Plant n Tissue Culture

ASSIGNMENT 1

“THE FACT AND FUTURE TREND OF

PLANT BIOTECHNOLOGY IN MALAYSIA”

PRINCIPLES OF CELL

AND TISSUE CULTURE

(BBD 1234)

Azizi Bin Ahmad (3123006961)

AZIZI BIN AHMAD <3123006961> (4/13/34)PRINCIPLES OF CELL AND TISSUE CULTURe (BBD 1234) – MISS EMI FAZLINA DIPLOMA IN BIOTECHNOLOGY INDUSTRY (3/12/34)

Introduction

Biotechnology has been referred to as the technology of the 21st century. It has been claimed by Bill Gates to be the most important technology after information technology (IT). Strong support has been given by the Malaysian government for the development of biotechnology in this country. The establishment of the National Biotechnology and Biodiversity Policy, the Malaysian Biosafety Guidelines and the attractive biotechnology incentives given to new biotechnology companies are many of the efforts put in by the government to encourage biotechnology development in the country. The government launched the Malaysian Biotechnology Policy in 2004, where biotechnology is envisioned as the engine of growth for knowledge-based economy in the country. The policy provides a conducive environment for R&D and industry growth through leveraging on country’s existing strength and capabilities. The government’s emphasis on the agriculture sector is seen in the Biotechnology Policy where it is placed as the first thrust of the policy. The Malaysian National Agriculture Policy 3 (NAP3) and action plans have outlined important elements for agriculture transformation by the utilization of high technologies including biotechnology. The main goal is to enhance food security and wealth creation through increased food production. Modern biotechnology is currently being applied for its potential to produce crops with higher yield, resistant to pests, disease and adverse conditions as well as improved quality. The establishment of the National Biotechnology Directorate in 1995 and now called BIOTEK has enabled coordination of various areas of biotechnology research and development, capacity building in cutting edge biotechnology and establishment of effective linkages with biotechnology institutes from advanced countries.


Agricultural Biotechnology

Historically, Malaysia has been actively pursuing agricultural research through a number of world recognized research institutes to promote higher and better quality yield of rubber, oil palm and agricultural commodities. The establishment of economic crops germplasm in the early part of the 1950s and its subsequent use of these materials in selective hybridization followed by rigorous selection protocols have resulted in plantations of high quality rubber and oil palm plantations, thereby contributing significantly to the Malaysian economy. The local orchid industry was the first to make extensive use of tissue culture to mass-produce orchid hybrids for the world market. The past decade has seen this form of agricultural biotechnology been exploited to mass-produce clonal materials of oil palm, bananas and ornamentals for consistent quality production of edible oils, fruits and essential oils for the perfume industry. Under the Industrial Master Plan in the 1970s, national emphasis was shifted from one based on agriculture to an industrial base involving electronics and computer chips for mass export.

Malaysia excels in plantation technology and has accumulated a phenomenalamount of information on the biology, breeding and management of crops such as rubber, oil palm, coconuts, cocoa, pepper and rice. Using this information, biotechnology applications such as genetic engineering, functional genomics and proteomics could be utilized to improve not only the productivity of plants and livestock but also to discover niche areas for increased agro-biotechnology products for use in healthcare and industrial biotechnologies. Towards this effort, the National Institute of Agrobiotechnology at MARDI has been selected to serve as the center of excellence for agro-biotechnology R&D, commercialization and diffusion. At this stage, it may be pertinent to mention that the recent concluded international exhibition held in November 2006 to showcase the country’s agricultural business and products under the auspices of Malaysia’s Agriculture, Horticulture and Agro-tourism (MAHA) was highly popular and had to be extended an additional day to accommodate the thousands who flocked to view the exhibits and to listen to talks

Although Malaysia may be viewed as an infant as far as biotechnology and/or recombinant DNA technology is concerned, it has the potential to develop biotechnology-enhanced products from its vast natural resources to be found in the tropical rainforest for use in human and animal healthcare, increased food production, environmental sustainability and monitoring. Owing to its rich flora and fauna with approximately 15,000 species of flowering plants, 150,000 species of invertebrates, 4000 marine fish species, numerous species of butterflies and moths, and many other life forms in its equally diverse ecosystems, Malaysia has the formidable reputation as one of the 12 major centers of mega biodiversity of the world. In spite of this natural advantage, Malaysia is still highly dependent on fixed direct investments and technology transfer from developed nations of the world in specific areas of advanced genetics and cell biology such as genomics, proteomics and bioinformatics.


Development of Biotech Crops

The activities in plant biotechnology started in Malaysia around 20 years ago in the area of plant tissue culture. The main research focus at that time was in its vast application in plant breeding and in production of elite planting materials. Tissue culture of crops like banana, pineapple, papaya, orchids and another culture of rice were actively pursued then. Tissue culture of banana and orchids have been commercialized and adopted by growers. Plant biotechnology has proven to create new opportunities for the advancement of the agriculture industry worldwide. With the advent of modern biotechnology, including molecular techniques and recombinant DNA, local research organizations began to incorporate the new approaches as early as the mid-eighties. The potential of overcoming constraints faced by the conventional breeding techniques has made modern biotechnology an attractive alternative to produce the new crop varieties constantly needed by growers.

Realizing this, the Malaysian government gave due prominence to this technology to enhance food security and wealth through the development of crop varieties and livestock with higher yielding capacity, the production of goods with higher value and quality by the innovation in processing of natural resources and the generation of value added agriculture products.

Under the Ninth Malaysian Plan (2006–2010), to increase value of the agriculture sector, greater efforts will be undertaken to enhance national capability in agro-biotechnology. New technologies suchas bioinformatics, genetic engineering, functional genomics and proteomics will find new applications in the agricultures sector. Applications of biotechnology platform technologies, such as genetic engineering, functional genomics and proteomics will be encouraged to produce agro-biotechnology products that increase plant and livestock productivity as well as improve their agronomic traits. Other agro-biotechnology activities that will be promoted include biopharming, which is the use of transgenic plants and livestock to produce high value proteins.


Various research institutions carry out research on agricultural commodities, namely oil palm by Malaysian Palm Oil Board (MPOB), rubber by Malaysia Rubber Board (MRB), cocoa by Malaysian Cocoa Board (MCB), rice, fruits, vegetables and other crops by Malaysian Agricultural Research and Development Institute (MARDI). The universities complement the research carried out in these research institutes. To enhance the productivity of these important crops, research on biotechnology, particularly plant biotechnology was emphasized and became an integral program that encompassed areas such as genetic engineering for plant improvement, molecular marker technology, plant cell culture/bioreactor system, and in vitro technology.

Plant biotechnology R&D is conducted mainly at MARDI where emphasis is placed on benefiting agriculture by addressing problems that cannot be achieved through conventional breeding. Besides this, the advancement in biotechnology today has also geared the institute

up to harness these potentials in producing novel traits in food crops.

The research is to complement the existing active breeding program on local crops in MARDI. The crops that are being addressed and the targeted traits are as follows:

1. Papaya for resistance to papaya ring spot virus (PRSV)

2. Papaya for delayed fruit ripening

3. Papaya for delayed fruit softening

4. Pineapple for resistance to fruit black heart

5. Pomelo for improved fruit colour

6. Orchid for increased flower shelf life and resistance to viruses

7. Passion fruit for resistance to viruses

8. Chili for resistance to viruses

9. Tomato for improved fruit colour

10. Rice for enhanced yield


11. Rice for resistance to shealth blight disease

The various priority areas of plant biotechnology research by various universities and research institutes are focussed on the following crops/plants:

• Oil palm: Clonal propagation of planting material, oil quality

• Rubber: Disease resistance, yield, production of high value products

• Rice: Disease resistance, yield

• Ornamentals: Flower shelf-life, flower colour, disease resistance

• Fruits: Shelf life, disease resistance, fruit quality

• Cocoa: Insect and disease resistance, butter content and cocoa flavour

• Forest trees for disease resistance and delay in flowering

The research is still ongoing and to date no local biotech derived food crops have been commercialized.

Rubber and oil palm are the two most common plantantion that can be found throughout Malaysia


Table 1 GM Crop R&D players in Malaysia

InstitutesMalaysian Agricultural Research and Development Institute (MARDI)

Forest Research Institute Malaysia (FRIM)

Malaysian Cocoa Board (LKM)

Malaysian Institute for Nuclear Technology Research (MINT)

Malaysian Palm Oil Board (MPOB)

Malaysian Rubber Board (MRB)UniversitiesNational University of Malaysia (UKM)

Malaya University (UM)

Malaysia Sarawak University (UniMas)

Malaysia Sabah University (UMS)

Putra University Malaysia (UPM)

Science University Malaysia (USM)

Technology University Malaysia (UTM)

Technology University MARA (UiTM)

Malaysian University of Science and Technology (MUST)

Asean Institute of Medicine, Science and Technology (AIMST)

Source: Nair and Abu Bakar, 2001


Commercialization of Biotech Derived Crops

The emergence of biotech crops and their subsequent release into the environment have raised concerns among the general public and highlighted issues regarding the safety of these to the environment and human health. A regulatory system has to be set up to oversee, assess and manage the safety concerns of these biotech derived crops. In Malaysia, commercialization of any biotech-derived crops from the lab will involve steps requiring biosafety and food safety approvals. Biosafety approvals are required for all the various stages of the different field trials necessary before commercialization, whereas food safety approval is required before placing the biotech-derived products in the market.

