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2.2 Commercialisation of genetically modified products
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Foods derived from genetically modified organisms and detection methods
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2.3.2 Summaries of national and multi-national approvals of genetically engineered products

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.

© Copyright Agency BATS: Contact Legal Advisor: Advokatur Prudentia-Law Date of publishing: 1997-02-08

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