1. Status of Agricultural Biotechnology and Biosafety in Romania Aurel Popescu, Prof., PhD University of Pitesti, Romania

2. TOPICS REGULATION: legislation status and institutional framework RESEARCH: modern biotech. projects APPLICATIONS BIOSAFETY RESEARCH: monitoring and surveillence

3. BIOTECHNOLOGY REGULATION

4. Legislation status Government Ordinance 49/2000  National Competent Authority: National Biosafety Commission (NBC) (24 members, scientists and representatives of public institutions: environment, agriculture, consumer protection, public health) BIOTECH LAW 214/2002  National Competent Authority: Ministry of Environment and Water Management

5. Legislation status Under GO 49/2000 NBC had a major role in the decision making process. Moreover, the presence of some scientific representatives in the NBC helped lead to a science based approach Under Law 214/2002, approving Ordinance 49/2000, Biosafety Commission became the scientific authority with a consultative role. Under these new circumstances, decisions regarding environmental release of bioengineered crops (either for commercial cultivation or experimental purposes), although requiring the scientific opinion from the Biosafety Commission, have been more susceptible to political climatic

6. Institutional Framework Ministry of Environment and Water Manangement National Competent Authority (approval) Biosafety Commission (scientific consent) Ministry of Agriculture, Forests and Rural Development (consent) Ministry of Health and Family (consent) National Authority for Consumer Protection (consent)

7. Romania harmonized biotech legislation with EU legislation

8. The Romanian legislative framework for regulating biotechnology After becoming a member state of EU, several “Government ordinances” and “Orders” of the ministers for agriculture, forestry and rural development, and respectively for environment and water management, have been released. These legislative acts cover all aspects of deliberate introduction of GMO into environment and on the market, authorization of the producers of genetically modified plants, transboundary movement of GMO, traceability and labelling of GMO, etc.

9. Legislation status Regulation (EC) 1829/2003 on genetically modified food and feed (HG 256/2006) provides general framework for regulating genetically modified (GM) food and feed in the EU. This framework pursues the global objective of ensuring a high level of protection of human life and health and welfare, environment and consumer interests, whilst ensuring that the internal market works effectively. The Regulation is supplemented by Regulation (EC) 1830/2003 (HG 173/2006) which ensures traceability and labelling of GMOs placed on the market. Regulation (EC) 1829/2003 on genetically modified food and feed Regulation (EC) 1830/2003 Directive 2001/18/EC on the deliberate release of GMOs into the environment outlines the principles for, and regulates, experimental releases and the placing on the market of GMOs in the EU (legea 247/2009) Directive 2001/18/EC (http://ec.europa.eu/environment/biotechnology/legi slation.htmhttp://ec.europa.eu/environment/biotechnology/legi slation.htm

10. Institutional Framework Ministry of Environment and Sustainable Development/ National Environment Protection Agency (competent authority for import into and deliberate release into environment); National Environment Guard (enforcement of the environmental legislation) Romanian Government/ National Sanitary Veterinary and Food Safety Authority (competent authority for food and feed) Ministry of Agriculture, Forests and Rural Development (the control and the certification of the quality of seeds non GM which can be contaminated with GM seeds) Ministry of Public Health and Family Ministry of Education, Research and Youth Biosafety Commission (risk assessment and scientific opinion) National Authority for Consumers Protection (responsibilities for the labeling control)

11. The use of Biotech products in Romanian Agriculture In 2000, Romania was the only country in Europe approving market release of two genetically modified (GM) crops: Roundup Ready (RR) soybean and Superior New Leaf potato GM potato has not been commercialized On the contrary, RR soybean was grown on thousands of hectares Romania is one of the few European countries with favorable conditions for soybean production and, in 2006, was one of the nine coutries in the world that cultivated this GM crop

12. RR Soybean in Romania

15. Modern Biotechnology Research In Romania, research in the field of agriculture biotechnology is carried out on:  laboratory level  field trial level Currently, two GM crops were obtained with the potential for market release: - plum resistant to plum pox virus; - potato resistant to Colorado beetle attack.

16. Potato project According to FAOSTAT (2007), Romania is the second potato grower in the European Union Annualy, 250,000 hectars of potato are cultivated Harvest yields are drastically affected by the attack of pathogen agents and pests. Among the last, the most harmful is Colorado beetle, which has become a quarantine organism in Western Europe, whilst in Romania has two or even three generations per year.

17. Study on the farm-level impact of using Bt potato in Romania  Annualy, up to 250,000 hectars of potato are cultivated  If Bt technology would applied, 10 million USD would be saved annualy, of which four million USD represents costs for insecticides and six million USD costs for treatments

18. Potato project At the University of Agronomic Sciences and Veterinary Medicine of Banat, Timişoara, a research project has been initiated with the objective of obtaining several Romanian potato varieties resistant to Colorado beetle attack through genetic modification. “Redsec” and “Coval” varieties, created and patented by the Potato Research Station Târgul Secuiesc, have been genetically modified. Field trials with selected lines have not yet been approved

21. Plum project Romania is the world's second largest plum producer (after United States) and as much as 75% of Romania's plum production is processed into the famous “ţuică” (a plum brandy obtained through one or more distillation steps) (FAOSTAT 2007). Transgenic clones of plum (Prunus domestica) transformed with the Plum pox virus coat protein gene (PPV-CP) were evaluated for “Sharka” resistance under high infection pressure in natural field conditions in Romania. As reported by the research team from the Fruit Research Station Bistriţa, the clone named “HoneySweet” showed resistance to local strains of PPV.

