INTRODUCTION

The field of biotechnology has had a lot of beneficial contribution in the area of healthcare, agriculture, food production, manufacture of industrial enzymes, and appropriate environmental management.With the flexibility of BSN online programs available, health care institutes, cultivating industries and other available resources the biotechnology field is growing rapidly and more professionals are educating and preparing themselves in this field as it arises. However, the advancement in this field has also lead to some concerns and controversies raised by a number of groups, NGOs etc. ELSI is the short form to represent the ethical, legal, and social implications of biotechnology. ELSI broadly covers the relationship between BIOTECHNOLOGY and SOCIETY with particular reference to ethical and legal aspects.

Concerns about the Genetically modified organisms (GMOs)

Biosafety is defined as the assessment of the impact and safety of products of modern biotechnology or recombinant DNA technology and the development of policies and procedures to ensure this. In general, concerns of biosafety of biotech products are basically the evaluation of the possible effects on the environment and to human health.

Historically also, in 1974, a group of experts lead by Nobel Laureate James D Watson voluntarily halted experiments involving transfer of genes of dangerous toxins from one group of microorganisms to another 
or involving genes of tumour viral genomes. In 1975, a group of experts met at Asilomar, California. This led to the establishment of guidelines for use in recombinant DNA research and development.  Research and Development and the commercial products involving GM technology are regulated from laboratory research, to field work and to product advancement in the market. Assessment is strictly science-based, is conducted by the regulatory body and its Scientific and Technical Review Panels and is done on a case-by-case basis. There is public consultation on any technology that will be field tested or commercialized.

Prior to the approval of any biotech product for commercialization, proper risk assessment is done regarding its impact of environment and human health. Risk assessment of a biotech product is a process by which hazards to health and environment which can be brought about by the release of said products are identified, as well as the magnitude and the probabilities of its possible adverse effects are determined. There are several components of risk assessment:

1. Risk identification- This process involves the identification of the possible danger if the GM plant is handled, or eaten as food or feed, or planted as a crop beyond that obtained when the traditional counterpart is used.
2. Risk evaluation- This involves calculation of the probability that such a danger or hazard will occur, the extent of damage expected from the occurrence of such danger and the comparison of these products with other products.
3. Risk mitigation- This involves finding measures to be adopted to reduce the probability that the danger will occur or to minimize the damage if such danger actually happens.

The food safety and the impact of GM crops is especially very important. The risk assessment of the GM crops involves finding the possible effects of GM crops on beneficial insects and biodiversity. There is concern about a possible gene flow or crossing with other varieties or wild relatives that may lead to the production of weeds or super weeds. There is also risk of formation of resistant insect pests and their possible persistence in the environment.  The food safety issue is concerned with the possible allergenicity and toxicity of the products.  

There are concerns regarding the biosafety, ethics and issues related to the release of GMOs in the environment. Many contries and NGOs have opposed the release of the GMOs due to these reasons. In order to address theses issues, the UNIDO/WHO/FAO/UNEP has built up an Informal Working Group on Biosafety. In 1991, this group prepared the “ Voluntary Code of Conduct for the release of Organisms into the Environment”. The ICGEB organizes annual workshops on biosafety and on risk assessment for the release of GMOs. It collaborates with the management of UNIDO’s BINAS (Biosafety Information Network and Advisory Service), whose aim is to monitor the global development in regulatory issues in biotechnology. An on-line bibliographic data-base on biosafety and risk assessment has also been created by ICGEB to evaluate the environmental release of GMOs.
Besides this, the ICGEB also assists its member states in developing the national biosafety framework.

The main areas of consideration for safety aspects in biotechnology are the following:

a) How to dispose off spent microbial biomass and purify the effluents from biotechnological processes?
b) The toxicity of the allergy associated with microbial production.
c) How to deal with the increase in the number of antibiotic resistant pathogenic microorganisms?
d) How to evaluate the pathogenicity of the genetically engineered microorganisms to infect humans, plants and animals?
e) How to prevent contamination, infection or mutation of the processed strains?
f) The evaluation of the interaction of the genetically engineered microbes with the elements of natural environment.

In the past, time and again, there has been public outrage against the use of genetically modified or transgenic plants and other organisms. In 1999, a British medical journal published the adverse effect of genetically modified (GM) potato (which was produced by Rowett Research Insitute). This potato was found to contain snow drop lectin which affected the small intestine of the rats and stunted the growth and damaged their immune system. This led to worldwide public concern about this issue and created a lot of controversy about the safety of GM foods.

