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Explanation of the table: Summaries of national and multi-national approvals of genetically engineered products

Table 3: Approved genetically modified crops in the United States

Product
Name
Company
Altered trait # Promoter Genes introduced (Sources of transgenes) Terminator Approval / Date Related approvals country (ID) ID
Corn
Maximizer®
Ciba Seeds
IR (L)
HT (pt)
1) P-PEPC and P-CDPK
2) P-35S
3) bacterial
synthetic, truncated cryIA(b) delta-endotoxin
(Bt ssp. kurstaki (HD-1)
bar
(Streptomyces hygroscopicus)
bla
(Tn3)
I9, T-35S
T-35S
bacterial
USDA: 5/95
FDA: 7/95
EPA: 8/95
US (61), UK (41)
Can (74), Jap (87), EC (-)
14
Corn

DeKalb
HT (pt)1) P-35S

2) bacterial

bar
(Streptomyces hygroscopicus)
bla (incomplete)
(Tn3)
Tr7 3'

bacterial

USDA: 12/95
FDA: 1/96
EPA: nda
 
19
Corn

Liberty Link®
Hoechst / AgrEvo
HT (pt)1) P-35S

2) bacterial

synthetic pat (same as in ID20 tg2)
(Streptomyces viridochromogenes)
bla (incomplete)
(Tn3)
T-35S

bacterial
USDA: 6/95
FDA: 12/95
EPA: uoh
pending.
UK (-) 15
Corn

YieldGard®
Monsanto
IR (L)
HT (gly)
1) P-35S, m-HSP70-utr

2) P-35S, m-HSP70-utr

3) P-35S, m-HSP70-utr

4) bacterial

synthetic cryIA(b) delta-endotoxin
(Bt ssp. kurstaki (HD-1))
CP4 epsps, with CTP2
(Agrobacterium (Arabidopsis))
gox, with CTP1
(Achromobacter (Arabidopsis))
nptII
(Tn5)
nos 3'

nos 3'

nos 3'

bacterial

USDA: 8/95
FDA: 1996
EPA: nda on
Bt, uoh
pending ?
UK (-), UK (-) 18
Corn

NatureGard®
Mycogen
IR (L)
HT (pt)
§
§
§USDA: §
FDA: §
EPA: 8/95
US (14), UK (41)
Can (74), EC (-)
Jap (87),
61
Corn

Northrup King /
Sandoz Seeds
R (L)
HT (pt)
1) P-35S with IVS6-utr

2) P-35S with IVS2-utr

synthetic, truncated cryIA(b) delta-endotoxin
(Bt ssp. kurstaki (HD-1))
synthetic pat (same as in ID15 tg1)
(Streptomyces viridochromogenes)
nos 3'

nos 3'

USDA: 12/95
FDA: 1/96
EPA: nda
Can (79), Jap (84), UK (-) 20
Corn

SeedLink®
Plant Genetic Systems
MS
HT (pt)
1) P-TA29 (ts, dr)

2) P-35S

3) bacterial (P-tac)

4, 5) bacterial

barnase
(Bacillus amyloliquefaciens)
bar
(Streptomyces hygroscopicus)
barstar
(Bacillus amyloliquefaciens)
bla and modified bla
(Tn3)
nos 3'

nos 3'

bacterial

bacterial

USDA: 2/96
FDA: 3/96
EPA: nar
 
21
Cotton

BXN cotton®
Calgene /
Rhône-Poulenc
HT (br)1) P-35S

2) P-35S

BXN gene (nitrilase)
(Klebsiella sp.)
nptII
tml 3'

tml 3'

USDA: 2/94
FDA: 10/94
EPA: √
Can (80), UK (-) 7
Cotton

DuPont
HT (su)1) P-als1
slightly altered acetolactate synthase (als)
(Nicotiana tabacum)
T-als1USDA: 1/96
FDA: 1996
EPA: nda
 
22
Cotton

Bollgard®
Monsanto
IR (L)1) e-P-35S or nda

2) P-35S

3) bacterial

altered, synthetic cryIA(c) delta-endotoxin
(Bt ssp. kurstaki (HD-73))
nptII
(Tn5)
aad
(Tn7)
7S 3'

nos 3'

bacterial

USDA: 3/95
FDA: 10/94
EPA: 5/95
Can (76), Aus (90) 13
Cotton

Roundup Ready®
Monsanto
HT (pt)1) P-CMoVb

2) P-35S

3) bacterial

synthetic CP4 epsps (with CTP2)
(Agrobacterium (Arabidopsis))
nptII
(Tn5)
aad
(Tn7)
E9 3' or nos 3' (?)

