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KEAMANAN, PENGATURAN, DAN HAKI ORGANISME TEREKAYASA SECARA GENETIK BIOSAFETY, REGULATION AND INTELECTUAL PROPERTY RIGT OF GMO

Pengantar Biotek Pertanian 2011-Biosafety

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Page 1: Pengantar Biotek Pertanian 2011-Biosafety

KEAMANAN, PENGATURAN, DAN HAKI

ORGANISME TEREKAYASA SECARA

GENETIK

BIOSAFETY, REGULATION AND

INTELECTUAL PROPERTY RIGT OF GMO

Page 2: Pengantar Biotek Pertanian 2011-Biosafety

What is Biotechnology?

• “Biotechnology is essentially the use of living organisms (often minute micro-organisms) and their products for health, social or economic purposes.”

It is considered to be the growth technology It is considered to be the growth technology of the 21st century.

• The global perception of life, economic possibilities, environmental impacts and social concerns have been changing through the development of biotechnology

Page 3: Pengantar Biotek Pertanian 2011-Biosafety

What is Biosafety?

• Biosafety : the “development and implementation of administrative work practices, facility design and safety equipment to prevent the transmission of biologic agents to workers, other persons or the environment.”

• Biosafety : one term to describe the policies and • Biosafety : one term to describe the policies and procedures adopted to ensure the environmentally safe application of modern biotechnology

• Biosafety : Policies and procedures adapted to ensure the environmentally safe application of biotechnology

Page 4: Pengantar Biotek Pertanian 2011-Biosafety

What is Biosecurity?

Security measures to protect the release of

high consequence microbial agents, biological

pathogens, toxins, critical information, pests

or diseases as a result of Biotechnology.or diseases as a result of Biotechnology.

Page 5: Pengantar Biotek Pertanian 2011-Biosafety

Biotechnology in Medical Study• Using Molecular Biology techniques an insulin

– producing gene was inserted into bacteria. (1970’s). The bacteria then could produce human insulin

• Medical biotechnology has been developed to solve many

• Medical biotechnology has been developed to solve many health problems

Antisense RNA

Therapy for HIV

Page 6: Pengantar Biotek Pertanian 2011-Biosafety

Biotechnology in Animal Agriculture

• 1997 - First cloned sheep

• Dolly was produced by a technique called

somatic cell nuclear transfer. DNA from the

nucleus of a cell from the body is put into nucleus of a cell from the body is put into

another sheep’s egg which had the nucleus

removed. Then implanted.

• Since Dolly, mice, goats cows and other

mammals have been cloned

Page 7: Pengantar Biotek Pertanian 2011-Biosafety

Biotechnology in Plant Agriculture• Transgenic plants were first created in the early 1980s

by four groups working independently at Washington University in St. Louis, Missouri, the Rijksuniversiteit in Ghent, Belgium, Monsanto Company in St. Louis, Missouri, and the University of Wisconsin.

• On the same day in January 1983, the first three groups announced at a conference in Miami, Florida, that they had inserted bacterial genes into plants. announced at a conference in Miami, Florida, that they had inserted bacterial genes into plants.

• The fourth group announced at a conference in Los Angeles, California, in April 1983 that they had inserted a plant gene from one species into another species

• Many other transgenic plants have been developed and distributed to solve many food production problems

Page 8: Pengantar Biotek Pertanian 2011-Biosafety

Current and potential benefits of gene technology

Medicine :

• Delivering vaccines

• Gene therapy

Agriculture:

• Resistance to insects or viruses – reduced need for insecticidesinsecticides

• Tolerance to herbicides

• Reduced need for irrigation

• Resistance to frost (tomatoes), salinity

Bioremediation

� bacteria that consume e.g spilled oil

Page 9: Pengantar Biotek Pertanian 2011-Biosafety

Genetic Engineering

• Has the potential to improve human health,

nutrition through the agriculture and comfort

• but…….

• It carries social, ethical and environmental • It carries social, ethical and environmental

risks, many of which may be presently

unforeseen

• How can we manage such a huge and

complex issue?

