
<p><strong>October 2016 | Progress Report </strong></p><p><strong>Joint Commiꢀee on the Handling of Security-Relevant Research </strong></p><p><strong>Publishing informaꢁon </strong></p><p><strong>Published by </strong></p><p>Deutsche Akademie der Naturforscher Leopoldina e. V. President: Prof. Jörg Hacker </p><p>– German Naꢀonal Academy of Sciences – Jägerberg 1, 06108 Halle (Saale), Germany </p><p><strong>Editor </strong></p><p>Dr Johannes Fritsch, Yvonne Borchert </p><p>German Naꢀonal Academy of Sciences Leopoldina </p><p><strong>Contact </strong></p><p>Office of the Joint Commiꢁee on the Handling of Security-Relevant Research German Naꢀonal Academy of Sciences Leopoldina </p><p>Head: Dr Johannes Fritsch </p><p>Reinhardtstraße 14, 10117 Berlin, Germany Tel.: +49 (0)30 2038 997-420 <a href="mailto:gemeinsamer-ausschuss%40leopoldina.org?subject=" target="_blank">[email protected] </a><a href="/goto?url=http://www.leopoldina.org/de/ausschuss-dual-use" target="_blank">www.leopoldina.org/de/ausschuss-dual-use </a></p><p><strong>Contact at the Deutsche Forschungsgemeinschaſt (DFG, German Research Foundaꢁon) </strong></p><p>Dr Ingrid Ohlert </p><p>German Research Foundaꢀon Kennedyallee 40, 53175 Bonn, Germany Tel.: +49 (0)228 885-2258 <a href="mailto:Ingrid.Ohlert%40dfg.de?subject=" target="_blank">[email protected] </a></p><p><a href="/goto?url=http://www.dfg.de" target="_blank">www.dfg.de </a></p><p><strong>Design and seꢂng </strong></p><p>unicom Werbeagentur GmbH, Berlin </p><p><strong>Recommended form of citaꢁon </strong></p><p>German Naꢀonal Academy of Sciences Leopoldina and Deutsche Forschungsgemeinschaſt (DFG, German Research Foundaꢀon) (2016): “Joint Commiꢁee on the Handling of SecurityRelevant Research”, progress report of 1 October 2016, Halle (Saale), 22 pages </p><p><strong>Joint Commiꢀee on the Handling of Security-Relevant Research </strong></p><p>Preface </p><p>3</p><p>Preface </p><p>This progress report begins with a summary in Chapter A of the developments leading up to the establishment of the Joint Committee on the Handling of Security-Relevant Research by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) and the German National Academy of Sciences Leopoldina in November 2014. Chapter B reports on the tasks of the Joint Committee and its activities up to 1 October 2016, with particular focus on the progress of implementing the DFG and the Leopoldina’s “Recommendations for Handling Security-Relevant Research” of June 2014. Chapter C provides an overview of the political debate on security-relevant research </p><p>in Germany, which was prompted by experiments with highly pathogenic influenza </p><p>viruses. Finally, Chapter D gives an outlook of the planned future development of the Joint Committee. </p><p>4</p><p>Contents </p><p>Contents </p><p>A. Background ............................................................................. 5 </p><p>1. Freedom and responsibility of research – the dual-use dilemma ............................. 5 2. Statement by the German Ethics Council on biosecurity and freedom of research..... 6 3. The DFG’s and the Leopoldina’s “Recommendaꢀons for Handling </p><p>Security-Relevant Research”...................................................................................... 7 </p><p>B. Status of implementaꢀon of the Recommendaꢀons for </p><p>Handling Security-Relevant Research...................................... 9 </p><p>1. Mandate of the Joint Commiꢁee on the Handling of Security-Relevant Research.....9 </p><p>2. Composiꢀon and office of the Joint Commiꢁee...................................................... 11 </p><p>3. Establishment of the Commiꢁees for Ethics in Security-Relevant Research (KEFs).... 11 4. Model statutes for the KEFs and a workshop on implemenꢀng the </p><p>recommendaꢀons of the DFG and the Leopoldina ................................................. 13 </p><p>C. Poliꢀcal debate on security-relevant research in Germany.... 15 D. Further development of the Joint Commiꢁee ...................... 18 </p><p>E. Appendix ............................................................................... 