Productivity, balancing with compliance

These specific, and other broader, concerns in corporate compliance with TSCA s requirements were discussed by Diamond Shamrock Corporation s D. Harlow. He described how corporate structures and procedures, including those for research and development, for companies of all sizes, have been impacted by TSCA. These impacts are generally positive in that they reflect greatly increased awareness, resources and responsiveness to questions of chemicals effects on health and environment. These benefits are seen to be in balance with their costs, expressed in the increased costs of products and services. 

In current industrial practice gas chromatographic analysis (glc) is used for quahty control. The impurities, mainly a small amount of water (by Kad-Fischer) and some organic trace constituents (by glc), are deterrnined quantitatively, and the balance to 100% is taken as the acetone content. Compliance to specified ranges of individual impurities can also be assured by this analysis. The gas chromatographic method is accurately correlated to any other tests specified for the assay of acetone in the product. Contract specification tests are performed on product to be shipped. Typical wet methods for the deterrnination of acetone are acidimetry (49), titration of the Hberated hydrochloric acid after treating the acetone with hydroxylamine hydrochloride and iodimetry (50), titrating the excess of iodine after treating the acetone with iodine and base (iodoform reaction). 

Yield and other mass-related metrics such as atom economy, reaction mass efficiency and mass intensity have been examined by Constable et al with regard to their significance concerning greenness and costs. The importance of using a (product) concentration term, which can be mass intensity or mass index, is additionally emphasized by Laird et al This is in compliance with Winterton, who in his twelve more green chemistry principles demands the establishment of full mass balances. 

In practice, the Patriot Act and its successors, has circumvented the check and balance system. The Executive Branch has, for example, lowered the threshold of probable cause to the level of suspicion it has equated criminal activity with terrorist activity it has removed or delayed notice requirements for warrants it has required mandatory compliance on third parties for the production of information gathered secredy it has imposed a gag order upon notice and production of information it permits sharing of confidential personal information between investigative units and minimized the role of the judiciary. The overall effect is the Executive Branch and Justice Department are assuming power to define application of the Fourth Amendment. An additional result is the collection of a wide variety of highly personal and sensitive information on law-abiding individuals. 

This chapter discusses regulatory issues in HPLC laboratories with a focus on procedures and requirements for system qualification, calibration, method validation, and system suitability testing. Examples in a cGMP pharmaceutical environment are used to illustrate the various tools and systems used to ensure the degree of HPLC data accuracy necessary to achieve the delicate balance of regulatory compliance and laboratory productivity. 

ISCC requires compliance with sustainability requirements for biomass production and cultivation, GHG emission savings, and traceability and mass balance (Scarlat and Dallemand, 2011). Also, in 2008, CEN (European Committee for Standardisation) established the CEN/TC 383 Committee for sustainably produced biomass for energy applications to elaborate a European standard of sustainable biomass for energy applications, such as transport, heating, cooling, and electricity (Ponte, 2014). EN 16214 standard series (i.e.. Parts 1—4) has already been published from 2012 to 2014. 

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