Required Report - public distribution

**Date:** 8/4/2005

**GAIN Report Number:** PO5017

PO5017

**Portugal**

**Biotechnology**

**Annual**

**2005**

**Approved by:**

![](media/image1.wmf)Stephen Hammond

U.S. Embassy

**Prepared by:**

Leonor Ramos

**Report Highlights:**

Spain is the only European Union Member with a substantial cultivation
area of biotech corn. Portugal began planting biotech corn this year for
the first time. Newly elected governments in both countries have meant
the evolution of Governmental positions on biotechnology, including new
biotechnology-event approvals, and coexistence decrees. Portugal has
just announced a coexistence decree, while Spain is currently working to
have one in place in early 2006. (LR32CM60SH5).

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Madrid \[SP1\]

\[PO\]

######## TABLE OF CONTENTS

[**Executive Summary 3**](#executive-summary)

[Biotechnology Trade and Production
3](#biotechnology-trade-and-production)

[Biotechnology Crops 3](#biotechnology-crops)

[Spain 3](#spain)

[Portugal 4](#portugal)

[Biotechnology Policy 4](#biotechnology-policy)

[Regulatory Framework for Agricultural Biotechnology
4](#regulatory-framework-for-agricultural-biotechnology)

[Spain 4](#spain-1)

[Portugal 7](#portugal-1)

[Marketing Issues -- Market Acceptance
9](#marketing-issues-market-acceptance)

[Spain 9](#spain-2)

[Portugal 10](#portugal-2)

[Capacity Building 10](#capacity-building)

[Outreach Activities 10](#outreach-activities)

[Future Actions 10](#future-actions)

#   {#section .unnumbered}

# Executive Summary

In Spain, biotech corn planted area during 2005 is expected to drop to
48,000 hectares (ha), down from 58,220 ha in 2004, and in Portugal to
increase to 1,000 ha from zero ha in 2004. The Iberian Peninsula
drought, which began in the fall of 2004, reduced corn-seeded area,
including biotechnology corn plantings this spring from last year's
level in Spain and from what would have been planted in Portugal. The
reduction is primarily due to a sharp decline in corn seeding in the
Ebro Valley region, where the corn borer incidence is particularly high.
In Portugal, farmers are just starting to plant biotech seeds, after a
5-year interregnum.

The Governments of Spain (GOS) and Portugal (GOP), socialist in
ideology, appear to be experimenting more with the EU "precautionary
principle" than their predecessor Governments. This has been evidenced
by a more negative approach to voting on biotech approvals in Brussels,
and in delays of approvals at home (in the case of Spain at least until
July 13, 2005 when Spain approved NK603 for planting). As an example, in
the EU Environment Ministers Council meeting on June 24, 2005, the GOS
supported a continued ban on planting certain corn and rapeseed biotech
seeds imposed in specific EU Member States, in opposition to the EC
proposal, and the GOP abstained in the same vote.

The GOP has just finalized a national coexistence decree that will
regulate biotechnology production, while Spain is still working on its
coexistence decree in time for the 2006 crop. The Portuguese decree sets
a minimum distance of 200 meters between biotech and conventional corn
plots, and a 300-meter distance between biotech and biological corn
plots, and establishes a framework for biotechnology-free regions. This
will likely mean the cultivation of biotechnology corn in the
mid-to-southern regions of Portugal, where farms are larger and more
responsive to technological opportunities.

# Biotechnology Trade and Production

## Biotechnology Crops

###  Spain

####### Spain: Areas Cultivated to Bt Corn

  ----------------- ------------------- ------------------- ------------------- ------------------- ------------------- ------------------- ------------------- -------------------
  []{.mark}         **[1998]{.mark}**   **[1999]{.mark}**   **[2000]{.mark}**   **[2001]{.mark}**   **[2002]{.mark}**   **[2003]{.mark}**   **[2004]{.mark}**   **[2005]{.mark}**

  Areas (1,000 ha)  22.32               24.95               25.82               11.54               23.28               32.16               58.22               48.0
  ----------------- ------------------- ------------------- ------------------- ------------------- ------------------- ------------------- ------------------- -------------------

Source: ISAAA and Spanish AGMIN.

-   Spain is a feed deficit country, so Spanish corn farmers have
    tremendous incentive to produce for a reliable local market, which,
    even with increased yields due to biotechnology seeds, they will not
    be able to satiate;

-   Currently the demand of biotech corn seeds is in *Ebro* Valley
    regions of Aragón and Cataluña where the corn borer is particularly
    intense. Industry sources report that in 2004, the Aragón and
    Cataluña regions represented respectively for 25,000 and 16,000 ha
    of Bt-corn areas.

