Voluntary Report - public distribution

**Date:** 4/6/2004

**GAIN Report Number:** EZ4010

EZ4010

**Czech Republic**

**Biotechnology**

**National Biosafety Framework**

**2004**

**Approved by:**

![](media/image1.wmf)Sarah Hanson

U.S. Embassy

**Prepared by:**

Petra Choteborska

**Report Highlights:**

In March 2004, the Czech Republic officially finished its United Nations
Environmental Program/Global Environmental Fund (UNEP/GEF) National
Biosafety Framework project. The Czech Republic joined the project in
July 2002. The goal of the project was to develop conditions for the
safe handling of living and genetically modified organisms (LMO/GMO) and
to meet the requirements of the Cartagena Protocol. The outcome of the
project is a detailed report describing Czech biosafety policy; the
regulatory regime; the system of handling LMO/GMO applications,
monitoring and enforcement; and mechanisms for informing the public.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Vienna \[AU1\]

\[EZ\]

######### National Biosafety Framework for the Czech Republic

The Czech Republic signed the Cartagena Protocol on Biosafety on May 24,
2000, in Nairobi, Kenya, when it was open for signature for the first
time. The Cartagena Protocol came into force on September 11, 2003, and
since that time it applied to the Czech Republic. The UNEP/GEF (United
Nations Environmental Program/ Global Environmental Fund) National
Biosafety Framework Development Project started in June 2001. Its major
goal is to create conditions for safe handling of living and genetically
modified organisms (LMO/GMO), meeting requirements of the Cartagena
Protocol, and enhancing sub-regional and regional cooperation. The whole
program lasts 3 years with individual projects lasting 18 months. Around
120 countries are participating in the program. The total cost is
estimated at \$38.4 million, GEF subsidizes two thirds of total cost,
amounting to \$26.1 million, participating countries contribute \$12.3
million. There are six regional groups in the world (French Africa, Aglo
Africa, Asia, developing countries on small islands, Latin America,
Middle and Eastern Europe and Middle Asia).

The Czech Republic joined the UNEP/GEF project "Development of the
National Biosafety Framework" in July 2002. The project was supposed to
last 18 months, but due to administrative problems was extended till
March 31, 2004. The National Coordinating Committee was established,
consisting of representatives of biosafety related sectors and
institutions, Czech Commission for the Use of GMO and products,
non-governmental organizations and private sector. The National
Executing Agency is the Ministry of Environment, Global Relations
Department and the Environmental Risks Department; the National Project
Coordinator is Prof. Kas of the Institute of Chemical Technology.

Great attention was paid to elaborate surveys in which experts from
different spheres participated. Several workshops were organized for
different groups -- specialists, environmental inspectors and the
public, in different country regions, including one sub-regional meeting
of specialist in April 2003 in Prague, Czech Republic.

The projects has four major phases:

-   Mission definition, work plan, institutional and managerial
    structures (Executing Agency, Project Coordinator, Coordination
    Committee)

-   Information gathering on biotechnology and biosafety (legislation,
    applications, risks, methods of detection of GMO, quality of
    laboratories), creation of national databases (biotech companies and
    institutions, universities, high schools, web pages, experts)

-   Identification of stakeholders (people and institutions related to
    GMO), evaluation of gathered information; organization of seminars,
    web pages, publications; identification of national priorities

-   Preparation of the Report on National Biosafety Framework -- in
    April 2004 will be available in English on this page:
    [http://gmo.vsch.cz](http://gmo.vsch.cz/)

Result of the project - **Report on National Biosafety Framework** has
five parts:

1.  [Description of National Biosafety Policy]{.underline} -- is based
    on precautionary principle

> Forms several policies and strategies:

-   State Environmental Policy

-   Strategy of Sustainable Development of the Czech Republic

-   State Nature Conservation and Landscape Protection Program

-   Strategy of Food Safety

1.  [Regulatory Regime]{.underline} -- the report lists all acts
    connected to GMO

-   Act 78/2004 on GMO (decree 372/2000) -- replaced 153/2000

-   Act 110/1997 on Food and Tobacco Products (decree 24/2001 on
    labeling)

-   Act 146/2002 on State Agricultural and Food Inspection

-   Act 91/1996 on Feed (decree 451/2000)

-   Act 21/2003 on Marketing of Seed and Planting Material of Cultivated
    Plants

-   Act 147/1996 on Phytosanitary Measures

-   Act 242/2000 on Organic Farming

-   Act 166/1999 on Veterinary Care

-   Act 154/2000 on Breeding and Registration of Domestic Animals

-   Act 246/1992 on Protection of Animals against Maltreating

-   Act 79/1997 on Pharmaceuticals

-   Government Regulation 178/2000 on Conditions for Health Protection
    of Employees

-   Act 25/2000 on Protection of Health

-   Act 206/2000 on Protection of Biotechnological Discoveries

-   Act 17/1992 on Environment

-   Act 114/1992 on Protection of Nature and Landscape

-   Act 148/2003 on Conservation and Use of Genetic Resources of Plants
    and Microorganisms Important for Food and Agriculture

2.  [System for the Approval Process]{.underline} -- a detailed
    procedure describes the approval process for all three regimes --
    contained use, release into the environment and placing on the
    market (information about the scheme is found in report EZ4009 on
    [www.fas.usda.gov](http://www.fas.usda.gov/))

3.  [Monitoring and Enforcement]{.underline} -- a scheme of responsible
    institutions is listed on the next page

> Future plans: to create a network of accredited laboratories involved
> in the European network of GMO laboratories (ENGL system)

4.  [Mechanisms for Promotion, Information for the Public, and
    Education]{.underline} -- web pages, workshops and courses,
    seminars, exhibitions, publications

> [Biosafety Clearing House (BCH)]{.underline}: was established at the
> Ministry of Environment, Department of Environmental Risks; collects
> data and enables exchange of information, publication of reports, etc.

