Regulatory References

Only in cases when regulators require information during evaluation or enforcement would detailed exposure calculations need to be submitted by a company. The recommendations would serve as a regulatory reference source for formulators or manufacturers. Therefore, a downstream user would only need to communicate a chemical use upstream for registration purposes when it believed the chemical application in a manufacturing process fell outside the exposure scenarios for which a recommendation or recommendation equivalent applies. 

This Section was written by David M. Moore, D.V.M.. It was written in 1994 so the reader should refer to current versions of any regulatory references. 

The design and development of MDs and drugs are supported by a series of general regulatory references that are beyond the specific product. Tables 6.3 and 6.4 lists the main reference standards classified by topic and institution of reference. 

The appendices offer PSSR examples, a compilation of checklist questions, industry references, and regulatory references... 

Scientific Regulatory Reference CD, Personal Care Products Council, Washington, D.C. 

To ensure disposal water quality is in line with regulatory requirements (usually 40 ppm), the oil content in water is monitored by solvent extraction and infrared spectroscopy. The specification of 40 ppm refers to an oil in water content typically averaged over a one month period. 

Research in physiology carried out in the 1930s established that the lipid fraction of semen contains small amounts of substances that exert powerful effects on smooth mus cle Sheep prostate glands proved to be a convenient source of this material and yielded a mixture of structurally related substances referred to collectively as prostaglandins We now know that prostaglandins are present m almost all animal tissues where they carry out a variety of regulatory functions... 

For carckiogen pesticides (70,71), animal testkigs are subject to maximum tolerated doses (M I L)). M I D is the maximum amount of a substance that can be administered to an experimental animal without causkig extreme health consequences, such as death, to occur but while continuing to produce some measurable toxic effects. Current regulatory theory holds that carckiogen effects do not have a threshold and caimot be related to reference doses. 

Tolerance refers to residue levels of a dmg or chemical that are permitted by regulatory agencies in food eaten by humans. 

Arrester Testing and Standards Regulatory and approval agencies and insurers impose acceptance testing requirements, sometimes as part of certification standards. The user may also request testing to demonstrate specific performance needs, just as the manufacturer can help develop standards. These interrelationships have resulted in several new and updated performance test procedures. Listing of an arrester by a testing laboratoiy refers only to performance under a defined set of test conditions. The flame arrester user should develop specific application requirements based on the service involved and the safety and risk criteria adopted. 

ISCST3 - Industrial Source Complex - Short Term This model is used in more detailed studies of maximum air quality impacts (Phase 3 - Refined Modeling Analysis). The purpose is to compute short term concentration or deposition values, from multiple sources, on specified locations (i.e., receptors). To download the file, click the filename. This is the latest version of the regulatory model ISCST3 (00101) which was released by U.S. EPA on April 27, 2000. The file ISCST.ZIP is 1.60 MB (Executable, Source, Test Cases). You can also download the ISCST3 model evaluation references. 

Some sites are easy to elassify due to their inehision on the National Priorities List (NPL), state superfund, or other regulatory list. In other eases, debate ean and does arise to determine if a site should be treated as hazardous. Eor example, some sites eommonly referred to as brown fields have eontamination levels that are eonsidered low. Sometimes levels of eontamination are so low that exposure levels to workers do not reaeh aetion levels or permissible exposure levels (PEL). Some firms have ehosen to treat low-level eontaminated sites as if they fell under HAZWOPER requirements. This is a somewhat eonservative approaeh whieh provides a eomfort faetor for management and potentially responsible parties (PRP) or other entities. 

This book, for the most part, is a stand-alone text. It addresses not only the fundamentals of PSA as a science, but insights on the regulatory framework affecting its development and apidication. In particular, it provides the basic methods of analysis that can be employed, available databases, an excellent set of examples, software resources, chapter summaries that tacilitate comprehension, and problem sets that are very well connected to the theory. While much has been written about probabilistic safety assessment over the last three decades, this is the most comprehensive attempt so far to provide a much needed college level textbook for the education of risk and safety professionals. It also provides a valuable reference for any individual curious enough about the risk and safety sciences to want to become much more informed. 

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