Consent decree

Various methods for the glc monitoring of EPA Consent Decree Priority PoUutants in water have been described (36) (see Regulatory agencies). The deterrnination of organic poUutants in water by glc and ms methods has also been detailed (37,38). Nonvolatile organic compounds in drinking water have been determined by hplc (39) (see Water, pollution). 

Conrad-Limpach-Knorr synthesis, of quinolines, 21 189 Conrad recycling process, 21 455 Conradson carbon test method, 11 705, 721 Consensus materials standards, 15 743 Consent decree protocols, in the United States, 11 692-694 Consent decrees, 11 689-690 Consequence analysis, 21 860-861 Consequence modeling, 13 165-166 Conservation applications, high performance fibers in, 13 398 Conservation of energy, 21 290 Conservation of mass, 11 737, 738-739 Conservation, of resources, 24 164-167 Conservation scientists, 11 398-399 Consistent force field, 16 744 Consolidants, in fine art examination/ conservation, 11 410... 

In May 2002, Schering-Plough was hned US 500 million for GMP violations by the FDA under the consent decree scheme. The issue centered on the GMP violations of the manufacturing facilities in New Jersey and Puerto Rico. A total of 13 inspections were carried out by the FDA from 1998 to 2002. The noncompliances were related to the facilities, quality assurance, manufacturing, equipment, laboratories, and labeling. 

After inspection, the inspector prepares a detailed Establishment Inspection Report (EIR). This is the FDA s primary record for the inspection. Time is given to the manufacturer to respond to the deficiencies found and recorded on Form FDA-483. Failure to comply with satisfactory resolution of the deficiencies found will result in the FDA sending out a Warning Letter notifying the manufacturer to comply. If the manufacturer is unable to resolve the deficiency after the deadline set by the FDA, the FDA may proceed to prosecute the manufacturer with an injunction. The injunction is a court order called Consent Decree, and the manufacturer may be required to cease operations until the problem is rectified (see Exhibit 10.4). 

Regulatory authorities inspect GMP facilities to ensure compliance to GMP. The FDA carries out surveillance and compliance inspections. A system-based approach is adopted quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control. Deficiencies are reported on Form FDA-483, which may lead to a warning letter and consent decree if unresolved. 

Actually, the department didn t have a vacancy. Because the university was under a federal consent decree, it had what is called a4>rogram. Under this program, if a person from an underrepresented group inquires alx)ut a position, the school will interview that person. Fortunately, I was offered a tenure-track position. I accepted the offer because I was in a nontenure-track position at a small historically white university. When I informed the department of my decision to leave, only then did they offer to convert my position to tenure track. 

FDA. FDA has therefore sought to obtain the equivalent in the form of stipulated agreements with companies that are filed in court as consent decrees and thus are fully enforceable as a requirement of law. 

EPA. 1980. Guidelines and methodology used in the preparation of healtheffect assessment chapters of the consent decree water criteria documents. US Environmental Protection Agency. Federal Register 45 79347- 79357... 

This was a significant turning point of the EPA s strategy. The Refining Initiative had the expressed goal to have 80% of the refining industry enter into voluntary consent decrees by 2005. The results as of December 2009 include ... 

Petroleum refineries under global consent decree... 

The status of EPA Consent Decree implementation has been documented previously [2-5]. Figure 14.1 highlights refineries that are covered by consent decrees and those that are not by regions. 

The graph in Figure 14.2 shows emission reduction trends for all refineries under consent decrees through 2005. 

Consent decrees may specify hardware or additive solutions for individual applications. When a refiner agrees to implement a hardware solution, emissions limits are typically specified in the Consent Decree. This requires the refiner to design and implement an appropriately sized unit to meet these limits. With FCC additive solutions or hybrid solutions combining hardware and additives (such as a hydrotreater and SOj reduction additive), final emissions limits are not generally defined in the Consent Decree. Instead, a testing and demonstration program is defined to determine the performance of the additive(s) in the FCC unit at optimized concentrations. This may also be the case for some hardware solutions. The process to determine the optimized additive rate and process conditions is also identified. A baseline period and model is often used to determine additive effectiveness. A series of kick-out factors based upon additive performance are evaluated to determine the optimized level... 

Over time the EPA has expanded the specificity of the Consent Decrees as they relate to FCC additive testing and demonstration. The Consent Decrees now generally require ... 

The increased structure and rigor of the Consent Decrees increases the complexity of executing FCC additive testing and demonstrations. A flowchart showing the various phases of the process identified for the Marathon CD is show in Figures 14.8 through 14.10. 

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