Page 10: Pengantar Biotek Pertanian 2011-Biosafety

Some Questions ????

• Will the use of recombinant DNA (R-DNA)

create new pests

• Can R-DNA accidently convert non-pathogens

to pathogensto pathogens

• Can introduced gene spread into microbial

population

• Please add more questions

Page 11: Pengantar Biotek Pertanian 2011-Biosafety

Genetic engineering – Are there negatives??

Crop failure Allergies

Antibiotic

resistant

bacteria

Gene

pollution

No long

term

testing

Unknown

side

effectsToxins

bacteria

Page 12: Pengantar Biotek Pertanian 2011-Biosafety

GMO

• Genetically Modified Organism

• An organism whose genetic characteristics have been altered by the characteristics have been altered by the insertion of a modified gene or a gene from another organism using the techniques of genetic engineering

Page 13: Pengantar Biotek Pertanian 2011-Biosafety

The need for

Institutional Biosafety Committees (IBC)

Roles of the IBC

• Direct contact with the Office of the Gene Technology regulator (OGTR). Legal obligations.obligations.

• Facility inspections and compliance responsibilities

• Biosafety manual – regularly updated

Page 14: Pengantar Biotek Pertanian 2011-Biosafety

• UN-Industrial Development Organization

(UNIDO) meeting in 1991 attended by

developed and developing countries

• Development of CODE of conduct on the safe • Development of CODE of conduct on the safe

handling, use and release of GMO into the

environment

• Development of Biosafety Guidelines

Page 15: Pengantar Biotek Pertanian 2011-Biosafety

Requests

• To conduct T-DNA research including in

developing countries

• Guidance for both investigators and regulators

in evaluating risks associated with in evaluating risks associated with

biotechnology

• Establishment of National Biosafety System to

provide appropriate regulatory mechanism

related to biotechnology

Page 16: Pengantar Biotek Pertanian 2011-Biosafety

National Policy for the regulation of

R-DNA needs

• Biosafety Committees that form the

regulatory authorities

• A set of biosafety legislation, regulations and

guidelines to be followedguidelines to be followed

• Availability of funds and appropriate scientific

and technical expertise for risk assessment

analysis and modeling

• Coordination with international organizations

Page 17: Pengantar Biotek Pertanian 2011-Biosafety

• Mechanism to gather information on local

agronomic and environmental condition

• System to monitor the developments in

biotechnology that could affect the health of biotechnology that could affect the health of

workers and safety

• Confidence in decision making expertise

• System for the provision of information to and

education of the public

Page 18: Pengantar Biotek Pertanian 2011-Biosafety

Keamanan kerja Bioteknologi

• Keamanan bagi peneliti / pekerja

• Keamanan bagi bahan / alat penelitian

• Keamanan bagi organisme yang digunakan /

dihasilkandihasilkan

• Keamanan lingkungan

Page 19: Pengantar Biotek Pertanian 2011-Biosafety

Keamanan bagi peneliti / pekerja

• Di laboratorium Bioteknologi banyak digunakan bahan / bahan

yang bersifat merusak jaringan atau yang menyebabkan mutasi

gen misalnya :

- phenol menyebabkan iritasi kulit

- chloroform menyebabkan iritasi mata dan pernafasan

- ethidium bromid menyebabkan kanker

- bahan-bahan radio aktif menyebabkan kanker dsb.

• Peneliti / pekerja lab harus mengenali bahaya bahan-bahan

tersebut sehingga tidak menimbulkan gangguan kesehatannya

dengan menggunakan pelindung ketika menggunakannya,

menjaga jangan sampai berceceran dan mengatur

pembuangannya dengan aman

Page 20: Pengantar Biotek Pertanian 2011-Biosafety

● Alat-alat tertentu menghasilkan gelombang atau

cahaya yang bersifat merusaka misalnya :