-   However, an increase in biotechnology seeded acreage in the coming
    years will depend on: (1) GOS biotech policies, in particular the
    coexistence decree (see below) and the approval of new biotech seeds
    resistant to herbicides; and, (2) the success local farmers enjoy
    when using these products.

-   CAP reform will likely lead to a reduction in corn production, but
    only in the marginal, non-irrigated areas that would not have
    otherwise embraced biotechnology corn production. As a result, the
    share of biotech seed planted will likely increase, as farmers will
    tend to use best production technologies available, and those who
    can't will opt for alternative production. The GOS approval of
    NK-603 may mean an increase other important Spanish corn areas,
    including *Ribera del Duero* and *Andalucia*. With new approvals,
    Spanish biotech corn areas will easily surpass 60,000 ha.

###  Portugal

-   Portugal did not cultivate biotech crops during the past five years
    due to AGMIN DISPATCH dated 12/27/99, which suspended sale/use of
    biotech seeds listed in the National Seed Catalogue (NSC). The same
    dispatch banned biotech seed trials with commercial purposes.

-   The GOP has not invoked any safeguard measures related to the
    planting of biotech crops, and so all biotechnology varieties
    approved by in the EC catalog can now be planted in Portugal.

# Biotechnology Policy

## Regulatory Framework for Agricultural Biotechnology

###  Spain

#### Responsible Ministries and Their Role

-   Three Ministries oversee biotech issues: Agriculture, Health and
    Environment.

```{=html}
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```
-   The Ministry of Agriculture approves and monitors biotech seeds for
    planting.

-   The Ministry of Health and Consumer Affairs monitors and enforces
    labeling.

-   The Ministry of Environment monitors and enforces evaluation of new
    GMO events, field trials, and applies penalties set by 2001/18
    Directive (transposed to national order by Law 9/2003).

```{=html}
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```
-   A Biosafety Committee, with representatives from these Ministries,
    studies and proposes changes;

-   An inter-ministerial council at the Director General level reviews
    each biotech event. The Council has final word on applications to
    cultivate biotechnology events.

#### Political Factors That May Influence Regulatory Decisions Related to Agricultural 

#### Biotechnology

-   External: (1) Prevailing EU policies towards GMOs; (2) EC motivation
    to support GMOs; (3) Seemingly weakening integration process within
    the EU, signaled by the setback in France and the Netherlands. This
    may lead to "re-nationalization" of GMO policies at the Member State
    level.

-   Internal: (1) GOS' internal debate to develop a coherent
    biotechnology policy. (2) Influence of NGOs on the perception of
    biotech products. Greenpeace has 40,000 affiliates in Spain, and
    carries out several high-profile activities with considerable media
    impact. (3) Consumer perceptions of biotechnology.

#### List of Biotechnology Crops

Maize Varieties Approved in Spain for Cultivation

+----------------+------------------+-----------------+---------------+
| **[E           | **[              | **[Co           | *             |
| vent]{.mark}** | Strain]{.mark}** | mpany]{.mark}** | *[Publication |
|                |                  |                 | Date in       |
|                |                  |                 | Official      |
|                |                  |                 | Jour          |
|                |                  |                 | nal]{.mark}** |
+----------------+------------------+-----------------+---------------+
| Bt-176         | COMPA CB         | Syngenta        | 03-26-98      |
|                |                  |                 |               |
| (SYN-EV176-9)  | JORDI CB         | "               | 03-26-98      |
|                |                  |                 |               |
|                | BRAMA            | "               | 03-11-03      |
|                |                  |                 |               |
|                | ESCOBAR          | "               | 02-16-04      |
+----------------+------------------+-----------------+---------------+
| MON-810        | ALICAN BT        | Limagrain       | 03-11-03      |
|                |                  |                 |               |
| (MON-00810-6)  | ARISTIS BT       | Nickerson Sur   | 03-11-03      |
|                |                  |                 |               |
|                | DKC 6575         | Monsanto        | 03-11-03      |
|                |                  |                 |               |
|                | PR33P67          | Pioneer Hi-Bred | 03-11-03      |
|                |                  |                 |               |
|                | CAMPERO Bt       | Advanta         | 02-16-04      |
|                |                  |                 |               |
|                | CUARTAL Bt       | Arlesa          | 02-16-04      |
|                |                  |                 |               |
|                | DKC 6550         | Monsanto        | 02-16-04      |
|                |                  |                 |               |
|                | GAMBIER BT       | Nickerson Sur   | 02-16-04      |
|                |                  |                 |               |
|                | JARAL Bt         | Semillas Fitó   | 02-16-04      |
|                |                  |                 |               |
|                | PR 32 P76        | Pioneer Hi-Bred | 02-16-04      |
|                |                  |                 |               |
|                | PORTECT          | Koipesol        | 02-16-04      |
|                |                  |                 |               |
|                | ELGINA, OLIMPICA | Pioneer Hi-Bred | EU Catalogue  |
|                |                  |                 |               |
|                | BOLSA, LEVINA    | Pioneer Hi-Bred | 09-17-04      |
|                |                  |                 |               |
|                | NOVELIS          | Coop de Pau     | "             |
|                |                  |                 |               |
|                | DK 513           | Monsanto        | "             |
+----------------+------------------+-----------------+---------------+

