El ABC de la Ley de Modernización en Inocuidad Alimentaria

Presentación del tema: "El ABC de la Ley de Modernización en Inocuidad Alimentaria"— Transcripción de la presentación:

1 El ABC de la Ley de Modernización en Inocuidad Alimentaria
Food Safety Modernization Act - FSMA Dr. Sergio Nieto-Montenegro Food Safety Consulting & Training Solutions, LLC “Culturally Compatible Food Safety Solutions” El Paso, TX V Congreso Internacional del Mango Ecuatoriano 4 de septiembre del 2014 Guayaquil, Ecuador

2 ¿Por qué es necesaria la ley?
Globalización El 15% del suministro de alimentos de los EUA se importa de 150 países El suministro de alimentos es más complejo y con una mayor tecnología Mayor cantidad de alimentos en el mercado Aparecen nuevos peligros

3 La Ley de Modernización en Inocuidad Alimentaria (FSMA)
La Ley de modernización en inocuidad alimentaria (FSMA), se firmó como ley el 4 de enero del 2011 El objetivo de la FSMA es proporcionar un suministro de alimentos más seguro y una industria alimenticia más estable, pero también amplía los poderes de la FDA para regular y vigilar cualquier aspecto de la producción de alimentos Esta nueva ley pone a la prevención como un asunto prioritario para la FDA. Las enfermedades transmitidas por los alimentos pueden PREVENIRSE

4 Las PROPUESTAS de norma establecen el marco de trabajo en inocuidad alimentaria
¿Qué se ha publicado? Estándares para la inocuidad productos agrícolas Controles preventivos para alimentos para el consumo Programa de verificación de proveedores extranjeros (FSVP, por sus siglas en inglés) Controles de prevención para alimentos destinados al consumo animal Programa de acreditación de tercerías (auditores y cuerpos certificadores) para hacer auditorías y emitir certificados Estrategias de mitigación para proteger a los alimentos de la adulteración intencional Transporte sanitario de alimentos para el consumo humano y animal These two proposed rules are the first among five rules that would lay the cornerstone of a prevention-based, modern food safety system. These proposed rules work together to address hazards in the commodities FDA regulates and to address food safety both in domestically produced and imported foods. We expect to soon propose the Foreign Supplier Verification Program, Preventive Controls for Animal Food and Accredited Third Party Certification.

5 FSMA - Norma propuesta en inocuidad de productos agrícolas
Estándares para el cultivo, cosecha, empaque y almacenamiento de productos agrícolas para el consumo humano Let me give you a brief overview of the produce safety rule.

6 Estándares para el cultivo, cosecha, empaque y almacenamiento de productos agrícolas para el consumo humano Puntos clave Considera el riesgo que tienen las prácticas de la operación y el producto en específico Basadas en ciencia y en riesgo Se enfoca en rutas de contaminación microbiana previamente identificadas Excluye productos agrícolas que rara vez son consumidos crudos Excluye productos agrícolas que serán procesados comercialmente (se requiere documentación)

7 Estándares para el cultivo, cosecha, empaque y almacenamiento de productos agrícolas para el consumo humano Puntos clave Flexible Tiempo adicional para que las fincas pequeñas cumplan Alternativas para algunas secciones. Por ejemplo: las fincas podrían establecer alternativas para ciertos requisitos relacionados con el agua y con los mejoradores de suelo biológicos de origen animal Los procedimientos alternos deben establecer con una base científica para proporcionar la misma cantidad de protección que la que brinda el requisito de la norma sin aumentar el riesgo de adulteración

