Required Report - public distribution

**Date:** 7/14/2006

**GAIN Report Number:** CO6009

CO6009

**Colombia**

**Biotechnology**

**Agricultural Biothechnology**

**2006**

**Approved by:**

![](media/image1.wmf)David J. Mergen

U.S. Embassy

**Prepared by:**

Adriana Uribe & Alberto Restrepo

**Report Highlights:**

Biotechnology has not been a major issue in Colombia. Agricultural
groups strongly support adoption of biotechnology, while some
environmental groups have raised limited concerns. The only
biotechnology materials planted on a non-restricted commercial basis in
Colombia is Bollgard cottonseed from D&P Land Co. and Bollgard
Roundup-Ready cotton to a lesser extent. Biotech blue carnations are
approved for limited commercial production. There are pending license
applications for other crops.The commercial materials originate mainly
in the U.S., and the EU. The institutional regulatory framework is being
developed.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Bogota \[CO1\]

\[CO\]

Section I. Executive Summary

Colombia is the largest market for U.S. agricultural products in Central
and South America (Colombia is one of the top ten markets for US corn).
Biotechnology requirements have not caused problems for U.S. exports.

The United States concluded the negotiation of a free trade agreement
with Colombia on February 27, 2006 as previously expected, and its
implementation will likely occur in late 2007 after the legal procedures
are completed in both countries.

The Colombian legal framework for biotechnology, for both plants and
animals, is composed of the following regulations (Resolution 3492 of
December 22 of 1998, Resolution 2935 of October 23 of 2001, and
Resolution 1063 of March 22 of 2005) by the Colombian Agricultural
Institute (ICA); Colombia approved the Cartagena Protocol on Biosafety
with law 740 of 2002. The law was later regulated by Decree 4525 of
December 6, 2005. ICA also issued resolution 1063 of March 22, 2005,
establishing the procedures for registration of those people and
organizations involved in biotechnology production, imports, handling,
research, etc. ICA's Resolution 946 of April 17, 2006 establishes
procedures for living modified organisms (LMO's) to be used in
agriculture, fishery, forestry and agro-industry.

The current status of biotechnology regulations in Colombia makes this a
good time to develop educational and training activities to facilitate
the issuance of science-based regulations.

The only biotechnology material planted on a non-restricted commercial
basis in Colombia is Bollgard cottonseed from D&P Land Co. and Bollgard
Roundup-Ready cotton. However, biotech blue carnations are approved for
limited commercial production. It is for multiplication of exportable
short-stem cut flowers under greenhouse conditions. There are pending
license applications for other crops as shown in the attached table.

Colombian regulations require the labeling of biotech planting seeds and
raw materials (such as grains), but they have not required labeling of
processed food and feed made from biotech materials. However, there is a
group called "Consumers for Colombia" which has proposed labeling of
processed food. No resolution has been issued after a year of
discussions.

The Ministry of Social Protection (previously known as Ministry of
Health) is in charge of regulating LMO's labeling for consumers.

Local distributors charge biotech fees for each hectare planted with
biotechnology seeds.

Section II. Biotechnology Trade and Production

a\. The only biotechnology material planted on a non-restricted
commercial basis in Colombia is Bollgard cottonseed from D&P Land Co.
Bollgard cotton area has increased from 6,200 hectares in 2003 to 18,700
hectares in 2004, and 21,500 hectares in 2005, with 13,385 hectares
planted in the interior valleys of Cauca and Tolima/Huila for harvest by
mid-2006. Bollgard R&R cotton and biotech blue carnations are approved
for limited commercial production. Area planted with Bollgard R&R has
been less than 300 hectares. Blue carnations planted under greenhouse
conditions are estimated at 4 hectares in central Colombia.