- UV transiluminator atau lampu UV tabung

menghasilkan sinar yang dapat menyebabkan

kerusakan kulit, kebutaan mata, kemandulan organ

reproduksi

- di ruang isotop terdapat alat dan bahan untuk- di ruang isotop terdapat alat dan bahan untuk

radiasi sinar gelombang pendek lainnya, bahan

yang bersifat radioaktif dsb yang dapat menyebab

kerusakan jaringan dan organ tubuh

● Penggunaan alat dan bahan tersebut harus

ditempatkan di lokasi khusus sehingga aman dari

kecelakaan kerja

Page 21: Pengantar Biotek Pertanian 2011-Biosafety

Keamanan dari alat / bahan penelitian

• Bahan dan alat untuk penelitian Bioteknologi banyak yang

sensitif terhadap suhu dan perubahan suhu udara, sensitif

terhadap cahaya, sensitif terhadap bahan kimia tertentu,

misalnya

- ensim-ensim akan rusak dan inaktif bila tidak disimpan pada

suhu dingin pada kisaran tertentusuhu dingin pada kisaran tertentu

- antibiotik akan rusak bila tercemar oleh kuman yang tahan

atau terekspose pada suhu yang tinggi atau perubahan suhu

yang tiba-tiba

- Pipet mikroliter akan rusak apabila dipaksakan untuk

menghisap volume bahan di luar kisaran yang tertera

- Dsb

Page 22: Pengantar Biotek Pertanian 2011-Biosafety

Keamanan bagi organism yang digunakan

• Dalam penelitian bioteknologi digunakan beberapa

mikroorganisme seperti beberapa macam / strain bakteri

(E. coli, Bacillus dsb), jamur (yeast, actinomyces dsb), virus

(Bacteriophage, CMV dsb.)

• Masing-masing spesies atau strain membutuhkan kondisi

tertentu untuk menumbuhkannya atau menjaga tertentu untuk menumbuhkannya atau menjaga

viabilitasnya sehingga harus diterapkan dengan benar

• Masing-masing spesies atau strain mempunyai bahaya

tertentu apabila lepas ke lingkungan atau mampu

menginfeksi manusia / hewan disekelilingnya sehingga

harus hati-hati dalam menanganinya

Page 23: Pengantar Biotek Pertanian 2011-Biosafety

Kemanan lingkungan

• Pembuangan bahan-bahan sisa penelitian bioteknologi

seperti gel-gel yang mengandung ethidium bromida, bahan

radioaktif atau mutagen lainnya harus secara bijaksana

karena apabila bahan tersebut masih aktif dan mencemari

lingkungan (misalnya tanah dan air) kemungkinan dapat

menyebabkan mutasi pada mikrobiota tanah/air. Mutasi

tersebut dapat menimbulkan dampak yang membahayakan tersebut dapat menimbulkan dampak yang membahayakan

kesehatan tanaman, hewan maupun manusia

• Penangannya untuk bahan-bahan tersebut dimungkinkan

untuk bekerja sama dengan dinas terkait. Penangan bahan

radioaktif harus dengan instalasi khusus atau bekerjasama

dengan lembaga khusus (misalnya Batan)

Page 24: Pengantar Biotek Pertanian 2011-Biosafety

GMO dan keamanan hayati

• GMO adalah genetic modified organism, yaitu

organisme yang sifat-sifat genetiknya telah

direkayasa dengan maksud untuk meningkatkan

kemanfaatannya bagi kesejahteraan umat manusia

• Pelepasan GMO masih terus menjadi perdebatan

karena kekhawatiran-kekhawatiran terhadap dampak karena kekhawatiran-kekhawatiran terhadap dampak

negatifnya baik dampak negatif bagi sekelompok

manusia yang tidak tahan dengan produk-produk

GMO maupun dampak terhadap keragaman hayati

dan kelestarian lingkungan khususnya lingkungan

biota.

