.
2) Procedure
relating the deliberate release of GMOs into the environment (Under Directive
No.2001/18) for uses other than food/feed.
[5] Art.18 para.1 of Regulation 1829/2003
states that the EFSA should attempt to give its opinion within a period of 6
months from receipt of a valid application.
[6] Only authorised GMOs can be
cultivated in the EU.
[7] Worldwide
Biotechnology regulation can be divided into two different systems. The first
one, typical in the USA ,
relies on the principle of substantial equivalence, a concept maintaining that
a GM food should be
considered the same as and as safe as a conventional food if it demonstrates
the same characteristics and composition as the conventional food (Product School Process
School
[8] Any presence
of GM material (however small but more than 0.9%) would need to be
labelled.
[9] The European
Commission on 24 June 2011 adopted the Regulation No. 619/2011 laying down the
methods of sampling and analysis for the official control of feed as regards
presence of genetically modified material for which an authorisation procedure
is pending or the authorisation of which has expired. The new regulation sets
at 0.1% the technical zero level (in the
Regulation, the technical zero is referred to as the Minimum Requited
Performance Limit or MRPL). It is important to remember that the 0.1% threshold
will only apply to imports of animal feed and not human food.
[10]
Agriculture is an open process, which means that, in practice, a perfect
segregation of different agricultural production types is not possible. See
Easthman K. & Sweet J., Genetically
modified organism: the significance of gene flow through pollen transfer,
European Environment Agency Eds, 2002.
[11]
See Rosso Grossman M., The coexistence of
GM and other crops in the European Union, in KLP 16-3: 2007 and Rosso
Grossman M., Coexistence of Genetically
Modified, Conventional, and Organic Crops in the European Union: The Community
Framework, in Cardwell M., Bodiguel L., The
Regulation of GMOs: Comparative Approaches, Oxford University Press, 2010.
See also Carpenter E., Impact of GM Crop in Biodiversity, in GM
Crops and Food: Biotechnology in Agriculture and the Food Chain 2:1, 7–23; January/February/March
2011, Landes Bioscience.
[12]
From a regulatory European standpoint, the key benchmark for distinguishing GM
and non-GM product is the 0.9% food and feed labelling threshold for
adventitious GM presence adopted by the EU.
[13] It
is important to underline that in the EU, in the past 5 years, public concern in the EU about GMOs has
increased to 66%, up 4 points (Source: Organic farming dwarfs GM crop production in
Europe, Friends of the Earth Europe, 2012 and European Commission, Eurobarometer
354: Food-related risks, November 2010).
[14]
The Council Directive No.2002/53/EC of 13 June 2002 on the common catalogue of
varieties of agricultural plant species and the Council Directive No.2002/55/EC
of 13 June 2002 on marketing of vegetable created the legal basis for the
establishment of the EU Common Catalogue of Varieties of Agricultural Plant
Species and for the EU Common Catalogue of Varieties of Agricultural Vegetable
Species.
[15] Source:
European Commission IP/10/1181 Brussels
[16]
The big European Bt maize MON 810 grower is Spain 2011 in Spain
97,346 hectares
were planted with Maize Mon 810 (Source: Organic farming dwarfs GM crop production in Europe , Friends of the Earth Europe, 2012).
Six EU countries grow Bt maize: Spain ,
Portugal , the Czech Republic , Poland ,
Slovakia , Romania and Germany
and, at the same time, six European countries have banned the MON810 cultivations: France , Germany ,
Austria , Greece , Hungary
[17] In
2011 the GM potato was planted on only 18 hectares in Sweden
and Germany but the cultivation is banned in 3 EU Countries (Austria,
Luxembourg and Hungary) because of the presence of an antibiotic resistance
marker (ARM) gene (Source: Organic farming dwarfs GM crop production in
Europe, Friends of the Earth Europe, 2012).
