TWL PF-2009 GMO's TERMS of REFERENCE

TWINNING LIGHT PROJECT FICHE

BASIC INFORMATION

1.1 CRIS and Twinning Number:BG 2007/019-303.07.03.17, BG/2007/IB/AG/06/UE/TWL

1.2 Title: Building-up administrative capacity of the Executive Agency for Variety

Testing, Field Inspection and Seed Control for GMO control ofseed and

propagating materialmoving on the EU and the International market

1.3 Location: Bulgaria

BACKGROUND

Agriculture is an important branch of the national economy of Republic ofBulgaria. It creates a considerable share of the domestic product of the country. The Seed sector plays a significant role in the Agriculture of Bulgaria. The seed is the bearer of the genetic and biological potential of each variety and a well-structured selection of varieties and highquality seedsused in seed production have a positive impact on the productivity in agriculture. Seed controland in particular GMO control is a prerequisite for the movement of certain specific agricultural and animal products across the territory of the European Community under contained conditions.GMO control is specifically required for the purpose of providing protection of the plants and the environment from hazardous factors thusensuring safety forthe lives and health of human beings and animals. The European Union continues to be a region where the commercial cultivation of GM crops is very limited. In addition, probably some of the strictest regulations in the World regarding traceability and labelling of GM products have been adopted in this region. As a MemberState of the Community Bulgaria is committed to enforce and implement the regulations adopted in this field and to undertake effective measures for monitoring of GMO content in seed.

Being an external border of the European Union Republic of Bulgaria has established well structured and efficient border pointsand internal control systems, including sufficient laboratory and testing capacity, in order to enforce official control schemes with respect to GMO release in the environment.

The Bulgarian law designates the Executive Agency forVariety Testing, Field Inspection and Seed Control within the Ministry of Agriculture and Food as the official body responsible for the internal control of GMO contentin seed and propagating material.

Aspecialised Laboratory for GMO control has been established at the premises of the EAVTFISC. The laboratory has been equipped under a Phare project with an up-date laboratory apparatus (Real Time PCR) for conducting quantitative and qualitative analyses on DNA level of seed samples from the varieties placed on the market. This is a part of the National seed certification scheme which ensures the movement of high quality seed on the domestic and on the international market.

The project aims to support the efforts of EAVTFISC to implement the GMO control in compliance with EU requirements and practices. Ensuring conformity with the EU validated testing methods and practices and efficient functioning of the established GMO laboratory to carry out the relevant analyses by well-trained experts is a vital necessity. There is also a necessity of training the Agency’s staff involved in the variety testing of candidate-varieties and in field inspection activities forGMO controlof the marketed seed lots subject to certification.

Completion of the proposed project will build up the administrative capacity of EAVTFISCfor carrying out an effective control of the GMO at the border inspection points which as part of the entire phytosanitary control is a prerequisite for achieving compliance with the EU regulations relating to monitoring of GMOsin seed.This is an important step towards meeting the criteria of the society in this sensible field – to receive adequate information regarding the measures undertaken for control and limitation of the contamination and protection of the environment for the present and future generations and for protection of human health, for conservation of the genetic diversity according to the bio-geographical characteristics of the country.

The strengthened administrative capacity creates prerequisites for EAVTFISC to be recognized asa reliable factor in the efforts of the European Community directed to protection of the environment and to be better-integrated in the European structures.

DESCRIPTION OF THE ASSIGNMENT

3.1Beneficiary

3.1.1. The ExecutiveAgency for Variety Testing, Field Inspection and Seed Control (EAVTFISC) was established at the end of 1999. It is the official controlling body of the Ministry of Agriculture and Food(MAF) in the seed sector responsible for the enforcement of the Law on Seed and Propagating Material (LSPM),published in State Gazette No.20/04.03 2003,last amended in SG 97/01.12.2006and for the enforcement of the Law on Protection of New Plant Varieties and Animal Breeds (LPNPVAB), published in State Gazette No.84 of 04.10.1996, last amended in SG No.36/2008.EAVTFISCis also responsible for the adoption and enforcement of the EU legislation in this field.

