Biosafety Regulationand GM Food Detection in Indonesia

Bahagiawati AmirhusinICABIOGRAD (Indonesian Center for AgricI ABIOGRAD (Indonesian enter for AgricBiotech and Genetic Resources R&D)IAARD (Indonesian Agency for Agricultural

h d l ) Research and Development), Department of Agriculture

I d i i iIndonesia position

A t th G tiAccept the Genetic Engineered Products withEngineered Products with precautionary approaches : based on scientific justification

Policies on GMOsPolicies on GMOs• 1996: Law no. 7 concerning food (GMO food safety1996: Law no. 7 concerning food (GMO food safety

in article 13)• 1997: Minister of Agriculture Decree: Biosafety of g y

Genetic Engineered Agricultural Products– Biosafety Committee (BC)

Bi f t T h i l T (BTT)– Biosafety Technical Team (BTT)

• 1998: Guideline for Environment Risk Assessment (general plant animal fish and microorganism)(general, plant, animal, fish, and microorganism)

• 1999: Joint Ministerial Decree: Biosafety and Food Safety of Genetic Engineered AgriculturalSafety of Genetic Engineered Agricultural products

– Biosafety and Food safety Committee (BFSC)– Biosafety and Food Safety Technical Team (BFTST)

• 1999: Presidential Decree no. 19: Labelling of gPackaging Processed Foods Derived fromGMO (article 35)GMO (article 35)

• 2004: Law no. 21: Rafication of CartagenaProtocol on BiosafetyProtocol on Biosafety

• 2004: Presidential Decree no.28: Safety,Q lit d N t iti f F d (GMOQuality and Nutrition of Food (GMOsafety in article 14)

• 2005: Presidential Decree no. 21: Biosafety of Genetic Engineered Products

• 2008: National Drugs and Food Control Agency: guideline of assessment for food safetyg y

Presidential Decree no 21/2005Presidential Decree no. 21/2005

• R&D of GEAP (containment and field test)• Obligation of risk assessmentObligation of risk assessment

(environment and food safety) of GMO f i t l l d d di tfor environmental released and direct use for food and processing

• Monitoring and mitigationReg lator Bodies (BC BTT BCH)• Regulatory Bodies (BC, BTT, BCH)

Regulatory Bodiesg y

Biosafety Commitee (ex-officio-inter-Biosafety Commitee (ex-officio-inter-Departmental Team) and Biosafety Technical Team (multi disciplinary scientists from different institutions–universities, NGOs, Ministry of Science and Technology, Department of Agriculture, Department of Health, Department ofAgriculture, Department of Health, Department of Forestry, Ministry of Environment)BCH (Biosafety Clearing House – Ministry of Science and Technology)Focal point for environment safety is Ministry of Environment; focal point for food safety isEnvironment; focal point for food safety is Ministry of Health

ProponentMinister of A i lt

Min. of Env.1

3Proponent Agriculture14 d2

3

414 d

56 d

BFSTT14 d

60 d

BCT CFT

5

BFSCPUBLIC

7 d

14 d5

6

7BCH 14 d

9

11

15 d

7 d

7

8

Mi i t f 14 d

11 7 d

Min.of Env.Minister of Agriculture 10

14 d

Information of GeneticInformation of GeneticInformation of Environment SafetyInformation of Environment Safety

WeedinesWeedinesPhenotypic charactersPhenotypic charactersI iI iInvasivenessInvasiveness

Impact on non targetImpact on non targetPredatorsPredatorsPredatorsPredatorsParasitesParasitesHoney beeHoney beeSilk wormSilk wormSoil microbesSoil microbes

Gene flowGene flowGene flowGene flow

FT Site Time IsolationFT Site

Local Maizenear harvestingnear harvesting

Bared land

MelonFT siteHerbicide Tolerant Maize

(7 days old)

Bi l i l I l tiBiological Isolation

Herbicide Tolerant Soybean

Bt cotton(MON531/757/1076)(MON531/757/1076)

RR cotton(MON1445/1698)

Bt corn (M 810)Bt corn (Mon810)

RR corn (GA21)( )

RR soybean(GTS40-3-2)

LBR Potato Free Amylose Cassava

Balitsa, Lembang

Drought Tolerant Sugarcane

LIPI, Cibinong

Bt Rice

PTPN XI, JatirotoBB-Padi, Kerawang

ProponentMOA/

MOF/NDFC 3

1

BFSTT

MOF/NDFC 3

14 d2

LabBFSTT

14 d

60 d56 d

4

Lab

5 BFSCPUBLIC

15 d

14 d

7 d6

4

BCH15 d

98

6

7 d7

MOA/

9

14 dMOA/

MOF/NDFC 8

f f • Information of Genetic• Information of Food Information of Food Safety

S b t ti ll E i l t– Substantially Equivalent– Changing Nutrition Value– Allergenicity– ToxicityToxicity– Other considerations