nos 3'

bacterial

USDA: 7/95
FDA: 9/95
EPA: √
 
16
Oilseed rape / canola

AgrEvo
HT (pt)1) P-35S

2) P-nos

synthetic pat
(Streptomyces viridochromogenes)
nptII
(Tn5)
T35S

ocs 3'

USDA: nda
FDA: 4/96
EPA: nda
UK (47), Can (69), Jap (85) 66
Oilseed rape / canola

Laurical®
Calgene
PQ (op)1) P-BcNa (napin), ss

2) P-35S

12:0 ACP thioesterase
(California bay)
nptII
(Tn5)
T-BcNa (napin)

tml 3'

USDA: 10/94
FDA: 1995
EPA: √
Can (77) 9
Oilseed rape / canola

Roundup Ready®
Monsanto
HT (gly)1) P-FMV

2) P-FMV

synthetic CP4 epsps (with CTP2)
(Agrobacterium (Arabidopsis))
synthetic, slightly altered gox (with CTP1)
(Achromobacter (Arabidopsis))
E9 3'

E9 3'

USDA: nda
FDA: 9/95
EPA: nda
UK (48), Can (68), Jap (82) 65
Oilseed rape / canola

Plant Genetic Systems
MS
HT (pt)
1) P-TA29 (ts, dr)

2) P-TA29 (ts, dr)

3) P-SsuAra

4) P-nos

barnase
(Bacillus amyloliquefaciens)
barstar
(Bacillus amyloliquefaciens)
bar (with CTP)
(Streptomyces hygroscopicus)
nptII
(Tn5)
nos 3'

nda

Tr7 3'

ocs 3'

USDA: nda
FDA: 3/96
EPA: pending
UK (45, 46),
EC (33),
Can (67, 71)
Jap (86)
60
Papaya

Cornell University/
Univ. of Hawaii
VR (PRV)1) P-35S, CMV-5' utr

2) P-nos

3) P-35S

4, 5) bacterial

chimeric CMV/PRV coat protein
(PRV (and CMV))
nptII
(Tn5)
gus
(E. coli)
gent, tet (both not present in all lines)
(E. coli (?/Tn196))
T-35S

nda

nda

bacterial

USDA: 9/96
FDA: nda
EPA: nar*
 
26
Potato

NewLeaf®
Monsanto
IR (C)1) e-P-35S

2) P-35S

synthetic cryIIIA delta-endotoxin
(Bt ssp. tenebrionsis)
nptII
(Tn5)
E9 3'

nos 3'

USDA: 3/95
FDA: 10/94
EPA: 5/95
US (24), Can (72), Jap (83) 11
Potato

NewLeaf®
Monsanto
IR (C)1) eP-35S or P-SSU1A

2) P-35S

3) bacterial

synthetic cryIIIA delta-endotoxin
(Bt ssp. tenebrionsis)
nptII (not present in all lines)
(Tn5)
aad (only present in some lines)
(Tn7)
E9 3'

nos 3'

bacterial

USDA: 5/96
FDA: 3/96
EPA: 5/952)
US (11), Can (72), Jap (83) 24
Soybean

AgrEvo / Hoechst
HT (pt)1) P-35S (+AMV 5' utr)

2) P-35S, AMV 5' utr

3) bacterial

bar or synthetic pat
(S. hygroscopicus or S. viridochr.)
gus (not present in all lines)
(E. coli)
bla (not present in all lines)
(Tn3)
T-SSU1A or T-35S

nos 3'

bacterial

USDA: 7/96
FDA: nda
EPA: uoh
pending
 
27
Soybean

Roundup Ready®
Monsanto
HT (gly)1) e-P-35S
CP4 epsps (with CTP4)
(Agrobacterium (Petunia hybrida))
nos 3'USDA: 5/94
FDA: 10/94
EPA: nar*
UK (52), NL (98), EC (34), CH/Aus (-)
Can (75), Jap (81)
8
Squash

