PENGATURAN DAN BIOETIKA

PEMANFAATAN ORGANISME
HASIL REKAYASA GENETIK
UNTUK TUJUAN KOMERSIAL

Y. Andi Trisyono

Departemen Hama dan Penyakit Tumbuhan

Fakultas Pertanian, Universitas Gadjah Mada
Yogyakarta 55281
Subjects of Discussion
• Regulations related to
GMO
• Registration of GMOs
products in Indonesia
• Biosafety in confined field
trial
 The development and
deployment of a GM crop
move through different
stages General
release

Full safety
assessment

Confined
Field Trials
Growth
Chamber or Safety Regulation
greenhouse
is Adapted to Each
Lab
Level
 PERATURAN DAN PEDOMAN
1. SK Mentan No. 856/Kpts/HK.330/9/1997 tentang
Ketentuan Keamanan Hayati PBPHRG
2. SK Bersama Empat Menteri (Pertanian, Kehutanan dan
Perkebunan, Kesehatan, dan Pangan dan Hortikultura)
No. 998.1/Kpts/OT.210/9/99; 790.a/Kpts-IX/1999;
1145A/Menkes/SKB/IX/199; 015A?Nmeneg
PHOR/09/1999 tentang Keamanan Hayati dan
Keamanan Pangan Produk Pertanian Hasil Rekayasa
Genetik (PPHRG)
3. Pedoman pengujian keamanan hayati PPHRG
4. SK Mentan No. 737/Kpts/TP.240/9/98 tentang pengujian,
penilaian, dan pelepasan varietas
5. UU RI No 21 Tahun 2004 tentang Pengesahan
Cartagene Protocol on Biosafety to the Convention on
Biological Diversity
6. Peraturan Pemerintah RI Tahun 2005 tentang
Keamanan Hayati Produk Rekayasa Genetik
 Peraturan terkait PRG (Djohor 2016)
1. Peraturan Presiden Nomor 53 Tahun 2014 tentang
Perubahan Atas Peraturan Presiden Nomor 39 Tahun
2010 tentang Komisi KKH PRG
2. Peraturan Menteri Pertanian No. 61/2011 tentang
Pengujian, Penilaian, Pelepasan dan Penarikan Varietas
3. Peraturan Kepala Badan POM tahun 2012 tentang
Pedoman Pengkajian Keamanan Pangan Produk
Rekayasa Genetik
4. Peraturan Menteri Lingkungan Hidup No. 25/2012
tentang Pedoman penyusunan dokumen Analisis Risiko
Lingkungan Produk Rekayasa Genetik
5. Peraturan Kepala Badan POM tahun 2012 tentang
Pengawasan Pelabelan Pangan Produk Rekayasa Genetik
PROTOKOL CARTAGENA

Indonesia telah meratifikasi Konvensi

Keanekaragaman Hayati (United Nations
Convention on Biological Diversity) dengan UU No.
5 Tahun 1995 yang mengamanatkan
ditetapkannya suatu Protokol tentang Keamanan
Hayati

Tahun 2004 melalui UU No. 21 Tahun 2004 telah

diratifikasi Protokol Cartagena

Berlaku bagi perpindahan lintas batas,

persinggahan, penanganan dan pemanfaatan
semua organisme hasil modifikasi genetik
(Djohor 2016)
 MENERIMA

PENDEKATAN
KEHATI-HATIAN

(Djohor 2016)
KEBIJAKAN PEMANFAATAN PRODUK
REKAYASA GENETIK (PRG)
Pemanfaatan PRG memberi peluang untuk
menunjang produksi pertanian, ketahanan
pangan dan peningkatan kualitas hidup
manusia.
Pemanfaatan bioteknologi harus dapat dijamin
tidak menimbulkan dampak negatif terhadap
lingkungan hidup, kesehatan manusia
dan/atau kesehatan hewan

(Djohor 2016)
 Peraturan
Pemohon Pemerintah RI No
FUT, LUT 21 Tahun 2005

Menteri yang
Tim Penilai dan berwenang/Kepala
Pelepas Varietas
LPND Menteri
Lingkungan
Hidup
Pelepasan KKHKP (= KKH)

BKKH
TTKHKP (= TTKH)

