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THE STATE OF

GMO’SRESEARCH IN BULGARIA
PROF. ATANAS ATANASSOV

‘Challenges of food safety and sanitary safety in


Candidate Countries’
4 – 5 November 2005, Bulgaria
BULGARIAN AGRICULTURE
 The oldest and still the most effective economic sector;
 40% of the land is an arable land, suitable for:

 Intensive agriculture – biotechnology base;


 Organic (ecological) farming;
 Seed production;
 Unique production – wine, grape, tobacco, vegetables,
fruits, essential oil crops, herbs, etc.
 The land is fully privately owned;
 The marketing of the land is expecting to occur in the next
one-two years.
BULGARIAN AGRICULTURAL SCIENCE
 Natural Center for Agricultural Science:

 At present 26 institutes – 4300 persons;


 The number is expected to be diminished twice in
course of the next few years;
 No private institutions yet;
 First contracts with the private sector;
 30 to 90% of the arable land still is occupied with
varieties and hybrids produced in this country;
 Sunflower hybrid Albena averagely occupies more
than 30% of the sunflower fields in France in course
of twelve years.
WHY PLANT BIOTECHNOLOGY IN BULGARIA
• Continental climate (Very cold winter and very hot summer). Every
year losses range from 20 to 60%;
• Climatic and soil variations from region to region, giving rise to a
large variation of diseases and pests; Every year losses range
from 15 to 50%;
• Plant biotechnology is the most suitable alternative,
complementing the drawbacks of traditional plant breeding
programs, which are rather labor intensive and time consuming:
 Diminishing the genetic erosion (at present narrow genetic germplasm);
 Preservation of genetic germplasm;
 To enhance the genetic variability;
 Low environmental impact and sustainable development;
 New quality, new products;
 Improve the efficiency of the breeding programs.
HOW PLANT BIOTECHNOLOGY IS ORGANIZED IN BULGARIA
ABI (IGE) - Kostinbrod
I. Methodological laboratories II. Tissue culture laboratories in Bulgarian III. Scientific – applied
breeding institutes laboratories
  
1. Doubroudja Institute of 1. Institute of Horticulture and Canned 1. ABI, Dept. of flowers,
Agriculture, G. Toshevo Foods, Plovdiv Negovan

2. Institute of Genetics, Sofia 2. Institute of Fruticulture, Plovdiv 2. Institute of Fruticulture,


Plovdiv
3. Institute of Plant and 3. Institute of Agriculture, Shumen 3. Institute of Horticulture
Genetic Resources, Sadovo and Canned Foods,
Plovdiv
4. Institute of Agriculture, Kjustendil

5. Institute of Viticulture and Vine


Production, Pleven
6. Institute of Forage Crops, Pleven

7. Institute of Maize, Kneja


8. Institute of Mountain Animal
Husbandry and Agriculture, Trojan

9. Institute of Plant Protection, Kostinbrod

10. Institute of Agriculture and Seed


Science “Obraszov chiflik”, Russe
STRUCTURAL UNITS OF ABI
MINISTRY OF AGRICULTURE AND FORESTRY
NATIONAL CENTRE OF AGRICULTURAL SCIENCE (NCAS)

AGROBIOINSTITUTE
GENETIC ENGINEERING TECHNOLOGY
(New Breeding Assisted Methods)
Tissue Culture + Molecular Genetics
I. Creation of new agronomically valuable variation (CNAVV)
Introduced
Induced Regeneration
•Embryorescue;
•Cell selection and mutagenesis; •Gametophytic = n
•In vitro fertilization;
•Somatic and gametoclonal variation; •Somatic = 2n
•Somatic fusion;
•Insertional mutagenesis;
•Gene isolation, cloning,
•Gene tagging
II. Invitro clonal micropropagation
transfer, expression and
regulation
•Meristem or/and shoots cultures
•Somatic embryogenesis (direct and indirect)
III.Analysis, estimation, detection and selection of NAVV
•Imunodiagnostics;
•Isoenzyme and +proteins
•Cytology – Giemsa, Cytoflowmetry, in situ hybridization;
•DNA markers – PELP, RAPD, AFLPs, SSRs, etc.
IV.Storage – low temperature, cryoreservation
•Cell culture, somatic embryos, meristems;
•DNA in plasmids and/or bacteria
Breeding new varieties
BULGARIAN CENTER OF EXCELLENCE IN PLANT BIOTECHNOLOGY
to the EUROPEAN UNION