Asgrow
(now Seminis)
VR31) P-35S, CMV-5' utr

2) P-35S, CMV-5' utr

3) P-35S, CMV-5' utr

4) P-35S

chimeric CMV/WMV2 coat protein
(WMV2 (and CMV))
slightly altered ZYMV coat protein
(ZYMV)
CMV coat protein
(CMV)
nptII
(Tn5)
T-35S

T-35S

T-35S

T-35S

USDA: 6/96
FDA: nda
EPA: nar*
US (6) 25
Squash

Freedom II®
Upjohn / Asgrow
(now Seminis)
VR21) P-35S, CMV-5' utr

2) P-35S, CMV-5' utr

chimeric CMV/WMV2 coat protein
(WMV2 (and CMV))
slightly altered ZYMV coat protein
T-35S

T-35S

USDA: 12/94
FDA: 10/94
EPA: nar*
US (25) 6
Tomato (cherry)

Agritope
PQ (frd)1) P-E8 (ts, dr)

2) P-nos

sam-k (slightly altered)
(E. coli bacteriophage T3)
nptII
(Tn5)
nos 3'

nos 3'

USDA: 3/96
FDA: 2/96
EPA: nar
 
23
Tomato

Flavr Savré
Calgene
PQ (frd)1) d-P-35S

2) mas 5' or P-35S

3) -

polygalacturonase (antisense)
(Tomato)
nptII
(Tn5)
LacZ (incomplete)
(E. coli)
tml 3'

mas 3' or tml 3'
-

USDA: 10/921)
FDA: 5/94
EPA: nar
UK (53), Can (70) 1
Tomato

Endless Summer®
DNA Plant Technology
PQ (frd)1) P-35S, Cab22R-5' utr

2) d-P-nos

truncated AccS
(Tomato)
nptII
nos 3'

ocs 3'

USDA: 1/95
FDA: 10/94
EPA: nar
Can (73) 10
Tomato

Monsanto
PQ (frd)1) P-FMV, p-HSP70-utr

2) P-35S

accd
(Pseudomonas chloroaphis)
nptII
(Tn5)
E9 3'

nos 3'

USDA: 9/95
FDA: 10/94
EPA: nar
 
17
Tomato

Zeneca
(& Petoseed)
PQ (frd) 1) P-35S

2) P-nos

3, 4, 5) -

truncated polygalacturonase (sense/antis.)
(Tomato)
nptII
(bacterial)
fragments of ocd, M13 geneIII and LacZ
(A. tumefaciens, M13, E. coli)
nos 3'

nos 3'
-

USDA: 6/95
FDA: 10/94
EPA: nar
UK (51, 54),
Can (78)
12

Primary sources: USDA/APHIS, FDA, EPA; -, not present; §, corn from Mycogen was filed together with corn from Ciba Seeds at the EPA, representing products deriving from the same transformation event; HT, herbicide-tolerant; pt, phosphinothricin; gly, Glyphosate; br, bromoxinyl; su, sulfonylurea; IR, insect-resistant; L, Lepidopterae; C, Coleopterae; MS, male sterile; PQ, product quality; frd, fruit ripening delayed; op, oil profile altered; VR, virus-resistant. 1), further approvals from USDA were granted in 10/94, 11/94, 3/95, 7/95; 2) , registration of the first insect-resistant potato from Monsanto (ID 11) also applies here; italics, data given in italics were taken from sources other than the responsible approving authorities (e.g. description of a related product); 'altered' gene indicates changes in the gene sequence that resulted in an alteration of the amino acid sequence of the transgene product as compared to the protein encoded by the original gene; 'synthetic' gene indicates a gene that was modified in such a way that the codon usage was altered without changing the amino acid sequence of the respective protein; nar, no approval required; nar*, the EPA registers and approves pesticidal components (here, these are the products of genes conferring insect or virus resistance) in plants and the agency also registers the large-scale use of herbicides (uoh) on transgenic plants (not the plants themselves). The use of viral coat proteins in transgenic plants currently does not require approval from EPA; √, use of herbicide (uoh) approved, but no data available on the date of approval; US, United States; UK, United Kingdom; Can, Canada; Jap, Japan; EC, European Community; NL, the Netherlands; CH, Switzerland; for other abbreviations see glossary.


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

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