Biosafety

Biosafety is shorthand for the regulatory systems designed to ensure that applications of biotechnology are safe for human health, agriculture and the environment. The Genetic Modification Advisory Committee (GMAC) of Malaysia was set up to formulate the National Guidelines on the release of these crops into the environment and also help draft the Biosafety Law of Malaysia. According to the guidelines and proposed Biosafety Law, all biotech research activities must be notified and development and marketing of biotech products must obtain approval form the National Biosafety Board (to be set up).

Public Awareness and Acceptance

Public acceptance of the biotech product is another important factor towards successful commercialization. Recent survey of key stakeholders in Malaysia conducted by the University of Illinois at Urbana Champagne (UIUC) and ISAAA had showed that attitude of various groups of stakeholders. They are positive towards biotechnology and they believe the technology will benefit small holders. In a survey of 1,400 Malaysian Muslims respondent around Kuala Lumpur conducted by the Institute of Islamic Understanding Malaysia (IKIM), showed that 66.7 % have heard of biotechnology but only 52.2% declared they know what it is about (5). The survey also showed that while about 67% could explain genetically modified organism (GMO), genetic engineering and bio-pharmaceuticals, only 40% know what is cloning. This indicates the acceptance level of Malaysians is quite promising. However, to ensure full public acceptance, public awareness efforts have to be emphasized. Organizations like IKIM and Malaysian Biotechnology Information Center (MABIC) have been active in organizing seminars, workshops and conferences on relevant areas of biotechnology to the public. Biotechnology awareness to students is being coordinated by the National Biotechnology Directorate, Malaysia. Government agencies conducting biotechnology R&D, like MARDI, are very supportive of any public awareness activities on biotechnology. Biotechnology scientists often participated in seminars and media interviews, held exhibitions as well as organized lab visits for the public


Challenges and Future Prospects

To improve consumer acceptance, biotech crop development should focus on characteristics which benefit the consumers. With the know-how well established in the development and commercialization of the existing biotech crops, we plan to focus research efforts on developing nutritionally enhanced food crops which provides direct benefits to the consumers. Efforts are already underway to look into the relevant pathways leading to enhancement of important metabolites through the genomic approaches. Efforts are also being taken by the government to better coordinate biotechnology development in the country by strengthening biotech R&Ds as well as improving the regulatory framework and encouraging public acceptance. With these, Malaysia hopes to be competitive in food production through biotechnology.

Conclusions

Current developments in plant biotechnology in Malaysia are encouraging. The various applications of molecular biology and in vitro technology being utilized reflect the thrust and confidence in using such tools to improve agricultural productivity. With greater emphasis expected in the next five years the future of plant biotechnology in Malaysia is ever brighter.In short, while Malaysia has identified biotechnology and agriculture as key economic drivers, commercialization of local grown technology is still at infancy. Scientists are struggling to translate their bench work into dollars and cents, whereas the local entrepreneurs and industry are not in the forefront yet to invest and buy technologies from public research institutes and universities. Hence, there is a real need for all those involved in this industry to rise to the challenges and impediments in order to enhance the growth in the Malaysian scenario of biotechnology in general and the agricultural biotechnology in particular. After all, Malaysia has all the vital ingredients to succeed in the biotechnology sector, namely, proper policy, clear direction, sound implementation as well as infrastructure, yet it needs to improve on its critical mass and to ensure sufficiently trained human resources to meet the requirement along the value chain of each biotech product, from R&D right through commercialization to prevent unwarranted delay.


References

(1) Hassan Mat Daud (2002) The current and future outlook of Agricultural biotechnology in Malaysia. ASIAN Biotechnology And Development Review of 5:1 Research and Information System.

(2) Norzihan A, Vilasini Pillai, Umi K Abu Bakar (2003). Status of research and development on plant biotechnology in Malaysia Proceedings Workshop on agricultural biotechnology for ASEAN countries. Beijing, People’s Republic of China. 10–21 March 2003.

(3) Nair H, Abu Bakar U B (2001). Agricultural biotechnology in Malaysia. Paper presented at the International Workshop in Agricultural Biotechnology for the Poor, ADB, Manila, 5–17 January.

(4) Anon (2003). South East Asian positive to Agri-biotech, exhibit high trust in University scientists and research institute. Crop Biotech Net 20th May 2003.

(5) Azrina Sobian, Siti Fatimah AR (2003). The understanding and acceptability of biotechnology among Muslim community. International seminar on the understanding and accepability of biotechnology from the Islamic perspective. 9–10 Sep 2003, IKIM. Kuching, Malaysia


ASSIGNMENT 2

“ANIMAL BIOTECHNOLOGY :

ETHICAL, LEGAL AND

SAFETY ISSUES IN MALAYSIA”

PRINCIPLES OF CELL

AND TISSUE CULTURE

(BBD 1234)


Azizi Bin Ahmad (3123006961)

Introduction : Biotechnology in animal production is widely used to increase not only the number of a species of livestock animals to meet the requirement for world demand of animal products but also for endangered species to enhance the propagation and sustaining the current levels of biodiversity and genetic diversity. Animal production biotechnology can be defined as the application of scientific and engineering principles to the processing or production of materials by animals or aquatic species to provide goods and services for the well-being of human population (NRC 2003). Examples of animal biotechnology include generation of transgenic animals or transgenic fish (animals or fish with one or more genes introduced by human intervention), using gene knockout technology to generate animals in which a specific gene has been inactivated, production of nearly identical animals by somatic cell nuclear transfer (also referred to as clones), or production of infertile aquatic species. However, the only alternative way to improvement or increase the animal production performance is through application of assisted reproductive techniques (ART) in the farm practices. The techniques are such as semen cryopreservation, artificial insemination (AI), oestrus synchronisation and superovulation, laparoscopic ovum pick-up (LOPU), in vitro maturation, fertilisation and culture (IVMFC), intracytoplasmic sperm injection (ICSI), embryo sexing, embryo/oocyte cryopreservation, cloning, stem cell, embryo transfer, ultrasonography (pregnancy diagnosis) and radioimmunoassay (RIA).

Livestock Industry in Malaysia

The livestock industry in Malaysia comprises the large and highly commercialised sub-sector of poultry and pigs. In Malaysia, the ruminant sub-sector products are highly dependent on importation, for examples 70% of beef, 90% of mutton/goat meat and 95% of milk and milk products are imported annually to meet the local demand. Correspondingly, Malaysia has attained self-sufficiency in poultry meat, egg and pork, but only 30% self-sufficiency in beef, 10 % in mutton/goat meat and 5% in milk. While, for the source of fish, marine fisheries account for over 90%, whereas aquaculture accounts for about 10%. The priority areas of animal biotechnology in Malaysia are as follows:

1) animal production improvement through reproductive technology, 2) animal feed improvement from local sources, 3) application of biotechnology in aquaculture health management, and 4) production of biological reagent through recombinant DNA technology (such as vaccines, diagnosis system and vaccines delivery).

In other words, the specific research priority areas in Malaysia are focused on genetic engineering of animals for improved production and quality, improvement of reproductive technologies, development of cheap feedstuff from local resources, novel vaccines and drug delivery systems and development of rapid diagnostic kits. Animal reproductive biotechnologies are essential to improve the genetics of animals at a rapid rate, to multiply the population of animals at a rapid rate, to facilitate import and export of animals through


cryopreservation of gametes and embryos and to increase the income of entrepreneurs and farmers especially in developing countries. As for the animal breeding and reproduction, the thrust areas are in vitro conservation and use of animal genetic resources from indigenous domestic and wild animals and genetic improvement of ruminants using reproductive biotechnologies and recombinant DNA technology. The stage is now set to expand the available technologies to accelerate genetic improvement for identification of individual genes to increase the accuracy of predicting breeding performance.

For the animal nutrition and production, the thrust areas include enzymes and microbial additives, growth promotants and regulators, manipulation of rumen ecosystem and bioprocessing of low quality feed. Feed constitutes a major portion of the total animal production costs. Efficient utilisation of feed to produce meat, milk and eggs can therefore significantly reduce overall production costs.

For the fish production and health, the thrust areas encompass genetic improvement of selected food and ornamental fish, disease diagnosis and control, conservation of genetic resources and fish as a sensor of pollution. Genetic manipulation and gene transfer can improve production and quality of both cultured and ornamental fish. Studies are also needed on conservation of genetic resources by cryopreservation and use of fish as a sensor of pollution of the aquatic environment.

