Dr. M.

Herman BB Biogen

PENGATURAN (sebagai langkah kehati-hatian)

BAGAIMANA MENGENDALIKANNYA?

Berbasis ilmiah, melalui Kajian Risiko Harmonisasi peraturan Hak konsumen untuk memilih

Informasi Genetik
1. Deskripsi Umum Tanaman PRG

2. Deskripsi Inang
3. Deskripsi Organisme Donor 4. Deskripsi Modifikasi Genetik 5. Karakterisasi Modifikasi Genetik

Informasi Keamanan Hayati

Weedines
Karakter fenotipik Invasiveness

Dampak terhadap non target

Predator Parasit Lebah madu Ulat sutera

Pengkajian Tanaman Transgenik

1
(Tanaman Pangan, Hortikultura, Perkebunan)

8
7
Tim Penilai & Pelepas Varietas

Publik
3 z
3.1
3.2 3.3 3.4

FUT

LUT LUT

Head house
Genetic engineering lab. Insect rearing lab. In vitro culture room Soil preparation room

Green-houses
Double doors of 6 units GH with poly- carbonate, 200 mesh screen wall and equipped with shell deck, exhaust fan, chiller, and AC room.

Screen-house

Exhaust fan

Water sprinkles

Shell deck

Exhaust fan Shell deck Water sprinkles

potato

Bt transgenic crops

T-herbicide transgenic crops

Non-transgenic crops

Biological Isolation
Planting in the field where isolated from the same kind of crop nearby (different crop).

Physical Isolation
Planting in the field where isolated with a fence or surrounding with residential area.

Time Isolation
Planting in the field where it has been planted with the same kind of crop nearby but with different time of planting.

IFT location
Corn- local variety Nearly harverted

Transgenic Corn T-herbicide 7 days

IFT Location
Melon

Sprayed w/herbicide

Hand weeding

TransgeniC Soybean T-herbicide

Pengamatan karakter fenotipik Studi invasiness Studi germinasi

Kesepadanan Substansial
Growth Color Texture

T : NT
0 25 50 75 100 Harvest-biomass at 3 weeks old Air-dry for 6 days Oven and weigh : 100 : 75 : 50 : 25 :0

T : NT
0 25 50 75 100 : 100 : 75 : 50 : 25 :0

Harvest-biomass at 3 weeks old Air-dry for 6 days Oven and weigh

Lebah madu Ulat sutera Predator Parasit

Laboratorium

Pollen
Bt vs Non Bt

Kontrol
(madu)

madu+pollen

madu+pollen

Rumah Kaca

Rumah Kaca

Mortalitas

Jagung

Kapas

Hari ke:1-5

Non Bt

Kontrol

Bt

Pollen
& Larva (1st, 3 hari)

Hari ke 5
Berat larva

Mortalitas Kontrol
(air)

Pollen
Bt vs Non Bt

Araneus inustus

Aphis

Ostrinia furnacalis
Ladybird

Uninfected eggs

Infected eggs

Semut Fire Merah Ants

Trichogramma sp.

H. Armigera
Instar I
5 HSI
Kapas Bt Kapas Non Bt Kapas Non Bt Kapas Non Bt

Kapas Non Bt

Kapas Bt

2 MSI

Kapas Bt

Bollworm Helicoverpa armigera

Pink Bollworm

Pectinophora gossypiella

Earias sp.

BISMA

P12 BT

P12 NON-BT

Jagung Bt

Jagung Non Bt

Jagung non Bt Jagung Bt Jagung Non Bt

Transgenik toleran herbisida

Non-transgenik

Transgenik

Non transgenik

Transgenik

Kapas non transgenik

Seed Btk Test Kit Cry IAc

Kapas Bt ke Kapas non Bt

di Sulawesi Selatan
(Agus

Purwito, Hajrial Aswidinnoor, Nur Amin) 2001

positif

positif

negatif

1 m = 7,6% 2 m = 3,3% 3 m = 1,9% 6 m = 0,0%

PCR-cry IAc

Informasi Genetik
1. Deskripsi Umum Pangan PRG 2. Deskripsi Inang dan Penggunaannya sebagai Pangan 3. Deskripsi Organisme Donor

4. Deskripsi Modifikasi Genetik

5. Karakterisasi Modifikasi Genetik

Informasi Keamanan Pangan

1. Kesepadanan Substansial 2. Perubahan Nilai Gizi

3. Alergenisitas
4. Toksisitas 5. Pertimbangan Lain-Lain

Phenotypic characteristics:
Morphology, growth, yield; Color, smell, taste, texture.

Compositional comparison:
Ash, carbohydrates, fat, fiber, protein; Amino acids; Fatty acids;

Kesepadanan Substansial
Growth Color Texture

Proximate Composition of Seeds From Roundup Ready Soybeans From Second Year Field Tests
50 45 40 35 30 25 20 15 10 5 0
P H P H P H

% Dry weight

P H

P H

Protein

Fat

Fibre Control seeds RRS seeds

Ash
H P

Carbohydrates Literature low Literature high

4 field sites in 1993 Thin lines = ranges of experimental values

*No significant difference from the control line were observed at the 5% level (protected LSD).

Fatty Acid Analysis of Seeds From Roundup Ready Soybeans

60 50 40
P H H P H P P H H P

30 20 10 0

C16:0 C18:0 C18:1 cis C18:2 C18:3 (palmitic) (stearic) (oleic) (linoleic) (linolenic) Control seeds RRS seeds
H P

9 field sites in 1992 Thin lines = ranges of experimental values

Literature low Literature high

*No significant differences from the control line were observed at the 5% level (protected LSD).

