Required Report -- Public Distribution

**Date:** 7/18/2006

**GAIN Report Number:** UY6003

UY6003

**Uruguay**

####### Biotechnology

**Annual**

**2006**

**Approved by:**

![](media/image1.wmf)Kari Rojas

U.S. Embassy

**Prepared by:**

Andrea Yankelevich

**Report Highlights:**

There are three events approved for commercialization in Uruguay: one
soybean variety

(MON 40-3-2) and two corn varieties (MON 810 and BT11). With the
creation of the National Coordination Committee, (CNC) the current
government has established a moratorium on GMO approvals until a new
biosafety framework is developed.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Buenos Aires \[AR1\]

\[UY\]

Table of Contents

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

[Production 3](#production)

[Soybeans 3](#soybeans)

[Corn 3](#corn)

[Rice 4](#rice)

[Other Crops Under Development 4](#other-crops-under-development)

[Corn 4](#corn-1)

[White Clover 4](#white-clover)

[Policy 4](#policy)

[Cartagena Biosafety Protocol 6](#cartagena-biosafety-protocol)

[Traceability and labeling 7](#traceability-and-labeling)

[Trade Barriers / Pending legislation
7](#trade-barriers-pending-legislation)

[Marketing 8](#marketing)

[APPENDIX A: Status of Products Approval
9](#appendix-a-status-of-products-approval)

[APPENDIX B: Relevant Current Laws and Regulations
10](#appendix-b-relevant-current-laws-and-regulations)

[Law 16.466: Environmental Impact Evaluation Law -- 1994
10](#law-16.466-environmental-impact-evaluation-law-1994)

[Law 17283: Environmental Protection Law -- 2000
10](#law-17283-environmental-protection-law-2000)

[Law 9202: Public Health Law -- 1934
10](#law-9202-public-health-law-1934)

[Law 16811: Seed Law: 1997 10](#law-16811-seed-law-1997)

[Law 3921: Plant Protection Law -- 1911
10](#law-3921-plant-protection-law-1911)

[Decree 249/00 - August 2000 10](#decree-24900---august-2000)

[Applications of Decree 249/00 10](#applications-of-decree-24900)

[APPENDIX C: Process to Obtain Approval from GOU
11](#appendix-c-process-to-obtain-approval-from-gou)

# Executive Summary

Uruguay, a relatively small country located between Argentina and
Brazil, now ranks 10^th^ among countries in the number of acres planted
with biotech varieties.

In 1995 the Government of Uruguay (GOU) formally endorsed the use of
biotechnology and took concrete steps towards the oversight and
regulation of biotechnology products by creating a risk assessment
commission for genetically modified organisms (GMOs). In 2000, per
Decree 249/00, with the creation of the Risk Assessment Commission of
Genetically Modified Plants (CERV), a regulatory framework was
established to authorize the introduction, use and manipulation of GMOs
in the country, but under the current administration, a new committee
that will be in charge of developing a new regulatory framework was
created. One of main objectives of this new approach is to allow more
participation of all the interested parties. In the meantime, a de facto
moratorium is imposed on the approval of new events until the new
framework is finalized. Labeling provisions are still not in place.
There is no law or regulation governing the use of labels such as "non
GMO" or "biotech free". In addition, consumer associations,
environmental groups and producer associations have a more active role
in the approval process, as they are represented in the CNC.

# Production

Authorized Biotech events for production and commercialization are:

Soybeans, event 40-3-2 (approved 1996)

Corn, event MON 810 (approved 2003)

Corn, event Bt 11 (approved 2004)

## Soybeans

Soybean harvested area, increased from 77,000 HAS. in MY2002/03 to
over300,000 HAS. in MY2005/06. Approximately 99 percent of total soybean
area is planted with Round-up Ready soybeans.

Expansion area in Uruguay is not as abundant as it is in Argentina, but
Uruguayan producers do have the benefit of not paying a 23.5 percent
export tax on production, as their Argentine counterparts must pay.

## 

## Corn

Until August 2003, GMOs were only used in soybean production in Uruguay.
In 2003, after much uncertainty, the authorization for the importation
and commercialization of Monsanto's insect-resistant corn (variety MON
810) was released by the GOU. More recently in 2004, Bt 11 corn was
approved, arousing opposition among environmentalists and leftists.

GMO corn (MON 810) was commercially planted in 2003 for the first time.
In 2004, Bt 11 maize was approved for production and commercialization.