Norman Borlaug Center Sub Regional ICGEB


NB PSR-DMU GMO Center of UNEP Global Consortium

Foreign Universities MINISTRY OF AGRICULTURE AND FORESTRY Breeding


Research Institutes NATIONAL CENTER FOR AGRICULTURAL SCIENCE Institutes
International AgroBioInstitute
Research Centers
International Consultative Council
> 50 agreement
Joint Contract Joint Bulgarian
Projects Research Ventures Universities
International
RESEARCH AREAS
Public Funding
Genetic resources – in vitro gene bank Public and
EU, NATO Functional Genetics
ICGEB, IAEA Biotic and abiotic stress Governmental
Ecology – GMP, biocontrol Organizations
Bioinformatics
Intellectual rights
Private Business Accredited laboratories – genetic authenticity, Bulgarian
phytosanitary status, quality Private Business
Multinational companies
AgroBioTech Park
SME SME
FUNDING OF ABI
80
70 national public sources
60
50 contracts with Bulgarian
companies
40
funds from international
30 projects
20 contracts with
10 international companies
0 donations
1985- 1992- 1998- 2000- 2001-
1991 1997 1999 2001 2002
WHAT IS THE PRESENT SITUATION
OF GMP
Farmers are choosing to plant more biotech crops each year
 8.25 million farmers Annual Hectares Planted (million) 81

 17 countries
20% increase over 2003 68
 Equivalent to 385 million 59
cumulative hectares in 2004 53
44
40
% Biotech
28
Crop Global
Soybeans 56 11

Cotton 28 2

Canola 19
9 6 97 98 99 00 01 02 03 04
Corn 14 19 1 9 1 9 1 9 2 0 2 0 2 0 2 0 2 0

Source: ISAAA
WHAT IS THE PRESENT SITUATION OF GMP
17 countries planted biotech crops in 2004 – benefits drive adoption

Spain Germany Romania India


Canada 0.1M Ha (13) <50k Ha (17) 0.1M Ha (11) 0.5M Ha (7) China
5.4M Ha (3) 3.7M Ha (5)
Canola Corn Corn Soybean Cotton
Corn, Soybean Cotton

USA Philippines
47.6M Ha (1) 0.1M Ha (14)
Soybean, Corn
Cotton, Canola Corn

Mexico Australia
0.1M Ha (12) 0.2M Ha (10)
Cotton
Soybean Cotton

Honduras Brazil
<50k Ha (16) 5.0M Ha (4)

Corn Soybean

Columbia Argentina Uruguay Paraguay South Africa


<50k Ha (15) 16.2M Ha (2) 0.3M Ha (9) 1.2M Ha (6) 0.5M Ha (8)
Soybean Soybean
Cotton Corn, Cotton Corn Soybean Cotton, Soy

Source: James, C. ISAAA, 2004.


WHAT IS THE PRESENT SITUATION OF GMP
Crop productivity gains preserve natural land & biodiversity

Global Crop Production & Cropland


(9 Year Period: 1995-2004)
 If no yield increase from 1995-2004:
+400 million cropland acres would
Prod: +21% Land: +2%
have been required
2.334
 Equivalent to:
1.931 2.077 2.122
 Total US or Chinese cropland

USA
China
1995 2004 1995 2004
Primary Crop Cropland
Production (Billion acres)  Or, 25% of Amazon rainforest
(Billion MT)

Source: CIA World Factbook & USDA/ERS


WHAT IS THE PRESENT SITUATION OF GMP
Commitment to safety is the top priority through R&D
process

Product Gene Crop Line Variety Seed Sales &


Concept Discovery Transformation Selection Development Production Market

Safety assessment Testing and Comprehensive Continuous QC


of genes / proteins selection of lines regulatory review protocols, audits
 Choice of genes
and varieties  Food
and standards
 Source of genes  Equivalence  Feed  Quality
 Ecology  Agronomics  Environment  Purity
 Efficacy  Performance
INTERNATIONAL PRODUCTION
AND TRADE IN GM PRODUCTS

Number of Producing Number of


states countries’ importers of
production GM share of global products
products exports (%)
Maize 8 85 168
Soybeans 6 88 114
Canola 2 50 68
Flax 2 81 74
Potato 4 12 177
Tomato 5 54 140
BIOTECHNOLOGY AND SEED WILL
DRIVE GROWTH
$ Billion 40

