Propuesta de Marco Nacional de Bioseguridad para Uruguay

PROPOSAL FOR A NATIONAL
BIOSAFETY FRAMEWORK FOR

URUGUAY
SUMMARY
DINAMA-PNUMA-GEF Project
URU-04-009
November 2007
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MINISTER FOR HOUSING, USE OF THE LAND AND THE
ENVIRONMENT
Architect Mariano Arana
VICE MINISTER FOR HOUSING, USE OF THE LAND AND THE

ENVIRONMENT
Architect Jaime Igorra
NATIONAL DIRECTOR FOR THE ENVIRONMENT
Agronomist Alicia Torres
PREPARED BY: MSc. Gonzalo Martínez Crosa
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Introductory letter by the NATIONAL DIRECTOR FOR THE
ENVIRONMENT
The publication of a work implies the achievement of a degree

of maturity worthy of a public presentation, analysis,
revision and criticism by other actors who did not take part
in the processes but who Hill not necessarily agree with the
conclusions or with the manner in which things were done.
During the last two years, a technical team worked

responsibly, diving deep into one of the most controversial
issues which divides modern societies, biosafety.
Scientific, technological, biological, environmental,

economic, productive and social aspects come together here in
this tissue which is hard to unweave and to analyse without
any passion.
The knowledge and the different points of view on the issue

generally have blurred boundaries and naturally this hinders
the best decisions.
However, it was possible to bring all the institutions, both

public and private together, in order to debate and analyse,
it was possible to systematise the contributions of almost
all the areas, it was possible to look at the whole Wide
range of positions without this meaning any rupture.
It was possible to take the fundamental step that we needed

to take as a society, to be organised as a country, to
progress towards key definitions which shall leave a mark on
Uruguay in many senses, and which shall constitute the basis
for the National Biosafety Framework.
There are no unanimous criteria. We knew this would be the

case.
We thought this would be a starting point, that it was

necessary to walk along this path in an orderly way, that it
was necessary to invest endless hours of study and debate,
that it was fundamental to open the issue to the
participation of the whole society.
And today, we are fortunately able to open this work to

public consideration, knowing that we fulfilled all the
demands that we had initially imposed on ourselves and
knowing, that beyond the milestone we have set by reaching
this point, our work has only just begun.
Agronomist Alicia Torres. National Director for the

Environment.
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Table of Contents
Acronyms and abbreviations ......................................................................................... 7
Introduction ................................................................................................................... 9
Project URU-04-009.................................................................................................... 9
Biotechnology in the national context..........................................................................15
Transgenic events in Uruguay.....................................................................................16
Political Framework......................................................................................................19
The Cartagena Protocol..............................................................................................19
Biosafety policy ..........................................................................................................19
Positions and recommendations..................................................................................21
Biosafety regulatory system ..........................................................................................22

Regulations in force....................................................................................................22
Proposals under study ................................................................................................24
Recommendations.......................................................................................................24
Decision-making system ................................................................................................25

Institutional procedures and competencies ..................................................................25
Procedures in force ....................................................................................................26
Information management ............................................................................................29
Risk assessment ..........................................................................................................30
Baseline for an ERA in Uruguay .................................................................................31
Administrative System Proposal..................................................................................33
Monitoring and control .................................................................................................42

Monitoring .................................................................................................................42
Control.......................................................................................................................43
Mechanisms for participation and access to information.............................................46

Access to information..................................................................................................46
Public participation ....................................................................................................48
References .....................................................................................................................50
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Annexes .........................................................................................................................51
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Acronyms and abbreviations
PEA Prior Environmental Authorisation
rDNA Recombinant deoxyribonucleic acid
AGESIC Agencia para el Gobierno Electrónico, la Agency for the Electronic Government,
Sociedad de la Información y del Information Society and Knowledge
Conocimiento
ALADI Asociación Latinoamericana de Latin-American Integration Association
Integración
ANB Agencia Nacional de Bioseguridad National Biosafety Agency
ANC Agencia Nacional Competente National Competent Agency
ANE Agencia Nacional de Ejecución National Execution Agency
ANII Agencia Nacional de Investigación e National Research and Innovation
Innovación Agency
ANTEL Administración Nacional de National Telecommunications
Telecomunicaciones Administration
ANV Agencia Nacional de Vivienda National Housing Agency
RA Risk Analysis
BCH Biosafety Clearing-House
CAAR Comisión Asesora de Análisis del Riesgo Risk-Analysis Advisorship Commission
CASI Centros de Acceso a la Sociedad de la Access Centres to the Information
Información Society
CDB Convention on Biological Diversity
CEAGRO Agricultural Evaluation Commission
CEINDUSTRIA Industry Assessment Commission
CERA Environmental Risk Assessment
Commission
CERV Commission for the Assessment of the
Risk of Genetically Modified Vegetables
CESALUD Health Assessment Commission
CET Technical Assessment Commission
BCH Biosafety Clearing House
NCC Comité National de Coordinación National Coordination Committee
COTAMA Technical Commission Asesora de la Technical Advisory Commission for
Protección del Environment the Protection of the Environment
CSIC Comisión Sectorial de Research Científica Scientific Research Sectoral
Commission
CUS Cámara Uruguaya de Semillas Uruguayan Seed Chamber
DGSG Dirección General de Servicios General Directorate for Livestock
Ganaderos Services
DGSSAA General Directorate for Agricultural General Directorate for Agricultural
Services Services
DICyT Dirección de Innovación, Ciencia y Innovation, Science and Technology
Tecnología para el Desarrollo Directorate for Development
DIGESA Dirección General de la Salud General Health Directorate
DINAMA Dirección Nacional de Environment National Environment Directorate
DINARA Dirección Nacional de Recursos Acuáticos National Water Resources Directorate
DNPI Dirección Nacional de Propiedad Industrial National Industrial Property
Directorate
DPA Dirección de Protección Agrícola Africultural Protection Directorate
EIS Environmental Impact Study
ERA EnvironmentalRisk Assessment
ES Substantial equivalence
FAGRO Facultad de Agronomía School of Agronomy
FAO Fondo de las Naciones Unidas para la
Alimentación y la Agricultura
FCIEN Facultad de Ciencias School of Sciences
FVET Facultad de Veterinaria School of Veterinary
GEF (Global Environmental Facility
GIM Grupo de Trabajo Interministerial Inter-Ministry Work Group
GMB Gabinete Ministerial de Bioseguridad Ministerial Group for Biosafety
GMI Gabinete Ministerial de la Innovación Ministerial Group for Innovation
WG Work Group
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WG AD Grupo de Trabajo “Aspectos “Administrative Aspects” Work Group
Administrativos”
WG R&D Grupo de Trabajo “Regulación en la “Regulation of Research +
Investigación + Desarrollo con OVM” Development with LMOs” Work Group
WG IN Grupo de Trabajo “Biotecnología “Industrial Biotechnology" Work Group
Industrial”
WG MA Grupo de Trabajo “Aspectos Ambientales” “Environmental Aspects” Work Group
WG SE Grupo de Trabajo “Aspectos Socio- “Socio-economic aspects" Work Group
económicos”
R&D Research & Development
IIBCE Instituto de Investigaciones Biológicas Clemente Estable Institute for
Clemente Estable Biological Research
INAC Instituto Nacional de Carne National Meat Institute
INASE Instituto Nacional de Semillas National Seed Institute
INDT National Institute for the Donation and National Institute for the Donation and
Transplant of Cells, Tissues and Organs Transplant of Cells, Tissues and
Organs
INIA Instituto National de Investigación National Institute for Agricultural
Agropecuaria Research
IPMont Instituto Pasteur de Montevideo Pasteur Institute of Montevideo
LATU Laboratorio Tecnológico del Uruguay Uruguay Technological Laboratory
MEC Ministerio de Educación y Cultura Ministry for education and Culture
MEF Ministerio de Economía y Finanzas Ministry for Economy and Finance
MGAP Ministerio de Ganadería, Agricultura y Ministry for Livestock, Agriculture and
Pesca Fisheries
MIEM Ministry de Industria, Energía y Minería Ministry for Industry, Energy and
Mining
NBF National Biosafety Framework
MOP Reunión de las Partes del Cartagena Meeting of the Parties to the
Protocol Cartagena Protocol
IRM Manejo de Resistencia a Insectos
MRREE Ministerio de Relaciones Exteriores Ministry for Foreign Affairs
MSP Ministerio de Salud Pública Ministry for Public Health
MVOTMA Ministerio de Vivienda, Ordenamiento Ministry for Housing, Use of the Land
Territorial y Medio Ambiente and the Environment
OECD Organisation for Economic Co-operation
and Development
WHO World Health Organisation
LMO Living Modified Organism
CP Cartagena Protocol on Biotechnological
Safety
EP Executive Power
PNUD Programa de las Naciones Unidas para el United Nations Development Program
Desarrollo
PNUMA Programa de las Naciones Unidas para el United Nations Environment Program
Medio Ambiente
PROGRAMA Programa de Cooperación Científica entre Scientific Cooperation Program
AMSUD- Institutions Académicas de Países de between Latin American Academia
PASTEUR América del Sur y el Instituto Pasteur Institutions and the Pasteur Institute
RENARE Dirección Nacional de Recursos Naturales National Directorate for Renewable
Renovables Natural Resources
GGRR Genetic Resources
SCDB Secretaría del Convenio sobre Diversidad Secretariat of the Convention on
Biológica Biological Diversity
SD Direct Sowing
HGT Horizontal Gene Transfer
UdelaR Universidad de la República University of the Republic
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Introduction
Project URU-04-009
The concept of biotechnological safety or biosafety includes a wide range of measures,
policies and procedures aimed at reducing the possible risks that biotechnology might pose
for the environment and human health, to a minimum.
In 2004, our country had altrady authorised the release into the environment of the three
transgenic vegetables which are grown at present: WGS$=-3-2 soybean (resistant to
glyphosate herbicide) and corn events MON810 and Bt11 (resistant to insects). research
was carried out with genetically modified microorganisms and animals In the laboratories of
the country but there were no specific regulations in force governing the use thereof or the
proceedings for their import/export. There was a fragmented and incomplete regulatory
framework for the treatment of Living Modified Organisms (LMO) altered with modern
technology, which included some specific regulations regarding their use on vegetables.
Within said context, our country thought it convenient to advance in the discussion and
proposal of a National Biosafety Framework (NBF).
Said framework should contain:
• a regulatory system;
• an administrative system to support it;
• a decision-making system to study assessment and risk management;
• mechanisms to guarantee the information of the civil society and their participation in
the decision-making processes.
The National Directorate for the Environment (DINAMA), in its capacity as National
Competent Authority in the area of environmental protection, has thus implemented Project
URU-04-009 PNUMA-GEF for the Development of a National Biosafety Framework in
Uruguay. It started in November, 2004, with the main aim of elaborating an NBF, taking int
consideration the regulations under the Cartagena Protocol. The Project was executed with
the active participation of the stakeholders who were directly involved in these issues. Said
participation was effected through the National Coordination Committee (NCC) and
completed with the integration of the Work Groups (WG) and a number of publication
symposia.
One of the main results of this Project was the organisation of the existing information and
the elaboration of diagnoses of the national situation regarding biosafety and the LMOs. The
Project did not elaborate any concrete regulatory instruments, even if some
recommendations were made for the improvement of the regulatory framework in force,
which still shows vacuums in some areas of application (research, industry, animal LMOs).
Another important achievement was the proposal for an adequate administrative decision-
making process based upon the experience gained during the process for the authorisation
of vegetable events, but expanding it to other areas which have no regulations yet,
proposing new functions for the existing institutions and the creation of new structures which
allow for networking. The latter follow the same line of work as the reformation of the State
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proposed by the Executive Power. Furthermore, it is a widely discussed proposal at the
spaces for participation created by the Project.
Several important vacuums were identified through the diagnostic study which was carried
out, regarding monitoring and control. Biosafety control is hindered by the lack of institutional
and human capabilities and due to a weak articulation between the stakeholders responsible
for it.
A public opinion study was carried out, revealing an important lack of information of the
population in general regarding biosafety issues. The creation of effective tools to guarantee
access to the information and to the participation constitute a substantial challenge to bridge
this information gap. The Project has also created a Web page containing easy-to-read and
up-to-date information. At the same time, the main points of the Project were presented at a
series of regional symposia.
The NBF’s proposal was materialised in a final draft, submitted by the end of September.
The same includes the recommendations made by the different Work Groups, the decisions
made by the NCC, as well as others which resulted from the Project team itself and from the
National Execution Agency. This does not mean that all said proposals have been validated
by the competent authorities.
Table 1: Technical sheet for Project URU-04-009
Start date November 2004
Date of submission of the

