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E6 COUNTRY OVERVIEW FOR TURKEY: BIOSECURITY LAWS AND REGULATIONS IN TURKEY Hüseyin Avni Öktem, Ph.D. Middle East Technical University, Turkey What high-containment biological (high BSL) laboratories exist in your country? What are the facilities’ main goals and priorities? • The Ministry of Agriculture and Rural Affairs has four BSL facilities that are focused on animal diseases and vaccines. • The Refik Saydam National Public Health Agency, Sihhiye/Ankara has one lab that focuses on infectious disease surveillance and prevention on a national basis. • The Gulhane Medical Military Academy, Etlik/Ankara has a medically focused lab. • The TUBITAK Marmara Research Center, Genetic Engineering and Biotechnology Institute, Gebze/Kocaeli has a research-focused lab. What government organizations are responsible for the safety and security of high BSL laboratories? The Ministry of Agriculture and Rural Affairs, General Directorate of Protection and Control and the Ministry of Health are responsible. If there are high BSL laboratories in your country, are there established criteria for deciding: a. Whether or not to establish such facilities? b. Where to place such facilities? c. What research will be done in such facilities? d. What scientific, technical, and management advice is available to governments when making their decisions? In Turkey there are rules and legislation about establishing and running analysis laboratories for food, animal feed, water, genetic testing, etc. These analysis laboratories are controlled by the Ministry of Agriculture and Rural Affairs and by the Ministry of Health. However, there is not yet legislation about establishing a high BSL laboratory in Turkey. What standards exist for high BSL laboratories for: e. Engineering and construction? f. Licensing? g. Safety and security? h. Regular oversight and re-certification? As there isn’t any established legislation for such laboratories, internationally established standards and guidelines (CDC’s Office of Safety, Health and Environment, National Institute of Health, World Health Organization’s Center for Applied Biosafety, etc.) are being used and followed. Have there been any accidents at high BSL labs in your country? i. If yes, how and why did the accidents occur? j. How, to whom, and when are they reported? k. Who has authority to investigate accidents? l. What disciplinary or legal actions can be taken? No accidents. Have any steps been taken to increase security at high BSL facilities? If so, by whom (i.e., regulation, voluntary measures, individual laboratory practices)? Security has been increased through individual laboratory practices. 169
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170 Biosecurity Challenges Furthermore, as a result of an increase in research and commercial activities in biotechnology along with the commencement of membership negotiations with the European Union, Turkey has passed biosecurity-related legislation in recent years. Among these laws, the most relevant ones are given below. Biosecurity-related laws and directives: • Directive About the Field Studies of Transgenic Culture Plants (05/08/1998) • The Cartagena Protocol on Biosafety (01/24/2004) • Directive on Import, Process, Export, Control, and Regulation of Genetically Modified Organisms for Human and Animal Consumption (10/26/2009) • Biosecurity Law (no.5997 – 09/26/2010) • Directive on Operational Procedures and Principles of Biosecurity Board and Committees (no.27671 – 08/13/2010) • Directive on Genetically Modified Organisms and Their Products (no.27671 – 08/13/2010) Like their equivalents in other countries, biosecurity laws and directives in Turkey are mostly concerned with Genetically Modified Organisms (GMOs) and their distribution, use, import, and export. One of the earliest examples of such a directive was the “directive about the field studies of transgenic culture plants” by the Ministry of Agriculture and Rural Affairs (MARA) in 1998. This directive aimed to prevent the import of GMOs for human consumption that had not first being tested in a field study in Turkey. In addition, all GMOs to be imported were required to have a certification from a country having biosecurity legislation. In the absence of a national law on biosecurity, in 2000, Turkey signed The Cartagena Protocol on Biosafety and it was ratified in the Turkish Parliament in 2003. In 2002, Turkey started to prepare a “Biosecurity Law” in compliance with The Cartagena Protocol and received project money from the United Nations Environment Program—The Global Environment Facility (UNEP-GEF) to prepare a draft. This project, entitled “Project on the Development of the National Biosafety Framework of Turkey” was started on September 18th, 2002 and finished on March 18th, 2005. Later in 2009, MARA finalized the Biosecurity Law, and it was passed by parliament in 2010. The law does not cover medical or cosmetic products that are approved by the Ministry of Health, but bans the production and release of any GMOs and their use in baby food. The Law also specifies terms of 5 to 10 years of imprisonment for unlawful acts related to unapproved use of GMOs. A “Biosecurity Board” involving scientists and experts was established by a directive from MARA and held its first meeting on September 27th, 2010. The Board started a web site called “Information Exchange in Biosecurity” at http://www.tbbdm.gov.tr. So far, the Biosecurity Board has had five meetings and accepted only one GMO (A2704-12 soy bean for use in animal feed). The board contains 9 members that are selected by the related ministries as follows: 4 by the Ministry of Agriculture and Rural Affairs (2 from the Ministry, 1 from a University, 1 from a NGO), 2 by the Ministry of Forestry and Hydraulic Works, 1 by the Ministry of Health, 1 by the Ministry of Science, Industry, and Technology, and 1 by the Ministry of Economy. Directives concerning BSL Labs are under development.