EAVTFISCis structured into Administrative and Financial Management Directorate and 3 specialised Directorates (“Variety Testing” Directorate, “Field Inspection and Seed Control” Directorate and “Central Laboratory” Directorate).

The testing of plant varieties is carried out by 12 Regional Trial Stations all part of a testing network throughout Bulgaria and 14 Regional Stations that are involved in the seed testing and certification services, executing the controlling functions of the Agency pursuant to the LSPM and the LPNPVAB. EAVTFISC conducts field trials for DUS testing (distinctness, uniformity and stability) and VCU testing (value for cultivation and use) in compliance with the UPOV and CPVO Rules.

Republic ofBulgaria is a UPOV member since 1998 with the ratification of the 1991 UPOV Convention. Being the official controlling body of MAF the Agency is the only state institution entitled to carry out DUS testing according to the UPOV and CPVO Rules related to the legal protection of plant varieties (Plant Breeder’s Rights).

The Central Laboratory of EAVTFISC is the only ISTA accredited Laboratory in Bulgaria. The seed control and certification procedures also require accurate seed testing and proper evaluation results for the seed moving in home and international trade.

The control of GMO (seeds, foods and feed) is in the competence of the Ministry of Environment and Waters, Ministry of Public Health and Ministry of Agriculture and Food.

The control of GMOs in seed is entirely the responsibility of the Executive Agency of Variety Testing, Field Inspection and Seed Control. The three Ministries exercise effective control along the entire food chain and on the use of GMOs for industrial purposes (e.g. the use of soybean oil in the pharmaceutical industry, industrial application of cotton). Competent representatives of the three Ministries participate in the work of the bodies of the European Council and the Commission (Working groups and Committees) for elaboration of legislative provisions and implementing measures for GMO control.

Legislativeframework

The National Law on the Protection of the Environment has laid down provisions reflecting the state policy in thisfield (State Gazette No. 91 of 25.09.2002, last amended in SG No.105 of 09.12.2008)

The relevant EU legislation in thedomainof GMO control has been transposed into the National Law on GMO, which has been adopted by the Bulgarian Parliament(StateGazette No.27/29.03.2005, and entered into force on 01.06.2005,amended in SGNo.88 of 4.11.2005, No. 99 of 9.12.2005, in force as from10.06.2006, SG No. 30 of 11.04.2006, entered into force on 12.07.2006), last amended in SG. No.54/2008.

Pursuant to the National Law on GMO 2 Ordinances have beenadopted whereinthe specifictechnical requirements and provisions have been laid down:

1. Ordinanceoncontained use of genetically modified organisms (under controlled conditions), SG No.81 of 11.10.2005 (adopted by Council of Ministers Decree No.211/4.10.2005)

2. Ordinance on release into the environment of genetically modified organisms and their placing on the market, SG.No. 81 оf 11.10.2005 (adopted by Council of Ministers Decree No.212/4.10.2005)

The National GMO Law is in full compliance with the EU acquisand the following Regulations and Directives:

- Regulation 1829/2003/ECof EU Parliament and Council on genetically modified food and feed;

- Regulation1830/2003/EC on traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from GMOs, amending Dir. 2001/18/EC.

-Regulation1946/2003/EC on transboundary movement of GMOs;

-Directive 2001/18/EC on deliberate release into the environment of GMOs, repealing

Council Directive 90/220/EEC;

-Directive 90/219/EEC on the contained use of genetically modified micro-organisms.

Presently there are no thresholds established for the conventional seed which is a limitation for their labelling as GMOs (unlike foods with threshold of 0,9 %). An intensive work is being carried out on this issue and quite soon it is expected to have a legal regulation and establishment of such a threshold within the framework of EU. DG Environment of the European Commission has signed a Gentlemen Agreement for a random representation of GMOs in the conventional seeds. The work for determination of the thresholds within the Community is continued.

