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FSMA: CHANGING CULTURE AT FDA ...

REGULATORY REPORT | April/May 2013

By Joseph A. Levitt and Veronica S. Knapp



















The U.S. Food and Drug Administration (FDA) is undergoing a major culture change, and nowhere is that impact being felt more than in the food industry. While visibly preparing new regulations to implement the Food Safety Modernization Act (FSMA), the agency is quietly becoming much more inspection-oriented and enforcement-minded, even before FSMA is fully implemented. This trend will only continue as FDA completes FSMA rulemaking and begins enforcing the act.


This cultural change means that the practices that made food companies successful in the past may not be enough to make them successful today. Companies must be fully prepared for today’s FDA inspections or expect to face enforcement consequences. This article outlines FDA’s recent increased emphasis on inspections and enforcement, and discusses the steps food companies can take to get ready.


From Brazil to Peru: Ambitious plan to drill through Andes to water desert ...

Fresh water that now tumbles down the eastern flank of the Andes mountains to the Amazon basin and eventually the Atlantic Ocean will instead move west through the mountains to irrigate a patch of desert on Peru's coast. It will then drain into the Pacific Ocean.













The Herculean project to reverse the flow of water and realise a century-old dream is in many ways the most important water work ever in Peru. It could serve as a blueprint for the kind of construction projects needed to tackle worsening water scarcity.




Call it extreme engineering in the age of global warming.













"All of this will be green," said engineer Giovanni Palacios, looking out over miles of brown shrubbery at a construction site he oversees for the Brazilian firm Odebrecht.






Palacios is the director of the Olmos Irrigation Project, an ambitious and - until it starts in 2014 - unproven vision with a $500 million price tag.







It has included drilling a 20 kilometre tunnel through the formidable Andes to capture abun…

SHIPPING LANES: PANAMA CANAL EXPANSION RUNNING 8 MONTHS BEHIND ...

A new visitor's center has been built overlooking the entrance to the locks on the Atlantic side of the canal. Ships waiting to go through the canal can be seen in the distance as well as the site where new locks are being built. Mimi Whitefield / For The Miami Herald







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Tugboats play critical role on Panama Canal


Competition heats up as U.S. ports prepare for Panama Canal expansion


Miami hopes for early advantage in the race to prepare for Panama Canal expansion


Southeast ports don’t want to be left out of the race for deep water as the Panama Canal expands


As Panama Canal expands, Latin America rushes to be ready








SUPER-SIZED LOCKS

New sets of locks on both the Atlantic and Pacific sides of the Panama canal will be able to accommodate super-sized ships.










Similar Stories:


Panama Canal’s $5 billion makeover could be boon for South Florida


Competition heats up as U.S. ports prepare for Panama Canal expansion


Latin American ports ready for Panama Canal expansion


As Panama Canal expand…

ESPERANZA: Capriles lidera la mayor concentración opositora desde 1999 ...

Es el mayor mitin organizado en Caracas al margen del chavismo desde hace 14 años




EWALD SCHARFENBERG


Caracas




7 ABR 2013 - 23:55 CET431











Capriles, en el acto central de su campaña este domingo en Caracas. / LEO RAMIREZ (AFP)







“Me dicen que son miles y miles caminando por las calles de nuestra Caracas! ¡Bravo! Somos millones y el 14 ganaremos!”. Así escribía en su cuenta de Twitter el gobernador del Estado de Miranda y candidato opositor, Henrique Capriles, minutos antes de dirigirse al acto central de su campaña para las presidenciales del próximo domingo.



El evento, llamado “Caracas Heroica”, resultó la mayor concentración organizada desde 1999 por sectores distintos al chavismo. Desde seis puntos de la capital de Venezuela marcharon cientos de miles de ciudadanos que apoyan la opción electoral de Capriles. La avenida Bolívar, que sirve tradicionalmente de prueba de fuego para cualquier opción electoral en Venezuela, no dio abasto para alojarlos.



El candidato opositor ratificó su poder de conv…