th
National Biosafety Framework 30 September, 2007
draft
Closing date December 2007
The Ministry for Housing, Use of the Land and the Environment
National Execution (MVOTMA), through the National Directorate for the Environment
Agency (NEA) (DINAMA), lead by Agronomist Alicia Torres was the organism in
charge of executing the Project.
Agronomist Marcos Frommel, PhD was appointed National Project
st
Coordinator, holding said position until 31 March, 2007. The final
National Project report was written after Agr. Marcos Frommel left his position as
Coordinator (NPC) NPC, under the responsibility of the Project's Technical Assistants,
Agnonomist María Fernanda Prado and MSc. Gonzalo Martínez
Crosa, coordinated by the National Director for the Environment.
Consulting and administrative organ of the Project. It was
integrated by 72 representatives, belonging to 34 organisations
National Coordination with specific interests and competences in specific aspects related
Committee (NCC) to the developments of modern biotechnology.
st th
16 sessions were held between 31 August, 2005 and 14
March, 2007.
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Table 2: Execution strategy
Work Groups
The NCC created six open integration Work Groups with the aim of elaborating
recommendations for the NBF, regarding different sectoral aspects. The recommendations
made by these WGs were expressed in the final report. The documents prepared by the
WGs were distributed for free among the WGs and the members of the NCC, pursuant to
the decision made.
Initially, two scenarios were considered:
1. LMO-free country: this would imply the complete restriction of the use of LMO or
parts thereof within the national territory.
2. Coexistence: this would imply having different primary production systems (organic
production, conventional farming and LMOs) simultaneously or adjacently with no
significant effects on one another, due to specific management measures (Altieri,
2005).
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Table 3: Characteristics of the Work Groups
Work Group Aim Scope
Only the coexistence scenario was
Regulation for Research & To identify the components which
taken into account, upon the belief
Development should be included in an NBF
that an LMO-free country would
with LMOs regarding the regulation of LMOs
mean closing the existing and
(R&D WG) for research uses.
potential lines of research.
Work was carried out on an
To identify the components of the
industrial scenario with LMO
Industrial Biotechnology NBF for the regulation of the use,
application, due to the scope of
(IN WG) manipulation and generation of
recombinant DNA (RDNA) in the
LMO in the industrial sector.
industrial area
Work was carried out widely,
To propose procedures for the covering the scope defined by the
study of requests for NCC for the NBF. The proposal was
Administrative Aspects
authorisations to use LMOs and made thinking of an environmental
(AD WG)
the administrative components for coexistence scenario, but also
the execution thereof. considering adjustments for a free
country scenario.
To study environmental aspects All the LMOs released into the
Environmental Aspects related to LMOs and to propose environment were taken into
(EN WG) elements for their management consideration, including
within an NBF. unintentional ones.
To assess the socio-economic
It was decided to restrict the
impact derived from the use of
Socio-Economic Aspects analysis to the agroalimentary
LMOs in the country and to
(SE WG ) sector. Only the coexistence
compare agronomical packages
scenario was touched.
with and without them.
To study the status of the risk
Health aspects assessment and management for
(The group did not start its activity).
(H WG) the use of LMOs from the point of
view of health.
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Table 4: Activities carried out within the framework of the Project
Date Activity Aims Participants
rd
3 August, Workshop for the To assess the institutional 20 guest
2005 assessment of management process of the release institutions (State,
institutional and follow-up of transgenic events in Private, NGOs)
management Uruguay.
(Montevideo) To analyse the performance of CERV.
To consolidate the establishment of
the NCC.
th
8 March, Regional Meeting: To broaden the communication and Departments of
2006 North information bases starting by the Tacuarembó,
(Tacuarembó) institutions which participate in the Artigas, Salto,
NCC, Paysandú, Río
To motivate the generation of a Negro and Rivera
nd
22 March, Regional Meeting: growing communication flow, starting Departments of
2006 Litoral and Centre with the participating Flores, Soriano,
(Trinidad) organisations/institutions, and Colonia, San José,
To dynamise the information flow from Canelones, Florida
the interested parties towards the and Durazno
th
5 April, Regional Meeting: NCC and within the Project. Departments of
2006 East Lavalleja,
(Minas) Maldonado, Rocha,
Treinta y Tres and
Cerro Largo.
th
26 October, Meeting at School of To discuss the aspects related to the Representatives of
2006 Sciences regulation of the scientific activity with the academic
(Montevideo) LMOs sector
th
11 Bases to outline Workshop to discuss the bases to Relevant
September, Policies for Research outline research policies in Agricultural institutions, general
2007 in Agricultural Biotechnology, held upon request of public
Biotechnology the GIM
(Montevideo)
th
30 October, Transgenic Integration of an interdisciplinary Work Academy, state
2007 Regulation, Group to support the health sector, general
contributions to the component of the GIM. public
vision from the Public
Health area
(Montevideo)
th
4 Final meeting Presentation of the Final report of the Authorities,
December, Project members of the
2007 NCC, NGOs,
Academy, Media,
general public.
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Research
• Revisions: A thorough revision was made of the scientific information arbitrated at the
national, regional and international level, regarding the environmental status of Maize Bt
and Glyphosate-resistant Soybean.
• Inventories: An inventory was made of the human and institutional resources for the
Research + Development (R&D) in Lepidoptera in Uruguay. Lepidoptera are insects
sensitive to the toxins contained in the transgenic corn events released at present. The
aim of this study was to analyse the strengths and needs in this area and to establish
bonds between the research teams. A work meeting was held with the main experts in
the area and a proposal for a Lepidoptera database for the country was prepared. In
this same aim, an inventory of the capacities for biotechnological research was made at
a national level. Said inventory was aimed at determining the present situation in terms
of installed capacity, capacity building and R&D programs in the field of biotechnology,
both at the national and regional levels. In order to effect it, a survey was conducted at
the academic and entrepreneurial levels, on the research lines, infrastructure and
human resources capacities dedicated to R&D in biotechnology. Said survey was
carried out in coordination with the Amsud-Pasteur Program.
• Opinion survey: The NCC implemented a public opinion survey to assess the degree
of awareness of different social actors regarding this issue. Said survey covered
politicians, journalists, producers and professionals in the biological branch, as well as
the general public.
Lessons learnt
1. Range of the phenomenon: The horizon of information related to LMOs was extended
beyond commercial vegetables. The information generated by the Project shows the
existence of a new reality: LMOs and products derived from them are used extensively in
the food industry, in medical and agricultural research.
2. Public opinion: The positions of some of the sectors involved as well as the population’s
great lack of information were clearly seen through the opinion survey.
3. Importance of participation: The systematic and constant contribution of the sectors
involved, many times with opposite opinions, nourished the discussion process. In spite
of some disagreements, a formal work agreement was achieved, which translated into
progress, so far as the positions represented in the NCC allowed it. It was possible to
include the issue in the agendas of all the institutions involved.
4. Commitment to future actions: The representatives of the institutions and organisations
which integrate the NCC and the members of the Work Groups expressed their
willingness to continue working in this area.
5. Regulatory vacuums: The lack of specific regulations in certain areas (research,
industry, animal LMOs) constitutes one of the main challenges to be faced.
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Biotechnology in the national context
Biotechnology-related activities in Uruguay cover the vegetable and animal orbits (agro
biotechnologies), biomedicine, industrial and, more recently, bioinformatics. Regarding the
use of LMOs, there is a large information vacuum regarding the industries which manipulate
these organisms. Even the industries themselves do not know their origin. At the same time,
despite the fact that there are lines of research centred in agro biotechnologies and
biomedicine which develop LMOs, our country does not have a registration system to collect
reliable information about said activities.
Notwithstanding the country’s relative biotechnological slowness if compared to other
countries in the region, in the last few years there has been an improvement in the degree of
equipment and infrastructure of the biotechnological platforms, such as the Pasteur Institute
of Montevideo (IPMont), Clemente Estable Institute for Biological Research (IIBCE), the
National Institute for Agricultural Research (INIA) and the School of Sciences.
Uruguay devotes the lowest percentages of its GDP to R&D, both, compared to the most
developed countries and to the countries in the region. Uruguay invests 0.21% GDP of its in
average (R&D/GDP relation). This figure rises to 1.61% if the agro-industrial GDP (agro-
industrial R&D/GDP relation) is taken into account, bearing in mind the fact that this is one of
the most demanding sectors in R&D (MGAP, 2005). Despite the unfavourable situation in
terms of investment, Uruguay is among the 35% of the countries with the highest number of
Internet nodes and it has an important scientific production in terms of publications and
patents. In the public sector, most of the researchers belong to the University of the
Republic.
There have been some activities aimed at promoting national biotechnology, at the level of
both, national and regional organisms. However, the growth of this area is still irregular and
there is a lack of high-interaction strategic programs. Biotechnological development
initiatives are carried out by public institutions and private companies.
Uruguay is positioned as a country with a good level of capacity for biotechnological
research in terms of number of laboratories, qualified human resources, infrastructure and
equipment. However, it lacks economic projections in the biotechnological activities, due to a
lack of qualified human resources in the area of management and technical support.
Regarding the education of human resources, there have been different opportunities to
promote training through postgraduate courses, mainly in the area of biological sciences;
there is a high percentage of publications in national and international magazines, as well as
important acknowledgements through awards and distinctions to our researchers. However,
HR qualified in biosafety are needed at government level.
The integration of the new public structures, the Ministerial Group for Innovation (GMI) and
the National Research and Innovation Agency (ANII) constitute promising initiatives for the
improvement of the present national situation in the area of biotechnology.
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Transgenic events in Uruguay
Soybean: Event WGS 40-3-2 (MON-Ø4Ø32-6)
nd
Its production, import and consumption were authorised in Uruguay on the 2 October,
1996 upon Resolution of the Agricultural Protection Services Directorate of the Ministry for
Livestock, Agriculture and Fisheries (MGAP).
Since then, there has been a significant increase in the culture, completely outnumbering
the conventional soybean productions as well as other production systems (Hernández et
al., 2001; INASE, 2006).
The soybean in this event, also known as Roundup Ready® Soybean (RR), was developed
through the recombinant DNA technology. It is tolerant to glhyphosate, the active principle
in the Roundup® herbicide. The glyphosate’s mechanism of action consists of inhibiting the
activity of the 5-enolpyruvyl-shikimato-3-phosphate syntase (EPSPS) enzyme. This
enzyme is essential in the metabolic route of shikimato, in charge of producing the
following aromatic aminoacids: phenylalanine, tyrosin and tryptophane (FAGRO, 2005;
Monsanto, 2002). The EPSPS is the biological target of glyphosate in plants, not inhibiting
any other enzymes; this is why soybean 40-3-2 allows for the use of this herbicide as an
alternative to control weeds in soybean production (FAGRO, 2005).
The introduction of soybean 40-3-2 was carried out without any Risk Assessment.
Maize Event MON 810 (MON-ØØ81Ø-6)
Its use, production, the commercialisation of its seeds, products and subproducts were
authorised upon a joint Resolution by the MGAP and the Ministry for Economy and Finance
(MEF), dated 20th June, 2003. Since then, the percentage of adoption of Maize Bt
(MON810 and Bt11) has raised and at present it is near 50%.
The CERV (Commission for the Assessment of the Risk of Genetically Modified
Vegetables) ran a study of the Environmental Risk Assessment (ERA) presented by the
proponent (CERV, 2002). The authorisation of this event in the country was justified by
virtue of its capacity to control pest rootworm populations. However, the School of
Agronomy was reluctant, based on the fact that the species of worm that this vegetable
had been designed for was not present in the country (Facultad de Agronomía, 2002).
Further criticism to the report status that it was limited to an interpretation of the
bibliography provided by the applicants and that no in vitro or in situ tests were run to
confirm the data, which had not been obtained in the country (Martínez, 2006b).
In order to counterbalance the risk of resistance in the pest species, handling measures
were put into practise, which include the installation of shelters and buffer areas. A shelter
is a plot planted with non-Bt maize with the same cycle and characteristics. The aim of the
shelter is to delay the appearance of pest varieties of insects which are resistant to the
toxin. The regulations in force set forth that the shelter area should correspond to at least
10 % of the plantation. It also sets forth a 250-metre buffer area between crops.
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Maize Event Bt 11 (SYN-BTØ11-1)
Its use, production, the commercialisation of its seeds, products and subproducts were
authorised by virtue of a joint Resolution by the MGAP and the Ministry for Economy and
Finance (MEF), dated 7th May, 2004.
Maize Bt11 is planted in less quantities than MON810 but no exact percentages may be
obtained because the statistics do not specify the nature of Bt events.
Apart from the CryIAb gene, event Bt 11 contains the gene that it codifies for the PAT
enzyme, which makes it resistant to the herbicide ammonium gluphosynate. This gene was
used as a marker and no ERA was requested for it by the CERV. The measures for its
management set forth by the regulations in force are identical to those set forth for maize
MON810.
White Clover Event ipt:atmyb32

