Author: Mehmet Artemel (Bogazici University, Turkey)
Regulations on Genetically Modified Organisms and Products Thereof, Regulations on the Operating Procedures and Rules for the Biosafety Council and Committees, Official Gazette, Issue No. 27671 of 13 August 2010
Journal of Intellectual Property Law & Practice (2011), doi: 10.1093/jiplp/jpq201, first published online 18 January 2011
Following the entry into force of the Biosafety Law together with the GMO and the Biosafety Regulations on 26 September 2010, three GM events were subjected to the scrutiny of the Biosafety Council, for the first time within the framework of the new Turkish biosafety regime, at its meeting on 26 October 2010.
The Turkish Biosafety Law (Law No. 5977), reviewed in the July 2010 issue of JIPLP, came into force on 26 September 2010 concurrently with two related Regulations: Regulations on Genetically Modified Organisms and Products Thereof (the ‘New GMO Regulations’) and the Regulations on the Operating Procedures and Rules for the Biosafety Council and Committees (the ‘Biosafety Council Regulations’), both published in the Official Gazette No. 27671, 13 August 2010.
The Regulations were issued by the Ministry of Agriculture and Rural Affairs under the authority derived from Article 16 of the Biosafety Law, under which the Ministry is entrusted with the responsibility to issue regulations pertinent to the implementation of the Law. Incidentally, these Regulations should have been issued by 18 June 2010 in accordance with the provision that ‘The Regulations which lay down the procedures and rules concerning the implementation of this Law [the Biosafety Law] shall be issued by the Ministry at the latest within three months as of the publication of the Law’. Notwithstanding, the Ministry's failure to comply with the prescribed legislative timeframe, the Regulations are welcome as they shed light on the implementation of the Biosafety Law and lay to rest the former Regulations which were dogged by legal mayhem and lawsuits before the Council of State.
Of the two Regulations, the New GMO Regulations are the heftier, consisting of 26 sections (‘Section’ and ‘Article’ denote the provisions of the Regulations and the Biosafety Law, respectively) and four appendices including a specimen application form for imports of GMOs (Appendix 1), a sample registration form (Appendix 4) as well as several lists on the information required where applications for the deliberate release of GMOs other than plants for experimental purposes (Appendix 2) and for the deliberate release of genetically modified plants for experimental purposes (Appendix 3) are concerned.
The Regulations Governing the Import, Processing, Export, Control, and Supervision of Organisms and Products, the Genetic Structure of which have been Modified for the Purposes of Foodstuffs and Animal Feed (the ‘Former GMO Regulations’, Official Gazette No. 27388, 26 October 2009), have thus been repealed through section 24(1) of the New GMO Regulations.
The Biosafety Council Regulations provide for the establishment of a Biosafety Council, a roster of Experts and Committees (section 4(1)), entrusted with the examination of applications relating to the placing on the market of GMOs and products derived from them for the purposes of food, feed and processing, and to the deliberate release of said products as well as the contained use of genetically modified microorganisms (GMMs). According to section 10(1), in respect of each application, the Council will form an ad hoc committee consisting of eleven members to be designated from among the enlisted experts who will be responsible for conducting a scientific assessment.
There follows below an examination of selected issues in the light of the new Regulations. Remarks made in the context of an earlier Current Intelligence note in JIPLP on the Biosafety Law remain relevant and require no further elaboration, save where the provisions of either Regulations render it necessary to do so.
According to the Biosafety Law, where the term ‘threshold’ is not defined, the Ministry of Agriculture is the competent authority to set the applicable threshold for a GMO, taking into consideration the opinion of the Biosafety Council and the characteristics of the particular GMO (Article 8(1)(h)). By contrast, the New GMO Regulations define ‘threshold’ in section 4(k) as ‘The minimum limit for approved genes, to be determined by the Ministry in the light of the Council's opinion, above which a product shall be required to be labelled as containing GMO’.