-   List of approved varieties for cultivation includes the 17 varieties
    listed in the EU seed catalogue (derived from MON-810), plus four
    varieties derived from Bt-176.

```{=html}
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```
-   Between 1998 and 2002, COMPA CB was the only variety planted in
    Spain. Other significant varieties are DKC 6575, PR33P67, JARAL Bt
    and PR 32 P 76.

-   On January 2003, the industry submitted a NK 603 strain for approval
    by the authorities. Finally on July 13, 2005 NK 603, a
    glyphosate-resistant event was approved for planting in Spain. The
    NK 603 approval will likely be used the *Ribera del Duero* and the
    *Andalucia* regions.

#### Field Testing

-   Industry sources report there are field trials with NK 603.

-   Full list of pending requests can be checked at
    [http://www.mma.es](http://www.mma.es/).

#### Coexistence Policy

-   Spain does not have a coexistence law in effect, but there is one
    under development;

-   Local authorities plan to have the new coexistence law in place by
    February 2006.

-   Previous GOS coexistence law projects considered a 25 meter minimum
    distance between biotech and conventional seed plots;

-   According to our sources, the distance currently under discussion
    has been raised to 50 meters. We do not know if this will be final,
    nor if the authorities will introduce further restrictions, namely
    buffer zones.

#### Spain's biotech agenda

-   The GOS is still finding its way regarding biotechnology policy;

-   The pro-active attitude of the previous GOS is still apparent in the
    Ministry of Agriculture, but the Ministry of the Environment seems
    to be finding its way;

-   On June 24, the GOS voted against the EC, in support of five EU
    countries that had banned certain biotech crops, which was and is
    concerning; and,

-   On recent EC proposals regarding biotechnology events, the GOS has
    abstained.

#### Technological Fees

-   Not charged by the authorities.

#### Relevant sites

> Legislation, Spanish National Safety Commission, trial requests,
> reports and table of approved products:
>
> [http://www.mma.es/calid_amb/seg_bio/index.htm#](http://www.mma.es/calid_amb/seg_bio/index.htm)
>
> Publications by *Fundación Genoma España*:
>
> <http://www.gen-es.org/02_cono/02_cono.cfm?pag=0300>

Information from the Spanish Agency of Food Safety on Transgenic crops:

<http://www.aesa.msc.es/aesa/web/AESA.jsp>

###  Portugal

#### Responsible Government Ministries and Their Role

-   The Environment Ministry is the ultimate authority on the national
    position on events submitted under the 2001/18 EU Directive.

-   The Portuguese Environment Ministry (PEM) represents the GOP at EU
    Environment Ministers Council level. The PEM develops its positions
    on the basis of the technical recommendations issued from the
    Environment Institute (IA), and in coordination with the political
    advice from the Ministry's office of international relations (GRI).

-   The IA represents the Ministry at technical level Committee
    meetings. For preparation of its dossiers on each event, IA follows
    a procedure of consultation with other GOP agencies: General
    Directorate of Health (DGS) in the case of products destined for
    human consumption, and the AGMIN's crop protection directorate
    (DGPC) for planting seeds.

-   The AgMIN is the ultimate body responsible for GM-submittals under
    the 1829/03 EU Regulation.

-   The AGMIN's food monitoring and quality general directorate (DGFCQA)
    has technical level responsibility for preparing biotech dossiers,
    issuance of technical-level recommendations to the GOP, and
    representing Portuguese authorities at technical-level meetings of
    specialized EU Committees.

#### Role of Biosafety Committee

-   The previous GOP instituted the Biosafety Committee in 2004, through
    joint decision 174/2004 from GOP Presidency, AGMIN/DGPC and
    Environment Ministry;

-   The Biosafety Committee was intended to provide coordinated
    technical support to GOP decision-making on new biotechnology seed
    requests;

-   The Biosafety Committee never became operational, and the Health
    Ministry seat is the only one presently occupied.

#### Political Factors That May Influence Regulatory Decisions Related to Agricultural 

#### Biotechnology

-   Political factors that may influence regulatory decisions are
    basically the same as in the case of Spain (see above).

#### List of Biotechnology Crops 

-   The 17 varieties inscribed in the EUSC.

#### Field Testing

-   AGMIN DISPATCH dated 12/27/99 bans the planting of biotech seed
    experimentation for commercial purposes.

-   Testing of seeds for non-commercial purposes remains permitted, but
    subject to IA approval. Earlier his year, the industry presented IA