[18]
With the Communication of 13 July 2010 on the freedom for Member States to
decide on the cultivation of genetically modified crops the European Commission
noted that, on the basis of the Council Conclusions of December 2008, the current
legislative framework on Genetic modified organisms is comprehensive and
complete but it is necessary to better implement the rules on GM crops
commercial cultivations.
[19] In
every Member State
[20]
Whereas 3- Commission Recommendation No.556 of 23
July 2003 on guidelines for the development of national strategies and best
practices to ensure the coexistence of genetically modified crops with
conventional and organic farming.
[21]
The seed is authorized and consequently the seed is safe and the coexistence
measures must not be environmental or health risks management measures.
[22]
The American Seed Trade Association defines the adventitious presence as “the
unintended or unintentional presence of another seed variety or genetic
material, and/or trait(s) from another variety as a result of natural,
mechanical, or human means” (Source: American Seed Trade Association, What is Adventitious Presence in Seed?,
paper available in the internet site www.amseed.com).
[23] It implied a burden to demonstrate
that the presence was truly unavoidable.
[24]
The threshold plays a very important role in the European Biotechnology system
(labelling threshold) and also in the coexistence scenario. The threshold
defines the limit for compulsory labelling. An important question arises: is
0.9% the right level? It is important to remember, in this scenario, a recent
research published in 2010 and carried out by Risgo L., Areal J.F., Sanvido O.,
Rodriguez.Cerezo E., Distances needed to
limit cross-fertilization between GM and conventional maize in Europe, in
Nature Biotechnology, 8, 2010, which shows that separating fields by 40 meters is sufficient
to keep GM adventitious presence below the legal labelling threshold. The above
distance (40 meters )
is needed to keep cross fertilization below 0.5% with a probability higher than
90% and non GM maize pollen barriers have been proven to reduce
cross-fertilization rates more effectively than an isolation of the same
distance.
[25]
Most significantly, the European Commission presents coexistence as an economic
issue: coexistence measures are not designed to avoid environmental or health
risks because these risks are addressed case by case in the European
authorisation process (all environmental or health issues are dealt with in
authorisation process or will be dealt with by safeguard clauses).
[26]
Thijs F.M. Etty, Legal Brief On
Coexistence – Best National Practices for Regulating the Cultivation of GMOs,
28 November 2007.
[27] A GM crop
grower shall not
be burdened with
additional costs.
[28]
And also para.2 art.26a defines that “The
Commission shall gather and coordinate information based on studies at
Community and national level, observe the developments regarding coexistence in
the Member States and, on the basis of the information and observations,
develop guidelines on the coexistence of genetically modified, conventional and
organic crops”. Article 26a of Directive No.2001/18 must be read together
with Article 22 of Directive No.2001/18 which provides that “Member States may not prohibit, restrict or
impede the placing on the market of GMOs … which comply with the requirements
of this Directive”.
[29] In
this scenario it is important to recall the Directive 98/34/EC of the European
Parliament and of the Council laying down a procedure for the provision of
information in the field of technical standards and regulations and of rules on
information society services.
[30]
See Gaskell G., Stares S., Allansdottir A., Allum N., Corchero C., Fischler C.,
Hampel J., Jackson J., Kronberger N., Mejlgaard N., Revuelta G., Schreiner C. ,
Torgersen H. and Wagner W., Europeans and
Biotechnology in 2005: Patterns and Trends, 2006 and Harrison R.W., Boccaletti S., House L., Risk perceptions of urban and United States
Consumers for Genetically Modified Foods, in AgBioForum, 7(4): 195-201, 2004. See also Gibson J., Markets in Tradition - Traditional
Agricultural Communities in Italy and the Impact of GMOs, in SCRIPT-ed, Vol. 3, No. 3, 2006.
Available at SSRN: http://ssrn.com/abstract=1128059.
