Coincidental manufacture

The term manufacture also includes coincidental production of a toxic chemical (e.g., as a byproduct or impurity) as a result of the manufacture, processing, use, or treatment of other chemical substances. In the case of coincidental production of an impurity (i.e., a chemical that remains in the product that is distributed in commerce), the de minimis limitation, discussed on page 11, applies. The de minimis limitation does not apply to byproducts (e.g., a chemical that is separated from a process stream and further processed or disposed). Certain listed toxic chemicals may be manufactured as a result of wastewater treatment or other treatment processes. For example, neutralization of acid wastewater can result in the coincidental manufacture of ammonium nitrate (solution). 

The purpose is to develop a guideline to validate the efhcacy of the sterility test method for a specihc product or material. The similarity of the validation approach with the other pharmaceutical manufacturers shall be considered coincidental due to the similarity of operations and the nature of the work. 

The purpose is to evaluate the bioburden, spore bioburden, and endotoxin present on rubber stoppers and unprocessed glass vials. The similarity of contents and equipment may be coincidental as the similar and common inventory are used by the generic manufacturers. 

The device is often operated with a refractive index detector in series in order to coincidentally measure the refractive index of the eluent. This is necessary to calculate (K) from the refractive index as given in equation (5). A common refractive index detector used for this purpose is that manufactured by the Wyatt Technology Corporation and it is described as the interferometer detector in chapter 11. As discussed above the molecular weight of a solute is determined from the intercept of the graph relating... 

The food fats in the Canadian food supply are shown again in Table I, but here they are expressed strictly as fat, as opposed to the retail weight of products (Fig. 1) and on a daily per capita basis, together with other sources of dietary fat. Table I is limited to the period beginning with 1966 to reflect those years in which rapeseed oil has made up a measurable part of the food supply. During this time, the total dietary fat available for daily consumption Increased some 4-8 g per person, coincidental with minor increases in fat from manufactured products, plant sources, and the meat group, and decreases In milk sources. Tablespreads, shortenings, and salad oils accounted for 40-43% of the fat in the Canadian food supply, which Is very much the same as in the United States (Rizek et al., 1974). 

The EPCRA was created nnder title 111 of the 1986 Snperfnnd Amendments and Reanthorization Act (SARA). One of the provisions of the EPCRA created the Toxics Release Inventory (TRl), which lists 16 metals (Table 7.3). The Toxic Chemical Activity Threshold triggers the TRl reporting reqnirements nnder EPCRA Section 313. These reqnirements apply to all federal facilities with more than 10 employees if an activity threshold is exceeded. There are three activity thresholds. If the facility mannfactnres a toxic chemical (including creating, importing, or coincidental mannfactnre), the activity threshold is 25,000 pounds within one calendar year. The activity threshold is the same if the facility processes a toxic chanical by incorporating it into a product. However, if the facility otherwise uses the toxic chemical, the activity threshold drops to 10,000 pounds. More detailed definitions of the terms manufacture, process, and otherwise use are provided in Title 40 C.F.R. Part 372.3. 

In manufacturing, the term is used to describe materials that can be molded—either by pouring a liquid into a mold and letting it cure into a solid, or by using heat and pressure to transform a malleable material into another shape. Collectively, these materials are referred to as plastics, or as plastic materials. Fortunately—and perhaps not coincidentally—most plastic materials also exhibit plastic behavior in use. While there are plastic materials that can be found in nature (such as latex rubber), most plastic materials are man-made, synthesized by combining various organic source materials. 

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