Required Report - public distribution

**Date:** 10/21/2005

**GAIN Report Number:** AR5033

AR5033

**Argentina**

**Biotechnology**

**Annual**

**2005**

**Approved by:**

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

U.S. Embassy

**Prepared by:**

Andrea Yankelevich

**Report Highlights:**

Argentina is a major producer of agricultural products, and the third
largest producer of soybeans, with an area of 15 million hectares
estimated for the 2005 crop season. No other Latin American country has
embraced Genetically Modified Crops (GMO) crops as wholeheartedly as
Argentina. Argentina is also an important ally of the United States in
international issues, and co-complainant with the United States in the
World Trade Organization challenge to the European Union moratorium on
GMO crop applications. The Argentine biosafety system is a useful model
for other countries facing the challenging task of ensuring the safe and
responsible use of agricultural biotechnology.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Buenos Aires \[AR1\]

\[AR\]

Table of Contents

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

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

[Biotechnology Policy 4](#biotechnology-policy)

[Soybeans 4](#soybeans)

[Corn 4](#corn)

[Cotton 5](#cotton)

[Biotechnology Policy 5](#biotechnology-policy-1)

[Biosafety Regulatory System 6](#biosafety-regulatory-system)

[Traceability 9](#traceability)

[Labeling 9](#labeling)

[Stacked events 9](#stacked-events)

[Coexistence 9](#coexistence)

[Intellectual Property Rights -- Royalties
9](#intellectual-property-rights-royalties)

[Biosafety Law 10](#biosafety-law)

[Marketing Issues 11](#marketing-issues)

[Public Perception -- Consumer's Attitude
11](#public-perception-consumers-attitude)

[Mirror Policy 12](#mirror-policy)

[Capacity Building and Outreach 12](#capacity-building-and-outreach)

[Proposed Activities 13](#proposed-activities)

[APPENDIX A: GMO Crops Approved in Argentina
14](#appendix-a-gmo-crops-approved-in-argentina)

[Appendix B: Resolution 39 14](#appendix-b-resolution-39)

# Executive Summary

Argentina is a major producer of agricultural products, and the third
largest producer of soybeans, with an area of 15 million hectares
estimated for the 2005 crop season. No other Latin American country has
embraced Genetically Modified Crops (GMO) crops as wholeheartedly as
Argentina. Soybean harvested area has increased from 36,000 has. (59,000
mt produced) in 1970 to 5.98 million has. in 1995/96 (12.43 mmt
produced). The introduction of genetically engineered soybeans in the
late 1990s sparked a further expansion of soy production, which now
surpasses 14 million hectares. At least 98 percent of all this soy
production is GMO.

Argentina is also an important ally of the United States in
international issues, and co-complainant with the United States in the
World Trade Organization challenge to the European Union moratorium on
GMO crop applications. However, there is a disagreement between Monsanto
and the Government of Argentina (GOA) on a royalty collection system for
Roundup Ready (RR) soybeans.

The Argentine biosafety system is a useful model for other countries
facing the challenging task of ensuring the safe and responsible use of
agricultural biotechnology. The key agency in the Argentine system is
National Advisory Committee of Agricultural Biosafety (CONABIA), within
the Secretariat of Agriculture, Livestock, Fisheries, and Food (SAGPyA),
pursuant to Resolution 124/91. CONABIA is a multidisciplinary and
inter-institutional organization with advisory duties. Its main
responsibility is to assess, from a technical and scientific
perspective, the potential environmental impact of the introduction of
GMOs in Argentine agriculture. CONABIA reviews and advises the
Secretariat on issues related to trials and/or the release into the
environment of GMOs and other products that may be derived from or
contain GMOs.

Although Argentina has an effective regulatory framework established
through resolutions dictated by SAGPyA, as of yet, no Argentine law on
agricultural biotechnology is in force.

