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2.3 Approval of genetically engineered products
Examples of the data derived from national approvals of GMOs or
GMO-products are presented below. Part of the available information
about a product and its approval in a certain country are summarised
in a database1. An example is given
in Box 1 which displays information available on the approval(s) of the
Flavr Savr tomato in the US
(ID 1). All sets of information are sampled in an extensive database
at the Centre BATS. The data are structured in such a way that
each approval in any of the countries surveyed is represented
by a single entry with a unique identification number (ID) assigned
to it (approval-based database)1.
If more than one country approved the same or virtually the same
product from a given company, a corresponding number of IDs was
assigned to the product.
List of Tables: Tables 4-10
contain some information
taken over from applications or approvals describing the respective
product in more detail (e.g. those summarised in Tables 3 or 4)
if it was obvious that the respective approvals related to the
same transformation event(s). Such information is presented in
italics.
2.3.1 Differences in national approvals of the 'same' products
The grounds on which approvals are garnted in different countries
for aparently the same products can differ significantly (with
respect to information relevant for identification methods), although
these differences become obvious only upon closer examination.
For example, the approval of processing products of the genetically
engineered tomato from Zeneca in the United Kingdom relates to
transformation events involving the plasmid pJR16S, whereas the
approval in the US covers lines transformed with either pJR16S
or pJR16A. In the former vector the transgene, a truncated version
of the tomato polygalacturonase gene, is oriented in the sense
orientation (S), while in the latter it represents the respective
antisense (A) construct. These different lines obviously do not
display different phenotypes; however, understanding the differences
described is essential for the design of reliable PCR-based detection
methods and for the evaluation of existing nucleotide-based methods.
Another example are differences in the number of distinct approved
lines of a new transgenic variety, which were derived by independent
transformation events using the same plasmid; the assessment of
the Flavr Savr tomato from Calgene by the ACNFP (United Kingdom)
includes only 10 lines, whereas in the United States the USDA-APHIS
has approved already more than 40 distinct lines of this transgenic
tomato (Box 1).
Box 1: Datasheet ID 1 (Flavr Savr™ Tomato)
| ID |
1 |
| Product |
Tomato |
| Further specification |
GM lines from approx. 40 different transformation events,
using 2 slightly different plasmids and crosses with traditional
varieties (501-1436-1001, 501-1436-1035,
502-1436-2021, 7B-1436-92, 22B-1436-215,
28B-1436-419, 28B-1436-425, 28B-1436-498,
N73-1436-111, 114F-4109a-26, 141F-4109a-81,
105F-1436-2018, 105F-1436-2035, 105F-1436-2049,
35F-4109a-3023, 84F-4109a-148, 88F-4109a-2797,
121F-4109a-333, 121F-4109a-1071,
121F-4109a-1120, 137F-4109a-71, 138F-4109a-164,
519A-4109a-4527, 519A-4109a-4621,
519A-4109a-4676, 531A-4109a-2105,
531A-4109a-2270, 532A-4109a-5097,
540A-4109a-1739, 585A-4109a-3530,
585A-4109a-3604, 519A-4109a-4645,
540A-4109a-1823 and 7 further lines in document
94-125-1) |
| Scientific name |
Lycopersicon esculentum Mill |
| Host organism |
Lycopersicon esculentum Mill, tomato lines 501,
502, 7B, 22B, 28B, N73, 114F, 141F, 105F, 35F,
84F, 88F, 121F, 137F, 138F, 519F, 531A, 532A,
540A and 585A) |
| Product name |
Flavr Savr™ Tomato (MacGregor's) |
| Company |
Calgene Inc. |
| Contact |
Keith Redenbaugh, Ph.D.; Regulatory Manager;
Calgene Inc.; 1920 Fifth Street; Davis, CA
95616, USA |
| Altered trait |
Fruit ripening delayed |
| Classification |
PQ |
| Purpose |
Enhanced fresh market value |
| Plasmid |
pCGN1436 (driving nptII by mas 5' and mas 3')