FUT LUT
 TIM TEKNIS KEAMANAN HAYATI PRG
(TTKH PRG)
TTKH PRG dibentuk berdasarkan Surat Keputusan Ketua
KKH PRG Nomor 01/KKHPRG/11/2011 tanggal 4 November
2011.
TTKH PRG bertugas melakukan pengkajian dokumen
teknis,uji lanjutan keamanan hayati dan evaluasi atas
permohonan pengujian PRG di laboratorium, Fasilitas Uji
Terbatas (FUT) atau Lapangan Uji Terbatas (LUT).
TTKH PRG terdiri atas :
TTKH PRG bidang lingkungan berkedudukan di
Kementerian Lingkungan Hidup;
TTKH PRG bidang pangan berkedudukan di Badan
POM;
TTKH PRG bidang pakan berkedudukan di Kementerian
Pertanian.
(Djohor 2016)
ANALISIS RISIKO LINGKUNGAN PRG
Pasal 47 UU 32/2009 : Setiap usaha dan/atau
kegiatan yang berpotensi menimbulkan dampak
penting terhadap lingkungan hidup, ancaman
terhadap ekosistem dan kehidupan, dan/atau
kesehatan dan keselamatan manusia wajib
melakukan analisis risiko lingkungan hidup
➔ termasuk pelepasan dan peredaran PRG
Analisis Risiko Lingkungan meliputi: analisis
risiko, pengelolaan risiko, dan komunikasi risiko

(Djohor 2016)
 Tim Pengkajian Hukum, Sosial Budaya,
Ekonomi Produk Rekayasa Genetik
(TIM PHSBE – PRG)

• Tim PHSBE dibentuk berdasarkan SK

Nomor: 02/KKH PRG/01/2012 tanggal 14
Januari 2012.
• TIM PHSBE – PRG bertugas untuk
membantu KKH PRG dalam memberikan
pertimbangan hukum, sosial budaya dan
ekonomi untuk kelayakan pemanfaatan
Produk Rekayasa Genetik
(Djohor 2016)
 Prosedur Sertifikasi PRG

1 Pengujian
PRG di Lab, 2 Pengkajian
Keamanan 3 Peredaran/
Pelepasan
FUT, LUT Hayati PRG

(Djohor 2016)
 Bagaimana PRG dikaji
keamanannya?

▪ Kajian keamanan pangan

▪ Kajian keamanan pakan
▪ Kajian keamanan lingkungan

Plus etika, agama, dan

sosio-ekonomi

HANYA YG LOLOS PENGKAJIAN YANG DIBERI IZIN EDAR

(Djohor 2016)
PRG yang telah mendapatkan
sertifikat Keamanan Hayati

Keamanan Pangan: 18 PRG

Keamanan Pakan : 3 PRG

Keamanan Lingkungan : 5 PRG (2

tanaman PRG + 3 Vaksin Hewan PRG)

(Djohor 2016)
 Komersialisasi
• Tim Pengawas Tanaman Produk Rekayasa
Genetik Pertanian (SK Kepala Badan
Penelitian dan Pengembangan Pertanian No
145 Tahun 2021)
• Tugas utama: pengawasan, melakukan
kajian adanya laporan dampak negative,
dan menyusun hasil kajian
 The development and
deployment of a GM crop
move through different
stages General
release

Full safety
assessment

Confined
Field Trials
Growth
Chamber or Safety Regulation
greenhouse
is Adapted to Each
Lab
Level
 Confined Field Trials
Prevent Gene Flow Genes in Pollen Environment
I
S
O
L
A
T
Seed I
O
N

C
O
Prevent Eating N
F
I Eaten by
Plant
N • Livestock
Parts
E
M
• Humans
E
N
T

Prevent Persistence Environment

M
O
N
I
T
O
R
I
Volunteers N
G
GENETIC ISOLATION FOR MAIZE

• Destroy before flowering, or

Detassel, tassel bag, or distance

200m

200m
Regulated 200m
Maize
Trial

200m
Alternative Methods -- Maize
 Gene flow in Maize
8

7
Percent Outcrossing

6
5

4
3

2
1
0
6 9 11 14 17
Distance ((m)
 Isolation Distances for Some Crop
Species
Crop OECD Malawi Zambia Can/US
Species
Maize 200m 200m 200m 200m
Sorghum 200m 200m
Groundnut 5m 10m
Cotton 200m 100m 300m 200m
Pearl Millet 200m 200m
Cowpea 5m 5m
Wheat 50m 30m/10m
• How do we Prevent Eating?

