Liability regulatory

Comprehensive costing procedure (CCP). The economic procedure includes not only the traditional capital and operating costs but also peripheral costs such as liability, regulatory related expenses, borrowing power, and social considerations. 

Mistakes or delays could have serious consequences (e.g., health hazards, liability exposure, regulatory sanctions). 

In considering the economics of process alternatives, it is important to think about the total life cycle costs. There is an increasing interest in this concept in the environmental area, with a recognition of the need to incorporate waste treatment, waste disposal, regulatory compliance, potential liability for environmental damage, and other long term environmental costs into project economic evaluation. Similarly, we must consider life cycle safety costs. Some examples of factors which should be considered include ... 

Chemical treatments for bacteria control represent significant cost and environmental liability. Because the regulatory pressure on the use of toxic biocides is increasing, more environmentally acceptable control measures are being developed. 

IkB kinase-p is a key regulatory enzyme in the NF-kB pathway, and inhibition of this enzyme has the potential for yielding treatments for inflammatory and autoimmune diseases. Morwick et al. [53] report on the optimization of a pM IKKp inhibitor with low aqueous solubility, moderate human liver microsome stability, and inhibition of several CYPs (3A4, 2C9, 1A2) with pM potencies. Modulation of the thiophene core (other thiophene isomer, pyrimidine and oxazole) produces compounds of similar potency to the hit. Fusing the 5-phenyl moiety to the thiophene to form a thieno[2,3-b]pyridine core increases aqueous solubility of the series as well as reduces the CYP liability. While the optimized compound still shows pM IKK(S potency, the aqueous solubility, HLM stability and CYP profiles are much improved. A pharmacophore model was generated that enabled scaffold hopping to yield this new chemotype (Scheme 7). 

In the U.S., three pieces of federal legislation that were passed from 1969 to 1980, and the implementing rules and regulations that followed, initiated a series of fundamental changes in the management of waste and byproduct materials. They presently affect the way in which regulatory agencies address waste and byproduct material use. These acts include the National Environmental Policy Act (NEPA, 1969), the Resource Conservation and Recovery Act (RCRA, 1976, 1980), and the Comprehensive Environmental Response, Compensation, and Liabilities Act (CERCLA) or Superfund (1980). 

Bioremediation offers several advantages over conventional methods of waste treatment such as landfilling or incineration. Bioremediation can be done on site, it is often less expensive, involves minimal site disruption, eliminates waste permanently, eliminates long-term liability, has greater public acceptance with regulatory encouragement, and can be coupled with other physical or chemical treatment methods. 

Both removal and remedial actions may be carried out at the same site. To accomplish these tasks, CERCLA has given cleanup authority to U.S. EPA, has established the Hazardous Substance Response Trust Fund (Superfund) to finance the remedial actions at CERCLA sites, has initiated a procedure for the emergency response to accidental spills, and has imposed cleanup liability on those responsible. The National Contingency Plan (NCP) was developed in 1982 and in 1985 as the regulatory framework to guide these responses. 

Figure 4.26 Representative instrument tube routing in a PWR. (From Fletcher and Bolander, 1986. Reprinted with permission of U.S. Nuclear Regulatory Commission, subject to the disclaimer of liability for inaccuracy and lack of usefulness printed in the cited reference.)...

Critics have long complained about the ineffectiveness of medical liability law both as a means of reducing the risks of injuries and as a system of compensation for injuries. So far, none of these critiques has led policy makers to jettison our fault-based medical liability system and to replace it with some type of no-fault system as proposed by some scholars. Thus some form of medical liability is going to be a feature of the social and regulatory... 

Noah, L., "Advertising Prescription Drugs to Consumers Assessing the Regulatory and Liability Issues," Ga. L. Rev., 32,141-180 (1997). 

It is worth noting that, presently, in silico prediction of hERG liability is not considered in regulatory documents, although this is an area of intense investigation... 

Some companies are already using substitution as a means of eliminating hazardous chemicals from their businesses, (see Annex I) A variety of reasons exist for why some companies are searching for safer substitutes and these include regulatory drivers (such as the recent Directive on the Restriction of Hazardous Substances), increased public awareness, demands from downstream users or clients, worker protection, liability issues, competitive advantage and company ethics. However, there are also barriers and the development and adoption of safer substitutes is happening only slowly, in a piecemeal fashion and in some sectors not at all. 

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