1 (c) (i) Genetic Engineering Approval Committee
(GEAC) and Cartagena Protocol on Biosafety (CPB)
A. BACKGROUND
Biosafety
concerns have led to the development of regulatory regimes in various countries
for research, testing, safe use and handling of GMOs and products thereof. India is one of the earliest countries to
establish a biosafety system for regulation of GMOs. The Ministry of Environment & Forests
(MoEF) had enacted Environment and Protection Act in 1986 to provide for the
protection and improvement of environment and the related matters. Environment
includes water, air and land and the interrelationship, which exists among and
between water, air and land, and human beings, other living creatures, plants,
micro-organisms and property. Under this act, the ‘Rules for Manufacture,
Use/Import/ Export & Storage Of Hazardous Micro Organisms/ Genetically
Engineered Organisms or Cells,
A
brief overview of the rules and procedures for the manufacture, import, use,
research and release of GMOs as well as products made by the use of such
organisms is given below.
B. RULES FOR THE MANUFACTURE, USE, IMPORT, EXPORT
& STORAGE OF HAZARDOUS MICRO ORGANISMS/ GENETICALLY ENGINEERED ORGANISMS OR
CELLS, 1989
I. SCOPE
The above rules commonly known as ‘Rules
There
are 20 paras in the Rules 1989 and some of the important paras along with relevant
details given in Table 1 below:
Table 1: Important paras of Rules, 1989
|
Para |
Deals with |
|
7 |
Approvals to individuals on the import, export,
transport, manufacture, process, use or sale of GMOs and use of GMOs for
research |
|
8 |
Authorization for production of genetically modified
microorganisms, plants and animals |
|
9 |
Approval for deliberate or unintentional release of GMOs
into the open environment |
|
10 11 |
Approval for production, sale and import of substances
and products which may contain GMOs or cells. Approval for production, sale and import of foodstuff,
ingredients in foodstuff including processing aid which may contain GMOs or
cells |
|
12 |
Procedures for obtaining approvals in different
conditions |
|
13 |
Conditions of approval of GMOs |
|
14 |
Mechanism for supervising the implementation of term and
conditions given with authorization for commercial use |
|
15 |
Penalties that can be levied for non compliance of
measures for safe use of GMOs and products thereof |
|
19 |
Redress mechanism through National Environment Appellate Authority |
II. IMPLEMENTING
AGENCIES
The implementation of Rules 1989 is being administered by
the Department of Biotechnology (DBT) and Ministry of Environment and Forests
(MoEF). These rules define the competent authorities and composition of such
authorities for handling of various aspects of the rules. Presently there are
six Competent Authorities i.e. The Recombinant
In accordance with Rule 4 (iv) of
Rules, 1989, the Genetic Engineering Approval Committee (GEAC) was
reconstituted by the Ministry vide OM No.10(20)/90-CS dated 24.3.2006. Shri B. S. Parsheera, Special Secretary, MoEF
is the Chairman of the GEAC, Dr. C.D. Mayee, Chairman, ASRB is the Co-Chairman
of the GEAC, Shri A. K. Goyal, Joint Secretary, MoEF is the Vice Chairman of
the GEAC and Dr. R. Warrier, Director, MoEF is the Member Secretary of the
GEAC. In addition the GEAC is represented by 12
experts and 16 inter-ministerial representatives.
III. BIOSAFETY GUIDELINES
The Rules 1989 are implemented
through a series of guidelines which are updated from time to time. The existing biosafety guidelines are listed
below:
Ø
Recombinant
DNA Safety Guidelines, 1990
Ø
Revised guidelines for research in
transgenic plants & guidelines for toxicity and allergenicity evaluation of
transgenic seeds, plants and plant parts, 1998
Ø
Guidelines for generating
preclinical and clinical data for rDNA vaccines, diagnostics and other
biologicals, 1999
Ø
Guidelines
for the Conduct of Confined Field Trials of Regulated, Genetically Engineered
Plants, 2008
Ø
Standard
Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically
Engineered Plants, 2008
Ø
Guideline
for the Monitoring of Confined Trials of Regulated, Genetically Engineered
Plants, 2008
Ø
Guidelines
for the Safety Assessment of Foods Derived from Genetically Engineered Plants,
2008
Ø
Protocols
for Food and Feed Safety Assessment of GE crops, 2008
A
brief overview of the existing biosafety guidelines are summarized below:
i. Recombinant DNA Safety Guidelines and
Regulations, 1990
The
“Recombinant DNA Guidelines in
The
research activities have been classified into three categories based on the
level of the associated risk.
Accordingly, the requirement for the approval of competent authority is
envisaged as follows:
Category I activities include those
experiments involving self cloning using strains and also inter-species cloning
belonging to organism in the same exchanger group which are exempt for the
purpose of intimation and approval of Competent Authority.
Category II activities require prior intimation
of Competent Authority and include experiments falling under containment levels
II, III and IV (details of each containment level have been provided separately
in the guidelines).
Category III activities require review and
approval of Competent Authority before commencement of experiments involving
toxin gene cloning, cloning of genes for vaccine production, and other
experiments as mentioned in the guidelines.
The levels of risk and classification of the organisms within these
categories have been defined in these guidelines.
Appropriate
practices, equipment and facilities necessary for safeguards in handling
organisms, plants and animals in various risk groups have been recommended. The guidelines enumerate the concept of
physical and biological containment and the principles of good laboratory
practices. For containment facilities and biosafety practices, recommendations
of the WHO laboratory safety manual on genetic engineering techniques involving
microorganisms of different risk groups have been incorporated therein.