**Evolution of area planted (conventional** **corn** **and Bt)**

###### Year Total Area (has) Bt Area (has) Percentage 

2003 44,923 1,150 3

2004 60,601 23,300 38

2005 53,400 30,000 56

## Rice 

Uruguay is traditionally a rice exporter. Thus, the adoption in Uruguay
of rice varieties containing biotech events will depend, almost
exclusively, on the acceptance of these events in Uruguay's export
markets. Rice producers are very open to the idea of biotechnology but
they are unlikely to adopt new technologies that may jeopardize their
export markets.

However, there is one event under research. Rice lines LLRICE06 and
LLRICE62, which are genetically engineered to express tolerance to
glufosinate ammonium, the active ingredient in phosphinothricin
herbicides, are currently under research in Uruguay.

## Other Crops Under Development

In general, approval of new events in Uruguay is linked to approvals
granted in Argentina. All studies and research done in the neighboring
country are taken into account.

### Corn

There are several corn varieties currently under research NK603, NK 603
x MON 810 and Herculex: DAS-01507-1 (TC 1507)

### White Clover

Approved for research, this variety, the first forage event under study
in Uruguay, was developed in Australia by Professor German Spangenberg,
an Uruguayan botanist currently at La Trobe University.

Numerous biotechnology strategies are being considered with respect to
the improvement of nutritional quality through altering the biosynthesis
of lignin, soluble carbohydrates, and protoantocianas and the regulated
expression of proteins rich in essential amino acids, resistant to
rumen. Attempts are also being made to increase resistance to pathogens
and pests and to manipulate growth and development in order to increase
persistence and delay senescence, impede flowering and negatively
regulate pollen allergens.

# Policy

Domestically, the GOU has set up guidelines and procedures to oversee
and regulate the introduction of biotechnology products into the
environment and market. Oversight and regulatory responsibilities are
vested in the Risk Assessment Commission of Genetically Modified Plants
(CERV), which is headed by the Ministry of Livestock, Agriculture and
Fisheries (MGAP.) Member organizations also include the Ministry of
Housing, Land Management and the Environment, the Ministry of Public
Health, the National Seed Institute; and the National Agricultural
Research Institute. The Commission is responsible for considering, on a
case-by-case basis, the potential risks and benefits of each new biotech
product.

Biosafety regulations were established following the mandate of the
Convention of Biological Diversity. At the 1992 Earth Summit in Rio de
Janeiro, world leaders agreed on a comprehensive strategy for
\"sustainable development\" \-- meeting our needs while ensuring that we
leave a healthy and viable world for future generations. One of the key
agreements adopted at Rio was the Convention on Biological Diversity.
This pact among the vast majority of the world\'s governments sets out
commitments for maintaining the world\'s ecological underpinnings
economic development ensures. The Convention establishes three main
goals: the conservation of biological diversity, the sustainable use of
its components, and the fair and equitable sharing of the benefits from
the use of genetic resources. Uruguay (along with Chile and Costa Rica)
adapted this existing legislation for seeds and plant health inspection
services.

The regulatory procedure, which does not cover laboratory research,
includes risk assessment and risk management. It includes consultation
with a broad range of specialists and stakeholders (social scientists
and representatives of civil society) apart from those usually included
(toxicologists, nutritionists, molecular biologists, and plant
breeders). However, the final decision on the release of GMOs falls
within the scope of both the MGAP and the Ministry of Economics and
Finance.

Main duties of the Risk Assessment Commission include:

1.  To create the rules to perform the risk assessment for the
    introduction, use, and manipulation of GMOs and their parts,

2.  To analyze case by case, using sound science, the risk inherent in
    each product,

3.  To provide advice to the competent authorities (Ministry of
    Livestock, Agriculture, and Fisheries, and the Ministry of Economy
    and Finance) regarding authorizations,

4.  To advise the competent authorities about risk management and
    communication measures to be adopted in each case; and,

5.  To advise the Uruguayan Government (GOU) about plant GMO biosafety.

The Risk Assessment Commission will also create working groups for
specific tasks when necessary and will request technical advice from
universities and public or private research centers, as well as of
independent specialists recognized by their technical proficiency.