Amino Acid Analysis of Seeds From Treated Roundup Ready Soybeans

9 8 7 6 5 4 3 2 1 0
P H P H P H P H P H P H P H P H P H P H P H P H H P

% Dry weight

P H

P H

P H

P H

P H

Proline

Serine

Histidine

Glycine

Alanine

Arginine

Leucine

Lysine

Valine

Isoleucine

Cysteine

Methionine

Threonine

Tyrosine

Glutamic Acid

Phenylalanine

Aspartic Acid

Control seeds GTS seeds

H P

Literature low Literature high

4 field sites in 1993 Thin lines = ranges of experimental values

*No significant differences from the control line were observed at the 5% level (protected LSD).

Tryptophan

Stabil/tahan dalam pencernaan Stabil/tahan dalam pemanasan Stabil/tahan dalam pH asam Biasanya dalam konsentrasi tinggi

Brazil nut Crustacean (shrimp) Eggs Fish Milk Peanut Rice Soybean

no
No homology No stability in digestion No prevalence in food Homology to safe prot.

yes
In Vitro Test (ELISA)

pos LABEL As Source pos

neg
In Vivo Test (skin prick)

neg

SAFE

neg

Challenge Test

pos

Gen Interes
CP4EPSPS < 15 detik Cry I ab < 20 detik
Cry II a < 30 detik

Alergen
B-lactaglobulin > 60 menit Ovalbumin > 60 menit

Protein Tan.
Lypoxygenase < 15 detik Rubisco LSU & SSU < 15 detik B-amylase < 15 detik

Kunitz Tryps.Inhibtr. > 60 menit Peanut ARA h2 > 60 menit

GUS < 15 detik

NPT II < 10 detik

Acid phosphatase < 15 detik

K.H. Engel, 1999

Detik 0 15 30

Menit 2 4 8 15 60

Detik 0 15 30

Menit 2 4 8 15 60

LSU Pepsin

Protein tanaman

Pepsin SKTI

SSU LSU SSU SKTI

Protein tanaman

Alergen

= Rubisco large subunit = Rubisco smal subunit = Soybean Kunitz Trypsin Inhibitor CP4EPSPS = 5-enolpyruvylshikimate3-phosphate synthase Agrobacterium strain CP4

Detik 0 15 30 CP4EPSPS

Menit 2 4 8 15 60

Gen interes

CP4 EPSPS - Digestion

Gastric fluid
Intestinal fluid

SGF = SIF = simulated intestinal fluid

0 15 30 60 120 CP4 + SIF, 5 10 minutes ng CP4 CP4 CP4 + SGF, SIF, SIF, EPSPS + seconds t=0 t = 1171 min buffer CP4 SGF, CP4 + SIF, SGF, + t = 120 sec 1160 min, t=0 buffer CP4 + SGF, entire sample 120 sec, quenched entire sample quenched simulated gastric fluid Detection by Western

5 10 ng CP4 EPSPS

32 270 10 100 1181

blot

Interest Gene
CP4EPSPS < 0,1 % Cry I ab < 0,01 %
Cry II a < 0,01 %

Allergen
B-lactaglobulin 9% Ovalbumin 54 %

Plant Protein
Lypoxygenase <1% Rubisco LSU & SSU 25 % B-amylase <1%

Kunitz Tryps.Inhibtr. 4% Peanut ARA h2 6%

GUS 0,01 %
NPT II < 0,01 %

Acid phosphatase <1%

K.H. Engel, 1999

a gene encoding storage protein

Soybeans are deficient in methionine, Brazil nuts are rich, and known as a source of allergen; A gene encoding a storage protein from Brazil nut was introduced into soybean to increase methionine content; Transgenic soybean expressed high methionine content; But the transgenic soybean showed (+) allergic reaction to some people; The project was discontinued.

Photo courtesy of the University of Toronto

Stabil/tahan dalam pencernaan

Stabil/tahan dalam pemanasan

Stabil/tahan dalam pH asam

Celery (celerin) Potato (glyco-alkaloids)

Soybean (trypsin inhibitor, lectin)

Kentang (var. Lenape di AS & Kanada; var Magnum Bonum di Swedia) yang mengandung glycoalkaloid --- biarpun direbus masih menyebabkan keracunan. Seledri tahan serangga (mengandung celerin 10 x lebih tinggi)----- menyebab-kan alergi.

CP4 EPSPS - Toxicity Assessment

Mean body weight, gm
35 30 25 20 15 10 5 0
Body wt., pre-test, males Body wt., day 7, males Body wt., pre-test, females Body wt., day 7, females

Vehicle control
363 mg/kg BSA control

49 mg/kg CP4 EPSPS

154 mg/kg CP4 EPSPS

572 mg/kg CP4 EPSPS

Toxicant Analysis of Seeds From Roundup Ready Soybeans

100 90 80 70 60 50 40 30 20 10 0
P

% Dry weight

Trypsin inhibitor, TIU/ mg sample DW

Lectin, H.U./mg protein extracted

H P

9 field sites in 1992 Thin lines = ranges of experimental values

Control seeds RRS seeds

Literature low Literature high

*No significant differences from the control line were observed at the 5% level (protected LSD).

Processing
45 40 35 30 25 20 15 10 5 0
P H

Pre-processing - means of the seed analyses for 9 sites

Post-processing- two batches of toasted meal per line

Control

RRS

Control 40-3-2
Pre Post Pre Post

Control
Pre Post

RRS
Pre Post

Pre Post Pre Post

Trypsin Inhibitor, TIU / mg sample DW

Lectin, H.U./mg ext. prot.

Urease, D pH