PerkembanganTanaman PRG di Lingkup Global

Topics

● Proses deregulasi produk PRG di Indonesia

● Area penanaman produk PRG secara global and pengenalan

produk yang di tanam di lingkup global

●Overview peraturan terkait stack di berbagai negara

●Regulasi stack di Jepang

● Pertimbangan

Perkembangan Peraturan Produk RekayasaGenetika di Indonesia

Peraturan bersama4 Menteri

Focal point : Kementan

Peraturan Pemerintah 21/2005

Focal point : KLHKKH ditunjuk oleh presidenPedoman pengkajian akanditerbitkan oleh departemen terkait

2020

Perdirjen 10/2017Petunjuk teknis pengisiandokumen ARL

Permentan 40 2017Pelepasan varietas (Non PRG

RatifikasiCartagenaProtocols

20181999 20142004 20162006 2008 2010

Perpres 39/2010Pembentukan KKH

2012

Perka BPOM**HK 00.05.23.3541Pengkajian Pangan

Kep.01/KKH/11/2011Pembentukan TTKH PRGPermentan 61 2011Pelepasan varietas PRG

Permen LH 25/2012Pedoman penyusunanDokumen ARL

Permentan 36/2016Pedoman pengkajiankeamanan Pakan

PermenLHK 69/2016Pengujian LUT

PedomanPemantauan danPengawasan PRG??Pedoman pelepasanVarietas PRG??

**Peraturan ini sudah 2 kali direvisi (tdk ditampilkan disini)

Persetujuan Keamanan Hayati di Indonesia ( 2005-2014)

•27(-1)

PANGAN

•6(-1)

PAKAN

•13(-9)

LINGKUGAN

Tanaman Produk Rekayasa Genetika yang telah mendapatkanpersetujuan keamananan Hayati lengkap:1. Tebu Tahan kekeringan event NXI 4T2. Jagung PRG toleran herbisida glifosat event NK 6033. Kentang tahan hawar daun Phytophthora infestans,

katahdin SP 9514. Jagung PRG toleran herbisida glifosat event GA21

Keamanan Hayati

Pelepasan Varietas

PEMANFAATAN TEKNOLOGI OLEHPETANI

Area Penanaman produk PRG di Dunia

Area Penanaman produk PRG di Dunia

Produk Breeding Stack yang di Komersialkan di lingkup Global

Stack event Pengembang Traits

Bt11XGA21 Syngenta Glyphosate herbicide tolerance ,Glufosinate herbicide toleranceLepidopteran insect resistance

Mon 89034 x NK 603 Monsanto Glyphosate herbicide tolerance , Lepidopteran insect resistance

Mon 810xTC1507xNK603 DuPont Glufosinate herbicide tolerance , Glyphosate herbicide tolerance , Lepidopteran insect resistance

5307 x MIR604 x Bt11 x TC1507 x GA21 x MIR162

Syngenta Glufosinate herbicide tolerance , Glyphosate herbicide tolerance , Coleopteran insect resistance , Lepidopteran insect resistance , Multiple insect resistance , Mannose metabolism

MON-87427-7 x MON-89Ø34-3 x DAS-Ø15Ø7-1 x MON-87411-9 x DAS-59122-7 x DAS-4Ø278-9

Monsanto Glufosinate herbicide tolerance , Glyphosate herbicide tolerance , Coleopteran insect resistance , Lepidopteran insect resistance , 2,4-D herbicide tolerance

Contoh produk yang dikomercialkan secara global

Tanaman PRG yang mendapatkan persetujuan keamanan Hayati 1992-2016

Overview on stack RegulationNo Negara Regulasi stack event Keterangan

1 Australia/ Selandia baru Tidak diregulasi

2 ArgentinaDiregulasi

High cover low concept , pengkajianpangan dan pakan tercakup di dalamlingkungan

2 Jepang - Kategori 1 : hanya perlupemberitahuan ke badan terkaitsebelum pelepasan

- Kategori 2 dan 3 diregulasi

High-cover-low concept, simplified data requirement

3 Filipina Diregulasi, namun sangatsederhana

High cover low concept. Data yang diperlukan adalah comparative southern Untuk keamanan lingkungan tidakperlu trial

4 Kanada Notification only

5 Amerika Serikat Stack event tidak diregulasi.

6 European Union Diregulasi High cover low concept

Mengapa regulasi stack di Jepang mungkin sesuai untuk Indonesia?