For the animal health, the thrust areas include development of diagnostic reagents and kits, development of vaccines and food safety. Effective disease control is a major prerequisite in enhancing livestock productivity. Effective rapid diagnostic tests to identify the causative agents are either not commercially available or they are too expensive to be cost effective. Food safety and zoonotic diseases are also of major concern

In the developing countries like Malaysia, application of animal biotechnology is essential to improve animal production and to conserve the indigenous animal genetic resources. Specifically, animal reproductive biotechnologies will be useful in augmenting reproduction, implementing embryo transfer and related technologies, diagnosing diseases and controlling and improving nutrient availability. One application of animal biotechnology is through the production of transgenic animals which is also known as genetically modified organism. Currently, no genetically modified animals have yet been released on farms. However, active research activities have been made globally to develop transgenic animals targeting specific genetic traits of interest, such as growth hormone gene (to increase growth rate), phytase gene (to reduce phosphorous emissions from pigs) and keratin gene (to improve wool of sheep). At this point in time, development of transgenic animal technologies is at its infancy and at research level due to high costs, inefficiency of the gene transfer technique and low reproductive rate of animals. However, human therapeutic proteins in their milk, have organs for xeno-transplantation and resistant to diseases have been produced satisfactorily through application of animal cloning research. In an effort to improve health through vaccines development, two approaches to develop vaccines using rDNA are proposed:

1) deleting genes that determine the virulence of the pathogen (producing attenuated organisms to produce live vaccines) and


2) identify ing protein subunits of pathogen that can stimulate immunity.

This approach is to improve human and animal health through vaccination is one of the most effective and sustainable methods of controlling diseases in the future. As for diagnostics and epidemiology, it is important for epidemic disease to pinpoint the source of infection in order to control the diseases and to enable to identify the agents causing diseases (e.g. viruses, bacteria and fungi) by nucleotide sequencing, enabling their origins to be traced. The nutrition and feed utilisation of livestock animals in developing countries include shortages of feed and increase cost of feed ingredients, improvement of nutrient availability and animal productivity currently used through biotechnology approaches {(enzymes, probiotics, single-cell protein and antibiotics in feed) and (gene-based technologies modifying feed to be more digestible or modifying digestive and metabolism systems to use feed efficiently)

Overall, then, the potential benefits of the genetic modification of animals are as follows. The benefits for the target animals include improved health and welfare through transgenic modification and through a better understanding of animal physiology, genetics, and management. There also could be a reduction in the number of animals needed for meat and milk production. The benefits for humans include novel or lower-cost treatments for disease, improved understanding of disease, and more nutritious or lower-cost meat and milk. Let’s also look at the potential risks. The risks for the target animal include negative outcomes affecting the health and welfare of the animal. Under current federal guidelines, however, animal welfare issues are monitored and addressed appropriately to minimize suffering. There also could be negative consequences from random gene insertions. The random insertions could cause harmful gene mutations which must be tested in homozygous animals. The risk also exists of narrowing the genetic diversity contained within a breed. The risks for humans, I think, if current regulatory guidelines are followed, are not significant. The therapeutics produced in animals must be as safe and effective as those produced through any other system.



GENERAL FACTS & INFORMATIONS

OF

ANIMAL BIOTECHNOLOGY IN MALAYSIA

Product Development:

In general, both the general public and regulators are opposed to using GE in animal production, and no R&D in this area is occurring in Malaysia. However, in 2010 NBB did approve a request from the Malaysian Institute of Medical Research (IMR) to do trials on GE mosquitoes for dengue fever control. After doing a controlled release in uninhabited areas in 2010, further developments in this effort have been stalled due to public resistance to release in inhabited areas. It is unclear when/if development will be reinitiated. The October 2010 NBB approval permitted the release of male GE mosquitoes, Aedes aegypti OX513A(My1) strain and male non-GM Aedes aegypti mosquitoes (wild type). In December 2010, IMR released the GE mosquitoes in an uninhabited area. The mosquitoes were developed by Oxitec a U.K. biotech firm that aims to fight dengue by releasing massive numbers of "genetically sterile" male Aedes aegypti mosquitoes. Public consultation was held in August 2010

Commercial Production: No commercial production of GE or cloned animals.

Biotechnology Exports: No exports of GE or cloned animals.

Biotechnology Imports: Malaysia is highly dependent on imports for genetics in livestock production, particularly for ruminants. It is conceivable that some of these imports may have been derived from clones.

Regulation: As is the case with plant material, the regulatory framework for GE animals is contained in the 2007 Biosafety Act and 2010 Approval Regulations

Depending on the particular animal species involved, the Department of Veterinary Services and/or Fisheries, as well as NRE would be the key government entities involved with the decision making


Labeling and Traceability:

In April 2013, Food Safety and Quality Division, MOH published new “Guidelines on Labeling of Foods and Food Ingredients Obtained through Modern Biotechnology.”

MOH will begin enforcing the guidelines on 8 July, 2014.

Some key elements of the labeling guidelines include the following:

1) If the GE content is not more than three percent labeling is not required, “provided that this presence is adventitious or technically unavoidable.”

2) For single ingredient foods, the words “genetically modified (name of the ingredient)” must appear in the main display panel.

3) For multi-ingredient foods, the words “produced from genetically modified (name of the ingredient)”should appear in list of ingredients and “contains genetically modified ingredient” must be stated on the main display panel.

4) Highly refined foods, defined as those where processing has removed all novel DNA and protein, are exempt from the labeling requirement. (e.g.: vegetable oils, corn syrup, acidic foods, and salty foods).

5) Meat from animals fed with GE grains do NOT need to be labeled.

6) Only GE crops that have been approved by NBB can be used for foods and food ingredients

There are no traceability mechanisms in effect.

Trade Barriers: No trade restrictions related to biotechnology issues.

Intellectual Property Rights: Nothing related to animal biotechnologies.


International Treaties/Fora:

Malaysia regularly sends officials to Codex and OIE meetings, but representatives have not taken noteworthy positions on GE animals or cloning.

Marketing: To the extent that they are aware, most consumers would be opposed to consuming products from GE or cloned animals.

Capacity Building and Outreach:

There have been no activities related to GE animals.

And in fact, outreach on GE animals would probably be counter-productive. Any efforts should focus on achieving greater acceptance of GE plants first.

Research and Laboratory Animals :

• National Biotechnology Policy, 2005, has accelerated more research using lab animals, which raised animal welfare concerned.

• The Animals Act, 1953 and Wildlife Conservation Act, 2010 has provision for such control.

• There is a need for establishment of regulations and Standard Operating Procedure under the supervision of Institutional Animal Care and Use Committee (IACUC) .

Ethical Issues

The ethical issues associated with transgenic animals and mammalian cloning (as these techniques are applied to traditional food animals) fit into three broad categories. First are issues that pertain to the impact of this technology on the animals themselves. Second are issues that relate to the institutions and procedures that govern the research and applications context within the agrifood system. Finally, there are issues that relate to the relationship between humans and other animals; the way that humans think of or act in regard to nonhumans, irrespective of the effect that human conduct has on the animals. The underlying ethical principles within each of these three domains are distinct, and the following discussion will treat them as such. Yet arguably, the very diversity of these issues contributes to the sense that animal biotechnology challenges the moral order of society. It is therefore important to recognize that introducing this analytic framework may itself seem to impose a rational ordering on the discussion of animal biotechnology, undercutting concerns that are difficult to express clearly but still may be the basis of negative reactions.

INTRINSIC CONCERNS

Intrinsic objection alleged that the process of modern biotechnology is objectionable in itself. This belief is associated with the unnaturalness claim, changing nature and to play ‘God’. People’s beliefs about nature play a role in their evaluation of the products of biotechnology (BABAS 1999). They embody values and prescriptions about what is morally right or wrong to do to the natural world. The argument is as follows: ‘Nature and all that is natural is valuable and good in itself; all forms of biotechnology are unnatural in that they go against and interfere with nature, particularly in the crossing of natural species boundaries’. In some cases the general moral concerns include a religious dimension when they are accompanied by an underlying set of religious beliefs and principles concerning the relationships between God, nature and human beings (BABAS 1999). The central problem underlying biotechnology is not just its short term benefits and long term drawbacks, but the overall attempt to ‘control’ living nature on an erroneous mechanistic view (Batalion 2000). Many religions does not allow unrestricted interference with life such as genetic engineering (Epstein 1998). In Islam for example, scientific research is encouraged in order to understand natural phenomenon and the universe, and to observ ethe signs of Allah’s glory and ultimately to find the truth (Hajj Mustafa 2001). However, not everything that is applicable is necessarily applicable, it is important to consider fully the purpose and any harmful effect


towards human, environment and society and must be in line with the rules of Shari’ah (9th Fiqh- Medical Seminar 2002; Hajj Mustafa 2000). Issues of halal products and sources of genes are also important for the Muslims and the second issue, for the vegetarians too Islam is similar to Judaism and Christianity in terms of its views of animals. In general, these Western religions give privilege to humans, while Hinduism and Buddhism do not. Like the Torah, the Qur’an forbids cruelty to animals, but it also goes further to suggest that animals possess some rationality and that all species are “communities” like human communities. Mohammed urged his followers to show compassion to animals and treat all animals gently because they are part of God’s family. In the afterlife, he said, one receives rewards in relation to how we treat animals in this life. Islam also teaches that animals possess a psyche; they have a lower-level consciousness than humans, but it’s higher than just instinct. And they communicate with God. Humans, they say, have spiritual volition and greater freedom of action. We are God’s vice-regents on earth. As such, we have stewardship responsibilities. Islam condemns blood sports and the use of animals in cosmetics research or the killing of animals for floor coverings. Animals can be killed only when needed for food, and then only in a ritual way (Halal) that minimizes suffering. In current guides for Muslim shoppers, GMOs are not mentioned, and no problems with factory farming are raised. The rules in the guides mostly center on avoiding products that may contain alcohol or pork. Three academies of Islamic Law (that met in Morocco, Saudi Arabia, and India) have held discussions on genetic modification. The key question for them is, Have humans taken on the power of creation through genetic modification? Because that belongs to Allah alone. The thought is thus that science shouldn’t create things, but it should make understandable the facts of Allah’s creation. These scholars thus see cloning as a miracle made possible by Allah, and genetic modification as knowledge made possible by Allah. If successful, it must have the consent of Allah. None of the elements in cloning are human made; all were made by Allah. So there is no change in the birth of the creation. The only difference is in how fertilization takes place. Thus it is then still an act of Allah. So, cloning is not creation nor a partnership in creation, since Allah is the creator of all things. At this point, Islamic scholars accept cloning for animals, but not for humans. They say that research in the field of cloning should be restricted so that it becomes a means of betterment for the world, not a cause of chaos and disturbance, and it should not result in suffering for animals