8 Estándares para la inocuidad de los productos agrícolas
Enfoque en la identificación de rutas de contaminación microbiana Subparte A – Provisiones generales Subparte B – Requisitos generales Subparte C – Capacitación del personal Subparte D – Salud e higiene Subparte E – Agua de uso agrícola Subparte F – Mejorador biológico de suelo de origen animal Subparte K – Cultivo, cosecha, empaque y almacenamiento Subparte L – Equipos, herramientas, edificio y saneamiento Subparte O – Registros Subparte P – Variaciones Subparte Q – Cumplimiento y aplicación As I indicated, the proposed rule focuses on identified routes of microbial contamination of produce. They are: Domesticated and wild animals Equipment, tools, buildings and sanitation Worker health and hygiene Agricultural water Growing, harvesting, packing and holding activities Biological soil amendments of animal origin Also, there are specific requirements for sprouts

9 Subparte A – Provisiones generales
Contiene disposiciones que establecen: Ámbito de aplicación y definiciones aplicables a esta norma Identifica quién está sujeto a los requisitos de esta parte Describe los requisitos y procedimientos que rigen las excepciones calificadas de esta regla In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

10 Subparte A – Provisiones generales
Solo aplica para huertas/fincas que cultivan, cosechan, empacan o almacenan productos agrícolas crudos o en estado natural (productos agrícolas sin procesar) Huertas y “porciones de huertas” con instalaciones de tipo mixto Productos nacionales e importados Huertas con ventas > $ 25,000 por año Se proponen limitaciones en la cobertura La norma no incluye granos Huertas muy pequeñas (ventas de menos de $ 25,000 al año) y huertas con ventas menores a $ 500,000 donde la mitad de las ventas se realizan a los consumidores finales, restaurantes cercanos o al por menor, están exentos de algunas o todas las disposiciones de la nueva ley In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

11 Subparte A – Provisiones generales
La norma no requiere que la huerta lleve a cabo una evaluación de riesgos operativos o que tenga un plan de inocuidad alimentaria por escrito No hay requisitos de evaluación de los productos (excepto para germinados). Sin embargo, la FDA espera comentarios en esta área Los MANGOS están incluídos en la definición de productos agrícolas In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

12 Subparte B – Requisitos generales
¿Qué requisitos generales aplican a personas que son sujetos de esta parte? Usted tiene que tomar medidas apropiadas para reducir al mínimo el riesgo de consecuencias graves a la salud o muerte, por el uso o exposición a productos agrícolas regulados, incluidas las medidas razonablemente necesarias para prevenir la introducción de peligros conocidos o previsibles en productos regulados, y para proveer garantías de que el producto no esta adulterado In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

13 Subparte B – Requisitos generales
¿Hay algunas alternativas para los requisitos establecidos en esta parte? Usted puede establecer alternativas para requisitos específicos si cuenta con estudios científicos adecuados para respaldar su conclusión: Los requisitos para los análisis de agua, y tomar acciones basadas en los resultados Los procedimientos de tratamientos de compostaje El intervalo de aplicación mínima de un mejorador de suelo de origen animal y de un mejorador de suelo de origen animal tratado con un proceso de composteo In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

14 Subparte C – Capacitación y credenciales del personal
Todo el personal (incluido el temporal, de tiempo parcial, estacional, personal contratado) que manejen productos regulados o superficies en contacto con los alimentos, o los encargados de la supervisión de los mismos, deben recibir capacitación adecuada, de acuerdo a sus deberes, al momento de su contratación, al inicio de cada temporada de cultivo y posteriormente de forma periódica Los principios de higiene e inocuidad de los alimentos La importancia de la salud e higiene personal Los cosechadores necesitan entrenamiento sobre inspección de productos Cuando no hay que cosechar debido a la presencia de un peligro Acciones correctivas cuando se observen riesgos In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

15 Subparte D – Salud e higiene
Prevenir la contaminación proveniente de los empelados con problemas de salud Exigir prácticas de higiene, incluyendo el lavado de manos, mantener la limpieza adecuada, evitar el contacto con los animales no relacionados al trabajo, y reducir al mínimo la probabilidad de contaminación de los animales de trabajo Política de visitantes In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