# Biotechnology Trade and Production

# 

**Percentage of GMO crops in Argentine Agriculture**

![](media/image2.wmf){width="5.708333333333333in"
height="3.064583333333333in"}

## Biotechnology Policy

## 

## 

## 

## 

## 

Source: Ing. Cesar Petrusansky

## 

## 

Argentina is the world\'s second largest producer of GMO crops after the
United States, with ten biotech crop varieties approved for production
and commercialization: one for soybeans (Monsanto 40-3-2), two for
cotton (Monsanto 531 and 1445) and now seven for corn (Ciba-Geigy 176,
AgrEvo T 25, Monsanto 810, NK 603, Novartis Bt 11, Syngenta GA 21 and
Dow/Pioneer TC 1507). (Please See Attachment A)

## Soybeans

Released in 1996, glyphosate tolerant soybeans were the first transgenic
crop introduced into Argentine agriculture. Since its release, this
technology has been adopted at a very high rate, with an estimate for
the current season of 15 million planted hectares, placing Argentina in
the second place after the United States. The main reason for this rapid
adoption is the great economic benefits that RR soybeans provide to the
producer. Besides, when the adoption process started, the patent for
Roundup (Monsanto´s commercial name for glyphosate) had expired several
years earlier. Thus, there was already a significant increase in
competition in the glyphosate market, which translated into significant
price reductions. At the same time, the new technologies facilitated the
incorporation of double cropping soybeans (following wheat) in many
areas where only one crop was planted before the availability of the GMO
varieties. (Trigo, Chudnosky, Cap & Lopez)

The Argentine soybean economy is geared almost entirely towards exports.
Only two percent of the harvested soybean reaches the national market,
whereas 30 percent is exported as grain and 68 percent is processed by
the oilseed industry within Argentina. Ninety-three percent of soybean
oil and ninety-nine percent of by-products (meals) are exported.

## Corn

GMO varieties of lepidoptera tolerant and ammonium-glyphosate tolerant
corn were commercially released for the first time in 1998. The adoption
of these varieties has also been significant. In the case of Bt maize,
benefits are derived from a net increase in production, resulting from
the reduction of losses caused by insects and not from increases in the
area planted.

The GOA forecasts that producers will plant between 2.5 million and 3.0
million hectares of corn this season, although those figures may
dramatically change, as it is difficult to estimate the amount that will
enter into the formal marketing chain.

![](media/image3.wmf){width="5.125in"
height="3.240972222222222in"}**Planted area with conventional maize and
GM Maize (percentage of total)**

## 

Source: DNMA/SAGPyA

## Cotton

Biotech cotton adoption represents 40 percent of planted area, according
to SAGPyA. Total area estimated for the next crop season is 370,000 has.

Biotech cotton contains a gene from Bacillus Thuringiensis (Bt), a
common soil microbe, allowing it to naturally protect itself against
insect pests, thereby requiring fewer applications of chemical
insecticides.

Through a research project done by the National Institute of
Agricultural Technology (INTA), it was found that in the leading
cotton-growing regions of Argentina, biotech cotton required almost 64
percent fewer applications of insecticide when compared to its
conventional counterpart.

In Argentina, this research showed that the average cotton grower had a
\$65 per hectare advantage (approximately \$26 per acre) using biotech
cotton versus conventional cotton. Similar economic advantages have been
found in the United States from the use of biotech cotton.

## 

# Biotechnology Policy 

## Biosafety Regulatory System

Argentine biosafety regulatory system is based on the evaluation of the
product and not of the process through which it was obtained. Therefore,
the evaluation takes place on a case-by-case basis, taking into
consideration the process only in those cases where the environment, the
agricultural production or the health of humans or animals could be at
risk.

The approval process for commercialization of GMOs involves different
agencies within SAGPyA:

-National Advisory Committee on Agricultural Biotechnology (CONABIA)

Role: Evaluate of impact in the agricultural ecosystem. Ensures
compliance with regulation 39. (Please See Appendix B)

\-**National Service of Agricultural And Food Health and Quality
(SENASA)**

Role: Evaluate the biosafety of food products derived of GMO crop for
human and animal consumption.

\-**National Direction of Agricultural Food Markets (DNMA)**

Role: Evaluate commercial impact on export markets by preparing a
technical report in order to avoid a negative impact on Argentine
exports. DNMA mainly analyzes the status of the event under study in the
destination markets in terms of whether the product has been approved or
not and, as a result, whether the addition of this event to Argentina's
export supply might represent a potential barrier to the access to these
markets.