The commission includes representatives of the following ministries:

1.  Ministry of Livestock, Agriculture and Fisheries (this
    representative occupies the presidency of the Commission),

2.  Ministry of Environment (this representative occupies the
    vicepresidency of the Commission),

3.  Ministry of Public Health,

4.  National Seed Institute (INASE); and,

5.  National Agricultural Research Institute (INIA).

Approvals from Argentina, United States and Canada are taken into
account as a precedent in the approval evaluation process.

## 

As anticipated in last year's biotech report (UY5003), the current
government has a completely different approach to GMOs, more
conservative and stressing the importance of strengthening multi
sectorial participation in the evaluation process, in a way to establish
a transparent framework. A few months ago, a new committee has been
created, the National Coordination Committee (CNC) that will develop a
new regulatory framework for GMOs. Approval of new events is suspended
until the new framework is developed. The CNC includes representatives
of all interested parties in the aspects related to biosecurity (23
organizations are represented), such as NGOs, environmentalists groups
and producer associations, among others, that now will be able to voice
their concerns, opinions and their analysis of the current approval
process.

The National Project will be based on the creation of six sub
commissions and the methodology to be used will be based in the
identification of strengths, weaknesses, opportunities and threats.

The focus is set mainly the integration of new institutional players for
the risk analysis and decision process. All sub commissions will
interact and work in conjunction in order to gather all relevant
information to develop a proposal of a national biosafety framework.
Those sub commissions evaluate different areas. Primary objectives are:

\- Evaluation of environmental impact,

\- Evaluation of effects in human health,

\- Evaluation of socioeconomic impact,

\- Evaluation of utilization of GMOs,

\- Research and development, and

\- Cover administrative aspects.

Besides the creation of the CNC, GOU took the first steps towards the
formulation of the national biosecurity framework by hiring a private
company that is generating a national survey directed to the public in
general, producers, and scientists not specialized in the subject. With
this information, GOU will have a segmented opinion study that will help
monitor the status of knowledge of the population.

The expected timeframe for the conclusion of the National Project for
the development of a biosafety framework is approximately 18 months.

## Cartagena Biosafety Protocol

Uruguay has yet to ratify the Cartagena Biosafety Protocol to the 1992
Convention on Biological Diversity (CBD). Up until the Protocol's entry
into force (September 2003) Uruguay operated within the framework of the
GRULAC Group (Group of Latin American and the Caribbean Countries) in
pursuing the implementation of the biosafety principles outlined in the
Cartagena Protocol.

Uruguay, a member of the former Miami Group, has strongly concurred with
USG positions on biotech at international fora, in the past, and is
highly likely to continue to do so.

## Traceability and labeling 

Related biotechnology issues such as traceability and labeling (T&L) of
GMOs are currently the focus of an internal debate that is being carried
out at the governmental level.

As to the European Union's T&L regulations, MGAP contacts have told us
that traceability would be a difficult issue in Uruguay since there are
commercial, not only scientific, issues at play. They believe that since
Uruguay is very dependent on the European market as an outlet for its
agricultural products, some kind of traceability system will probably be
imposed on Uruguay. However, they have repeatedly made it very clear
that the GOU would not support the EU in its efforts to force the issue
in international fora.

With regard to labeling of biotech products, contacts at the GOU working
level indicate that the GOU does not have a clear position on the issue.
Reportedly, however, the MGAP's own position is that labeling should be
mandatory for products that are substantially different from their
original version, and for those products with a lowered safety
threshold.

Meanwhile, there are currently several draft bills enforcing the
mandatory labeling of products containing genetically modified
components.

**Stacked genes**

No policy. A stack event is considered to be a whole new event, and it
must undergo a full review.

**Coexistence**

No policy. The European Union's norm was used as a base, but adapted to
Uruguay.

**Refuges**

It is mandatory that 10% of the planted area is kept as a refuge.
Uruguay is a small country; therefore, the Seed Institute (INASE) visits
the producers in person.

**Royalties**

All seeds pay extended royalties and the seed law makes a provision for
the use of seed at the following year. The company requests the producer
to sign a contract promising to pay royalties the next year, therefore
they sign a contract between parts.

# Trade Barriers / Pending legislation

The current government, favors full "end-product" and "process-based"
labeling. On several occasions during the past administration the
opposition publicly urged the former president to halt the
liberalization of transgenic crops, based on the country's goal of
becoming a "natural country" and on the application of the precautionary
principle.