16 Subparte E – Agua de uso agrícola
Los productores deben demostrar que toda el agua agrícola es segura y de calidad sanitaria adecuada para el uso previsto Agua agrícola significa agua usada en el cultivo, cosecha, empaque o almacenamiento de la producción, donde el agua puede tener contacto con el mango o con las superficies de contacto con los alimentos E. coli genérica. Indicador de contaminación fecal y de un riesgo elevado de la presencia de otros patógenos La frecuencia de las pruebas y los límites dependerán de la fuente y uso del agua In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

17 Subparte F – Mejorador biológico de suelo de origen animal
Mejorador de suelo cualquier material químico, biológico (como fertilizantes elementales, humus, estiércol, subproductos animales no fecales, musgo, perlita, residuos vegetales, lodos biosólidos, residuos de alimentos, restos agrícolas y de poda), añadidos de manera intencional al suelo para promover las condiciones químicas y físicas en relación al crecimiento de plantas o para mejorar la capacidad del suelo para retener agua In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

18 Subparte F – Mejorador biológico de suelo de origen animal
Un mejorador de suelo biológico es un compuesto o mezcla de compuestos de origen animal. Se incluye estiércol o sub productos no fecales o desecho de origen animal El concepto de mejorador de suelo biológico de origen animal NO incluye ninguna forma de desechos humanos In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

19 Subparte F – Mejorador biológico de suelo de origen animal
Los mejoradores de suelo deben ser manipulados, transportados y almacenados de manera que no contaminen: Productos Superficies de contacto con alimentos y áreas de trabajo Fuentes de agua y sus fuentes de distribución Otros mejoradores de suelo en almacenamiento El tratamiento debe ser científicamente validado. Tiempo y temperatura mínimos demostrados para reducir la cantidad de patógenos hasta un nivel seguro Hay intervalos de aplicación específicos basados en la mejora y forma en que se aplica (0 a 45 días hasta 9 meses) In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

20 Subparte I – Normas dirigidas a animales domésticos y silvestres
Si se permite pastar a los animales o son utilizados como animales de trabajo en campos donde se cultiva un producto regulado, y hay una probabilidad importante de que los animales contaminen los productos, la huerta debe: Establecer un periodo de espera adecuado entre el pastoreo y la cosecha Establecer medidas o prácticas de gestión de riesgos para prevenir la introducción de peligros conocidos o previsibles, en o sobre productos regulados Monitorear la intrusión de animales. En caso de intrusión, la finca debe evaluar si el producto regulado se debe cosechar In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

21 Subparte K – Cultivo, cosecha, empaque y actividades de almacenamiento
Mantenga los productos regulados separados de los productos que no contemple la regla (o trabájelos bajo los mismos estándares) Prácticas en campo para evaluar el riesgo de contaminación antes de la cosecha Manipular la producción de manera que se proteja contra contaminación No distribuya los productos que caigan o toquen el suelo Utilice material de empaque adecuado para el uso previsto y no re-utilice materiales de empaque a menos que se garantice que las superficies de contacto con alimentos estén limpias In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

22 Subparte L – Equipos, herramientas, edificio y saneamiento
Saneamiento del equipo y herramientas Las áreas de empaque requieren drenaje de agua, control del goteo de condensación, programa de control de plagas, control de animales, limpieza regular, eliminación de residuos y basura Instrumentos de control (temperatura, saneamiento, pH, etc.) Las instalaciones sanitarias deben: Ser fácilmente accesibles Mantenerlas razonablemente limpias Contar con papel higiénico La estación de lavado de manos debe estar cerca de las instalaciones sanitarias y abastecida adecuadamente In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

23 Subparte N – Métodos analíticos
Especifica los métodos particulares para el análisis de calidad del agua AOAC, FDA BAM, Agua y Aguas residuales, Métodos de la Asociación Americana de Salud Pública o equivalente. In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