Colombia has not developed domestically any biotechnology crops as of
this date, but there are several domestic organizations conducting some
specific research projects. The sugar cane research center (Cenicana) is
looking to develop a sugar cane variety resistant to cane yellow leaf
virus; the International Center for Tropical Agriculture (CIAT) is
working on rice, grazing grass, and cassava; and the Coffee Research
Center (Cenicafe) is working on a coffee variety that is resistant to
coffee borer (broca). The latter has not received much emphasis due to
European coffee consumer concerns about biotechnology-developed
products. The research efforts have continued on coffee borer.

b\. Colombia currently has several biotech crops in the process of
regulatory approval for planting in Colombia. Some recent information
indicates that Flower Development is working on roses with blue petals.
Additionally, the following crops may be commercially released in 2008:
Yield-gard and R&R corn by Monsanto; Herculex I corn (resistant to some
lepidopterous) by Dupont, and corn Bt 11 (resistant to some
lepidopterous) by Syngenta.

The table in Appendix A lists all the products currently in the process
and the status of approval. The Ministry of Agriculture has placed a
priority on approval for planting of yield-gard corn. It seems unlikely,
however, that the yield-gard corn will move into the semi-commercial
trials in the short-run due to opposition from the Ministry of
Environment. Although the Ministry of Agriculture (through the Colombian
Agricultural Institute (ICA)) has the lead on biotechnology issues
regarding agriculture, fishery, forestry and agro-industry, the Ministry
of Environment is involved in regulatory approval of biotech materials
released in the environment.

c\. Colombia imports the following biotechnology seeds: Bollgard cotton
(trade mark) resistant to lepidopterous insects, and Roundup-Ready
cotton (trade mark) tolerant to round up herbicides. Delta and Pine Land
Company owns both registered marks. The imported cottonseed originates
in the U.S., as well as South Africa, Argentina and Australia, on some
occasions.

d\. Colombia receives limited food aid from the U.S. There are no
biotech related restrictions on the food aid.

e\. Colombia approved in 2000 the commercial release in the Bogota area
of Dutch blue carnation for export only. The carnation exports are
entirely destined to the European markets. Florigene in Holland
developed this variety.

Section III. Biotechnology Policy

a\. Regulatory framework for agricultural biotechnology:

i.  Responsible Ministries: Ministry of Agriculture and Rural
    Development through the Colombian Agricultural Institute (ICA).

> Ministry of the Environment, Housing and Territorial Development

# Ministry of the Social Protection through Invima (for food products only)

Colciencias (Colombian Entity for the Development of Science and
Technology)

ii. Decree 4525 of December 6, 2005, established three interagency
    committees responsible for evaluation and approval of biosafety
    issues:

> a\) National Technical Committee for Agriculture, Fishery, Forestry
> and Agro-industry.
>
> b\) National Technical Committee for Environment.
>
> c\) National Technical Committee for Health or Human Nutrition.

iii. The Government of Colombia has been a decisive supporter of
     agricultural biotechnology, but lobbying by some environmental
     groups has put pressure on some GOC decisions. The GOC's structure
     for biotechnology regulations is based on making science-based
     decisions on accepting or rejecting new biotechnology products. The
     basic principle is to adopt the technologies that may help the
     economic/social development of Colombia. The Ministry of
     Environment has been the most conservative voice on biotechnology
     approvals.

b\. Approved crops

i.  Appendix A shows the applications received for introduction of
    biotechnology materials for different agricultural uses and their
    current status.

ii. The government of Colombia only allows biotechnology materials for
    commercial plantings after the material has been previously
    approved. In order to be approved, each variety with a specific gene
    must go through the approving process that is lengthy and has to
    comply with the strict regulations step by step. The approval is
    subject to an environmental risk assessment.

c\. Colombia allows field-testing for biotechnology crops (see Appendix
A) after a risk assessment that is submitted to the National Biosafety
Council. The Council recommends ICA to conduct the biosafety evaluation.
No estimated time for commercial release has been made due to
institutional obstacles. These dissenting institutional reservations
have to be resolved before new applications for admittance are
considered.

d\. The treatment given to "stacked" events consists of running the
field-testing again as if the new seed were a completely new one.
Although the individual traits were already accepted, the "stacked"
variety has to begin the process all over.

e\. There is no written regulation on the coexistence between
biotechnology and non-biotechnology crops in Colombia. However, ICA has
carried out an evaluation of cross-pollination on cotton and found out
that both LMO and non-LMO's crops may coexist. Nevertheless, farmers
continue to use buffer areas, i.e., a natural barrier of fallow terrain
between the two plantings.

f\. Finished packaged foods and feeds do not have a labeling requirement
as of this date. Nevertheless, ICA resolutions (3492 of December 22 of
1998 and 2935 of October 23, 2001) require labeling on biotechnology
materials (seeds or other plant reproductive materials and animal
products). The requirement is based on consumer information.