19 </p><p>Model statutes for Commiꢁees for Ethics in Security-Relevant Research ....................19 </p><p>A. Background </p><p>5</p><p>A. Background </p><p>1. Freedom and responsibility of research – the dual-use </p><p>dilemma </p><p>poultry. The infection was fatal in around half of the cases, prompting widespread concern not only among breeders of livestock. At this time, research groups from <br>Freedom of research as protected by Ar- the Netherlands and Japan/US were pubticle 5(3) of the German Basic Law gives lishing findings that showed the genetic researchers the right to raise their own mutations the virus would have to un- </p><p>scientific questions and to address these dergo for airborne transmission between </p><p>questions independently within the con- mammals to occur.<sup style="top: -0.2755em;">2 </sup>This caused great ditions laid out in the Basic Law. Freedom concern worldwide about the usefulness of research plays a fundamental role in ex- and risks associated with such research. panding human knowledge and in ensur- </p><ul style="display: flex;"><li style="flex:1">ing social progress and prosperity. How- </li><li style="flex:1">The two research groups led by </li></ul><p></p><p>ever, useful research findings and research Yoshihiro Kawaoka and Ron Fouchier de- </p><p>methods can also be misused for harmful fended the importance of their work on purposes by third parties. One example of the transmission of flu viruses, arguing this “dual-use dilemma” in research is the that their findings had made it possible </p><p>discovery of nuclear fission in the 1930s, to understand how the virus could de- </p><p>which also led to the development and velop into a potential threat for humans use of nuclear weapons of mass destruc- through spontaneous, naturally occurring tion. This triggered an intense debate on mutations. Surprisingly, only five simple the responsibility of researchers<sup style="top: -0.2733em;">1 </sup>that still point mutations were required for the vi- </p><ul style="display: flex;"><li style="flex:1">continues to this day. </li><li style="flex:1">rus to become airborne transmissible be- </li></ul><p>tween the ferrets used in the experiment. <br>The dual-use dilemma sparks con- The two scientists believe that this knowltinuous debate over the benefits and po- edge makes it far easier to classify the new </p><p>tential risks of specific research projects. viruses continually emerging in nature in </p><p>In 2012, for example, research into the terms of their potential to spark a pantransmission of highly pathogenic influ- demic, and to take more targeted protec- </p><p>enza viruses – the so-called avian influ- tive measures. enza or “bird flu” viruses of the subtype H5N1 – came to the forefront of interna- </p><p>Critics of this type of research fear tional public debate. No human-to-hu- that the pathogens produced for research man transmission of the virus had ever purposes could escape from the high-sebeen documented and around one hun- curity laboratories into the environment dred people in Asia were infected – pre- through negligent conduct. These risks sumably through very close contact with are addressed in numerous regulations in- </p><p></p><ul style="display: flex;"><li style="flex:1">2</li><li style="flex:1">See also Herfst S. et al (2012), “Airborne transmission </li></ul><p></p><p>of influenza A/H5N1 virus between ferrets”, <em>Science </em></p><p>336.6088: 1534-1541 and Imai M. et al. (2012), “Ex- </p><p>perimental adaptation of an influenza H5 HA confers </p><p>respiratory droplet transmission to a reassortant H5 HA/H1N1 virus in ferrets”, <em>Nature </em>486.7403: 420-428. </p><p></p><ul style="display: flex;"><li style="flex:1">1</li><li style="flex:1">See, for example, the Russell-Einstein Manifesto (1995), </li></ul><p></p><p><a href="/goto?url=http://www.pugwash.de/rem.pdf" target="_blank">available at: www.pugwash.de/rem.pdf, and the Göttin</a>- </p><p><a href="/goto?url=http://www.uni-goettingen.de/de/54320.html" target="_blank">gen Manifesto (1957), available at www.uni-goettingen. </a></p><p><a href="/goto?url=http://www.uni-goettingen.de/de/54320.html" target="_blank">de/de/54320.html (both last accessed: 21 September </a>2016). </p><p>6</p><p>A. Background </p><p>tended to achieve optimal biological safe- materials research and nanotechnoloty, or biosafety.