The relevant provisions of the Biosafety Council Regulations refer, in addition, to the role of the committees, whereby the Council is to provide its opinion as to the threshold level in the light of the respective committee's scientific assessment (sections 7(1)(g) and 10(1)). Although the Regulations might have been appropriate instruments wherein a standard statutory threshold limit could have been set, in hindsight, not to have done so seems to have been a sensible strategy considering that the European Commission's ‘Recommendation of 13 July 2010 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops’, which in the context of co-existence measures have arguably allowed greater leeway to Member States to adopt varying threshold levels, notwithstanding that co-existence is not an issue in Turkey's case since cultivation of GMOs is not in any event permitted under the current legislation. Accordingly each application for a GM event will prove to be a test case as regards the threshold level to be established in connection with it. For instance, at the second meeting of the Biosafety Council, a threshold has been set for soybean as mentioned under the ‘Practical Significance’ section below.
Positive claim labelling
The New GMO Regulations enable positive claim labelling where, it shall be permissible, according to sections 18(1)(g) and 19(1)(e) respectively for food and feed labels to bear statements on equivalent products that are free of GMOs that they ‘do not contain’, ‘do not consist of’ or ‘do not derive from GMOs’.
Local gene owners
The so-called ‘gene owner’ (‘gen sahibi’) was defined under section 4(1)(h) of the earlier GMO Regulations as ‘the one who holds the rights to the patent over the modified gene or genes in the GMO or in products derived from it. Despite retaining the expression in the subsequently enacted Biosafety Law, the definition was removed. Likewise, neither of the two new regulations provides a definition for ‘gene owner’. References are, however, still made to ‘gene owners’ in sections 4(1)(f) and 8(1) of the New GMO Regulations. The latter section is noteworthy in that, for the first time, the possibility that local ‘gene owners’ might exist has been explicitly acknowledged, according to which ‘natural or legal person gene owners who have developed a GMO in the country are required to lodge an application with the General Directorate of Agricultural Research’ of the Ministry of Agriculture.
R&D on GMOs
Applications for R&D purposes have been considerably streamlined under the New GMO Regulations, possibly in response to concerns raised over the fact that the Biosafety Law did not sufficiently recognise the exigencies of such activities. Thus, while an application will not be required for R&D that originates in the country (section 7(1)), an authorisation from the Ministry is needed where GMOs are to be imported for R&D and educational purposes (section 7(2)) by filing a special application form with General Directorate of Agricultural Research (section 7(2)(a)) which is obliged to complete the requisite authorisation procedures within 15 days (section 7(2)(b)). Irrespective of whether GMO is imported, the Ministry is to be notified of the R&D results, within three months following the completion of R&D.
Uniform authorization procedure
Article 12 of the New GMO Regulations allow for the Biosafety Council to conduct a simplified authorisation (in Turkish ‘basitleştirilmiş işlem’) procedure by taking into consideration a ‘socio-economic assessment’ provided that the application is accompanied by previously conducted environmental risk assessments and is supported by information indicating that there exists no possibility of any harm deriving from the GMOs and products derived from them, to human, animal and plant health, nor to the environment or biodiversity. By contrast, under the relevant EU legislation, whereas in respect of genetically modified food and feed for placing on the market, Regulation 1829/2003 prescribes a standard authorisation procedure, a simplified procedure is applicable where the deliberate release into the environment of genetically modified plants is concerned (Article 7(6), Directive 2001/18).
One month to the day following the entry into force of the Biosafety Law and the two related regulations, an application by the Turkish Feed Manufacturers' Association for the import of soybean and soybean meal to be used as feed ingredients in mixed feeds came before the Biosafety Council on 26 October 2010. The Council deferred its decision to a subsequent meeting on whether a simplified procedure should be conducted concerning the Association's application for feed containing three GM events, namely MON 40-3-2 and MON89788 by Monsanto and A2704-12 by Bayer CropScience, on the ground that the requisite dossier was incomplete. The Council did, however, at this same meeting, determine the threshold value for GM soybean at 0.9 per cent which marks the first substantive decision of the Biosafety Council within the framework of the new Turkish biosafety regulatory regime.