23. The future of GM potato and plum  Although Romanian researchers obtained potato and plum GM lines with the potential for commercialisation, these will never reach the market, if the EU does not change policy in the field of modern biotechnology.  The cost is prohibitive for a public institution.

24. An example of negative impact of EU legislation on agricultural biotechnology in Romania From January 2007, when Romania became member of EU, cultivation of transgenic soybean has been prohibited. As a consequence, both the surface cultivated with soybean and total seed production have decreased dramatically, this leading to massive increase of (transgenic) soybean imports and a 8 times higher amount of money spent for them.

25. The impact of discontinuing RR soybean cultivation in Romania Year SeedsOil Cakes Quantity (t)Value (US$)Quantity (t)Value (US$) 2006 26 mil. $ 11 945 4 244 413 81 544 21 851 061 2007 108 mil.$ 68 60034 022 346217 039 74 500 459 2008 211 mil.$ 94 49155 512 308315 012155 403 943

26. Impact of discontinuing RR soybean cultivation Total soybean cultivated area in Europe is small in comparison to the potential this crop has in Romania. Area cultivated could go up to 500,000 Ha which, at a normal yield, would result in an exportable surplus 800,000 - 1 million tonnes of beans, meal and cakes. Another opportunity generated by the current dynamics of the global market is the use of soybean oil for biodiesel production. In spite of all these possibilities, Romania is currently increasingly dependent of soybean imports.

27. Impact of discontinuing RR soybean cultivation

28. Romania has become a net importer of vegetable protein, similar to the European Union itself. The EU imports about three quarters of its total soybean supply, mainly from the USA, Argentina and Brazil, countries in which mainly RR soybean is cultivated. At the national economy’s level, hard currency losses (as a result of increased imports) are estimated to exceeded millions of euros per year (Otiman et al., 2008; Dinu and Alecu, 2009)

29. Status of cultivation/field trials as MS  As EU Member State, Romania can commercially grow genetically modified plants approved for market release in EU. Beginning with 2007, MON810 was cultivated on about 300 Ha. In 2009, Bt maize was grown on about 3000 Ha.  In the 27 Member States of the European Union, 13 million hectares with maize are planted annually.  According to Eurostat, Romania is in first place regarding the area cultivated with this crop (2 304 200 ha/2009). This is not the same case when it comes to yield.  The growth in maize production quantity and quality may bring Romania in a leading position on the European market of agricultural foodstuffs, seed and maize derived products.  Currently in Romania, field trials with second generation of corn hybrids with stacked genes belonging to Monsanto, Pioneer and Syngenta companies are being carried out.

30. The impact of discontinuing RR soybean cultivation Another opportunity generated by the current dynamics of the global market, which is the use of soybean oil for bio-diesel production, cannot be exploited by Romania, if becomes increasingly dependent of soybean imports.

31. Transgenic maize cultivation in Romania Transgenic line MON810 is cultivated for several years in Romania Some other transgenic lines of maize (created by Monsanto, Syngenta and Pioneer) were tested in recent years, being close to getting approval for introduction into cultivation.

35. Map of Diabrotica distribution in EU, in 2008

36. Western corn root worm For another maize pest, the western corn root worm, resistant GM maize is already in use in the US, and currently three applications have been submitted for approval in the EU. The pest was first detected 1992 in Yugoslavia, and has since then spread from there into other parts of Europe, including Romania. Especially over summer 2009, the so-called million-dollar bug was spotted in many new places, including Romania.

37. Some causes of the serious troubles in obtaining authorization for field trials with genetically modified plants The tax that must be paid for obtaining the permit for field trials is considered very high by the public research institutions (1000 €/transformation event/location/year). Time interval for approval of the field trials is uncertain, due to the conflicts existing between different authorities involved in taking such decisions (some of them are pro GMO, while other are against, and influenced by the Green Peace activists).

38. Conclusions Romania has implemented successfully the legislation in accordance with EU acquis The institutions, central and local, are active and efficient Farmers perceptions about biotech products are good Romania having a potential of more 500 000 ha of soybean cultivation is harvesting about ten time less (65 000 ha, in 2009) Instead of exporting one million tons, we are importing about 315000 t The existence of a legal framework is a necessary, but not the sufficient, conditions for adopting right decisions Up to date in EU, although the biological and biosafety research on GM major crop plants were both intensively and extensively carried out, and many events are imported for processing and food and feed utilisation, only one maize event was approved for commercialization. This policy is thought to bring about enormous effects to the agricultural production of Romania in the future.

39. Conclusions The existence of a legal framework is a necessary, but not the sufficient condition for adopting right decisions. An excessive legislative framework, enforced without responsibility, may have dramatic socio- economic consequences. This policy is thought to bring about enormous effects to the agricultural production of Romania in the future.