<sup style="top: -0.2773em;">3 </sup>Another potential hazard gy could contribute to the development </p><p>is that publication of such research find- of offensive weapons; research findings </p><p>ings makes knowledge available that may on industrial robots could be used in the be misused for the purposes of bioterror- construction of combat drones; research ism attacks or biological warfare. A num- methods and results gained in the field of ber of regulations on this issue, known protection from computer viruses could as biosecurity, are in place to prevent the also be used to develop strategies for their distribution of chemical and biological dissemination; research that includes the weapons. These include regular criminal extensive collection and analysis of perlaw, the United Nations’ Biological Weap- sonal data could lead to a violation of perons Convention and the regulations of the sonal rights; findings and methods from </p><p>German Federal Office of Economics and the behavioural and social sciences could </p><p>Export Control (BAFA). Alongside pre- be used to manipulate public opinion in ventative measures on the part of security a certain way. The list is almost endless. agencies<sup style="top: -0.274em;">4 </sup>and the work of law enforcement However, failure to carry out certain reauthorities, self-governance by the scien- search can also be problematic from an </p><p>tific community is also of great importance ethical point of view if, for example, this </p><p>here (see Chapter A.2 and Chapter A.3). hinders the development of treatments, The international debate on the so-called vaccines and other protective measures “gain-of-function” experiments outlined and prevents important innovations in </p><p>above<sup style="top: -0.276em;">5 </sup>– that is, experiments in which other fields. viruses and other pathogens acquire new gene functions – is still ongoing.<sup style="top: -0.277em;">6 </sup></p><p>2. Statement by the German </p><p>The dual-use dilemma extends far beyond the sphere of the life sciences, af- </p><p>fecting all scientific fields. Results from </p><p>Ethics Council on biosecurity </p><p>and freedom of research </p><p>In the summer of 2012, as a response to the gain-of-function debate that had triggered international concern on how to manage biosecurity risks, the German Federal Government commissioned the German Ethics Council to prepare a statement on biosecurity and freedom of re- </p><p>search. The central question under scruti- </p><p>ny was whether the relevant German legal regulations as well as the codes of conduct<sup style="top: -0.275em;">7 </sup>of science and industry are suitable </p><p></p><ul style="display: flex;"><li style="flex:1">3</li><li style="flex:1">In particular, in Germany, the Biological Agents Ordi- </li></ul><p>nance (<em>Biostoffverordnung</em>), the Genetic Engineering Act (<em>Gentechnikgesetz</em>) and the Protection Against Infection Act (<em>Infektionsschutzgesetz</em>); for more information on laws and regulations relevant in the handling <a href="/goto?url=http://www.vbio.de/informationen/wissenschaft__gesellschaft/thema_biosicherheit/normen_und_gesetze" target="_blank">of biological agents, visit: www.vbio.de/informationen/ </a><a href="/goto?url=http://www.vbio.de/informationen/wissenschaft__gesellschaft/thema_biosicherheit/normen_und_gesetze" target="_blank">wissenschaft__gesellschaft/thema_biosicherheit/nor- </a></p><p><a href="/goto?url=http://www.vbio.de/informationen/wissenschaft__gesellschaft/thema_biosicherheit/normen_und_gesetze" target="_blank">men_und_gesetze (last accessed: 21 September 2016). </a></p><ul style="display: flex;"><li style="flex:1">4</li><li style="flex:1">See comments made by the German Federal Office of </li></ul><p></p><p>Civil Protection and Disaster Assistance, Unit III.2 on <a href="/goto?url=http://www.bbk.bund.de/DE/AufgabenundAusstattung/CBRNSchutz/Biologie/biologie_node.html" target="_blank">CBRN protection, available at: www.bbk.bund.de/DE/ </a></p><p><a href="/goto?url=http://www.bbk.bund.de/DE/AufgabenundAusstattung/CBRNSchutz/Biologie/biologie_node.html" target="_blank">AufgabenundAusstattung/CBRNSchutz/Biologie/biolo</a><a href="/goto?url=http://www.bbk.bund.de/DE/AufgabenundAusstattung/CBRNSchutz/Biologie/biologie_node.html" target="_blank">- </a></p><p><a href="/goto?url=http://www.bbk.bund.de/DE/AufgabenundAusstattung/CBRNSchutz/Biologie/biologie_node.html" target="_blank">gie_node.html (last accessed: 21. September 2016). </a></p><ul style="display: flex;"><li style="flex:1">5</li><li style="flex:1">On the importance of gain-of-function experiments, see </li></ul><p>also the policy report from the European Academies Science Advisory Council (EASAC) “Gain of function: experimental applications relating to potentially pan<a href="/goto?url=http://www.easac.eu/fileadmin/PDF_s/reports_statements/Gain_of_Function/EASAC_GOF_Web_complete_centred.pdf" target="_blank">demic pathogens” (2015), available at: www.easac.eu/ </a></p><p><a href="/goto?url=http://www.easac.eu/fileadmin/PDF_s/reports_statements/Gain_of_Function/EASAC_GOF_Web_complete_centred.pdf" target="_blank">fileadmin/PDF_s/reports_statements/Gain_of_Func</a><a href="/goto?url=http://www.easac.eu/fileadmin/PDF_s/reports_statements/Gain_of_Function/EASAC_GOF_Web_complete_centred.pdf" target="_blank">- </a></p><p><a href="/goto?url=http://www.easac.eu/fileadmin/PDF_s/reports_statements/Gain_of_Function/EASAC_GOF_Web_complete_centred.pdf" target="_blank">tion/EASAC_GOF_Web_complete_centred.pdf (last </a>accessed: 21 September 2016). </p><p></p><ul style="display: flex;"><li style="flex:1">7</li><li style="flex:1">See, for example, “Guidelines and Rules of the Max </li></ul><p></p><p>Planck Society on a Responsible Approach to Freedom of Research and Research Risks” (2010), available at: </p><p><a href="/goto?url=http://www.mpg.de/232129/researchFreedomRisks.pdf" target="_blank">www.mpg.de/232129/researchFreedomRisks.pdf, the </a></p><p>Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) (2013) “Arbeit mit hochpathogenen Mikroorganismen und Toxinen”, available at: </p><p><a href="/goto?url=http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2013/130313_verhaltenscodex_dual_use.pdf" target="_blank">www.dfg.de/download/pdf/dfg_im_profil/reden_stel</a><a href="/goto?url=http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2013/130313_verhaltenscodex_dual_use.pdf" target="_blank">- </a></p><p><a href="/goto?url=http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2013/130313_verhaltenscodex_dual_use.pdf" target="_blank">lungnahmen/2013/130313_verhaltenscodex_dual_use. </a></p><p><a href="/goto?url=http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2013/130313_verhaltenscodex_dual_use.pdf" target="_blank">pdf, the Leibniz Association (2012) “Verhaltenskodex </a></p><p>für Biosicherheit für Einrichtungen im Umgang mit </p><p><a href="/goto?url=http://www.leibniz-gemeinschaft.de/fileadmin/user_upload/downloads/Presse/Dokumente/Verhaltenskodex_fuer_Biosicherheit_deutsch.pdf" target="_blank">biologischen Ressourcen”, available at www.leibniz-ge</a><a href="/goto?url=http://www.leibniz-gemeinschaft.de/fileadmin/user_upload/downloads/Presse/Dokumente/Verhaltenskodex_fuer_Biosicherheit_deutsch.pdf" target="_blank">- </a><a href="/goto?url=http://www.leibniz-gemeinschaft.de/fileadmin/user_upload/downloads/Presse/Dokumente/Verhaltenskodex_fuer_Biosicherheit_deutsch.pdf" target="_blank">meinschaft.de/fileadmin/user_upload/downloads/ </a><a href="/goto?url=http://www.leibniz-gemeinschaft.de/fileadmin/user_upload/downloads/Presse/Dokumente/Verhaltenskodex_fuer_Biosicherheit_deutsch.pdf" target="_blank">Presse/Dokumente/Verhaltenskodex_fuer_Biosicher</a><a href="/goto?url=http://www.leibniz-gemeinschaft.de/fileadmin/user_upload/downloads/Presse/Dokumente/Verhaltenskodex_fuer_Biosicherheit_deutsch.pdf" target="_blank">- </a></p><p><a