Dated: 11th August, 2011 No.MZU/Acad-6/25/11/3470 NOTIFICATION ` In pursuance of the Resolution No. AC:19:4(4) adopted at the 19 th Meeting of Academic Council held on 1.7.2011 and in accordance with Rules for the manufacture, use/import/export and hazardous Micro-organism/Genetically Engineered Organisms or Cells, 1989, The Vice-Chancellor, Mizoram University is pleased to constitute Mizoram University Biosafety Committee (MZUBSC) for a term of 3 years consisting of the following members : 1. Head of the Organization or his Designate as the Chairperson: i) Prof. G.C. Jagetia, Dean, School of Life Sciences. 2. Three or more Scientists engaged in rDNA work or Molecular Biology with at least one Outside Expert in the Relevant Discipline: i) H.T. Lalremsanga, Deptt. of Zoology, MZU. ii) Dr. N. Senthil Kumar, Deptt. of Biotechnology, MZU. iii) Dr. J. Bhattacharya, Deptt. of Biotechnology, MZU. iv) Prof. H. Lalramnghinglova, Deptt. of Environmental Science, MZU. v) Dr. S.K. Mehta, Deptt. of Botany, MZU. vi) Dr. A.C. Shukla, Deptt. of HAMP, MZU. vii) Dr. Lalnundanga, Deptt. of Forestry, MZU. viii) Dr. Diwakar Tiwari, Deptt. of Chemistry, MZU. ix) An External Member to be nominated by the Vice Chancellor. Prof. Sankar K. Ghosh, Assam University 3. Members with Medical Qualifications : i) Dr. Pauline L. Vanchhawng, Medical Officer, MZU. ii) Dr. John Zohmingthanga, Pathologist, Civil Hospital, Aizawl. 4. A nominee of Department of Biotechnology, Govt. of India. Dr. J. Bhattacharya will be Member Secretary of the committee. Sd/( Prof. Thangchungnunga ) Registrar CONSTITUTION OF MIZORAM UNIVERSITY BIOSAFETY COMMITTEE (MZUBSC) Any Institution/Organization that undertake research in Genetic Engineering, Genetically Modified Organisms (GMO), recombinant DNA (rDNA) materials, Living Modified Organisms (LMOs) is required to constitute an Institutional Biosafety Committee as per the Rules for the manufacture, use/import/export and hazardous Micro-organisms/Genetically Engineered Organisms or Cells, 1989 as notified by the Ministry of Environment and Forests (MoEF), Govt. of India under the Environment (Protection) Act, 1986. These Rules are implemented by the Department of Biotechnology (DBT), Govt. of India. Accordingly, Mizoram University Biosafety Committee (MZUBSC) has been constituted vide notification No.MZU/Acad-6/25/11/3470, Dt. 11th August, 2011. II. Functions of MZUBSC The responsibilities of the MZUBSC include i) Review and clearance of project proposals falling under restricted category and as per guidelines issued by DBT from time to time. ii) Tailoring biosafety programme to the level of risk assessment. iii) Assess and monitor the research facilities, procedures and experts involved in GMOs/LOMs and rDNA research. iv) Inform the Principal Investigator about MZUBSC review, approval or rejection of their projects. v) Information of all relevant activities involving the use of GMOs/LMOs and rDNA research to the RCGM. vi) Ensure that the information provided in the application form is correct and complete. vii) Provide guidance to Principal Investigator on the issues related to biosafety while using GMOs/LMOs and rDNA research including safety of all the members associated with the research activity. viii) Assess field experiments to ensure that the proposed risk assessment, risk management and emergency plan are sufficient. ix) Review the emergency plan proposed by the Principal Investigator for responding to an accidental release of a GMO and those adopted to meet any exigencies. Copies of site emergency plan to be submitted to RCGM, GEAC, State Biotechnology Coordination Committee (SBCC) or District Level Committee (DLC) as the case may be, as per Rules, 1989. x) MZUAEC will also monitor, review and prepare compliance report of Institutional Biosafety Committees of affiliated colleges of University where ever applicable. III. MZUBSC Terms of office, Conduct of Business and Quorum 1) MZUBSC shall have a term of office for 3 years. 2) The MZUBSC shall meet as required. However, MZUBSC has to meet al least twice in a year to review and approve the rDNA projects. Each meeting of the MZUBSC is expected to look into : a) Action taken on the decisions of the earlier meetings. b) Assessment of Work Element and approval as per risk category of organism involved. c) Evaluation of projects and direction for submission to appropriate agencies for statutory approval. d) Inspection of containment facilities, unit process areas, greenhouses etc and preparation of reports for regulatory agencies. e) Review the medical reports of the employees. f) Examining and recommending procedures and other approval requirements. 3) The Chairperson may call an Emergency Meeting of the MZUBSC to address any urgent issues and unexpected events involving GMOs/LMOs /rDNA materials. 4) At least 50% of the total MZUBSC members along with DBT nominee will form the quorum for the conduct of the meeting. If a quorum is lost at any time during the meeting, the meeting shall be adjourned and no further action shall be taken up by the MZUBSC until a quorum is reestablished or a new meeting is appropriately convened. 5) Attendance at members at MZUBSC meetings is mandatory. Members who are unable to attend the meeting should inform the Chairperson and provide a written summary of their review and any comments to the MZU BSC. 6) Prior to regular meeting each member should be sent a copy of the documents to be reviewed at the meeting, in addition to other information to be discussed. 7) Minutes of MZUBSC meetings shall include the following information a) Attendance of members and invitees, if any. b) MZUBSC’s review and decisions on all applications considered in the meeting including modifications to project proposals, if any. c) Remarks on suitability of facilities with respect to containment requirements after inspection of GMOs/LMOs/rDNA facilities and suggestions, if any. d) The minutes should clearly indicate about discussions and decisions taken during the meeting. 8) A copy of the minutes of MZUBSC meetings is required to be sent to DBT, GoI, New Delhi. 9) All members including DBT nominee and external experts are expected to maintain confidentially of the proposals and other related information made available to them for review, reference or discussion and not divulge any confidential or Intellectual Property (IP) or commercial business information (CBI) of an applicant/organization/institute acquired as a result of review of such proposals and subsequent discussions. MZUBSC members are also expected to respect the confidential nature of the opinion expressed by other MZUBSC members on invited experts during discussions in the meetings or provided in written form and not divulge to any person, press or media. If desired, MZUBSC can sign a confidentiality agreement with the members including DBT nominee and/or external experts so as to ensure confidentiality of applications, issues and other matters placed before the MZUBSC. ...