The guideline gives
principles of occupational safety and hygiene for large-scale practice and
containment. Safety criteria have also been defined in the guidelines. Physical
containment conditions that should be ensured for large-scale experiments and
production have been specified in the guidelines.
ii. Revised Guidelines for research in
Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of
Transgenic Seeds, Plants and Plant parts, 1998
The “Revised Guidelines for Research in Transgenic Plants”
brought out in 1998 cover areas of
recombinant DNA research on plants including the development of transgenic
plants and their growth in soil for molecular and field evaluation. The
guidelines also deal with import and shipment of genetically modified plants of
research use. These also include the “Guidelines for Toxicity and Allergenicity
Evaluation of Transgenic Seeds, Plants and Plant parts”.
The guidelines include complete design of a contained green
house suitable for conducting research with transgenic plants. Besides, it
provides the basis for generating food safety information on transgenic plants
and plant parts.
iii. Guidelines for generating Pre-Clinical
and Clinical Data for r-DNA based Vaccines, Diagnostics and other Biologicals,
1999
A set of
guidelines was issued in 1999 to provide guidance for generating relevant
pre-clinical and clinical data for rDNA
based Vaccines, Diagnostics and other
Biologicals for submission to
regulatory authorities. The guidelines specially focus on safety, purity,
potency and effectiveness of the products.
iv. Guidelines and Standard Operating
Procedures (SOPs) for Confined Field Trials of Genetically Engineered Plants
“Guidelines for the conduct
of confined field trials of regulated, GE plants and Standards Operating
Procedures (SOPs)” have been prepared to provide instructions to help
applicants meet requirements for the application and authorization/ approval of
confined field trials of regulated, GE plants under Rules for Manufacture, Use,
Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered
Organisms or Cells Rules, 1989 of the Environment (Protection) Act, 1986. These
guidelines approved by RCGM and GEAC in June 2008, summarize the information
requirements and procedures used by the two regulatory committees, that are
responsible for evaluating and approving applications for confined field
trials. These guidelines cover all GE/transgenic plants modified through
recombinant DNA (rDNA) technology.
The
guidelines describe the application process and general requirements for
confined field trials and the SOPs are for transport, storage, management,
harvest/termination and post harvest management during the conduct of the
trials.
These Guidelines supplement the biosafety measures for
field trials given in Section 7 of the “Revised Guidelines for Research in
Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of
Transgenic Seeds, Plants and Plant Parts,
v. Guidelines for Safety Assessment of
Foods Derived from Genetically Engineered Plants
The
Indian Council of Medical Research (ICMR), in its capacity as the scientific and
technical advisory body to the Ministry of Health and Family Welfare (MoHFW),
has formulated “Guidelines for Safety Assessment of Foods Derived from
Genetically Engineered Plants”, to establish the safety assessment procedures
for foods derived from GE plants taking into consideration the international Guideline for the Conduct of Food Safety
Assessment of Foods Derived from Recombinant-DNA Plants.
These
guidelines apply to all whole foods, food products, and foods used as
ingredients that are derived from GE plant sources. These guidelines are intended
to provide guidance to both applicants and reviewers for regulatory purposes.
They are not intended to explicitly define all the data that might be required
in the course of a safety assessment as further data requirements may be
identified during the safety assessment process
The
safety assessment of foods derived from GE plants in these guidelines is based
on the evaluation of these foods relative to their conventional counterparts
that have a history of safe use.
vi. Protocols for Food and Feed Safety
Assessment of Genetically Engineered Plants
A
series of protocols to provide guidance to applicants seeking approval for
environmental release of genetically engineered (GE) plants in India under ‘Rules,
1.
Acute Oral Safety Limit Study in Rats or Mice
2.
Subchronic Feeding Study in Rodents
3.
Protein Thermal Stability
4.
Pepsin Digestibility Assay
5.
Livestock Feeding Study
These
protocols address key elements of the safety assessment of foods and/or
livestock feeds that may be derived from GE crops.
The
protocols are based on international best practices, including guidance and
peer reviewed publications available from the Codex Alimentarius Commission,
the Food and Agriculture Organization, the World Health Organization, the
Organization for Economic Cooperation and Development, and the International
Life Sciences Institute.
For
additional guidance the “ICMR Guidelines for the Safety Assessment of Foods
Derived from Genetically Engineered Plants” provide a comprehensive summary of
the information and data requirements that must be provided to regulatory
authorities to demonstrate the human health safety of foods derived from GE
plants.
IV. APPROVALS AND
PROHIBITIONS
The approvals and prohibitions under Rules 1989 are
summarized below:
·
No
person shall import, export, transport, manufacture, process, use or sell any
GMOs, substances or cells except with the approval of the GEAC.
·
Use
of pathogenic organisms or GMOs or cells for research purpose shall be allowed
under the Notification, 1989 of the EPA, 1986.
·
Any
person operating or using GMOs for scale up or pilot operations shall have to
obtain permission from GEAC.
·
For
purpose of education, experiments on GMOs IBSC can look after, as per the
guidelines of the Government of India.
·
Deliberate
or unintentional release of GMOs not allowed.
Production in which GMOs are generated or used shall not be commenced except with the approval of GEAC
·
GEAC
supervises the implementation of rules and guidelines.
·
GEAC
carries out supervision through SBCC, DLC or any authorized person.
·
If
orders are not complied, SBCC/DLC may take suitable measures at the expenses of
the person who is responsible.
·
In
case of immediate interventions to prevent any damage, SBCC and DLC can take
suitable measures and the expenses incurred will be recovered from the person
responsible.
·
All
approvals shall be for a period of 4 years at first instance renewable for 2
years at a time.
·
GEAC
shall have powers to revoke approvals in case of:
i.
Any
new information on harmful effects of GMOs.
GMOs cause such damage to the environment as could not be envisaged when approval was given.
Non-compliance of any conditions stipulated by GEAC.
V. Notifications under Rules, 1989
Various notifications issued under Rules, 1989 from time to
time to address various issues are:
·
Notification
(S.O. 843) (E) dated, July 2000) listing the laboratories allowed to use
pathogenic micro-organisms or genetically engineered organisms or cells for the
purpose of research.