24 Subparte O – Registros No deben ser gravosos ni se requiere un plan de inocuidad alimentaria escrito La norma propuesta requiere ciertos registros, por ejemplo, para documentar que ciertas normas se están cumpliendo Ejemplo: resultados de las pruebas al agua agrícola, mejoradores de suelo, entrenamiento y salud de los trabajadores, animales domésticos e intrusión de animales, saneamiento del edificio, del equipo y gestión de saneamiento. Los registros deben incluir la información básica de las huertas Deben ser exactos, legibles, indelebles, deben estar firmados y fechados. Conservar por 2 años, en el sitio o fuera de él si son mayores a 6 meses/ disponibles las 24 horas Los registros con otros propósitos no requieren ser duplicados. In terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities. It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule. The proposed rule would cover both domestic and imported produce. The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule. There are proposed limitations on coverage that I will explain in a moment.

25 Subparte P – Variaciones
Un estado o país extranjero puede solicitar a la FDA una variación de una o todas las disposiciones si lo considera necesario con base en las condiciones locales de cultivo . Las prácticas bajo variaciones deben proveer el mismo nivel de protección que la norma propuesta sin aumentar el riesgo de adulteración. The proposed rule also is flexible in that the proposed rule also would allow a state or foreign country to request a variance from some or all provisions of the proposed rule The state or country would need to determine that it is necessary in light of local growing conditions. Practices under the proposed variance provide the same level of public health protection as the requirements of the proposed rule without increasing the risk of adulteration. The proposed rule provides a process by which FDA would consider such requests and approve or deny them.

26 Fechas de cumplimiento
Únicamente es propuesta y sin efecto legal hasta finalizada Después de que la FDA recibe todos los comentarios, se comienza a escribir la regla final Después de que la regla final es publicada, las huertas tienen tiempo para cumplir con ella Fincas grandes > 500 mil – 2 años Fincas pequeñas < 500 mil – 3 años Fincas muy pequeñas < 250 mil – 4 años El calendario de aplicación está abierto a comentarios públicos Compliance dates for the produce safety rule are staggered based on size. FDA is proposing 60 days as the effective date, but farms do not have to meet the requirements on this date FDA is proposing staggered compliance dates for farms that would be covered based on size. Very Small Farms Very small farms have an average annual value of food sold of more than $25,000 and no more than $250,000. These farms would have four years after the effective date to comply. For some water requirements, they would have six years to comply.

27 FSMA Norma Propuesta: Controles preventivos para alimentos para el consumo humano
Las buenas prácticas de manufactura actuales y el análisis de peligros y controles preventivos basados en riesgos para alimentos para el consumo humano Let me now give you an overview of the Proposed Rule on Preventive Controls for Human food.

28 Principios claves Confirma el papel prioritario de la industria en la inocuidad alimentaria Tiene un enfoque más amplio que el HACCP en relación con la identificación de riesgos en la operación Controles preventivos basados ​​en riesgos Se requiere que cada instalación implemente un plan de inocuidad alimentaria por escrito y centrado en la prevención de riesgos en los alimentos "HARPC" o análisis de peligros y controles preventivos basados ​​en el riesgo - se centran en los controles preventivos basados en el riesgo/ciencia La regla de los controles preventivos es reorganizar y actualizar las cGMPs o BPM actuales Incluye peligros biológicos, químicos, físicos y radiológicos The rule has two major features: Hazard analysis and risk-based preventive controls are required Each facility would be required to implement a written food safety plan that focuses on preventing hazards in foods. Updated Good Manufacturing Practices

29 ¿A quién aplica? Las instalaciones que fabrican, procesan, envasan o almacenan alimentos para consumo humano En general, a las instalaciones que deben registrarse con la FDA bajo la sec. 415 de la Ley de FD & C Aplica a los alimentos nacionales e importados Se han propuesto algunas exenciones y algunos requisitos se han modificado Facilities that would be covered by the proposed rule are those that manufacture, process, pack or hold human food In general, facilities required to register with FDA under current regulations are covered. The proposed rule would apply to domestic and imported food Some exemptions and modified requirements are being proposed.