$5.1B
35
$2.6B Biotech Seed
CAGR ‘00-’04
Conventional  Biotech Seed +18.3%
 Total 4.5%
Seed
30

CAGR ‘00-’04
Crop Chem
25
 Herbicides (0.4)%
 Insecticides (0.3)%
 Fungicides +0.8%
20
'95 '00 '04
Crop Chem. Conventional Seed Biotech Seed

Source:
Source: Phillips
PhillipsMcDougall
McDougall
OVERALL IMPACT OF
BIOTECHNOLOGY
FIELD TRIALS IN EUROPE

release trials in Europe


number of release trials

3000 2529
2328
2500 2155
2099
2000 1 665 1548
1334 1147
1500 852 1036
1000 377
500 66 207
1 3
0

9 0 9 2 9 4 9 6 9 8 0 0 0 2 0 4
19 19 19 19 19 20 20 20

release trials in Europe


CULTIVATION OF GMP
GM MAIZE IN SPAIN
• In 2004, insect-resistant Bt-maize varieties are being
cultivated on 40,000ha in Spain (8% of the country’s total
maize area)
GM SOYBEAN IN ROMANIA
• GM soybean have been cultivated in Romania since 1999,
the total area in 2003 being 35,000ha equivalent to about half
of Romania’s soybean area.
EXPERIMENTAL CULTIVATION IN GERMANY
• Just under 30 farms in seven of the federal states are taking
part in experimental cultivation in 2004. GM Bt-maize has
been cultivated over about 300ha since May.
15 YEARS OF SAFELY RESEARCH IN
EUROPE: NO HAZARD FROM GM CROPS
THE EU RESEARCH REPORT:

• A European Research Report of November 2001 drew up a clear balance


of European safety research – over the last 15 years, 400 workgroups
with a budget of 70 million EURO have carried through 80 different
projects. Light was thrown on the wide range of ecological interactions
between GMOs and the environment.

• It emerged that investigated GMOs and the foodstuffs produced from them
are at least equally safe for humans, animals and the environment as
conventional plants and products. In a number of cases it is possible
that GMO products are even safer as aresult of the strict controls (EU
Commission, 2001). Theses findings have been confirmed in a large
number of other national and international research projects.
PREREQUISITE
Romania and Bulgaria are facing full
membership in EC in year 2007
– CAP reform
– Life science and biotechnology - A strategy for
Europe
– Technology Platform “Plants for the Future”
– European Research Area Network (ERA-NET)
initiative – for example Plant Genomics
– European Commission proposal for the 7th
Research Framework program
SCIENTIFIC ACHIEVEMENTS OF ABI
Plant Species Clonal Genetic Genetic Germpla New
and number of micropropagation (DNA) improuvement(cellul sm varieti
lines/varieties and virus markers ar and molecular preserva es
included diagnostics approaches) tion

Crops
Forage:
Alfalfa - 12 +++ + +++ +++ +++
Cereals:
Barley - 8 - +++ ++ +++ -

Wheat - 5 - ++ + +++ -
Maize - 5 - + ++ +++ -

Technical crops
Tobacco - 14 +++ +++(CMS) +++ +++ +++
Sunflower
Varieties - 6 + ++(CMS) - - -
Wild spp.- 3 +++ ++(CMS) ++ ++ -
Potato - 3 +++ - + +++ -
Sugarbeet –3 +++ - ++ ++ -
Flax - 5 ++ - + ++ +
SCIENTIFIC ACHIEVEMENTS OF ABI
Sustainable crops
Grapes
Rootstocks 7. +++ + +++ +++ -
Wine var.-10. +++ + ++ +++ -
Table var - 10 +++ + +++ +++ -
Apples:
Rootstocks 7. +++ - ++ +++ -
Table var.-8. +++ - + +++ -
Strawberries-20 +++ - + +++ -
Vegetable Crops:
Tomatoes- 3 +++ ++(CMS) +++ +++ +++

Ornamental
species: + + +++ +++
Roses-14. +++ - +++ +++ +++
Carnation-13 +++ - ++ - +++
Others +++ + ++
- +++
Medicinal
species and +++ - - +++ -
herbs-18.
WHO IS ABI - GENETICALLY ENGINEERED
PLANT PRODUCTS
Plant Nr.of cultivars New valuable traits Nr. of genes
species introduced
Tobacco 14 Bulgarian • Resistance to viruses 4
3 USA cultivars • Resistance to herbicides 3
• Resistance to bacterial pathogens 1
• Resistance to heavy metals 1
• Tolerance to abiotic stress 1
Tomato 1 Bulgarian cultivar • Resistance to viruses 2

