Biosecurity Laws and Regulations in Turkey Prof. Dr. Hüseyin Avni Öktem Nanobiotechnology R&D Group, Department of Biological Sciences Middle East Technical.

Biosecurity Biosecurity Laws and Laws and Regulations Regulations in Turkeyin Turkey

Prof. Dr. Hüseyin Avni ÖktemProf. Dr. Hüseyin Avni Öktem

NanoNanobiobiotechnology Rtechnology R&D &D Group, Department of Group, Department of Biological SciencesBiological Sciences

Middle East Technical University, Middle East Technical University, AnkaraAnkara TURKEY TURKEY

• As a result of– Increased research & commercial activities in

biotechnology– Commencement of membership negotiations with EU

on October 3rd, 2005

• Turkey has passed/signed certain biosecurity related legislations

1998 - Directive About The Field Studies of Transgenic Culture Plants (1998/05/08)

2004 - The Cartagena Protocol on Biosafety (2004/01/24)

2009 - Directive on Import, Process, Export, Control and Regulation of Genetically Modified Organisms for Human and Animal Consumption (2009/10/26)

2010 - Biosecurity Law (no.5997 - 2010/09/26)

2010 - Directive on Operational Procedures and Principles of Biosecurity Board and Committees (no.27671 - 2010/08/13)

2010 - Directive on Genetically Modified Organisms and Their Products (no.27671 – 2010/08/13)

• biosecurity laws and directives in Turkey are mostly related with Genetically Modified Organisms (GMOs)– their distributions, uses, imports and exports, …

• earliest examples of such a directive– the “directive about the field studies of transgenic culture plants” by The

Ministry of Agriculture and Rural Affairs (MARA) in 1998

– aimed to prevent the import of GMOs to be used in human consumption without first being tested in a field study in Turkey

– all GMOs to be imported were required to have a certification from a country having biosecurity legislation

• In 2000, in the absence of a national law on biosecurity– The Cartagena Protocol on Biosafety was ratified in the Turkish Parliament in

2003

• In 2002, Turkey has started to prepare a “Biosecurity Law” in compliance with The Cartagena Protocol

– project money from the United Nations Environment Program – The Global Environment Facility (UNEP-GEF) entitled “Project on the Development of the National Biosafety Framework of Turkey” was started on September 18th, 2002 and finished on March 18th

• In 2005, first circulating draft of “Biosecurity Law”• In 2009, finalized by the MARA• In 2010, been passed from the parliament

• In accordance with the new “Biosecurity Law”• Two directives have been published by the MARA

– 2010 - Directive on Operational Procedures and Principles of Biosecurity Board and Committees (no.27671 - 2010/08/13)

– 2010 - Directive on Genetically Modified Organisms and Their Products (no.27671 – 2010/08/13)

• The Biosecurity Law and two directives– Came into force on September 26th, 2010

• MARA suspended the export of all material containing GMO.• “Biosecurity Board” has been established

– 1st meeting on September 27th, 2010– The Board started a web site called “Information Exchange in Biosecurity” at

http://www.tbbdm.gov.tr

Biosecurity BoardBiosecurity Board

• Total 9 members – selected by related ministries– Ministry of Agriculture and Rural Affairs (4 members)

• MARA – 2 members• University – 1 member• NGO – 1 member

– Ministry of Environment & Forestry • Now: Ministry of Forestry & Hydraulic Works (2 members)

– Ministry of Health (1 member)– Ministry of Industry and Trade

• Now: Ministry of Science, Industry & Technology (1 member)

– Undersecretary of the Prime Ministry for Foreign Trade• Now: Ministry of Economy (1 member)

Biosecurity Board Biosecurity Board responsibilitiesresponsibilities

• Establishes lists of experts and terms of responsibilities• For each GMO certification application

– Establishes committees – Selects members from the expert pool– Determines committees works

• Generates “Biosecurity Board Decisions”– Using committees’ feedbacks and analysis reports

Biosecurity BoardBiosecurity Boardhow it works?how it works?

• Holds meetings on a call basis• All written communications, meeting notes, etc. are kept

by the Agricultural Research General Directorate (ARGD)

• At least 7 members need to be present for the Board to start a meeting

• At least 5 members for a consensus• Board’s decisions, directives, legislations, etc. are

passed to the Ministry via ARGD

Scientific CommitteesScientific Committees

• Members are selected from the expert pools, universities, Scientific and Technological Research Institute of Turkey and/or any expert approved by the Board.

• 11 members are selected for each GMO application– the committee’s responsibilities is limited for that specific

application and its term ends with it

• Board can also establish committees for– Risk assessment– Socioeconomical assessment

• At least 9 members need to be present for the Committee to start a meeting

• At least 6 members for a consensus

Biosecurity Knowledge Biosecurity Knowledge Exchange PortalExchange Portal

Biosecurity Knowledge Biosecurity Knowledge Exchange PortalExchange Portal

Biosecurity Knowledge Biosecurity Knowledge Exchange PortalExchange Portal

Biosecurity BoardBiosecurity Boarddecisions (summary)decisions (summary)

• 6 meetings since September 26th, 2010• Limit value for GMO content in food has been established as 0.9%

in accordance with EU regulations (2010/10/26)• A2704-12, MON 89788, MON40-3-2 have been approved to be

used in animal feed (2011/01/03)• Application of the Turkish Federation of Food and Beverage

Associations about the use of 3 soy bean, 21 maize, 3 canola, 1 sugar and 1 potato GMO events in food has been accepted (2011/01/10)

– Committees for risk and socio-economical risk assessments are being established

THANKS