ProponentMin. of

Agriculture DG

1

2 3CqIAARD2 3

7 d30 d

qPPI

5

BFSTT 4 7 d30 d

7 d7 d 5

6

5 BFSC30 d7

9

7 d 5

67

DG

Min. ofAgriculture

7

7 dCq DG IAARD

Agriculture8

CqPPI

Institution Laboratory MethodsNational Agency for Drug and National Quality Qualitative NestedNational Agency for Drug and Food Control(NADFC)

National Quality Control of Drug and Food (NQCDF)

Qualitative Nested-PCRQuantitative

(NQCDF) Real time-PCR

Indonesian Center for Agriculture Biotechnology

Biology Molecular Division lab

Qualitative-conventional PCRAgriculture Biotechnology

and Genetic Resources Research and Development ( C OG )

Division lab conventional PCR

(ICABIOGRAD)

PT Saraswanti GM laboratory Qualitative-PCRQuantitative PCRQuantitative PCR (competitive PCR)

Institution Proficiency

National Agenc Dr gs and Asia Pacific Laborator accreditationNational Agency Drugs and Food Control(NADFC)

Asia Pacific Laboratory accreditation Cooperation/ APLAC- China (2004)ASEAN-Malaysia (2005)

Indonesian Center for Agriculture Biotechnology and genetic Resources

Indonesian Accreditation Committee (KAN)- ISO 17025 (2003)A i P ifi L b t A dit tiand genetic Resources

Research and Development (ICABIOGRAD)

Asia Pacific Laboratory Accreditation Cooperation/ APLAC- China (2004)

PT Saraswanti Indonesian Accreditation Committee (KAN)-2003Central Science laboratory (CSL)-UKCentral Science laboratory (CSL)-UK (2003)Asia Pacific Laboratory accreditation C ti / APLAC Chi (2004)Cooperation/ APLAC- China (2004)

Available Equipments related to GM Food Testing

Spektrofotometer PCR-Tetrad PCR-Single

ChemiDoc Gel System Freezer -20oC Real Time-PCR

Sample type & MatricesSample type & MatricesSample type & MatricesSample type & Matrices

Crop: Soya MaizeCrop: Soya, Maize.Matrices:

Raw seed / grain (mainly soy and maize)Raw seed / grain (mainly soy and maize)Semi processed food (starch etc)Processed food (tempe tofu soy sourceProcessed food (tempe, tofu, soy source,

tauco, snack, syrup etc)

DNA Extraction DNA Extraction

GMO screeningGMO screening

GMO specific qualitative GMO specific qualitative

GMO ifiGMO ifi

PCR Mastermix

GMO specific GMO specific quantitative quantitative

We are testing about We are testing about 77--10 10 samples per monthsamples per monthp pp p

DNA added

•• CTAB non kitCTAB non kit•• CTAB/WizardCTAB/WizardCTAB/Wizard CTAB/Wizard

DNA CleanDNA Clean--up up SystemSystemyy

•• CTAB/QIAquick CTAB/QIAquick PCR Purification PCR Purification

iKit & QIAmp DNA Kit & QIAmp DNA Maxi kit (Qiagen)Maxi kit (Qiagen)

DNA Extraction

•• Genespin Genespin isolation kitisolation kit

GMO detection protein basedGMO detection protein-based

• Lateral Flow Strip– RR-soybeany– Cry 1

LL maize– LL-maize– LL-rice

Indonesian GMF Testing NetworkIndonesian GMF Testing Network

I d i GMF• Indonesian GMF Testing Network was established since 2006.

• Several representatives from several i tit ti ( bliinstitutions (public research, university and private company) joint p ate co pa y) jo tthe meeting

• Some of institutions ll b t d icollaborated in

strengthening their testing capacitytesting capacity

Future planFuture plan

• amendment act/decree on biosafety and amendment act/decree on biosafety and food safety following updated international and regional standard - setting the f k framework

• Capacity building in risk assessment of GMO• Conducting method validation among GMF

testing laboratories in Indonesia and increase participation in International increase participation in International Proficiency Testing Programs

• Increase networking and collaboration • Increase networking and collaboration among international/regional

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