Required Report - public distribution

**Date:** 9/12/2005

**GAIN Report Number:** UY5003

UY5003

**Uruguay**

**Biotechnology**

**Annual**

**2005**

**Approved by:**

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

U.S. Embassy

**Prepared by:**

Andrea Yankelevich

**Report Highlights:**

Uruguay ranks 10th among countries in the number of acres planted with
biotech varieties. Currently, there are three events approved for
commercialization: one soybean variety (MON 40-3-2) and two corn
varieties (MON 810 and BT11). The new government, which took office in
March 2005, has yet to define its biotech policy.

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 4](#corn)

[Rice 5](#rice)

[Other Crops Under Development 5](#other-crops-under-development)

[Corn 5](#corn-1)

[NK603 5](#nk603)

[NK 603 x MON 810 5](#nk-603-x-mon-810)

[Herculex: DAS-01507-1 (TC 1507) 5](#herculex-das-01507-1-tc-1507)

[White Clover 6](#white-clover)

[Policy 6](#policy)

[Cartagena Biosafety Protocol 7](#cartagena-biosafety-protocol)

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

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

[Marketing 8](#marketing)

[Capacity Building and Outreach 9](#capacity-building-and-outreach)

[Proposed Activities 9](#proposed-activities)

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

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

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

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

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

[Law 16811: Seed Law: 1997 11](#law-16811-seed-law-1997)

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

[Decree 249/00 - August 2000 11](#decree-24900---august-2000)

[Applications of Decree 249/00 11](#applications-of-decree-24900)

[APPENDIX C: Process to Obtain Approval from GOU
12](#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, a regulatory framework was established to authorize the
introduction, use and manipulation of GMOs in the country. Labeling
provisions are not yet in place. There is no law or regulation governing
the use of labels such as "non GMO" or "biotech free". However, under
the current government, which just took office in March 2005, draft laws
are being debated, and the GOU may present new restrictive proposals to
the Congress. So far, the new administration has not yet defined its
biotech policy. It is possible that with the new government in place,
the approval process for biotech events could take more time than
before. In addition, it seems that consumer associations will have a
more active role in the approval process.

# Production

######## Uruguay Main Crop Area (has.) 2003-04

***(Biotech and conventional crops)***

![](media/image2.wmf){width="5.997916666666667in"
height="2.282638888888889in"}**Note**: Only Soybeans and Corn are
authorized biotechnology crops

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

The influx of Argentina capital into the Uruguayan countryside has
changed the face of Uruguayan agriculture. Similar to Argentina in
climate, culture, infrastructure, and in some instances, soil structure,
many Argentines view the Uruguayan production regions as an extension of
the productive region of Argentina (the so-called Pampa Humeda). Soybean
harvested area, alone, increased from 77,000 has. in MY2002/03 to over
240,000 has. in MY2004/05. Approximately 98 percent of total soybean
area is planted with Round-up Ready soybeans.

The advantages of production in Uruguay are many. The most attractive
difference between the two countries is the absence of agricultural
export taxes. Soybean exports in Argentina are taxed at 23.5 percent.
Additionally, a newly constructed bridge over the Argentine Delta area
now facilitates transit between Argentina's main soybean port area,
Rosario, and Uruguay.

## 

## 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.

Immediately following the controversial decision to allow MON 810 maize,
the opposition to the ruling government drafted a bill proposing a
system that would require a new law be passed for each event and called
for a one-year moratorium on the release and use of GMOs to allow time
for a complete debate of the issue. At the request of the opposition, a
statement was issued by Parliament urging the President to halt the
liberalization of GMO maize, based on the country's goal of becoming a
"natural country" and on the application of the precautionary principle.

While the battle between the opposition and the President was
developing, the Ministry of Environment (MOE) unexpectedly entered the
fray and issued strict regulations under which MON 810 could be planted.
Based on provisions already established in the General Environmental
Protection Act, the MOE claimed to be in charge of the prevention and
control of potential environmental hazards deriving from the creation,
manipulation, use and release of genetically modified organisms, in as
much as they may affect biodiversity and the environment as a whole.
However, the president at the time, Jorge Batlle, pressured the MOE and
the regulation was significantly toned down.

To further complicate the issue, Parliament requested an interpellation
with then Minister of Agriculture Martin Aguirrezabala concerning his
approval of MON 810. The opposition faction who instigated this action
made a rather emotional presentation about GMOs, predicting that the
approval of this event would lead to the invasion of Uruguay by
multi-national companies, would oust the small producers, and in the end
would ruin the image of "Uruguay: Natural Country". Minister
Aguirrezabala testified before Parliament in a grueling eight-hour
session, indicating that there is no evidence suggesting foods produced
through biotechnology pose a threat to health. On the contrary, he
pointed to GMOs' potential to ensure food safety, dramatically reduce
hunger and malnutrition, and raise agricultural productivity. Minister
Aguirrezabala also said that the use of GMOs does not interfere with the
"Uruguay, Natural Country" theme, since the environmental and human
health benefits of GMO technology include lower pesticide and
insecticide use, reduced spoilage, and greater nutritional value.

Aguirrezabala further argued that the proposed bill requiring a law for
each event would be neither convenient nor reasonable, since GMO
evaluation is an activity of a technical nature. He noted that the
current legal framework of the country is sufficient and includes all
the necessary safeguards to preserve the commercial viability of
Uruguayan products. The Minister's explanations were considered
satisfactory and the testimony ended without any calls for follow-up.

