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Keamanan Pangan Transgenik

Jun 02, 2018

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  • 8/10/2019 Keamanan Pangan Transgenik

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    Deteksi Keamanan Pangan

    Transgenik

    Dahrul Syah

    Teknologi Pangan - IPB

    Agenda

    Pengantar

    Substantial Equivalen

    Beyond Substantial Equivalen

    Pro Kontra

    Pengaturan di Indonesia

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    Biotech Products in

    Food Supply

    1. Fermentation products Yeasts and molds used to make cheese,

    bread, wine, beer, soy sauce

    2. Enzymes Lactase tablets to breakdown lactose in

    milk - for allergies

    Chymosin (rennet) for cheese

    manufacture

    Amylase in beer

    3. Hormones

    Bovine growth hormone(rbst)

    Vitamin D

    added milk

    Insulin

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    4. Whole foods/crops

    FLAVR SAVR,Endless Summertomatoes

    Virus resistantsquash

    Insect resistantpotatoes, corn

    Herbicide resistantsoybeans, canola

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    Acceptance of Technologies

    Public accepts new technologies with personal

    benefits

    rInsulin vs rBST

    Benefits of many

    bioengineered

    products unknown or not

    perceived as personal

    Platform of omics

    PLANT

    TISSUE

    DNA/mRNAs

    PROTEINS

    COMPONENTS

    DIFFERENCES

    AGRONOMICS

    PHENOTYPICS

    GENOMICS

    PROTEOMICS

    METABOLOMICS

    STATISTICSUnintended effects?

    Metabolite

    expression

    Protein

    expression

    Gene

    expressionFunctionStructureData

    integration

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    Potential Food Safety Effects

    Toxicants

    New Substances

    Nutrients

    Allergenicity

    Other Effects - Unintended

    -- IFT Expert Report on Biotechnology and Foods, 2000

    Considerations in Safety

    Evaluations Substantial Equivalence based on

    comparison of recombinant product with

    traditional product

    Not an absolute guarantee of safety

    Process to establish that no NEW hazards have

    been introduced into the plant or product

    Toxins?

    Nutrient Effects? Proteins, fats, carbohydrates,

    vitamins, minerals

    Allergens?

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    Genetic characterisation

    Comparison

    with Traditional

    Counterpart

    Agronomic characterisation

    Chemical characterisationnutrientstoxicants

    allergensDietary patterns

    History of safe useSelection of Traditional

    Counterpart

    Equivalency testing

    Nutrients: Carbohydrates

    Proteins

    Lipids

    Vitamins

    Minerals

    Allergens

    Asam Lemak

    Asam Amino

    Kesetaraan Substansial

    Tempe yang dibuat dari kedele import dan kedele lokal

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    Oil Oil

    1.EquivalentNo further testing

    2.Equivalence except forpredictable, well-defined traitsFocused evaluation on limiteddifferences

    3.Lack of equivalence, multiplecomplex differences or notraditional counterpartRigorous case-by-case safetyassessment

    Three Levels of Equivalence

    Kesetaraan; Proksimat

    Air Abu Protein Lemak0

    10

    20

    30

    40

    50

    60

    %B

    B

    Tempe Kedele Import

    Mean

    Air Abu Protein Lemak0

    10

    20

    30

    40

    50

    60

    %B

    B

    Tempe Kedele Lokal

    Mean

    Perbedaan signifikan : kadar air

    Sumber: Syah (2005)

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    %

    C16:0(palmitic)

    C18:0(stearic)

    C18:1 cis(oleic)

    C18:2(linoleic)

    C18:3(linolenic)

    0

    10

    20

    30

    40

    509 field sites in 1992

    %

    Chemical CharacterisationFatty Acid Analysis of Seeds

    *No significant differences from the control line were observed

    Sumber: Hugget (2001)

    Komposisi Asam Lemak (% AL/Total AL)

    0

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    Palmitat Stearat Arakhidat Dodekanoat Oleat Linoleat Linolenat