\-**National Seed Institute (INASE)**

Role: Establish requirements for registration in the National Registry
of Cultivars.

Upon completion of all of the steps mentioned above, CONABIA\'s Office
of Technical Coordination compiles all pertinent information and
prepares a final report to the Secretary of Agriculture, Livestock,
Fisheries and Food for final decision.

It is worth noting that CONABIA is a multi-sectorial organization made
up by representatives from the public sector, academia and private
sector organizations related to agricultural biotechnology. CONABIA
members perform their duties as individuals and not as representatives
of the sector they represent, and they are active participants in the
international debate of biosafety and its related regulatory processes.

CONABIA has reviewed over 500 permits since its creation, developing new
capacities as the sector required. Regarding its legal and institutional
framework, CONABIA is an advisory agency that operates pursuant to a
resolution by the Argentine Secretary of Agriculture. In absence of a
law, this fact prevents the establishment of an adequate system of
penalties of those who do not comply with stipulated procedures.

In sum, Argentina was among the earliest countries to establish a
biosafety regulatory framework, and there is consensus regarding its
effectiveness adjusting to new developments.

**FIELD TEST APPROVAL PROCEDURE FOR GMOs IN ARGENTINA**

**Preliminary review by Technical**

**Coordination staff**

***(data lacking)* *(data complete)***

**Request for additional**

**Information**

**Complete analysis and review**

**By full commission**

**Response by Applicant Recommendations**

> **Official Resolution**

**Notice to Applicant**

> **Letter with conditions**
>
> **for the test**
>
> **Applicant conducts field tests**
>
> **Site inspections by INASE,**
>
> **SENASA and CONABIA**
>
> **Final Report to CONABIA**

Source: Trigo, Cap et al

**COMMERCIAL RELEASE APPROVAL PROCEDURE FOR GMOs IN ARGENTINA**

## 

**Food Safety review Environmental review**

**Decision proposal**

**Flexibilization**

**Market analysis**

**Technical Report Technical Report**

## 

## 

## 

## 

## 

## 

**Project of Final Resolution by the Agriculture Direction of SAGPyA**

**(Commercialization approval)**

Seed Registration

Commercial Release

Source: Trigo, Cap et al

## Traceability

There is no official system in place. At this stage, only private
companies (authorized labs) have the capability to perform the required
tests. For example, the National Institute of Agricultural Technology
(INTA) does it on private basis.

## 

## Labeling 

There is no specific regulation in Argentina in reference to labelling
GMO products. The current regulatory system is based on the
characteristics and identified risks of the product and not in the
production process of that product. Therefore, there is no regulation
governing the use of labels such as "BIOTECH FREE" or "NON-GMO", which
are voluntarily used by the producer.

According to SAGPyA, for the implementation of a regulatory labelling
system, the discussion should be based on the type of food product
derived from a specific GMO taking into account that:

-   Any food product obtained through biotechnology and substantially
    equivalent to a conventional food product, [should not]{.underline}
    be subject to any specific mandatory label.

-   Any food product obtained through biotechnology and substantially
    different from a conventional food product for any specific
    characteristic [may be]{.underline} labelled according to its
    characteristics as food product, not according to aspects concerning
    the environment or production process.

-   Differential labelling is not justified, as there is no evidence
    that demonstrates that food products produced through biotechnology
    may represent any risk for the consumers' health.

-   In the case of agricultural products, as the majority of them are
    commodities, the identification process would be complicated and
    expensive. The increased production costs as a result of labelling,
    would end up being paid by the consumers, without assuring that this
    would represent better information or increased food security.

## Stacked events

No defined policy as of yet.

## Coexistence

Refuge system is in place.

## Intellectual Property Rights -- Royalties

Argentina is a major producer and exporter of agricultural biotechnology
products, yet it does not have an adequate and effective system in place
to protect the intellectual property rights of new plant varieties or
plant-related technology. Penalties for unauthorized use of protected
seed varieties are negligible. Judicial enforcement procedures in
Argentina likewise are ineffective as a mechanism to prevent the
unauthorized, commercial use of protected varieties.