# Marketing

There is still misunderstanding and misperception about the safety of
GMO plants and foods on human health or in the environment. NGOs have
opposed the introduction of GMO crop planting and strongly request
labeling on GMO products. There is a scattered, albeit unorganized
movement against biotechnology, led by NGOs that systematically
misinform the population.

The opposition is based mainly on the controversy between GMO crops and
the concept of "Uruguay Natural" and on the lack of scientific evidence
regarding the innocuousness for human health.

Consumer associations raised concerns about possible negative impacts on
human health and the environment. They mainly advocate labeling and
traceability and local field trials of GMOs prior to approval. They also
question the potential for toxicity and allergenicity of biotech
products. These NGOs are now represented in the CNC.

There is some resistance in the meat industry to the approval of White
Clover. Clover is used in pastures, and for this reason "natural meats"
will cease to be reliably "natural" according to their arguments. But
the problems for the beef industry won\'t be as serious as the problems
for the dairy industry, because clover is used more often in dairy
production. Additionally this is a threat to the sheep industry. More
than anything, clover is used to feed sheep exported to Arab countries
that want absolutely nothing to do with GMOs.

Uruguayan meat comes from animals that don't consume GMOs, A study
prepared by the National Meat Institute (INAC) concludes that based on
the existence of control systems for the entry and use of GMOs in
Uruguay, the use of pastures of genetically modified origin in animal
feed in pasture production systems is considered to be highly unlikely.

There are no relevant, specific studies on the marketing of
biotechnology products in the country.

The Uruguayan Seed Chamber has conducted a survey among farmers in
reference to the use of Bt corn seed that provided the following
conclusions:

-   Bt corn has a high penetration level (67% of total area planted),

-   Bt seed reaches good performance compared to the conventional seed,

-   Total cost of plague control is lower with the utilization of Bt
    corn,

-   86% of consulted farmers are more satisfied with the plague control
    with Bt seed that conventional seed,

-   9 out of 10 farmers do not mention any damage related to the use of
    Bt corn,

-   100% of consulted farmers use refuges,

-   30% of consulted farmers plans to increase the area dedicated to Bt
    corn, 50% expressed they will maintain the same area, and 18%
    expressed they will diminish the area, where the reasons voiced are
    not related to Bt seed, and

-   Farmers are even more optimistic when talking about the future of Bt
    seeds. 86% believe that global area planted will increase in the
    next 5 years, and 66% of them expressed that they will personally
    increase the use of Bt seed in that timeframe.

# APPENDIX A: Status of Products Approval

+-------------+-------------+-----------+----------------+-----------+
| **Crop**    | **Trait     | **Event/  | **Trait**      | *         |
|             | Category**  | Ap        |                | *Status** |
|             |             | plicant** | *              |           |
|             |             |           | *Description** |           |
+-------------+-------------+-----------+----------------+-----------+
| Soybean     | Herbicide   | 40-3-2    | Glyphosate     | Approved  |
|             | Tolerant    |           | Herbicide      | Feed      |
|             |             | Monsanto  | Tolerant       | and/or    |
|             |             |           |                | Food      |
+-------------+-------------+-----------+----------------+-----------+
| Corn        | Insect      | MON 810   | Resistant      | Approved  |
|             | Resistant   |           |                | Feed      |
|             |             | Monsanto  | European Corn  | and/or    |
|             |             |           | Borer          | Food      |
+-------------+-------------+-----------+----------------+-----------+
| Corn        | Insect and  | Bt 11     | Resistant      | Approved  |
|             |             |           | EuropeanCorn   | Feed      |
|             | Herbicide   | Syngenta  | Borer and      | and/or    |
|             |             | Seeds     | Glufosinate    | Food      |
|             | Tolerance)  |           | Ammonium       |           |
+-------------+-------------+-----------+----------------+-----------+
| Corn        | Herbicide   | NK 603    | Gliphosate     | Research  |
|             | Tolerance   |           | Herbicide      |           |
|             |             | Monsanto  |                |           |
|             |             |           | Tolerant       |           |
+-------------+-------------+-----------+----------------+-----------+
| Rice        | Herbicide   | LLRice 06 | Glufosinate    | Research  |
|             | Tolerance   |           | resistance     |           |
|             |             | Bayer     |                |           |
+-------------+-------------+-----------+----------------+-----------+
| White       | Virus       | LXR       | Alfalfa.Mosaic | Research  |
| Clover      | Resistance  |           | Virus          |           |
|             |             | Phytogene |                |           |
+-------------+-------------+-----------+----------------+-----------+
| Corn        | Insect and  | TC 1507   | Resistant to   | Research  |
|             | Herbicide   |           | European Corn  |           |
|             | Tolerance   | Herculex  | Borer and to   |           |
|             |             |           | Glufosinate    |           |
|             |             | DowAgro   | Ammonium       |           |
|             |             | Sciences  |                |           |
+-------------+-------------+-----------+----------------+-----------+
| Corn        | Insect      | NK603 x   | Gliphosate     | Research  |
|             | Resistance  | MON 810   | Tolerance and  |           |
|             | and         |           | Resistance to  |           |
|             | Herbicide   |           | European Corn  |           |
|             | Tolerance   |           | Borer          |           |
+-------------+-------------+-----------+----------------+-----------+