·
Notifications
(G.S.R. 584) (E) to 589 (E)) dated 1st September, 2006 empowering
Seed Inspectors/Seed Analyst/ Laboratories notified under Seed Act, 1966 and
Seed Control Order, 1983 under Environment (Protection) Act, 1986.
·
Notification
(G.S.R.616) (E) 1st
September, 2006) exempting certain categories of recombinant
pharmaceutical products for purview of Rules, 1989
·
Notification
(S.O. 1519) (E) dated, 23rd
August, 2007) exempting GM food stuffs, ingredients in food stuffs and
additives from the purview of Rules, 1989.
This notification has been withdrawn at the behest of Ministry of Health
and Family Welfare who have informed that it would take some more time for the
Food Safety and Standards Authority to become operational. During the interim period the GEAC has been
requested to continue with the regulation of GM foods.
PROCEDURE FOR CONVENING THE MEETINGS OF THE GEAC
In accordance with the guidelines for best practices in
environmental regulations, the meetings of the GEAC are convened on every
second Wednesday of the month. All
proposals received in the Ministry 30 days prior to the meeting are placed in
the agenda for consideration of the GEAC. Information regarding the agenda items for
the GEAC meeting, decisions taken therein and other relevant documents (policy
issues, Sub committee / Expert Committee reports, Biosafety data etc.) are
posted on the GEAC website on a regular basis and may be viewed at http://www.envfor.nic.in/divisions/csurv/geac/geac_home.html.
Project proponents / NGOs / other stakeholders are given an
opportunity for personal hearing in the GEAC meetings on request.
STATUS OF GEAC
APPROVALS
A. Commercial
Release of transgenic Crops:
Bt cotton is the only transgenic crop approved for
commercial cultivation in India. Bt
technology was deployed in cotton crop through genetic engineering techniques
for control of bollworms the major pest thereby reducing the risk of crop
failures and use of pesticides. Bt cotton producing a
natural insecticide that comes from the ubiquitous soil bacterium known as
Bacillus Thuringiensis was approved by the Genetic Engineering Approval
Committee (GEAC) for introduction in India in
As of date the GEAC has approved Bt cotton
hybrids
expressing Cry
In addition the GEAC also
approved the commercial release of BN Bt (variety) developed by CICR, Nagpur.
For the first time Bt technology has been introduced in a varietal background
whereby the farmers can save seeds.
During the period 2002 to
2008 the GEAC has approved 267- Bt cotton hybrids of which 132 were approved
during 2008.
B. Status of approval of GM Food crops in
India:
The large scale field trials of Bt brinjal developed by M/s
Mahyco expressing cry 1Ac gene from Bacillus thuringiensis tolerant to the
fruit and shoot borer is under progress at 11 locations within the research farms of Indian Institute of
Vegetable Research(IIVR) /State Agricultural Universities/ Indian Council of
Agriculture Research. The trials are being conducted under the supervision of
Director IIVR, Varanasi.
Details of other GM crops under various stages of field
testing are as follows:
FIELD
TRIALS OF GM CROPS (CONTAINING NEW GENES/EVENTS) APPROVED BY THE GEAC IN YEAR
2008:
|
S.No. |
Crop |
Company Name |
Trial |
Trait |
Gene/Event |
|
1 |
Cauliflower |
Sungro Seeds Research Ltd. |
BRL-I |
Insect Resistance |
cry1Ac |
|
Nunhems India Pvt. Ltd |
Event selection |
Insect Resistance |
cry1b and
cry |
||
|
2 |
Cotton |
Dow AgroSciences India Pvt. Ltd. |
BRL-I |
Insect Resistance |
cry1Ac&
cry1F
(WideStrike = Event 3006-210-23 and Event 281-24-236) |
|
JK Agrigenetics Ltd. |
BRL-I |
Insect Resistance |
cry1Ac (Event-1) and cry1EC (Event-24) |
||
|
MAHYCO |
BRL-I |
Insect resistance and Herbicide tolerance |
cry1Ac &
cry2Ab (MON
15985) and CP4EPSPS (MON 88913) |
||
|
Metahelix Life Sciences |
LST |
Insect Resistance |
cry1C (MLS9124 event) |
||
|
Central Institute for Cotton Research |
LST |
Insect Resistance |
cry 1Ac |
||
|
3 |
Rice |
Bayer Bioscience Pvt. Ltd. |
Event selection |
Insect resistance |
cry 1 Ab,
cry |
|
Avesthagen Ltd. |
Event Selection |
Oxdative stress |
Orya sativa
taipae 309 |
||
|
4 |
Tomato |
Avesthagen Ltd. |
Event selection |
Increased lycopene content |
unedited NAD9 |
|
5 |
Groundnut |
ICRISAT |
Event selection |
Tobacco streak virus against peanut stem necrosis
disease. |
Coat protein gene |
|
6, |
Cabbage |
Nunhems India Pvt. Ltd |
Event selection |
Insect Resistance` |
cry1b and
cry |
|
7. |
Potato |
Central Potato Research Institute. |
Event selection |
Late blight resistance |
RB gene |
|
8. |
Corn |
Monsanto India Ltd. |
BRL-I |
Insect resistance and herbicide tolerant |
Cry 1A.105
(chimeric gene) and cry2Ab2 |
BRL-I: Biosafety Research Level-I
BRL-II: Biosafety Research Level-II
LST: Large
Scale Trial
The present status and locations
of field trials may be viewed at www.igmoris.nic.in
C. Streamlining of the Regulatory Procedure
for transgenic crops.
a. The GEAC has adopted the ‘event based
approval’ mechanism in respect of Bt cotton expressing approved events in its
meeting held on 2.4.2008. In accordance
with the decision taken by the GEAC in its meeting held on 14.1.2009 a new
procedure for commercial release of Bt cotton hybrids expressing approved
events has been notified and shall be applicable from 1.3.2009. The new
procedure may be viewed at http://www.envfor.nic.in/divisions/csurv/geac/geac_home.html
b. Review of the existing national
regulatory biosafety framework with a view to harmonize the obligations under
Cartagena Protocol on Biosafety (CPB) has been initiated.
c.