or pCGN4019a (driving nptII by P-35S and tml3') |
| Inserted genes |
Flavr Savr™ gene (= antisense
polygalacturonase) (1-3 copies), nptII (1-3
copies), partial LB and RB, at a single site
(haploid) |
| Transfection method |
Agrobacterium tumefaciens |
| Transgene 1 |
Flavr Savr™ gene (polygalacturonase (PG)
antisense gene) |
| Source of tg 1 |
Tomato |
| Protein product 1 |
None |
| Expression 1 |
No; level of native PG mRNA is >90 % reduced;
residual enzyme activity of native PG is < 1 %
of control lines |
| Mechanism 1 |
Antisense RNA complexes endogenous sense mRNA
for PG (transcription for native mRNA might
also be downregulated), thus reducing the
levels of PG which normally degrades pectin, a
major component of the cell wall in tomato
fruit |
| Promoter 1 |
(double-) CaMV 35S |
| Terminator 1 |
tml 3' |
| Transgene 2 |
nptII (=kan r, neo r = neomycin phosphotransferase II gene) |
| Source of tg 2 |
Transposon Tn5 (E. coli K12) |
| Protein product 2 |
APH(3')II (Aminoglycoside-3'-phosphotransferase II) |
| Expression 2 |
< 0.08 % of total protein |
| Mechanism 2 |
Allows for selection during plant tissue
culture. APH(3')II inactivates neomycin,
kana-mycin and genticin/G418) by ATP-dependent
phosphorylation of the 3'-hydroxyl group of the
aminohexose moiety of these aminoglycoside
antibiotics. This phosphorylation interferes
with uptake and binding of the aminoglycoside
to the bacterial ribosome |
| Promoter 2 |
mas 5' (mannopine synthase) or CaMV35S promoter
(different plasmid) |
| Terminator 2 |
mas 3' (polyA region from mannopine synthase
gene of pTiA6) or tml 3' (see plasmid) |
| Transgene 3 |
parts of lacZ |
| Source of tg 3 |
E. coli |
| Protein product 3 |
None |
| Expression 3 |
No |
| Mechanism 3 |
|
| Promoter 3 |
- |
| Terminator 3 |
- |
| Gene sources |
Tomato, bacteria |
| Detailed sequences |
pCGN1436 sequence from LB to RB |
| References for |
pg, nptII |
| Approved by 1 |
APHIS docket-no 92-087-1, 94-096-1, 94-125-1,
95-015-1, 95-056-1 |
| Approved for 1 |
USA |
| Restrictions 1 |
|
| Requirements 1 |
|
| Labelling 1 |
|
| Date 1 |
10/92, 10/94, 11/94, 3/95, 7/95 |
| Approved by 2 |
FDA approved |
| Approved for 2 |
USA |
| Restrictions 2 |
|
| Requirements 2 |
|
| Labelling 2 |
not required |
| Date 2 |
5/94 |
| Approved by 3 |
EPA approval not required |
| Approved for 3 |
|
| Restrictions 3 |
|
| Requirements 3 |
|
| Date 3 |
- |
| References |
USDA/APHIS; Safety assessment (Redenbaugh et al., 1992) |
| Safety remarks |
Data on potential toxins, tomatine level, acute
toxicity tests in rats |
| Qualities checked |
Increased fungal resistance, stable inserted, taste, horticultural
traits, Ca, Mg, Fe, Na; vitamins A, B1, B2, B6 and C |
The data were derived from official documents (e.g. the Official
Journal of the European Communities, Federal Register), approving
and consulting authorities (e.g. EC, USDA/APHIS, FDA, EPA, Health
Canada, MAFF, GMAC, RIKILT-DLO, RKI and the Federal Offices for
Public Health of Denmark, Japan and Switzerland), petitions, company
information and scientific publications.
In addition, certain information that is relevant for the design
of identification methods is mentioned in one approval, but was
not mentioned in the available documentation concerning the approval
of the same product in another country. For example, the executive
summary of the approval of the genetically engineered oilseed
rape from Plant Genetic Systems in Great Britain did not mention
that the sequence of the gox-gene was 'optimised for plant expression'
as was noted in documents of the FDA, indicating that the codon
usage of this gene (and thus the DNA sequence) has been specifically
changed (Communication, Monsanto). The latter is, again, important
for the application of nucleotide-based detection systems employing
specific oligonucleotide primer that should bind to the respective
gene.
1 All entries in the
List of Tables: tables 3-10 with
assigned identification numbers are included in the database.
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antibodies on hand