Page 25: Pengantar Biotek Pertanian 2011-Biosafety

Kekhawatiran tersebut anatara lain adalah :

• Sifat sensitifitas / resistensi terhadap anibiotik yang sering

digunakan sebagai gen penanda (marker) dalam proses

transformasi gen

• Berpidahnya / meluasnya perpindahan gen dari GMO

kepada organisme-organisme lain di lingkungan secara tak

terdeteksi / tak terkendali sehingg menimbulkan ketidak

seimbangan populasi organisme tertentuseimbangan populasi organisme tertentu

• Menyebabkan reaksi alergi pada konsumen / non

konsumen yang secara sengaja atau tidak mengkonsumsi

produk GMO

• Punahnya plasma nutfah organisme tertentu karena

terdesak oleh penggunaan, penyebaran dan pemasaran

GMO

Page 26: Pengantar Biotek Pertanian 2011-Biosafety

"Terminator" Genes

• To make them produce sterile seeds (and thus force the farmer to buy fresh seeds for the following season rather than saving seeds from the current crop).

• The process involves introducing three transgenes into the plant:

• A gene encoding a toxin which is lethal to developing seeds but not to mature seeds or the plant. This gene is normally inactive because of a stretch of DNA inserted between it and its promoter

• A gene encoding a recombinase — an enzyme that can remove the • A gene encoding a recombinase — an enzyme that can remove the spacer in the toxin gene thus allowing to be expressed.

• A repressor gene whose protein product binds to the promoter of the recombinase thus keeping it inactive.

Page 27: Pengantar Biotek Pertanian 2011-Biosafety

How they work

• When the seeds are soaked (before their sale) in a solution of tetracycline, synthesis of the repressor is blocked

• the recombinase gene becomes active

• the spacer is removed from the toxin gene and it can now be turned on. be turned on.

• Because the toxin does not harm the growing plant — only its developing seeds — the crop can be grown normally except that its seeds are sterile

Page 28: Pengantar Biotek Pertanian 2011-Biosafety

• The use of terminator genes has created much

controversy:

• Farmers — especially those in developing

countries — want to be able to save some countries — want to be able to save some

seed from their crop to plant the next season.

• Seed companies want to be able to keep

selling seed.

Page 29: Pengantar Biotek Pertanian 2011-Biosafety

Peraturan dan perundang-undangan pembuatan,

pelepasan dan penggunaan GMO

• Diatur oleh peraturan internasional misalnya

Kesepakan Cartagena yaitu hasil kesepakatan

bersama berbagai negara untuk membuat peraturan

yang harus ditaati oleh semua pihak dengan sanksi-

sanksi pelangarannya terhadap pelepasan, sanksi pelangarannya terhadap pelepasan,

pengiriman, dan penggunaan GMO

• Diatur pula dengan peraturan nasional di masing-

masing negara untuk melindungi keamanan,

kesehatan masyarakat luas maupun kelestarian dan

keamanan lingkungan di negara tersebut.

Page 30: Pengantar Biotek Pertanian 2011-Biosafety

Protokol Cartagena

• Adalah kesepakatan antara berbagai pihak yang mengatur

tatacara gerakan lintas batas negara secara sengaja (termasuk

penangananan dan pemanfaatan) suatu organisme hidup

yang dihasilkan oleh bioteknologi modern (OHMG) dari suatu

ke negara lain oleh seseorang atu badan

• Bertujuan untuk menjamin tingkat proteksi yang memadai • Bertujuan untuk menjamin tingkat proteksi yang memadai

dalam hal persinggahan (transit), penanganan, dan

pemanfaatan yang aman dari pergerakan lintas batas OHMG.

• Tingkat proteksi dilakukan untuk menghindari pengaruh

merugikan terhadap kelestarian dan pemanfaatan

berkelanjutan keanekaragaman hayati, serta resiko terhadap

kesehatan manusia.