Alfalfa 3 Bulgarian cultivars • Nodule like structures formation 1


2 American cultivars • Changes lignin structure + 1
improved digestibility

Carnation 2 cultivars • Change in petal color 2

Grape 1 Bulgarian • Resistance to viruses 2


3 France cultivars • Resistance to bacterial pathogens 1
3 Rootstocks • Cold resistance 1

Maize 1 Bulgarian cultivar •Resistance to herbicides 1

Barley 1 Bulgarian cultivar • Resistance to herbicides 1

Apple 1 cultivar Granny Smith •Changes in the habitus 3


1 rootstock M26 Resistance to diseases
WHO IS ABI - GENETICALLY ENGINEERED
PLANT PRODUCTS
Plant species Nr.of cultivars New valuable traits Nr. of genes
introduced

Potato • Bt resistance

Corn 1 Bulgarian • Resistance to 1


herbicide Basta

Rose 2 Bulgarian • Changes in growth; 11


1 German shape of flowers; long 11
vase life; resistance to
Basta
Plum 1 Bulgarian • Marker gene GUS

Strawberry 1 American • Resistance to 2


1 Dutch pathogenic bacteria
1 Asian with antibacterial
peptide gene
• Marker gene GUS
2
WHY BULGARIAN GENETICALLY ENGINEERED
PRODUCTS ARE NOT YET COMMERCIALIZED?

• IPR’s problem;
• Financial constrains in inability to pay fees in
local and foreign legal and biosafety
organizations;
• No clear state policy yet;
• Controversial policy of Europe in the area of
plant biotechnology.
WHY BIOSAFETY IN BULGARIA?

• Since 1994 - worldwide commercialization of


the transgenic plants;

• Since 1991 – transgenic tobacco, alfalfa and


tomato are tested in small field trials in
Bulgaria;

• Since 1998 – the first application forms from


the private sector.
THE ROLE OF ABI IN BIOSAFETY

• 1996 - First regulation of GMPP in the CEEC


• 1999 - Sub-regional Center for Biosafety
• 2002 – Chairmanship of the CEE Steering
committee for Biosafety
• 1996 - First regulation of GMPP in the CEEC
• Active participation in the preparation of Bulgarian
GMO law
• Leading role in plant biotech R&D. Recently ABI
has been selected as Plant Biotech Center of
Excellence from EC with highest grade (50/50)
among all countries and competitors
COUNCIL FOR BIOSAFETY OF
GENETICALLY MODIFIED HIGHER PLANTS
• Chairman is the Minister of Agriculture and Forestry
• Secretary – Distinguished Scientist

Members:
• Under the Ministry of Agriculture and Forestry functions:
• National Service for Plant Protection – pests and plant diseases
• Executive Agency for Approbation and Seed Control - approves new plant varieties

Under the Ministry of Environment and Waters


• Executive Environmental Agency

Under the Ministry of Health Care function:


• Central Hygiene Epidemiological Inspection - controlling the safe production and
distribution of foods

Academic sector
• National Center for Agricultural Science - AgroBioInstitute
HOW THE SYSTEM IS ORGANISED?
Procedure for applying and approval of GMHP
Issue of Application

CBGMHP - Consideration

1st year small field trials Rejection Request of additional


information

Large scale field trials – up to 5 years (performed by the applicant)


The Council keeps files with following data: Technology manuals;
Order, place; Distance to other fields; Storage; Sales.
The trials are supervised by four expert commissions in the frame of
the Council: herbology; entomology, food safety and field control.

Every year the Council reviews the results and considers the
next step

Approval Rejection
EXPERT COMMISSIONS

 Commission on herbology:
- Agronomic traits;
- Cross-pollination /gene transfer/;
- Soil microorganisms;

 Commission on entomology:
- Target organisms;
- Non-target organisms;

 Commission on food safety:


- Safety of expressed protein;
- Compositional analyses;
- Toxicity and Alergenicity assessment;

 Independent commission for Council’s activities control


WHAT APPLICATIONS WERE SUBMITTED
/1998-2001/
• Corn
– Companies: Novartis – 1, HiBred Pioneer – 16, Monsanto – 4
– Traits: Herbicide resistant, Bt