    Tempe Kedele Import Tempe Kedele Lokal

    %AL/TotalAL

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    H

    leucine

    tyrosine

    phenylalanine

    histidine

    lysine

    arginine

    c

    ysteine

    methionine

    tryptophan

    0

    1

    2

    3

    %DryWeight

    9 field sites in 1992

    Control seeds

    RRS seeds

    Literature low

    Literature high

    *No significant differences from the control line were observed

    Chemical CharacterisationAmino Acid Analysis of Seeds

    Sumber: Hugget (2001)

    Kesetaraan : Komposisi Asam Amino

    0

    1

    2

    3

    4

    5

    6

    As p Glu Se r His Gly Thr Arg Ala Tyr M et Val Phe Le u L ys

    Tempe Kedele Import Tempe Kedele Lokal

    %

    BB

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    Polar Chart Asam Amino (%AA/AA Total)

    0

    5

    10

    15

    2025 Glu

    Ser

    His

    Gly

    Thr

    Arg

    Ala

    Tyr

    Met

    Val

    Phe

    Leu

    Lys

    Tempe Kedele Import Tempe Kedele Lokal

    Spektrum

    Asam Amino

    yang identik

    Toxicant Analysis of Seeds fromRoundup Ready Soybeans

    Trypsin inhibitor

    TIU / mg DW

    Lectin

    H.U./mg protein extracted

    0

    20

    40

    60

    80

    100

    %

    Dryweight

    9 field sites in 1992

    Control seeds

    RRS seeds

    Literature low

    Literature high

    *No significant differences from the control line were observed Sumber: Hugget (2001)

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    0

    20000

    40000

    60000

    80000

    Kedele Tempe

    Import Lokal

    Kesetaraan : Tripsin Inhibitor

    TIU/g

    0,25

    0,26

    0,27

    0,28

    Kedele Tempe

    Import Lokal

    Kesetaraan : Asam Fitat

    mg/g

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    Kesetaraan : Hemaglutinin

    Tempe Kedele Import (1681 HU/g)

    Tempe Kedele Lokal (1648 HU/g)

    No Changes in EndogenousAllergens

    RR1: GTS line 61-67-1RR2: Parental line A5403RR3: GTS line 40-3-2C1: Cargill control 1C2: Cargill control 2C3: ADM control

    106 kD

    80 kD

    49.5 kD

    32.5 kD

    27.5 kD

    18.5 kD

    Total ProteinSoyabean Sensitive

    SerumNon-sensitive

    Serum

    RR-1

    RR-2

    RR-3

    Control2

    Control3

    Control4

    RR-1

    RR-2

    RR-3

    Control2

    Control3

    Control4

    RR-1

    RR-2

    RR-3

    Control2

    Control3

    Control4

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    Based on assessment of over 400 components in 2000 independent analyses -J. Nutr. (1996) 126:702-716

    Confirmed with soybeans treated with Roundup herbicide - J. Agri. Food Chem.1999, 47:4469-4473

    No changes in endogenous soya allergens - J. Allergy Clin. Immunol. 1996,96:1008-1010

    Chemical Characterisation - Summary

    Component Beans Meal Flour Isolate Conc. Oil

    Proximate analysis = = = = =Amino acids =

    Fatty acids = =

    Trypsin inhibitors = = =

    Lectins = =

    Phytoestrogens = =

    Urease = =

    Stachyose, raffinose =

    Phytate =

    Known allergens = =

    Component

    Nutritional/Toxicant composition

    Animal feed performance

    Processing

    Dietary use

    Tolerance to glyphosate

    One additional protein / gene

    Unchanged

    Changed

    X

    X

    GM Soybeans vs Traditional Varieties

    Sumber: Hugget (2001)

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    Teknologi Pangan - IPB

    Agenda

    Pengantar

    Substantial Equivalen

    Beyond Substantial Equivalen

    Pro Kontra

    Pengaturan di Indonesia

    Keamanan seluruh Komponen;

    gen sisipan, pembawa dan inang

    Tomato Fish

    Tomato-fish

    Replicated DNA

    Denucleated fish egg

    Fish cell

    Fish DNATomato cell

    Tomato DNA

    Desired gene

    Credit: Owen Koo

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    Safety of Genetic Material

