Risk assessment biotechnology

G.S. Sayler and G. Stacey. 1986. Methods for Evaluation of Microorganism Properties. In Biotechnology Risk Assessment (J.R. Fiksel and V.T. Covello eds.) Pergamon Press, N.Y. 

OECD. 2003. Descriptions of Selected Key Generic Terms Used in Chemical Hazard/Risk Assessment. Joint Project with IPCS on the Harmonisation of Hazard/Risk Assessment Terminology. OECD Series on Testing and Assessment No. 44. Environment Directorate, Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. ENV/JM/MONO (2003)15. Paris OECD. 

JRC is structured into seven institutes, one of these being the Institute for Health and Consumer Protection (IHCP). The IHCP activities are related to genetically modihed organisms, biotechnology, chemicals and risk assessment, nano-biotechnology, exposure to environmental stressors, food contact materials and consumer products, and alternative methods to animal testing (IHCP 2006). 

Since risk analysis plays an important role in public policy decision making, efforts have been made to devise a means by which to identify, control, and communicate the risks imposed by agricultural biotechnology. A paradigm of environmental risk assessment was first introduced in the United States by Peterson and Arntzen in 2004. In this risk assessment, a number of assumptions and uncertainties were considered and presented. These include (1) problem formulation, (2) hazard identihcation, (3) dose-response relationships, (4) exposure assessment, and (5) risk characterization. Risk assessment of plant-made pharmaceuticals must be reviewed on a case-by-case basis because the plants used to produce proteins each have different risks associated with them. Many plant-derived biopharmaceuticals will challenge our ability to define an environmental hazard (Howard and Donnelly, 2004). For example, the expression of a bovine-specihc antigen produced in a potato plant and used orally in veterinary medicine would have a dramatically different set of criteria for assessment of risk than, as another example, the expression of a neutralizing nonspecihc oral antibody developed in maize to suppress Campylobacter jejuni in chickens (Peterson and Arntzen, 2004 Kirk et al., 2005). 

Sterner TR, Robinson PJ, Mattie DR, Burton GA. 2005. The toxicology of chemical mixtures risk assessment for human and ecological receptors. AFRL-HE-WP-TR-2005-0173. Wright-Patterson AFB (OH) Air Force Research Laboratory, Human Effectiveness Directorate, Biosciences and Protection Division, Applied Biotechnology Branch. 

Carol N. Scott. Executive Director of the Committee to Coordinate Environmental Health and Related Programs, U.S. Department of Health and Human Services, speaking from the perspective of the public policy analyst, noted that in an ideal political and social climate a risk assessment should, in advance of a crisis, present to knowledgeable risk managers a quantitative risk assessment which expresses all of the uncertainties incorporated in the assumptions. However, too often the crisis occurs first, and the public-press-politician synergistic relationship takes over, as in the case of the ethylene dibromide situation, or someone leaks misinformation to the press, as in the case of Alar, or politics takes over, as in the case of the controversy over the appropriate ways to use and regulate biotechnology. 

The safety issues associated with GMO process-based biotechnology have resulted in a formalised set of regulations. In the UK, the Contained Use (1992) Regulations have implemented the EC Contained Use Directives. Risk assessment is a key requirement of the GMO regulations. For contained use, the emphasis historically has been on human health and safety but environmental considerations have gained increasing significance. 

Keir, D. (1991). Role of probabilistic safety assessment in biotechnology risk assessment. In Proceedings of the SCI Symposium Risk Assessment in Biotechnology, London, 20/06/ 91. 

Veterinary medicines, including vaccines and other products derived from biotechnology, also have the capacity to enter the environment and these too are subject to regulation, risk assessment and guidelines, as discussed in Chapter 2 these too have the capacity to affect environmental and human health. ... 

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