pengantar biotek pertanian 2011-biosafety
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KEAMANAN, PENGATURAN, DAN HAKI
ORGANISME TEREKAYASA SECARA
GENETIK
BIOSAFETY, REGULATION AND
INTELECTUAL PROPERTY RIGT OF GMO
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
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
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.
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
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
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
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
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?
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
Genetic engineering – Are there negatives??
Crop failure Allergies
Antibiotic
resistant
bacteria
Gene
pollution
No long
term
testing
Unknown
side
effectsToxins
bacteria
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
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
• 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
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
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
• 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
Keamanan kerja Bioteknologi
• Keamanan bagi peneliti / pekerja
• Keamanan bagi bahan / alat penelitian
• Keamanan bagi organisme yang digunakan /
dihasilkandihasilkan
• Keamanan lingkungan
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
● 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
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
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
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)
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.
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
"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.
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
• 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.
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.
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.
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)
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
Pedoman Pelaksanaan Pengujian Keamanan
Hayati Produk Bioteknologi Pertanian Hasil
Rekayasa Genetik
• Seri Hewan
• Seri Ikan
• Seri Jasad Renik
• Seri Tanaman
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
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
• 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
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”
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
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 ….???
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
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