[31]
The initiatives of GreenPeace, Coldiretti, Friends of the Earth, the Italian GM
Free Regions and Genetic Rights Council. There were also some actions pro GMOs
as the initiatives of Confagricoltura or Assobiotech. In this scenario it is
useful to remember that in November 2004 about 20 most significant Italian
scientific societies working in the agronomic field and representing over
10.000 scientists signed and publicized a Consensus Document on "Food Safety and GMOs" where
they noted that GMOs are governed by rules unparalleled elsewhere in the food
industry and consequently they are more strictly controlled than any other food
product. Authorised GM foods on the EU market have now passed a lot of safety
tests and controls (see the rigid authorization process under the rules of
Regulation 1829/2003) and have been properly authorized: therefore, on the
basis of current knowledge, they should be considered safe for both human and
animal consumption. The document concluded that all GMOs on the market are safe
and any manichean approach should be
laid aside and replaced by a rational approval, based on correct scientific
information.
[32] From 15 September to 15 November 2007.
[33]
The coalition called the initiative National
Consultation but in reality it was very limited (about 3.000.000 voters).
[34] On the basis of 3.086.524 voters. The
overwhelming victory of the votes against GM products was clear because the
initiative came from and was supported by an anti-GM organization.
[35]
Source: www.liberidaogm.org.
[36] Source:
USDA, GAIN Report IT 1123 of 07 July
2012.
[37] As an EU Member State, Italy
may not exclude any type of farming from its territory, nor may it prohibit the
cultivation of GM crops of the varieties appearing in the Common Catalogue of
Agricultural Varieties or in the Common Catalogue of Varieties of Vegetable
Species.
[38] Source: Executive Summary
ISAAA, Global Status of Commercialized
Biotech/GM Crops: 2010, Brief 42:2011. Italy Italy
[39]
Source: USDA GAIN Report IT 7016, 19
July 2007.
[40]
Art.76 of the Italian Constitution specifies the role of a Legislative Decree “The exercise of the legislative function
may not be delegated to the Government unless principles and criteria have been
established and then only for a limited time and for specified purposes” (Art.76 Constitution of the Italian Republic
[41] The Decree acknowledges all
principles contained in Directive 2001/18. It was
published in the Official Journal of the Italian Republic No.194 of 22 August
2003.
[42] A Law Decree is an urgent
temporary law promulgated by the Government and it is valid for 60 days. A
Law Decree loses its effect if within 60 days, unless it is reissued, the two
chambers of the Parliament fail to approve it and thus convert it into a law,
as stated by Art.77 of the Italian Constitution.
[43] The Italian Coexistence Law-Decree. It was published in the
Official Journal of the Italian Republic No.280 of 29 November 2004.
[44] It was published in the
official Journal of the Italian Republic No. 22 of 28 January 2005. See also Barone A., Organismi geneticamente modificarti e rischi
per la libertà economica: prime riflessioni sulla legge 28 gennaio 2005 n. 5, in Foro it., V, 2005;
[45] The law is general (a
framework law) and it does not contain technical specifications but only the
principles and objectives which need to be followed to protect consumers’ and
growers’ freedom of choice. The implementation of coexistence rules must assure
farmers, production chain operators and consumers the possibility to choose
among conventional, organic and transgenic products. Also GM crops production
must be practiced as a separate chain from those of conventional and organic
farming (Art.2 para.3 Law No.5/2005). Field trials are out of the scope of this
provision.
[46] The law
guarantees the principle of freedom of choice
for Italian farmers.
[47] The Advisory Committee should be instituted as part of the Ministry of Agriculture,
Food and Forestry Policies (Ministero delle Politiche Agricole, Alimentari e
Forestali).
[48] Trento and Bolzano.
[49] The Regional Plans will
develop the technical rules for coexistence, identifying the best agricultural
practices.
[50] The parties who fail to
comply with the measures bear the burden of proof arising from their non
compliance. GM crop growers will not be held liable for the economic loss if
they have used certified seeds.
[51] It is the period before the
competent Region has issued a Coexistence Law.
