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 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 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.

Biotechnology in Medical Study

Using Molecular Biology techniques an insulin producing gene was inserted into bacteria. (1970s). The bacteria then could produce human insulin 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 another sheeps 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. 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 insecticides 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 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 pathogens Can introduced gene spread into microbial population Please add more questions

Genetic engineering Are there negatives??

Unknown side effects Crop failure Allergies No long term testing

Gene pollution Antibiotic resistant bacteria

Toxins

GMO
Genetically Modified Organism An organism whose genetic 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. 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 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 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 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 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 / dihasilkan 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 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 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 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 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 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 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 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. 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 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 sanksisanksi pelangarannya terhadap pelepasan, pengiriman, dan penggunaan GMO Diatur pula dengan peraturan nasional di masingmasing 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 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 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, 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 mencetuskan ide serta merealisasikan idenya dalam bentuk suatu produk

IPRs in Agriculture Biotechnology

For example, patents and plant variety protection certificatesare frequently used to protect technological advances These rights allow their owners to exclude competitors 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 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. 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 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 turfgrass 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:
Who owns what? Will patent remain valid?

Holdup problem