(9) Commission Response to March submission, 12 July 2010
In his recent letter, the petitioner expresses disappointment and dissatisfaction with the Commission's observations provided so far on his petition and identifies 9 specific points of concern.
The Commission wishes first to reiterate that it considers the protection of health and the environment as a top priority and is committed to ensuring that genetically modified (GM) seed, food and feed are authorised only when they are not likely to have adverse effects on human health, animal health or the environment. It provides hereunder information that complements its previous answers provided in the framework of this petition. Points 1, 2, 3, 6, 7: The Commission maintains that the safety assessment of GMOs is carried out based on the highest standards. This is in particular apparent when requirements for the safety assessment of GMOs are discussed in the international arena such as Codex Alimentarius for food safety aspects. In contrast to what is indicated in the petition, the assessment of potential chronic or long-term effects is part of the risk assessment of GM food and feed as outlined in particular under point 3 of chapter IV of the current EFSA guidelines.[1]
The development of a Commission Regulation for the authorisation of genetically modified food and feed is one of the actions that were decided by the Commission in April 2006 to improve the authorisation procedures. To this end, the European Food Safety Authority (EFSA) was requested to update its current guidance document which will be used as a basis to draft the legal text in respect to the evaluation of GM food and feed and more specifically to clarify which standards and protocols should be used by applicants to carry out scientific studies, provide a better structure and define clear objectives and conclusions in each part of the safety assessment.
Transparency of this process was ensured by the fact that EFSA held public consultations during the review of its guidance and that the Commission Directorate General for Health and Consumer Protection consulted the Advisory Group on the Food Chain and Animal and Plant Health, a group created by the European Commission which brings together key stakeholders including farmers, the food industry, retailers, consumer organisations and others seek advice on food safety policy.
In accordance with Regulation (EC) No 178/2002[2] establishing EFSA, EFSA has to provide scientific and technical assistance to the Commission. It is thus normal practice that EFSA assists and provides scientific expertise when the Commission is preparing legislation in the various areas of food safety including GMOs. By way of a concluding remark, the Commission underlines that the EFSA is an independent body.
The draft Commission Regulation, which was notified in January 2010 under the "Sanitary and Phytosanitary" (SPS) (reference G/SPS/N/EEC/ 369) and the "Technical Barrier to Trade" (TBT) (reference G/TBT/N/EEC/ 304) agreements, is based on this review by EFSA as well as of intensive discussions with Member States agreement in the framework of the Standing Committee on the Food Chain and Animal Health. The discussions in the framework of this Committee are still ongoing but the draft Commission Regulation could be soon submitted for opinion as the first step of adoption through the comitology procedure.
The designation of Panel members is fully within the responsibility of EFSA and the Commission is not involved. Stringent procedures are in place to ensure independence and avoidance of conflicts of interest. The same provisions apply to the scientific staff of EFSA.
Point 4. The Regulation (EC) No 1829/2003 on GM food and feed[3] requires that applicants are obliged to provide studies, including where available independent peer-reviewed studies to demonstrate that the GMOs do not have adverse effects on human or animal health or the environment. In addition and in accordance with the EFSA guidance and the draft Regulation, test methods used have either to be fully justified or be those described by OECD or the European Commission and the studies have to be carried out according to the principles of Good Laboratory Practice (GLP).
Point 5. EFSA opinions provide the reasoning followed from the characterisation of the GMO, the various tests that have been performed and its conclusions in terms of safety. There are circumstances where surrogate proteins have to be used for toxicological testing because the protein produced from the plant cannot be obtained in sufficient quantity. Under these circumstances, EFSA also considers whether the surrogate protein is acceptable for the safety assessment (i.e. if the protein is not identical, whether the differences between the surrogate protein and the protein produced by the plant are of relevance in terms of safety).
Point 8. Under Regulation (EC) No 1829/2003, it is the role of the Commission to decide which information that the applicant wishes to be treated as confidential may effectively be granted this status. The Commission has not received any formal complaint regarding its decisions on confidential information. In practice, limited information is deemed confidential and, for example, all the results of the compositional analysis or of toxicological studies are never granted confidential status.
As an independent Agency, it is the full responsibility of EFSA to organise the way it grants access to documents. The organisation through the granting of a password and for a limited period of time is made for security reasons and compatible with the legislative requirements in this respect. It is stressed that this organisation allows the public to retrieve the information and subsequently to consult it without time limitations.
