Ground
Rules for Consideration of Proposals by the GEAC as per the good practices in
environmental regulation adopted by MoEF.
The Ministry of Environment
& Forests has formulated procedural guidelines to
streamline the working of the regulatory bodies constituted by the Ministry. In
this context a document on “Good Practices in Environmental Regulations” has
been prepared. These guidelines would
be applicable to the functioning of the GEAC.
As per these guidelines a number
of checks and counter checks have been put in place to ensure that the
regulator adopts the operational guidelines for observations of good practices
in environmental regulations. Accordingly, to ensure transparency in the
decision making process a set of information such as Ground Rules, Name of the
Chair/ Co-Chair/ Vice Chair, Standing time table of the Committee, Agenda for
the next meeting, Status of Pending Projects etc. are to be posted on the MoEF
web-page. Information for applicants seeking approval of GEAC are enumerated
below
1.0 A
brief note on the Biosafety Regulatory Framework in India.
1.1 The
Ministry of Environment & Forests (MoEF), has notified the Rules for the
Manufacture, Use, Import, Export and Storage of Hazardous
Microorganisms/Genetically Engineered Organisms or Cells 1989 under the
Environment (Protection) Act, 1986, These rules and regulations cover the areas
of research as well as large scale applications of GMOs and products made
therefrom throughout India. The rules
also cover the application of hazardous microorganisms, which may not be
genetically modified. Hazardous
microorganisms include those, which are pathogenic to animals as well as
plants. The rules cover activities involving
manufacture, use, import, export, storage and research. The target substances covered are, besides
the hazardous natural microorganisms, all genetically engineered organisms
including microorganisms, plants and animals.
1.2 These
rules also define the competent authorities and composition of such authorities
for handling of various aspects of the rules.
Presently there are six competent authorities that is, Recombinant DNA
Advisory Committee (RDAC), Institutional Biosafety Committees (IBSC), Review
Committee on Genetic Manipulation (RCGM), Genetic Engineering Approval Committee
(GEAC), State Biotechnology Coordination Committee (SBCC) and the District
Level Committee (DLC). The RCGM established under the Department of
Biotechnology (DBT) supervises and accords approval for research activities
including small-scale field trials/pre-clinical trials, whereas approvals for
large-scale releases and commercialization of GMOs are given by the GEAC,
established under the Ministry of Environment and Forests. The SBCC’s and DLC’s
have a major role in monitoring. The Rules also mandate that every institution
engaged in GMO research establish an IBSC to oversee such activities and to interface with the RCGM in regulating
it.
The ‘Rules 1989’ have been
supplemented by technical guidelines with a view to address various biosafety
concerns. The various guidelines issued by DBT include:
A copy of the ‘Rules 1989’ and
the Biosafety Guidelines are annexed.
2.0
Rules for Consideration of the Proposal
2.1
All new proposals received in the Ministry 30 days prior to the
GEAC meeting would be placed for consideration of the GEAC in the next GEAC
meeting, which is scheduled every 2nd Wednesday of the month in the
Ministry of Environment & Forests. In case the information is not received
within the prescribed time limit, the proposal would be considered in the
subsequent GEAC meeting.
2.2
In reconsideration cases, the requisite information sought by the
Committee should be submitted 15 days prior to the next GEAC meeting for it’s
consideration in the meeting; in case the information is not received within
the prescribed time limit, the proposal would be considered in the subsequent
GEAC meeting.
2.3
The requisite information required for consideration of the
application by the GEAC include:
a. The Project Proponent
should submit their request through an application as per the prescribed GEAC
proforma.
b. The request for
approval of large-scale trials of transgenic crops should be accompanied by
RCGM and MEC recommendation.
c. The request for
commercial cultivation of transgenic crops should include data on large-scale
trials and ICAR trials and recommendation of MEC.
d. In case of Pharma
products, the request for Phase-III clinical trials should be accompanied by
recommendation of RCGM.
e. The request for
manufacture and marketing of pharma products should include details of
containment facilities and clinical trials and recommendation of RCGM on the
containment facilities.
f. The request for import
and marketing of Pharma products should include detailed information on the
trials conducted in the country of origin and approvals obtained.
2.4
The application and other requisite information should be
submitted in both hard copy as well as electronic copy to the Member Secretary
GEAC. Subsequently a copy of the same should be made available to the members
of the GEAC.
2.5
The request for import of transgenic seeds/ genetically engineered
microorganisms for the purpose of research activities should be submitted to
RCGM as per the prescribed DBT proforma.
3.0 Schedule
of GEAC Meeting
3.1
The GEAC Meeting would be held every 2nd Wednesday of
the month at 10.30 am in Paryavaran Bhavan, CGO Complex, Lodhi Road, New Delhi-
110003. In case the 2nd Wednesday is a holiday, the GEAC meeting
would be held the following day.
3.2
The agenda for the meeting would be displayed on the MoEF website
15 days prior to the next GEAC Meeting.
3.3
All Project Proponents would be given an opportunity for a
personal hearing. The project
proponents who wish to present their case may be present in the Ministry on the
date of the meeting.
3.4
Decisions taken in the GEAC meeting would be displayed on MoEF
website within 5 working days after the GEAC meeting.
3.5
Status of pending projects and reasons for pendency would be
updated every 15 days.
4.0
Chairman /Co- Chairman of the GEAC is as follows:
1. Mr. Suresh
Chandra Chairman
Special Secretary,
Ministry of Environment
& Forests
Paryavaran Bhavan
CGO Complex, Lodhi Road
New Delhi -110003
2. Dr. Amit
Ghosh Co-
Chairman
Co-Chairman GEAC & Former Director
Institute of Microbial Technology
(IMTech),
Sector 39,A
Chandigarh – 160 036
All application/communication regarding GEAC approval may be
addressed to Chairman GEAC.
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