Regulatory and Environmental Issues

Engineering and high-performance plastics can be recycled, but economics favor postindustrial rather than postconsumer sources, in order to have an identifiable and relatively clean waste stream of sufficient size. For example, nylon fiber waste is an ideal source for recycled nylon molding and extrusion compounds. Most processors recover sprues, ruimers, and scrap parts as part of their normal operations if recycled material is not permitted to be used in making parts, then the regrind material can be sold to brokers or other processors, where it ends up being recycled. 

Another promising approach is to use heat and pressure to reduce waste polymers back to crude oil several test programs are in progress to demonstrate commercial potential. In any event, it is wasteful and a poor business practice to send plastics scrap of any type to landfills. 

Thermoset materials can also be recycled in the form of filler for use in virgin compounds. This has been successfully demonstrated in polyester and epoxy molding compounds there would not seem to be any technical reason why other thermoset resins carmot be recycled in the same manner. 

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The Japanese plant is a technology leader within the BioPharma network in terms of its ability to handle regulatory and environmental issues. Some developments in the Japanese plant had been transferred to other plants in the network. The German plant is a leader in terms of its production ability. The plant has routinely... 

Boxhammer J. Design and validation characteristics of environmental chambers for photostability chambers. Photostability A 1997 Update—Scientific, Regulatory and Practical Issues, AAl 1997 Seminar Series, Arlington, VA, Feb 24-25, 1997. Boxhammer J. Technical requirements and equipment for photostability testing. In Tonnesen HH, ed. Photochemical Stability of Drugs and Drug Formulations. London, UK Taylor Francis, 1996 39-61. 

A final point that also needs to be presented is related to quality assurance, i.e. the requirement to satisfy regulatory frameworks concerned with safety and environmental issues. Traditionally, only national regulatory bodies had to be satisfied. Now, however, international regulatory bodies have to be satisfied while national regulatory bodies must, in many cases, accept the regulations of other nations. In this context, quality assurance of a plant or a process may often require a demonstrable pedigree for each number in the calculation of some aspect of the plant. 

The toxicological and environmental issues for Phase 3 product candidate promotion are dependent upon the site of manufacture, product form, final end-use, and ultimate method of disposal. The Team Leader, along with a representative of the Regulatory Affairs Department, will ensure that the appropriate issues have been addressed and summarize the results in the Product Candidate Dossier for each product candidate that will be submitted for promotion to Phase 3. 

Safety, Health, and Environment—course in which students gain knowledge and skills to reinforce the attitudes and behaviors required for safe and environmentally sound work habits. Emphasizes safety, health, and environmental issues in the performance of all job tasks, and covers regulatory compliance issues. 

Regulatory, safety and environmental issues - some practical points (see also Chapter 4)... 

Develop Cultor s environmental database to better meet the needs of both the Group and divisions. Improve the reliability of the data collected through the database. Develop indicators for environmental, quality, regulatory, and ethical issues to measure performance and conduct a pilot study to test the suitability of the indicators chosen. Implement Cultor s new Quality and Environmental Poliqy in operations. 

Objectives and targets. Table E-9 describes the progress that Cultor has made in implementing the objectives detailed in its 1995 Environmental Report. New objectives are also given, linked to four key areas implementation of Cultor s sustainable development value process, the environment, quality, and regulatory and ethical issues. The objectives and corporate target objectives are updated annually. 

Cement plants in the United States are now carehiUy monitored for compliance with Environmental Protection Agency (EPA) standards for emissions of particulates, SO, NO, and hydrocarbons. AH plants incorporate particulate collection devices such as baghouses and electrostatic precipitators (see Air POLLUTION CONTROL methods). The particulates removed from stack emissions are called cement kiln dust (CKD). It has been shown that CKD is characterized by low concentrations of metals which leach from the CKD at levels far below regulatory limits (63,64). Environmental issues continue to be of concern as the use of waste fuel in cement kilns becomes more widespread. 

The definitions of method detection and quantification limits should be reliable and applicable to a variety of extraction procedures and analytical methods. The issue is of particular importance to the US Environmental Protection Agency (EPA) and also pesticide regulatory and health agencies around the world in risk assessment. The critical question central to risk assessment is assessing the risk posed to a human being from the consumption of foods treated with pesticides, when the amount of the residue present in the food product is reported nondetect (ND) or no detectable residues . 

Studies conducted in the laboratory provide fundamental data on processes by which a pesticide is degraded and on its mobility. In combination with field observations, which integrate multiple processes, these data describe a pesticide s environmental fate. This section provides a discussion of several important specific analytical issues which should be considered in the design of environmental fate studies to ensure that the data generated address the needs of scientists and regulatory agencies for information on the environmental fate and environmental and ecological impacts of a pesticide to the fullest extent. 

U.S. EPA promulgated MACT standards for most HWCs on September 30, 1999. These emission standards created a technology-based national cap for HAP emission from the combustion of hazardous waste in these devices. A number of parties, representing both industrial and environmental communities, requested judicial review of this rule, and challenged its emission standards and several implementation provisions. On July 24,2001, the United States Court of Appeals for the District of Columbia Circuit vacated the emission standards however, it allowed EPA to promulgate interim standards that were in place since February 13, 2002. U.S. EPA issued the new Final Rule and standards on April 20, 2004. Today s standards30 31 shown in Tables 23.5 and 23.6 result from the above judiciary and regulatory actions. 

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