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UNEPROMANIA

Ministry of Environment and Water Management

BUCHAREST, January 2006

NATIONAL BIOSAFETY FRAMEWORK

FOR ROMANIA


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UNEPROMANIA




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This publication is addressing to authorities, non-governmental organizations and civil societyfromRomaniaanditwaselaboratedwithintheUNEP/GEFProjectDevelopmentoftheNationalBiosafetyFrameworkforRomaniaGF/2716-02-4596runningwithintheMinistryofEnvironmentandWaterManagement,theNatureConservation,BiodiversityandBiosafetyDirectorate

UNEP/GEFNationalProjectCoordinatorInstitute of Biology of Romanian Academy, 296 Splaiul Independentei St., 060031, District 6,Bucharest,Romania

DirectorMinistry of Environment and Water Management, the Nature Conservation, Biodiversity andBiosafetyDirectorate

12Libert

,UNEP/GEFBiosafetyUnit,InternationalEnvironmentHouse,Geneva,Switzerland,EnvironmentAgencyLtd.,Vienna,Austria

,EnvironmentAgencyLtd.,Vienna,AustriaEnvironmentAgencyLtd.,Vienna,Austria

HorizonsSprl,Belgium

Ministry of Environment and Water Management, Institute of Biology of Romanian Academy,UNEP/GEF

MEWMarchive

SCEurografixSRL

100

Ministry of Environment and Water Management, the Nature Conservation, Biodiversity andBiosafetyDirectorate,12 Distr ict5,Bucharest ,RomaniaInstitute of Biology of Romanian Academy, 296 Splaiul Independentei St., 060031, District 6,Bucharest,RomaniaWebpage:

Editorsand Authors

Maria-MihaelaAntofie,

AdrianaBaz,

Reviewedby

LiinaEekMichaelEckerstorferHelmutGaugitschAndreasHeissenberger,Pietvander Meer

Copyright

ISBN973-87565-2-9

Photos

PublishingHouse:

Exemplars

Availabletothe address

iiBd.,040129,District5,Bucharest,Romania

Bd.Libertii,040129,

www.biosafety.ro



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Genetically modified organisms, which are created and experimented by using

modernbiotechnology techniques,is a subject ofgreat actualityat international

level. Using the instruments offered by the modern biotechnology may

constitute one of the main factors required for the socio- economic system

development, especially for developing countries, under condition of strictly

applying the precautionary principle and taking into account the possible

adverseeffectson biologicaldiversityandon humanhealth.

Forward

Sulfina BARBU


As a country which ratified the Cartagena Protocol on Biosafety to the Convention on Biological Diversity,Romania beneficed of technical and financial assistance offered by international organizations such as

United Nations Environment Programme and Global Environment Facility by joining the Project

Development ofthe NationalBiosafety frameworkfor Romania. Themain objectivesof thisproject,ruled

undertheaegisof theMinistryofEnvironmentand WaterManagement,are theevaluationanddevelopment

of the National Biosafety Framework, respectively Romanian capacity building in implementing Cartagena

Protocol. During the Project development, Romania beneficed of the scientific and technical assistance of

some famous experts in the field from EU Member States such as: Austria, Belgium and Netherlands.

Regarding the Project results we can enumerate: regulatory framework evaluation regarding biosafety

according to Cartagena Protocol and EU regulations, authorization procedure management evaluation,

modern biotechnology research capacity evaluation as well as the evaluation of the level of education,

information andawarenessfor publicparticipationindecisionmakingprocess.

Also, it should be mentioned the sub-regional collaboration activity and Romania preparation to access the

international biosafety information system. Biosafety is a major goal of national interest as well as global

interest and it will be not possible without the Biosafety Clearing-House mechanism established by the

CartagenaProtocol.

Weexpressour hopethatthe information ofthispublicationwillcontributeforthe furtherdevelopment ofthe

regulatory system as well as for the development at national level of Biosafety Policies and Strategies

accordingtoEU accessiondemands.

We are expressing our gratitude to United Nations Environment Programme- the Biosafety Unit from

Geneva, toGlobalEnvironmentFacility aswell asto allNationalCoordinatingCommitteemembers andall

collaboratorsfromour countryor fromabroad.


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Biosafety is one of the issues addressed by the Convention. This

concept refers to the need to protect human health and theenvironment from the possible adverse effects of the products of

modern biotechnology. At the same time, modern biotechnology is

recognized as having a great potential for the promotion of human

well-being, particularly in meeting critical needs for food,

agriculture and health care.The Conventionclearlyrecognizes these

twin aspects of modern biotechnology. On the one hand, it provides

for the access to and transfer of technologies, including

biotechnologies, thatare relevantto theconservation andsustainable

use of biological diversity and on the other hand seek to ensure the

development of appropriate procedures to enhance the safety of

biotechnology in the context of the Convention's overall goal of

reducing all potential threats to biological diversity, taking also into

accountthe risksto humanhealth

CartagenaProtocolon Biosafety,Introduction


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IntroductionRomanian UNEP/GEF project

Chapter IRomanian biosafety policy

Chapter IIRomanian biosafety regulatory system

Chapter IIISystem for handling notifications and requestsfor permits or product authorizations

Chapter IVMonitoring

Content

Chapter VLabelling and traceability

Chapter VIEnforcement

Chapter VIIMechanisms to promote andfacilitate public awareness,education and participation

Chapter VIIIRomanian modern biotechnologydevelopment strategy

Annex I .......................................99

Annex II ...................................101

Annex III .................................101Annex IV .................................117

Annex V ...................................121

Annex VI .................................123

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Romania, through the Ministry of Environment and WaterManagement, joined the UNEP/GEF project Development of theNational Biosafety Frameworks by signing the subprojectDevelopmentof the National Biosafety Framework for RomaniaGF/2716-02-4596. 1 April 2004 wasthe starting date forthe Projectand the National Executing Agency (NEA), represented by theMinistry of Environment and Water Management, the NatureConservation, Biodiversity and Biosafety Directorate, establishedthe National Coordinating Committee composed of stakeholderssuch as: government authorities with mandates relevant to theCartagena Protocol on Biosafety, research institutions,representativesfromthepublicandprivatesectors(Annex4).

As a Party to the Convention on Biological Diversity (CBD),Romania signed the Cartagena Protocol on Biosafety, on 11October,2000.ItalsoratifiedtheProtocolbytheLaw59/2003from30June2003whichenteredintoforceon 28September2003.

The project was carried out according to administrative andfinancial procedures of the United Nations DevelopmentProgramme for Romania. The administrative and technicalsupport of UNEP was ensured through the constant collaborationwith Liina Eek PhD, Assistant Regional Coordinator for Centraland Eastern Europe (CEE), UNEP/GEF Biosafety Unit,InternationalEnvironmentHouse,Geneva,Switzerland.

Generally,the projectfollowedthe proposed quarterly workplan.The greatest attention was focused on inventories, survey actions,

Introduction

ROMANIAN UNEP/GEF PROJECT

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[8] Approaches on the Development of the Romanian Modern Biotechnology

Strategy Thischapterdescribesproposalsforthefuturedevelopment.

We address our thanks to the Ministry of Environment and Water Managementwhichensuredtheconstantpositivesupportandexpertiseduringprojectactivities.

National Coordinating Committee (NCC) members have actively participatedduring all project actions, establishing an exceptional collaboration with the project(Annex 4). Special thanks are addressed to all NCC members, which by theirexpertise ensured a constant and appropriate framework required for projectactivitiesdevelopmentandalsoforprojectresults.

We are expressing our thanks to all contributors in the development of theUNEP/GEFproject activities (Annex2 and4). Getting together allstakeholders wasthe most important achievement of drafting the Romanian National BiosafetyFramework. Thus, there were got together for the first time in biosafety domain:authorities, research area, industry, non governmental organizations, and massmediaas well asRomanianandForeignexperts:wethankyouall.

Maria-MihaelaAntofieNationalProjectCoordinatorUNEP/GEF

AdrianaBazDirectorNatureConservation,BiodiversityandBiosafetyDirectorateMinistryofEnvironmentandWaterManagement

ROMANIAN UNEP/GEF PROJECT

3

and on evaluating the regulatory system taking also into account the modernbiotechnology research capacity. Biosafety stakeholders participated in a broadspectrum because of the open attitude and transparency of the project team (Annex2).

Thisreportisstructuredineightchaptersasfollows:This chapter describes the Romanian political

orientation on the biosafety domain and reveals specific aspects belonging to thepresentGovernmentfor theperiod 2005-2008.It isimportantto underlinethatin thechapter 18 entitled Environment Policy belonging to the GovernmentalProgramme 2005-2008 relevant issues regarding the development of the nationalbiosafetyframeworkarepresented.

This chapter includes a listing of allregulatory legislation related to biosafety focusing on genetically modifiedorganisms(GMOs).Interfacingregulatoryactsarealsodescribedaswellasthemaininternational environmental conventions and agreements to which Romanian is asignatory Party (Annex 3). Moreover, since 1995 Romania is a Party to the WorldTrade Organization (WTO) andsignedthe Agreement on Trade-RelatedAspects ofIntellectual Property Rights (TRIPs), Agreement on the Application of Sanitary andPhyto-sanitaryMeasures(SPS),and Agreementon TechnicalBarriersto Trade(TBT)under theWTO.Legislative acts regardingthe transposing of European Union (EU)regulation are also underlined as Romania is preparing for EU accession in January2007.