Development
of a new biosafety website has been initiated.
D. Capacity Building to facilitate
compliance of Biosafety regulation:
Extensive capacity building
activities have been planned for efficient management of field trials of GM
crops covering 12 states where the field trials are being undertaken. Training of 16 SAUs with respect to use of
new guidelines for confined field trials, safe operational practices (SOPs),
formats for monitoring and recording of data etc. have been recently completed.
As part of the USDA Capacity
Building project on biosafety, the 3rd
DVC was organized in June 2008. As an
outcome of the 3rd DVC deliberations, a Short Term course for ‘Confined field trials’
was organized jointly by the Ministry, DBT and
Michigan State University (MSU) in
August, 2008 at MSU, USA. The
exchange program was attended by 10 scientists from State Agriculture
Universities, Indian Institute of Agriculture and ICAR institutions. The second short term course for ‘Risk
Assessment of GM crops’ at Michigan State University’ is tentatively scheduled
in June, 2009.
******************
CARTAGENA PROTOCOL ON BIOSAFETY
INTRODUCTION
Although many countries have enacted national biosafety
legislations to ensure the safe use of genetically modified organisms (GMOs)
and products thereof, biotechnology being a global industry and GMOs traded
across borders, international rules are needed as well. Cartagena Protocol on
Biosafety (CPB) is an attempt to produce a globally harmonized regime for biosafety
under the Convention of Biological Diversity (CBD). The Protocol named after the Colombian city
where the final round of talks was launched, sets out a comprehensive
regulatory system for ensuring the safe transfer, handling and use of Living modified
organisms (LMOs) subject to transboundary movement. In every day usage LMOs are
considered to be same as GMOs although definitions and interpretations vary
widely. The Protocol deals primarily with LMOs that are to be intentionally
introduced into the environment (such as seeds, trees or fish) and with
genetically modified farm commodities (such as corn and grain used for food,
animal feed or processing). It does not cover pharmaceuticals for humans
addressed by other international agreements and organizations or products
derived from LMOs, such as cooking oil from genetically modified corn.
ORIGIN
The objectives of the Convention on Biological Diversity
(1992) are “the conservation of biological diversity, the sustainable use of
its components and the fair and equitable sharing of the benefits arising out
of the utilization of genetic resources”. When developing the Convention, the negotiators
recognized that biotechnology can make a contribution towards achieving the objectives
of the Convention, if developed and used with adequate safety measures for the environment
and human health. The Contracting Parties agreed to consider the need to
develop appropriate procedures to address the safe transfer, handling and use
of any Living Modified Organism (LMO) resulting from biotechnology that may
have adverse effect on the conservation and sustainable use of biological
diversity (Article 19.3 of the CBD). The Biosafety Protocol is the result of
that process.
STATUS
The protocol entered into force from September 11, 2003. India
ratified the Cartagena Protocol on Biosafety on January 23, 2003. As on
5.3.2009, 153 countries are Parties to the Protocol.
OBJECTIVE
The objective of the Protocol is to contribute to
ensuring an adequate level of protection in the field of the safe transfer,
handling and use of LMOs resulting from modern biotechnology that may have
adverse effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health, and specifically
focusing on transboundary movements.
SALIENT FEATURES
The Protocol promotes biosafety by establishing rules and
procedures for the safe transfer, handling, and use of LMOs, with specific
focus on transboundary movements of LMOs. It features a set of procedures
including one for LMOs that are to be intentionally introduced into the
environment (Advance Informed Agreement procedure), and one for LMOs that are
intended to be used directly as food or feed or for processing. Parties to the
Protocol must ensure that LMOs are handled, packaged and transported under
conditions of safety. Furthermore, the shipments of LMOs subject to
transboundary movement must be accompanied by appropriate documentation
specifying, among other things, identity of LMOs and contact point for further
information. These procedures and requirements are designed to provide
importing countries with the necessary information needed for making informed
decisions about whether or not to accept LMO imports and for handling them in a
safe manner. The importing country makes its decisions in accordance with
scientifically sound risk assessments. The Protocol sets out principles and
methodologies on how to conduct a risk assessment of the Protocol. In case of
insufficient relevant scientific information and knowledge, the importing
countries may use precaution in making their decisions on import.
Socio-economic considerations may also be taken into account, consistent with
their international obligations, in reaching decisions on import of LMOs.
Parties must also adopt measures for managing any risks identified by the risk
assessment, and they must take necessary steps in the event of accidental
release of LMOs. To facilitate its implementation, the Protocol establishes a
Biosafety Clearing-House for Parties to exchange information, and contains a
number of important provisions, including capacity-building, financial
mechanism, compliance procedures and public awareness and participation.
GOVERNING
BODY OF THE PROTOCOL
The
governing body of the Protocol is the Conference of the Parties to the
Convention serving as the meeting of the Parties to the Protocol (COP-MOP). The
main function of this body is to review the implementation of the Protocol and
make decisions necessary to promote its effective operation. As of date, four meetings of the COP-MOP have
been convened. Decisions taken therein
may be viewed at CBD website http://www.cbd.int/biosafety/.