30 La norma propone que cada instalación prepare e implante un plan escrito de inocuidad alimentaria
Evalúa los peligros que pueden afectar a los alimentos Cualquier riesgo que se considere razonablemente probable de ocurrir debe tener un control preventivo Identificar e implementar controles preventivos Supervisar o monitorear el desempeño de los controles Mantener registros Covered facilities will be required to prepare and implement a written food safety plan, which would include the following: Hazard analysis – identifies or evaluates known or reasonably foreseeable hazards Preventive controls – would depend on which, if any, hazards are reasonably likely to occur: Monitoring procedures to provide assurance that preventive controls are consistently performed and records to document the monitoring required Corrective actions that would be used if preventive controls are not properly implemented Verification Recordkeeping

31 Controles preventivos requeridos según corresponda
Controles de proceso Controles de alérgenos alimentarios Controles de saneamiento Plan de retiro de producto del mercado No todos los controles aplican para todas las plantas procesadoras The preventive controls required would depend on which, if any, hazards are reasonably likely to occur. They are: Process controls Food allergen controls Sanitation controls Recall plan We do not expect that all possible prevention measures and verification procedures would be applied to all foods at all facilities. FDA believes that a supplier approval and verification program is a risk-based and appropriate control to significantly minimize or prevent hazards from raw materials and ingredients and that such a program is consistent with current scientific understanding of food safety practices. We are seeking comments on such a program.

32 Verificación requerida
Es necesario asegurarse de que los controles preventivos están siendo implementados y que son eficaces a través de la: Validación Calibración Revisión de los registros Verification activities are required to ensure that preventive controls are consistently implemented and effective. They include: Validation Calibration Review of records We are seeking comment on the following as verification activities: review of complaints finished product and environmental testing

33 Recepción de comentarios
Programas de aprobación de proveedores y de verificación. Estos son programas basados en riesgos, donde nos preguntamos ¿que peligros están asociados con la compra de suministros o ingredientes? Revisión de las quejas Verification activities are required to ensure that preventive controls are consistently implemented and effective. They include: Validation Calibration Review of records We are seeking comment on the following as verification activities: review of complaints finished product and environmental testing

34 Recepción de comentarios
Análisis del producto: La FDA no requiere análisis como parte de la verificación de la eficacia de los controles preventivos Sin embargo, están buscando comentarios sobre análisis de producto terminado y si se utilizarán las pruebas Análisis de medio ambiente: La FDA considera que el análisis del medio ambiente para un microorganismo de importancia para la salud pública o un indicador puede ser útil como medida de verificación para algunos controles preventivos, por ejemplo, saneamiento La FDA identifica Salmonella spp. y Listeria spp. como buenos candidatos Verification activities are required to ensure that preventive controls are consistently implemented and effective. They include: Validation Calibration Review of records We are seeking comment on the following as verification activities: review of complaints finished product and environmental testing

35 Registros Deben mantenerse cinco tipos de registros:
Plan escrito de inocuidad alimentaria que incluya el análisis de peligros, controles preventivos, procedimientos de monitoreo, planes de medidas correctivas, procedimientos de verificación y un plan de recuperación de producto Registros que documenten la vigilancia de los medios de prevención Registros que documenten las acciones correctivas Registros que documenten la verificación y validación de los controles y las calibraciones de los equipos Los registros de capacitación de las personas "calificadas" Updated Good Manufacturing Practices also are part of the proposed rule. The CGMPs would be modified to clarify that certain existing provisions requiring protection against contamination of food also require protection against cross-contact of food by allergens. Further, language in the regulation would be updated and certain provisions containing recommendations would be deleted and may be added to guidance. In addition, FDA is requesting comment on: whether it should mandate training for employees and supervisors whether it should require, rather than recommend, certain provisions, such as cleaning non-food-contact surfaces of equipment as frequently as necessary to protect against contamination of food and food-contact surfaces.