This chapterdescribes all appropriate procedures required for permits, authorization andapprovalissuing.

This chapter describes the importance of monitoring activity within

thebiosafetysystemThis chapter describes the current situation in

Romaniafortheseactivitiesandalsoincludesfuturerecommendations.Themost important activity of thenational biosafety frameworkis

described in this chapter and reveals how the regulation system is enforced inRomanianow.

This chapter describes procedures,methods,toolsandinstrumentsaswellasrelevantdevelopmentalgoals.

[1] Romanian Biosafety Policy

[2] Romanian Biosafety Regulatory System

[3] System for handling notifications or requests for authorizations

[4] Monitoring

[5] Labelling and traceability

[6] Enforcement

[7] Mechanisms for promoting and facilitating public awareness, education and

participation in decision making process

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Cartagena Protocol onBiosafety to the Conventionon the Biological Diversityis the main internationalinstrument protectingbiodiversity in a

transborder context againstthe potential negativeeffects that can arise fromnot properly applyingmodern biotechnology


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Romania was one of the first countries in Eastern Europe thatput in place its national biosafety framework. In this context, atthe end of the year 1999, the Government Ordinance 49/2000(GO) on the obtaining, testing, use and commercialization ofgenetically modified organisms obtained through the modernbiotechnologytechniques,and of the productsresultingthereof,was issued. Two years later, Law no. 214/2002 for the approvaloftheGOno.49/2000,withmodificationsandcompletions,waspromulgated,whichatthesametimealsolargelytransposedthefollowing Direct ives : 90/219/EEC, 98/81/EEC and2001/18/EC.

Romania signed on 11 October, 2000, as a Party to theConvention on Biological Diversity, the Cartagena Protocol onBiosafety, which was ratified on 30 June, 2003 by the Law no.59/2003. TheProtocol enteredintoforce on 28 September,2003,thusRomaniahastoimplementallitsprovisions.

It is expected that before Romania's accession to EU, all EUbiosafety regulatory provisions to be transposed in the nationallegislation. Thus, in the next period, new legal acts will beprepared to amend and complete Law 214/2002 addressingother specific ROMANIAN BIOSAFETY REGULATORYSYSTEMs. At present, new regulations are to be enforced inorder to strengthen theNational BiosafetyFramework(NBF) inaccordance with EU Biosafety Policyand the maininternationalinstrumentsinthefieldtowhichRomaniaisasignatoryParty.

CHAPTER 1

ROMANIAN BIOSAFETY POLICY

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regarding the assessment of the impact on the environment associated with cross-border movement, Aarhus Convention regarding access to information, publicparticipationin decision makingand access to justice with regards to environmentalissues, Helsinki Convention regarding industrial accidents with significant impactupontheenvironmentinrelationtocross-bordermovements).

Romania has great concerns in preserving its natural resources as it is well knownthat it is possessing oneof therichest biodiversity in theregion. Thus, developmentof this chapter is supported by the numerous conventions and internationalProtocols, as well as bilateral and multilateral agreements signed by Romania andpresentedinthechapter2ofthedraft.

Having as main objectives, strengthening the administrative structures, as basicelementto builda solidsystem of environment management andthecontributiontoa durable development, the activity of Romanian Government will rely on thefollowingpriorities:

1. Integrationof theenvironmentpolicy withinthe elaborationand implementationof sector and regional policies by: [i] Situating the Ministry and the National

Romania will enter a new phase with the closing of accession negotiations, whichwill facilitate capacity building and ROMANIAN BIOSAFETY REGULATORYSYSTEMimplementationtakenfromthe duringnegotiat ions.

In addition, Romania has to develop a specific Modern Biotechnology Strategy,following the example of other EU countries, and to include biosafety in thisstrategy. However, research in the field of modern biotechnology, which is aprerequisite for the development of a reliable NBF, has not been developedadequately, due to the lack of funds necessary for competitive research activities.Thisresearchfieldiswell-developedinWesternEuropeandinseveralneighbouringcountries. Modern biotechnology development needs substantial funding, for theacquisition of equipment and reagents as well as an adequate training of humanresourcesandasustainablemanagement.

The current Romanian Government Programme 2005-2008 briefly underlines thedevelopment policy and strategy throughout its 27 chapters, and a shortpresentation of chapter 18 will be presented bellow. Other relevant chapters of theGovernmentProgrammearebrieflypresentedinboxes1-4.

Chapter 18 of the Governmental Programme 2005-2008 focuses upon theEnvironmental Protection Policy of the Ministry of Environment and WaterManagement. It can be considered that one of the main concerns of RomanianEnvironmentalPolicy is biosafety, underlining the importance of implementingtheprovisions of the Cartagena Protocol on Biosafety to the CBD. At the same time, itimposes complying with the provisions of other international conventions withsignificant impact upon the conservation of genetic resources and ensuring anadequate level of environment and human health protection (Espoo Convention

acquis communautaire


Box 1

GovernmentProgramme 2005-2008

Chapter 6

Policies in the fieldof Research-Development andInnovation

The Romanian Government will grant a special

attention to research . innovation sector in order tohelp the Romanian economy obtain a durable

competitive advantage as well to decrease thedevelopment gaps existing among Romanian

regions andamongtheseand theregionsof otherEUmemberstates.

Box 2


Chapter 9

Agricultural andRural DevelopmentPolicy

The Ministry of Agriculture, Forests and RuralDevelopment will observe and promote certaindemocratic principles and values, the most importanttotheenvironmentbeingthefollowing:

[1] sustainable rural development and increase in population incomes by capitalization of all potentialresources in the rural area, diversification ofagricultural and non-agricultural economic activitiesa n d s e rvi ce s , i m pr o ve m en t o f pu bli c r u ra linfrastructure and of general population welfare; [2]recognition and orientation towards Europeandemocracy and values. The integration of Romaniainto the European Community and integration ofRomanian agriculture into the Common AgriculturalPolicy (CAP), while also protecting the interests ofdomestic producers; [3] preserving the environment,the geographic landscape and th e spiritual, traditional

andmaterialvaluesfromRomanian ruralareas;

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Environment Agency in a decision position that would intersect horizontally allsector policies( industry, energy, transports, agriculture, tourism, regional policies,local administration and health); [ii] Effective introduction of environmentevaluationas mechanismto integratethe newformulatedpoliciesand toissuesomeeffective assessmentindicatorsof the progress achieved in caseof existing strategiesand policies; [iii] Intensification of the actions to integrate the environment policywithin five priority sectors with significant impact on environment, namely:industry, energy, transport, agriculture and tourism; [iv] Promoting progressivelyeconomicinstrumentsinordertoimplementenvironmentpolicies;

2. Assessment of theactual stage of ecologicalfactorsand enforcement of a strategyoflong term development withinthe environmentfield, ofthe regenerative andnonregenerativeresources;

3. Strengtheningtheinstitutional capacitywithin theenvironmentfield;

4. Improvement of the quality of environment agents within urban and rural areasImprovingthequalityofenvironmentalfactorswithinurbanandruralareas;

In this context, several objectives are mentioned in relation to the management ofchemical substances,the monitoring of the geneticallymodified organisms and theforbidding use of those substances that represent a threat for the population healthonRomania'sterritory,asfollows:[i]DevelopingtheBiosafetyNationalFrameworkin order to implement the Cartagena Protocol (Law 59/2003); [ii] Assuring thelegislative framework upon the transport cross border of genetically modifiedorganisms, labeling and traceability of food and feed products obtained from

geneticallymodifiedorganisms;[iii]ConstitutinganationalCatalogueofgeneticallymodified organisms accepted on Romanian territory, accessible to population; [iv]Creating and developing the laboratories specialized in detecting the geneticallymodified organisms; [v] Participating at the Mechanism upon the InformationExchangewithintheBiosafetyfield(BiosafetyClearing-House);[vi]transposingandimplementing the legislation on risk assessment and risk control of hazardouschemicalsonhumanhealthandtheenvironment.

Box 3


Chapter 8

Policy in the HealthField

Among the priority objectives, the following three canbe mentioned:1. Effectiveand equalaccessof citizensto basicmedicalcare;2. Increase of life quality by improving the quality andthesecurityof medicalact;3. Approach of health and demographic indicators ofcivilized countries, at the same time with decrease ofthepathologyspecificto underdevelopedcountries;

Box 4


Chapter 19

Policy uponConsumerProtection

Thispolicy is basedon the followinggeneralobjectives

in promotingthe interest of consumers:[1] achievingahigh level of consumer protection;[2] effectiveenforcement of legislation with regards to consumers'

protection and [3] developing the activities forconsumers information,counselling and education.

This Governmental strategy, through its objectivesand priorities, intends to align consumer protectionregulation in Romania with that existing in theEuropean Union Member States, including consumersafety, economicinterests, information and education,as wellas the developmentof consumersorganizations

for playing an active role in developing consumerprotection policies.

Within the strategy for the period 2005-2008, theNational Authority for Consumers Protection(NACP)aims at developinga systematic, efficientandwell-organized consumer protection policy,

prevention, a fast response mechanism through the presence of its representatives all over Romanian

territory, as well as an efficient activity, includingcooperation withothergovernmentalcompetent bodiesa t n a t io n a l a n d l o c al l e ve l. F u r ther m o re ,strengthening the partnershipwith the civil society, in

general, and with the business sector, in particular,will lead to a better knowledge and understanding ofconsumers' problems and to a better protection ofconsumers.