• A good reference country • Berpengalaman selama 15 tahun dalam mengelola stack

• Kejelasan strategi dan pedoman sejak awal

• Semua informasi/prosesnya transparan

• Peraturan direview secara periodik dan direvisiberdasarkan pengalaman dan sains

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PP21 2005 :Pasal 13 Ayat 1(Penjelasan) Yang dimaksud dengan PRG sejenis adalah PRG hasil rekayasa genetic yang sama termasuk hasil persilangan konvensional. Varietas yang sama dari hasil PRG berbeda bukan PRG sejenis. Kata sejenis di sini bukan merupakan pengertian taksonomis. PRG sejenis wajib diuji keamanan hayatinya hanya untuk pemasukan pertama kali. Sekali telah memenuhi syarat keamanan hayati maka pemasukan PRG berikutnya untuk jenis yang sama tidak perlu lagi diuji keamanan hayatinya. Izin dari Menteri hanya diperlukan untuk setiap pemasukan pertama kali suatu PRG

Overview Regulasi PRG di Jepang

Law

Risk

Management

Risk

Assessment

Food

Safety

Food Sanitation

Law

MHLW

FSC

Feed

Safety

Feed Safety Law

MAFF

AMC

FSC

Environ.

Safety

Cartagena

Law

MAFF

MOE

Bio-diversity

Risk Assmt Committees

MHLW: Ministry of Health, Labor and Welfare

MAFF: Ministry of Agriculture, Forestry and Fisheries

MOE: Ministry of the Environment

FSC: Food Safety Commission

AMC: Agricultural Material Council

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Overview Regulasi PRG di Jepang

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Pengkajian Keamanan Pangan produk event tunggalStandar data yang diperlukan

*Source : http://www.fsc.go.jp/english/standardsforriskassessment/geneticallymodifiedfoodfeed_e1.html

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Status of inserted genes in plant(southern, sequencing etc)

Genetic/protein stability(southern, ELISA etc)

Toxicity/Allergenicity(Bioinformatics/SGF/SIF/heat studies)

Nutritional Equivalency(Compositional analysis)

Effect to host plant metabolic pathway(Literatures, studies)

Penentuan kategori berdasarkan pengkajian keamanan pangan eventtunggal

Category Definitions

1 Not altering metabolic pathway of host plant

2 Altering metabolic pathway of host plant resulting increase or decrease of endogenous metabolites

3 Altering metabolic pathway of host plant resulting introduction of novel metabolites

3 Categories based on the potential impact to host plant metabolic pathway and novelty.

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Source :Safety Assessment of Crossing of Genetically Modified Plants (January 29, 2004)

http://www.fsc.go.jp/senmon/idensi/gm_kangaekata.pdf

Pengkajian keamanan pangan event tunggalBagaimana menentukan kategori ?

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Effect to host plant metabolic pathway

Mode of action• Enzymatic activity• Potential interaction

Literatures

Data

Category

Examples : Cry proteins• No enzymatic activity is reported• Not known to interact with plant metabolic

pathway

Pengkajian Keamanan Pangan Event Tunggal Categorization

Category Definitions Events

1 Not altering metabolic pathway ofhost plant

- HT and IR traits (except GAT)- 3272 (α-amylase corn)- MON87460 (drought corn)- MON 87403 event (increased biomass)

2 Altering metabolic pathway of host plant resulting increase or decrease of endogenous metabolites

- LY038 (High lysine corn)- DP-305423-1 (High oleic acid soy)- DP-356043-5 (HT, GAT soy)- MON87705 (High oleic acid, Low sat FA & HT

soybean)- MON87769 (stearidonic acid soy)- KK179 (Low lignin alfalfa)

3 Altering metabolic pathway of host plant resulting introduction of novel metabolites

- None classified so far

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96 out of 105 single events fall under category 1.Source : http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000207387.pdf

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000071173.pdf

Stack food assessmentHigh-Cover-Low concept adopted in Japan

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A C

A x B

There shall be no scientific reason to anticipate

interaction in its sub-combinations, A x B, A x C

and B x C.