href="/goto?url=http://www.leibniz-gemeinschaft.de/fileadmin/user_upload/downloads/Presse/Dokumente/Verhaltenskodex_fuer_Biosicherheit_deutsch.pdf" target="_blank">heit_deutsch.pdf (all last accessed: 21 September 2016). </a></p><ul style="display: flex;"><li style="flex:1">6</li><li style="flex:1">For the current discussion on and progress of implemen- </li></ul><p>tation of biosafety and biosecurity measures in the US, see the Federal Select Agent Program (available at: <a href="/goto?url=http://www.selectagents.gov" target="_blank">www. </a><a href="/goto?url=http://www.selectagents.gov" target="_blank">selectagents.gov), </a>the White House memorandum (2015; </p><p>available at: <a href="/goto?url=http://www.whitehouse.gov/sites/default/files/docs/10-2015_biosafety_and_biosecurity_memo.pdf" target="_blank">www.whitehouse.gov/sites/default/files/ </a></p><p><a href="/goto?url=http://www.whitehouse.gov/sites/default/files/docs/10-2015_biosafety_and_biosecurity_memo.pdf" target="_blank">docs/10-2015_biosafety_and_biosecurity_memo.pdf) </a>and the National Science Advisory Board for Biosecurity (NSABB) report “Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function Research” (2016), available at: <a href="/goto?url=http://osp.od.nih.gov/sites/default/files/NSABB_Final_Report_Recommendations_Evaluation_Oversight_Proposed_Gain_of_Function_Research.pdf" target="_blank">http://osp.od.nih.gov/sites/default/ </a></p><p><a href="/goto?url=http://osp.od.nih.gov/sites/default/files/NSABB_Final_Report_Recommendations_Evaluation_Oversight_Proposed_Gain_of_Function_Research.pdf" target="_blank">files/NSABB_Final_Report_Recommendations_Evalua</a><a href="/goto?url=http://osp.od.nih.gov/sites/default/files/NSABB_Final_Report_Recommendations_Evaluation_Oversight_Proposed_Gain_of_Function_Research.pdf" target="_blank">- </a></p><p><a href="/goto?url=http://osp.od.nih.gov/sites/default/files/NSABB_Final_Report_Recommendations_Evaluation_Oversight_Proposed_Gain_of_Function_Research.pdf" target="_blank">tion_Oversight_Proposed_Gain_of_Function_Research. </a><a href="/goto?url=http://osp.od.nih.gov/sites/default/files/NSABB_Final_Report_Recommendations_Evaluation_Oversight_Proposed_Gain_of_Function_Research.pdf" target="_blank">pdf (all last accessed: </a>21 September 2016). </p><p>A. Background </p><p>7</p><p>and sufficient as normative instruments 3. The DFG’s and the Leopoland whether they represent an adequate </p><p>basis for promoting research. The German Ethics Council took this assignment as an opportunity to carry out a system- </p><p>dina’s “Recommendations for Handling Security-Relevant Research” </p><p>atic analysis on the topic of biosecuri- In the opinion of the DFG and the Leopty-relevant research and to put forward oldina, legal provisions offer only a very recommendations for the future handling limited means of controlling the oppor- </p><ul style="display: flex;"><li style="flex:1">of such research and its funding. </li><li style="flex:1">tunities and risks associated with free re- </li></ul><p>search. Research methods and content are </p><p>The statement “Biosecurity – free- constantly changing and research find- </p><p>dom and responsibility of research”<sup style="top: -0.2756em;">8 </sup>was ings, as well as their future application, </p><p>published on 7 May 2014. The paper’s key tend to be almost impossible to predict. </p><p>recommendations included measures to The DFG and Leopoldina continuously increase awareness of biosecurity issues work to ensure that ethical principles and </p><p>within the scientific community as well as mechanisms for the responsible handling </p><p>tighter legal regulation of so-called dual of freedom of research and research risks use research of concern (DURC) in Ger- are developed in science. As part of the many. The German Ethics Council de- gain-of-function debate, the two organi- </p><p>fined such research as “work that can be sations appointed a joint interdisciplinary </p><p>reasonably anticipated to provide knowl- and cross-institutional working group in edge, products, or technologies that could the summer of 2013 that was tasked with be directly misapplied by others to cause analysing and discussing the complex redamage to public health and safety, the lationship between freedom of research environment or to other important legal and research risks.