36 Registros Los registros deben tener valores reales/numéricos - no algo como "satisfactorio” u ”OK" Permitir un análisis subjetivo de tendencias Los registros deben estar firmados y fechados Los registros deben estar disponibles con prontitud a la FDA o su representante bajo petición Los registros deben mantenerse por dos años y el plan debe almacenarse en las instalaciones Updated Good Manufacturing Practices also are part of the proposed rule. The CGMPs would be modified to clarify that certain existing provisions requiring protection against contamination of food also require protection against cross-contact of food by allergens. Further, language in the regulation would be updated and certain provisions containing recommendations would be deleted and may be added to guidance. In addition, FDA is requesting comment on: whether it should mandate training for employees and supervisors whether it should require, rather than recommend, certain provisions, such as cleaning non-food-contact surfaces of equipment as frequently as necessary to protect against contamination of food and food-contact surfaces.

37 ¿Quién está a cargo del plan de inocuidad alimentaria?
El propietario, operador o agente responsable de las instalaciones es responsable de la preparación y ejecución del plan escrito de inocuidad alimentaria Un tercero puede preparar el plan en nombre del propietario, pero el propietario es responsable de su ejecución Compliance dates for the produce safety rule are staggered based on size. FDA is proposing 60 days as the effective date, but farms do not have to meet the requirements on this date FDA is proposing staggered compliance dates for farms that would be covered based on size. Very Small Farms Very small farms have an average annual value of food sold of more than $25,000 and no more than $250,000. These farms would have four years after the effective date to comply. For some water requirements, they would have six years to comply.

38 ¿Quién está a cargo del plan de inocuidad alimentaria?
Debe ser responsable de la ejecución del plan alguien que fue capacitado en el desarrollo y la aplicación de controles preventivos o haya adquirido este conocimiento a través de la experiencia laboral La definición de lo que es una "persona calificada" se presenta en la norma Debe tener formación en el desarrollo de los controles preventivos basados ​​en riesgos en un plan de estudios que sea reconocido por la FDA o bien ser personal calificado a través de la experiencia laboral. El "individuo calificado" participa en (1) la preparación del plan de inocuidad alimentaria, (2) la validación de controles preventivos, (3) la revisión de los registros de la efectividad de los controles preventivos (4) re-análisis del plan de seguridad alimentaria El plan debe ser específico de las instalación- ”no hay un plan que aplique para todos” Compliance dates for the produce safety rule are staggered based on size. FDA is proposing 60 days as the effective date, but farms do not have to meet the requirements on this date FDA is proposing staggered compliance dates for farms that would be covered based on size. Very Small Farms Very small farms have an average annual value of food sold of more than $25,000 and no more than $250,000. These farms would have four years after the effective date to comply. For some water requirements, they would have six years to comply.

39 Fecha de vigencia: 60 días después de la publicación de la norma final
Recomendación: ¡Empiece a trabajar en el programa de inocuidad alimentaria! Las propuestas de norma no tienen ningún efecto legal hasta que se han finalizado Hasta después de que la FDA reciba todos los comentarios, comienzan a redactar la norma final Fecha de vigencia: 60 días después de la publicación de la norma final Después de que se publique la norma final, las empresas tendrán tiempo para estar en cumplimiento. Pequeñas empresas - 2 años Muy pequeñas empresas - 3 años Empresas más grandes- 1 año Compliance dates for the produce safety rule are staggered based on size. FDA is proposing 60 days as the effective date, but farms do not have to meet the requirements on this date FDA is proposing staggered compliance dates for farms that would be covered based on size. Very Small Farms Very small farms have an average annual value of food sold of more than $25,000 and no more than $250,000. These farms would have four years after the effective date to comply. For some water requirements, they would have six years to comply.