[52] The appeal, notified on 22
March 2005, focused on allocations of legislative competences. The complaints
focused on a statutory provision which conferred to the State the power to
legislate, even if the contamination problem concerned not only a matter of
exclusive legislative competence of the Central State (protection of the environment, the ecosystem and cultural heritage),
but also of concurrent competence between State and Regions (health protection) and exclusive
competence of Regions (agriculture).
[53] For an analysis in italian
language see, for example, Altili P., La
coesistenza tra colture transgeniche e colture convenzionali nella sentenza
della Corte Costituzionale n. 116 del 17 marzo 2006, in Diritto
e Giurisprudenza agraria, alimentare e dell’ambiente, II, 2007; Motroni M., La
disciplina degli OGM a metà tra ‹‹tutela dell'ambiente›› e ‹‹agricoltura››,
ovvero della problematica 'coesistenza' di competenze legislative
statali e regionali, in Federalismi.it, 18, 2006; Borghi P., Colture
geneticamente modificate, ordinamenti e competenze: problemi di coesistenza, in
Le Regioni, 5, 2006.
[54] “…sono da ritenersi non fondate le censure rivolte avverso gli artt. 1
e 2 del decreto-legge n. 279 del 2004, giacché tali disposizioni, nel fornire
una definizione di colture transgeniche, biologiche e convenzionali, e
nell'affermare il principio di coesistenza di tali colture, in forme tali da
“tutelarne le peculiarità e le specificità produttive”, sono espressive della
competenza esclusiva dello Stato nella materia “tutela dell'ambiente”, e della
competenza concorrente nella materia “tutela della salute…” (Judgement
No.116/2006 Italian Constitutional Court).
[55] “Legislative powers shall be vested in the State and the Regions in
compliance with the Constitution and with the constraints deriving from EU
legislation and international obligations. The State has exclusive legislative
powers in the following matters… ……
s) protection of the environment, the ecosystem and cultural heritage.
Concurring
legislation applies to the following subject matters: international and EU
relations of the Regions; foreign trade; job protection and safety; education,
subject to the autonomy of educational institutions and with the exception of
vocational education and training; professions; scientific and technological
research and innovation support for productive sectors; health protection;
nutrition; sports; disaster relief; land-use planning; civil ports and
airports; large transport and navigation networks; communications; national
production, transport and distribution of energy; complementary and
supplementary social security; harmonisation of public accounts and
co-ordination of public finance and taxation system; enhancement of cultural
and environmental properties, including the promotion and organisation of
cultural activities; savings banks, rural banks, regional credit institutions;
regional land and agricultural credit institutions. In the subject matters
covered by concurring legislation legislative powers are vested in the Regions,
except for the determination of the fundamental principles, which are laid down
in State legislation.
The Regions have legislative powers in all subject
matters which are not expressly covered by State legislation…………..” (Art.117 Constitution of the
Italian Republic). For the Italian Constitution the Environment Protection is a
matter in which the State has an exclusive power and Agriculture, which is a
matter not expressly covered by State legislation, falls within the legislative
power of the Italian Regions. See Germanò A., Manuale di diritto agrario,
Giappichelli, 2010, pag.36.
[56] Cultivation
for GM production touches the heart Agriculture subject and it is a regional
matter (la materia deve essere disciplinata in via residuale a
livello regionale). See Tarchi R., Agricoltura
e ambiente, in Rook Basile E. (a cura di), Dopo la modifica dell’art. 117 Cost.: problemi ed esperienze sulla
competenza della materia agricoltura (Atti del Convegno IDAIC in Siena,
25-26 novembre 2005), Milano, 2006.
[57] Judgement No.116/2006. The power to adopt, by law, coexistence rules is attributed to
Italian Regions because of the “nocciolo duro” of the matter agriculture, according to the Court, coincides with the production, for food, of plants and
animals (Source: Motroni M., La disciplina degli OGM a metà tra
‹‹tutela dell'ambiente›› e ‹‹agricoltura››, ovvero della problematica
'coesistenza' di competenze legislative statali e regionali, in Federalismi.it,
18, 2006).