Its assessment under contained essay conditions was authorised by the CERV in March
2005. The material was developed in Australia and assessed in laboratory and greenhouse
conditions. This event has a transgene which includes the sequence that codifies the ipt
enzyme (which comes from the bacteria called Agrobacterium tumefaciens), as well as the
sequence of the promoter atmyb32, isolated from the plant Arabidopsis thaliana. The
purpose of the same is to delay the cell’s programmed ageing and to enable normal growth
to continue for some time. Event ipt:atmyb32 has a higher concentration of cytokinin, a
phytohormone present in plants which regulates their growth and development. It is being
tested at present in Uruguay (INIA-La Estanzuela) and Argentina (University of Buenos
Aires).
The essay conducted in Uruguay shall take approximately 2 years and all the materials
used must be destroyed once it is finalised. To this date, it is the only vegetable event
authorised for research in contained use under Dec. 249/000.
Other events
The remaining LMOs under assessment in the country are shown in Table 5.
In Uruguay there are also research lines in the academic sector which develop vegetable
LMOs as study models or with educational aims. In most cases the receiving organism is
Arabidopsis thaliana. The situation concerning microorganisms is similar.
Regarding animals, development of LMOs is done exclusively at the academic level. the
activity is concentrated at the Clemente Estable Institute for Biological Research (IIBCE),
the School of Medicine and the Pasteur Institute of Montevideo (IPMont). These institutions
work with rodents for biomedical aims. An important development is predicted in this area
for the yeas to come, due to the recent creation of a bioterium and a transgenic animals
unit at the IPMont.
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Table 5. LMO vegetables assessed in the country
Unique
Event 1 Crop Characteristics Level of application requested
identifyer
NaturGard
Resistance to Assessment for the National Crop
BT 176 SYN-EV176-9 KnockOut™
Lepidoptera Registry (INASE)
Maize
Tolerance to
Liberty Assessment for the National Crop
T 25 ACS-ZMØØ3-2 ammonium
Link™ Maize Registry (INASE)
gluphosinate
Roundup
MON-ØØØ21- Tolerance to Assessment for the National Crop
GA 21 Ready™
9 glyphosate Registry (INASE)
Maize
Resistance to
Lepidoptera
Starlink™ Assessment for the National Crop
CBH 351 ACS-ZMØØ4-3 Tolerance to
Maize Registry (INASE)
ammonium
gluphosinate
Roundup
MON-ØØ6Ø3- Tolerance to
NK 603 Ready® 2 Field tests and essays
6 glyphosate
Maize
Resistance to
MON-ØØ6Ø3- Roundup
NK 603 X Lepidoptera
6 x MON- Ready™ Field tests and essays
MON 810 Tolerance to
ØØ81Ø-6 YieldGard™
glyphosate
CP4
Tolerance to
(Event not Eucalyptus Field tests and essays
glyphosate
specified)
11 / 25
Low lignin
(Event no Eucalyptus Field tests and essays
content
especificado)
gen BAR Tolerance to
Assessment for the National Crop
(Event no Rice ammonium
Registry (INASE)
especificado) gluphosinate
Assessment for the National Crop
Tolerance to Registry (INASE)
Liberty Link™
LLRICE62 ACS-OSØØ2-5 ammonium
Rice
gluphosinate Production and import for direct
consumption or transformation
1
The code between brackets corresponds to the unique identifier, pursuant to OECD (2002) OECD guidance for the
designation of a unique identifier for transgenic plants. In: Series on Harmonization of Regulatory Ovesight in
Biotechnology Nº 23, pp. 1-12. Organisation for Economic Co-operation and Development, Paris.
Page 18 / 55
Political Framework
The Cartagena Protocol
The first international agreement related to biological diversity was entered into at the United
Nations in the year 1992. The Convention on Biological Diversity (SCDB, 1993) was entered
into by nearly 190 governments, with the following aims: (1) the protection of biological
diversity; (2) the sustainable use of the components of biological diversity, and (3) the just
and equitable distribution of the benefits derived from the use of genetic resources.
The Cartagena Protocol (CP), was adopted in Montreal in the year 2000 and it arises from
paragraph 3 of article 19 of the aforementioned Convention. The CP sets the Basic
guidelines for an international regulatory system to ensure the safe transfer, handling and
use of the LMOs subject to transboundary movements. The Protocol specifically deals with
those LMOs that are to be directly introduced into the environment (seeds, small plants, fish,
etc.) and genetically modified agricultural products (maize or cereals used for animal or
human consumption). It does neither cover pharmaceutical products destined for human
use, which are regulated under other agreements and international organisations, nor
products derived from LMOs.
Uruguay followed the negotiation process which led to the final CP closely, sending
representatives and positions. After having signed the CP, it did not directly take part in the
Meetings of the Parties of the CP (MOP), except for the last one, held in Curitiba in the year
2006. Notwithstanding, it has accompanied the international process with decisions at the
national level. As an example we may say that in the same year the Cartagena Protocol was
adopted, the General Law for the Protection of the Environment Nº 1,.283 was passed,
setting forth specific biosafety provisions, together with Decree 249/000 which sets forth an
administrative framework for the treatment of requests for genetically modified vegetables
for different uses.
Biosafety policy
One of the first steps in the elaboration of an NBF coincides with the request for the
introduction of soybean WGS 40-3-2 into the country, thus motivating the establishment of
an Advisory Committee for Risk Analysis (CAAR) at the Agricultural Protection Directorate
(DPA) with the Ministry for Livestock, Agriculture and Fisheries (MGAP). Other vegetable
LMOs were authorised for testing and other uses under restricted conditions (no commercial
release) by the CAAR.
In response to the growing demand for the release of vegetable LMOs for culture in the year
2000 the Commission for the Assessment of the Risk of Genetically Modified Vegetables
(CERV) was established by Decree 249/000, setting the first precedent of a national
biosafety policy. Environmental exposure categories (levels of application) were set as well
as competencies for the corresponding authorisations, Risk Assessments to be run prior to
any authorisation, and some opportunities for public participation and consultation are
created. As of the establishment of the CERV, the release of the events of maize Bt MON
Page 19 / 55
810 and Bt 11 into the environment was authorised, as well as essays under controlled
conditions of the events of maize NK603 (discontinued at present) and wite clover
ipt:atmyb32.
In that same year, the General Law for the Protection of the Environment, Nº 17.283 was
passed, tracing in Article 23 the main guidelines of a national biosafety policy. Among the
most relevant aspects of this Law, there is the appointment of MVOTMA as national
authority with primary competence regarding the LMOs released into the environment, the
need to have prior authorisations and the extent of the scope beyond the limits of the CP,
since it also includes LMOs for pharmaceutical use. Despite the wide scope of Article 23,
until this date the administrative framework for the prevention and control of risks derived
from LMOs still presents some vacuums in some areas.
During the course of Project URU-04-009 a discussion and exchange process took place
between the different public, private and civil society stakeholders, on the need to revise the
national biosafety policy. After the national presidential elections held in 2004, the new
government expressed their willingness to review the decisions made, upon the basis of an
adequate debate on the subject, for which it was a priority to have more participation.
As a result of this revision, the suspension of the use, the commercialisation and production
of transgenic maize was decreed for the varieties of sweet maize and in January, 2007 the
treatment of new requests for the authorisation of genetically modified vegetables for any of
the uses under the regulations in force was suspended for 18 months. By establishing said
suspension, Decree 037/007 takes a significant step in the development of a biosafety
policy, since it creates an Inter-Ministries Work Group (GIM) to the effect of elaborating a
legal framework project and to design the guidelines and policies on biotechnology,
incorporating a public participation component for the elaboration of said policies.
The GIM is integrated by a delegate and two substitutes of each Ministry (MEF, MGAP,
MSP, MVOTMA). It has been holding regular meetings since 29th May, 2007. The work done
by the GIM so far has focused on the provisions under Article 5 of said Decree (socio-
economic, environmental, health, intellectual property issues, participation of the Civil
Society, technological transfer and cooperation, as well as matters related to coexistence in
relation to the use of vegetable LMOs in agriculture).
On the other hand, the GIM has focused on the analysis of the feasibility of different political
scenarios in terms of biosafety (coexistence, transgenic-free country). The documents
prepared during the implementation of Project URU-04-009 are being used by the GIM as a
fundamental input for the elaboration of their recommendations. The remarks, comments
and contributions made by different Civil Society organisations which were invited to submit
additional points for consideration to the ones which had already been submitted within the
framework of the Project, are also being taken into consideration.
Pursuant to the regulations of Article 5 of the Decree, the GIM has produced a preliminary
Progress Report which has been under consideration by the corresponding Ministers since
th
this last 24 August, 2007. In this Report, the need to face institutional building challenges
is acknowledged in three parallel areas:
• Political. To advance towards the elaboration of a proposal for a National Biosafety
Law.
• Operative. To develop a Plan to strengthen and install all such new operative
Page 20 / 55
capabilities as shall be required in order to implement the biosafety policy.
• Participation. To create institutionalised spaces for consultation, which are capable
of fulfilling the aim of giving advice to the Executive Power in connection with the
implementation of the biosafety policy.
Even though the scope of the work is restricted to vegetable LMOs, particularly to those
associated to agriculture, the GIM deems that a National Biosafety Law should at least
cover the scope of Article 23 of Law Nº 17,283.
The MVOTMA has acknowledged the fact that, as a result of the Project, progress has been
made in the area of publication of information, as well as in the opportunities for
participation, which constitute one of the main links of this Government's biosafety policy.
However, it is necessary to further the debate, to develop publication policies about these
matters and to define a national position regarding the ratification of the CP.
Positions and recommendations

1. The NCC recommends to consider the revision of the authorisations of maize event MON
810 and Bt11 and soybean event CP4, until the proposal for the creation of an NBF is
finalised.
2. Notwithstanding the fact that Uruguay World decide to ratify the CP or not, it should
include the analysis of the certification within the framework of a national biosafety policy.
3. The claim for the ban is frequently based upon the lacks and the difficulties to enforce the
regulations, but it is necessary to make a warning regarding the fact that if there is no
faith in the possibility of establishing effective regulatory systems, the effectiveness of the
ban or of a moratorium could not be guaranteed either.
Page 21 / 55
Biosafety regulatory system
Regulations in force
Table 6. National Laws
Year Law Nº Comments
9.902 Organic Law of It sets forth the competencies of the MSP as national health
1934
MSP police, and as sanitary food police in particular.
9.463 Establishment of It sets forth the primary competency of the Ministry in the
1935
the MGAP agriculture and fishery area.
15.605 (Decree-Ley)
It sets forth the Institute’s competency for the proposal,
1984 Establishment of the
advisorship and execution of the National Meat Policy.
INAC
It sets forth the exclusive competency of the National Customs
1985 15.591.Customs Code Directorate in customs matters, including transit control, customs
police and the fulfilment of the international customs agreements.
It establishes this mixed integration institute and appoints the
16.065 Establishment of
1989 formulation and execution of agricultural research programs,
the INIA
participating in the R&D processes in this area.
16.112 Establishment of It sets forth the primary competency of the Ministry, through
1990
the MVOTMA DINAMA in the area of environmental protection .
1993 16. 408 CDB The Convention on Biological Diversity is adopted.
It declares the protection of the environment a matter of national
interest, it defines environmental impact and it prescribes the
1994 16.466 Environment
implementation of Environmental Impact Studies for certain
projects.
It establishes this mixed integration institute, granting
16.811 Establishment of competencies in the fields of development and control of the
1997
the INASE seeding activity and advisorship to the EP for the development of
a national seed and phytogenetical policy.
It singles out Uruguay as a Natural Country. It establishes the
17.283 General Law for Precaution Principle as fundamental for decision-making in
2000 the Protection of the environmental conflicts. It establishes the participation and the
Environment articulation in environmental management. It dictates punctual
considerations in reference to LMOs.
It sets forth the consumer’s basic rights and all the activities
17.250 Consumer’s
2000 related to the protection of health and safety, labelling criteria and
Defence
regulation of publicity.
17.942 Phytogenetic
The FAO Convention on phytogenetical resources for food and
2006 resources for food and
agriculture is adopted.
agriculture
It creates an individual traceability system for bovine cattle and
17.997 Animal
declares the System for Animal Identification and Registration of
2006 identification and
national interest to build the traceability of products of animal
registration system
origin within the national territory.
Page 22 / 55
Table 7. Decrees and Resolutions
Year Legal Instrument Comments
1993 Dec. 261/993 It establishes COTAMA.
It sets forth the competencies of DINARA in relation to
1997 Dec. 149/997
agriculture.
1999 Dec. 135/999 It regulates the handling of hospital waste.
It creates the CERV and sets forth the procedures for the
2000 Dec. 249/000 request for the authorisation of the use of vegetable LMOs in
different orbits.
It regulates the registration and operation of wild animal
2002 Dec. 186/002 MGAP (vertebrates) breeding facilities, within the sphere of
RENARE.
Min Res. n/nº 20/06/03 It authorises the production or the import of maize MON810
2003
(MEF-MGAP) for direct consumption or for transformation.
Min. Res. 236A/003 and It sets forth conditions for the introduction, use, production
2003
276/003 (consolidated text) and commercialisation of maize MON 810.
Min. Res. 290/004 (MEF- It authorises the production or import of maize Bt11 for direct
2004
MGAP) consumption or for transformation.
It sets forth conditions for the introduction, use, production
2004 Min. Res. 292/004
and commercialisation of maize Bt11.
It sets harmonised field and laboratory tolerance levels for
the production and commercialisation of seeds belonging to
2005 Dec. 05/05/05 (MGAP) the different certification categories (MERCOSUR). It
establishes 200m of exclusion for maize and 3m for
soybean.
It regulates the Environmental Impact Evaluation Law and
2005 Dec. 349/005
Environmental Authorisations
2005 Dec. 136/005 It creates the Ministerial Group for Innovation .
Min. Res. n/nº 17/08/06 It stops the use, production and commercialisation of the
2006
(MVOTMA) genetically modified sweet maize seed.
It establishes control, quality and safety regulations for the
2006 Dec. 160/006
transplant of human cells and tissues.
It sets forth the suspension of new requests for transgenic
vegetable events and it creates an Inter-Ministries Work
2007 Dec. 037/007
Group aimed at defining national policies in the field of
biotechnology.
Internal regulations
At present there are no regulations which specifically govern Research & Development
activities with LMOs. However, the different organisms and institutions related to national
biotechnology have internal regulations. These are guides, internal regulations or other
kinds of regulations drawn up to maintain biosafety levels at research laboratories. This is
the case of the Ordinance on the use of animals for university testing, teaching and
research. This ordinance was drawn up by the Honorary Committee for Animal Testing of
the University of the Republic. It establishes and standardises the use of animals for testing
and the facilities necessary for said aim. It also determines a protocol of applications for the
use of animals for testing, teaching and R&D, within the framework of the University of the
Page 23 / 55
Republic.
Furthermore, most of the laboratories where R&D in biotechnology is carried out, have
work guides which include, among other things, biosafety guidelines based on international
regulations, known as Good Laboratory Practices (GLP).
Proposals under study