# g. Colombia approved the Biosafety Protocol through Law 740 of 2002 that became fully enforced in September 2003. As of today, regulations to implement the above-mentioned law are decree 4525 of December 6, 2005 and ICA resolution 000946 of April 17, 2006. Colombia follows the procedures established by the Biosafety Protocol and attends the different meetings to fully implement.

h\. Trade contacts have reported no commercial barriers related to
biotechnology products.

i\. While there have been proposals to place additional restrictions on
biotech products, no new requirements are currently pending. Restrictive
new regulations were withdrawn for further review in April 2005 after
concerns were raised by the industry and FAS/Bogota.

j\. There is no legislation in place to collect "technology fees", but
the biotechnology seed distributor charges the equivalent to US\$75 per
hectare planted to cotton. The fee is a key factor in adopting the new
technology since the Colombian farmers complain that the seeds available
were the first generation of biotechnology seeds for cotton. They are
anxious to receive more advanced varieties.

Section IV. Marketing Issues.

a.  Biotechnology is a relatively new issue in Colombia and there are
    few press commentaries about it. Most press coverage is favorable.
    Consumers have not voiced any concerns about biotechnology products
    or products containing biotechnology raw materials as of this date.

b.  There are no relevant studies on marketing of biotechnology products
    in Colombia.

    Section V. Capacity Building and Outreach

    a\. Outreach activities:

-   Three leading Colombian journalists attended a biotechnology tour in
    the U.S. in September 2003.

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-   Farmer-to-Farmer Biotechnology Workshop at the University of
    Zamorano in Honduras. A leading cotton producer and agricultural
    leader attended in August 2004.

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-   In July 2004, two Colombian officials attended a two-week "Biotech
    Short Course" on regulator and trade issues at Michigan State
    University.

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-   A Cochran candidate was selected and approved to attend
    biotechnology training in February 2006.

    b\. Colombia would greatly benefit from more aggressive educational
    efforts on biotechnology issues. Some misinterpretations and
    misunderstandings among government officials rise from ignorance.
    Therefore, FAS/Bogota would like to work with appropriate USG
    agencies to put together programs addressed to solve doubts and
    hesitations. If appropriate, EMO, Section 108, and Cochran funds
    should be an option:

    -   An emphasis on the media would help to solve some of the public
        misconceptions. Something like a follow-up activity to the
        previous journalists visit of September 2003.

    -   Organized visits by specific commodity farmers to the United
        States would render great service in overcoming obstacles and in
        dissemination of the benefits of biotechnology.

    -   Organize an educational visit to the USG and private sector for
        GOC officials dealing with biotechnology regulations.

    -   Organize a seminar on relevant biotechnology aspects to
        disseminate information to GOC officials and interested parties.

