Overview of GM food policy

1. Biosafety Regulation
and GM Food
Detection in Indonesia
Bahagiawati Amirhusin
ICABIOGRAD (Indonesian Center for AgricI ABIOGRAD (Indonesian enter for Agric
Biotech and Genetic Resources R&D)
IAARD (Indonesian Agency for Agricultural
h d l )Research and Development),
Department of Agriculture

2. I d i i iIndonesia position
A t th G tiAccept the Genetic
Engineered Products withEngineered Products with
precautionary approaches :
based on scientific
justification

3. 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 ofg 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)

4. • 1999: Presidential Decree no. 19: Labelling ofg
Packaging Processed Foods Derived from
GMO (article 35)GMO (article 35)
• 2004: Law no. 21: Rafication of Cartagena
Protocol on BiosafetyProtocol on Biosafety
• 2004: Presidential Decree no.28: Safety,
Q lit d N t iti f F d (GMOQuality and Nutrition of Food (GMO
safety 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

5. 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 mitigation
Reg lator Bodies (BC BTT BCH)• Regulatory Bodies (BC, BTT, BCH)

6. 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

7. Proponent
Minister of
A i lt
Min. of Env.
1
3Proponent Agriculture
14 d2
3
4
14 d
56 d
BFSTT
14 d
60 d
BCT CFT
5
BFSC
PUBLIC
7 d
14 d
5
6
7
BCH 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

8. Information of GeneticInformation of Genetic
Information of Environment SafetyInformation of Environment Safety
WeedinesWeedines
Phenotypic charactersPhenotypic characters
I iI iInvasivenessInvasiveness
Impact on non targetImpact on non target
PredatorsPredatorsPredatorsPredators
ParasitesParasites
Honey beeHoney bee
Silk wormSilk worm
Soil microbesSoil microbes
Gene flowGene flowGene flowGene flow

10. FT Site Time IsolationFT Site
Local Maize
near harvestingnear harvesting
Bared land
Melon
FT siteHerbicide Tolerant Maize
(7 days old)
Bi l i l I l tiBiological Isolation
Herbicide Tolerant Soybean

11. 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)

12. LBR Potato Free Amylose Cassava
Balitsa, Lembang
Drought Tolerant Sugarcane
LIPI, Cibinong
Bt Rice
PTPN XI, JatirotoBB-Padi, Kerawang

13. Proponent
MOA/
MOF/NDFC 3
1
BFSTT
MOF/NDFC 3
14 d
2
LabBFSTT
14 d
60 d
56 d
4
Lab
5 BFSCPUBLIC
15 d
14 d
7 d
6
4
BCH
15 d
9
8
6
7 d
7
MOA/
9
14 d
MOA/
MOF/NDFC 8

14. f f• Information of Genetic
• Information of FoodInformation of Food
Safety
S b t ti ll E i l t– Substantially Equivalent
– Changing Nutrition Value
– Allergenicity
– ToxicityToxicity
– Other considerations

15. Proponent
Min. of
Agriculture
DG
1
2
3Cq
IAARD
2
3
7 d30 d
q
PPI
5
BFSTT
4 7 d30 d
7 d
7 d 5
6
5
BFSC
30 d
7
9
7 d 5
6
7
DG
Min. of
Agriculture
7
7 d
Cq DG
IAARD
Agriculture
8
Cq
PPI

16. Institution Laboratory Methods
National 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-
PCR
Quantitative
(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-PCR
Quantitative PCRQuantitative PCR
(competitive PCR)

17. 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)-2003
Central Science laboratory (CSL)-UKCentral Science laboratory (CSL)-UK
(2003)
Asia Pacific Laboratory accreditation
C ti / APLAC Chi (2004)Cooperation/ APLAC- China (2004)

18. Available Equipments related to GM Food Testing
Spektrofotometer PCR-Tetrad PCR-Single
ChemiDoc Gel System Freezer -20oC Real Time-PCR

19. 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)

20. DNA ExtractionDNA Extraction
GMO screeningGMO screening
GMO specific qualitativeGMO specific qualitative
GMO ifiGMO ifi
PCR Mastermix
GMO specificGMO specific
quantitativequantitative
We are testing aboutWe are testing about 77--
1010 samples per monthsamples per monthp pp p
DNA added

21. •• CTAB non kitCTAB non kit
•• CTAB/WizardCTAB/WizardCTAB/WizardCTAB/Wizard
DNA CleanDNA Clean--upup
SystemSystemyy
•• CTAB/QIAquickCTAB/QIAquick
PCR PurificationPCR Purification i
Kit & QIAmp DNAKit & QIAmp DNA
Maxi kit (Qiagen)Maxi kit (Qiagen)
DNA Extraction
•• GenespinGenespin
isolation kitisolation kit

22. GMO detection protein basedGMO detection protein-based
• Lateral Flow Strip
– RR-soybeany
– Cry 1
LL maize– LL-maize
– LL-rice

23. 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) jointp ate co pa y) jo t
the meeting
• Some of institutions
ll b t d icollaborated in
strengthening their
testing capacitytesting capacity

24. Future planFuture plan
• amendment act/decree on biosafety andamendment act/decree on biosafety and
food safety following updated international
and regional standard - setting the
f kframework
• Capacity building in risk assessment of GMO
• Conducting method validation among GMF
testing laboratories in Indonesia and
increase participation in Internationalincrease participation in International
Proficiency Testing Programs
• Increase networking and collaboration• Increase networking and collaboration
among international/regional

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