Provided A, B and C transgene products are

independent from host metabolism, and there is

no protein-protein interactions among A, B and C

proteins.

Additional assessments shall not be required

for A x B, A x C and B x C stack varieties once

A x B x C is approved.

Courtesy of Professor H. Kodama (modified)

B

X X

B x CA x C

A x B x C

Stack food assessmentHigh-Cover-Low helps assessment efficiency

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Quality traits

Insect Resistant traits (ECB)

Insect Resistant traits (CRW)

Herbicide Tolerant traits

BT11

MIR162 5307

MIR604 GA21

BT11 MIR604GA21

BT11 GA21

MIR162 5307

BT11 MIR604GA21 3272

X

X X

X X

X X X

Stack A

Stack B

Stack C

Stack D

Safety conclusion of Stack D covers stack A, B and C

Stack food safety assessment (2004-2014)Summary

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• All the stack products didn’t show any unexpected results through confirmation.

• Based on this accumulated experience and knowledge, stack assessment process was reviewed in 2014 and 2017.

Total 48 stack combinations were assessed.• 32 corn, 4 soy, 10 cotton, 1 canola and 1 alfalfa stacks

assessed.

Source : FSC website (http://www.fsc.go.jp/fsciis/evaluationDocument/list?itemCategory=010)

Stack food safety assessment (2014-) Summary of changes in 2014 and 2017

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• Stack contains only category 1 singles

• Safety assessment is required for the time being if cross is made beyond sub-species or food usage is changed.

• Confirmation is required if cross is made in the same species and usage remains the same.

1 x 1

• Stack containing category 2 or 3 single(s)

• Safety assessment is required for the time being.

2 x 1

3 x 1

• Stack containing category 3(s)

• Safety assessment is required.

2 x 2

3 x 2

3 x 3

Source : Amendment of notice No. 370 and No. 233, MHLW (2014)

Stack food safety assessment (2017-) 2 x 1 stacks – simplified data requirement

• FSC continues to assess 2 x 1 stacks but the data requirement is simplified.• Data to demonstrate the trait presence

• Data to demonstrate the similarity of category 2 trait profile to single.

Past Current

1. Bio-efficacy2. Southern 3. Expression4. Composition

1. Southern, expression OR Bio-efficacy.

2. Limited compositional profile (not whole composition)

22Reference : FSC memorandum (Dec 22, 2017)

http://www.fsc.go.jp/senmon/idensi/index.data/gm_taisha_kaihen_kakeawase.pdf

1x1 stack food assessment (2014-) 1 x 1 stacks – exemption from June 2014

23Source: Amendment of notice No. 370 and No. 233, MHLW (27 June 2014)

MHLW updates approved category 1 events on website

Applicant notifies 1 x 1 stack to MHLW prior to sales*

No assessment is required by FSC(if not cross beyond subspecies and usage is the same)

MHLW updates notified 1 x 1 stacks on website.

*Condition : Trait, species and usage shall not be changed

from the scope of single events.

Stack food safety assessment (2014-) 30 stacks were exempted since June 2014

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2004-2014Assessed

2014-2018Assessed

2014-2018Exempted*

Total

Corn 32 1 18 50

Soy 4 3 4 11

Canola 1 1 2 4

Cotton 10 0 6 16

Alfalfa 1 1 0 2

Total 48 5 30 83

Source : FSC website http://www.fsc.go.jp/fsciis/evaluationDocument/list?itemCategory=010)

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000210015.pdf

All stacks 1 x 1 stacks2 x 1 stacks

As of 31 May 2018

Japan stack food safety regulationSummary

• Rely on the safety conclusion of single events• Stack assessment considered as time-bound from the beginning

based on categories.

• Stack process/data requirement is based on category

• High-cover-low is adopted• Scientifically accepted and contributing to regulatory efficiency

• Revised in 2014 and 2017 based on science and experience• Exemption for 1 x 1, notification for management

• Simplified data for 2 x 1

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Pertimbangan

• Untuk menyederhanakan proses pengkajian untuk stack event• Penerapan kategori produk

• Exemption/Notification

• Penyederhanaan data yang diperlukan (Southern dan profil komposisi

• Penerapan konsep high-cover-low

• Safety Assessment Sharing (food/feed/ERA)

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