Page 31: Pengantar Biotek Pertanian 2011-Biosafety

BKKHI• Balai Kliring Keamanan Hayati Indonesia (Biosafety Clearing

House of Indonesia)

• Pelaksanaan mandat Protokol Cartagena tentang Keamanan

Hayati

• Peraturan Presiden Nomor 39 Tahun 2010 tentang Komisi

Keamanan Hayati Produk Rekayasa Genetik

PP No. 21 tahun 2005 Tentang Keamanan Hayati Produk PP No. 21 tahun 2005 Tentang Keamanan Hayati Produk

Rekayasa Genetik

• UU No. 21 tahun 2004 Tentang Ratifikasi Protokol Cartagena

• Keputusan Bersama Empat Menteri Tentang Keamanan Hayati

dan Keamanan Pangan Produk Pertanian Hasil Rekayasa

Genetik (1999)

Page 32: Pengantar Biotek Pertanian 2011-Biosafety

Departemen Lingkungan Hidup RI

• Mempunyai aturan yang relatif serupa dengan yang diberlakukan di USA

• Menteri Pertanian dan lembaga lain yang terkait membuat aturan untuk pembuatan, terkait membuat aturan untuk pembuatan, pelepasan dan penggunaan GMO yang kemudian diterbitkan sebagai SK Menteri Pertanian Nomor 856/Kpts/HK.330/9/1997 tentang Ketentuan Keamanan Hayati Produk Bioteknologi Pertanian Hasil Rekayasa Genetik

Page 33: Pengantar Biotek Pertanian 2011-Biosafety

Pedoman Pelaksanaan Pengujian Keamanan

Hayati Produk Bioteknologi Pertanian Hasil

Rekayasa Genetik

• Seri Hewan

• Seri Ikan

• Seri Jasad Renik

• Seri Tanaman

Page 34: Pengantar Biotek Pertanian 2011-Biosafety

Intellectual Property Rights (IPRs)

/ Hak Pekayaan Intektual

• Diadakan untuk melindungi hasil pemikiran

atau tindakan yang menghasilkan manfaat

dengan nilai ekonomi atau nilai ilmiah bagi

seseorang atau kelompok orang yang seseorang atau kelompok orang yang

mencetuskan ide serta merealisasikan idenya

dalam bentuk suatu produk

Page 35: Pengantar Biotek Pertanian 2011-Biosafety

IPRs in Agriculture Biotechnology

• For example, patents and plant variety protection

certificates—are frequently used to protect technological

advances

• These rights allow their owners to exclude competitors

from "making, using, offering for sale, or selling" an from "making, using, offering for sale, or selling" an

invention for a limited period of time.

• As the peace of scientific discovery in agricultural

biotecnology has accelerated over the past few decades,

the use of patents and other intellectual property rights to

protect these discoveries has increased tremendously

Page 36: Pengantar Biotek Pertanian 2011-Biosafety

• Intellectual property rights are a complex,

multifaceted area and one in which corporate

strategies are very poorly understood.

• Fundamentally, IPRs are essential for the • Fundamentally, IPRs are essential for the

incentive to create easily copied products

Page 37: Pengantar Biotek Pertanian 2011-Biosafety

Intellectual Property Rights Proliferation:

The Downside

• Biotechnology patents are the strongest

incentive to research when there are no

prior intellectual property claims on the

research results.research results.

• Second round:

– Reduced “free ride” on prior research

– Proliferation of competing claims:

“Tragedy of Anticommons”

Page 38: Pengantar Biotek Pertanian 2011-Biosafety

Patenting of Agricultural Biotechnology

• Crucial rulings

– Living organisms: Diamond v. Chakrabarty (1980)

– Plants: ex parte Hibberd (1985)

• Protects • Protects

– Breeding technology: genes, markers, methods,

seeds

– Hybrid parent varieties

• Made enforceable by concurrent biotechnology

Page 39: Pengantar Biotek Pertanian 2011-Biosafety

Holdup Examples

• University of California: long shelf-life tomato

• Michigan State University: transgenic turfgrassturfgrass

• CLIMA (Australia): herbicide tolerant lupin

• University of California: herbicide tolerant barley

• UGM ….???

Page 40: Pengantar Biotek Pertanian 2011-Biosafety

Arms-Length Licensing as Means of

IPR Transfer

• Some successes

• Many failures

• High transaction costs

• High uncertainty:• High uncertainty:

– Who owns what?

– Will patent remain valid?

• Holdup problem