CONSUMER’S RIGHT TO FOOD SAFETY AND INFORMATION

Basic consumer claims concerning GM food are about the rights to health to be informed and to choose (BABAS 1999). The first one refers to food safety and the right of consumers to have their health protected from possible hazards derived from eating GM food. Three main areas of concerns area: toxicity, allergenicity and nutritional value. The second issue is the right of consumers to know the information about the foods offered to them (mainly the natural or GM character of food products and their composition especially of those animal-based products) so that they can make an informed choice. This freedom is important because there are food related religious or cultural belief such as the halal (Muslim dietary rule) and kosher (Jewish dietary rule) practices, as well as vegetarians

In Malaysia since the majority of the citizens are Muslims and the official religion is Islam, Divine law should be used as the moral basis for law and society (Hamid 2000; Majdah


2001). The prohibitory status of modern biotechnology applications should be studied case by case and in line with the Islamic principles. In Islam, the sources of rules are first and foremost is the al-Qur’an, followed by the sunnah or hadith (traditions of the Prophet Muhammad) (Hamid 2000). In facing a problem that is not answered in a straightforward manner by earlier two sources, ijma’ (consensus) have to be sought collectively from the views of mujtahid (Muslim jurists who are competent enough to deduce precise inferences regarding the commandment from the al-Qur’an and sunnah). The last source of guideline for the Muslims is aq’il (reasoning). Issues of halal is also very important for Muslims (BABAS 1999). The acceptance of modern biotechnology applications by other major religions in Malaysia such as Buddha, Hindu and Christian should also be considered.

Also, some cloned animals have been shown to have significant developmental problems and deformities. Another potential consequence mentioned was that the genetic engineering of species that can escape into the wild could have detrimental impacts not just on individual

animals, but on whole species and/or ecosystems

The future development and commercialization of modern biotechnology products in Malaysia depends heavily on public acceptance. The acceptance or social rejection on using modern biotechnology needs to be considered and scrutinized before developing any modern biotechnology in Malaysia. Complete information on both the pros and cons of modern biotechnology should be informed to the public accurately and honestly. The real facts about the impact of modern biotechnology usage are very important to respect the consumer’s right to information and to choose their consumptions.

Transgenic and cloned animals and their welfare

The development of transgenic and cloned animals inspires concerns in the public mind. Biosafety issues, concerning the open release of these animals in the environment or their use in feed or food are commonly shared by genetically engineered crops and animals. Another concern is that such research could push humanity on a "slippery slope" and constitute the


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first step towards giving birth to transgenic or cloned human beings in a not so distant future. Applying modern biotechnology to animals, however, has also revealed original public concerns relating to animal welfare and animal integrity.

Public concerns regarding animal welfare in other countries

In most countries, indeed, animals are generally considered by the public as quite different to simple organisms, thus implying special care. Within Europe, such considerations are most visible in the Nordic countries and the United Kingdom, and much less influential in more Latin cultures such as those of Spain, Italy, and, partly, France. In Japan, public concern for the welfare of animals started in the late 1940s, when numbers of stray dogs started wandering around fields and towns, and this interest increased in the 1970s when an ageing society with fewer children started caring for home pets. From then, many Japanese citizens claim they have a moral duty towards animals or that taking care of them implies subjective consideration close to love or familial attachment; animal welfare is therefore a very emotional issue in Japan (Kishida & Macer, 2003). Moreover, in countries such as India, respect for animal welfare is rooted in religious beliefs. However, "Animals and birds are thought not only as Vahanas or Vehicles on which God rides, but much more useful as well. Over the centuries this has brought about a very healthy respect in the Indian mind for all forms of life. The cow is sacred not because it is a divine vehicle alone, but because it has an overall utility value. Buddhism and Jainism carry this attitude further, leading to vegetarianism and respects for all living beings. To the Sufis, steeped in equally considerate attitudes the prevalent Indian mind set was extremely acceptable. Thus, in the East, regardless of specific sects or religions, the attitude to other life forms was not exploitative, but appreciative. Even pigs, boars, buffaloes and monkeys are referred in holy books and the Indian mind set can become easily sensitive when it comes to these animals. These religious sentiments could be one major reason why the animal activism in this country has found firm roots, while in the West it may be because of the writings of some secular philosophers." (Indian Council of Medical Research, 2000)

It is against such background that research on and production of transgenic and cloned animals takes place. Developed in the United Kingdom, the "Three Rs" doctrine (Russell & Burch, 1959), raised awareness on the welfare of animals used in research, as it promoted the “Refinement” of research techniques in order to minimize animal suffering and distress, “Reduction” in the number of animals used, and “Replacement” of these animals where possible so as to avoid the use of animals in research. The United Kingdom, indeed, has developed a highly comprehensive framework for animal use. The Brambell Report of 1965 AZIZI BIN AHMAD <3123006961> (4/13/34)PRINCIPLES OF CELL AND TISSUE CULTURe (BBD 1234) – MISS EMI FAZLINA DIPLOMA IN BIOTECHNOLOGY INDUSTRY (3/12/34)

was highly influential in this matter, as it identified the "five freedoms" an animal should be recognized : freedom from hunger and thirst, from discomfort, from pain, injury or disease, from fear and distress, and freedom to express natural behaviour (Kaiser, 2005) Issues of animal welfare have gradually been voiced in the European political arena and elsewhere since the mid-1970s, and have been major issues in the European research policy since circa 1986, when the European Convention and Council Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes were adopted. Such issues also imply that animals' integrity should be protected, so that they can live a life as close as possible to natural life, in terms of mental state, capacity to withstand unfavourable fluctuations of the environment, express natural instincts and fulfil its natural activity. Animal welfare, thus, is not only a physiological consideration, but it involves a general philosophical notion of what an animal is, against which the use of animals for purposes such as research or farming is evaluated. The main principle for such evaluation is the principle of proportionality, such that research going against animal welfare should be clearly aiming at higher benefits for society.

As legal regulation cannot fully detail the application of such a proportionality principle, best practice guidelines are deemed useful by many, as they make sure that research conforming to public regulation can be considered moral as well (Nuffield, 2005).

With such a frame of mind, since the intense media coverage of the cloning of the sheep Dolly in 1997, many people express some defiance towards biotechnology applied to animals, disregarding the fact that classical animal breeding already constitutes a form of "biotechnological" production. In the United States, for instance, Americans are much more likely to support the genetic modification of plants, than that of animals (Pew Survey, Nov. 2005). The greater part of the public worldwide, however, does not oppose to any experimentation on animals whatsoever, but is either indifferent to animals or would like animal welfare to be taken into account within such experimentation. Animal rights considerations have thus very little effect on the public opinion, while animal welfare issues concern some part of the public. In all cases, most of the public is willing to consider the purpose as it evaluates the engineering of animals. In Japan, leisure purposes have been generally deemed an insufficient justification for genetically engineering an animal, such as a "larger sports fish" (Inaba & Macer, 2003). Transgenic and cloned animals engineered for medical or research purposes have been met with more approval worldwide. Concerns have been raised, however, that, while the general number of animals used in research is going down, the proportion of animals used for cloning or transgenic research are quickly rising. Animal designed for food and agricultural purposes do not receive general support from the public. Religious belief plays a role in the public acceptance of food from transgenic and cloned animals. Some Christians, on the one hand, object to the genetic engineering of animals as such, arguing it is equivalent for human beings to play God and goes beyond moral limits. Animal food is not their specific concern, but the modification of the Creation is. Hinduism, Buddhism, Judaism and Islam, on the other hand, do not refer to the 'Playing God' argument, but express more concerns about specific aspects regarding food, such as, for instance, whether genes have been introduced from animals such as pigs or cows (Kaiser, 2005). Arguments against GM animal farming, nevertheless, mostly relate to animal care and animal welfare considerations. In Japan, animal welfare issues certainly plays a part in the fact that although support for GM crops and GM food is low, surveys since 1993 consistently AZIZI BIN AHMAD <3123006961> (4/13/34)PRINCIPLES OF CELL AND TISSUE CULTURe (BBD 1234) – MISS EMI FAZLINA DIPLOMA IN BIOTECHNOLOGY INDUSTRY (3/12/34)

show more support for genetic engineering of crops than that of animals producing less fatty meat or cows producing more milk (Inaba & Macer, 2003). Thus, even alimentary and agricultural purposes do not inspire high approval, as a part of the public shares an emotional sympathy for the animal and an indistinct but firm decision to no to eat what it considers "unnatural" food, be it derived from GM crops or GM animals. Regarding cloned animals, many advocacy groups have argued, from scientific reports, that, among the few cloned animals that survive a cloning process, many are deformed or have significant abnormalities. As scientists have stated, the low-success rate and abnormalities appear, for the present time, "inherent to the cloning techniques", though technical improvement is nonetheless entirely conceivable (AFSSA, 2005). Animal welfare associations have been raising such issues in countries as the UK, and in India where "religious sentiments could be one major reason why the animal activism in this country has found firm roots, while in the West it may be because of the writings of some secular philosophers," (Indian Council of Medical Research, 2000). In such countries, however, the welfare of the animals is also advocated by national ethics committees, such as the Indian Council of Medical Research as it states that inducing heritable deviations in a species is also a form of violation against their living normativity (Indian Council of Medical Research, 2000)