    with a request for carrying out experimentation in northern *Ponte
    da Barca*, and near-Lisbon *Cadaval* regions.

-   Applications refer to field testing with seeds containing
    modifications not yet approved in the U.S. -- E 5846.49.7.12 and E
    5846.53.9.4 - and the following seeds with stacked modifications:
    1507 x NK 603; 59122 x NK 603; 59122 x NK 603 x 1507.

-   IA posted applications for public comment in its site, at
    [http://www.iambiente.pt](http://www.iambiente.pt/). Concerned
    Municipalities expressed a negative view.

-   The commenting period has just expired, and IA will deliberate
    shortly.

GM-planting seed experimentation for commercial purposes

#### Coexistence Policy

-   The GOP has just approved the national coexistence law, which will
    regulate biotech crop production starting in 2006. The coexistence
    decree will be published shortly.

-   Local authorities justify the need for coexistence law on the basis
    of the precautionary principle, and public concern over GMOs.
    Coexistence law sets technical cultivation parameters, inter-crop
    minimum distances, buffer zones, procedural requirements, and
    facilitates the designation of biotechnology-free zones;

-   A 200 meters distance is required between biotech and traditional
    corn crops and 300 between biotechnology and organic corn
    production. This distance can be replaced with a buffer zone of
    24-rows planted to conventional seeds or may be reduced to 50
    meters, with a 28-row buffer zone. In case of insect tolerance
    strains, producers need to create "refuge" conventional variety
    zones inside the biotech seed plots, representing at least 20
    percent of total crop area.

-   The Portuguese AGMIN/DGPC recently concluded a three-year study on
    the impact of GMOs in agriculture -- Project AGRO-17. The
    conclusions of this study have just been presented in Lisbon, being
    of favorable in nature. DGPC is now planning to carry out a new
    multi-year project to study field cross-contamination and other
    matters directly tied to the regulation of coexistence.

#### Portugal's biotech agenda

-   Above remarks on Spain apply to Portugal, with the difference that
    the previous GOP was less favorable than the previous GOS;

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-   In the June 24 EU Environment Ministers Council meetings, Portugal
    abstained in the EU Commission vote to overthrow five Member State
    decisions to ban cultivation of biotech seeds;

-   Anti biotechnology lobbying is coordinated and led by a movement
    titled "Transgenic out of the Plate" (TOTP). TOTP integrates a vast
    spectrum of organizations, from environment NGO Quercus to the
    Nature Protection League (LPN) and small farmers confederation
    (CNA). TOTP has been gaining increased visibility with high profile,
    well-staged events;

-   Earlier this year, a well-known attorney filed a well-publicized
    case in the Portuguese Courts, advocating the banning of biotech
    seeds due to absence of national coexistence law;

-   Over the years, large-scale farmers have supported biotech-free corn
    production, invoking commercial reasons. CAP changes now should now
    encourage these farmers to be more interested in biotechnology;

-   AGOFFICE contacts report that farmer enthusiasm resulting from the
    coexistence courses is very high, which suggests considerable farmer
    interest in biotech seeds. Under the new coexistence decree,
    attendance at these courses is mandatory for cultivating biotech
    crops.

#### Technology fees

-   No technology fees are charged in Portugal.

# Marketing Issues -- Market Acceptance

## Spain

-   According to the "The Eurobarmeter," Spain is one of the EU
    countries with greater GMO acceptance;

-   In 2004, 14 percent of Spaniards expressed concern over GMOs (24
    percent in the EU-25), down from 18 percent in 2002 (30 percent in
    the EU-15).

-   Food manufacturers with recognized labels have eliminated potential
    biotech products from food product composition. This concerns
    multinationals and national manufacturers with well-asserted brands.

-   An extremely small percentage of food products are sold at retail
    with the "contains GMO" mention, without problems to-date. This
    mention is carried primarily by certain vegetable oil brands.

-   The local feed industry has instructed its members to label all feed
    by default with "Contains GMO."

##  Portugal

-   Market acceptance of biotech products is considered reasonable;

-   Multinationals and local manufacturers with higher-profile brands
    have eliminated biotech-derived products;

-   The feed association has instructed its members to always label feed
    with "contains GMO."

# Capacity Building

## Outreach Activities

N.A.

## Future Actions

N.A.