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Developing the collaboration between Romaniaand region countries as well as other Biosafety

Protocol parties, is essential to implement aninternational biosafety system

5. Extension of the national network of protected areas and natural reservations,rehabilitation of the coast infrastructure of the Romanian seaside, economic andecologicalresizingoftheDanubeDelta;

6. Strengthening the cross-border and international partnership with similarinstitutions from other countries in order to monitor the implementation stage ofinternational agreements by: [i] Signing Conventions, Agreements, Bilateral andmultilateral Cooperation within the field of Environment protection at Europeanand world level for the purpose of capitalizing the opportunities and facilities ofinstitutional and financial technical financial assistance and identifying somepossibilities to finance the environment reconstruction projects; [ii] Observing the

notice and reporting requests undertaken by Romania as part within differentConventions, Protocols and International Agreements; [iii] Assuring theinstitutional framework established through different bilateral and multilateralagreements, for the purpose of assuring the implementation of conventions thatsettlethecross-borderpollution,itspreventionandreducing;

7. Elaboration of strategies to protect citizens against natural disasters, ecologicalaccidentsandexposurewithinareaswithecologicalrisk;

8. Strengthening the partnership with NGOs, in the process of elaboration andenforcement of publicpolicieswithin thefield, by[i] Granting a priority attentiontothe ecological education of population through conceiving and implementing anationalactionplanforthepublicawarenessoftheenvironmentprotectionissue;[ii]Implementation of the Aarhus Convention requests upon access to information,publicparticipationin decision makingand access to justice withinthe environmentissues, by concludingthe legislativeframework,introduction of an informed systemat central, regional and local level, upon management of environment information;[iii] Achieving some yearly campaigns to increase public awareness upon itsparticipation in decision making process on environment, especially upon its rolewithinthe process of evaluatingthe environment impactof projects with significantimpact, authorization, environment evaluation for plans and programs; [iv] Mediacoverage of some punctual environment protection issues: GMO GeneticallyModified Organisms, POPs Persistent Organic Pollutants, PCBs- PolychlorinatedBiphenyls, climatic changes, in order to protect not only the environment but alsopeoplehealthfromthedamagingeffectofthesesubstances.

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In Romania, progress has been made with regards toenvironmental legislation, especially after the year 1989. Thenew Romanian Constitution was published in the RomanianOfficial Journal, PartI, no.233 on 21 November, 1991, approvedby a national referendum held on 8 December, 1991. Beginningwith the year 1990, environmental protection becomes a majorpart of environmental policies through the development of alegal regime in direct correlation with the major changes in allsectors of the Romanian economy and also in accordance toEuropeanPolicy.

Also, following this period, Romania has become a Party to themostinternationalenvironmental conventions and instrumentswhich require a legal basis and capacity building for theirimplementation. Thus, Romania is a signatory Party to theConvention on International Trade in Endangered Species ofWild Fauna andFlora(CITES),theEuropeanConvention fortheProtection of Animals during International Transport, the

Convention on the Conservation of European Wildlife andNatural Habitats, the Convention on the Protection and Use ofTransboundary Watercourses and International Lakes, theConvention on Environmental Impact Assessment inTransboundary Context, the Convention on Persistent OrganicPollutants, the Rotterdam Convention on Prior InformedConsent Procedure for Certain Hazardous Chemicals andPesticides in International Trade, the Convention on control ofTransboundary Movements of Hazardous Wastes and theirDisposal,the Kyoto Protocolto theFrameConvention ofUnited

CHAPTER 2

ROMANIANBIOSAFETY REGULATORY SYSTEM

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Nations on Climate Changes, the Convention on Biological Diversity and theCartagenaProtocolonBiosafety.

To-date,almost allthe countriesin theregionhave ratified,togetherwiththe EU,theCartagena Protocol on Biosafety; therefore, constituting a Biosafety - relatedRegionbecomes imminent as the national biosafety systems will be developed andharmonized in connection with systems existing in the countries in this region. Themain Romanian environmental legal acts that are ratifying, accepting or approvingtheseinstrumentsarepresentedchronologicallyinannex3.Romaniahasdoneandisdoing sustainable efforts towards protecting the environment and human healthaccordingtoEUBiosafetyPolicy.

Starting with 1995 Romania is also a signatory Party of WTO and it also signed thethreeagreements:SPS,TBTandTRIPSs(Law133/1994,publishedinOfficialJournalno.360/1994).

Starting with the year 1999, Romania has been developing a pragmatic andtransparent regulatory system and capacity building in the field of geneticallymodified organisms by, publishing the GO 49/2000 approved with modificationsand completions by the Law 214/2002. Currently, Romania is one of the fewcountries in Europe where approved GMOs are actually commercially grown.InterfacingregulationsarealsolistedinAnnexno3.

Several authorities are committed to promulgate legislative acts for biosafetydomain and the legal acts described bellow belong to the Ministry of Environmentand Water Management (MEWM), the Ministry of Agriculture Forestry and RuralDevelopment (MAFRD), the National Sanitary-Veterinary and Food SafetyAuthority(NSVFSA)andtheNationalAuthorityforConsumerProtection(NACP).

(30 January, 2000) is the first GMO regulation regarding the regimeof obtaining, testing, use and commercialization of genetically modified organismsobtained through modern biotechnology techniques and also of the productsresulting thereof (published in the Official Journal no. 48/ 2000). After two years,

GO no. 49/2000

2.1. REGULATORY REGIME RELEVANT

TO GENETICALLY MODIFIED ORGANISMS (GMOs)

based on the new experience in the field of EU countries and also of Romania, thisordinancewascompletedandamendedbythenewLaw214/2002.

(19 April, 2002) for the approval of the GO 49/2000 regarding theregime for obtaining, testing, use and commercialization of genetically modifiedorganisms obtained through modern biotechnology techniques and also of theproductsresultingthereof waspublishedintheOfficialJournalno316/2002.

Thepurposeof this lawis primarilyreflected inthe contentsof Art. 1.theobtaining,testing, use and commercialization of genetically modified organisms obtainedthroughmodernbiotechnologytechniquesandproductscontaininggmos.

Article 1 definestheactivitiesthat fallunder theprovisionsof this law:(a) containeduse of genetically modified microorganisms; (b) deliberate release into theenvironmentof genetically modified organisms,for other purposes thanplacing onthemarket;(c)placingonthemarket;(d)import.

In thesamearticlethe objectivesof thelaw arepresented:activitiesthat involvetheobtaining, testing, use and commercialization of genetically modified organismsobtained through modern biotechnology techniques are subjected to specialregulatory regime, including authorization and administration, in accordance withthe provisions of the GO 49/2000 and of other legal international acts to whichRomaniais a Party. Among these objectivesare included:[i] activitiesregarding thecontaineduse of geneticallymodifiedmicroorganisms;[ii] definitionof termsfor thedeliberate release into the environment and placing on the market of geneticallymodified organisms and of the products resulting thereof, such that these activitiesare carried out in the safest conditions with regards to human health andenvironment protection;[iii] definition terms of import/export of genetically

modifiedorganismsandoftheproductsresultingthereof.

Exemptionsfromtheenforcementofthelawarealsoforeseen:a)organismsobtainedthrough genetic modification techniques mentioned in annex no.1, part B and inannex no.2, part A of the present law; b) processed products; c) transport activities,regardless the mean or way; d) trade, import that are the subject of other normativeacts.

The law regulates: [1] competent authorities, [2] the Biosafety Commission, [3]procedures (notification procedure, notification contents, authorization process

Law no. 214/2002

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duration, simplified procedures), [4] risk assessment, [5] risk management, [6]monitoring, [7] labelling, [8] public information and consultation, [9] guarantee oninformation confidentiality and publishing rights, [10] accidental situations, [11]emergencyplans, [12]financialmechanisms, [13]entry intoforce, [14]sanctions,[15]prejudice,[16] liability,[17] internationalcollaboration in thisfield, [18] definitionofterms,[19]annexesinterfacingGO49/2000.

Law 214/2002 largely transposes the following EU legislation: Directive90/219/EEC regarding the use in contained conditions of genetically modifiedmicroorganisms, amended by Directive no. 98/81/EEC; Directive no. 2001/18/ECthat repeals Directive no. 90/220/EEC regarding the deliberate release into the

environmentofGMOsandnotcompletelytheCartagenaProtocolonBiosafety.

This lawis already amended byother legislative acts (MEWMOrdersno: 606/2005,838/2005, 923/2005) and it will be changed and completed in the future, as it isnecessary to improve the clarity and transparency in accordance to internationalagreementsinthisfield.

Moreover, law provisions regarding the contained use cover only geneticallymodified microorganisms, but does not specifically include plants and animals. Inturn, the concepts of plant and animal cell cultures are included in the definition ofmicroorganisms, which scientifically is not correct. In this context, the chapterreferring to definitionsshouldbe revised in accordancewith thedefinitionsforeseenbytheCartagenaProtocolonBiosafety.

The law does not gives details on simplified procedures foreseen in the CartagenaProtocol on Biosafety. It is necessary to revise the chapters that describe the riskassessment and management procedures in accordance with the Directive

2001/18/EC.Also,enforcementproceduresarenotclearlyspecified.

