Governmental-related safety

After reviewing a number of safety management systems from around the world and comparing their elements side by side, it is evident that a basic theme forms the overall core foundation of these systems. Refer to Appendix H , Comparison of Governmental-Related Safety Management Systems Process Elements . 

The Hydrocarbon Processing Industry (HPI), has traditionally been reluctant to invest capital where an immediate direct return on the investment to the company is not obvious, as would any business enterprise. Additionally financial fire losses in the petroleum and related industries were relatively small up to about the 1950 s. This was due to the small size of facilities and the relatively low value of oil and gas to the volume of production. Until 1950, a fire or explosion loss of more than 5 million U. S. Dollars had not occurred in the refining industry in the USA. Also in this period, the capital intensive offshore oil exploration and production industry were only just beginning. The use of gas was also limited early in the century. Consequentially its value was also very low. Typically production gas was immediately flared or the well was capped and considered as an uneconomical reservoir. Since gas development was limited, large vapor explosions were relatively rare and catastrophic destruction from petroleum incidents was essentially unheard of. The outlays for petroleum industry safety features were traditionally the absolute minimum required by governmental regulations. The development of loss prevention philosophies and practices were therefore not effectively developed within the industry. 

The data analysis included evaluating the number, impact, profile, and causes of reactive incidents. CSB examined more than 40 data sources (e.g., industry and governmental databases and guidance documents safety/loss prevention texts and journals and industry association, professional society, insurance, and academic newsletters), focusing on incidents where the primary cause was related to chemical reactivity. 

In the environmental/safety context, "regulation" should be given a broad meaning. It should include all forces (both governmental and non-governmental) that are related to the governmental effort to ameliorate environmental or safety problems. 

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

The conduct of toxicology studies in laboratory animals has been driven by experience, historical precedence, and governmental requirements, and the results of these studies usually, and reasonably, have led to restrictions on the use, or method of use, of the chemicals concerned [1], The primary objective of pharmaceutical preclinical safety evaluation is to provide information essential for the initiation of clinical trials. Scientific rationale and controlled reproducible data are used to show that the initial human risk is so low as to be ethically and practically acceptable in relation to the medical value of the information to be obtained from humans. Preclinical safety studies performed throughout the course of product development facilitate and may guide work... 

Non-governmental organizations (NGOs) addressing environmental, public safety, and other chemical-related issues... 

Although we have access to an enormous amount of information, the quality and reproducibility of data varies considerably. Governmental and regulatory influences have not provided any guarantees as to the accuracy of data related to xenobiotics and the researcher needs to understand the purpose and mandates behind an information resource to fully evaluate the data contained within. For example, the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS) criteria for selection of data is not based on the reproducibility of that data. Other sources, such as the National Library of Medicine s Hazardous Substances Databank (HSDB), present information compiled from a wide variety of source materials that are extensively reviewed by experts. 

Sterility knows no frontiers. Sterile products are manufactured in all countries they are used within national boundaries, they are imported, and they are exported. However. nxKt governments will not permit the marketing of sterile [diarmaceutical products or medical devices unless the products have been noti> fied to them, acntinized for safety and efficacy, and approved. It is not the intention of this chapter to describe in detail the activities of governmental authorities throughout the world in relation to sterile products but to draw attention to some of the issues that are peculiar to sterile products and sterilization. 

American National Standards Institute (ANSI)—A non-governmental industrial consensus institute responsible for developing and distributing a variety of standards, including those related to safety and health standards (see Appendix A-3 and Section 6.5). Online at http //www.ansi.org/. 

National Fire Protection Association (NFPA)—A non-governmental professional association whose members specialize in safety and health standards related to fire protection, including the electrical standards in the National Electrical Code. Online at http //www.nfpa.org/index.asp. 

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