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CERTIFICATION
(A certificate to the following effect be submitted by the applicant)
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I/ We ___________________________________
Son(s)/ Daughter(s) of ________________________ certify that to the best
of my knowledge and belief the information provided in the application
includes all information and views on which a judgment can be made to
decide about the status of the product under the Indian Environment
(Protection) Act, 1986 and that it includes all relevant information and
data known to me/ us.
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Signature of the Applicant(s)
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Name of the
Applicant(s) _____________________
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Representing
_____________________________
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Full Address
of the Applicant & the Representative Organization
______________________________
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Place :
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Date :
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EXPLANATORY NOTE APPENDED FOR THE REVIEW
(This
should justify the design of the work, the citation of the past literature
if any on the subject with proper referencing, the authentication of the
gene/s and the gene product/s by method/s to be stated if unpublished, and
any other relevant information published in the literature with proper
citation. The idea is to enable the reviewers to appreciate the special
features of the product/s being reviewed).
PARTICULARS OF THE APPLICATION SEEKING APPROVAL UNDER RULES 8,9,10
& 11 OF THE NOTIFICATION NO. GSR 1037(E) DATED 05.12.1989 ISSUED BY THE
MINISTRY OF ENVIRONMENT &FORESTS UNDER THE ENVIRONMENT PROTECTION ACT,
1986, FOR TRANSGENIC PLANTS
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Name of the
Project
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Submitted by
under Section/s of the EPA-1986
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Name & Address
of the Applicant indicating telephone No., Fax No., E-mail No. etc., and
the Section/s under which application is submitted.
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Document
Prepared by and responsible for further responses
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Name &
Address of the person who is responsible for furnishing replies to
subsequent queries.
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Names &
Addresses of the Contributor to the substantive parts of the document
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1.
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2.
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3.
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etc.
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ABBREVIATIONS USED IN THE APPLICATION
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Abbreviations/
symbols used
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Expansion of
the Abbreviations/ symbols with explanations if required
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Content
of the Chapters
(Data required for the appraisal of Environmental Risks and Safety from the
use of Transgenic plants)
PART A
Chapter
I : Introduction
1.
Rationale
for the development
2.
Benefits
- Economic Benefits, Agronomic benefits etc.
3.
Regulatory
approvals required for, and earlier approvals obtained if any for specific
purposes in India with approval No. etc.
4.
Other
relevant information including status of regulation in the country of
origin with documentation, and status of regulation in other countries.
5.
Discussion
and conclusions.
6.
Referencing.
Chapter
II : Biology of the Plant System
1.
Relevance
of the plant in India
2.
Taxonomy,
genetics, pollination pattern etc.
3.
Description
of the near relatives of the plant in the ecosystem
4.
Methods
of pollen dispersal in target plants & in near relatives
5.
Others
including documented references
6.
Conclusions.
7.
Referencing.
Chapter
III : Molecular Biology of the Plant and Transformation Methods
1.
Description
of the plant materials to be transformed.
2.
Source
of the gene and the cloning strategy followed.
3.
Characteristics
of the plant expression vector
4.
Characteristics
of the inserted genes with sequence details
5.
Characteristics
of the vectors and the transformation system employed with description of
sequences used.
6.
Genetic
analysis including insert No., Copy No., Insert Integrity, Segregation,
Stability of the gene transfer, Description of the expressed gene,
Biochemistry of the expressed gene products, authentication of the gene
products by physical, chemical, immunological and biological methods etc.
7.
Discussion
and conclusions.
8.
Referencing.
PART B
Chapter
IV : Field Trial Plans
1.
Field
test permit, locations and design of trial
2.
Plant
growth and specific observations required to be made including the extent
of gene escape, persistence of escape etc.,
3.
Strategy
adopted for determining efficacy of the transgenics in the field trials and
plan for presentation of data
4.
Summary
and conclusions highlighting expectations from the trail.
5.
References.
Chapter
V : Results of Phenotype of the Transformed Plant & Fruits / Seeds
1.
Germination
and vigor results of the transgenic line in field & in the lab
2.
Description
of the Phenotype of the transformed plant
3.
Composition
and quality of the transformed plant and the seeds/ fruits of the plants and
comparison with non-transgenic phenotypes.
4.
Competitive
Toxicant analysis of the transformed plant and potential for weediness in
cases of uncontrolled release of transgenic plants
5.
Risks
during the processing / handling of the transformed plant/ fruits
6.
Susceptibility
of the plant products / fruits to diseases and pests
7.
Long
term influence of the plant pests to the transformed plants, fruits and
seeds.
8.
Gene
transfer to non-transgenic lines including near relatives and percentage of
transfer under specific field conditions.
9.
Out-crossing
potential including pollen transfer to cultivated genotypes, and wild
species and its implications.
10. Implication of transfer of genetic
information to species to which it can inter breed.
11. Possible impact on environment on
over all assessment.
12. Summary and conclusions.
13. Referencing.
PART C
Chapter
VI : Consequences to the Environment
1.
Environmental
consequence of introduction of transformed cultivars
2.
Statement
of unfavorable grounds
3.
Effect
on non-target organism including non-target insects, non-target birds and
fish and non-target animals including mammals and wild life on extensive
exposure of transgenics.
4.
Impact
on endangered species
5.
Response
plans for controlling unfavorable grounds in the environment.
6.
Plans
for protecting human and animal health from undesirable effects.
7.
Summary
and conclusions.
8.
Referencing.
PART D
Chapter
VII : Food Safety Evaluation
1.
Evaluation
of food safety assessment in approved protocol including nutritional
studies (anti-nutritional factors if any and substantial equivalence
studies etc.), sub acute and chronic toxicity studies & allergenicity
status if any etc.
2.
Classical
animal feeding trials
3.
Immuno-toxicological
studies
4.
Gut
toxicological studies
5.
Fundamental
molecular biological studies including gene integration, gene regulation,
gene expression and effects of transgenic proteins
6.
In vitro hemolytic behavior of the
transgenic proteins if any and its relevance to in-vivo studies in target
animals
7.
Summary
and conclusions
8.
Referencing.
PART E
Chapter
VIII : Supportive Evidences for All The Chapters
1.
Supporting
evidences in statements of annexure cataloguing Chapter No. and Annexure
No.
2.
Supportive
evidence providing lists of figures cataloguing Chapter No. and Figure No.
3.
Supportive
evidence providing lists of tables cataloguing Chapter No. and Table No.
PART F
Chapter
IX : Summary and Conclusions
1.
Executive
summary and overall conclusions.
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