It is necessary as well to revise the procedure for public participation in decisionmakingprocesssothatthepublicparticipateseffectivelyandnotonlyformally.

(5 August, 2002) is the main legal act regarding theorganization and functioning of the members of the Biosafety Commission. Itincludes also the names of the Biosafety Commission members related to theirofficialaddress(publishedintheOfficialJournal,PartI,no.793/2002

MEWM Order no. 684/2002

With regards to the functioning of the BC, it is necessary to revise the rights andobligationsof BC members. Also, itis necessaryto enforcethe financialmechanism,ascurrentlytheyaredoingvoluntarywork.

(6 July 2005) regarding the approval of the Format fortheresults of deliberate releaseinto theenvironment of genetically modified plants,forpurposesother than placingon themarket(published inthe OfficialJournal,PartI,no.707/2005).

This order entirely transposes the provisions of the Decision no. 2003/701/EC forestablishing on the basis of Directive no. 2001/18/EC a format for the results of

deliberate release into the environment of geneticallymodified plants, for purposesotherthanplacingon themarket,publishedin theEUOfficialJournalno.254 /2003.

fortheapprovalofGuidelinesregardingtheapplicationof the Annex 122 Monitoring Plan belonging to Law 214/2002. This guidelines arecomplying with Decision 2002/811/EC for the applying the Annex VII of Directive2001/18/EC

regarding the approval of the Format for notificationsummary for placing on the market genetically modified organisms such as or inproducts.

(11 March, 2003) is the legal act for ratification of the CartagenaProtocol on Biosafetyto theConventionon BiologicalDiversity(the Convention wassigned on 5 June, 1992 in Rio de Janeiro). Cartagena Protocol was adopted inMontrealon 29January,2000 (published inthe OfficialJournal,Part I,no. 192/2003).Thislaw enteredinto force on28 September,2003.

(15 May, 2002) regarding the production, processing,controland qualitycertification,seed and reproductivematerialcommercialization,and also the registering of plant varieties (published in the Official Journal, Part I,no.343/2002).

The Law stipulates that in the case of genetically modified varieties, allaccompanying labels and documents will clearly indicate that the variety has beengenetically modified. Also, interdiction measures can be taken, for the use of agenetically modified varietyon a part or allof Romania's territoryif it isascertained


MEWMOrderno. 838/2005


Law no. 59/2003

MAFRD Law no. 266/2002

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thatthe varietyisharmfulto othercropvarietiesorotherspeciesor presentsa risk forthe environment or to human health. Also, another important provision strictlyrefers to the genetically modified variety that can not be tested and registeredwithout the notifier proving that such activities are in accordance with legalprovisions regarding the protection of the environment, to human health andanimals.

(27November, 2002)for theapprovalof theregulationsand technical norms regarding the production, control, quality certification andcommercializationof viticulturebreedingmaterial (publishedin the Official JournalPartIno.937/2002).

This order has been issued on the basis of the provisions of Article 12 of Law no.266/2002 regarding the production, processing, control and quality certification,commercializationof seedsand reproductivematerialand also,registration of plantvarieties, taking into consideration the need for harmonizing the Romanianlegislation with the regulations foreseen in Directive no.68/193/CEC of theEuropean Commission regarding the commercialization of plant (vegetative)grapevine reproductivematerial,last amended by the Directive 2002/11/EC, on thebasis of the provisions of GD 362/2002 regarding the organization and functioningof the MAFRD with subsequent modifications and completions. In this order it isstipulatedthat geneticallymodifiedvarietiescan be approvedfor testing, breedingor commercialization onlyif allnecessary measureshave been taken to avoid risk tohuman health and the environment, according to legal regulations in force.Genetically modified varieties registered in the catalog will be clearly indicated.Moreover, in the case of reproductive multiplying material derived from agenetically modified variety, all labels attached or all accompanying official

documents of the supplier must clearly indicate that the variety is geneticallymodified.

(15July,2003)regarding theregisteringof alleconomicoperators that are cultivating genetically modified plants (published in the Official

Journal, Part I no. 542 /2003). This law is very important for traceability and inpresent Ministry of Agriculture Forestry and Rural Development has developed anarchiveregardingthenumberofeconomicoperators,cultivatedsurfacesandyields.

Theorder foresees thatall economic operators (legalor natural persons, associations

MAFRD Order no.550/2002

MAFRD Order no.462/2003

without legal power) are obligated to declare (sign a statement) to the countydepartments for agriculture and rural development, respectively, BucharestMunicipality, the land surface area cultivated with genetically modified plants andthe yield obtained. This statement is completed in two copies one copy is for thecountydepartmentforagricultureandruraldevelopmentandhastobesubmittedinmaximum tendaysfrom completingsowing(Annex 1 of theOrder), andharvesting(Annex2oftheOrder);onecopyiskeptbytheeconomicoperatorforaperiodoffiveyears; the information is collected and processed by the county department foragriculture and rural development and is sent electronically to the centralinformation centre of the Ministry of Agriculture, Forests and Rural Development

(Recordregister of all economic operators that cultivate genetically modified plantsinRomania).

(14 May, 2004) for the approval of GO no. 11/2004 regarding theproduction,commercialization anduse of reproductiveforestrymaterial(publishedin the Official Journal, Part I no. 466 /2004) stipulates that the use of geneticallymodified reproductive forestry material that is harmful to human health and theenvironment is an offence and is punishable with imprisonment from two to fiveyearsorfine(Article.442).Moreover,thislegalactisstatingthatstipulatesthatnotdeclaring that any reproductive/breeding forestry material is derived from agenetically modified seedling is punished with imprisonment from one year to fiveyearsorfine(Article443).

(29 September, 2003) for the approval of sanitary-veterinary normsregardingnational proceduresfor authorizing and surveillanceofveterinary medical products (published in the Official Journal no 787/2003) ispresenting the contents of the request for authorizing a genetically modified

veterinarymedicalproduct(Article6).(28 February, 2002) approving the Sanitation

RegulationProceduresforprojectsenvisagingthelocation,building,equipping,andregulating- from thesanitarypointof view- theoperationof facilities andactivitiescarried out therein, other than the ones subject to registration with the TradeRegistry, as well as the Sanitation Regulation regarding the market introduction ofsubstancesandproductsthatareeithernew,orhavebeenimportedforthefirsttimeanddestinedto human useor consumption (published in theOfficialJournal, PartIno.181/2002).

Law no 161/2004


MAPDR Order no. 117/2002

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This Orderlistssubstances andproductcategories that areeither new,or havebeenimported for the first time, subject to a sanitary regulation before being introducedinto the market, mentioning, under item 13, the genetically-modified organismsand products derived thereof, destined for human use or consumption cleared bytheClearanceCommission.

(14 October, 2002) regarding the labelling of food products(published in the Official Journal, Part I, no. 147 /2002). This regulation stipulatesmethodological norms regarding labelling in the case of food products obtainedfromorcontainsgeneticallymodifiedorganismsorfoodstuffs.

(14 October, 2004) for modifying and completing GovernmentalDecisionno.106/2002regardinglabellingoffoodproducts(publishedintheOfficial

Journal,PartIno.1014/2004).

This Decision transposes: [1] Regulation 1139/98/ECE regarding the obligation forindicating on the labels of food products obtained from genetically modifiedorganisms of supplementary information other than that foreseen by Directive79/112/ECE, published in the Official Journal of the European Commission no.L159/3 June, 1998, modified by regulation 2000/49/EC, published in the Official

Journal of the European Commission no. L006/11 of January, 2000; [2] Regulationno. 2000/50/EC regarding the labelling of foods and foodstuff that containsadditives and aromas that have been genetically modified or that have beenproduced from genetically modified organisms, published in the Official Journal oftheEuropeanCommissionno.L006/11thofJanuary,2000.

(21 June, 2001) regarding the regulatory regime for theproduction, movement and commercialization of food (published in the Official

Journalno.349/2001).

TheOrdinance definestransgenicfoodas containing a newcombinationof geneticmaterial obtained through biotechnology techniques and/or organisms (as anybiologicalentitycapable toreproduceor totransferits geneticmaterial)in which thegenetic material has been modified through a process that does not naturally occurby breeding and/or natural recombination. In section 9 are presented theconditions regarding food designated for special nutritional, nutritivesupplementary, improving food nutritive quality purposes and those geneticallymodified.

GD no.106/2002

GD no. 1719/2004

Ordinance no. 97/2001

Law no. 215/2004

GD no. 917/2001

(27 May, 2004) for the approval of Government Ordinanceno.42/2004(29thofJanuary,2004,publishedintheOfficialRomanianJournal,PartI,no.94 of the31stof January, 2004) regardingthe organization of veterinaryactivities(publishedintheOfficialJournal,PartI,no.531/2004).

According to this Law, the sanitary-veterinary authority grants scientific adviseand technical and scientific assistance regarding human nutrition, taking intoconsideration the provisions of national, community legal documents, issuesscientificpermitsregardingissuesrelatedtohealth,animalandplantprotection,andalso scientific permits regarding products, other than food and feed for animals,relating to genetically modified organisms as defined by GO no.49/2000regarding

the regime for the obtaining, testing, use and commercialization of geneticallymodified organisms obtained through modern biotechnology techniques, and also,of the products resulted thereof, approved with modifications and completions byLawno.214/2002.