The transgenic Bt-plants such as cotton, corn, soybean, and potato were approved for cultivation in USA. However, some countries did not allow Bt-plants in their fields e.g. Br-rice was not allowed in Philippines, Bt-cotton in France. Many Governments are also suspicious of the use of GMOs due to various reason-risks, societal beliefs, and economic concerns.

Biological Warfare?

Most of the countries of the world are signatories to the Biological Weapons Conventions of 1972. As a signatory, it is a voluntary pledge by a nation “never to produce microbial or other biological agents or toxins, whatever may be their method of production, for use in wars. However, many people have expressed their concerns about the possible use of genetic manipulations for military purposes in the near future.

Intellectual Property

With the fast pace development in the field of biotechnology, the issues related to legal characterization and the treatment of trade related biotechnological processes and products are of immense importance. These are popularly known as Intellectual Property. Intellectual Property includes Patents, trade secrets, copyrights, and trademarks. Intellectual Property Rights (IPR) is a collective term applied to a number of different types of legal rights granted by each country.
The rights to protect this property prohibits others from making, copying, using or selling the proprietary subject matter.

In biotechnology, the intellectual property covers the processes and products which result from the development of genetic engineering techniques through the use of restriction enzymes to create recombinant DNA.

Another example of intellectual property is the development of crop varieties which are protected through “plant breeder’s rights or PBRs. The PBRs ensures that the plant breeder who developed a particular variety gets the exclusive rights for marketing the variety.
Agriculture for the first time was included in the trade related intellectual property rights (TRIPS) and TRIPS is a major concern for developing countries. The following two major steps were taken in consideration of PBRs:
(a) The Food and Agriculture Organisation (FAO) has an International treaty on plant genetic resources for food and agriculture. This treaty consists of a particular classes which refers to operation of farmer’s rights.
(b) The ‘Plant Varietal Protection and Farmer’s Rights Act 2001 agrees for the right of farmers, breeders, and researchers. The protection is provided by making compulsory licensing of rights, and inhibiting the import of plant varieties consisting of ‘genetic use of restriction technology’ (GURT) e.g. terminator technology of Monsanto.

Following conditions should be fulfilled to grant protection to the new varieties:

a) the new variety must always be new i.e. it should not have ever been exploited commercially.
b) It should be biologically distinct and possess different characters.
c) The new variety of the plant must have uniform characters.
d) The distinguishing character of new variety must be stable for generations.
e) The new variety should have taxonomic validity i.e. systematic position, generic and species names etc.

Recently Utility patents for both plant and animal genetic materials, have been allowed in some countries. This forbids the use of patented material for further breeding. The farmers are allowed to use and save the seeds for cultivation only after paying a fee to the patent holder.

Some concerns have been voiced regarding the implications of IPR on the genetic diversity and the conservation of genetic resources. IPRs will directly or indirectly affect the food security and distribution around the globe, biological diversity and ecological balance, employment avenues in the poor and developing countries, and the use of new and effective agricultural practices.

Biopiracy

The act of Piracy is unauthorized publication or reproduction of another person’s work or material. When someone indulges in piracy, the accused is using someone’s else’s work illegally or with out taking any permission. Biopiracy is the appropriation of another’s knowledge of use of biological resources. Of late, the major issue involving biopiracy is the exploitation of patent biological resources or knowledge of farmers and traditional communities and indigenous tribes  by many organizations and multinational companies. The innovations and discovery of the pharmaceutical and agricultural researches are not new as to qualify as invention as they are based on centuries of knowledge of the traditional societies.

Example of Biopiracy

Patenting of Neem  (Azadirachta indica)

The people of India in a variety of ways have used neem, since time immemorial. Indians have shared the knowledge of the properties of the neem with the entire world. Pirating this knowledge, the USDA and an American MNC W.R. Grace in the early 90s sought a patent (No. 0426257 B) from the European Patent Office (EPO) on the “method for controlling on plants by the aid of a hydrophobic extracted neem oil.” The patenting of the fungicidal properties of Neem was an example of biopiracy.

Patenting of Basmati

Basmati is a long-grained, aromatic variety of rice indigenous to the Indian subcontinent. In 1997 the US Patent and Trademark Office (USPTO) granted a patent (No. 5663484) to a Texas based American company Rice Tec Inc for “Basmati rice line and grains”. The patent application was based on 20 very broad claims on having “invented” the said rice. Due to people’s movement against rice Tec in March 2001 the UPSTO has rejected all but three of the claims.