There are already existing GMO varieties, which participate further in the chain of food and feed products. These varieties are authorized within the framework of EU but no common system for control of GMOs has been developed yet. Besides the above mentioned products there are also GMO varieties, which are not approved by EFSA (European Food Safety Association, dealing withdetermination of the risk on human health and environment).

It is of exceptionally great importance for human health and the environment toensure exercising of control not only on the legally approved but also on the non-regulated GMOs.

According to the LSPM the control of imported and exported seed is designated to be the responsibilityofEAVTFISC.

PCR (polymerase chain reaction) for detecting the presence of GMOs on DNAlevel and with a possibility for labelling of the controlled seed lots intended for home and international marketing in accordance with the EU requirements wasdelivered in the EAVTFISC Central laboratory at the endof 2008 under PHARE project BG 2005/017-353.03.02 .

Subsequent training of the Agency’s staff to operate the supplied sophisticated equipment and to carry out GMO analyses in compliance with the EU Rules and validated test methods is a strong necessity. The Agency’s staff needs to get acquainted with specific SOPs and procedures relating to dissemination of authorized and non-authorized GMOs by the European Food Safety Authoritywithin the EU.

3.1.2 The context in the beneficiary country (BC) and linked activities.

Phare project BG2004/IB/AG-TWL.

Training was offered by the German Twinning partners in variety testing: DUS (distinctness uniformity and stability) and VCU (value for cultivation and use) testing of plant varieties and training in seed certification and control. The Agency’s DUS experts were trained in variety testing (DUS) of a number of plant species - other than the ones envisaged to be covered by the new project - and started implementing the CPVO (Community Plant Variety Office) protocols and practices in variety testing of the respective species conducted in R Bulgaria. A software programme for VCU data processing was purchased after the training by the German partners.

The limited scope of the project activities was not sufficient to cover all the necessary training topics in variety testing and the other activities of the Agency.

Phare project BG 2005/017-353-03.02 - Supply of equipment.

The equipment supplied under this project is intended for carrying out of laboratory analyses for quantitative and qualitative determination of a genetic modification and achieving of effective control on the GMO’s placed on the market with regard control of any possible breaches of the requirements of the Law.

Phare project BG 2006/018-343.03.03 – TWL & Supply of equipment.

The purpose of this project was to achieve strengthening of the administrative capacity of EAVTFISC and up-lifting of the professional skills of the staff for conducting of the DUS and VCU testing of plant varieties for Plant Breeders’ Rights (PBR) and listing in the national and EU catalogues, to comply with the EU practices.

The training activities envisaged were focused on the following topics:

I. Variety Testing

1. DUS testing (distinctness, uniformity and stability) of:

- Winter crops: soft and durum wheat, oats, barley, rye, triticale

- Maize and sunflower *; oil rape;

- Vegetables; cabbage, carrots, cucumbers

2. DUS - Post Control Testing (cereals, maize and sunflower)

3. VCU Testing – Post registration testing (cereals, maize and sunflower)

II. Variety listing: Preparation and publishing of:

-Descriptive lists and a Bulletin (Official Gazette) for newly accepted plant varieties

-Recommendation lists based on Post-registration testing (VCU)

* Maize and sunflower are requested again as training topics because of necessity for clarification of certain details related to characters observed for the purposes of elaboration of variety descriptions.

The current project will provide training of the EAVTFISC laboratory specialists in the sophisticated methods using the supplied under project BG 2005/017-353-03.02 equipment for GMO detection.

The competence concerning DUS testing of plant varieties gained after the implementation of project BG 2006/018-343.03.03 will be used as a basis for improvement of the qualification of the DUS examiners (staff of Variety Testing Directorate) with regard of the technical aspects and requirements for conducting DUS testing of genetically modified candidate-varieties.

3.1.3 The proposed methodology for implementing the intended reform.

The project is focused on ensuring of a sustainable protection for the human health and the environment in accordance with the EU standards. Project goals are intended to be achieved through implementation of trainings in the BC and a study visit in the MS as follows:

Activities A – Training of Central Laboratory’s staff.

Activities B – Training of the staff of Field Inspection and Seed Control Directorate – seed samplers and field inspectors.