Monsanto, grower organizations, and commodity exporters are at an
impasse regarding a solution to the continued high level of saved and
illegally traded RR soybeans, which has depressed Monsanto's Argentine
operation revenues. In January 2004, Monsanto announced that it would
cease investments in and sales of RR soybeans in Argentina. The central
issue, according to Monsanto, was its inability to collect fully
RR-technology-related royalties from Argentine growers. Monsanto applied
for and was denied a patent on RR soybeans, a decision it appealed
unsuccessfully with the Argentine Supreme Court. Argentine law currently
allows farmers to save seed from one harvest and to use it the following
year if a royalty is paid to the original seed breeder. However, it is
illegal to sell, trade, or pass saved seed from one producer to another.

In May 2004, Argentina's National Seed Institute implemented Resolution
44/2004, requiring that each sack of seed be labeled with quantity, unit
price, total sales price, and seed species, type or variety. However,
the illegal seed sales continued and Monsanto articulated that if an
acceptable solution could not be reached with producer organizations and
commodity exporters by March 2005, Monsanto would begin to enforce
royalty payments on unlicensed Argentine soybeans exports at ports of
destination in countries in which Monsanto holds a patent on RR
soybeans. In March 2005, Monsanto informed Argentine soybean and product
exporters of imminent enforcement actions on unlicensed shipments of
soybeans, soybean meal, and other soy products containing the RR gene.
This move by Monsanto provoked heated reactions from GOA and Argentine
farm organizations.

Since then, SAGPyA, Monsanto and interested parties have tried
unsuccessfully to reach an agreement on royalties collection.

The lack of effective enforcement options for plant variety rights,
combined with the absence of patent protection for a significant range
of biotech inventions, renders Argentina's intellectual property system
inadequate from the perspective of the biotechnology industry.

## Biosafety Law

During 2001, the SAGPyA actively cooperated with members of the
Argentine Congress in drafting a biosafety law. This draft represented a
major improvement on the current situation, since it clearly set forth a
conceptual framework, as well as issues and instances to be considered
as participants in risk analysis procedures. But due to the
institutional and economic crisis that broke out on December 2001, the
draft was never discussed in Congress and there is no evidence that it
will be in the near future.

**International Negotiation Fora**

###### Cartagena Biosafety Protocol

In the international biotechnology negotiation arena, CBP is probably
the most significant issue. Argentina signed the Biosafety Protocol in
May 2000 in Nairobi, Kenya, but has not yet signed its ratification.
Argentina is currently undergoing a consultation process, analyzing and
debating with all the involved sectors the position the country will
take to this respect.

The overlapping of environmental and human health concerns, as well as
commercial implications, have resulted in an extremely difficult
negotiation for the countries that, like Argentina, are commodity
exporters.

It has to be taken into account that although Argentina has not ratified
the BCP, it will have to comply with the commercial obligations when
negotiating with countries that are parties.

The CBP has been signed and ratified by 117 countries, 16 of which are
developed countries. It is important to mention that most of the
undeveloped countries that ratified the CBP, do not posses biosafety
regulatory systems and are currently evaluating their possibilities to
adjust to the obligations of the CBP. Argentina considers that prior to
setting basis of commercial issues, the countries that ratified the CBP
should have their respective biosafety framework in place.

####### Codex Alimentarius

Argentina is strongly working to reach consensus on GMO labelling and
traceability, and actively participating to avoid potential trade
disruptions and unnecessary cost increases.

###### Other Agreements

Other important international negotiation areas are the creation of an
ad-hoc group on agricultural biotechnology within the framework of the
MERCOSUR and the Memorandum of Understanding on biotechnology signed
between the GOA and the government of China. During President Kirchner's
visit to China in 2004, The Argentine Secretariat of Agriculture,
Livestock, Fisheries and Food signed a MOU with the Chinese Ministry of
Agriculture, in reference to agricultural biotechnology and biosecurity.
The objective of the MOU was to move forward the cooperation,
stimulating communication and understanding related to biotechnology
policies in both countries. Argentina recently signed a bilateral
cooperation agreement with Nicaragua as well.

Through all these agreements, Argentina is trying to create a
coordinated dialogue framework for the application of biotechnology
policy and biosafety, in a way to avoid negative impacts of trade.