Organizations promoting animal cloning for food, such as the US Biotechnology Industry Organization (BIO), insist there is nothing special in food derived from cloned animals. They promote ethical values such as the liberty of research, the freedom of rational thinking in "demystifying cloning", and the necessity not to issue useless, demagogic public regulation. In this setting, animal welfare, though important, is probably not the main concern. BIO's Comments to the European Food Safety Authority's Request for public comments on the “Implications of animal cloning on food safety, animal health and welfare and the environment” (May 29, 2007), for instance, call for extensive biosafety assessments, but do not raise issues such as animal welfare or animal integrity. It could be that industry would benefit from addressing such issues where possible, if it is admitted that the long-term economic success of biotechnology generally seem to depend on consumer acceptance (McCluskey, 2004)

Public legal and safety regulation issues

From this situation, public regulation is varied. In many countries, research on transgenic and cloned animals is not regulated as such, but wholly depends on the pre-existenting national frameworks adopted for the management of animal research, often in line with cultural and religious specificities. Transgenic animals in research settings do not often require specific legal provisions. Contained use and release are addressed as with any animals used in research. Animal welfare is often considered by specific advisory national commissions or ethics committees within the research institution. Some national legislation, however, explicitly applies to transgenic or cloned animals. The Norwegian Animal Protection Act, for example states that "It is forbidden to change the genetic make-up of an animal by use of biotechnology or traditional breeding techniques if:

a) this makes the animal poorly equipped to engage in normal behaviour or influences physiological functions negatively;

b) the animal has to suffer unnecessarily; AZIZI BIN AHMAD <3123006961> (4/13/34)PRINCIPLES OF CELL AND TISSUE CULTURe (BBD 1234) – MISS EMI FAZLINA DIPLOMA IN BIOTECHNOLOGY INDUSTRY (3/12/34)

c) the modification triggers common ethical reactions’ (Kaiser, 2005).

Such is also the case in Asian countries such as Japan. However, even in the United Kingdom, inducing "morally objectionable changes" (Banner Committee, 1995) to an animal, for instance producing pigs of reduced sentience or disinclined to engage in activity normal to them, has never been rejected without proper consideration of the purpose of such modifications, in accordance with the principle of proportionality. Thus, theproduction and use of transgenic and cloned animals remains a very controversial issue.

Consensus in regulation of biotechnology engineered animals is unlikely to happen within the European Union (CeBRA, 2005) or Asia. The presence or absence of national regulation on animal cloning is an indicator of such tension between incentives to accelerate medical and biological research, and the willingness, as embodied in the Danish Law on cloning, to consider that cloning is a moral issue calling for exceptional measures of regulation.

BIOSAFETY ACT 2007

An Act to establish the National Biosafety Board; to regulate the release, importation, exportation and contained use of living modified organisms, and the release of products of

such organisms, with the objectives of protecting human, plant and animal health, the environment and biological diversity, and where there are threats of irreversible damage,

lack of full scientific evidence may not be used as a reason not to take action to prevent such damage; and to provide for matters connected therewith.

In Malaysia, the biosafety aspect of the 2007 Act generally aims at protecting public health and the environment. Also, it envisages to promote and/or to enable consumer choice and in fostering useful research by adopting a precautionary approach. In order to achieve these objectives, bioethical concerns should be part of the Act so as to assist decision-makers formulate more informed policy decisions and to improve stakeholders’ abilities to make judgment about what is morally wrong and right in this technology. It is rightly contended that it is rather difficult to set a standard of ethics in biotechnology, what is more to prove a case based on these considerations. However, in order to legislate on bioethics, the term must be clearly defined as to avoid uncertainty (Ida, 2009). Despite the provision on socio-economic consideration under section 35 of the Act and regulation 25(b) of the Biosafety (Approval and Notification) Regulations 2010 (hereinafter ‘the 2010 Regulation’), the new legal framework is rather vague on the protection of bioethical issues as the scope and definition of ethics is not explicitly clarified anywhere in the 2007 Act nor the 2010 Regulations. Section 35, does not comprehensively explains the precise requirements on socio-economic consideration. Although under the new regulation 25(b) of the 2010 Regulations, ethical issues is part of this socio-economic consideration, however, the regulation does not specifically define the meaning and scope of “ethics” relating to modern biotechnology. Thus, the definition of “ethics” in the 2007 Act and the 2010 Regulations remains questionable. Due to this vagueness it is uncertain as to the type of ethical issues that AZIZI BIN AHMAD <3123006961> (4/13/34)PRINCIPLES OF CELL AND TISSUE CULTURe (BBD 1234) – MISS EMI FAZLINA DIPLOMA IN BIOTECHNOLOGY INDUSTRY (3/12/34)

should be regulated under the said Act. While the 2007 Act lacks provision on the types and scope of bioethics, the Cartagena Protocol of Biosafety, which is an international instrument that governs biosafety issue relating to GMOs, requires its party to have their own national biosafety framework and Malaysia is a party to this protocol. Under Article 26, the said Protocol seems to have adopted ethical concerns in its socio-economic considerations provision. Experiences in other countries such as the European Union (EU) have also shown that they have incorporated ethical considerations in their socio economic consideration provisions in their national biosafety laws (Celine, 2007). Korea (Jose, 2007) and Norway (Jan, 2007) too, have specifically created provision on bioethics in their biosafety laws, in which GM assessment must be based on scientific evidence as well as ethical considerations. These are some lessons that Malaysia could emulate in creating a clear meaning and scope of ethical issues in the 2007 Act so as to avoid uncertainty. Bioethical issue is a pertinent issue under the 2007 Act as this law generally aims at protecting human and animal health as well as the environment. Scientific assessment solely should not be a measure to assess the release of GM. However, this issue is problematic under the 2007 Act. Despite the fact that ethical issue has been included under the scope of socio-economic consideration in section 35, the 2010 Regulations does not clearly explain whether or not bioethical issues is part of the consideration in assessing GM. This is because, in section 35 of the 2007 Act and regulation 25(b) of the 2010 Regulation, the Board or Minister may take into account socio-economic consideration in his decision making. The word “may” under section 35 and regulation 25(b) gives an indication that it is the discretionary power of the Board or the Minister whether or not to take socio-economic consideration into account in assessing any GM application. The question remains at what level will this consideration be taken into account and whether or not the Genetic Modification Advisory Committee (GMAC) will dispense with this consideration in processing any GM application. In addition, this provision seems contrary to section 15 of the 2007 Act. This is because, in considering the application of GM under section 15 of the Act, the National Biosafety Board will act on the recommendation of the Genetic Modification Advisory Committee (GMAC) on whether to approve or reject the application. Such recommendations are usually based purely on scientific and not ethical ones. This is inconsistent with the 2007 Act and in some ways does not promote the objectives of the protectionist principles of this law. It is recommended that ethical consideration should be taken into account together with any scientific evidence in the decision making of the National Biosafety Board. Both considerations, scientific and ethical, should be assessed collectively in any application affecting the GM technology. These issues remained unresolved despite the recent enforcement of the Act and creation of the 2010 Regulations under it. As biotechnology is affecting people’s lives, it is vital that the law provide them with sufficient understanding of the matter, including the potential benefits and hazards as well as the freedom to make the right choices. This is consistent with the requirement of the Cartagena Protocol and also the 2007 Act itself that Prior Informed Consent must be applied before any introduction of the GMOs (Ruth, 2003). If the public is allowed to be involved, they could help address bioethical issues at an early stage. Such public views should be an essential part in assessing any GM application. This could in some measures lead to a greater transparency of the potential risks involved in this particular technology. Open conversation and transparent decision-making processes are critical to the foundations of any liberal democratic society. Indeed, it is a truism that everyone must be involved in the debate and they must be allowed to state their opinions about GM no matter what their opinion happens


to be, or their level of acquaintance with the science and technology happens to be (Gary, 2010). In view of this, public participation should be clearly defined in the 2007 Act, including the mechanism of such participation. However, it is apparent that the 2007 Act is silent on the involvement of the general public in any GM assessment. Section 14(c) provides an opportunity to the public to participate in the decision making of the Board. However, this opportunity is limited if the information contains business confidentiality under section 59. Furthermore, it is also unclear as to whether the public could raise any bioethical concerns in their involvement in public participation under section 14(c) since there is no clear definition of public participation in the said Act.