Transgenic maize (MON 810) was commercially planted in 2003 for the
first time. In 2004, Bt 11 maize was approved for production and
commercialization. At the moment, total Bt corn area is 30,000 has.

## 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 neighbor
country are taken into account.

### Corn

There are several corn varieties currently under research:

#### NK603

The NK603 line of maize was developed to allow the use of glyphosate,
the active ingredient in the herbicide Roundup, as a weed control
option.

#### NK 603 x MON 810

NK603 x MON 810-hybrid maize consists in the combination of two
genetically modified parental inbred lines, derived from maize
transformation events NK603 and MON 810, respectively, by traditional
breeding,. No additional genetic modification is involved.

NK603 × MON 810 maize results from a single conventional cross of the
inbred parental lines NK603 maize and MON 810 maize, homozygous in their
respective inserted sequences.\
By crossing NK603 and MON 810 maize, NK603 × MON 810 maize inherits the
inserted DNA fragments from both its parental lines.

#### Herculex: DAS-01507-1 (TC 1507)

The GMO maize line TC1507 was genetically engineered to resist European
corn borer (ECB), Southwestern corn borer, fall armyworm, and black
cutworm by producing its own insecticide. Herculex has been recently
approved in Argentina and is under investigation in Uruguay.

### White Clover

Recently 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,
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.

## 

## 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 for a, 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. In that respect, a bill has been drafted advocating the
enforcement of an authorization by-law system for GMOs, while calling
for a one-year moratorium on the release and use of GMOs to allow time
for a complete debate on the issue. 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.

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.

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.

# Capacity Building and Outreach

**2002**

A.  FAS Buenos Aires organized a biotechnology seminar in Uruguay that
    was successful in terms of attendance (over 300 participants).

B.  Through Cochran funds, FAS Buenos Aires sponsored two-week
    biotechnology training in the United States for 3 Uruguayan
    Government officials, organized by ICD and Michigan State
    University.

**2004**

A.  FAS Buenos Aires selected 2 Uruguayan journalists that participated
    in a US Grains Council activity in Hawaii, where they learnt about
    the papaya industry.

B.  The Agricultural Counselor accompanied State's Biotech Negotiator to
    Uruguay to participate in a series of round tables on biotechnology
    organized by Embassy Montevideo.

C.  Through Cochran funds, FAS Buenos Aires sponsored two-week
    biotechnology training in the United States for 1 representative of
    the Uruguayan Seed Chamber, organized by ICD and Michigan State
    University*.*

D.  Two Uruguayan producers attended the Farmer-to-Farmer workshop at
    the University of Zamorano in Honduras.

E.  FAS Buenos Aires sponsored the trip of an Argentine Expert to
    participate in a seminar in Santiago, Chile, directed to the Chilean
    Parliament.

**2005**

A.  The Agricultural Counselor accompanied State's Biotech Negotiator to
    Uruguay to participate in a series of round tables on biotechnology
    organized by Embassy Montevideo.

B.  FAS Buenos Aires in concert with FAS Santiago organized and
    accompanied a Southern Cone CODEL to the United States, to
    demonstrate how the United Sates uses and regulates agricultural
    biotechnology.

##### Proposed Activities

FAS Buenos Aires proposes a continuation of education and outreach as
well as a more targeted information campaign. Specific activities may
include:

\- Workshops in different cities to target audiences around the country,

\- A two-day conference directed mainly to Congressmen, but also to
media, academia and government officials among others,

\- Coordination with local universities to demonstrate the benefits of
Biotechnology in Uruguay,

\- Continue Cooperator, Cochran and International Visitor program
activities,

\- Special activities designed for Consumer Association leaders and
consumers in general,

\- Workshop especially directed to medical doctors and nutritionists,
explaining the innocuousness of biotech products; and,

-Workshop in risk assessment that will be directed to Argentine,
Paraguayan and Uruguayan experts.

# 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      |
+-------------+-------------+-----------+----------------+-----------+
| Maize       | Insect      | MON 810   | Resistant      | Approved  |
|             | Resistant   |           |                | Feed      |
|             |             | Monsanto  | European Corn  | and/or    |
|             |             |           | Borer          | Food      |
+-------------+-------------+-----------+----------------+-----------+
| Maize       | Insect and  | Bt 11     | Resistant      | Approved  |
|             |             |           | EuropeanCorn   | Feed      |
|             | Herbicide   | Syngenta  | Borer and      | and/or    |
|             |             | Seeds     | Glufosinate    | Food      |
|             | Tolerance)  |           | Ammonium       |           |
+-------------+-------------+-----------+----------------+-----------+
| Maize       | 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 |                |           |
+-------------+-------------+-----------+----------------+-----------+
| Maize       | Insect and  | TC 1507   | Resistant to   | Research  |
|             | Herbicide   |           | European Corn  |           |
|             | Tolerance   | Herculex  | Borer and to   |           |
|             |             |           | Glufosinate    |           |
|             |             | DowAgro   | Ammonium       |           |
|             |             | Sciences  |                |           |
+-------------+-------------+-----------+----------------+-----------+
|             |             |           |                |           |
+-------------+-------------+-----------+----------------+-----------+

#  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.