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Chapter: Basic Concept of Biotechnology : Animal Biotechnology

Ethical Issues(biosafety and regulatory issues) - Animal Biotechnology

Biosafety and Ethics: All procedures involved in the collection of human material for culture must be passed by the relevant hospital ethics committee.

Ethical Issues; (biosafety and regulatory issues):


Biosafety and Ethics

All procedures involved in the collection of human material for culture must be passed by the relevant hospital ethics committee. A form will be required for the patient to sign authorizing research use of the tissue, and preferably disclaiming any ownership of any materials derived from the tissue [Freshney, 2002, 2005]. The form should have a brief layman’s description of the objectives of the work and the name of the lead scientist on the project. The donor should be provided with a copy. All human material should be regarded as potentially infected and treated with caution. Samples should be transported securely in double-wrapped waterproof containers; they and derived cultures should be handled in a Class II biosafety cabinet and all discarded material autoclaved, incinerated, or chemically disinfected. Each laboratory will have its own biosafety regulations that should be adhered to, and anyone in any doubt about handling procedures should contact the local safety committee (and if there is not one, create it!). Rules andregulations vary among institutions and countries, so it is difficult to generalize, but a good review can be obtained in Caputo [1996]. Genetic modification of organism can have unpredictable/ undesirable effects when such organisms are introduced into the ecosystem. The modification and use of such organism for public service has also resulted in problems with the granting of patents. Hence, the Indian Government has set up organizations which are authorized to make decisions regarding the validity of genetic modification and the safety of introducing genetically modified organisms fro public services. One such organization is the Genetic Engineering approval committee (GEAC).

Biosafety Levels

The regulations and recommendations for biosafety in the United States are contained in the document Biosafety in Microbiological and Biomedical Laboratories, prepared by the Centers for Disease Control (CDC) and the National Institutes of Health (NIH), and published by the U.S. Department of Health and Human Services. The document defines four ascending levels of containment, referred to as biosafety levels 1 through 4, and describes the microbiological practices, safety equipment, and facility safeguards for the corresponding level of risk associated with handling a particular agent.


Biosafety Level 1 (BSL-1)

BSL-1 is the basic level of protection common to most research and clinical laboratories, and is appropriate for agents that are not known to cause disease in normal, healthy humans.


Biosafety Level 2 (BSL-2)

BSL-2 is appropriate for moderate-risk agents known to cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure. Most cell culture labs should be at least BSL-2, but the exact requirements depend upon the cell line used andthe type of work conducted.


Biosafety Level 3 (BSL-3)

BSL-3 is appropriate for indigenous or exotic agents with a known potential for aerosol transmission, and for agents that may cause serious and potentially lethal infections.


Biosafety Level 4 (BSL-4)

BSL-4 is appropriate for exotic agents that pose a high individual risk of life-threatening disease by infectious aerosols and for which no treatment is available. These agents are restricted to high containment laboratories. For more information about the biosafety level guidelines, refer to Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, which is available for downloading at www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm.


The industrialized/ developed nations are rich financially, bur poor in biodiversity and traditional knowledge, while the developing and underdeveloped countries are rich in bioresources and traditional knowledge. Some such developed countries use the bio resources and traditional knowledge of other countries without proper authorization and/ or compensation to the countries concerned (Biopiracy). Eg: Basmati rice grown in India is distinct for its unique flavor and aroma, but an American company got patent rights on Basmati through the US patent and trademark office; the new variety of Basmati has been developed by this company by crossing an Indian variety with semi-dwarf varieties. Now some nations are developing laws to prevent such unauthorized exploitation of their bioresources and traditional knowledgeEthical issuesassociated with transgenics and cloning.


Technology isn’t perfected yet with very low success rate, the animal developed has high mortality rates.


·        Safety/risk of consumption


According to the U.S. Food and Drug Administration cloned animals probably safe to raise and eat. Transgenic ones may not be safe to consume.


·        Animal welfare


Birth weights, longer gestation, difficult births in clones. Poor survival rate of fetuses using some techniques. Anatomical, physiological, behavioral abnormalities


·        Suffering of transgenic animals


Case of Beltsville pigs (human GH introduced): High mortality, arthritis, gastric ulcers, degenerative joint disease, infection, lethargy. Cloned animals found to have shortened life spans with health problems.

Implications for application of technologies to humans

Moral concerns: “are we playing God?” Impact on ecosystems and genetic diversity –What if GE organisms escape reproduce? What might be the impact of limited gene pools on livestock faced with new (deadly) pathogens? Potential for GE animals to move into areas previously unused for agriculture disrupt fragile ecosystems habitat preservation issues for wild animals.Lack of controls to prevent GE animals from entering the food chain (e.g., cows that produce drugs in their milk)

Animal biotechnology and law

“Any food system practice that does not allow individuals who do not want to consume meat or milk from clones to act upon theirvalues at a reasonable cost is ethically unacceptable and ought to be illegal.” (Thompson, 1997)

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