– Material Confinement
Plant material produced at site
– Storage, labeling,
packaging, transport,
disposal
Crop Destruction
Looking for Volunteer Corn the 2nd Year over 45 Acres
Ethics in Biotechnology

Y. Andi Trisyono
Department of Crop Protection
Faculty of Agriculture, GMU
 GM Products: Benefits and Controversies
(Sakarindr Bhumiratana [2005], The Ethical Use of GMOs)
Benefits
Crops
Enhanced taste and quality
Reduced maturation time
Increased nutrients, yields, and stress tolerance
Improved resistance to disease, pests, and
herbicides
New products and growing techniques
Animals
Increased resistance, productivity, hardiness, and
feed efficiency
Better yields of meat, eggs, and milk
Environment
"Friendly" bioherbicides and bioinsecticides
Conservation of soil, water, and energy
Better natural waste management
Society
Increased food security for growing populations
Controversies
Safety
Potential human health impact: allergens, transfer of
antibiotic resistance markers, unknown effects.
Potential environmental impact: unintended transfer
of transgenes through cross-pollination, unknown
effects on other organisms (e.g., soil microbes),
and loss of flora and fauna biodiversity
Access and Intellectual Property
Domination of world food production by a few
companies
Biopiracy—foreign exploitation of natural resources
Ethics
Violation of natural organisms' intrinsic values
Tampering with nature by mixing genes among
species
Labeling
Not mandatory in some countries
Society
New advances may be skewed to interests of rich
countries
 Agenda
• Definition of ethics and bioethics
• Opportunities and making decisions
• Example: Issues related with biotech
food
• Communications
 13.1 What Is Ethics?

• Ethics identifies a code of values for our

actions
• Bioethics – area of ethics that deals with
the implications of biological research and
biotechnological applications on humanity,
especially regarding medicine
– Ask "Should this be done?" not "Can this be
done?"

(Source: Lisa Werner, Ethics and Biotechnology)

© 2013 Pearson Education, Inc.
 13.1 What Is Ethics?

• Approaches to Ethical Decision Making

– Two main viewpoints
• Utilitarian approach – states that something is
good if it is useful, and an action is moral if it
produces the "greatest good for the greatest
number"
• Deontological approach (Kantian approach or
duty ethics) – focuses on certain imperatives, or
absolute principles, which we should follow out of a
sense of duty and which should dictate our actions

(Source: Lisa Werner, Ethics and Biotechnology)

© 2013 Pearson Education, Inc.
 13.1 What Is Ethics?

• Modern Bioethics
– Primarily the work of two ethicists in the 1970s
• Joseph Fletcher refined utilitarian or "situational
ethics"
• Paul Ramsey refined deontology or "objectivism"

(Source: Lisa Werner, Ethics and Biotechnology)

© 2013 Pearson Education, Inc.
 13.1 What Is Ethics?

• Utilitarianism
– Emphasizes consequences, not intentions
– Analyze possible consequences to determine
course of action which will have the greatest
positive effect
– Disadvantages:
• Must assign a value to what is being considered
– Love and family not easily quantified
– Quantifiable things, such as material goods and life span
could be emphasized
• Who does the calculating and assigns the values?
(Source: Lisa Werner, Ethics and Biotechnology)
© 2013 Pearson Education, Inc.
 13.1 What Is Ethics?

• Deontology (objectivism)
– There are some absolutes – definitive rules
that cannot be broken
– Deeply held convictions (may or may not be
religious)
– Advantage: firm guidelines, clear cut ethical
formula for decision making
– Disadvantage: rigid, may not take important
factors into account, or changes in values

(Source: Lisa Werner, Ethics and Biotechnology)

© 2013 Pearson Education, Inc.
 13.1 What Is Ethics?

• There can be other approaches or blending

of the two main approaches
• Key objective is to gather information,
consider the facts, and make a thoughtful,
informed decision
• When debating contentious ethical issues,
respect and consider other viewpoints

(Source: Lisa Werner, Ethics and Biotechnology)

© 2013 Pearson Education, Inc.
 Food Biotech Public Issues
• Food Safety
• Labeling
• Intellectual property
• Environment
 Biotechnology and Food

Personal Choices & Public Policies

Thomas M. Zinnen
Biotechnology Policy & Outreach Specialist
University of Wisconsin-Madison/Extension
The Challenge of Perception is
the Potential for The Feeling
of Deception
• How Consumers Think New Foods Are
Developed, Tested and Regulated
• How New Foods Are Actually
Developed, Tested and Regulated
 The Consumer Sovereignty
Argument:
• The consumer has a right to know what
goes in the consumer’s body.
• WWW2NO: Whatever We Want to
Know
Need to:
3. Communication
▪ increase public understanding of the science
behind GMOs debate
▪ develop tools for public communication and
promoting the public understanding of this and
related issues
▪ not just one-way communication but should
encourage dialogue between all participants
(Sakarindr Bhumiratana [2005], The Ethical Use of GMOs)
Need to:
3. Communication (cont’d)

▪ two-way flow of understanding

between scientists and the
public is also required

▪ make sure all stakeholder

voice are heard
(Sakarindr Bhumiratana [2005],
The Ethical Use of GMOs)