Point 9. The Commission reiterates that neither the European Commission nor EFSA have any influence on how companies award contracts for carrying out independent research, a situation similar to other areas of endeavour. Regulation (EC) No 1829/2003 on GM food and feed of the European Commission and the Council is setting requirements that have to be fulfilled to obtain an authorisation.
This matter was also subject to the written question to the European Parliament E-1672/09. The relevant extract of the supplementary answer provided by the Commission on 10 September 2009 is the following:
In the EU, the legal protection of biotechnological inventions is regulated by Directive 98/44/EC[4]. As is the case in all other fields of technology, biotechnological inventions which are new, which involve an inventive step and which are susceptible to industrial application are patentable. This also concerns products consisting of or containing biological material, and processes by means of which biological material is produced, processed or used[5]. Consequently, in the case where the GM material of a plant is patented, restrictions on the use of the patented genetic material may be imposed by the patent holder on the basis of the specific rights stemming from the patent.
In the biotechnology industry, as in other fields, the industry concludes contractual agreements with researchers (commonly called "Material Transfer Agreements") to conduct research while ensuring the protection of intellectual property rights. These agreements may vary per company and topic, and are most often designed and negotiated on a case-by-case basis. The Commission has not received any complaints by researchers or any other stakeholders in the EU about the legality of these agreements. Research projects on risk assessment studies and other scientific research in relation to GMOs have been funded under EU Framework programmes, a selection of the results of which are publicly available onhttp://ec.europa.eu/research/quality-of-life/ gmo/. More detailed information on these and further projects can be found on http://cordis.europa.eu/home_en.html.
In accordance with the Union legislation on the authorisation of GMOs[6], the environmental risk assessment is carried out by the notifier, and then by the Competent Authorities and EFSA. This assessment is based on the specific data required by Annex III of Directive 2001/18/EC, which must be collected and submitted by the notifier. The Competent Authorities and EFSA assess these data, as well as any other relevant data they may be aware of, in accordance with the principles established by Annex II of the Directive. This assessment is carried out in the light of the available scientific literature and studies, regardless of the source of their financing or commissioning. Under GMO legislation there is no requirement to make any distinction between "independent" or "non-independent" studies. These procedures and principles apply also for the assessment of maize lines Bt11 and 1507, as well as for the authorisation of any other GMOs.
As a general background, the Community System on Plant Variety Rights (CPVR) which provides for the granting of industrial property rights valid throughout the Union sets limitations to the effects of such exploitation rights. More specifically, whereas the holder can dispose of his varieties for commercial reasons as he wishes, the Community plant variety rights of a holder cannot extend to acts done privately and for non-commercial purposes, acts done for experimental purposes and finally to acts done for the purpose of breeding, or discovering and developing other varieties[7]. Additionally the CPVR system foresees the possibility to grant compulsory exploitation licensing under certain circumstances on grounds of public interest such as to promote scientific research (e.g. to maintain the incentive for continued breeding of improved varieties)[8]. Therefore, as mentioned above, research on GMO plants may be subject to the limitations stemming from the eventual patent on the genetic patented material and restrictions on its use may be imposed by the patent holder. Moreover, limitations in research may not be linked to the system of intellectual property rights, but to provisions of the agreements which have been voluntarily signed by the researchers.
The Commission will continue investigating the matter and gather information relevant to access to research in the area of biotechnology."
The evaluation of Directive 2001/18 of which the final report will be published this summer will provide elements in this respect.
[1] http://www.efsa.europa.eu/en/scdocs/doc/99.pdf
[2] OJ L31, 1.2.2002., p. 1.
[3] OJ L 268, 18.10.2003, p. 268.
[4] Directive 98/44/EC of Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ L 213, 30.7.1998.
[5] Article 3(1) of Directive 98/44/EC.
[6] Directive 2001/18/EC of Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of GMOs, and Regulation(EC) No 1829/2003 of Parliament and of the Council of 22 September 2008 on GM food and feed, OJ L 268, 18.10.2003.
[7] Article 15 of Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights, OJ L 227, 1.9.1994. [8] Article 29 of Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights, OJ L 227, 1.9.1994.