(13September, 2001) forthe approval of methodological norms forimplementing the provisions of EGO 34/2000 (published in the Official Romanian

Journal, Part I, no 172 of the 21st of April 2000) regarding ecological agro-foodproducts (published in the Official Journal, Part I no. 640 of the 12th of October,2001). The EGO 34/2000 was abrogated by Law 38/2001 (published in the OfficialRomanianJournal,PartI,no.122/2001).

This act underlines in the methods for ecological production used for obtainingnon-processed vegetable, animalproductsand animals, with theexception of seedsand regenerating material is compulsory not to use genetically modified organismsand/or products derived from such organisms, with the exception of veterinarymedicine use. Also, it is forbidden the use of genetically modified organisms andofproductsderivedthereofinobtainingfeed,primematerials,feedcompounds,andfeed additives, auxiliary for producing feed and of other products used in animalfeed. Moreover, the use of genetically modified microorganisms or productsagainstpestsisexcluded.

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Tradition preserving may influencethe modern biotechnologydevelopment and subsequently thebiosafety system


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The National Competent Authority for receiving notificationsregarding genetically modified organisms (GMOs), inconformity with the GO 49/2000 on the obtaining, testing, useand commercialization of genetically modified organismsobtained through modern biotechnology techniques as well asof the products resulting thereof, approved with completionsand modifications by Law 214/2002, is the Ministry ofEnvironment and Water Management (MEWM). Theorganization andfunctioning of MEWM is regulated by GD no.408/2004.

In Romania the management systems for notifications andauthorization requests are achieved through a specificinstitutional framework regulated in accordance with severallegalactspresentedinBoxno5.

Theinstitutionalframeworkisprovidedbyseveralauthorities:

a) Ministry of Environment and Water Management (MEWM),as the CentralPublic Authority for EnvironmentProtection;thisauthority is responsible for issuing import permits,authorizations for GMOs deliberate release into theenvironment andplacingon themarket andfor theenforcementofthelaws;

3.1. INSTITUTIONAL FRAMEWORK

CAPITOLUL 3

SYSTEM FOR HANDLING NOTIFICATIONSAND REQUESTS FOR PERMITSOR PRODUCT AUTHORIZATIONS

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b) Central public authorities from the following sectors agriculture, food, healthwith responsibilities in approval/consent and control of activities (they areregulatedbythefollowinglegalacts:Law214/2002andLaw215/2004):

- MinistryofHealth

- MinistryofAgriculture,ForestsandRuralDevelopment

- National Sanitary-Veterinaryand FoodSafety Authority

- NationalAuthorityforConsumerProtection

c) BiosafetyCommission(BC) as thescientificbody witha technicalconsultative rolein decision-making for the MEWM. Structure, organization and operating rules ofthe Biosafety Commission are established by MEWM Order 684/2002. Thiscommissionconsistsof members belonging to theRomanian Academy (3 members),the Academy for Agricultural and Forestry Sciences "Gheorghe Ionescu-Sisesti" (3members), the Academy of Medical Sciences (3 members) and universities andresearch institutes in biology, agriculture and health (3 members). The ordernominates the 12 members of the Biosafety Commission, in the exercise of itsattributions having consultative role, while decisions are taken by consensusagreement.

3.2. AUTHORIZATION PROCEDURES

3.2.1. GMO FOR DELIBERATE RELEASE INTO THE ENVIRONMENT

(Cultivation and commercialization)

This procedure is regulated by articles 1, 11, 24, 25, 49 of the GO 49/2000, approvedwith modifications and completions by the Law 214/2002 and follows the schemepresentedinAnnex1.

[i]NotificationAny legal entity, beforereleasinginto theenvironmentor placing onthemarket a GMOor a combination ofsuch organisms,should send a notificationtothe MEWM that should contain the information presented in Box no 6. OtherobligationsoftheNotifierarelistedinBoxno7.

Box 5

The legal basis for theinstitutional frameworkworking in the system forhandling notifications orrequests forauthorizations is providedby the following legalacts:

1. GO 49/2000 on the obtaining, testing, use andcommercialization of genetically modifiedo r g a n i s ms o b t a i n e d t h r o u g h m o d e r nbiotechnology techniques as well as of the

products resulting thereof, approved withcompletionsand modificationsby Law214/2002;2.MEWMOrder 648/2002onthe approvalof thestructure of the Biosafety Commission and of theset of rules regarding its organization andoperation;3. Law 215/2004 for the approval of GovernmentOrdinance no. 42/2004 on the organization ofveterinary activities: The National Sanitary-Ve te r in a ry a n d F o od S a fe ty Au tho r ity(NSVFSA).

Box 6

Content of a GMONotification

1. Technical specifications (the Dossier) will

include GMOinformationas follows:[a] Generalinformation, including data on the personnelinvolved and the level oftraining;[b] informationo n ge n e ti ca l l y m o di fi e d o r ga n is m s ;[c ]Information on releasing conditions and thecharacteristics of the potential recipientenvironment;[d] Information on the impact of

genetically modified organism(s) on theenvironment;[e] Monitoring plan, in agreementwith the content of Annex 12.2., for theidentification of GMO effects on human healthand environment;[f] Information on the control,rehabilitation measures, waste management andaction plans in emergency situations;[g]Summary ofthe dossier, alsoin electronicformat,availableto thepublic.2. Environmental Risk Assessment (ERA)study, together with any references andindicationsregardingthe usedmethods;

3. Information on the results of previous releasesof the same GMOs or GMOs combinations onRomanianterritory and/oroutside Romania.

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AUTHORIZATION SYSTEM


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[ii]Confidentialinformationregime In the notificationsubmittedto the MEWM, theNotifier mayindicatethe information that he/she wishesbe treated as confidential,alsopresentingtheappropriatereasonssupportingit.

[iii] Checking notification and additional information The MEWM makes a firstevaluation of the enclosed information and may requests for eventual completionsor clarifications.In thecasethat thescientificinformation isincomplete, theMEWMmay ask for additional information and/or apply the precautionary principleinvoked by the Law 214/2002 Annex 121 B and also by the Cartagena Protocol onBiosafety, andalso canask forspecificconditions or evenreject importor banGMOreleaseintotheenvironment.

[iv]AuthorizationWhentheMEWMisconsideringthattheNotificationiscomplete,based on the information included in notification and other documents, starts theauthorizationproceduresranging fora 90 days period(see Annex 6) which consistsin:a)Informingandconsultingthepublicregardingthenotification;b)ConsultingtheBiosafetyCommission;c) Requesting the written consents from the central public authorities withresponsibilities in the following fields: agriculture, food, human health andconsumerprotection.

The MEWM can not issue any authorization for deliberate release into theenvironment of a GMO crop without being tested and homologated at the StateInstitute for Variety Testing and Homologation, which is organized and operating

according to Law no. 266/2002. MEWM takes into consideration the conclusions ofthe environmental and human health risk assessment studies, included in theNotification'sDossier, theadvice of theBC, written consentsfrom theother involvedauthorities as well as public comments. The MEWM should also take intoconsideration the socio-economic aspects and verifies the observance ofinternational obligations in this field, established by bilateral and multilateralagreements. Permits or approval can only be denied on grounds related to theprotectionoftheenvironmentand/orhumanhealth.

[i] Notification Before placing on the market for the first time, a GMO or a GMOcombinationas a produce, a notificationshouldbesubmittedto theMEWMthatwillinclude:

a)recordeddataandresultsobtainedduringR&Dactivities;b)EnvironmentalRiskAssessment(ERA)study;c) conditions for placing on the market, including the specific use andhandling conditions, as well as a labelling and packaging proposal. The labelshould clearly specify whether the product contains GMO. The label readingThisproductcontainsgeneticallymodifiedorganismsiscompulsory.d)amonitoringplan;e)asummaryofthenotification.

Each new product that contains or consists of the same GMO or of a GMOcombination,intendedforadifferentuse,willbeseparatelynotified.

[ii]Authorization Theproduct willbe placedon themarketonly after obtainingtheauthorization issued by the MEWM and after complying with the establishedconditions.

The registration in the State Register and the Official List ofVarieties/Cultivarsof genetically modified cropswill be carried out after obtainingtheauthorizationfor release intothe environmentfor experimentalpurposes,issuedby the MEWM. In other words, it cannot be possible to give a permit under Law214/2002withoutcomplyingwiththevarietyregistration,andalsoitcannotcomply

3.2.2. PLACING ON THE MARKET OF GMOAND PRODUCTS RESULTING THEREOF

Important

Box 7

Other Notifier'sObligations

[1] Follows the legal authorization procedure,providing all the necessary data to the competentnationalauthority;[2] Begins the proposed activity only afterobtaining the authorization issued by the

MEWM and complying with the conditions

established;[3] Respects and follow other procedures

followingthe GMOreleaseintothe environment.


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withvarietyregistrationwithoutapermitissuedaccordingtotheLaw214/2002.

In the case when authorization renewal is requested, the Notifier should address anew notification to the MEWM within 9 months before the authorization expires.ThistimethecontentofnotificationisdifferentandispresentedinBox.8.

[i]NotificationIn accordance with Art. 35.- (1)and GO no.49/2000, approved withcompletionsandmodificationsbyLaw214/2002,theimportersareobligedtonotifyin written form to the MEWM before any import of LMOs or of products resultingthereof.

TheMEWMwill establishthe notification proceduresand willmakethem availableto interested parties; the Notifiers are responsible for the accuracy of informationprovidedtoMEWMinthenotification.