        APPENDIX A. COLOMBIA: BIOTECHNOLOGY APPLICATIONS AND CURRENT
        STATUS

        AS OF JUNE 2006

<table>
<colgroup>
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 3%" />
<col style="width: 6%" />
<col style="width: 0%" />
<col style="width: 3%" />
<col style="width: 25%" />
<col style="width: 25%" />
<col style="width: 25%" />
</colgroup>
<tbody>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td colspan="7"><strong>Crop</strong></td>
<td><strong>Requesting Company</strong></td>
<td><strong>New Characteristics of Biotechnology</strong></td>
<td><strong>Authorized Activity</strong></td>
</tr>
<tr class="odd">
<td colspan="7">Carnation</td>
<td>Flower Development</td>
<td>Blue Carnation</td>
<td>Approved in 2000 for multiplication of cut flowers. Approved for
biosafety studies per risk assessment in 2005.</td>
</tr>
<tr class="even">
<td colspan="7">Roses</td>
<td>Flower Development</td>
<td>Blue petal roses</td>
<td>Approved for biosafety studies per risk assessment in 2005.</td>
</tr>
<tr class="odd">
<td colspan="7">Bollgard Cotton</td>
<td>COACOL-Monsanto</td>
<td>Resistant to some lepidopterous insects.</td>
<td>Approved for commercial plantings since 2004.</td>
</tr>
<tr class="even">
<td colspan="7">RR Cotton</td>
<td>COACOL-Monsanto</td>
<td>Tolerant to Roundup herbicide.</td>
<td>Approved in 2004 for commercial plantings in the dry Caribbean and
humid Caribbean regions. Approval pending for Huila and Tolima.</td>
</tr>
<tr class="odd">
<td colspan="7">Bollgard/RR Cotton</td>
<td>COACOL-Monsanto</td>
<td>Resistant to a wider variety of lepidopterous insects and completely
tolerant to Roundup herbicide.</td>
<td>Approved at a semi-commercial stage.</td>
</tr>
<tr class="even">
<td colspan="7"><p>Bollgard II and Roundup Ready Flex</p>
<p>Cotton</p></td>
<td>COACOL-Monsanto</td>
<td>Resistant to a wider variety of lepidopterous insects and completely
tolerant to Roundup herbicide.</td>
<td>Approved for biosafety studies per risk assessment in 2005.</td>
</tr>
<tr class="odd">
<td colspan="7">Rice</td>
<td>CIAT</td>
<td>Resistant to White Leaf Virus</td>
<td>Approved in 2000 for restricted research and small-scale plantings
in open fields, in accordance with risk assessment.</td>
</tr>
<tr class="even">
<td colspan="7">Cassava</td>
<td>CIAT</td>
<td>Resistant to the borer of stem/stalk</td>
<td>Approved in 2000 for restricted research per risk assessment</td>
</tr>
<tr class="odd">
<td colspan="7">Cassava</td>
<td>CIAT</td>
<td>Modification of cytokine production</td>
<td>Approved for biosafety studies per risk assessment in 2005.</td>
</tr>
<tr class="even">
<td colspan="7">Cassava</td>
<td>CIAT</td>
<td>Modification of amilopectin production</td>
<td>Approved for biosafety studies per risk assessment in 2005.</td>
</tr>
<tr class="odd">
<td colspan="7">Cassava</td>
<td>CIAT</td>
<td>Modification of cyanide content</td>
<td>Approved for biosafety studies per risk assessment in 2005.</td>
</tr>
<tr class="even">
<td colspan="7">Brachiaria (grass)</td>
<td>CIAT</td>
<td>“frog hopper” resistant</td>
<td>Approved for biosafety studies per risk assessment in 2005.</td>
</tr>
<tr class="odd">
<td colspan="7">Coffee</td>
<td>CENICAFE</td>
<td>Borer resistant</td>
<td>Approved in 2000 for restricted research per risk assessment.</td>
</tr>
<tr class="even">
<td colspan="7">Sugar cane</td>
<td>CENICAÑA</td>
<td>Resistant to the yellow leaf syndrome</td>
<td>Approved in 2003 for restricted research and small-scale plantings
in open fields per risk assessment.</td>
</tr>
<tr class="odd">
<td colspan="7">Yield-gard Corn</td>
<td>COACOL-Monsanto</td>
<td>Resistant to some lepidopterous insects</td>
<td>Currently under second phase of biosafety field trails.</td>
</tr>
<tr class="even">
<td colspan="7">RR Corn</td>
<td>COACOL-Monsanto</td>
<td>Tolerant to Roundup herbicide.</td>
<td>Currently under biosafety field trails.</td>
</tr>
<tr class="odd">
<td colspan="7">Herculex I Corn</td>
<td>Dupont</td>
<td>Resistant to some lepidopterous insects</td>
<td>Approved for biosafety studies.</td>
</tr>
<tr class="even">
<td colspan="7">Bt 11 corn</td>
<td>Syngenta</td>
<td>Resistant to some lepidopterous insects</td>
<td>Approved for biosafety studies per risk assessment in 2005.</td>
</tr>
<tr class="odd">
<td colspan="7">Potatoes</td>
<td>Corporacion de Investigaciones Biologicas (CIB)</td>
<td>Resistant to some lepidopterous insects</td>
<td>The National Biosafety Council postponed the study of risk
assessment.</td>
</tr>
</tbody>
</table>