###### National Fora

-Creation of a Biotechnology office within SAGPyA with the objective of
centralizing all the information and activities.

-CONABIA's development of a 15 year Strategic Plan

The Strategic Plan anticipates a future scenario, which is the context
of the vision proposed. Policies are defined and an action plan is
outlined for the realization of that vision. Objectives are classified
by areas of strategic concentration to define the main issues addressed.

\- Announcement of a Biotech Promotion Bill

The Argentine Minister of Economy recently anounced a bill to promote
biotech initiatives. The project is to stimulate, through fiscal
benefits, research, development and investment in products, services or
biotech processes.

# Marketing Issues

## 

## Public Perception -- Consumer's Attitude

While Argentine scientists and farmers are optimistic and enthusiastic
about the prospects of using biotech to improve yields and nutritional
value of crops while decreasing the input of chemical pesticides,
Argentine consumers are concerned about the introduction of GMOs into
the human diet, possibly due to a lack of knowledge about genetic
engineering as compared to conventional plant breeding and the extensive
testing being done to insure the safety of a GMO crop. As yet, Argentine
consumers do not see GMOs as a benefit to themselves but they can see
these products as economically productive to farmers and multinationals.
Therefore, they are hesitant about supporting the technology. As
Argentina has been a leader in the adoption of biotechnology, there is
an urgent need for dialogue and communication among scientists, farmers,
private companies, consumers, government, and regulatory organisms.

## Mirror Policy

Argentine Secretary of Agriculture, Miguel Campos, announced his
decision to approve Monsanto\'s Roundup Ready Corn (RR corn) for
commercialization, even before the European Union (EU) granted the
import authorization. This generated a controversy within the
agricultural sector, as the exporters raised their concerns regarding
the impact the approval could have in the European market. This
represents a step forward against the \"mirror policy\" with the
European Union, or a risky step, as it might represent the potential
loss of the European market.

Up until now, Argentina has not approved any commercial GMO plant
material unless approved in the European Union. The Argentine media has
highlighted that this approval breaks the trend in the Argentine policy
towards GMOs and puts away fears about the negative commercial
consequences of approving GMOs without the green light from Europe.

## 

# Capacity Building and Outreach

**2002**

A.  FAS Buenos Aires organized a biotechnology seminar 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 Argentine Government
    officials, organized by ICD and Michigan State University.

C. FAS Buenos Aires organized a series of lectures byDr. Quiros, Davis
University, targeting Argentine Universities, Schools and consumers in
general.

**2004**

A.  FAS Buenos Aires selected two Argentine journalists to participate
    in a US Grains Council activity in Hawaii, where they learned about
    the papaya industry.

B.  The Agricultural Counselor accompanied State's Biotech Negotiator to
    participate in a series of biotechnology round tables organized by
    FAS Buenos Aires.

C.  Through Cochran funds, FAS Buenos Aires sponsored a two-week
    biotechnology-training course in the United States for one
    representative of CONABIA, organized by ICD and Michigan State
    University.

D.  Two Argentine 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.

F.  FAS Buenos Aires organized a series of lectures in several local
    universities for Dr. Bruce Chassy, expert in Nutrition and
    Biotechnology.

**2005**

A.  The Agricultural Counselor accompanied State's Biotech Negotiator to
    participate in a series of biotechnology discussions organized by
    FAS Buenos Aires.

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 States uses and regulates agricultural
    biotechnology.

C.  FAS Buenos Aires organized a biotechnology workshop in several
    Argentine provinces, targeting universities and media. Dr. Wayne
    Parrott, from Georgia University was the invited speaker.

D.  FAS Buenos Aires participated in the organization of the NABI/CAS
    meeting in Buenos Aires.

E.  FAS Buenos Aires participated in the meeting of the parties prior to
    CBP in Canada.

F.  FAS Buenos Aires selected one Argentine journalist to participate in
    a US Grains Council activity in the United States.

## 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,

\- Activities with local universities to demonstrate the benefits of
Biotechnology in Argentina

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

\- Special activities designed for consumer association leaders and
consumers in general,

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

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

\- Technical workshop to discuss treatment and analysis of stacked
biotech events.