Rice Biopiracy

Syngenta  is a biotech company that tried to grab the precious collections of 22,972 varieties of paddy, India’s rice diversity, from India’s rice bowl, Chattisgarh in India. Syngenta has signed an MoU with the Indira Gandhi Agricultural University (IGAU) for access to Dr. Richharia’s priceless collection of rice diversity. Dr. Richharia is the ex-director of Central Rice Research Institute (CRRI), Cuttack and is known as the rice sage of India who has done pioneering work in this field.

Biopiracy of African Super-sweet Berries

A west African plant, Pentadiplandra brazzeana is a source of a protein called Brazzein which is 2000 times sweeter than sugar. Natives have used Brazzein as a low calorie sweetener for centuries. Sometime back the gene encoding brazzein was isolated, sequenced and patented in USA. It is proposed to transfer the brazzein gene into maize and express it in maize kernels. These kernels will then be used for the extraction of brazzein. This development could have serious implications for countries exporting large quantities of sugar.

Biowar/Biological war

Biological war or bioterrorism is the deployment of biological weapons against people, their crops and animals. Bioterrorism is a threat being faced by the world over. Bioterrorism refers to the intentional or threatened use of viruses, bacteria, fungi or toxins from living organisms to produce death of disease in humans, animals and plants. Historically, the first reported use of biological weapons was in 5th century BC when Assyrians poisoned enemy wells with rye ergot. On several occasions, small pox was used as a biological weapon, Pizarro is said to have presented South American natives with variola-  contaminated clothing in the 15th century. Iraq is reported to have conducted research and development work on anthrax, botulin, aflatoxin, wheat cover smut and ricin. It was reported that Al-Qaeda activists used Anthrax spores against USA and her allied countries.

 A biological weapon or bioweapon carries and delivers to the target organism a pathological biological agent or a toxin derived from it.  The biological agent or the biotoxin/bioweapon agent is safely kept in a suitable container to keep it active and virulent during delivery. This container can be delivered using various ways including missiles and aircraft.

Among weapons of mass destruction, biological weapons are more destructive than chemical weapons including the nerve gas. Under certain circumstances, biological weapons can be as devastating as a nuclear explosion e.g. a few kilograms of anthrax can kill as many as people as a Hiroshima-sized nuclear bomb. It is feared that Bioweapons are low cost, invisible and difficult to detect and at the same time far more potent causing far more casualties than chemical or conventional weapons. These features make bioweapon very convenient to use and hence are being favored by terrorist organizations and some governments. Unconfirmed sources suggest that these have been already used on a limited scale. Mass-produced pathogens or their toxins are delivered either as powder or in the form of spray, using a variety of delivery devices.

Various poisons produced by different biological pathogens act like some neurotoxins, such as saxitoxin can kill individuals by blocking nerve conduction directly. Botullin toxin is a very potent toxin that can enter nerve terminals and block the release of neurotransmitters. Another plant toxin, ricin kills by blocking protein synthesis in many cells. Since 1998, the US government has started efforts to create a biological weapons defense mechanism that includes the use of respirator or gas mask, vaccination, treatment with suitable antibiotics and decontamination. Sensitive detection systems are being developed to control and minimize the damage.

Table summarizing various Biological Warfare Agents

Pathogens	Smallpox virus Viral encephalitides Viral hemorrhagic fevers Bacillus anthracis   Brucella suis Coxiella burnetii Francisella tularensis Yersinia pestis
Toxins	Botulinum Ricin Stylococcal enterotoxin B
Anticrop Agents	Rice blast Rice stem rust Wheat stem rust

 
Bioethics

Bioethics is the branch of ethics, philosophy, and social commentary that deals with the biological sciences and it’s impact on the society. It can be useful in focusing attention on problems that need to be solved. Biotechnology has been getting conflicting opinions ranging from “being unnatural” to “being detrimental to biodiversity”. The more serious aspect of bioethics is known as ELSI- Ethical, Legal, and Social Issues. Some of the major concerns regarding this field range from using animals for experiments to jumping of transgenes and diluting of concept of humanness. Animal Rights Activists point out their cause of concern that the use of animals in biotechnology causes great suffering to them. When animals are used for production of pharmaceutical proteins, they are virtually reduced to the status of a “Factory”.

Further, the introduction of a transgene from one species into another species violates the concept of the “Integrity of the species”. Transfer of human genes into animals and vice versa dilutes the perception of “humanness”. Biotechnology may cause unforeseen risks to the environment including the threat to biodiversity. Biotechnology is being perceived as a science that is disrespectful to living organisms and exploits them only for the benefit of human beings.