Benefit/risk analysis

As you know, organic products provide many of the necessities and comforts of your life. They are also responsible for a great deal of damage, including environmental pollution and harm to human health. In this Thought Lab, you will perform risk-benefit analyses on three organic compounds. 

Estimation of risk. This is based on mouse data perhaps supplemented with ancillary information from other sources, to be used by those who have to make risk-benefit analyses. 

Mutational risk-benefit analysis is quite different from most risk-benefit analyses. It is not unusual for... 

Despite its beneficial effects as a metal chelator and its use in the treatment of heavy metal intoxication, EDTA and its related compounds are still chemical agents and, as was pointed out by Paracelsus almost 500 years ago, all chemicals are toxic if given in sufficient quantities. As with any medical procedure, the risk of the treatment has to be balanced against its beneficial effects. For realistic risk-benefit analyses it is necessary to understand all of the risks involved. 

I have included in today s presentation three of these issues first, the distinction between a "new" and a "naturally occurring" chemical substances for the purpose of the applicability of the premanufacture notification (PMN) requirement of TSCA second, the scope of the research and development exemption from the PMN requirements, and its implication for open field testing of microorganisms and third the type and amount of information that EPA might need for risk/benefit analyses of new microorganisms. I will also briefly mention some technical areas in which further research would greatly facilitate the processes of risk/benefit assessment. 

We cannot continue to propagate the notion that all animal carcinogens are equally hazardous any more than all other toxins are equally hazardous. This totally discourages any attempts by individuals in society to prioritize and discriminate in their own risk/benefit analyses, and the public should clearly have this privilege. Much of the misinformation admittedly is the result of media coverage and sensationalism. But it should be... 

A typical example of risk/benefit analyses by EPA was the recent RPAR against the herbicide pronamide. Pronamide was found to produce liver tumors in male mice. After careful evaluation of the exposure levels in humans, the number of excess tumors to be expected from this exposure, the monetary loss if the registration of pronamide were canceled, and the availability of... 

Risk-benefit analyses" and "public health impact estimates" were the basis of "draft reports" released by the EPA in January 1975 (40, 41) (after they had been unofficially "leaked"). These "issue papers", which either included no references (41) or made references primarily to internal EPA memos, studiously overlooked completely the EPA s own clinical studies on the health effects on animals of exhaust from non-catalyst and from catalyst-equipped engines, which had been reported to the scientific public (42) and at the EPA S3nnposium on "Impact of Mobile Emission Controls" in April of 1974 (43). Those studies indicated no adverse effects on animals exposed to 1 10 diluted catalytic converter-treated exhaust during a period (1 week) which produced mortality rates of greater than 70% in infant rats exposed to similarly diluted non-catalyst-treated exhaust. 

Risk/benefit analyses may answer a spedfier s questions, but once the commitment is made to meet a spedfic standard, formulators must be certain they meet it. A couple of key issues are discussed below. 

Several risk-benefit analyses have favored the use of the flame retardants, since fire and smoke cause severe environmental injury besides the direct losses of life and property. For example, the polycyclic aromatic hydrocarbons which occur in copious amoimts in soot have been indicated to be orders of magnitude more... 

Nakanishi, J. Oka, T. (1998) The Importance of Risk-Benefit Analysis in Risk Management Decision Makings A Cast Study of a Mercury Pollution Prevention Measure in Japan. Paper presented to OECD Workshop, London. 

The Belmont Report s principle of beneficence refers to the need to ensure that all aspects of a study are designed to obtain the desired knowledge in a way that maximizes benefits and minimizes risks to the participants. The principle of beneficence also means that a risk-benefit analysis must be performed on every proposed study. In determining if fhis ratio is ethical, consideration must be given to the impact on both the participants and society. 

How can you make the most informed decision possible when analyzing the risks or benefits of a product or issue The following steps are one way to carry out a risk-benefit analysis for the manufacture and use of an organic compound. 

Follow the four steps for a risk-benefit analysis, given at the beginning of this section. You will need to carry out additional research on the compounds of your choice. 

O In section 2.3, you learned about some of the risks and benefits of polymers. Choose a synthetic polymer from section 2.3. Carry out a risk-benefit analysis of this polymer. 

Use print and electronic resources to study compounds that have been produced as diet aids, such as aspartame and olestra. How do these compounds work Are there drawbacks or risks involved in using these compounds Choose one compound, and conduct a risk-benefit analysis. 

Wilson, R. and Crouch, A. C. (2001) Risk-Benefit Analysis. Cambridge, MA, Harvard Center for Risk Analysis. 

Renwick, A.G., A. Flynn, R.J. Fletcher, D.J.G. Muller, S. Tuijelaars, and H. Verhagen. 2004. Risk-benefit analysis of micronutrients. Food Chem. Toxicol. 42 1903-1922. 

Ocular endotamponades based on FCL are and will be interoperative tools. They have to be removed after use. The risk-benefit analysis must be the base for defining the maximum treatment period. The mean task of these devices is space filling/maintaince. 

The risk-benefit analysis should include a clear and concise description of ... 

Risk assessment is a scientific process. The next stages are risk benefit analysis and risk management, which require a different type of approach. 

B-81MI10602 Risk-Benefit Analysis in Drug Research , ed. J. F. Cavalla M.T.P. Press,... 

Kieffer, R. Validation, risk-benefit analysis. PDA J Pharm Sci Tech 49(5) 249-252 (1995). 

The accepted risk is a risk inferior to a level defined in advance either by law, technical, economical, or ethical considerations. The risk analysis, as it will be described in the following sections, has essentially a technical orientation. The minimal requirement is that the process fulfils requirements by the local laws and that the risk analysis is carried out by an experienced team using recognized methods and risk-reducing measures that conform to the state of the art It is obvious that non-technical aspects may also be involved in the risk acceptation criteria. These aspects should also cover societal aspects, that is, a risk-benefit analysis should be performed... 

Risk benefit analysis in review of marketing applications for drugs to treat life-threatening and severely debilitating illnesses. 

Risk/Benefit Analysis of Recombinant Microbe-Based Screens... 

Table 4 Risk/Benefit Analysis of Screens Based on Recombinant Microorganisms Advantages Disadvantages...

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