    Inserted

    Characterization of

    Source

    Size

    Number

    Location of insertion

    Identification of sequences in the plantSafety of DNA itself is not in question

    Safety of CTP-EPSPS

    No toxicity associated with CTP-EPSPS gene

    No toxicity associated with CTP-EPSPS protein- EPSPS family of proteins have a long history of safe

    consumption

    - No amino acid sequence homology to known toxinsor allergens

    - No toxicity observed in animal studies

    - Shows none of the properties of allergens

    J. Nutrition, 1996, 126:728-740

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    Males, pre-test Males, day 7, Females, pre-test Females, day 7

    0

    5

    10

    15

    20

    25

    30

    35

    Meanbodyweight(g)

    Vehicle control

    363 mg/kg BSA control

    49 mg/kg CP4 EPSPS

    154 mg/kg CP4 EPSPS

    572 mg/kg CP4 EPSPS

    CP4 EPSPS - Toxicity Assessment

    Digestion of CP4 EPSPS in vitro

    CP4 EPSPS does not have the stabilitycharacteristics of known food allergens

    Gastric fluid Intestinal fluid

    0 15 30 60 120

    SecondsC 0 10 32 100 270

    MinutesC 1181

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    Molecular weight (10-70 kD) + +High concentration in food + -Heat stable + -pH stable + -Protease stable + -Glycosylated + -Sequence homology + -

    Comparison of CP4 EPSPS to knownallergenic proteins

    no significant concern

    Allergen CP4 EPSPS

    Unintended Effects:

    the unintended expression of someunknown or unexpected toxic orantinutrient factor, or the otherwiseunintended enhanced production ofknown toxic constituents. - (Royal Society,1998)

    Evidence of such effects has not beenfound as result of bioengineering.

    Effects are less likely in bioengineeredthan in conventional products.

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    Food Allergens:

    All food allergens are proteins: only a small

    fraction of food proteins cause allergic

    response.

    Common foods with allergenic proteins:

    peanuts, milk, seafoods

    Potential allergenicity of genetic material

    (proteins) introduced into a plant is an

    important part of safety assessment.

    Allergenicity Assessment

    Follows a decision-tree process

    Includes:

    Source of the gene

    Sequence homology of newly introducedprotein

    Reactivity of newly introduced proteins withImmunoglobulin E (IgE) antibodies frompeople with known allergies to sourcematerial

    Other properties, such as digestibility of theprotein

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    Metode : Pengujian Alergenitas

    Test Passive Cutaneous Anaphylaxis.- Sensitisasi mencit dengan pemberian ransum tempeselama 2 bulan.

    - Mencit dianestasi, darahnya diambil, diperoleh serummencit anti-alergen

    - Antiserum diinjeksikan secara intradermal dipunggungmencit

    - Mencit diinjeksi lagi dengan sampel dan evans bluemelalui ekor

    - Sampel menyebabkan alergi jika terlihat area biru padapunggung

    Allergenitas ; PCA

    Negatif

    untukkedua

    tempe

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    Allergenitas ; Ig E

    0Protein tempe kedelai lokal (3%)60Protein tempe kedelai lokal (1%)5

    0.2Protein tempe kedelai import (3%)4

    0Protein tempe kedelai import (1%)3

    0.4Ovalbumin (1%)2

    0Standar1

    Hasil(IU/ml)

    PerlakuanNo

    Substantial

    Equivalence Tox Testing

    Pro Kontra (1)

    Assumption based

    risk assessment

    SCIENCE/Evidence

    based

    risk assessment

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    EVENT-Specific

    Whole Food

    Tox testing

    Tox Testing

    with Protein

    (from E.coli)

    Pro Kontra (2)

    (Unproved) model

    testing risk

    assessmentTest as consumed

    risk assessment

    GM

    Labelling

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    Teknologi Pangan - IPB

    Pengaturan di Indonesia

    UU 7 Tahun 996 dan PP turunannya

    Pasal dan Ayat Khusus

    Labelling

    Pengaturan

    Komisi Keamanan Hayati dan Keamanan Pangan

    Komisi Teknis Keamanan Hayati dan Keamanan

    Pangan