BENEFITS OF BECOMING A PARTY TO THE PROTOCOL
Becoming a Party to the Protocol presents a number of
benefits, such as :
o
Influence on the implementation of the Protocol and
shaping of its further development through participation in the decision-making
processes of the COP-MOP.
o
For developing country Parties and Parties with economies
in transition, eligibility for financial support from the Global Environment
Facility (the financial mechanism for the Protocol) for capacity-building, as
well as other support for implementation of the Protocol and participation in
its processes;
o
Enhanced visibility and credibility of national systems
for regulating biosafety within the global community;
o
Contribution to harmonized rules, procedures and
practices in managing the transboundary movement of LMOs;
o
Facilitation of mechanisms and opportunities for
governments to collaborate with other governments, the private sector and civil
society on strengthening biosafety;
o
Improved access to relevant technologies and data, and
benefiting from a regular exchange of information and expertise; and
o
Demonstration of commitment to conservation and
sustainable use of biological diversity through the implementation of biosafety
measures.
The full text of the protocol is placed at CBD website http://www.cbd.int/biosafety/
INSTITUTIONAL
ARRANGEMENTS AT THE NATIONAL LEVEL
Parties
are required to designate national institutions to perform functions relating
to the Protocol. Each Party needs to designate one national focal point to be
responsible on its behalf for liaison with the Secretariat. Each Party also
needs to designate one or more competent national authorities, which are
responsible for performing the administrative functions required by the
Protocol and which shall be authorized to act on its behalf with respect to
those functions.
In
accordance with the above requirement, the Ministry of Environment and Forests
has been designated as the competent national authority. The National Focal Point for the CPB is Shri
A. K. Goyal, Joint Secretary, MoEF and the BCH Focal Point is Dr. R. Warrier,
Director, MoEF.
NATIONAL REPORTING ON THE IMPLEMENTATION OF THE PROTOCOL
Towards fulfillment of our obligations under Article 33
of the CPB to which we are a Party, India has submitted its ‘Interim National
Report’ and ‘First National Report’ in 2005 and 2008 respectively. These reports are available on CBD website http://www.cbd.int/biosafety/.
BIOSAFETY CLEARING HOUSE (BCH)
In accordance with Article 20 of CPB, the India BCH has
been launched in 2006 (http://indbch.nic.in/).
CAPACITY BUILDING
The Ministry of Environment and Forests (MoEF) has
successfully completed the Phase-I Capacity Building project on Biosafety
through GEF-World Bank assistance in June, 2007. Project details may be viewed
at http://envfor.nic.in/divisions/csurv/biosafety/default.htm.
The MoEF has initiated the Phase-II Capacity Building
Project on Biosafety through GEF-UNEP assistance. The PIF has been approved by the GEF council
in its meeting held in October, 2008.
The preparation of Full Scale Project (FSP) has been initiated.
STATUS OF LIABILITY AND
REDRESS NEGOTIATION UNDER ARTICLE 27.
The
issue of liability and redress for damage resulting from the transboundary
movements of LMOs was one of the themes on the agenda during the negotiation of
the CPB. The negotiators were, however, unable to reach any consensus regarding
the details of a liability regime under the Protocol. The matter was,
nevertheless, considered both critical and urgent. As a result, an enabling
clause to that effect was included in the final text of the Protocol.
Article 27 of the Cartagena Protocol on Biosafety required
the Conference of Parties /Meeting of Parties (COP/MOP) to adopt, at its first
meeting, a process with respect to the appropriate elaboration of international
rules and procedures [instrument] in the field of liability and redress for
damage resulting from transboundary movements of living modified organisms
(LMOs). Accordingly, at its first
meeting, the COP/MOP established an Open-ended Ad Hoc Working Group of Legal
and Technical Experts on Liability and Redress (hereafter referred to as “the
Ad Hoc Group on Liability and Redress”) to carry out the process pursuant to
Article 27 of the Protocol within a
period of four years (September, 2007).
Accordingly, at its first meeting, the Conference of the
Parties serving as the meeting of the Parties to the Protocol established an
Ad Hoc 0pen-ended working Group on Liability and Redress to review information relating to liability and
redress for damage resulting from transboundary movements of living modified
organisms (LMOs); analyze general issues relating to the potential and/or
actual damage scenarios of concern, and application of international rules and
procedures on liability and redress to the damage scenarios; and elaborate
options for elements of rules and procedures on liability and redress, with a
view to completing its work in 2007.
As of date five meetings of the Ad Hoc 0pen-ended working
Group on Liability and Redress has been convened. In the absence of a
consensus, it was decided during the
fifth meeting of the Ad Hoc 0pen-ended working Group on Liability and
Redress held at Colombia during March 2008, to convene a meeting of the Friends
of the Co-Chairs with a view to further negotiate the rules and procedure and
further streamline the operational text.
The meeting of the ‘Friends of the Co-Chairs’ was held at
Bonn, Germany from May 7-9, 2008 back to back with COP-MOP-4. While the group
did not complete its mandate to adopt an international regime to liability and
redress, it reached a consensus for adopting a legally binding regime on an
administrative approach but including a provision on civil liability that will
be complemented by non-legally binding guidelines on civil liability. The Group was also successful in streamlining
the operational text substantially.
The recommendations of the ‘Friends of the Co-Chairs’ were
considered in the fourth meeting of the COP-MOP held at Bonn from 12-16 May
2008. The major decisions adopted by COP-MOP-4 are as follows:
·
To
continue negotiations on international rules and procedures in the field of
liability and redress on the basis of the annex;
·
Decided
to set up a group called ‘ Group of the Friends of the Co-Chairs’. The
composition of the group will be: six representatives of the Asia-Pacific region; two
representatives of the EU; two representatives of Central and Eastern Europe;
six representatives of the African Group; six representatives of the Latin
American and Caribbean Group; and New Zealand, Norway, Switzerland and Japan;
·
Advisors
are selected by the Friends of the Co-Chairs and their participation may be
facilitated subject to the availability of funds;
·
Observers
may be invited to be participants in the meeting at the discretion of the Co-Chairs; and
·
The
outcome will be presented to COP/MOP 5 for its consideration.
In accordance with the above decision, the first meeting of
the ‘Group of the Friends of the Co-Chairs’ was held at Mexico from 23-27
February 2009.