[i] Notification acknowledgment The MEWMacknowledges that it has received the

notification to theNotifierby issuing a writtenform,within 90 days fromitsreceipt.According to Law 214/2002, the confirmation contains the following: a) date ofnotificationreceipt;b)whetherthenotificationcontainsallnecessaryinformationformakingadecision;c)otherspecifications,ifappropriate.

Non-compliancewith the procedure for receipt acknowledgment of the notificationby the MEWM should not be interpreted as a tacit agreement of the MEWMregardingtheimport.

[ii] Import decision The MEWM decision with respect to the approval of an import

3.3. IMPORT PERMIT

intended for the activitiesregulatedby GO no. 49/2000,approvedwith completionsand modifications by Law no. 214/2002, will be based on the data referring to riskassessment (risk assessment should be based on a scientifically sound information)and precautionary principle, taking into consideration the possible adverse effectsonbiologicaldiversity,conservationandsustainableuse,therisksonhumanhealth.

TheMEWMwill informthe Notifier,withinthe established period,whether: (a)theimport can take place without a written permit and in what conditions; and (b) theimportcantakeplaceonlyaftertheMEWMgivesitswrittenpermit.

Based on any new information provided by the risk assessment and monitoringstudies, the MEWM after consultation with the other central authorities in the fieldand the BC may: [1] limits the approval for GMO use or [2] modifies the conditionsforGMOuse.

If certain information that mighthave significantconsequences regarding the GMOpotential risks on the environment becomes available after issuing the approval,MEWM is obliging the notifier to modify conditions for deliberate release and/orplacing on the market, and in case of non-compliance, can suspend or cancel allactivities.

Whenever the user has new, relevant information, or changes the use conditions toan extent that might have significant consequences as regards risks, he is obliged toimmediatelyinformtheMEWMandconsequentlymodifythenotification.

The public is consulted during the authorization procedure for GMO deliberatereleaseintotheenvironmentandplacingonthemarketsince2000.

Within 10 days from the date when the MEWM accepts the notification asappropriate (the notification contains the information stipulated by the legal

3.4. NEW INFORMATION RELEVANT TO BIOSAFETY

3.5. PUBLIC INFORMATION AND CONSULTATION

IN THE DECISION MAKING PROCESS

Box 8

The content of a

notification in the case of

authorization renewal

a)a copyof thereceivedauthorization;

b) a report onthe monitoring activityresults;

c) any new information that became availableafterobtainingthe authorization;

d) if appropriate, a proposal for amending the

conditionsspecifiedin theauthorization.


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provisions), and the authorization procedure is started, it should inform the publicabout this notification, specifying the means by which information can be obtainedandthedeadlineforreceivingcomments.

Forthis purpose, theMEWMpublisheson itsown website (www.mappm.ro)TheNotification Summary as well as the Risk Assessment Study and other relevantdocuments (i.e. monitoring reports) and transmits a press release, through theDirectorate for Public Relations within the MEWM which will inform mass mediafromRomania.

At the same time, announcements are transmitted to the Territorial Environment

ProtectionAgenciesthatbelongtotheMEWM.

Comments of the public can be submitted within 30 days from the date of publicannouncement and will be taken into consideration by the MEWM in the decision-making process for the authorization of the proposed activity. Depending on thereceived comments, public debates can be organized regarding any aspects relatedtoscopeofthepresentordinance.

In accordance with Art. 491.- (1)of theGO no.49/2000, approved withcompletionsand modifications by Law no. 214/2002, in the notifications sent to the MEWM, theNotifier can indicate the information that should be treated as confidential, whilealsopresentingthereasonsforthis.

Furthermore, the MEWM will decide, after consultation with the Notifier, which

information is meant to be treated as confidentialand willinform theNotifier on itsdecision.

It is important to underline that according to Romanian legislation the followinginformationcannot be consideredas beingconfidential: (a) generalcharacteristics ofmicro-organisms/genetically modified organisms, name and address of Notifier,purpose and place of activity; (b) the class of contained use and the containmentmeasures; (c) conclusions of risk assessment studies on environment and humanhealth; (d) methods and plans for monitoring and response in case an accidentacquires.

3.6. CONFIDENTIAL DATA REGIME

TheMEWMwillnot provideto anythirdparty anykindof confidentialinformationandwillprotectthecopyrightsinrelationtothereceivedinformation.

If,regardless of reasons, theNotifier withdrawshis notification,the MEWM shouldrespecttheconfidentialityofallreceivedinformation.


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Box 9

Romanian Research

Capacity on Modern

Biotechnology

Final recommendations of UNEP GEF workshopof 17 November, 2004, Bucharest RomanianResearchCapacityon Modern BiotechnologyThe conclusions of the workshop on theevaluation of the biosafety research capacity arerelevantfor thisfield:1. No research development strategy has beenestablishedin thefieldof modern biotechnology;

2. There is a regulation system in place for GMOcontained use or testing; however, until 2004 noresearch application in this field was notified totheMEWM.3. At present, Romaniahas facilities thatmakes it

possible to create GMOs only on a collaborationbasis(itcan notcreatetransformationvectors);4. Romania does not have the full capacity todevelop anduse modern biotechproducts;5. Romania has the scientific competence(humanresources) for research-monitoring activities;however,it hasnotbeensupported sofarto obtain

fundsrequiredfor facilitiesacquisition;6. Romania has no accredited laboratories forGMOspecifictests;7. Through theState Institutefor Variety Testingand Homologation, Romania has the necessarycapacity and competence to test and registervarietiesand hybridsofGM crops.

8. Research in the private sector practically doesnot exist.


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3.7. GMO FOR CONTAINED USE

[i] NotificationThe National Competent Authority for contained use activitiesis theMEWM, in accordance with GO 49/2000, approved with completions andmodifications by Law 214/2002. This authority will check the notification on thebasis of documentation provided by the user whether the adequate measures havebeen taken in order to avoid the adverse effects on human health and environment(seeAnnex2oftheLaw214/2002).

Any public or private research institution, as users, should notify any researchactivity that involves GMO contained use. These institutions should present a

contained use assessment study regarding the risks on human health and onenvironment, also obliging to keep an assessments record and making themavailable to theMEWM. Recentconcluding remarks regardingthe evaluationof themodern biotechnology research capacity in Romania are listed in Box no. 9 and theentirereportis availableon thewebsite:

The assessment will be carried out in accordance with the procedure foreseen inAnnexno.3ofthelawanditshouldleadtotheclassificationofthecontaineduseintooneoftheclassespresentedinBoxno10.

When uncertainty exists in relation to theclassof theproposed contained use, moresevereprotection measuresshouldbe applied exceptfor thesituation inwhichthereare sufficient evidences that justify the application of less severe measures, in jointagreementwiththecompetentauthority.

[ii] AuthorizationThe Notifier mayrequestauthorizationfromthe MEWM that willmake a decision within 45 or 90 days from the notification, depending on the risk

class.The MEWM will analyse the compliance of notification with the provisions of theGO 49/2000, the accuracy of assessment, as well as the contained use class, theprotection and response measures in emergency cases, as well as wastemanagement.

The approvals for the activities related to GMO contained use, according to theprovisionsof Art. 12-15 (GO49/2000),are given under theform of an authorizationwhosetemplateisestablishedbytheMEWM.

www.biosafety.ro

The necessary information for notifying is in accordance with the provisions ofAnnex no. V to the EU Directive 98/81/EC, on the contained use of geneticallymodifiedorganisms.

The objective of environmental risk assessment is the identification and assessmentof the possible adverse effects that GMOs may have on human health or onenvironment as a result of the deliberate release into the environment or placing on

themarket;theseeffectsmay bedirector indirect andtheymay appearimmediatelyorwithdelay.ERAshouldbecarriedouttoestablishwhetheritisnecessaryornottodevelop a risk management plan; in case this proves to be necessary, the bestmethods forenforcement shouldbe specified. Theprocedure isregulatedby GOno.49/2000,approvedwithitsmodificationsandcompletionsbyLawno.214/2002thattransposesEUDirective2001/18/CE.

The general rules, in agreement with the precautionary principle in conductingenvironmental risk assessment study, should comply as follows: [1] the identifiedGMO characteristics that can induce adverse effects during GMO use should becompared with the characteristics of the non-genetically modified organism fromwhich it is derived; [2] should be scientifically-based and transparent, based onexisting data; [3] should be done on a case-by-case basis, as the information may bedifferent according to the GMO type, the purpose for use and the characteristics ofthe environment where it is released; the results of the GMO previous releases intothe environment should be considered as inter alia. [4] When new informationappears regarding to the genetically modified organism and its effects on the

environment, the environmental risk assessment study should be revised toestablishif:a) therisksare modified;b)it isnecessary tomodify theriskmanagementplan.

Developing guides for implementing risk assessment is one of the present concerns(e.g.Guidefornotificationsandriskassessmentforreleasesofgeneticallymodifiedorganisms - Draft 9 November 2005 ).www.pubresreg.org

3.8. RISK ASSESSMENT


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3.9. RISK MANAGEMENT

Risk management consists of the establishment and enforcement of a set of riskmitigation or monitoring measures and intervention measures in case of accident.Theprocedure isregulatedby GOno. 49/2000,approvedwithits modificationsandcompletionsbyLawno.214/2002thattransposesEUDirective2001/18/CE.

