NOTIFICATION

advertisement
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.
...
Download