• Access to Information Bill: The aim of this bill is to allow every legal or physical
person to have free access to the information of the national or departmental public
administration.
• Preliminary Draft La won Genetic Resources and the Traditional Knowledge
Associated (2006): It proposes the establishment of a National registry of traditional
knowledge and the implementation of mechanisms for the distribution of the benefits
derived from the use of Genetic Resources (GGRR).
• Sustainable Land Use and Development Bill (2006): It establishes the
competences and the planning, participation and action in this area and it designs
the instruments for the execution of the plans and territorial action.
Recommendations
1. Regulation System: It is necessary to have a clear Regulation System which can be
enforced no matter what the policy regarding LMOs shall be. The regulation system
must be adequate but it must be reliable from the risk assessment process to the
management of the coexistence with conventional productions.
2. Update of the regulations in force: the proposal for an NBF should include the
update of the regulations in force in the area of consumer's defence (Law Nº 17.250),
since it does not include the aspects related to biosafety.
3. Specific regulations: it is necessary to establish clear Biosafety regulations for the
processes which involve research with LMOs (said regulations should be different to
the one applicable to LMOs for commercial aims).
4. Regulation of the biomedical sector: by virtue of the scope given to NBF by the
NCC , it is necessary to fill the regulation vacuum in the biomedical area in terms of
LMO-derived products.
5. Articulation with other agreements subscribed: It is necessary to take into
consideration the international conventions signed by our country in relation to
commercial relations and para-tariff barriers (CDB, OMC, Codex Alimentarius, etc.).
Page 24 / 55
Decision-making system
Institutional procedures and competencies

With the establishment of the la Commission for the Assessment of the Risk of Genetically
Modified Vegetables (CERV) by Decree 249/000, the first legal competencias regarding
LMO authorisations are defined. The CERV operates as an advisory board, integrated by
representatives of the Ministry for Livestock, Agriculture and Fishieries (institution which
presides the Commission), the Ministry for Housing, Use of the Land and the Environment
(vicepresident), the Ministry for Public Health, the National Seeds Institute and the National
Institute for Agricultural Research. The Decree also establishes a series of levels of use
partially related to growing levels of exposure. Said levels appear listed below:
Table 8. Levels of use of Vegetable LMOs pursuant to the regulations in force

2
Par. Detail
A Experiments under contained use conditions
B Field tests and essays or under protection, under specific biosafety conditions.
C Assessment for the National Registry of Cultures
D Seed multiplication under specific biosafety conditions
E Import for direct consumption or transformation. Release into the environment.
The competent authorisations authorities as defined under the Decree are the MGAP and
the MEF for clause E and the General Directorate for Agricultural Services (DGSSAA) of
the MGAP or the INASE for the remaining clauses. The MSP and the MVOTMA may also
participate by virtue of their competencies pursuant to Laws Nº 9,292 (MSP) and Nº 16,112
and 17,283 (MVOTMA).
Table 9 describes the main institutions having specific competencies regarding LMOs for
the orbits defined by the NCC:
2
Inciso correspondiente del Art. 2 del Dec. 249/000
Page 25 / 55
Table 9. Competencies of the public sector
Human
Function Agricultural Industry R&D Environment
health
Definition of GMI, DICYT,
DINAMA
policies and MSP OPYPA MIEM University of
RENARE
regulations the Republic
MEC,
Decision-making DGSSAA,
MSP DNPI University of DINAMA
(resolution) RENARE
the Republic
FAGRO,
MSP, FCIEN,
ERA INASE - DINAMA
FMED FVET,
FQUIM, INIA
Information MSP, INASE, DNPI MEC, DICYT,
DINAMA
management FMED DIEA DNI ANII
Monitoring and
DIGESA INASE DNPI ANII DINAMA
Control
Procedures in force
Agricultural Production
The country has generated an explicit procedure in the area of agricultural production, as
per Decree 249/000. Said procedure regulates the authorisations for the use of vegetable
LMOs as set forth in Article 2 (see Table 8). The procedure in force is summarised in
Table 10.
Environment
DINAMA carries out Environmental Impact Studies (EIS) as its main measure to protect the
environment. Certain facilities require a Prior Environmental Authorisation (PEA) and some
specific proceedings to obtain said authorisation. The impact studies compare the
conditions priorto and after an action on the environment. Within the orbit of DINAMA there
are no specific procedures to study the impact of LMOs released into the environment.
Research + Development (R&D)

Regarding R&D with LMOs, there are no defined procedures, except for vegetable LMOs in
3
contained use . This situation constitutes one of the most important lacks identified by the
R&D WG.
Health
In the health sector, as well as in the R&D sector, there are no specific procedures
regarding LMOs. However, there are procedures for the assessment of toxicological risks
and food innocuousness, carried out by DIGESA. Likewise, the National Institute for the
Donation and Transplant of Cells, Tissues and Organs (INDT) is the organism responsible
of safeguarding the quality and safety of the procedures with biological material done in the
country and of controlling the import and export of the same, in reference to the handling of
stem and embryo cells.
3
Decree 249/000. Art. 2 par. a and b.
Page 26 / 55
Industry
At the industrial level, Uruguay has product certification procedures based on national and
international regulations. Imported products must go through a process to verify their
compliance with national bromatological regulations, in order to protect the consumer and
to make sure said products are apt from the sanitary point of view and labelled with
comprehensible, true and clear information. The LATU is responsible for controlling and
certifiyng manufactured products for export pursuant to the regulations under Decree
338/982. Notwithstanding the above, the situation regarding LMOs is not governed by any
industrial regulation.
Pursuant to the Customs Code in force since the year 1985, Law Nº 15,591, the National
Customs Directorate has the authority to run the corresponding tests on the goods
introduced into the Uruguayan territory, as a measure for sanitary prevention.
Page 27 / 55
Table 10. Procedure for the authorisation of vegetable LMOs, pursuant to Dec.
249/0004
4
Pursuant to the regulations under Decree 037/007 the treatment by CERV of new requests for vegetable LMOs is
interrupted. This means that only the requesting party may submit the form before CERV, waiting for the decision once
the period established in the Decree has ended.
Page 28 / 55
Information management
National environmental and territorial information systems
Law Nº 17,283 sets forth the adequate management of environmental information as a
Basic principle of the State’s environmental policy, so as to ensure its availability and easy
access for the interested parties. The management of information on LMOs is vital for an
adequate management and particularly for an efficient monitoring. It is necessary due to
the fact that this is a new technology, the risks of which have not yet been studied to their
full extent.
There is a group of information tools, some of which have a long-term effect, which provide
relevant data for decision-making regarding the release of LMOs into the environment. The
continuous existence of these databases and HRs qualified for the use thereof are a
positive precedent for the elaboration of an NBF. The following could be considered
examples of these systems: National Geographical Information System (FFAA), National
Registry of Cultures (INASE) or the Agricultural and Livestock Census (MGAP). Other tools
are being prepared, such as the Environmental Information System or the National
Protected Areas System (both belonging to the MVOTMA).
Maize database
The management of the maize events released in the country (MON810 and Bt11) is
governed by a group of ministerial resolutions which, among other things, require the
public registration of the transactions and the statement of the sowing of the respective
events. DINAMA is the competent authority for the reception of said forms. During the
implementation phase of Project URU-04-009 a database was built with the information
taken from the forms, which required hiring digitisers to process and enter the information.
This was done in order to generate a maize data registration program compatible with the
software used in DINAMA and with the databases of MVOTMA and MGAP.
Lepidoptera database
The maize events released in Uruguay contain the CryIAb protein, which has a specific
toxic action for Lepidoptera (moths and butterflies). The Project carried out a survey of the
human resources (research teams) and institutional resources (biological collections,
databases) in R&D on Lepidoptera (Martínez, 2006a). As a result of this survey and of the
interviews done to the experts in the area, the creation of a national Lepidoptera database
was proposed, which would allow for an adequate follow-up of the national biodiversity of
the group as well as for the elaboration of sustainable management strategies for the Bt
crops. The prototype for the database has already been prepared and it is currently at the
implementation stage.
R&D database
As a result of the inventory of the national biotechnological capabilities, (Pardo, 2006b)
databases were created following the R&D lines in biotechnology and the resources
destined in this area to human resources and institutional capabilities (Pardo, 2006a). This
information allowed us to make a diagnosis of the national situation in this area and to
identify the needs that the country should cover for the elaboration of an NBF.
Biosafety Clearing House
Page 29 / 55
This year Uruguay signed the Memorandum of Understanding to participate in the Project
for Capacity Building for an Effective Capacity of the Biosafety Clearing House (BCH).
5
BCH is an Internet Portal which contains all the information about LMOs and aspects
related to biosafety in the CP member and non-member countries (the latter must
communicate their interest in making their information public in said Portal to the SCDB).
Since Uruguay is a non-member country of the CP, it still has not submitted all the
information that this protocol demands. However, this new initiative means a step forward
towards the consolidation of a National Information System on Biosafety.
Risk assessment
General concepts
Risk Assessment is one of the three dimensions of a larger process called Risk Analysis
(RA), which is completed by Risk Management and Communication. These three
components are so deeply linked that only specialists can understand it.
Risk Assessment is defined as a process based upon a technical-scientific methodology
aimed at the determination and the characterisation of the risks a new substance, physical
factor or practice represents for a given population or environment. It is the technical-
scientific instance which serves as the basis for the further management and
communication stages. The Cartagena Protocol sets forth that Environmental Risk
Assessment (ERA) should be the methodology to be applied by the member countries,
prior to the release of an LMO (SCDB, 2000).
Risk Management is the process used to select an action strategy in response to an
already characterised risk. It is based upon the technical information obtained from the
assessment but it also involves social, legal, political and economic issues (Omenn et al.,
1996). Through Risk Management the society determines how the same shall be taken.
The decisions made may follow three ways (Hilbeck, Andow, 2004): (1) to tolerate the risk
as it is; (2) to live with it, elaborating mitigation measures, or (3) to avoid it.
Risk Communication is the Exchange of information and opinions all along the Risk
Analysis process. It includes information about the risks, related factors and the perception
of the same among the assessors, managers, consumers, industry, the academic
community and other parties involved. It also includes the explanation of the risk
assessment results and of the grounds for the decisions made regarding risk management
(FAO/WHO, 2005).
Intentional and unintentional release