During the risk assessment procedure, the risks should be identified for which it isnecessarytoelaboratemanagementplansandtoestablishtheadequateplanthathastobeapplied.

GMO general risk assessment is carried out taking into consideration each strategyproposedfor theriskmanagement,on a case bycasebasis.

This procedure is extremely important as it facilitates the management of anyadverse possible impacts on the environment and human health that may emergeimmediatelyand/orwith delay,ina directorindirectway,as a resultof usingGMOsor GMO-based products (contained use, cultivation for commercialization andplacingonthemarket).

Co-author AnaMariaCom noiu

Box 10

Contained use

classification

class 1

class 2:

class 3

class 4:

: activities with negligible or no risk, i.e.activities for which containment level 1 isadequate for human health and environment

protection;

activities with low risk, i.e. activitiesfor which containment level 2 is adequate forhuman health and environment protection;

: activities with moderate risk, i.e.activities for which containment level 3 isadequate for human health and environment

protection;

activities with high risk, i.e. activitiesfor which containment level 4 is adequate forhuman health and environment protection

Soyabean Roundup Ready is the only biotechcrop approved for cultivation in Romania

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GMO import, release into the environment and placing on themarket, as well as contained use are followed by specificbiosafety activities. One of these activities is the monitoring ofGMO effects on the environment and human health and theidentification of unforeseen effects not identifiedduring the riskassessmentstudies.

In accordance with GO no. 49/2000, approved withmodifications and completions by Law 214/2002, GMOactivities will be subjected to the monitoring procedure withregard to the potential adverse effects on human health andenvironment. The monitoring will follow certain procedures,clearly stipulated in the law, according to a monitoring planpresented by the Notifier; the scientific information obtained asa result of the application of this procedure will be used for

future risk assessment procedures as regards the placing on themarketofthesameGMO.

The monitoring activity can be carried out for contained useand/or after obtaining the approval for GMO release into theenvironment or placing on the market. The data collected as aresult of the monitoring process should provide newinformation on theimpact of GMOreleaseinto theenvironmentor on the market, under different conditions. When such newinformation appears, this should be automatically considered

MONITORING ACTIVITY

C APTER 4H

MONITORING

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when carrying out the following environmental risk assessment studies. Theexperienceand informationcollectedthrough themonitoringof GMO for deliberaterelease in the environment should be the basis for the design of the monitoringsystemforplacingon themarket,assuchor undertheformof differentproducts.

The objectives of the monitoring plan stipulated by the law 214/2002 are accordingto Directive 2001/18/EC [1] confirm that assumptions in the environmental risk

assessment regarding the occurrence and impact of potential adverse effects of theGMOoritsuse were correct;[2]identifytheoccurrenceof adverse effectsof theGMOor its use on human health and the environment that were not anticipated in theenvironmentalriskassessment.

Accordingto theLaw,the designof themonitoring planhavecomplywith Directive2001/18/ECand these requirements areas follows: [1]be detailed on a case by casebasis takinginto accountthe results of theenvironmental risk assessment (ERA);[2]take into account the characteristics of the GMO, the characteristics and scale of itsintendeduse andthe range of relevantenvironmental conditionswherethe GMOisexpected to be released; [3] incorporate general surveillance for unanticipatedadverse effects and, if necessary, (case-) specific monitoring focusing on adverseeffects identifiedin ERA; [i]whereas case-specific monitoringshouldbe carried outfor a sufficient time period to detect immediate and direct as well as, whereappropriate, delayed or indirect effects which have been identified in ERA; [ii]whereas surveillance could, if appropriate, make use of already established routinesurveillance practices such as the monitoring of agricultural cultivars, plant

protection, or veterinary and medical products. An explanation as to how relevantinformation collected through established routine surveillance practices will bemade available to the consent-holder should be provided; [4] facilitate theobservation, in a systematic manner, of the release of a GMO in the receivingenvironment and the interpretation of these observations with respect to safety tohumanhealthor theenvironment;[5]identifywho (notifier,users) will carryout thevarioustasksthe monitoringplan requires andwho is responsible forensuring thatthe monitoring plan is set into place and carried out appropriately, and ensure thatthere is a route by which the consent holder and the competent authority will be

MONITORING PLAN

informed on any observed adverse effects on human health and the environment.Time points and intervals for reports on the results of the monitoring shall beindicated);[6] give consideration to the mechanisms for identifyingand confirmingany observed adverse effects on human health and environment and enable theconsent holderor thecompetent authority,whereappropriate,to take themeasuresnecessarytoprotecthumanhealthandtheenvironment.

The MEWM Order no. 606/2005 approves the Format for presenting the results ofdeliberate release into the environment of genetically modified crops, for otherpurposes than placing on the market. As it has been mentioned in chapter 2, theOrder fully transposes the Commission Decision no. 2003/701/EC, based on

Directive no. 2001/18/EC. Clear procedures are specified: [1] or each notificationnumber, the Notifier submits a final report or a final and intermediary report onpost-releasemonitoring,according to eachcase. Bothtypes of reports are elaboratedinaccordancewiththe ReportFormat;[2] thefinalreportcan betransmittedafter thelast harvesting of genetically modified crops. If for a notification no post-releasemonitoring is required, no subsequent reports are needed; [3] the final post-releasemonitoringreportissubmittedafterthecompletionofthepost-releasemonitoring.

Co-author AnaMariaCom noiu

MONITORING

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The Romanian arable surface especiallydevoted for tradition crop cultivation isaround 9.38 mil ha . Modern Biotechnology ispromising to obtain new cultivars, expressingnew traits, considered as superior comparedto the traditional crops


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Labelling and traceability are other important elements of thefollowup phase of a biosafetysystem. Themain legal actthatcovers these activities is GO no. 49/2000, approved withmodificationsandcompletionsbyLaw214/2002.

thefoodstuffs on themarketthatare based on GMOsor thatcontain additivesand flavours thathave beengeneticallymodified or obtained from GMOs, is currently regulated by theGD 106/2002, Appendix no. 3, initiated by the NACP (theMinister of Environment and Water Management has noresponsibilities in this field). The label should clearly specifywhether GMOs are present. It is compulsory that the labelshould clear specify This product contains geneticallymodifiedorganisms.GD106/2002onfoodlabelling,stipulatesin Appendix no.3 the Methodological Norms on additionalinformation that shouldbe compulsory specified by labelling inthe case of food obtained from GMOs or that containsgenetically modified additives and flavours that are obtained

fromGMOs.Thisreferstofoodstuffsorfoodingredientsthatarefully or partly obtained from genetically modified soybeans,tolerant to glyphosate and to genetically modified maize,tolerant to ammonium glufosinate. The line product obtainedfrom genetically modified will be clearly specified onthefoodstuff labelor inthe list that specifiestheingredients. Theproducts containing more than 1% GMOs will be labelled,which for the moment is not complying with the EU regulation(0.9%). Foodstuffs and food ingredients should not be labelled,according to this decision if they do not contain protein and/or

Labelling

CHAPTER 5

LABELLING AND TRACEABILITY

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DNAofGMO(i.e.oil,alcohol,starch).

may be achieved only through appropriate labelling throughout thechain forexampleGMO fromthelaboratory toplantbreeders, toseed producers, tofarmers, processors, and importer/exporters. It will be effective after transposingthe Regulation 2003/1830/EC and by ensuring the means of GMO detection andanalysis. This responsibility lies with to the National Sanitary-Veterinary and FoodSafety Authority (NSVFSA) that will collaborate with the MEWM, the Ministry ofAgriculture, Forests and Rural Development (MAFRD), the National Authority forConsumer Protection (NACP) and the Ministry of Health (MH). The transposingdeadline,establishedbythePositionDocument,isthesecondsemesterof2006.

CertaintraceabilityelementshavealreadybeenintroducedbyArt.29,par.1(c)oftheGO 49/2000, approved with modifications and completions by Law no. 214/2002,referringtolabellingandpackaging.

Traceability elements have been also introduced through the MAFRD Order no.462/2003 regarding the evidence of farmers cultivating GMO crops. It is specifiedthat in the approval process regarding the deliberate release into the environmentand placing on the market of GMO crops in the year 2005, MAFRD approved theGMO imports and deliberate release in the environment for testing or cultivationpurposes, only on the condition of complying with the provisions of Order462/2003,byalltheeconomicoperatorscultivatingGMOcrops.TheMAFRD,onthebasis of this Order,is thecompetent national authorityfor theevidenceof economicoperators that cultivate GMOs. The Order stipulates that it is compulsory for alleconomic operators (natural or legal persons, non-legal associations) to declareGMOs cultivated plots with and the yields obtained to the County Directorates forAgriculture and Rural Development (CDARD), and to the Directorate of BucharestMunicipality. The statement is filled in two copies: one copy is to be sent to theCDARD in 10 days maximum after the crop cultivation is completed (Appendix 1),after thecrop harvesting(Appendix 2);and anothercopy is kept at thecentral officeof the economic operator for 5 years. Information are collected at the CDARD andelectronically transmittedto the Computing Centreof MAFRD(the RecordRegisterof Romanian Economic Operators Cultivating GMO crops). In order to ensure theobservance of the Order no. 462/2003 of the MAFRD, the companies provide theirclients with thestatementTemplates, together with theseed sellingdocumentsthatthey have to fill in and send to the Agricultural Directorates. At the same time, the

Traceability

companies should provide information to the MAFRD referring to the clientidentification data, sold seed quantities, varieties and biological categories. Thisinformation is necessary for checking the data received through the Agriculturaldirectorates.

