Evaluating regulators

Brown RC Carcinogenicity of the insulation wools reassessment of the lARC evaluation. Regul Toxicol Pharmacol 14 12-23, 1991... 

It is important to note that separate branches of the TGA are responsible for prescription drug evaluation, OTC drug evaluation, regulation of therapeutic devices and compliance issues. There are approximately 350 staff involved in TGA operations. The offices and the laboratories are located at S5mionston in Canberra. Some evaluation work is contracted to external organisations, such as academic and teaching institutions. 

When evaluating regulators for reliability and performance, the following criteria are used. 

A leading method for evaluating regulations is cost-benefit analysis. A major feature of cost-benefit analysis is the desire to express the valuation of non-pecuniary benefits and costs such as time savings and deaths and injuries avoided in dollar terms. This permits a strictly numerical comparison of benefits and costs. Transportation has been at the forefront of the development and application of cost-benefit analysis, and the DOT has a tradition of appraising investments and proposed regulations using it (Viscusi, 1996). 

The parameter r continues to measure the ratio of the number of A and B groups the factor 2 enters since the monofunctional reagent has the same effect on the degree of polymerization as a difunctional molecule with two B groups and, hence, is doubly effective compared to the latter. With this modification taken into account, Eq. (5.40) enables us to quantitatively evaluate the effect of stoichiometric imbalance or monofunctional reagents, whether these are intentionally introduced to regulate or whether they arise from impurities or side reactions. 

Flammability. The results of small-scale laboratory tests of plastic foams have been recognized as not predictive of their tme behavior in other fire situations (205). Work aimed at developing tests to evaluate the performance of plastic foams in actual fire situations continues. All plastic foams are combustible, some burning more readily than others when exposed to fire. Some additives (131,135), when added in small quantities to the polymer, markedly improve the behavior of the foam in the presence of small fire sources. Plastic foams must be used properly following the manufacturers recommendations and any appHcable regulations. 

Naphthalene Acetic Acid and Naphthalene Acetamide. Naphthalene acetic acid [26445-01-2] (38) is historicaHy one of the first plant growth regulators. Reports concerning its activity in crops and plants have been a subject in much of the eady Hterature (57). Consequently, it has been used as a starting matedal for other compounds, eg, vide infra Sevin. Naphthaleneacetamide [31093-43-3] (39) has been used as a standard matedal to evaluate abscission pnor to 1953 and its effect on apple drop was reported in 1953 (58). The substance is used as an internal standard in the abscission bioassay (59). 

Toxic Substances Control Act. EPA regulates the manufacture, use, and exposure to ha2ardous or toxic chemicals under a number of laws. Eor the chemical industry, the law of prime concern is the Toxic Substance Control Act (TSCA) (10), which was passed by the U.S. Congress in 1976. The two main goals of TSCA are acquisition of sufficient information to identify and evaluate potential ha2ards from chemical substances, and regulation of the production, use, distribution, and disposal of these substances. 

Center for Biologies Evaluation and Research (CBER). This center is responsible for the regulation and approval of ah biological products intended for use in the treatment, prevention, or cure of diseases or injuries to humans. A biological product is any vims, therapeutic semm, toxin, antitoxin, vaccine, blood or blood component or derivative, or analogous product (5). It also includes products produced by biotechnology, such as interferons and erythropoietins. 

Following enactment of this regulation, a study was sponsored by Hickman, WiUiams Company to evaluate the impact of gases evolved by the contact of water with 50%, 75%, and magnesium ferroshicon. The study concluded that "commercial ferroshicon does evolve phosphoms—hydride when... 

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