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Estimados socios:

A continuacin dos bloques de informacin sobre FSMA, queconsideramos de su inters, y les invitamos a analizar los

documentos y opinar al respecto.

I. El da viernes 7 de marzo recin pasado, se realizo unapresentacin sobre la normativa propuesta sobre adulteracin deproductos y transporte sanitario, realizada por funcionarios deFDA en las instalaciones de IICA.

Uno de los beneficios de participar en estos talleres, es laactualizacin sobre las herramientas que FDA est desarrollandopara apoyar la implementacin de FSMA, como el software

parea elaborar el Plan de defensa de los alimentos a fin de evitaradulteraciones y otros condicionantes de sancin. Asimismo, enel panel izquierdo encontrarn otras herramientas para sudescarga.

Software parea elaborar el Plan de defensa de los alimentoslo podrn encontrar en el siguiente link:http://www.fda.gov/food/fooddefense/toolseducationalmaterials/ucm349888.htm

Es importante recordarles, que la elaboracin del plan y demsdocumentacin requieren la gua de un individuo calificado, por locual COEXPORT cuenta con especialistas, material yherramientas para apoyar tanto en la educacin/capacitacin delpersonal y equipo de inocuidad/calidad de la empresa, como conasistencias tcnicas para la correcta implementacin de losrequerimientos. .

En su presentacin el FDA indica que para las propuestas

relativas a la actualizacin de BPM y estndares para productosfrescos, han recibido ms de 13,000 comentarios para cada uno,por lo cual les llevara su tiempo analizarlo.

En lo relativo a la norma de agua, estn pensando en cambiar suredaccin por lo cual hay que estar pendientes e inscribirse en supgina para recibir las actualizaciones (o revise nuestro sitio yaque nosotros remitimos dichas actualizaciones).

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Las fechas para emitir opinin a las normas presentadas este da,son las siguientes:

-- viernes 7 de marzo venci el periodo de consulta de la norma

que se refiere a adulteracin, no obstante es importante queconozca la propuesta dado que hay nuevas definiciones, en estamateria se distinguen 3 tipos de adulteracin:

a) La considerada como bioterrorismo, por causar daosgeneralizados a la salud pblica.

b) Intencional, por empleados o competidores, u otros.c) Por motivos econmicos, es decir utilizando ingredientes

diferentes a los declarados, nocivos o no.

-- 31 de marzo, cierra el plazo de consulta para la norma

propuesta sobre transporte que establece requisitos para eltransporte sanitario, importante dado que cambiar larelacin con los proveedores, al establecerlesrequerimientos de inocuidad y seguridad en el manejo dematerias primas y productos terminados, como son:registros sobre procedimientos de limpieza, temperatura,etc. tanto al transporte interno como al internacional.

II. ACTUALIZACION NOTICIA DE FDA, ver en documentoadjunto el link.

El 4 de abril FDA realizar una consulta pblica para discutir elalcance relativo a impacto ambiental para la regal propuestasobre produccin sanitaria, asimismo, extienden el periodo deevaluacin publica hasta el 18 de abril de 2014.

Cualquier consulta o comentario favor dirigirse a la Lic. AnaLeonor Daz de Pocasangre, Gerente Tcnica de COEXPORT,

gtecnica@coexport.com.sv

A continuacin la informacin sobre el Plan y los requerimientostcnicos del equipo para instalarlo.

Food Defense Plan Builder

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The Food Defense Plan Builder is a user-friendly software program designed to assistowners and operators of food facilities withdeveloping personalized food defense plans fortheir facilities. This user-friendly tool harnessesexisting FDA tools, guidance, and resources for

food defense into one single application.