MoEF has been working towards evolving country position on
the issues related to liability and redress in consultation with the
Consultative Group on Biodiversity and Biosafety since 2004. India’s country
position and negotiating text on the proposed Liability and Redress regime was
finalized based on a consultative approach as follows:
1. An Expert Advisory Committee comprising of legal and
scientific experts for preparation of “An approach paper on Liability &
Redress (L&R) was set up by the Ministry to prepare an approach paper. Seven meetings of the Expert Advisory Group
were convened.
2. The recommendations of the Expert Advisory Committee was
further discussed by the Consultative Group on Biodiversity constituted by the
Ministry to advise the Government on matters related to the Convention on
Biological Diversity, Cartagena Biosafety Protocol and Ramsar Convention. Two meetings of the Consultative Group were
convened.
3. A national consultation for obtaining stakeholder feedback
from the L&R regime and India’s country position is also proposed in
January, 2008. The national consultation
was attended by more than 50 participants represented by the Government,
Industry, NGO, Academia etc.
Hosting International
Meetings
The Fourth Coordination Meeting for Governments and
Organizations Implementing or Funding Biosafety Capacity Building Activities
during 11-13 February, 2008 and the Fifth Meeting of the Liaison Group on
Capacity Building for Biosafety during 14-15 February, 2008 at International
Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi was
organized by the Ministry of Environment and Forests jointly with the
Convention on Biologically Diversity.
****************
IMPORTANT
NATIONAL AND NATIONAL LINKS ON BIOSAFETY
The Ministry of Environment & Forests is the nodal
agency in the administrative structure of the Central Government, for the
planning, promotion, co-ordination and overseeing the implementation of
environmental and forestry programmes. The Ministry is also the nodal agency
for the implementation of the Convention on Biological Diversity (CBD) and
Cartagena Protocol on Biosafety. The
decisions of GEAC are also hosted on this website.
http://www.envfor.nic.in/divisions/csurv/biosafety/default.htm
Information on the
activities under GEF-World Bank project on capacity building in biosafety is
available as part of the website of Ministry
of Environment and Forests (MoEF) i.e. http://www.envfor.nic.in (sub heading BiosafetyNew).
The website also has information on the related topics such as regulatory
framework, lists of various statutory committees, lists of approved GMOs and
products thereof, links for further reading, list of upcoming events etc.
Under the GEF-World Bank
Capacity Building project, the India Biosafety Clearing House has been
established by the Ministry of Environment and Forests, Government of India at http://www.indbch.nic.in.
The website has information
under various headings as defined by the CBD secretariat. These include national
contacts, laws and regulations, decisions and declarations, capacity building
and roster of experts.
Department of Biotechnology, Government of India
The Department of Biotechnology (DBT), under the Ministry
of Science and Technology is the nodal department for biotechnology in Government
of India. In more than a decade of its existence, the department has promoted
and accelerated the pace of development of biotechnology in the country.
Through several R&D projects, demonstrations and creation of
infrastructural facilities a clear visible impact of this field has been seen.
The department has made significant achievements in the growth and application
of biotechnology in the broad areas of agriculture, health care, animal
sciences, environment, and industry. Along with MoEF, DBT is the implementing
agency for biosafety regulations in the country.
Indian GMO
Research Information System (IGMORIS)
Indian GMO Research Information System (IGMORIS) is a
database on activities involving the use of GMOs and products thereof in India.
The primary purpose of this website is to make available objective and
realistic scientific information relating to GMOs and products thereof under
research and commercial use to all stakeholders including scientists,
regulators, industry and the public in general. It is also expected to promote
collaborations and avoid duplication of work.
http:// 203.122.19.19/gmdb/gmdbhome.html
National Research Center on
Plant Biotechnology (NRCPB) has established an integrated database on post
release risk assessment and monitoring transgenics in order to share the
information from India and other countries. The database is divided into two
main modules, i.e., Transgenics and GM publications. The module Transgenics
contains information on genetically modified crops. It has been divided into
several sub-databases, which have information on genes and promoters that are
being used for the production of transgenic crops, unique features of
transgenic crops, effect of GM crops on soil microflora, possible environmental
hazards and gene flow. The second module, GM Publications contains published
literature on biosafety and all issues related to GMOs.
Department
of Agriculture and Cooperation, Ministry of Agriculture, Government of India
The Department of Agriculture and Cooperation is
responsible for the formulation and implementation of national policies and
programmes aimed at achieving rapid agricultural growth through optimum
utilization of the country’s land, water, soil and plant resources.
Biotech
Consortium India Limited (BCIL)
BCIL provides linkages amongst research institutions,
industry, government and funding institutions, to facilitate accelerated
commercialization of biotechnology. The Company is engaged in technology
transfer, project consultancy, fund syndication, information dissemination and
manpower training and placement related to biotechnology.
Cartagena
Protocol on Biosafety (CPB)
http://www.biodiv.org/biosafety
This is the main site for
information about the CPB, including the background and full text of the
agreement, articles, updated list of signatures and ratifications, meetings,
and documents of the Intergovernmental Committee for the Cartagena Protocol
(ICCP), the Biosafety Clearing House, and a database of biosafety
capacity-building activities.
Biosafety
Clearing-House
As per the article 20 of the
Cartagena Protocol on Biosafety, the Biosafety Clearing House (BCH) has been
established which serves as an information exchange mechanism to assist Parties
to implement its provisions and to facilitate sharing of information and
experiences with Living Modified Organisms (LMOs). It provides a “one – stop shop” where users
can readily access or contribute relevant biosafety related information with an
objective to assist governments to make informed decisions regarding the
importation or release of LMOs. The BCH
also facilitates scientific and technical cooperation between parties and
stakeholders by allowing interested stakeholders to access or contribute
information on existing biosafety capacity building activities, thus
facilitating coordination and synergy between various initiatives. For industry
and other stakeholders the BCH allows easy access to information vital to their
activities including details of the national contacts, relevant laws and
regulations governing LMO activities and the decisions and declarations made by
Parties, especially regard to transboundary movements.