In the most recent and controversial step of releasing genetically modified (GM) male mosquitoes (OX513A) into the wild (in Bentong, Pahang and Alor Gajah, Melaka) as part of an experiment to test their survival in natural conditions, the Malaysian National Biosafety Board has approved the male GM mosquitoes to be released for a field trial to the Institute of Medical Research (IMR). The purpose of this experiment is to combat dengue epidemic inMalaysia. The Board made its decision after its Genetic Modifications Advisory Committee (GMAC) had analysed the risk factors for the experiment. The issue was opened for public consultation from 5 August to 4 September 2010. The said Board claimed that in reviewing the application, they received valuable feedback through public consultation and responses from other countries. According to the press statement, the majority of the inputs supported the field trials and only one third of them raised objections (NRE, 2010). Even though feedback was obtained, transparency and meaningful public participation were lacking due to insufficient publicity and the short timeline of public consultation. Besides, it is unclear as to what was the feedback received from the public. Based on the commentsand letters in the media, it seems that the public were not fully aware of the GM mosquito release. What is most amazing about the whole scenario is the fact that the local communities in Bentong and Alor Gajah were not part of the mandatory consultations (one of the conditions of the approval, which has to be fulfilled before the start of the field releases, is that of public notification and consensus) before the approval was made by the Board. Forthe purpose of ethical conduct of research trial, informed consent is important to be obtained before the release of the research trial (Macer, 2005). Therefore, in this case, local communities in the release sites should be consulted with the highest standards of prior informed consent when it comes to obtaining the consensus and approval. Such lack of information to the local communities and to the general public and the lack of consultation with the affected communities suggest the lack of transparency in the GM application procedures. It is not surprising that such glaring oversight have attracted considerable criticisms from consumer association, environmentalists and the public at large. For instance, the Consumer Association of Penang (CAP) is concerned about the safety of the residents within the area due to the lack of scientific consensus of the safety of GM insects and the numerous uncertainties involved in genetic engineering, which eventually will result in the difficulty in assessing their risks (CAP, 2010).

Given that the risk assessment and regulatory experience for GM insects worldwide is still immature and the World Health Organization (WHO) guidelines on the matter is yet to be established, the recent release of the GM mosquitoes in Malaysia is rather valiant, if not too hasty (CAP, 2010). Risk assessment process should have been more transparent by listing down all the potential hazards and its evaluations of their likelihood, consequences and


estimated overall risk (Helen, 2011). A Supreme Court of the United States decision in Monsanto Co. v. Geertson Seed Farms (June 2010) to ban the planting of genetically modified alfalfa until the USDA’s Animal and Plant Inspection Services (”APHIS”) had fully analyzed the impacts of these crops on the environment, farmers and the public in an Environmental Impact Statement (“EIS”) is a good precedent to be referred to in this GM mosquitoes issue. This is because, not only will the approval process for the GM mosquitoes set a precedent for all future field trials and release of genetically modified organisms in the country, it has far reaching implications for other GM crops, food, feed and processing in the future. Experience from the Cayman Island on the open release of GM mosquitoes cannot be set as a benchmark as that country is not covered by the Cartagena Protocol being a non-signatory to that protocol. As such, their process of approval did not include public consultation or consent procedure (Helen, 2011). Therefore, it is submitted that the lack of public participation in the decision making process of the National Biosafety Board in any application on GMOs is a concern that must be urgently addressed by the relevant authority. Such participation is important in order to ensure that the public is aware of and participate in this process that may have serious implications on their lives.

In the context of freedom of information on the release of GM mosquitoes, Article 10 of the Malaysian Federal Constitution (Freedom of Speech, Assembly and Association) is silent about the freedom of information. However, Article 19 of the Universal Declaration of Human Rights (UDHR) 1948 states that “Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.” According to Section 4(4) of the Suhakam Act, the UDHR is applicable to Malaysia as long as it does not contravene the Federal Constitution. It is submitted that freedom to information does not contravene the Federal Constitution. In fact, it may be argued that for freedom of expression (as stated in Article 10 of the Federal Constitution) to be truly practiced, then the freedom of information is a necessary element. Therefore, in this respect, Article 19 of UDHR should be applicable in Malaysia. Experience in Brazil on public participation suggests a much different legal landscape than that of Malaysia. Access to information is repeatedly mentioned in the Brazilian Biosafety Law. For instance, paragraph 10 of Chapter III states that representatives from the scientific community, the public sector and civil society can be invited to attend Brazil's National Technical Committee on Biosafety (CTNBio) meetings. In addition, in Article 14 of the same law, any proceedings with regard to GMOs will be published in the Federal Gazette to provide easy access to the public. In Article 15, public hearings will be carried out with the participation of civil society as conducted by CTNBio. Furthermore, parties involved in commercial clearance cases can request for a public hearing to provide proof of their relevant interests which must be in line with the provisions of the law. It is submitted that, it is crucial that Malaysia should have similar provisions, which would include transparency and effective public participation under the 2007 Act. In the long run, such an approach would serve Malaysia in good stead in governing the biotechnology industry as well as protecting the wider interests of the society.


Recently, the Ministry of Science, Technology and Innovation (MOSTI) has already set up the National Bioethics Council (NBC) to provide an arena in which stakeholders with widely differing moral views to discuss, interact and negotiate about controversial matters relating to bioethical issues in various aspects including biotechnology. Despite the setting up of a relevant committee for bioethical issues that invites the public to participate in giving constructive criticism, such participation and discussion have yet to reach all levels and sections of the community. It is correctly contended that despite considerable research in several advanced countries on public perceptions of and attitudes to modern biotechnology, limited effort has been in Malaysia that is geared towards developing a structural model of public attitudes to modern biotechnology (Latifah, 2010). Thus, even though the council has link to the government in an official advisory capacity, but if the council is to be implemented effectively and regarded as legitimate, the society as a whole should be included in the construction of the proposal and represented on the council, which in turn, should have the benefit of specialist advice when that is needed. Bioethical issue is pertinent in the biosafety legal framework in Malaysia. Litigation in bioethical controversies is a poor method of resolution because “judicial decisions, once made, become precedent and thus have normative effect on the actions and conduct of citizens other than those before the court in the present controversy (Schaller, 2008). Due to this the uncertainty of the scope and the role of bioethics need to be clearly spelled out in the legal framework. If bioethical issue is not regulated in the legal framework, it can lead to endless litigation suit.

In the eyes of the biotechnology industry, the inclusion of bioethical considerations in the 2007 Act could be an obstacle as in some cases such consideration may delay or even block the release of potentially valuable products. However, this consideration should be balanced with the biotechnology development so as to ensure that the objectives of the 2007 Act could be attained. In this respect, the consideration must be transparent, well defined and understood by all actors and stakeholders in the biotechnology industry. The 2007 Act must properly accommodate the safety issues raised by GMOs and, in so doing, restore public confidence through bioethical consideration. Despite the existence of the 2007 Act and 2010 Regulations governing GMOs in Malaysia, it is evident that the Act and 2010 Regulations lack clear provisions for the protection of bioethical issues and socio-economic implications of risks and hazards arising from biotechnology. Apparently this would suggest the ambiguity of the provisions in the 2007 Act and 2010 Regulations in protecting bioethical concerns representing wider societal interests and welfare, would in some ways, overwhelm the protectionist principles of the 2007 Act intended to uphold. In spite of its flaws, the 2007 Act is without doubt a significant piece of legislation in governing biosafety practices and the biotechnology industry. Against the current social, political and economic terrain in Malaysia, it remains to be seen if the 2007 Act in its current form would be adequate enough in protecting bioethical issues. Its future role could be enhanced if it could play a balancing role between promoting the development of the biotechnology industry and business interests as well as ensuring public safety, health and interests at large.


In general, stakeholders’ awareness towards biosafety legislations in this country is still very low. Except for those from research institutions and universities and regulatory

bodies/enforcement bodies/policy makers, not many respondents are aware that there is a law in Malaysia to regulate activities involving GMO.

Conclusions

Decisions about the development and use of animal biotechnology can be based on multiple factors. Knowledge of the science of animal biotechnology is needed to understand exactly what animal biotechnology involves and to appreciate its possible areas of applicability. Philosophical reflections on the moral significance of animals can inform the way applications of genetic engineering are evaluated, with respect both to their impact on animals and to the way that attempts to modify and control animals are viewed from an ethical perspective. A review of religious traditions of animal use highlights specific applications of biotechnology that may arouse sensitivities among adherents of those traditions. Social science research on the public’s attitudes toward animal biotechnology illuminates the way that philosophical or religious attitudes toward animals and biotechnology may be reflected broadly throughout the public. This kind of research can be used in making inferences about those applications of biotechnology that are most likely to spark opposition or consumer resistance. When science, ethics, religion, and social science are viewed concurrently in light of previous attempts to regulate animal biotechnology, it becomes apparent that society is struggling to develop public policies that appropriately reflect the diverse set of considerations that bear on applications of animal biotechnology in agriculture and the food system.