The Food Defense Plan Builder guides the userthrough the following sections:

Company Information Broad Mitigation Strategies Vulnerability Assessment Focused Mitigation Strategies Emergency Contacts Action Plan Supporting Documents

DOWNLOAD the Food Defense Plan Builder (view system requirements)

Workshops available introducing the Food Defense Plan Builder

Webinar

Frequently Asked Questions

What is Food Defense?Food Defense is the effort to protect the food supply against intentionalcontamination due to sabotage, terrorism, counterfeiting, or other illegal,intentionally harmful means. Potential contaminants include biological,chemical and radiological hazards that are generally not found in foods ortheir production environment. Food defense differs from food safety, which isthe effort to prevent unintentional contamination of food products by agentsreasonably likely to occur in the food supply (e.g., E.coli, Salmonella, Listeria).

What is a food defense plan?A food defense plan is a written document that records the practicesimplemented to control/minimize the risk of an intentional contaminationincident. Having a food defense plan can reduce the overall vulnerability ofthe facilitys food operation, and therefore the nations food supply, from

intentional contamination.How do I get the Food Defense Plan Builder?You can download the Food Defense Plan Builder by following theinstructions on DOWNLOAD the Food Defense Plan Builder.

Is there a cost to download or use the tool?As with all of FDAs food defense tools, there is no fee for downloading orusing the Food Defense Plan Builder.

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Who will benefit from using the Food Defense Plan Builder?The tool is designed for use throughout the food industry, both domesticallyand internationally, and will aid companies in protecting their food productsfrom an intentional contamination incident. All food facilities can benefit fromhaving a food defense plan.

Are food defense plans required by the FDA?Currently, food defense plans are voluntary. However, FDA encourages allfood facilities to develop and implement a food defense plan. A food defenseplan will help you maintain a safe working environment for your employees,provide a quality product to your customers, and protect your bottom line.FDAs guidance, tools, and resources for industry on food defense representthe agencys current thinking on the measures that food facilities may take tominimize the risk for intentional contamination.

Is FDA planning to provide any additional training on the use of theFood Defense Plan Builder?Yes, FDA is currently planning a series of one-day Food Defense

Awareness Workshops, based on the Food Defense Plan Builder, to assistmembers of the food industry in developing a food defense plan for theirfacilities.

How is the Food Defense Plan Builder different from other FDA tools?The Food Defense Plan Builder is an additional tool available free of chargefrom the FDA to assist the food industry with food defense planning. TheFood Defense Plan Builder harnesses existing FDA tools and resources forfood defense planning into one single place. These existing tools andresources include FDAs food defense guidance documents, VulnerabilityAssessment Software Tool, and the Mitigation Strategies Database.

If I download the tool will FDA have access to my computer or the files

Ive created using the tool?The Food Defense Plan Builder is a desktop tool that resides only on theusers computer. FDA does not track or monitor its use and does not haveaccess to any content or documents developed using this tool. FDAencourages but does not require users to provide their contact informationwhen downloading the tool in order to receive updates and news on theFood Defense Plan Builder. Food defense plans and other relateddocuments created by using this tool are stored only in the locationsselected by the user. Food defense plans may include sensitive informationand it is the users responsibility to ensure files are saved in a securelocation.

What are the computer requirements to download and use the tool?Users computer configuration must meet the minimum requirementsoutlined in the table below in order for the Food Defense Plan Builder tooperate correctly. Please note that the tool is only compatible with WindowsOperating Systems and is not compatible with Mac Operating Systems.

If you have add i t iona l ques t ions or need more in format ion , p lease

emai lFoodDefense@fda.hhs.gov.

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System Requirements

Components Minimum Recommended

Computer 2.80 GHz 3.0 GHz

RAM 512 MB 1000 MB (1 GB)

Hard Disk Space 100 MB 125MB

Operating System Windows XP Windows XP,Windows Vistaand Windows 7

Graphics Card VGA VGA

ACTUALIZACION..

El 4 de abril FDA realizar una consulta pblica para discutir el alcance relativo a impactoambiental para la propuesta sobre produccin sanitaria, asimismo, extienden el periodo deevaluacin publica hasta el 18 de abril de 2014.

Para obtener ms informacin sobre las consultas pblicas, ingresar a FSMA Meetings,

Hearings, & Workshops.