The central portal of BCH is
at http://bch.biodiv.org. All the Parties to the Protocol are expected
to participate in BCH either by providing information through the central
portal or setting up their own websites linked to the central portal.
UNEP-GEF
Biosafety Project
The UNEP-GEF Biosafety
Project is funded by the Global Environmental Facility and is based on its
“Initial Strategy for assisting countries to prepare for the entry into force
of the Cartagena Protocol on Biosafety” (GEF/C.16/4). The main objectives of
this strategy are to assist countries in the establishment of their national
biosafety frameworks; promote information sharing and collaboration, especially
at the regional and subregional level; and promote collaboration with other
organizations to assist capacity-building for the Cartagena Protocol on
Biosafety.
Codex Alimentarius
http://www.codexalimentarius.net
The Codex Alimentarius, or
the food code, has become the seminal global reference point for consumers,
food producers and processors, national food control agencies, and the
international food trade. Codex standards have become the benchmarks against
which national food measures and regulations are evaluated. This site carries
provisional agendas for forthcoming meetings and working papers and reports of
Codex Meetings. Of particular interest is the Preliminary Report of the ad hoc
Intergovernmental Task Force on Foods Derived from Biotechnology (final report
due in 2003).
OECD - BioTrack
http://www.oecd.org/ehs/service.htm
BioTrack Online, the web
site of OECD's Programme on the Harmonization of Regulatory Oversight in
Biotechnology, was created in 1995. This site focuses on information related to
the regulatory oversight of products of biotechnology. BioTrack Online aims,
not only to help member country governments and industries with biotechnology
product notifications/assessments, but also to make the information, developed
by the Working Group on Harmonization of Regulatory Oversight in Biotechnology,
accessible to all who need it, including non-OECD countries that might find it
useful.
World Health
Organization (WHO) – Biotech Foods
http://www.who.int/fsf/GMfood/index.htm
WHO has been addressing a
wide range of issues in the field of biotechnology and human health, including
safety evaluation of vaccines produced using biotechnology, human cloning, and
gene therapy. This site briefly describes the activities of WHO in regard to
biotechnology and food safety.
Food and
Agriculture Organization (FAO) of the United Nations
http://www.fao.org/biotech/index.asp?/lang=en
This site on food and
agriculture is available in Arabic, French, Chinese, Spanish, and English. It
carries news and events, FAO documents, sectoral overviews, and a glossary
(English only).
BioBin
http://www.oecd.org/ehs/biobin
BioBin is a cooperative
resource on safety in biotechnology developed between OECD’s BioTrack Online
and Biotechnology Information Network and Advisory Service (BINAS) sponsored by
the United Nations Industrial Development Organization (UNIDO). A resource for
regulations, field trials, biotechnology product database, biotechnology
libraries, and tools related to biosafety.
AgBioWorld
This site provides
information about technological advances in agriculture to the developing
world; particularly to teachers, scientists, journalists, and the general
public on the relevance of agricultural biotechnology to sustainable
development; maintains the declaration of “Scientists In Support Of Agricultural
Biotechnology,” and offers a discussion list serve.
AgBioForum Online
Magazine
Publishes articles which enhance the on-going dialogue on
the economics and management of agricultural biotechnology. The purpose of
AgBioForum is to provide unbiased, timely, information and new ideas leading to
socially responsible and economically efficient decisions in science, public
policy and private strategies pertaining to agricultural biotechnology.
Agricultural
Biotechnology Support Project II (ABSPII)
The Agricultural Biotechnology Support Project II (ABSPII)
focuses on the safe and effective development and commercialization of
bio-engineered crops as a complement to traditional and organic agricultural
approaches in developing countries. The project helps boost food security,
economic growth, nutrition and environmental quality in East and West Africa, Indonesia,
India, Bangladesh and the Philippines. Funded by the United States Agency for
International Development (USAID) and led by Cornell University, ABSPII is a
consortium of public and private sector institutions.
Biotechnology and
Development Monitor
The Monitor provides
a forum for discussion on the positive and/or negative impact of
biotechnological innovations and international regulations on issues such as
economic growth, agricultural production, food security, shifts in national and
global markets, access to technology, employment, social differentiation, and
human rights. The analyses are interdisciplinary and emphasize the integration
of theoretical and empirical information from social sciences and natural
sciences.
Biotechnology
Industry Organization
This organization is the
largest trade organization to serve and represent the emerging biotechnology industry
in the United States and around the globe. The site includes a media guide to
biotechnology; a biotechnology food products list; a citizen’s guide to
biotechnology; laws and policies; and a guide to bioethics.
Biotechnology
Information Center
The Biotechnology
Information Center (BIC), is one of ten information centers at the National
Agricultural Library of the US Department of Agriculture - ARS. BIC provides
access to a variety of information services and publications covering many
aspects of agricultural biotechnology.
Biosafety
Information Network and Advisory Service (BINAS)
http://www.binas.unido.org/binas
BINAS, a service of the
United Nations Industrial Development Organization (UNIDO), monitors global
developments in regulatory issues in biotechnology providing information on
worldwide national regulations and field trials.
Biotechnology
Australia
http://www.biotechnology.gov.au
Biotechnology Australia is a multi departmental government
agency responsible for coordinating non-regulatory biotechnology issues for the
Commonwealth Government. It seeks to provide balanced and factual information
on biotechnology to the Australian community.
Canada: Canadian
Food Inspection Agency
http://www.inspection.gc.ca/english/ppc/biotech/bioteche.shtml
The Canadian Food Inspection
Agency (CFIA) is responsible for the regulation of products derived through
biotechnology including plants, animal feeds and animal feed ingredients,
fertilizers, and veterinary biologics. For genetically modified crop plants,
the CFIA assesses the potential risk of adverse environmental effects and
authorizes and oversees import permits, confined trials, unconfined release,
and variety registration.