According to Law no. 266/2002, seeds can be imported only after receiving theimportapproval issuedby theMAFRD. Thecommodity ispackedintobags,and onthe labels and accompanying documents it should be specified that the variety isgeneticallymodified.For a clearrecord regardingof theseed distribution, theclientsare obliged to return the empty packages to the respective companies, after thecultivation season. The MAFRD can forbid the use of a GMO variety in a certain

region of the country or on the whole territory, if it is found that the respectivevariety is harmful for other crop varieties (i.e. outcross pollination) or it endangerstheenvironmentorhumanhealth.Ageneticallymodifiedvarietycannotbetestedorregistered ifthe applicantdoesnotprovethatthiscomplieswiththe legalconditionsregardingenvironmentandhumanhealthprotection.

So far, a proper record of the imported quantities of GMO soybean for processingpurposescouldnotbe kept,as thereis nodistincttarifflineinthe ImportScheduleforthe genetically modified products. It is necessary to establish, together with theNCA, a recording system. In the same context, the MAFRD, together with theNSVFSA, imposed to the notifying companies the obligation to report the accuratesituationof cultivatedareas,of theyieldobtainedandof itsuseto theMAFRD.

Other traceability elements were also introduced in Romania through food safetylegislation, namely Law no. 412/2004 for the modification and completion of Lawno.150/2004on foodsafety. Thislaw providesfor checkingthe meansby whichfeedtraceabilityis carried outby alltheoperatorsandagents inthe foodindustry.On thisbasis, for the year 2005, the notifications of GMO producing companies, regardingGMO imports and deliberate release into the environment for testing as well as forcultivation purposes were approved only on the following condition: the economicoperators, authorized natural or legal persons operating in this field, shoulddemonstrate the destination of the GMO seeds, up to the point of theircommercialization of GMO as food or feed. At the same time, the labelling ofproducts was imposed. The users of GMO seeds are to be informed by notifiers ontheobligationstheyhaveintraceabilityandlabelling .

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Applying the isessential for the credibility of the biosafetysystem

transparency principle

Recommendations

Traceability or the application of the traceability procedure of a GMO from thelaboratoryto production,marketand then toconsumeror into theenvironmentis anessential condition that is imposed at EU level. The methods and techniquesnecessary for certifying the transformation event for traceability purposes are notregulatedby theLaw214/2002.Theuse ofservicesfroman accredited laboratoryforISO17025iscompulsory.

Co-author : AnaMariaCom noiu,ConstantinSins

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Enforcement is of utmost importance to the credibility of anybiosafetysystem.Theestablishmentandoperationofabiosafetyinspection body, accreditation of a laboratory according to ISO17025 (performing specific tests along the biosafety chain:import, contained use, greenhouse, field testing, deliberaterelease into the environment and placing on the market), areessential conditions for organizing a functional system in thisdomain, in close correlation with similar issues developed incountriesfromsub-regionandEUMemberStates.

Several authorities have responsibilities and capacities ofinspection and control. A brief presentation of them will begivenbellow.

(BC) is the scientific bodyestablishedby GO no. 49/2000,approvedwith completionsandmodificationsby Law214/2002,as wellas bythe MEWM Orderno 684/2002, to participatein controlactivitiesorganizedby thecentral public authorities. The BC a) participates in inspectionsandchecks thecompliance with legal provisionswithrespect to

INSPECTION AND CONTROL

6.1. MINISTRY OF ENVIRONMENT

AND WATER MANAGEMENT

THE BIOSAFETY COMMISSION

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the GMO contained use, deliberate release into the environment, placing on themarket; b) participates in inspection activities and checks the observance of legalprovisions with respect to import operations with GMOs or with products that arebasedon, contain or originate from GMOsobtained throughmodern biotechnologytechniques.

(NEG) for public inspection andcontrol operates as the specialized body of the central public administration underthe MEWM according to Government Decision 440/2005. The Directorate forControl of Natural Habitats, Biodiversity and Protected Areas is habilitated forcontrol and inspection activities with respect to biosafety, in accordance with the

MEWMOrder684/2002(Art3.2.).

The NEG is a specialized control and inspection body in charge of the effective,professional,uniform andintegrated enforcement of theGovernment policyfor theenforcement of the EU environment legislation which is transposed into theRomanianenvironmentlegislation.Technicalnormsregardingtheorganizationandcarrying out of the Control and Inspection activities in the field of environmentprotection are designed in accordance with the European Parliament and CouncilRecommendation (April 4, 2001) regarding the minimum criteria for environmentinspections in the EU Member States, with the provisions of Art. 65.s and Art.68 ofthe Environment Protection Law no. 137/1995, republished with its subsequentamendments(Appendix2ofthelaw).

TheNEG hasto enforceGovernment policy so as to prevent, ascertainand sanctionthe infringement of legal provisions with respect to environment protection,including the observance of legal provisions in relation to issuing environment andwater management permits, licenses and authorizations by the competentauthorities, according to the legislation in force, for the regulation of projects,programsandactivitiesspecifictothesefields.

Environment inspection is compulsory for those objectives having a significantimpact on the environment and it is exercised by the inspectors (commissioners)from the NEG structures; the inspection plans should be made available for publicconsultation, according to the legislation in force regarding public access to theenvironmentinformation.

The Commissariats at regional and county level, the Commissariat from Bucharest

THE NATIONAL ENVIRONMENTAL GUARD

and the Environment Commissariat of the Danube Delta Biosphere Reserveelaborate the TerritorialRegistersof the ControlledObjectives, containingthe listsof controlled objectives in their respective areas. The regional commissariats collectandapprove theTerritorialRegistersof theControlledObjectivesfrom their areaandsubmitthemtothe GeneralCommissariatof theNEGforthe approval.

Atnationallevel,theNationalRegisterofControlledObjectivesisestablished;thisdatabase is managed and periodically updated by the NEG General Commissariat.After checking, the NEG General Commissariat will approve and send theTerritorialRegisterofControlledObjectivestotheNEGterritorialcommissariats.

The environment inspection is an activity consisting of: 1) checking compliance; 2)investigating the impact on the environment that can result in future inspections(includingthe issuing, reviewing, suspendingor cancellingof legislativeacts) or theapplicationofsanctions,ifappropriate.

The environment inspections can be both scheduled and unannounced. Inspectionpreparation is an obligatory step, being necessary for ensuring efficiency andfulfillinginspectionobjectives;theinspectionactivityfollowsastrictprocedure.

TheNEGdocumentsavailableto thepublicare asfollow: [1] The National Registerof Controlled Objectives, at the NEG General Commissariat; [2] TerritorialRegister of Controlled Objectives'', at the NEG territorial commissariats; [3]RegistersofInspectionReports'',attheNEGcommissariats.

Confidential data (i.e. international relations, national or public security, the courseofjustice,therightofapersontobenefitfromrightjudgementortherightofapublicauthority to conduct a civil or penal investigation) and also the confidentiality of

commercial and industrial information, when this is stipulated in the law for thepurposeofprotectingalegitimateeconomicinterestwillnotbemadeavailabletothegeneralpublic. In this context, onlythoseinformation willbe available to thepublicregarding the emissions with significant effect on the environment; the copy rightcompliance.

Presently BC and NEG do not perform GMO-related inspection and controlactivities.As NEG is a very specializedstructurein inspection and controlactivities,

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this capacityshouldbe used forbiosafety activitiesas well. Itis necessaryto developthe GMO inspection body specialized in sampling and conducting specializedinspectionsandtoincludeitintothenationalbiosafetynetwork.

ThereareseveraldepartmentswithintheMAFRDthatenforcethelaw.

has the following tasks [1] it control theenforcement of regulations in wine and grapevine sector, vegetables, fruit, flowers,

as well as in the other activity sectors; [2] it checks the compliance with cultivationand land clearing norms, with all the technical norms governing agriculturalproduction; [3] it inspects the way legal provisions are observed with respect to theactivityinagricultureandforestrybytheunitssubordinatedtotheMAFRD.

(SITCVFP) operates within this directorate, established bytheOrderof theMAFRDno. 143/2004, on thebasisof theprovisions of Lawon fruitfarming no. 348/2003, Law no. 312/2003 on the production and marketing of fieldvegetables and Law no. 469/2003 on the production and marketing of greenhouse'vegetables,flowers and ornamental plants. At the sametime, thisdirectoratechecksupthedocumentationandapprovesthecultivationandlandclearingauthorizationsof the fruit and berry cultures, issued by the agricultural and rural developmentdirectorates at county level and of the municipality of Bucharest; it also checks on arandom basis the application of crop technologies in the commercial farms thatproducefruit,vegetables,melonsandmushrooms.

(SITVWC) also operates within this directorate, that was established onthebasisof theprovisionsof Lawno. 244/2002on grapevineand winein thesystemof joint market organization, providing for [1] the observance of legislationregarding the establishment and clearing of grapevine plantations; [2] the approvalof applications for the establishment and clearing of grapevine plantations on areaslarger than 0.1 ha per family or economic operator; [3] checking and control theenforcement provisions on the production, commercial purposes, of grapes, winesandothervineandwineproducts,regardlessofproducer.

6.2. MINISTRY OF AGRICULTURE, FORESTS AND RURAL DEVELOPMENT

draft nbf romania

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