United States regulatory systems

But the impact of Deepwater Horizon/Macondo went beyond the United States the accident caused oil companies all over the world to think through the effectiveness of their safety management programs. Moreover, events such as the Montara blowout in Australian waters in the year 2009 showed that these events are not confined to one place. The contents of this book therefore go beyond the United States regulatory environment. The book describes some of the major offshore incidents that have occurred over the last 40 years or so, some of which occurred onshore, that led to the development of modem safety management systems and regulations. So, for example, it contains a thorough discussion of the Safety Case approach—a system that was first used in the North Sea but that has now spread to many international locations. 

In addition to rodent studies, regulatory guidelines for pharmaceuticals require that repeated dose safety studies of up to nine months (in the United States, six months elsewhere) in duration be conducted in a nonrodent species. The most commonly used nonrodent species is the dog, followed by the monkey and pig. Another nonrodent model used to a limited extent in systemic safety evaluation is the ferret. The major objectives of this chapter are (1) to discuss differences in rodent and nonrodent experimental design, (2) to examine the feasibility of using the dog, monkey, pig, and ferret in safety assessment testing, and (3) to identify the advantages and limitations associated with each species. 

The Clean Water Act (CWA or the Water Pollution Control Act) is the cornerstone of surface water quality protection in the United States and employs a variety of regulatory and nomegulatory tools to sharply reduce direct pollutant discharges into waterways and manage polluted runoff. The objective of the Clean Water Act is to restore and maintain the chemical, physical, and biological integrity of water systems. 

Three categories of regulatory limitations apply to wastewater discharge from industrial facilities such as oilfields and petroleum refineries [20]. The first category includes effluent limitations, which are designed to control those industry-specific wastewater constituents deemed significant from the standpoints of water quality impact and treatability in conventional treatment systems. In the United States, these limitations are the EPA Effluent Guidelines, issued under Public Law 92-500. 

This brief survey of the FDA regulation of pharmaceutical products demonstrates the breadth and depth of FDA activity in this field. Although there are repeated calls for reform of the IND/NDA system, it appears unlikely that any substantial change will occur in the near future. It is therefore important that any person who enters the prescription drug industry in the United States be fully informed about the requirements, understand the regulatory risks involved, and comply adequately with all of the FDA requirements. 

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