Development of National Biosafety Framework for Republic of Croatia

The following agencies are implementing and financing this Project: United Nations Environment Programme (UNEP), the Global Environment Facility (GEF) and the State Institute for Nature Protection (SINP).

Duration of the Project: 7th February 2003 until 31st December 2004.

Republic of Croatia has signed and ratified the Cartagena Protocol (with the Convention on Biological Diversity) on 29th August 2002, which came in force on 11th September 2004.

Cartagena Protocol on Biosafety aims “to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements”.

The Ministry of Environmental Protection and Physical Planning has on 7th February 2003 signed with UNEP-GEF project of Development of the National Biosafety Framework for Republic of Croatia. For this Project the Ministry is National Executing Agency appointed by UNEP-GEF. Meira Bosnić holds the position of National Project Coordinator for the duration of the project. National Coordinating Committee (NCC) members have been selected from involved ministries, research institutions, universities, non-governmental organisations and industry. The first NCC meeting was held on 20th May, 2003. From the beginning of the Project NCC held its meetings ten times.

In December 2003 there were elections in Croatia and a new goverment has been appointed. The new goverment has restructured goverment bodies together with Ministries. The Ministry of Environmental Protection and Physical Planning (MEPPP), the National Executing Agency for NBF project, has been split in two. The Ministry of Environmental Protection and Physical Planning have been combined with Ministry of Construction. The part of previous MEPPP that is concerned with the Nature Protection (where NBF project was placed) was combined with Ministry of Culture. The State Institute for Nature Protection was on 2nd April 2004 appointed as the National Executing Agency for this Project. The State Institute is funded by Government through the Ministry of Culture.

The main objective of this National Project is the preparation of a National Biosafety Framework in accordance with the relevant provisions of the Cartagena Protocol on Biosafety. The Project officially ends on 31st December 2004.
Following a long legal vacuum in the GMO area where a de facto moratorium had been implemented with no base within the law, during the period from May to October 2003 numerous laws regulating biotechnology and biosafety have been adopted in Croatia. These laws are mostly in coordination with existing EU legislation.

The overall objective of this Project is to prepare countries for the entry into force of the Protocol, by, among others, assisting in the following activities:

1. Carrying out an assessment of current technological capacity to manage Biosafety issues, and the implications of this on the implementation of a National Biosafety;
2. Strengthening national capacity to develop national regulatory biosafety frameworks;
3. Strengthening national capacity for competent decision making on notifications and requests related to Living Modified Organisms (LMOs), including the establishment of administrative systems;
4. Support regional and sub-regional collaboration, including harmonisation of the implementation of national regulations;
5. Raise public awareness and improve information flow to the public on the issues involved around the release of Living Modified Organisms to promote informed debate and to ensure transparency with respect to the regulation of LMOs;
6. Provide all stakeholders with an opportunity to be involved in the design and implementation of a National Biosafety Framework.

By now, The Project achieved following objectives:

1. The Ministry of Environmental Protection and Physical Planning was nominated as The National Executing Agency. But, on 2nd April 2004 The State Institute for Nature Protection took over this function;
2. Meira Bosnić B.Sc., was appointed by the National Executing Agency as the National Project Coordinator, on a full time basis for the duration of the National Project. She is responsible for the overall co-ordination, management and supervision of all aspects of the National Project;
3. The National Executing Agency established the National Co-ordinating Committee to advise and guide the preparation of a National Biosafety Framework. Members of the NCC have been selected from four Ministries, six universities & research institutions, five non-governmental organisations and one industry;
4. The NPC with help from NCC members had conducted the National survey of:
   Existing uses of biotechnology and the arrangements for safe use of biotechnology.
   At the beginning of August 2003, after research, a questionnaire was constructed and was sent to 280 institutions in Croatia (Universities, Pharmaceutical companies, Food industry and Research institutions). A database was then created detailing relevant outputs of the National surveys. The questionnaire response was 64% from the institutions approached. In addition the Project has also used other sources for the required information. By doing so, data was gathered from 220 institutions with 518 laboratories.
   From this number of laboratories, only 6% out of the 13% that were using biotechnology, and had acknowledged that they had worked with GMO's. In the questionnaire they were asked to list their arrangements for the safe use of biotechnology in their labs. From received answers, only 13% of laboratories had some kind of safety system in place and only 5% were implementing principles of Good Laboratory Practice. An extra 2% of laboratories had acknowledged that they are in the process of implementing ISO 14000 or ISO 17025. The laboratories that have some kind of control system/quality standards are mainly comprised from Pharmaceutical companies and the Food industry.
   More detailed findings of this National survey can be found in Annex 1..
   National experts in fields related to biotechnology and biosafety, as well as in fields relevant to risk assessment and risk management of GMO’s and on existing National, bilateral and multilateral co-operative programmes in capacity building, Research & Development and application of biotechnology.
   A list of 50 National experts in fields related to biotechnology & biosafety, and fields relevant to risk assessment & risk management of LMO’s, in consultation with NCC members had been finalised during this survey.
   During this survey the Project had tried to find existing National, bilateral and multilateral co-operative programmes in capacity building, Research & Development and application of biotechnology. The Ministry for Science, Education & Sports (MSES) is the only one that keeps records and finances different research and technological projects in Croatia. There are also other projects financed by private companies, or from abroad and International organisations. Data on these projects is not stored and people who are working within them do not like to disclose such information. The only information that could be gathered was on the CARDS and TWINNING projects.
   To find out how much Croatia is actually investing in biotechnology the Project had asked the MSES about the projects they had financed in 2003 ( Annex 2.);
   
5. The survey of existing National legislation or legal instruments related to biotechnology /biosafety was conducted four times during the projects lifetime.
   Under current legislations, mechanisms are planned but they haven’t been structured as yet. The new GMO Act will be changing the administrative procedures for the setting up of these mechanisms.
   The list of National legislation can be found under Croatian legislation with translated Acts;
   
6. A survey on existing National biosafety frameworks in the countries of the sub-region had been conducted in April 2004;
7. A survey on the extent and impact of release of LMO’s and commercial products
   This survey had been conducted in April 2004. From 1997 until 1999, there were approved field trials of GM maize in Croatia. The Ministry for Agriculture and Forestry had appointed the Scientific Committee. This Committee was responsible for receiving applications, for risk assessment, for giving approval, for monitoring and giving expert opinion on trials.
   From 1999 until now, not one ‘official’ permit has been issued for field trials or the commercial growth of GM plants. The Ministry of Health had issued an Order banning the import of GM food products in the same year, which in effect meant a ban on import into or production of GM food products in Croatia. The border sanitary inspections would ban import of GM food products that had been declared as such and they would random sample test other imports. No un-declared GM food products had been found during that period.
   From the beginning of 2004, the GMO laboratory began sampling & testing. In this period two GMO incidences have happened in Croatia. One incident involved a meat product (sausages), which contained GM Soya, and the second involved maize seeds, which had already been planted;
   
8. The list of the bilateral, regional and multilateral agreements that Croatia is member of or has ratified and are relevant for establishment of NBF can be found under Bilateral, regional and multilateral agreements with PDF format of relevant Agreement.
9. Preparation of a National Biosafety Framework, including procedures for the safe application of biotechnology in accordance with the Cartagena Protocol on Biosafety (administrative, legislative, risk assessment and public participation systems). In June 2004 the MC had given authorization to the Project, to assemble a team of experts (more than 30), who will draft all the required by-laws (more than 20) needed for implementation of the Nature Protection Act. This has been achieved and all drafts of the bylaws had been delivered to the Ministry in September 2004. They are in Annex 3.;
10. Until now, we have organized six Workshops.
11. We published the "Glossary" of commonly used terminology in this field. A booklet entitled "Development of National Biosafety Framework in Republic of Croatia" was published in 70 000 copies. It was distributed through "Nacional" (weekly paper) and "Priroda" monthly journal for popularisation of Natural Sciences and Ecology.