Apart from intentionally released LMOs, the environment may receive them unintentionally.
The sources of unintentional LMOs are:
• Industrial effluents: An industry using LMOs in its processes could be eliminating them
through its effluents, particularly in the case of microorganisms. LMOs could also be
used for wastewater treatments and enter into the environment in this way.
• Accidental leaks of LMOs in confined use: This could happen due to a breach in the
biosafety protocols used by the facilities (laboratories, bioteria, greenhouses, breeding
5
http://bch.biodiv.org
Page 30 / 55
establishment, aquariums) or due to accidents during the transportation of said
organisms.
• Disposals: Recombinant proteins or even whole organisms could enter into the
environment without an adequate management of industrial wastes and research
laboratories.
• Deviation in the use: One of the sources of the unintentional entry of LMOs into the
environment is the deviation in the use, which could be defined as the accidental or
preconceived assignation of an unauthorised use of an LMO. The NCC discussed
widely the possibility that most of the maize imported for livestock feeds from Argentina
could be used for sowing, an aspect the control of which is not provided for in the
regulations in force.
Baseline for an ERA in Uruguay

Soybean Event WGS 40-3-2 (MON-Ø4Ø32-6):
• The possibility of hybridisation of transgenic soybean with weeds is almost null in our
country, due to the fact that there are no related wild species.
• The current transgenic soybean monoculture systems in our country present a high-risk
scenario for the appearance of glyphosate-resistant weed biotypes. This situation is
accentuated given the regional precedents.
• The extension of large monoculture areas, followed by the elimination of weeds with
herbicides, results in the disappearance of the vegetation used for mating and shelter by
many of the natural enemies of the soybean pests (Ribeiro, 2000). This generates a
recrudescence of the pests and the subsequent increase in the use of pesticides on the
crop.
Maize Events MON 810 and BT 11 (MON-ØØ81Ø-6 and SYN-BTØ11-1):

• There is enough evidence at present to think that events MON 810 and BT 11 are not
adequate for our pest matrix.
• The impact of the Bt events on biodiversity are difficult to assess in Uruguay because
there is no detailed information about the land invertebrates present in the receiving
environments.
• At the secondary consumers level, the information found suggests that the Insect
Resistance Management (IRM) strategy set forth by the regulations in force, which
establishes building shelters with a minimum 10% area, could be insufficient to fulfil the
assumptions of the model used.
• Further, this IRM strategy could be affecting the biological efficiency of some natural
enemies, having a long-term effect on the survival of their populations and on the
sustainability of the system.
• Likewise, the implementation of this measure could be having an impact on the dynamics
of the population of some ground invertebrates which are vital to the sustainability of the
national agro-ecosystems, such as earth worms. These data were revealed by the Project
as part of the information obtained alter the CERV authorisation.
Other LMOs:
Page 31 / 55
• There is a vacuum in the information about LMOs or their derivates used for other uses
(biomedicine, industry, etc.). It is deemed that the industry uses modified microorganisms
for industrial processes but there are no official records or the existing ones are
inaccessible. Regarding animals (invertebrates and vertebrates) knock out mice are used
for research. The records about these animals are not official and they correspond to the
University of the Republic through the Honorary Commission for Animal Experimentation.
Page 32 / 55
Administrative System Proposal
File recording
National Biosafety Agency (ANB)
All proceedings and requests regarding LMOs would be centralised at a single office, which
would receive all the requests for LMOs, depending on the area considered by the NCC for
all the levels of use. Said office should be supra ministerial, in order to allow for the
implementation of an articulated decision-making system at the operative level. Its
objectives would be as follows:
• to collect all the information necessary regarding the authorisation in order to initiate the
file,
• to submit the information for the corresponding person or people to study,
• to appoint the Technical Commission (specific for the treatment of LMOs) and to
control the working terms of the same,
• to publicise basic information about the requests: in this aim, the information under
study shall be free to access (except the information the company may deem
confidential) and a “desk” structure shall have to be created to receive requests and to
deliver the requested materials. Said desk should be located in the same office
receiving the requests.
The ANB should be created as an inter-institutional and multisectoral organism to coordinate
the biosafety policies and management. This proposal would be along the same line as
other recently-created agencies, such as the ANII, the National Housing Agency (ANV), or
the Agency for the Electronic Government, Information Society and Knowledge (AGESIC),
among others.
Table 11 shows the process for the authorisation of LMOs according to their use (production
or R&D). The treatment of the requests would go through different technical commissions,
depending on the nature and the destination of the LMO under study. Between the treatment
of the request by one commission and the other, the file would return to the ANB secretariat,
where it would be recorded and followed-up accordingly.
Page 33 / 55
Table 11. LMO authorisation process according to their destination
Page 34 / 55
Authorisation process for LMO requests for R&D
R&D Biosafety Commission:
Scope: exclusively those LMOs destined for R&D.
Members: specialists from the different institutions directly involved in R&D
Competencies:
• To receive the research authorisation requests and the notices of accidental release,
abnormal situations or the corresponding ones in case the LMO should manifest
undesired characteristics, from the abovementioned office in order to study them and to
express its technical opinion. Said opinion should be issued within a time period
coherent with the execution times of the research line, to the effect of allowing for their
normal development.
• To issue biosafety certificates and credentials to laboratories
• To generate and update their registries of LMOs and the laboratories which handle
them
• To elaborate Standard biosafety protocols for the laboratories (BPL)
• To elaborate import protocols for certain genotypes.
Likewise, this Commission would receive from the single office the notices of transportation
of LMOs (import and/or internal transportation), to the effect of notifying the competent
authority to carry out the corresponding control.
The administrative system proposed above shall also demand the creation of Internal
Biosafety Commissions at laboratories and institutions, which shall be responsible for
creating biosafety guidelines and internal control mechanisms, to guarantee and revise
research proposals, to identify risks and to formulate mitigation recommendations, to
elaborate contingency plans in case of accident, to register research projects, to inspect and
approve safety in laboratories.
It would also be convenient to create an Animal Ethics Committee, competent in all kinds of
research involving the manipulation of animals.
Process for the authorisation of LMO use requests for production uses
The file registered with the front desk at the ANB would be derived to the specific Technical
Assessment Commissions (Table 12) to be analysed. Said commissions would correspond
to the different areas of application of the LMOs, thus, they would be integrated by
technicians representing the competent Ministries and by duly qualified experts. The latter
could be included in an expert-certification system, authorised by the ANB itself. Depending
on the destination of the LMO under study, different subgroups of specialised technicians
should be activated (ERA, health, industry, economy, etc.) which, according to the case,
would receive the requests to express their technical opinion before the Ministerial Group on
Biosafety. This working scheme would speed up the dynamics of the technical commissions.
Each commission could, in turn, request advice and support through consultorships and/or
the assistance of national and international experts.
Page 35 / 55
Table 12. Authorisation process for LMOs for production.
Page 36 / 55
Environmental Risk Assessment Commission (CERA)
Scope: all such LMOs as the use of which shall entail any degree of environmental release.
Members: DINAMA would be the competent organism to house these activities. It would
also be integrated by experts of different research institutions, depending on the nature of
the LMO under study.
Competencies:
• To revise the authorisation file and to analyse the information sent by the requesting
party
• To grade the ERA and to express their technical opinion
• To report their decision to the ANB
A favourable ERA shall be a primary requirement for environmental release LMOs and the
continuation of the file shall be subject to the CERA’s opinion that all the necessary studies
have been run in order to duly characterise the risks and that the same are reasonably
tolerable or mitigable.
Agricultural Assessment Commission (CEAGRO):

Scope: all such LMOs as may be destined for animal food, veterinary or phytosanitary use,
as well as the agricultural exploitation such as culture or rodeo of any kind.
Members: technical representatives of MGAP, INASE, INAC, INIA, University of the
Republic and Producers.
Competencies:
• To study the authorisation requests
• To express their technical opinion related to socioeconomic, agronomic-productive
aspects, etc. before the ANB.
• Technical-economic feasibility in a coexistence framework.
Industry Assessment Commission (CEINDUSTRIA):

Scope: all such LMOs as may suffer any degree of industrial transformation or which are
part of industrial processes, released into the environment or not. Among those released
into the environment, there are those products designed for culture, biological control,
biomonitoring or bioremediation, pharmaceutical industry (medicines, hormones, regulation
factors, vaccines), food industry (probiotics, foods, enzymes, colouring agents, etc.), textile
industry (detergents, enzymes, colouring agents, modified fibres, etc.), agro veterinary
industry (feeds, hormones, growth factors, manure, vaccines, etc.).
Members: representatives of MIEM, MEF, INIA, LATU, University of the Republic, Industry
chambers and Consumers.
Competencies:
• To provide technical advice about the requests received by the front desk regarding
LMOs for industrial use, by means of a case-by-case study (this shall mean the creation
of subgroups to assess the different levels of application of the LMOs in industrial
activities, such as scientific and socio-economic aspects)
• To carry out case-by-case assessments for new LMO lines, strains, varieties, etc.,
setting defined terms for the issue of the technical opinion regarding the requests.
• To submit the technical opinions about the industrial use of LMOs to the ANB
Page 37 / 55
• To elaborate technical materials such as handbooks and industrial procedure guidelines
(Good Manufacturing Practices) to be submitted to the ANB
• To elaborate quality certification protocols taking into account both, the LMOs and the
industrial procedures
• To elaborate a Registration System for the LMOs used in Industries
• To authorise laboratories and companies through a Certification System
• To carry out a retrospective assessment of the national situation regarding the LMOs
that are being used in the industry at present (upon new evidence showing potential
risks). In the event of a possible reconversion in the industrial sector or changes in
some of the proceedings, it shall be fundamental not to hinder industrial development.
In such sense, reasonable time frames should be proposed.
This commission shall be able to receive technical support from institutions or organisations
which carry out specific consultancies (for instance: LATU, Customs, University of the
Republic, INIA, DINAMA or Consumer’s Defence).
As well as for the case of the laboratories which manipulate LMOs, those companies using
LMOs shall have to create at least one commission responsible for: setting biosafety
regulations, controlling them, identifying existing risks, elaborating mitigation plans, keeping
a written record of the kind of LMO used or produced and running internal inspections.
Health Assessment Commission (CESALUD)

Scope: LMOs or parts of the same destined for human food, biomedical use (vaccines,
hormones, regulation factors, antibiotics and other medicines, xenotransplants) and
cosmetic products.
Members: MSP, INDT, University of the Republic, Laboratories and Consumers.
Competencies:
• To study the LMO requests the use of which shall affect human health to some extent
• To submit its technical opinion to the ANB
Political decision stage