[58] See Martirano L., Divieto confermato alle colture transgeniche,
in L’Informatore Agrario n.15 del
7/13 aprile 2006, pag. 9.
[59] Agricultural Ministry
Ministerial Decree 2003 of November 2003 “Measures
for control of maize and soybean seeds for the presence of GMO”. Under the Ministerial Circular disposition,
GM crops commercial cultivations are not allowed in Italy until the adoption of regional laws that
regulate coexistence between conventional,
organic and GM crop production and the identification of appropriate
solutions to manage coexistence between
neighboring areas.
[60] Legislative Decree No.212 of
24 April 2001 “Implementation of
Directives 98/95/EC and 98/96/EC on the marketing of seeds and on the common
catalogue of varieties of agricultural plant species and on the specific
controls” (The Decree was published in the Official Journal of the Italian
Republic No.131 of 8 June 2001).
[61] Under the coordination of the
Ministry of Agriculture, Food and Rural Policies.
[62] The State-Regions Conference
on 11 September 2006 published the Dossier
OGM where they noted the four possible following scenarios for the Italian
Coexistence Approach: Scenario a) No measures of Regional Moratorium (High exposure to
indiscriminate introduction of GM seeds in agriculture, taking advantage of
regulatory gaps in regional and state legislations); Scenario b) Regional
Moratorium (temporary or no expiry date); Scenario c) Review existing GMO legislations (rules
notified to the European Commission under Directive 98/34 or rules not notified
to the European Commission under Directive 98/34); Scenario d) National
Moratorium about GM crops cultivation.
[63] General Guidelines to provide
a basis for the regions to draw up detailed coexistence plans.
[64] See in Italian language:
Bussinello O., Chiarello L., Vuoi
produrre OGM? Paga la tassa, Italia Oggi, pag.29, 16/01/2010; Fornovo L., L’Italia sdogana gli OGM, La Stampa , pag,23, 17/01/2010;
OGM le Regioni bloccano l’esame del
documento sulla coesistenza, La
Stampa , pag.26, 23/01/2010.
[65] The Guidelines are like a
manual which will be useful (when officially approved) for the future regional
coexistence laws. The State-Regions Conference has chosen, as a basic
principle, the acceptance of coexistence among conventional or organic and GM
crops cultivation but this choice does not appear to be shared by the Italian
GM free Regions; in fact the Guidelines are not official because they are only
a draft and they are not approved by the Presidents of the Italian Regions.
[66] It is important to remember
that the Guidelines are only a draft measure because they are not yet approved.
The Guidelines cover GM maize and GM rape commercial cultivation and GM soybean
as a crop approved for animal feed. For maize two levels of tolerance will
apply: under 0,01% (absence of GM admixture) and 0.9%. For soya one level will
apply: under 0,01%. For a legal analysis see Paoloni L. (2008), Le linee guida per la coesistenza tra
colture convenzionali, biologiche e geneticamente modificate, in Rivista di Diritto Alimentare, Anno II,
n° 2, aprile-giugno 2008.
[67] Covering the area where the
farm is located.
[68] By the end of November of the
previous year and in any case at least 3 months before the date of sowing GM
crops.
[69] Chapter 9 of the Coexistence
Guidelines.
[70] The PGA has to contain
following information: techniques used for the separation of the fields, the
conservation of seeds, sowing, harvesting, transport and storage of products;
Activities during GM crops cultivation; destination of the products (Chapter 7
para e) of the Guidelines).
[71] Cadastral Reference of the
Area.
[72] (Chapter 7 para b) of the
Guidelines). A GM crop grower has to inform the nearest farms in conformity
with procedures established by the Region or Self Governing Province.
[73] (Chapter 7 para d) of the
Guidelines). GM crop growers must attend a Regional Training Course about
coexistence rules.
[74] Chapter 7 para i) of the
Guidelines.