• Potato
– Company: Monsanto – 1
– Traits: Bt/ New Leaf

• Sunflower
– Company: Pioneer – 1
– Traits: Fungal tolerance

• Tobacco
– Company: Vector tobacco – 1
– Traits: Reduced level of nicotine
AREAS PLANTED WITH GM CROPS /1999-
2002/
• 1999: 130 000 dka (maize)
• 2000: 190 000 dka (maize)
• 2001: 64 000 dka (maize)
• 2002: 22 000 dka (maize)
• 2003: 22 195 dka (maize)
GEF/UNEP PROJECTS

• GEF/UNEP Pilot Enabling Biosafety Activity Project /1998-


1999/ National Biosafety Framework for Bulgaria was
elaborated under UNEP/GEF Pilot Enabling Project

• GEF/UNEP Implementing project “Support for the


Implementation of National Biosafety Frameworks in
Bulgaria” /2002-2005/ 11 countries all over the world have
been selected.
GMO DRAFT LAW

• Prepared under the UNEP/GEF Project

• Based on all relevant EU directives –


2001/18/EC, 90/219/EC and its amendments and
the Cartagena Protocol for Biosafety.
EU – THE WORLD’S MOST
INNOVATIVE REGION?
• NATIONAL REGULATION AS BLOCKADE.
BULGARIAN CASE:
• With relevance to co-existence, it goes much beyond the EU
biosafety framework and particularly the EC recommendation on
guidelines for co-existence as of July 2003 that states ‘No form of
agriculture, be it conventional, organic or agriculture using
genetically modified organisms (GMOs), should be excluded in the
European Union’, by putting a ban on:

– Carrying on research that involves genetic modification with specific plant


species: tobacco, vine, and oil rose;
– Deliberate release into the environment and placing on the market of
tobacco, vine, cotton, damask rose, wheat, and all vegetable and orchard
crops;
– Applying GMO-based farming ‘if organic farming is practiced on an adjoining
field’
– The deliberate release of any GMOs into the areas included in the National
Ecological Network, as well as into the adjoining areas within a zone of 30
kilometres around any such areas.
HOW TO PROCEED – A WEAK SITUATION
OF BULGARIAN AGRICULTURE
• Some of foreign agricultural products
dominate in the Bulgarian market;
• The contribution of Bulgarian agriculture in the
GNP is 14% (twice less than in 1988);
• Globalization – the danger foreign varieties to
dominate entirely;
• The modern varieties and hybrids are private
sector’s owning;
• Poor financing – no any subsidies.
HOW TO PROCEED - WHAT TO DO?
• Clear state policy and strategy – priorities;
• The place of modern plant biotechnology. The
genomic program is a priority;
• Technology transfer – active dialogue with
private sector (ecological and genetic
balance?!);
• 6th FP of EC;
• High Tech Parks (business incubators);
• Biosafety regulations in place; public
education and public perception.
WHAT IS THE FUTURE? STRATEGIC CHALLENGES & INITIATIVES: RESEARCH
TOPICS & APPLICATIONS
Present and new options for research and Development in ABI Scheme 2
Platforms
Elite •Biodiversity
Germplasm
•Weed Disease and
Breeding Pest Management
Seed products •Abiotic stress
Molecular
Seeds
DNA Markers tolerance
Breeding •Feed Quality
•Food Quality
With

•Crop productability New Traits


•Plant proteins
Gene sequencing Trait Development •Phytopharmacultures
Genes Plant Biotechnology
Genomics •Heterozis
•Biomass Better
Functional Genomics
Plant Transformation •Color Quality in Variety
ornamentals
•Phytoremidiation
Faster
•Biosafety

Healthy
Elite Gene Banks Nurseries
Diagnosis and
Propagation Or and
Fingerprinting genetically Farmers
Plant Material
Certified Accredited Laboratory
Authentic
material
CONCLUSION
“I use this to point out the nonsense of those who oppose
biotechnology. Mother Nature does the same thing. The debate
over genetically modified food crops needs to end’ Norman Borlaug
said. He said he resents activists who campaign against
biotechnology in Third World countries, creating unwarranted fear
and skepticism. “Most of them have never produced a kilo of food,”
he noted. Speak out on benefits.

“I have a dream that someday, we will be able to transfer rice’s


immunity to rusts to other cereals, such as wheat, maize, sorghum
and barley,” he said. “I also envision the transfer of bread wheat’s
protein to other cereals, especially rice and maize. In moving in this
direction, wonderful things are starting to happen.”