\- Work with Senators and Representatives on the regional forum created
after the Southern Cone Reverse CODEL; and,

\- Meetings to develop lines of communication between the GOA and the
USG during the review process of biotech events.

# APPENDIX A: GMO Crops Approved in Argentina

+------------+------------+-----------+---------------+---------------+
| **Crop**   | **Trait    | **Event/  | **Trait**     | **Status**    |
|            | Category** | Ap        |               |               |
|            |            | plicant** | **            |               |
|            |            |           | Description** |               |
+------------+------------+-----------+---------------+---------------+
| Soybean    | Herbicide  | 40-3-2    | Glyphosate    | Approved Feed |
|            | Tolerant   |           | Herbicide     | Food          |
|            |            | Monsanto  | Tolerant      |               |
|            |            |           |               | Comm          |
|            |            |           |               | ercialization |
+------------+------------+-----------+---------------+---------------+
| Maize      | Herbicide  | T 25      | Resistant to  | Approved Feed |
|            | Tolerant   |           |               | Food          |
|            |            | AgrEvo    | Glufosinate   |               |
|            |            |           | Ammonium      | Comm          |
|            |            |           |               | ercialization |
+------------+------------+-----------+---------------+---------------+
| Maize      | Insect     | 176       | Resistant to  | Approved Feed |
|            |            |           |               | and/or Food   |
|            | Tolerance  | C         | lepidoptera   |               |
|            |            | yba-Geigy |               | Comm          |
|            |            |           |               | ercialization |
+------------+------------+-----------+---------------+---------------+
| Maize      | Herbicide  | NK 603    | Gliphosate    | Approved Feed |
|            | Tolerance  |           | Herbicide     | and/or Food   |
|            |            | Monsanto  |               |               |
|            |            |           | Tolerant      | Comm          |
|            |            |           |               | ercialization |
+------------+------------+-----------+---------------+---------------+
| Maize      | Insect     | MON 810   | Resistant to  | Approved Feed |
|            |            |           |               | and/or Food   |
|            | Tolerance  |           | lepidoptera   |               |
|            |            |           |               | Comm          |
|            |            |           |               | ercialization |
+------------+------------+-----------+---------------+---------------+
| Maize      | Insect     | Bt 11     | Resistant to  | Approved Feed |
|            |            |           |               | and/or Food   |
|            | Tolerance  | Novartis  | lepidoptera   |               |
|            |            |           |               | Comm          |
|            |            | Agrosem   |               | ercialization |
|            |            | S.A:      |               |               |
+------------+------------+-----------+---------------+---------------+
| Maize      | Insect and | TC 1507   | Resistant to  | Approved Feed |
|            | Herbicide  |           | European Corn | and/or Food   |
|            | Tolerance  | Herculex  | Borer and to  |               |
|            |            |           | Glufosinate   | Comm          |
|            |            | DowAgro   | Ammonium      | ercialization |
|            |            | Sciences  |               |               |
+------------+------------+-----------+---------------+---------------+
| Maize      | Herbicide  | GA 21     | Gliphosate    | Approved Feed |
|            | Tolerance  |           | Herbicide     | and/or Food   |
|            |            | Syngenta  |               |               |
|            |            |           | Tolerant      | Comm          |
|            |            |           |               | ercialization |
+------------+------------+-----------+---------------+---------------+
| Cotton     | Insect     | Mon 531   | Resistant to  | Approved Feed |
|            |            |           |               | and/or Food   |
|            | Tolerance  | Monsanto  | lepidoptera   |               |
|            |            |           |               | Comm          |
|            |            |           |               | ercialization |
+------------+------------+-----------+---------------+---------------+
| Cotton     | Herbicide  | MON 1445  | Gliphosate    | Approved Feed |
|            | Tolerance  |           | Herbicide     | and/or Food   |
|            |            | Monsanto  |               |               |
|            |            |           | Tolerant      | Comm          |
|            |            |           |               | ercialization |
+------------+------------+-----------+---------------+---------------+

**Source:CONABIA**

# Appendix B: Resolution 39

Specifies the conditions under which environmental releases of
transgenic material should be conducted. Resolution 39 is part of the
general regulatory system governing the existing agricultural
regulations in Argentina related to Plant Protection (Decree-Law of
Agricultural Production Health Defense. n° 6704/66 and its amendments),
Seeds and Phytogenetic Creations (Seed and Phytogenetic creations law,
nº 20.247/73 and its regulatory decree), and Animal Health (Law of
Veterinarian Products, and Supervision of Creation and
Commercialization. nº 13.636/49).