[75] Chapter 7 para j) of the
Guidelines. Today in Italy there is no such type of insurance and
also in EU Member States there is no such type of insurance (Source: European
Commission, Staff Working Document accompanying the Report from the
Commission to the Council and to the European Parliament, on the coexistence of
genetically modified crops with conventional and organic farming.
Implementation of national measures on the coexistence of GM crops with
conventional and organic farming, 2 April 2009).
[76] The Register is published in
the internet web site of the Region.
[77] Chapter 10 of the Guidelines.
[78] Anyone mentioned in the Farm
Coexistence Plan is meant to respect the coexistence measures. The Farm
Coexistence Plan must be drafted on the basis of the Regional law.
[79] Chapter 7 para g) of the
Guidelines.
[80] It is
compulsory for GM workers as well to attend a GM training course.
[81] The cultivation distances
established in the national Guidelines are general; in order to be effective
and legal they must be established at regional level.
[82] Today the available
researches made in Italy are based largely on simulations with mathematical
models. In the Italian
scenario it is
important to remember
the scientific study
by the Documentation Centre on Agricultural Biotechnology
(CEDAB) presented on 27 January 2006 during the Workshop Vegetalia. The research shows that in the Po Valley, under optimal conditions, the
GM maize gene flow falls below the critical threshold of 0.9% at a distance
from the source of
pollen of 17.5 meters , and below 0.5% at a distance from the source of pollen of 30 meters . The results of the research involved about 40 hectares
in different areas of Lombardy Region
and they are in line with similar field trials conducted in
Germany
by the Institut für Pflanzenschutz
und Pflanzenzüchtung of Halle
and in Switzerland by the Institut für Pflanzenwissenschaften
of Zurich 20
metri limitano il flusso genico tra colture di mais
contigue a valori inferiori allo 0,9% indicato dalla UE come soglia per la
coesistenza tra colture ogm, convenzionali e biologiche – www.cedab.it).
[83] Chapter 12 of the Guidelines.
[84] With qualitative analysis (detection
of the
contaminant) and quantitative analysis (detection
of the contaminant’s quantity).
[85] The highest Court of Appeals
in Italy.
[86]
The case was brought to the Council of State by farmer Silvano Dalla Libera, a member of Futuragra, a pro-biotech farming
association. In
April 2007 the Ministry of Agriculture rejected Dalla Libera’s request for
legal authorization to start a GM maize commercial cultivation; therefore the
farmer started a legal action. The claimant showed the impossibility to start a
GM maize commercial cultivation in Italy due to the non adoption of the Regional
Coexistence Plans.
[87] The Council’s ruling means
that the Government can no longer delay the approval procedures. As a member of
the European Union, Italy is required to allow biotech cultivation for the EU
approved varieties. The Italian Minister of Agriculture, Food and Rural
Policies referring to the Council decision, noted that “...the overwhelming majority of farmers don’t want genetically
modified plants in their fields” (Source: Italian court gives GM
go-ahead, in GMO-Compass news of 5 February 2010). See also United
States Department of Agriculture GAIN Report IT 1016, 5 March 2010.
[88] The Ministry of Agriculture,
Food and Rural Policies was obliged to release the GM crops cultivation
authorization.
[89] And also after the
establishment of the Regional Coexistence Management Plans.
[90] “Regarding the matters that lie within their field of competence, the
Regions and the Autonomous Provinces of Trento and Bolzano participate in any
decisions about the formation of community law. The regions and autonomous
provinces also provide for the implementation and execution of international
obligations and of the acts of the European Union in observance of procedures
set by State law. State law establishes procedures for the State to act in
substitution of the Regions whenever those should fail to fulfill their
responsibilities in this respect”.
[91] Art.1 Joint Decree 19 March
2010 “La richiesta di messa in coltura di
ibridi di mais geneticamente modificati, contenente l’evento MON 810, formulata
dall’Azienda Dalla Libera Silvano con nota del 14/08/2006 è da considerarsi
respinta”.