The Muslim seemed not to be very accepting of the transfer of animal genes particularly from pork to plants. They were also indecisive with regards to whether humans have the right to modify living things for their benefit as well as whether modern biotechnology is regarded as threatening the natural order of things. There is a need for the Islamic religious authorities and the Islamic scholars to come out with clear guidelines on the permissible status of various kinds of interspecies gene transfers to guide the Muslim public. In Malaysia, since the majority of citizens are Muslims and the official religion is Islam, Divine law should arguably be used as the moral basis for law and society (Hamid, 2000; Majdah, 2001). The regulatory status of modern biotechnology applications should be studied on a case by case basis and in line with Islamic principles as well as the consideration of the acceptance by other major religions in Malaysia. The government regulatory bodies should also come out with clear ethical guidelines regarding modern biotechnology, and suitable information should be disseminated to the public. The low level of familiarity identified indicates the need for more dialogue, forums for discussion and more balanced information to be made available to the public via the media. Government regulatory bodies related to modern biotechnology were only perceived as moderately efficient. So it is recommended that the relevant government regulatory bodies in Malaysia be more visible and responsible in setting the direction and pace of development to prevent questionable or premature commercialization of biotechnology applications/products. In Malaysia, the Biosafety Act was gazetted by parliament in 2007, and has been in force since 2009. The Act regulates the release, importation, exportation and the contained use of living modified organisms and the release of the products of such organisms, with the objective of protecting human, plant and animal health, the environment and biological diversity. However the regulation which will provide the detailed risk assessment procedure has still not been released.

REFERENCES

[1]Federal Constitution Malaysia [2]Biosafety Act 2007 (Act 678) [3]Suhakam Act (Act 597) [4]Cartagena Protocol on Biosafety (39 ILM 1027 (Cartagena Protocol)) [5]Universal Declaration of Human Rights (UDHR) 1948 [6]National Biotechnology Policy 2005 [7]National Biodiversity Policy 1998 [8]National Agriculture Policy (NAP) 3 [9]Monsanto Co. et al. v. Geertson Seed Farmset et al (561 U. S. ____ (2010)) [10]Abu Bakar Abdul Majeed, Bioethics- Ethics in the Biotechnology Century , 2002,IKIM [11]Barry R. Schaller, Understanding Bioethics and the Law, 2008, Todd (FRW) Brewster . [12]Carl E. Pray , “Costs and enforcement of biosafety regulations in India and China “ , Int. J. Technology and Globalisation, 2006 , Vol. 2, Nos. 1/2. [13]Celina Ramjoue, “The Transatlantic Rift In Genetically Modified Food Policy”, 2007, Journal Of Agricultural And Environmental Ethics (2007) 20:419–436 At Pg 431 AZIZI BIN AHMAD <3123006961> (4/13/34)PRINCIPLES OF CELL AND TISSUE CULTURe (BBD 1234) – MISS EMI FAZLINA DIPLOMA IN BIOTECHNOLOGY INDUSTRY (3/12/34)

[14]Darryl Macer, “Ethical, Legal and Social Issues of Genetically Modifying Insect Vectors for Public Health”, Insect Biochemistry and Molecular Biology 35 ,2005, 649-660 [15]Gary Comstock, Ethics and Genetically Modified Foods, 2010,Springer New York. [16]Helen Wallace, “GeneWatch UK comments on Risk Assessment report of the Malaysian Genetic Modification Advisory Committee (GMAC) for an application to conduct a limited Mark-Release-Recapture of Aedes aegypti (L.) wild type and OX513A strains”, 2011,extracted from http://bch.cbd.int/database/record-v4.shtml?documentid=101480.

Biotechnology or Genetic Engineering in Malaysia as seen through the MAHA show.



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Let's watch some of the photographs which I managed to collect, not just from the MAHA 2010 show but from other sources. Are you impressed?

How huge is the papaya, the jack fruit, the pumpkin and the star fruit! What about the chickens with no feather, just flesh so that you can just pop them into the oven or cut them up as you please on your dinner table. What about the goat which is almost as tall as a man or the black beast that you see which is neither a goat nor a horse. I didn't take a picture of the huge cows for they are already too familiar.

These genetically engineered vegetable, fruits and animals are already here in Malaysia, some of which are the product of our own scientific research endeavors in biotechnology. Even years ago we already have mangoes the size of a coconut called mangga harum manis. I did grow them once but few of the huge fruits could be enjoyed since the skin and flesh broke open while still too young to pluck and stow away to ripen.

Genetic engineering or biotechnology holds a lot of promise to become the science that will save human beings from hunger in the future with food production of fruits, vegetables, and farm animals that are huge and one unit itself can feed so many people ( like the ostrich egg). You will need only one papaya or starfruit to serve as an appetizer or dessert for maybe ten people at a dinner table. One pumpkin or a jack fruit would be able to serve a whole commumity of people.

Would that be nice? Would it be nice to eat an apple as big as a pumpkin? Would it be nice to eat rice with the grains as big as a groundnut seeds?

Obviously there are those who are opposed to the genetic engineering of food products and farm animals. One result that has been known is the spread of certain herbal strain that will resist weed control. It will just grow and grow and maybe overcome other herbal or vegetable growth. The effect on animal can be seen in the huge goats and cows that now exist, some with real ugly faces and appearance ( the chicken in the picture for instance). What if the transgenes in the genetically engineered vegetables and animals also affect human beings that consume them? AZIZI BIN AHMAD <3123006961> (4/13/34)PRINCIPLES OF CELL AND TISSUE CULTURe (BBD 1234) – MISS EMI FAZLINA DIPLOMA IN BIOTECHNOLOGY INDUSTRY (3/12/34)

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Genetic engineering on a human being might produce a frankenstein. I wonder what woudl happen to us if the dogs, horses, bulls, even the cats and chickens started growing to become bigger than we human beings. The age of the dynosaurs might yet return if genetic engineering is not property controlled and supervised.

These were some of the thoughts that filled up my mindght as i walked through the throngs of people visiting MAHA 2010 show ar Serdang. Other concern includes the crazy traffic jams, the great distance that you must walk without trams that can pick up people from anywhere at all in the expo area and drop them anywhere they want. The animals on display can do with a little bit of animal shows to attract the cowd and entertain the children.

As far as agricultural implements are concerned. the MAHA expo shows that only the simple and light inventions such as the oil-palm fruit cutter, the coconut husking device etc seemed to have been produced locally. The heavier machines are all produced overseas. I couldn't even find a small ride-on lawn mover which i needed very much. Only the light tilling machines are available and they are made outside the country.

The most obvious improvement made by our entrepreneurs seemed to be the packing and merchandizing of local food products. Yes the packing has certainly reached a standard suitable for overseas marketing. The variety of food products now commercialized is indeed very encouraging. You can have a free tasting of them all at the MAHA fair. Where else can you do such a thing?

Activists protest animal testing plans in Malaysia

By EILEEN NG

KUALA LUMPUR, Malaysia

An Indian biotech company's plans to set up laboratories for testing dogs and primates in Malaysia have angered animal rights groups who say the trial subjects could face suffering because the country has no regulations on animal research.

India's Vivo BioTech Ltd. inked a 450 million ringgit ($141 million) joint-venture deal in January to set up a biotechology center in southern Malacca state to develop and manufacture medicine. The center will include laboratories where trial medicines will be tested on animals.

Vivo officials declined to comment on the issue when contacted Monday. Malacca state officials could not be immediately reached for comment.


Activists say tougher regulations on animal testing in the West are pushing companies to outsource to Asia, where there are lax regulations and cheaper costs.

In a joint statement issued over the weekend, Malaysia's Society for the Prevention of Cruelty to Animals, the British Union for the Abolition of Vivisection and the European Coalition to End Animal Experiments cried foul over the project because Malaysia has no laws protecting the welfare of animals used in experiments.

"Malaysia currently has no legislation governing the use of animals in research," the statement said, adding that they opposed the proposed facility for "both ethical reasons and the lack of scientific validity of using animals in testing."

The groups submitted a protest letter to the government last week, urging it to halt the project, and also requested a meeting with the local authorities to discuss the issue, SPCA official Jacinta Johnson said Monday.

"Malaysia should not open the economy to businesses like this as it promotes cruelty," she said.

Officials from the wildlife and veterinary departments said Monday they were not aware of the project and have not received any application from Vivo Biotech to import animals for research.

The company has said previously that Vivo may import beagles from Holland and try to obtain domestic primates for testing before turning to overseas sources. Companies need permits to import or export wildlife or any protected species in Malaysia.

Last year, a French pharmaceutical research company proposed setting up an animal testing laboratory in southern Johor state using imported macaques, but the project was suspended amid an outcry from environmental groups.


The proposed facility in Malacca is a joint venture involving key majority shareholder Vivo BioTech, state government-owned Melaka Biotech Holdings and local firm Vanguard Creative Technologies.

Biotechnology, being one of the five core technologies that will accelerate Malaysia's transformation into a highly industrialized nation by 2020 has received strong governmental support and commitment. Accordingly, the government has encouraged the development of biotechnology through financial support for its research and development (R&D), infrastructure and human resource development (HRD). Currently, the majority of biotechnology R&D activities are being carried out in the public sector. The private sector on the other hand, has focused primarily on plant tissue culture. The annual production of orchids by tissue culture alone has been estimated to be worth RM 50 million, with an export earning of RM 33 million. Since biotechnology is carried out mainly in local universities and R&D institutions, a National Biotechnology Directorate (BIOTEK) was established in 1996 to promote and coordinate biotechnology R&D activities in the country and to promote private-public sector participation in the national biotechnology program.