Electronic Forum
on Biotechnology in Food and Agriculture
http://www.fao.org/biotech/forum.htm
This site provides an open
forum that will allow a wide range of parties, including governmental and
nongovernmental organizations, policy makers, and the general public, to
discuss and exchange views and experiences about specific issues concerning
biotechnology in food and agriculture for developing countries.
European
Federation of Biotechnology (EFB) Agri-Biotechnology (Europe)
The EFB is an association of
European scientific and technological societies in biotechnology together with
universities, scientific institutes, companies, biotechnology associations, and
individual members. Their mission is “. . . to promote the safe, sustainable,
and beneficial use of Nature’s resources in the life sciences and technologies;
to facilitate exchange of people and ideas; and to contribute to a better
understanding and perception of biotechnology by the general public in Europe.”
European
Federation of Biotechnology (EFB) Task Group on Public Perceptions of
Biotechnology
This group works to increase
public awareness and understanding of biotechnology and the life sciences
throughout Europe, to advance the public debate about their applications, and
to facilitate dialogue between interested parties. The site’s primary aim is to
foster greater public awareness and understanding of biotechnology and to
encourage public debate.
Information
Systems for Biotechnology (ISB)
This site has documents and
searchable databases pertaining to the development, testing, and regulatory
review of genetically modified plants, animals, and microorganisms within the
United States and abroad.
International
Centre for Genetic Engineering and Biotechnology (ICGEB)
http://www.icgeb.trieste.it/~bsafesrv
The role of the International Centre for Genetic
Engineering and Biotechnology(ICGEB) is to promote the safe use of
biotechnology world-wide, with special regards to the need of the developing
world. It has played, since its inception, an important role on issues related
to biosafety and the sustainable use of biotechnology.
The Biosafety Unit of the
ICGEB is dedicated to biosafety and risk assessment for the environmental
release of genetically modified organisms. It offers information on biosafety
concerns, upcoming meetings and training courses, and a regularly updated index
of selected scientific articles published on biosafety and risk assessment from
1990 onward. This site also carries an outstanding collection of links to
databases on GMO releases, scientific bibliographies, decision support systems,
patents, and numerous other topics.
International
Service for the Acquisition of Agri-biotech Applications (ISAAA)
The International Service
for the Acquisition of Agri-biotech Applications. ISAAA’s objectives are the
transfer and delivery of appropriate biotechnology applications to developing
countries and the building of partnerships between institutions in the South
and the private sector in the North, and by strengthening South-South
collaboration.
The primary site describes
ISAAA’s activities and initiatives in biosafety, food safety, intellectual
property, and technology transfer. The Global Knowledge Center on Crop
Biotechnology section (http://www.isaaa.org/activities/ knowledge_center.htm)
is organized into several main areas.
Global Network provides a status of biotechnology in the developing
countries of Asia, South America, and Africa. Crop Biotech Update is a weekly
summary of world developments in agricultural biotechnology for developing
countries. Separate pages cover GM products and biotechnology issues.
International
Field Test Web Sites
http://www.isb.vt.edu/cfdocs/globalfieldtests.cfm
This site has a list of
links to information about field tests conducted in twenty-nine countries.
International
Life Sciences Institute (ILSI)
http://www.ilsi.org/site_search/index.cfm
ILSI is a nonprofit,
worldwide scientific research foundation seeking to improve the well being of
the general public through the pursuit of sound and balanced science. It works
towards understanding of scientific issues relating to nutrition, food safety,
toxicology, risk assessment, and the environment. This site lists ILSI
publications pertaining to biotechnology.
ILSI Crop
Composition Database
http://www.cropcomposition.org
The ILSI Crop Composition Database is a project of the
International Life Sciences Institute. Additional support has been provided by
Covance Laboratories Inc. Through ILSI, contributors have standardized and
pooled their crop data in order to make the data available to scientists from
academia, government agencies, and industry, and to the general public.
Program for Biosafety Systems
http://www.ifpri.org/themes/pbs/pbs.htm
The Program for Biosafety Systems (PBS) supports partner
countries as they develop the policy and legal framework, administrative
procedures, technically qualified personnel and outreach mechanisms integral to
their national biosafety systems. PBS work emphasizes sound, science-based,
decision making and research, while also addressing socioeconomic
considerations.
Transgenic Crops:
An Introduction and Resource Guide
http://www.colostate.edu/programs/lifesciences/TransgenicCrops
This Colorado State
University site provides broad coverage of the subject, including the history
of plant breeding, a clear explanation of what transgenic plants are and how
they are made, biosafety evaluation and
regulation, current and future transgenic products, and a question-and-answer
format for information on risks and concerns.
United Kingdom:
Advisory Committee on Releases to the Environment (ACRE)
http://www.defra.gov.uk/environment/acre
The site has extensive
background information on the release of GMOs in the European Union, lists of
applications for experimental trials and to market GMOs, application formats
for deliberate releases and marketing of higher plants and organisms other than
higher plants, a statement on GM animals, and more. The Guidance on Principles
of Best Practice in the Design of Genetically Modified Plants documents how the
design and construction of GM plants could be used to further improve their
safety and/or to simplify the risk assessment.
United States:
Regulatory Oversight of Biotechnology
http://www.aphis.usda.gov/biotech/usregs.htm
This site is a portal to the
agencies primarily responsible for regulating biotechnology: the U.S.
Department of Agriculture (USDA), Environmental Protection Agency (EPA), and
the Food and Drug Administration (FDA). Products are regulated according to
their intended use; some products are regulated under more than one agency.
The FDA regulates foods and
feed derived from new plant varieties (GMOs)
as well as conventional products. The biotechnology site carries extensive
documentation on regulations, labeling, consumer information, and products
approved for commercial sale.
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