Ministerial Group on Biosafety (GMB)
The GMB would be responsible in the last resort to make a decision regarding the request.
In said aim, it would make a decision based on the report submitted by the corresponding
CETs and taking into account all the aspects of the macro policy. This Group would be
integrated by, at least, the Ministries which might be directly involved. The regulation
framework shall define which Ministry will be in charge of coordinating the Gropu. it is
suggested that, at the time of defining this role, the competencies of each Ministry, the
controls carried out by them and the resources they count on, be taken into consideration.
The GMB shall be responsible for defining the biosafety policies in all the areas of
application of the LMOs.
Public consultation
A public consultation shall be made in order to assess the convenience or not of the
authorisation of the LMOs. The ANB shall adapt the dossier to be submitted to the interested
parties for consultation, it shall also set the date and place of the call and carry out all the
logistics activities it shall require. Pursuant to the regulations in force, said consultations are
Page 38 / 55
compulsory for all the vegetable events released into the environment for production aims,
for human consumption or for industrial transformation.
Assignment of responsibilities
• The requesting party pays: All requests entail expenses which must be paid by the
requesting party. These expenses cover, among other things, the possibility of hiring
specialists to run specific studies and/or tests. The evaluations of the performance of
a given event (evaluations at the experimental field level) could be funded in whole
or in part by the seed industries which request the authorisation of the event.
• The requesting party provides the basic information for the ERA: Said
information shall have to be in Spanish and it shall be submitted in hard copy and in
digital format.
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Recommendations
1. Environmental Authority: We suggest that DINAMA preside the CERA.
The seat for this commission should be the Biodiversity and Protected
Areas Division, for it has human resources qualified in these areas.
Furthermore, having CERA in this division would favour a more efficient
articulation with the activities of the CDB, the BCH and the SNAP.
2. Agricultural Authority: CE AGRO should be presided by the MGAP
through its general directorates (especially DGSSAA, RENARE, DGSG)
3. Health Authority: DIGESA should preside the CE SALUD and consider
the possibility of including the LMO variable in the procedures for the
toxicological and innocuity evaluation of foods, cosmetic products and
biomedical products.
4. Due to the exclusiveness of its aims and functions, the National Customs
Directorate is the institution in charge of controlling the transboundary
transit of LMOs. This is why it should be adequate to integrate an NBF,
including the regulations in force.
5. The INASE should have to broaden its present competencies regarding
biosafety, in the sense of incorporating the biotechnological and non-
biotechnological options into the present process for the assessment of
cultures. Likewise, it should coordinate training sessions with the National
Customs Directorate, in the areas of control and monitoring of the
transboundary transit of LMO seeds.
6. LATU should incorporate the “transgenic-free” category for technological
products into its present Certification System, as well as creating a
Labelling System for the same. These actions would lead to the
generation of a traceability system and also to gain easier access to very
demanding markets.
7. We recommend the articulation of the diverse information tools to the
effect of strengthening a National Environmental Information System. This
system shall be vital in all the scenarios it shall be applicable to.
8. If the country were to prevent the transit of LMOs in the environment, it
should have an information tool to let it know what LMOs are released in
the different countries. The BCH, a mechanism for the exchange of
information among the parties to the Cartagena Protocol could be a
source of said information but it would not be enough, since the non-
member countries have no obligation to provide any information.
9. There should be an LMO registration system. Such a registry should
allow for the elaboration of an inventory of LMOs and of laboratories
working with these organisms. It would be ideal that they implemented
systems for the regular update of this information.
10. The knowledge about Risk Analysis and Environmental Risk Assessment
in particular should be strengthened.
Page 40 / 55
11. Criteria for the certification of the qualified personnel to implement the
ERA should be set.
12. A validity date for the ERAs should be stipulated, as well as establishing
a priori mechanisms for case revision.
13. The convenience of analysing the effectiveness of a vegetable LMO with
insecticide genes for the control of our pest matrix should be discussed
prior to its release. The relevance of such a study shall depend on the way
the country shall assume the cost of a possible failure of the implemented
technological package and it constitutes a political decision tool,
connected to management but separated from the ERA.
14. Regarding invertebrates, the dynamics of their population and the rapid
succession of their generational cycles compromise the control of the
populations released into the environment. Not releasing fertile organism
could be an efficient measure of precaution.
15. The levels of containment of LMOs should be established and described.
There is already a level criterion for vegetables under Dec. 249/000 but
there are none for other organisms. The competence in terms of the
authorisations for each level could vary, according to a scheme similar to
the one under Dec. 249/000.
16. It is recommended not to authorise the release of organisms which have
Uruguay as primary or secondary centre of origin.
17. The release of vegetable organisms modified modified with TRUGS or
Terminator should not be authorised.
18. The ERA should not only take LMOs into consideration, but also the whole
of the technological package that they imply. By way of example: an ERA
of the event soybean WGS 40-3-2, apart from the internal characteristics
of this event, should consider the risk of the use of glyphosates and of the
extensive monoculture in direct sowing with no rotation, since these two
management strategies are directly associated to this event.
19. It would be convenient to define restricted areas for the production of
LMOs, since they present an acknowledged genetic diversity in all the
country. The territory could be classified in units, according to
environmental and productive characteristics and differential levels of
exclusion could be established for the release of LMOs.
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Monitoring and control
Monitoring
Environmental monitoring has been deficient in our country. In spite of this, some initiatives
are being launched aimed at changing this situation.
Under the CP, each country shall create and maintain adequate mechanisms, measures
and strategies for the regulation, management and control of the risks associated with the
use, handling and transboundary movement of LMO6. The General Law for the Protection
of the Environment (Nº 17.283) establishes prevention and prevision as priority criteria for
7
environmental management .
Due to its status as exporter of raw materials from the agricultural sector, Uruguay has
implemented a boundary control system in order to preserve the sanitary conditions of its
crops and livestock. In this sense, MGAP is implementing a sanitary barrier system which
bans the entry of products and subproducts of animal and vegetable origin into the country,
with the exception of those which are formally imported. Other measures have also been
implemented to manage the risks derived from those activities which might have a negative
impact on the integrity of the environment. Some of them are directly related to biosafety.
Table 13. Measures for the management of risks associated to LMOs.