#  APPENDIX B: Relevant Current Laws and Regulations

# 

#### Law 16.466: Environmental Impact Evaluation Law -- 1994

This law states that it is of general and national interest to protect
the environment against any type of degradation, destruction or
contamination, as well the prevention of the negative or noxious
environmental impacts.

#### Law 17283: Environmental Protection Law -- 2000

Art. 23 Biosafety. The Ministry of Environment will apply the measures
needed to prevent and control environmental risks from the creation,
manipulation, use or environmental release of GMOs until a competent
authority is designated.

#### Law 9202: Public Health Law -- 1934

This law establishes the Ministry of Health as the regulatory
organization in all the issues related to public health.

#### Law 16811: Seed Law: 1997

This law regulates the production, certification and trade of seeds, the
National Register of Production Fields and the protection of plant
creations.

INASE, among other duties must:

> -Control the seed production and trade, overseeing for the compliance
> of the rules established by the law.

-Control the national registration of cultivars.

#### Law 3921: Plant Protection Law -- 1911

This law prevents the introduction and dissemination of plant pests.

The MAGP is responsible for the development and organization of the
plant health protection in Uruguay, and for the administration and
supervision of the national system for plant protection and
phytosanitary surveillance.

#### Decree 249/00 - August 2000

The objective of Decree 249/00 is to promote the safe use of
biotechnology by creating an adequate level of protection for GMOs,
preventing adverse effects on agricultural production and conservation
and sustaining biodiversity.

The introduction, use and manipulation of plants and their genetically
modified parts, independently from the manner or regime under which this
operation is performed, will only be allowed with previous
authorization, granted by the competent authorities.

#### Applications of Decree 249/00

The development of events under contained use.

-Development of tests and field trials under specific biosafety
conditions.

-The evaluation of trials according to law 16811

-Seed multiplication

-Initial production or importation (with the intended use of food, feed
or processing).

# APPENDIX C: Process to Obtain Approval from GOU

The process to obtain approval from GOU involves a formal application
(form SOL-OGM- 1) that includes the following data:

**A**. Applicant: name, address and registration number in the general
register of seed producers and traders.

**B**. Legal responsible: name and address

**C**. Technical responsible

**D**. Specie:

Regular name

Botanical name

**E**. Event

**F**. Cultivar, if applicable

**G**. Origin of material

**H**. Proposed use

1\. Development of experiments under contained use

> 2\. Development of tests and field trials under protection or under
> specific Biotech conditions.
>
> 3\. Evaluation of National Production Cultivars

4\. Seed multiplication

> 5\. Production or first time importation with the intended use (food
> or feed processing)

6.  Other:

**I**. Countries where application has been submitted (if any)
indicating which states and date of submission

**J**. Countries where authorization has been granted (if any)
indicating states and date of approval.

Once the applicant has complied with this request, the risk analysis
commission will perform the risk analysis evaluation on the following
basis:

-   Case by case

-   Adherence to sound science

-   The impact on the environment, biological diversity and the eventual
    effects on human, animal, and plant health.

-   Compliance with international guidelines.

After the risk analysis evaluation is performed, the Commission will
advise the competent authorities about risk management and communication
measures.

Before adopting a resolution, the Competent Authority will publish in
national newspapers the name of the GMO, name of the applicant,
requested use as well as a summary of the risk analysis evaluation.
During a 20 days period after publication, the public has the
opportunity to voice opposition.

Failure to comply with all conditions of a granted authorization may
lead to cancellation of the permit and to legal actions.