Regulatory climate

The most cost-effective, technically feasible remediation procedures are not always in agreement with regulatory controls. Environmental regulations, by their very nature, must be applicable for a wide variety of settings and must protect the overall environment. In past years remediation standards were established as general numerical concentrations usually based on drinking water standards or other health-related criteria borrowed from related public health fields. This type of remediation was often generic, not site specific. 

Recent regulatory thinking has focused on site-specific criteria derived from assessments of the risks to human health and the environment. Risk assessments are based on concentration of contaminants and exposure pathways. 

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Recently, there has been a substantial shift in conditions and user attitudes. With increasing cost of power, the return on capital investment has vastly improved. A more favorable regulatory climate and changes in attimde of utility companies toward remrning electricity to tlieh grid have made novel power producing schemes practical and attractive. 

Prior to designing an automated system, it may be worthwhile to understand the regulatory climate and the... 

The current regulatory climate of QbD places an emphasis on clinically relevant specifications and methods for in vitro dissolution.20 Development scientists should identify dissolution methodology that has been closely examined for its relevance to in vivo performance, as well as for mechanistic information. In other words, the release mechanism of the product should be understood and the dissolution test should be able to detect changes reflecting deviation of the mechanism. There is also the quality control (QC) side of dissolution testing, which, until the process analytical technology (PAT) develops beyond the current capabilities, is very important for stability and end-product release testing. 

The regulations are also constantly changing. Practices that are common today will probably disappear over the next decade. It is imperative that the Project Manager stay abreast of the regulatory climate. Projects are built for today but also have to meet tomorrow s environmental thrusts. 

As a coauthor of Prudent Practices for the Disposal of Chemicals from Laboratories, National Academy of Sciences, Washington, D.C., 1983, I have continued to follow closely the rapidly evolving regulatory climate and changes in laboratory safety rules and regulations. The safety information in this text is as current as it can be, but this is a rapidly changing area of chemistry local rules and regulations must be known and adhered to. 

The regulatory climate and growing consumer preference for natural products caused the U.S. and European food industries to search for natural sources of antioxidants rather than invest in synthetic antioxidants. 

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