<sup style="top: -0.2727em;">9 </sup>interests.” <br>In discussion with various research <br>The Ethics Council recommended organisations and members of the Leop- </p><p>drafting a legal definition of DURC and oldina and DFG, the working group devel- </p><p>appointing a legally legitimate central oped a set of general guidelines on han- </p><p>DURC Commission. A prerequisite for dling security-relevant scientific research </p><p>private and/or public funding of poten- based on the “Guidelines and Rules on a tial DURC should be that scientists are Responsible Approach to Freedom of Reobliged to seek the advice of the central search and Research Risks”,<sup style="top: -0.2757em;">10 </sup>which the </p><p>DURC Commission. The final funding Max Planck Society approved in 2010. </p><p>decision should also depend on a DURC These guidelines were presented to the Commission vote. Another possible in- public on 26 June 2014 in Berlin under strument for monitoring and controlling the title “Scientific Freedom and ScientifDURC put forward by the German Ethics ic Responsibility – Recommendations for Council is the transferral of decision-mak- Handling Security-Relevant Research”.<sup style="top: -0.276em;">11 </sup>ing powers to a federal agency as part of This document places great importance </p><ul style="display: flex;"><li style="flex:1">an approval procedure. </li><li style="flex:1">on instruments of self-governance within </li></ul><p></p><p>the scientific community. The advantage </p><p></p><ul style="display: flex;"><li style="flex:1">9</li><li style="flex:1"><a href="/goto?url=http://www.leopoldina.org/en/policy-advice/working-groups/completed-working-groups/dual-use" target="_blank">For more information, see: www.leopoldina.org/en/pol</a><a href="/goto?url=http://www.leopoldina.org/en/policy-advice/working-groups/completed-working-groups/dual-use" target="_blank">- </a></li></ul><p></p><p><a href="/goto?url=http://www.leopoldina.org/en/policy-advice/working-groups/completed-working-groups/dual-use" target="_blank">icy-advice/working-groups/completed-working-groups/ </a><a href="/goto?url=http://www.leopoldina.org/en/policy-advice/working-groups/completed-working-groups/dual-use" target="_blank">dual-use (last accessed: 21 </a>September 2016). </p><p>10 Av<a href="/goto?url=http://www.mpg.de/232129/researchFreedomRisks.pdf" target="_blank">ailable at: www.mpg.de/232129/researchFreedom</a><a href="/goto?url=http://www.mpg.de/232129/researchFreedomRisks.pdf" target="_blank">- </a></p><p><a href="/goto?url=http://www.mpg.de/232129/researchFreedomRisks.pdf" target="_blank">Risks.pdf (last accessed: 21 September 2016). </a><br>11 Available <a href="/goto?url=http://www.leopoldina.org/uploads/tx_leopublication/2014_06_DFG-Leopoldina_Scientific_Freedom_Responsibility_EN.pdf" target="_blank">at: www.leopoldina.org/uploads/tx_leo- </a><a href="/goto?url=http://www.leopoldina.org/uploads/tx_leopublication/2014_06_DFG-Leopoldina_Scientific_Freedom_Responsibility_EN.pdf" target="_blank">publication/2014_06_DFG-Leopoldina_Scientif- </a><a href="/goto?url=http://www.leopoldina.org/uploads/tx_leopublication/2014_06_DFG-Leopoldina_Scientific_Freedom_Responsibility_EN.pdf" target="_blank">ic_Freedom_Responsibility_EN.pdf (last accessed: 21 </a>September 2016). </p><ul style="display: flex;"><li style="flex:1">8</li><li style="flex:1">Av<a href="/goto?url=http://www.ethikrat.org/publikationen/stellungnahmen/biosicherheit" target="_blank">ailable at: www.ethikrat.org/publikationen/stellung- </a></li></ul><p><a href="/goto?url=http://www.ethikrat.org/publikationen/stellungnahmen/biosicherheit" target="_blank">nahmen/biosicherheit (last accessed: 21 September </a>2016). </p>
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