Integrated weed The resowing of sensitive biotypes of the potentially resistant species
management is being considered as a management measure.
Insect resistance Ministerial Resolutions 236A/003, 276/003 and 292/004 regulate the
management conditions for sowing maize Bt. They establish measures for the
management of the risk of resistance in these crops, through the
strategy of shelters, establishing a minimum area of 10% of the
culture. The INASE is the institution in charge of enforcing these
decisions. The CUS is the organism in charge of implementing the
Program for the Management of Resistance in Insects (as per
Ministerial Resolution s/nº 20 dated June, 2003), and the INASE is
the institution in charge of controlling the program.
Seed traceability system The seeds of the events of transgenic maize must be packed in
adequately labelled containers which show the full name of the event.
The INASE is the institution in charge of enforcing this regulation.
The Consumer’s Defence Law regulates the management of
information about consumer products. Among other things, it sets
forth that publicity which, by omitting information might lead the
consumer to have a wrong idea of the nature of a product, shall be
considered misleading publicity.
6
PC art. 16.
7
Law Nº 17.283 Art 6º par. B
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Control
INASE has the competence to control the adequate identification (labelling) of the
transgenic maize seed containers as well as to control the IRM Program, under the
8
Ministerial Resolutions corresponding to the maize events MON 810 and BT 11. The
existence of such an institute is a strategic advantage for the country in terms of the
capacity for registration, monitoring and control.
The National Customs Directorate and the DGSSAA are the organisms responsible for the
control of the transboundary movement of animals, vegetables and their derivates.
Recommendations
1. Monitoring protocols of the released LMOs should be created. The same should be
more intense in the first years of the release.
2. The country is in condition to gradually implement individual traceability systems for
all the animal species released into the rodeo. In this aim, all LMOs released as
cattle should have individual traceability systems as a compulsory requisite for their
authorisation.
3. We recommend the monitoring of the entries of vegetable or animal components
for feeds and to control the right destination of vegetable events, in order to prevent
deviation of their use.
4. The generation of qualified HUMAN RESOURCES for transgenic cultures in the
country should be considered.
5. The NBF should be adjusted to the control of transboundary movements. The
National Customs Directorate is the responsible organism in this area, this is why
its capacity should be strengthened, both from the point of view of the infrastructure
and the HUMAN RESOURCES and it should be adapted to the particular demands
of the LMOs.
6. It is necessary to control the entry of LMOs or other kinds of biological materials to
be used for R&D into the country.
7. The DGSSAA, in its capacity as organism in charge of controlling the entry into the
country of animals, vegetables and their derivates, should adjust its procedures for
LMOs.
8. Inter and intra institutional coordination for monitoring and control should be
enhanced.
9. Due to the appearance of herbicide-resistant and tolerant weeds, some countries
have created Weed Resistance Committees in charge of preventing, detecting,
managing and training people in the area. Our country should have an organism
with similar aims.
10. Adequate planning of the expansion of the soybean monoculture is required to the
effect of minimising the dangers that the reduction of the spatial heterogeneity and
of the fragmentation of the habitats entails. It is recommended to consider the
46
Min. Res. n/nº 20/06/03. (MEF-MGAP). Authorises the import or the production of maize event MON810 for direct
consumption or for transformation; Min. Res. 290/004 (MEF-MGAP). Authorises the import or the production of
maize event Bt11 for direct consumption or for transformation
Page 43 / 55
connectivity of the protected areas, through the control of the protected areas, by
controlling the use of the land in this kind of facilities. This action should favour the
exchange of information between the National System for Protected Areas and the
stakeholders associated to agricultural exploitation (MGAP, Rural Associations,
Industrial chambers, etc.).
11. There should be a defined traceability system for LMOs destined for productive
use, to the effect of centralising all the information available on the products,
guaranteeing the certainty of their origin and background, as well as to have
access to specific markets.
12. Labelling the products as “transgenic-free” should be considered.
13. The ANB should be competent to manage policies in the area of industrial biosafety
industrial, to control and monitor as necessary.
14. The biosafety certificates for companies and industrial procedures should be
governed by a control and control program acknowledged by the ANB.
15. The creation of a system for the registration and declaration of LMOs used in the
internal industry should be considered.
16. A certification system should be created to credit the laboratories and/or institutions
to work with LMOs under certain biosafety rules and criteria.
17. The authorisations to release LMOs into the environment and for research lines
should be part of an adequate follow-up and control program.
18. The control of the unintentional release of LMOs into the environment, be it due to
a leak, an accident or disposal, should be carefully considered. This situation
should be considered in any proposal for an NBF, through the creation of a
National Mitigation Plan. This plan should define the role of the competent
authorities in this area, action and communication mechanisms and penalties in
case of failure to comply.
19. It is also recommended to implement strategies to monitor and control industrial
effluents for those industries using LMOs in their processes or for wastewater
treatment.
20. The NBF should establish procedures for the elimination or the disposal of LMOs or
parts thereof, as well as establishing penalties in case of failure to comply.
21. Development of territorial location and traceability of individual organisms
mechanisms should be encouraged.
22. There are different certification protocols (organic meat, natural meat, etc.) which
pose different demands for the content of the feeds. It is recommendable to include
aspects referring to LMO-derived feeds among the elements to be regulated in a
coexistence scenario.
23. In an LMO-free country scenario:
a. The institutional capacity of the controlling authorities should be
strengthened. This would imply training the technical personnel, having
access to new LMO-detection technologies, implementing programs to
control and monitor productive activities.
Page 44 / 55
b. An emergency plan should be prepared in case a claim were filed for the
release of LMOs into the environment. Said plan should include
quarantine and analysis protocols, fine mechanisms, among others.
c. The institutional capacities for control should be reinforced as a necessary
and inevitable requirement to fulfil the regulations in relation to LMOs.
d. The current situation of the vegetable events released at present
(soybean WGS 40-3-2, maize MON810 and maize Bt 11) should be
reverted. This should be done in stages, in no less than 5 seasons. This
reconversion period would mean elaborating a follow-up plan for the
converted areas in order to prevent unintentional LMO growths.
e. The technical staff should be trained for the detection of LMOs for live
organisms or the parts of the same, which are entered into the country.
The quarantine systems implemented at present should take into account
the presence of LMOs or parts of the same in the products which are
brought into the country, in the case of reproductive or embryo structures
in particular. This situation would demand capacity building within the
National Customs Directorate.
f. It should be determined which institutions shall be responsible of applying
the controls to ensure the non presence of LMOs in the country.
g. Should a partial limitation be determined regarding the use (for example to
authorise the use of LMOs for research) the same should be made
explicitly and it should also state which institutions would be responsible
for running the corresponding controls.
h. It would be necessary to determine a dynamic mechanism to receive
claims related to the breach of the biosafety regulations in force and to
derive the same to the organisms designed to act in such sense.
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Mechanisms for participation and access to information
Access to information
A public opinion survey was carried out within the context of the Project (Table 13). Said
study included the general public, professionals, producers, press and politicians, as shown
in the table below. The following were the most outstanding results:
• Lack of information: The information handled by the different target groups was
deficient, with some exceptions. There is no information in the media, it is not
managed by professionals, neither is it discussed at the commissions of Parliament.
• Limited information: Reference to agriculture and animals was made in all cases
but there was reference to other areas of use such as industry or medicine.
• Hope: There is an idea that the use of LMOs in agriculture increases productivity
and that it will reduce hunger in the world.
• Concerns: Fear of the unknown appears at all levels. There is concern about the
LMOs harming human health or the environment.
Table 13. Public opinion survey about LMOs
Target public Findings
General public High level of distrust and rejection of LMOs; most people associate them
(Survey, 933 cases) with food and vegetables.
There is little discussion of the subject and scarce attention is paid.
Producers Lack of information and the regulations in force are almost completely
(Survey, 200 cases) unknown. 41 % think the State is responsible for the lack of information
among the population.
LMOs are deemed to be totally favourable by the producers who use them
and somehow negative by the remaining percentage.
Those who do not sow LMOs do not use them due to lack of information or
because they deem them harmful.
Professionals in the They express an interest in the subject, even if they think there is little talk
biology area, not about it.
specialised in LMOs They know transgenic maize and soybean, even if they associate
(Survey, 200 cases) transgenics to other vegetables. They have no knowledge of the regulations
in force or they have a bad opinion thereof.
Agronomist are the main referents for professionals to answer questions in
these areas.
Main positive aspect of using LMOs for production: increased productivity
Main negative aspect: they hinder tourism and the image of a natural
country, closing markets and creating dependence from multinational
companies.
Members of Parliament They have no knowledge about the topic, the regulations or the genetic
(In-depth interviews, 15 manipulation process. The information available to the public is not enough,
cases) they think that the existing information is not neutral.
The subject is not dealt with frequently at the Legislative Power
commissions.
Positive elements of LMOs: they increase production, they reduce hunger in
the world
Negative elements: harm to the environment, unknown effects.
Journalists They have more information but they do not know about the areas sown or
(In-depth interviews, 15 the names of the events.
cases) They share the opinion that there is no information, neither at the reach of
the public opinion, nor at the reach of the journalists.
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Challenges
There is a digital gap in Uruguay’s territorial context. Digital Gap refers to the difference
there is between the States or the layers of the population in terms of their access to
information tools and instruments and their ability to use them (ALADI, 2003) . Even though
almost half of the population of the capital city uses computers frequently, in towns with less
than 5,000 inhabitants and in rural areas, less than a quarter of the population has used a
computer in the last six months (Pittaluga, Sienra, 2007). If we take into account that most of
the information on LMOs, biotechnology and biosafety is transmitted through digital media,
bridging the digital gap is of vital importance to guarantee adequate access to this
information by the civil society and rural producers in particular.
The National Telecommunications Administration (ANTEL) has been developing a project
called “Uruguay: Information Society” since 2002. The aim of this Project is to contribute to
bridge the digital gap, particularly for those citizens living in the provinces. Since then, 25
Access Centres to the Information Society (CASI) have been created in small towns in the
provinces. They are community centres with Internet access sponsored by ANTEL and
operated by public or private counterparts which provide public access to computers and to
the Internet, as well as computer training for free or at a very low cost. Uruguay’s Digital
Agenda for 2007-2008 plans to continue implementing the CASI within the national territory
(Rivoir, Ríos, 2007), which constitutes a positive indicator to achieve this challenge.
Another problem which was repeatedly mentioned by the NCC stakeholders, hired
consultants and even members of the government, was the resistance of some sectors of
the State to provide information. Different strategies have been put into practise in the last
decade, aimed at improving the situation.
National Committee for the Information Society was created in 2000, under Dec. 225/000,
aimed at opening the discussion about a national policy for the development of an
Information Society in the country, in terms of the technological literacy for the population
and the modernisation of the public administration. In 2005 the Agency for the Electronic
9
Government, Information Society and Knowledge (AGESIC) was established and it entered
into force on the 12th September, 2007. The AGESIC impulses the generation of “single
office” systems which serve as portals to access files and proceedings, such as the one
proposed for this present decision-making system.
In compliance with the development of the aims proposed by the EP in relation to the
information society, a Bill for the Access to Public Information and Information Protection
was presented in Parliament, establishing the right of physical and legal persons to request,
have access to and receive information from any organ of the national or departmental
public administration. This right includes the freedom to have access to the information
contained in written or photographic documents in magnetic, digital or any other format, as
well as the power of making requests.
9
Law Nº 17,930 National Budget, Art. 72 and Law Nº 18,046 Annual accounts, Art. 54
Page 47 / 55
Public participation
Trans-sector commissions
There are several commissions working at ministry level at present. A clear example of the
same is the Technical Advisory Commission for the Protection of the Environment
(COTAMA), created by a Decree10, which makes different sorts of decisions and which
advises the MVOTMA and the Executive Power about environmental issues. The COTAMA
is integrated by several different actors of the political system, academics, industrial and
company chambers, rural producers, workers’ unions and environmental NGOs, thus being
an important precedent in the area of co-management at State level.
Public consultation
Public consultation has been a mechanism used for decision-making in the environmental
area, directly related to the assessment of environmental impact11, 12, 13.
The regulations in force make it compulsory for the competent authority to hold public
14
information sessions and to consult the public prior to releasing vegetable LMOs into the
environment. Said sessions must be called upon the expiry of the term established for the
interested parties to examine the corresponding file.
10
Dec. 261/993. Se constituye la Comisión Técnica Asesora de la Protección del Medio Ambiente y se
fijan sus cometidos
11
Ley Nº 17.283 Art. 7º inc. E
12
Ley Nº 16.466 Art. 14
13
Dec. 349/005 Art. 16
14
Dec. 249/000 art. 8
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Recommendations
1. The creation of institutionalised consultation opportunities which advise the EP in
relation to the implementation of a national biosafety policy. These opportunities
should ensure clear access to the information in order to guarantee an informed
participation.
2. There should be information about the origin of the products or about the contents
of the same.
3. It is recommendable to have a national inventory of LMOs for industrial use. said
inventory would be created and updated by CEINDUSTRIA.
4. It is necessary to ensure the public’s adequate access to environmental
information. This information should include the descriptive and technical aspects
related to the environment, as well as the regulations which correspond to their
regulation. The tendency of some sectors of the State not to allow public access to
the national databases is a problem that should be treated as a priority.
5. In the search for an adequate management of the information on the biosafety of
the biotechnology, the inclusion of these topics in the formal education curricula
should be analysed.
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References
ALADI (2003) La brecha digital y sus repercusiones en los países miembros de la ALADI, pp. 1-194.
ALADI - Latin-American Integration Association
Altieri M (2005) The Myth of coexistence: why transgenic crops are not compatible with agroecologically
based systems of production. Bulletin of Science, Technology & Society 25, 361-371.
CERV (2002) Documento sobre la release a producción y comercialización del event MON 810 de
maize. Commission for the Assessment of the Risk of Genetically Modified Vegetables,
Montevideo.
Damgaard C, Løkke H (2001) A critique of the "concept of familiarity" as used in ecological risk
assessments of genetically modified plants. Bio Safety Journal 6.
Facultad de Agronomía (2002) Informe sobre la release comercial del event MON 810. Maize-Bt
(transgénico). pp. 1-6. Facultad de Agronomía, Montevideo.
FAGRO (2005) Guía práctica Nº 11 Curso de genética., Montevideo.
FAO/OMS (2005) Comisión del Codex Alimentarius. Manual de Procedimiento., 15 edn., Roma.
Hernández A, Murguía JM, Rodríguez N, Vasallo M (2001) Survey sobre el uso de transgenic soybean
en el Uruguay. Departamento de CCSS. Facultad de Agronomía. University of the Republic.,
Montevideo.
Hilbeck A, Andow DA (2004) A Case Study of Bt Maize in Kenya. In: Environmental Risk Assessment of
Genetically Modified Organisms eds. Kapuscinski AR, Schei PJ), p. xviii+283. CABI
International, Wallingford, UK.
INASE (2006) Actualización Registro Cultivos de Verano. In: Boletín Nº 94.
Martínez G (2006a) Lepidoptera de Uruguay. Relevamiento de human resources e institucionales., pp.
1-14. Project Desarrollo del National Biosafety Framework DINAMA-PNUMA-GEF,
Montevideo.
Martínez G (2006b) Maize Bt en Uruguay: Elementos para una Risk Assessment Ambientales, pp. 1-45.
Project Desarrollo del National Biosafety Framework. DINAMA-PNUMA-GEF, Montevideo.
MGAP (2005) Evolución del GDP. Ministry for Livestock, Agriculture and Fisheries. Dirección de
Estadísticas Agropecuarias, Montevideo.
Monsanto (2002) Evaluación de la seguridad de la soybean Roundup Ready, Event 40-3-2. In:
Cuaderno Técnico (ed. Monsanto). Monsanto Company.
OECD (1993) Safety Evaluation of Foods Derived by Modern Biotechnology. Concepts and principles,
pp. 1-74. Organisation for Economic Co-operation and Development.
OECD (2002) OECD guidance for the designation of a unique identifier for transgenic plants. In: Series
on Harmonization of Regulatory Ovesight in Biotechnology Nº 23, pp. 1-12. Organisation for
Economic Co-operation and Development, Paris.
Omenn GS, Kessler AC, Anderson NT, et al. (1996) Risk Assessment and Risk Management in
Regulatory Decision-Making. Commission on Risk Assessment and Risk Management.
Pardo MF (2006a) Aportes al inventario de human resources biotecnológicos, pp. 1-66. Project
Desarrollo del National Biosafety Framework DINAMA-PNUMA-GEF, Montevideo.
Pardo MF (2006b) Inventario de las capacidades en Research + Development (R&D) en Biotechnology,
pp. 1-85. Project Desarrollo del National Biosafety Framework DINAMA-PNUMA-GEF,
Montevideo.
Pittaluga L, Sienra M (2007) Utilización de las Tecnologías de la Información y las Comunicaciones en
el Uruguay. In: Survey National de Hogares Ampliada. Módulo de TIC. Segundo Trimestre de
2006. (ed. INE), pp. 1-30. Instituto National de Estadística, Montevideo.
Ribeiro A (2000) Manejo de insectos plaga. In: Manejo de Plagas en pasturas y cultivos. INIA. Serie
Técnica nº 112 (eds. Zerbino MS, Ribeiro A), pp. 1-12.
Rivoir AL, Ríos MD (2007) Recomendaciones de objetivos y metas para la Agenda Digital Uruguay
2007-2008 para la Sociedad de la Información y del Conocimiento, pp. 1-14. AGESIC -
Agency for the Electronic Government, Information Society and Knowledge. Presidencia de la
República, Montevideo.
SCDB (1993) Convenio sobre la Biological diversity: texto. SCDB (Secretaría del Convenio sobre la
Biological diversity).
SCDB (2000) Cartagena Protocol sobre Biotechnological Safety del Convenio sobre la Biological
diversity: texto y anexos. SCDB (Secretaría del Convenio sobre la Biological diversity).
Montreal.
Page 50 / 55
Annexes
I. PROJECT URU-04-009 TEAM
National Coordinator • Agronomist (PhD) Marcos Frommel

Technical Assistants • Agronomist Mª Fernanda Pardo
• MSc. Gonzalo Martínez Crosa
Executive Secretary • Graciela Arrambillety
II. MEMBERS OF THE NCC
• Asociación Civil Uruguaya para la Protección de los Obtentores Vegetales (URUPOV)