SAGPyA is the authority that issues the licences for experimentation on
and/or release into the environment of genetically modified plant
organisms, relying on the previous opinion from CONABIA.

\- Licences are issued in the following cases:

a)  Laboratory-greenhouse trials;

b)  Field trials; and or

c)  Pre-commercial multiplication of GMOs

\- Fifteen (15) copies of the appropriate application must be submitted
to CONABIA. The procedure begins in the National Seed Institute at the
following address: Paseo Colon 922 - 3° floor - office 349. zip code
1063 - Capital Federal, Buenos Aires, telephone no.:
54-11-4349-2433/2420/2498. fax: 54-11-4349-2417.

\- Each copy of the application must be signed by a legally responsible
person of the applicant organization, who will assume responsibility for
the compliance with all of the conditions under which the pertinent
authorization is granted.

\- Information included in the summary of the application shall be
contained in all other sections of the application, as it is required.

\- The assertions in the additional information form must be accompanied
by the supporting literature references. All information should be
provided in the original language.

\- The form must be written in the Spanish language.

\- Supplementary information may include reports presented to the
competent authorities of foreign countries, with the amendments and
additions that may be relevant for the local conditions, as well as
references to previous reports presented to CONABIA.

\- Upon evaluation of the application, CONABIA shall decide on the
suitability of permitting the release of the G MO in question, and shall
submit its decision for the approval of the Secretary of Agriculture,
Livestock, Fisheries and Food.

\- At the end of the period for which the authorization was granted, the
applicant shall submit to CONABIA a final report.

\- An authorized experiment will be deemed correctly concluded, upon
compliance with the following conditions:

-Correct risk management by the applicant,

-Consistency between the conditions under which the authorization was
granted and the conditions observed at the site of experimentation,
and/or release by the inspectors appointed by the competent authority;
and

-Submission of the final report.

-Any applicants who had already obtained authorizations for
experimentation and/or release into the environment of GMOs, may request
through a letter addressed to CONABIA, filed at the National Seed
Institute, the flexibility status of the conditions under which the
above mentioned permits are granted. Upon granting the flexibility
status from the Secretary of Agriculture, Livestock, Fisheries and Food,
further releases into the environment will only require the submission
of the following information: the area sown, the date of sowing, the
site of release, and the harvest date. CONABIA will only recommend that
inspections be made at harvest and of the measures taken for the final
disposition of the material.

-Obtaining the flexibility status permit will not mean an authorization
for seed commercialization. Seed commercialization is subject to the
following terms and conditions:

\- Authorization to follow more flexible conditions for the granting of
permits for release into the environment of GMO material.

\- Compliance with the requirements set forth by the National Seed
Institute for registration of the material in the National Cultivar
Registry and in the official certification regulations.

\- Compliance, if applicable, with the requirements set forth by SENASA
regarding authorizations for the commercialization of agrochemical
products.

\- A letter addressed to the Technical Coordination of CONABIA at Paseo
Colón 982 - 2° floor - office 220 - zip code 1063 - Federal Capital.
Telephone no.: 54-11-4349-2222/2226, fax no.: 54-11-4349-2224,
requesting the initiation of the procedure necessary to comply with the
requirements under the jurisdiction of SENASA in connection with the use
of transgenic material and its derived products for human and animal
consumption. SENASA may request from the applicant any information it
may deem necessary for the purposes of carrying out the pertinent
evaluations.

\- Thereupon, CONABIA will request the technical review of the National
Direction of Agricultural Food Markets regarding the convenience of
commercialization of the GMO material.

-Upon completion with all of the steps mentioned above, CONABIA\'s
Technical Coordination will compile the pertinent information for the
purposes of preparing a final report to the Secretary of Agriculture,
Livestock, Fisheries and Food for its final decision.