######### Related Reports

EZ4001 Status of Biotech Regulations -- Central Europe

EZ3020 Consumer Perceptions of Biotechnology

EZ3015 Biotechnology from a Czech Perspective

EZ3012 Status of Biotech Regulations

Important Contacts

[National Project Coordinator]{.underline}

Prof. Jan Kas

Institute of Chemical Technology

Technicka 3, 166 28 Praha 6, Czech Republic

Tel: +420-224-353-018

Fax: +420-224-355-167

E-mail: <jan.kas@vscht.cz>

[http://gmo.vscht.cz](http://gmo.vscht.cz/)

[National Executing Agency]{.underline} -- [Ministry of
Environment]{.underline}

Vrsovicka 65, 110 10 Praha 10, Czech Republic

Milena Roudna Zuzana Doubkova

Global Relations Department Environmental Risks Department

Tel: +420-267-122-769 Tel: +420-267-122-922

Fax: +420-267-311-949 Fax: +420-267-310-013

E-mail: <roudna@env.cz> E-mail: <doubkova@env.cz>

[www.env.cz](http://www.env.cz/) [www.env.cz](http://www.env.cz/)

[Czech Commission for the Use of GMOs and Products]{.underline}

Institute of Plant Molecular Biology

Academy of Sciences of the Czech Republic

Dr. Slavomir Rakousky

Branisovska 31, 370 05 Ceske Budejovice, Czech Republic

Tel: +420-387-775-537

Fax: +420-387-775-537

E-mail: <ray@umbr.cas.cz>

[Czech Environmental Inspection]{.underline}

Tomas Marik

Na brehu 267

190 00 Praha 9, Czech Republic

Tel: +420-283-890-568

E-mail: <marik@cizp.cz>

[www.cizp.cz](http://www.cizp.cz/)

[Ministry of Agriculture]{.underline}

Dr. Ivan Branzovsky

Tesnov 17, 117 05 Praha 1, Czech Republic

Tel: +420-221-812-693

Fax: +420-224-812-989

E-mail: <branzovsky@mze.cz>

[www.mze.cz](http://www.mze.cz/)

[Ministry of Health]{.underline} -- contact: National Institute of
Public Health

[National Institute of Public Health]{.underline}

Dr. Jiri Ruprich

Palackeho 3a, 612 42 Brno, Czech Republic

Tel: +420-541-211-764

E-mail: <jruprich@chpr.szu.cz>

[www.chpr.szu.cz](http://www.chpr.szu.cz/)

[Czech Agricultural and Food Inspection]{.underline}

Martin Sindelar

Kvetna 15, 603 00 Brno, Czech Republic

Tel: +420-543-540-237

E-mail: <martin.sindelar@szpi.gov.cz>

[www.szpi.gov.cz](http://www.szpi.gov.cz/)

[Central Institute for Supervising and Testing in
Agriculture]{.underline}

Karel Riha

Hroznova 2, 612 42 Brno, Czech Republic

Tel: +420-543-548-239

Fax: +420-543-212-440

E-mail: <karel.riha@ooz.zeus.cz>

[www.ukzuz.cz](http://www.ukzuz.cz/)

[State Phytosanitary Administration]{.underline}

Miloslava Navratilova

Zemedelska 1a, 613 00 Brno, Czech Republic

Tel: +420-545-137-045

Fax: +420-545-211-078

E-mail: <navratiloa@srs.cz>

[http://tesnov.srs.cz](http://tesnov.srs.cz/)

[State Veterinary Administration of the Czech Republic]{.underline}

Dr. Radomir Belza

Slezska 7, 120 00 Praha 2, Czech Republic

Tel: +420-227-010-134

Fax: +420-221-812-979

E-mail: <r.belza@svscr.cz>

[www.svscr.cz](http://www.svscr.cz/)

[Research Institute of Crop Production]{.underline}

Dr. Jaroslava Ovesna

Drnovska 507, 161 06 Praha 6, Czech Republic

Tel: +420-233-022-424

E-mail: <ovesna@vurv.cz>

[www.vurv.cz](http://www.vurv.cz/)

[Institute of Agriculture and Food Information]{.underline}

Olaf Deutsch

Slezska 7, 120 56 Praha 2, Czech Republic

Tel: +420-227-010-324

Fax: +420-227-010-114

E-mail: <deutsch@uzpi.cz>

[www.uzpi.cz](http://www.uzpi.cz/)

[Foreign Agricultural Office]{.underline}

American Embassy

Petra Choteborska

Agricultural Specialist

Trziste 15, 118 01 Praha 1, Czech Republic

Tel: +420-257-531-170

Fax: +420-257-531-173

E-mail: <petra.choteborska@usda.gov>