• Asociación de Producers Orgánicos del Uruguay (APODU)
• Asociación National de NGO (ANNGO)
• Asociación Rural del Uruguay (ARU)
• Asociación Uruguaya de Empresas de Biotechnology (AUDEBIO)
• Asociación Uruguaya de Producers pro Sowing Directa (AUSID)
• Cámara de Comercio de Productos Agroquímicos (CAMAGRO)
• Cámara Uruguaya de Semillas (CUS)
• Comisión National de Fomento Rural (CNFR)
• Confederación Uruguaya de Entidades Cooperativas (CAF – CUDECOOP)
• CNGOreso de Ediles
• CNGOreso de Intendentes
• Consumers Uruguayos Asociados (CUA)
• Cooperativas Agrarias Federadas (CAF)
• Dirección General de Recursos Naturales Renovables (RENARE)
• General Directorate for Agricultural Services (DGSSAA)
• Dirección National de Environment (DINAMA)
• Facultad de Veterinaria (FVET– University of the Republic)
• Federación Rural del Uruguay (FRU)
• Instituto de Investigaciones Biológicas Clemente Estable (IIBCE)
• Instituto National de Carnes (INAC)
• Instituto National de Research Agropecuaria (INIA)
• Instituto National de Semillas (INASE)
• Instituto Pasteur de Montevideo (IPMont)
• Laboratorio Tecnológico del Uruguay (LATU)
• Mesa Tecnológica de Oleaginosos (MTO)
• Ministry de Economía y Finanzas (MEF)
• Ministry de Relaciones Exteriores (MRREE)
• Ministry de Salud Pública (MSP)
• Ministry for Housing, Use of the Land and the Environment (MVOTMA)
• Oficina de Planeamiento y Políticas Agropecuarias (OPYPA)
• Red de Acción en Plaguicidas y sus Alternativas para América Latina, Filial Uruguay (RAP- AL)
• Red de NGO ambientalistas
• Red Temática de Environment (RETEMA- University of the Republic)
• Redes Amigos de la Tierra
• Unión International de Trabajadores de la Alimentación (UITA)
Page 51 / 55
III. GLOSSARY OF TERMS RELATED TO BIOTECHNOLOGY
BIOSAFETY
Accident: Any incident implying a significant or involuntary release of an LMO during its confined use or
its specific use, which might mean an immediate or a long-term danger and risks for human health,
the environment and biological diversity.
Bacillus thuringiensis: Common soil bacteria which produces insecticide proteins. Some of its genes
have been incorporated into several vegetable species with modern biotechnological techniques. Two
of these genetically modified cultures are planted at present In Uruguay: maize Mon 810 and maize
Bt11.
Bioinformatics: Scientific discipline which places its interest in all the aspects related to the acquisition,
processing, distribution, analysis and interpretation of biological information, through the application
of mathematical, biological and computational techniques and tools, in the aim of understanding the
biological meaning of a great variety of data. Eg.: Genetic Internet libraries.
Biological diversity: Variability of living organisms of any origin including, among other things, land
and sea ecosystems as well as other water ecosystems and the ecologic complexes they integrate. It
covers the diversity within each species, between species and ecosystems.
Bioreactor: Live organism used to produce some kind of substance. Genetically modified bacteria have
been used to produce human proteins (insulin, clotting factor) and at present research is being done
for the incorporation in fish and in the milk of cows and other mammals.
Biosafety Clearing House (BCH): Information-exchange mechanism created under the Cartagena
Protocol to provide assistance to the parties for the application of the relevant regulations and to
facilitate the exchange of information an expertise in relation to LMOs. http://bch.biodiv.org/
Biosafety Clearing-House (BCH): Centre for the exchange of information on Biotechnological Safety.
Biosafety: Policies, rules and procedures adopted in order to guarantee an adequate protection of the
population’s health and safety, a maximum respect for human dignity and the protection of the
environment, facilitating the development of activities or businesses connected to biotechnology, as
well as the right to the information of consumers and citizens.
Biotechnology: Technique which uses living cells, tissue cultures or molecules derived from an
organism to obtain or modify a product, to improve a plant or animal or to develop a microorganism to
be used for a specific aim.
Cartagena Protocol: International instrument created to guarantee an adequate level of protection in
terms of the safe transfer, handling and use of the living organisms which result from modern
biotechnology and which might have adverse effects on the conservation and the sustainable use of
biological diversity, taking into account the risks for human health, with a specific focus on
transboundary movements.
Case by case: The CP sets forth that the ERA must be done “case by case”, that is to say, that each
event in the biotechnological transformation must be assessed for each organism in particular and for
each receiving environment. The case-by-case criterion is the one set forth by the regulations in
force.
Classical biotechnology: An area of biotechnology which exploits already existing organisms for
technological purposes.
Coexistence: Status in which different primary production systems such as organic production,
conventional farming and farming with LMOs are simultaneously or adjacently used without having a
significant impact on one another, thanks to specific management measures (Altieri, 2005).
Confined use: Any operation carried out inside a closed facility or physical structure, which implise the
manipulation of LMOs controlled by specific measures which limit their contact with the outside ot
their effects on the environment in an effective manner.
Deviation of use: Random or preconcieved assignation of an unauthorised use of an LMO.
Donor: Organism or cell from which the DNA inserted into a genetically modified organism comes.
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Expression: Process through which the information codified in a gene gives way to the synthesis of a
protein. It is said that a gene expresses itself when it is transcribed into ARNm and into protein. This
entails the manifestation of the characteristic specified by said gene in the phenotype.
Familiarity: The concept of familiarity was invoked during the first years in which commercial transgenic
vegetables were released. It is based upon the affirmation that there are no relevant differences
between a culture obtained through genetic engineering and its conventional counterparts in terms of
environmental performance. Based on this criterion, an LMO could be released upon the basis of the
information gathered about its conventional counterparts or other events of similar characteristics
(that is to say, the degree of familiarity with the LMO). In Uruguay, the familiarity criterion was quoted
as part of the process for the approval of maize Bt 11. This criterion has been thoroughly criticised for
not having a scientific basis and many authors deem it to be opposed to the precaution criterion.
Fusion gene: A gene which codifies a product of interest with an element which will regulate its
expression in the guest.
Gene: DNA sequence which constitutes the functional unit for the transmission of hereditary
characteristics. Said sequence contains specific information for the synthesis of a structural protein or
an enzyme, or which regulates its transcription. Genes are located in the chromosomes, where they
occupy a certain position called locus.
Genome: The entire set of genes of an individual or a species, contained in a haploid set of
chromosomes.
Genomics: Research area which studies the complete genomes of the live organisms and which aims
at understanding the structure, the function and the evolution of the genes in order to find answers to
fundamental biological concerns.
Genotype: An individual’s genetic load. An individual's set of genes, including their allelic composition.
Glyphosate: (N-phosphonomethyl glycine) Systemic, post-emergent and non-selective herbicide widely
used for weed control.
Insert: DNA sequence constituted by the fusion gene, the selection marker (should there be one) and
the respective promoting and termination sequences which are transferred to the receiving organism.
Isogenic: Variedad de cultivo de origen similar a una variedad genéticamente modificada pero que no
contiene el event.
Knock Out: Replacement of an active gene with an inactive version, through modern biotechnology
techniques, generating the cease of the expression of said gene. Knock out techniques are used to
study the function of certain genes in a given organism. The use of these techniques has also been
proponed for the elimination of allergenic proteins in some foods for human consumption. There are
laboratory knock out varieties of soybean.
Living Modified Organism (LMO): Any living organism which has a new combination of genetic
material obtained through the application of modern biotechnology.
Risk Management: Group of processes which lead to the presentation of alternative scenarios for
decisión-making regarding a given risk, once the corresponding risk assessment has been run. these
decisions may be aimed at preventing, mitigating or tolerating the risk, depending on environmental,
social, cultural, political and economic variables, among others.
Selection marker: Gene introduced together with the fusion gene and which makes a lethal substance
to the hosting cell or tissue more resistant. It allows for the selection of transformed cells in an LMO
which has undergone a transformation event, since the cells and organisms which have not been
transformed, die.
Modern biotechnology: It is the use of in vitro nucleic acid techniques, including recombinant
deoxyribonucleic acid (DNA) and the direct injection of nucleic acid in cells or organelles, or the
fusion beyond the taxonomic family, which exceeds the natural physiological barriers to reproduction
or recombination and which are not techniques used in traditional reproduction and selection.
Receiving Organism: The one which receives DNA through artificial procedures
Phenotype: The outward manifestation of the genotype of a given environment. The phenotype of an
individual organism is any biochemical or physiological characteristic or a specific physical trait (for
example: the amount of a given nutrient contained in a vegetable).
Page 53 / 55
Precaution principle: Environmental ethical guideline. A possible definition would be that when an
activity should mean a threat to human health or to the environment, precautionary measures should
be taken, even when some of the cause-effect relations have not been clearly established.
Proteomics: Area of research which tries to identify and characterise a complete group of proteins and
the interaction of the same in a given species.
Recombinant DNA: Process which implies the extraction of a DNA segment from an organism, to
manipulate it and to introduce it into a new organism. It is one of the main techniques used by
modern biotechnology, originally aimed at studying genic expression.
Trophic Web: Group of relationships between the food chains of a biological community, representing
the flor of energy and matter which runs through an ecosystem. It describes the routes that the solar
energy takes in any ecosystem. The trophic web is formed by the different trophic levels.
Research & Development (R&D): Systematic creative work aimed at increasing the volume of
knowledge and the use of the same to create new applications. It includes basic research, applied
and experimental research.
Resistance: 1. Hereditary capability of some biotypes of a weed population to survive and breed after
having been exponed to a dose of herbicide to which the population is originally sensitive. 2.
Hereditary capacity of some individuals of a population of pest insects to survive and breed after the
application of an insecticide.
Risks: Probability for an adverse event, problem or damage and the consequences of the same.
Off-target risks: Possible impacts of a transgenic culture beyond the aims for which it was created. It
usually refers to the impacts on the biological diversity, the structures and composition of the
communities, flows of energy and matter in the ecosystems and the dynamic structure of the trophic
webs.
Risk Analysis: Methodological tool used for the assessment, measurement and prevention of
undesired events related to LMOs, which may affect people and the environment. It involves several
stages: risk assessment, risk management and risk communication.
Risk assessment: Within Risk Analysis, group of methodological instruments used to identify dangers
to the health or to the environment and to characterise the associated risk, measuring the exposure
to danger and to the intensity of its effects.
Step by step: Step by step implies stages of increased environmental exposure for which authorisation
requires different studies. A higher exposure level shall require further studies. The step-by-step
concept is implied in Dec. 249/000, due to the creation of fields of application which need to be
studied by the different competent institutions.
Substantial equivalence: The assessment of the LMOs used for animal and human food is based
upon the concept of substantial equivalence (SE). This concept was introduced in 1993 by the
Organisation for Economic Co-operation and Development (OECD) and adopted by the FAO and the
WHO since 1996. It is based upon the idea that an existing organism used for food or as the basis for
the elaboration of foods may be used for comparison against a modified food, in the aim of assessing
its safety for human consumption. The comparison is made in terms of its composition, nutritional
characteristics, toxin and allergen content, among other properties. If the modified food is equivalent
to the organism it was compared against (called traditional counterpart or traditional homologue) it
does not pose new risks, thus being acceptable for human consumption. The application of this
concept considers that the traditional counterpart is inocuous to human health, based upon a safe
use history, even if some may contain natural toxins or antinutritional substances (OECD, 1993). The
use of the SE criterion has been a source of disagreements among the scientific commmunity, for
many authors doubt its validity.
Sustainable development: Economic development which guarantees the recovery of the resource
exploited and of the ecological conditions of the same. The Brundtland Commission definió el
sustainable development como “development that meets the needs of the present without
compromising the ability of future generations to meet their own needs”.
Target species: In Bt cultures, it is applicable to those kind of insects which constitute the aim of the
insecticide proteins. They are species sensitive to the toxins contained in these vegetables.
Traceability: 1. Property of the result of one measure or of the value of a standard in which the latter
may be related through specified references, usually national or international standard, through an
ongoing chain of comparisons, all with specified uncertainties” (International Standards Organisation,
Page 54 / 55
ISO).2. The capability to follow the trace of the LMOs and their derivates along the production and
distribution chains at all their commercialisation phases” ( European Parliament and the European
Union Council).
Genetic Transfer: Dispersion of the genes incorporated into an LMO to a non-modified population of
the same species or sexually compatible species, by sexual contact. It also includes horizontal
transfer to procaryotes.
Horizontal gene transfer (HGT): Flow of genetic information from a procaryote organism by means of
a transformation mechanism.
Transformation event : Action of modifying an organism of a given species through an insert.
Transgene: Gene installed in an organism of a different species than that in which it naturally exists, by
means of modern biotechnology techniques.
Transgenesis or Transgenia: Processes which allow to transfer a gene into a receiving organism
which may generally pass it on to its descendants. This technique allows for the association of genes
which do not exist in nature, breaking the species and even the kingdom barriers.
Transgenic foods: Those obtained directly from an LMO (corn), which contains LMO derivates (soy
lecithin) or in the production of which LMOs were used (transgenic yeasts).
Transgenic: Organism which contains genes which come from another species, introduced through
modern biotechnological techniques.
Vector: Self-replicating agent used to transfer DNA from a donor to a receiving organism.
Page 55 / 55

Propuesta de Marco Nacional de Bioseguridad para Uruguay

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Propuesta de Marco Nacional de Bioseguridad para Uruguay

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PROPOSAL FOR A NATIONAL

BIOSAFETY FRAMEWORK FOR

Architect Mariano Arana

VICE MINISTER FOR HOUSING, USE OF THE LAND AND THE

Architect Jaime Igorra

NATIONAL DIRECTOR FOR THE ENVIRONMENT

Agronomist Alicia Torres

PREPARED BY: MSc. Gonzalo Martínez Crosa

The publication of a work implies the achievement of a degree

During the last two years, a technical team worked

Scientific, technological, biological, environmental,

The knowledge and the different points of view on the issue

However, it was possible to bring all the institutions, both

It was possible to take the fundamental step that we needed

There are no unanimous criteria. We knew this would be the

We thought this would be a starting point, that it was

And today, we are fortunately able to open this work to

Agronomist Alicia Torres. National Director for the

Biosafety regulatory system ..........................................................................................22

Decision-making system ................................................................................................25

Monitoring and control .................................................................................................42

Mechanisms for participation and access to information.............................................46

Table 1: Technical sheet for Project URU-04-009

Start date November 2004

Date of submission of the

Closing date December 2007

Initially, two scenarios were considered:

Maize Event MON 810 (MON-ØØ81Ø-6)

White Clover Event ipt:atmyb32

The Cartagena Protocol

Positions and recommendations

Proposals under study

Institutional procedures and competencies

Table 8. Levels of use of Vegetable LMOs pursuant to the regulations in force

Research + Development (R&D)

Biosafety Clearing House

Intentional and unintentional release

Baseline for an ERA in Uruguay

Maize Events MON 810 and BT 11 (MON-ØØ81Ø-6 and SYN-BTØ11-1):

Agricultural Assessment Commission (CEAGRO):

Industry Assessment Commission (CEINDUSTRIA):

Health Assessment Commission (CESALUD)

Political decision stage

Table 13. Measures for the management of risks associated to LMOs.

I. PROJECT URU-04-009 TEAM

National Coordinator • Agronomist (PhD) Marcos Frommel

II. MEMBERS OF THE NCC

• Asociación Civil Uruguaya para la Protección de los Obtentores Vegetales (URUPOV)

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