Under the management of BIOTEK, biotechnology R&D activities in the country are categorized into seven sectors. These are namely molecular biology, plant biotechnology, animal biotechnology, medical biotechnology, environmental & industrial biotechnology, biopharmacy and food biotechnology. R&D activities in each sector are carried out via a Biotechnology Cooperative Center (BCC) which is overseen by a coordinator. Since Malaysia is basically an agriculture-based country, it is not surprising that agricultural and food biotechnology have received greater emphasis. Agricultural biotechnology is envisaged as a potentially powerful tool to ensure food security for the country. It is also a vehicle for wealth creation. Tissue culture of several industrial crops (oil palm, rubber, rattan, forest trees) together with food crops (rice, banana, sago, herbs and medicinal plants) and ornamentals (orchids, pitcher plants) have been successfully carried out for sometime.

Several genetically modified crops and plants containing traits of value have been produced at the experimental stage. Prominent among these products are genetically modified rice, manipulated to resist the tungro virus and papaya modified to resist ringspot virus infection and with prolonged shelf life. Other crop plants such as pineapples are manipulated to resist "black heart", bananas and papaya for delayed ripening, chili for virus resistance, and sweet potatoes (albeit, preliminary), for delivery of edible vaccines. Flowers such as orchids are being engineered to express novel colors as well as increased shelf life. Transgenic technologies have now been developed to genetically modify such critical crop species as oil palm and rubber.

DNA marker techniques have been applied to several plants (oil palm, rubber, cocoa, sago, acacia, sentang, bananas, etc.) for identification, inheritance studies, marker assisted selection in breeding AZIZI BIN AHMAD <3123006961> (4/13/34)PRINCIPLES OF CELL AND TISSUE CULTURe (BBD 1234) – MISS EMI FAZLINA DIPLOMA IN BIOTECHNOLOGY INDUSTRY (3/12/34)

and genetic mapping. Preliminary genetic maps for oil palm and rubber have been generated and these can be further exploited for making quantitative trait loci (QTL) maps to locate traits of economic importance. These will be utilized in marker-assisted selection, resulting in reduced costs and increased efficiency of conventional breeding.

In general, food biotechnology is relatively new in Malaysia although food and food ingredients produced by traditional biotechnology like fermentation technology have brought to market products like soy sauce, yogurt, nata, tempeh, tapai and budu. Food biotechnology has also yielded high quality clarified fruit juices. Currently biotechnology processes, which are being employed by the food industry in the private sector, are the production of monosodium glutamate, vinegar, yeast, and syrups (glucose, fructose and maltose).

Several animal recombinant vaccines have been produced to assist the development of animal husbandry. Marker assisted breeding strategies are also being practiced to increase the efficiency of livestock breeding programs. To reduce the costs associated with importing food and feed, research is also underway to generate livestock feed through biotechnology that can substitute for the imported corn currently used for animal feed.

A number of industries producing industrial solvents, sweeteners and food additives based on conventional biotechnology such as fermentation processes have been in existence for decades in this country. The application of bio-remediation techniques in the treatment of industrial and agricultural wastes has found widespread acceptance. New developments in industrial biotechnology in Malaysia encompass activities such as the optimization and enhancement of new treatment systems through bio-augmentation or genetic engineering. Research into the development of new monitoring tools viz. biosensors are in progress. This will facilitate accurate and real time monitoring of the environment.

Research in medical biotechnology has generated several diagnostics kits for dengue and other infectious tropical diseases. Although R&D activities in biopharmacy are relatively new in this country, a bioenhanced formulation of the anti-malarial drug artermisinin, with increased efficacy has been produced. Other projects that have been planned or are currently under development include medium through-put screening for bioactive compounds, the experimental production of biomolecules using biotechnological approaches, and the development of advanced drug delivery systems for biomolecules.

One international partnership is with the Massachusetts Institute of Technology and entitled the Malaysian-M.I.T. Biotechnology Partnership Program (MMBPP). Established less than two years ago,


the program has focused on natural product discovery and oil palm biotechnology. The program has already generated intellectual property with two natural products by focusing on fundamental questions relevant to the establishment of new products and processes. A proposal for commercializing one of the technologies is being formulated.

Cognizant that biotechnology is a knowledge-driven technology, the government has established a National Biotechnology and Bioinformatics Network (NBBnet). This has helped to promote closer collaboration and networking within and outside the country, initiated the setting up of databases and bioinfomration of our local genetic resources and core R&D activities of the BCCs. Nabbinet has also facilitated the establishment of high computing facilities for protein modelling and DNA analysis.

Despite the many R&D activities that have been undertaken in Malaysia, the country has not experienced a significant growth in its biotechnology industry. Global benchmarks such as the number of biotechnology companies founded or the number of biotechnology-related patents that have been issued to Malaysian inventors all indicate that the considerable investment the country has made in biotechnology has not captured the opportunity to translate the nations biotechnological assets into the growth of the K-economy. The greatest causes underlying this unfortunate state of affairs are the lack of a critical mass of co-located innovators, lack of state-of-the-art facilities and the lack of a strong entrepreneurial environment and mechanism for commercialization. Given the current state of biotechnology in Malaysia, there is now a tremendous opportunity to capitalize on developments in biotechnology by addressing the two major shortcomings in the Malaysian biotechnology industry. The BioValley project has been designed specifically to do this.

For example, participants said some people clearly just feel there is something intrinsically immoral about the processes of transgenesis and cloning. They “just don’t like it.” They feel it is akin to “playing God.” They may also feel that animal biotechnology negatively alters our view of our relationship to animals and to the natural world more broadly. Regarding transgenesis specifically, some people believe we should not be altering animal biology in such a specific way. They raise the concern that manipulating DNA has the potential to violate an animal’s fundamental nature. “An animal is a being or has a being,” one person said, “and that animal’s nature should be taken into account as we decide what we want to do with it.” Transgenesis also may conflict with some people’s religious beliefs regarding the crossing of species and the need to respect animals. Others question the motives behind the need to genetically engineer animals. They wonder why it must be done, and whether it is simply so companies can increase profits and/or agricultural production. These individuals believe that GE animals should be created only if a compelling need exists, and we should not use animals in a purely


instrumental way (i.e., simply for our own wants and needs) or for frivolous purposes. At the same time, some suggest it is unethical to stifle or stop a technology that has the potential to save human lives. Other critics of animal biotechnology focus on the consequences of transgenesis and cloning. One participant said that one of the obvious ethical concerns is that transgenesis and cloning could result in undue pain and suffering for animals. For example, cloning, for the first generation anyway, requires animals to undergo invasive surgical procedures, and a high percentage of attempted clones are lost through miscarriage or early death. Also, some cloned animals have been shown to have significant developmental problems. One participant argued that it was important not to generalize about these problems, because transgenic catfish and carp have been developed without the use of invasive methods and they have not had any deformities, nor have their survival rates differed from their non-transgenic counterparts. Another potential consequence mentioned was that the genetic engineering of species that can escape into the wild could have detrimental impacts not just on individual animals, but on whole species and/or ecosystems

In the process of summarizing the ethical and moral concerns, workshop participants also delved into why these concerns exist—what the reasons are behind them. Several people pointed out that the public does not understand the processes of transgenesis and cloning; these are very complex technologies that are difficult for the layperson to grasp. Because the technologies are complex, and also because they are new and unfamiliar, they make people uncomfortable. New technologies often meet with skepticism and resistance. (“When artificial insemination was introduced into the dairy industry after World War II,” said one participant, “people thought it would be the demise of the species.”) At the same time, it was noted that polls show that people who know something about biotechnology are not necessarily more accepting of it.Others said that some of the concerns can also be explained by the fact that the general public still does not understand much about the breeding techniques that have been used for years in conventional agriculture. If people used the right comparators, it was said, they would see that transgenesis and cloning are just the next steps in the continuum of reproductive technologies. Also, people do not understand how animals are treated in conventional production agriculture, and if they did, they would see that animals used in agricultural biotech research are treated the same as or better than those in conventional agriculture. As one person put it, “The range of possible harms to animals due to human intervention is almost endless, and biotechnology does not increase that in any material way.” Another person noted that the kinds of questions being raised about animal biotechnology—the framework being used to assess it—were not that different than those raised about industrial animal agriculture in general. “The ethical litmus test is,” one person said, “are we reducing animal suffering and pain? Are we providing the animal with the freedoms it needs?”Some of the concerns about animal biotechnology may also stem from the fact that biotechnology allows scientists to do things that they have not been able to do before, and to accomplish them faster. One participant questioned whether the development of the technology is outpacing the development of normative ethical behaviors regarding its use. “Has the right groundwork been laid?” he asked. “Have the right


kinds of discussions taken place that would establish normative behaviors against which you could then gauge immoral or unethical behavior?” A related point that some raised is that we have no public forum in the U.S. for

discussing and addressing these concerns. Also, we live in a multi-ethnic, multi-religious society, and we have no way to reconcile our diverse ethical viewpoints. Thus the concerns escalate rather than being discussed and handled. Finally, one person said he felt some of the concerns were due to the fact that the science of genomics has shown us that we are not as different from animals as we have thought in the past. Perhaps the knowledge of that, he said, simply makes us uncomfortable.


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