Activity C - Training of the staff of Variety Testing Directorate – DUS examiners.

3.1.4 Steering Committee.

In order to control the project progress and results a Steering Committee of the project shall be established. The Steering Committee meetings shall be held on a quarterly basis during the project implementation as follows:

Kick-off Meeting at the project’s start.
Steering Committee during the 3rd month of implementation to discuss and approve the start-up report.
Final Steering Committee to discuss and approve the final report.

The Steering Committee will consist of the institutions and bodies involved in the implementation of the project: CFCU, MEUFD, PIU, EAVTFISC and the Twinning light Partner. Close contact will be kept to the CFCU throughout the whole project in order to ensure the correct TF procedures and to guarantee the smooth functioning of the project.

The CFCU (Ministry of Finance) will be the Contracting Authority responsible for tendering, contracting, payments and financial reporting and will work with close co-operation with the beneficiary. The acting PAO of the project is Mrs.Tania Georgieva, Secretary General of the Ministry of Finance. Her contact details are:

Address: 102 Rakovski Str.

1040 Sofia

Tel: 359 2 9859-2772

Fax: 359 2 9859 2773

E-mail:

The PIU at the Ministry of Agriculture and Food will be responsible for monitoring of project implementation and coordination of the activities at all stages of the project cycle. Contact details of the PIU:

Director of European and International Programs and Projects Directorate

Ministry of Agriculture and Food

Address: 55, Hristo Botev blvd.

1040 Sofia

Tel: 359 2 981 6163

Fax: 359 2 981 75 42

E-mail:

3.1.5 BC Project Leader.

The Executive director of EAVTFISC will act as a BC project leader of the project.

Contact details:

Executive Agency for Variety Testing, Field Inspection and Seed Control (EAVTFISC)

Address: 125, Tzarigradsko Shosse Blvd., Block 1

1113 Sofia, Bulgaria

Ms. Nevena Ivanova, Executive Director of EAVTFISC

Tel: +359-2- 870 03 75 - Secretary

Fax: +359-2- 870 65 17

e-mail:

3.2Global and specific objective(s)

3.2.1.Overall objective

Ensuring of a sustainable protection for the human health and the environment in accordance with the EU standards.

3.2.2.Specific objectives

3.2.2.1. Improvement of the laboratory capacity of EAVTFISC concerningquantitative and qualitative analyses for GMO control for the purposes of seed certification.

3.2.2.2. Improvement of the administrative capacity of EAVTFISC for enforcement and implementation of the European and National legislation on variety testing, field inspection and seed control.

3.3Requested services / nature of activities

The required types of servicesare detailed below:

- Training of BG Experts from the Central Laboratory of EAVTFISC in quantitative and qualitative methods for control of GMOs for which very specific procedures are applied and the use of sophisticated equipment is required.Such equipment is available in the EU MemberStates and they have the necessary experience as theyhavecreated and are using GMO plant varieties in the field of agriculture; Theoretical and practical training of Central Laboratory’s staff in validated test methods and practices for GMO detection in maize and soybean seeds;

- Theoretical and practical training of field inspectors and seed samplers in MS procedures and practices for GMO control- measures for prevention and limitation of the dissemination of GMOs on the market;

- Training of the Agency’s experts from Variety Testing Directorate in testing of GM candidate-varieties.

Activities:

Activity A- Training of Central Laboratory’s staff.

A.1.Theoreticaland practical training of laboratory expertsin GMO detection in maize–EUlegislation and MS practices. Application of validated methods worked out by the EU Joint Research Centre (JRC) and practical training by using the PCR equipment (maize):

-Preparation of extractions;

-Analysis of 2 samples per day (10 days x 2 samples);

-Statistical data processing of the results obtained from the analyses.

Location: Bulgaria

Duration: 3 weeks

Participants: 4 BG experts

A.2. Theoretical and practical training of laboratory experts in GMO detectionin soybean -

EU legislation and MS practices. Application of validated methods worked out by the EU Joint Research Centre and practical training by using the PCR equipment (soybean):