40 El FSVP debe ser hecho por alguien calificado
Propuesta de norma: Programa de verificación de proveedores extranjeros (FSVP, por sus siglas en inglés) Requiere que los importadores verifiquen a sus proveedores usando controles preventivos basados en riesgos para que provean el mismo nivel de protección que los requerimientos de EUA Un importador es el dueño o consignatario del alimentos al entrar a los Estados Unidos. Si no lo hay entonces es el agente o representante en EUA El FSVP propone que un importador debe desarrollar, mantener y seguir un FSVP para cada alimento que importa El FSVP debe ser hecho por alguien calificado

41 Propuesta de norma: Programa de verificación
de proveedores extranjeros Algunos puntos relevantes que debe tener el programa: Revisión del estado de cumplimiento Analisis de riesgos Actividades de verificación Acciones correctivas Reevaluación periodica del FSVP Identificación del importador Mantenemiento de registros Control de peligros El importador El cliente del importador El proveedor extranjero o proveedor

42 para las importaciones
Mandatos en inocuidad para las importaciones Sec Programa voluntario de importadores calificados Permite la revisión y entrada acelerada; es necesario contar la certificación El importador solicitará este programa para acelerar las actividades de importación

43 Propuesta de norma: Transporte sanitario de alimentos para el consumo humano y animal
Prevenir prácticas que durante el transporte creen riesgos de inocuidad alimentaria Refrigeración inadecuada Mala limpieza y desinfección de los vehículos entre las cargas Fallas en la protección de los alimentos durante el transporte Establece criterios para el transporte seguro de los alimentos De forma resumida, la norma aplica a los enviadores, recibidores o compañías transportistas (Shippers, receivers o carriers) que transportan alimentos en los Estados Unidos. Un exportador se considera shipper

44 Propuesta de norma: Transporte sanitario de alimentos para el consumo humano y animal
La norma propuesta establece requisitos para: Equipo y vehículos de transporte Operaciones de transporte Intercambio de información Capacitación Identificación del importador Mantenimiento de registros Exenciones (waivers)

45 Propuesta de norma: Transporte sanitario de alimentos para el consumo humano y animal
Algunos ejemplos de quien está exento: Shippers, receivers o carriers con ventas menores a $500,000 USD Operaciones de transporte en la huerta Alimentos que únicamente pasan por EUA hacia otro país Alimentos que son importados a los EUA para su futura exportación pero que no son distribuidos o consumidos en los EUA

46 Propuesta de norma: Estrategias de mitigación para proteger a los alimentos de la adulteración intencional Tener un plan de defensa escrito para determinar y documentar mediante una evaluación de vulnerabilidades si tienen “actionable process steps”. Punto, etapa o procedimiento en el proceso donde se puede aplicar una medida y ésta es esencial para prevenir o eliminar una vulnerabilidad significativa. Algunos puntos relevantes adicionales al programa de defensa si hay “actionable process steps”: Estrategias enfocadas en la mitigación Monitoreo Acciones correctivas Verificación Capacitación Mantenimiento de registros Exentos si estas cubierto en el “produce rule” o ventas menores a 10 millones USD

47 Referencias Food and Drug Administration
Produce Marketing Association The United Fresh Produce Association Department of Food Science – Penn State University We encourage comments on the proposed rule from a wide variety of stakeholders. The proposed and final rules and supporting documents will be filed in FDA’s official docket on and also can be accessed at The comment period is 120 days and the exact date will be set in the Federal Register. However, we plan to coordinate the comment periods on the major FSMA proposals as fully as possible to enable public comment on how the rules can best work together to create an integrated and effective food safety system.

48 Thanks - Questions Sergio Nieto-Montenegro, Ph.D.
Food Safety Consulting and Training Solutions, LLC El Paso, TX Phone: (864) Alimentos y Nutrición / Chihuahua, Chih. Mexico Tel: (521614)