[92] The joint decree was drawn up by the
Minister of Agriculture, Food and Rural Policies on 19 March 2010 after having
acquired the Biotech Seed Commission (BSC)’s opinion of 18 March
2010 that was to ignore the EU obligations and to reject the request of the GM
crop growers for the following reasons: the precautionary principle, lack of
coexistence regulations, lack of research, and the need to safeguard the
so-called Made in Italy brand. The
Commission was established by Decree No.212/2001; it is an Advisory Body that
consists of two members from the Ministry of Agriculture, two members from the
Ministry of Health and two members from the Ministry of the Environment as well
as the representatives from Basilicata, Emilia
Romagna, Friuli Venezia
Giulia, Lombardy, Tuscany and Veneto
Regions. After the Decree the members of the Pro-Biotech
Association Futuragra organised some pro biotech actions especially during
August 2010 when, in Vivaro, a small town in Friuli Venezia Giulia
Region, they illegally tried to plant GM maize to protest against the Italian
rules about GM crops commercial cultivation.
[93]
TAR Lazio Judgement No.5532 of 21 June 2011. The appeal was promoted by the biotech
farmer Silvano Dalla Libera in 2010 against Decree 19 March 2010.
[94] The Court, again, notes that “È
stato riconosciuto definitivamente in sede giurisdizionale che il procedimento
di cui trattasi è di competenza esclusivamente statale e che l’amministrazione
ministeriale, in caso di inerzia da parte delle regioni nell’adozione dei piani
di coesistenza, debba attivare i propri poteri sostitutivi previsti dalla
vigente normativa in materia di attuazione degli obblighi comunitari gravanti
sulle regioni e non possa, pertanto, rifiutarsi di provvedere in caso di
persistente inerzia di queste ultime”. It is very interesting to underline
that TAR noted that the Decree was not notified to EU Commission as stated by
the EU rules, “Il decreto è, altresì, illegittimo in quanto non è stato
notificato agli organi della Commissione europea e, conseguentemente, gli
organi comunitari non hanno potuto svolgere l’esame delle dette disposizioni
nazionali adottate in deroga agli obblighi di armonizzazione di cui al
richiamato par. 6 dell’articolo 95 del trattato CE”.
[95] The Italian Minister of
Agriculture declared “After the decision
of the Tar of Lazio I think we have reached the point which further complicates
the current situation regarding Gmos, and I will avail myself of the right to
ask the application of the safeguard clause. At this moment I instructed my
offices to take all necessary measures in the EU to ask for the safeguard
clause that would prevent the Gmo cultivation in the national territory”
Source: The Minister of agriculture
intervenes on the issue of the Gmo cultivation in Italy, Agricoltura
Italiana on Line, 26 June 2011. The Italian Region Committee, in
April 2012, formally requested (for the second time) that the Ministry of
Agriculture invoke the safeguard clause to ban the GM crops commercial
cultivations and the Committee justified the request on the need to protect
italian organic production and Italian quality production as PDO and PGI
(Source: USDA GAIN Report IT 1211, 16
April 2012). It useful to underline that the request does not provide any new
or additional scientific information indicating the EU-approved biotech crops
to be a risk to human health or the environment, as required by Directive
18/2001/EC (Source: USDA GAIN Report IT
1222, 5 July 2012).
[96]
In fact as stated by the judgement of the European Court C-36/11 of 6 September
2012 “the cultivation of GMOs such as the
MON 810 maize varieties cannot be made subject to a national authorisation
procedure when the use and marketing of those varieties are authorised pursuant
to Article 20 of Regulation No 1829/2003 and those varieties have been accepted
for inclusion in the common catalogue provided for in Directive 2002/53; Article 26a of Directive 2001/18 does not
entitle a Member State to prohibit in a general manner the cultivation on its
territory of such GMOs pending the adoption of coexistence measures to avoid
the unintended presence of GMOs in other crops”.
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[ReDeco no se hace responsable de las opiniones de los autores de lo artículos que publica]
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