viernes, 6 de noviembre de 2015

Complying With HARPC: A Must for the Frozen-Foods Sector

The Food Safety Modernization Act is requiring a major overhaul in most sectors of the food industry.
The Food Safety Modernization Act (FSMA) aims to prevent food-contamination events before they occur, rather than reacting to them. Part of this change has been the requirement of a Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan for frozen-food manufacturers.
Frozen-food manufacturers must establish and maintain a qualifying HARPC plan which identifies food-safety and adulteration risks specific to their food products and facility. Procedures must be established to minimize those risks, verify that controls of those risks are actually working, and provide for corrective actions if deviations occur. Maintenance on the plan is required to review and verify procedures with appropriate documentation, updating it as needed.
However, some food-industry sectors do not have to adhere to HARPC requirements, including:
  1. Makers of products regulated by the USDA, such as meat and poultry
  2. Makers of products regulated under Standards for Produce Safety, mainly produce handling by farm producers
  3. Most seafood and juice manufacturers who complied with HACCP regulations
  4. Most canned food processors, however, there are some exceptions
  5. Manufacturers and processors with an average product value of less than $500,000 as determined by a three-year average
  6. Small and very-small businesses (with size and definition to be determined by FDA)
In other words, if you are a medium- or large-sized frozen-food processor that isn’t solely focused on meat, you are required to follow HARPC regulations. Failure to do so can result in public warning and disclosure by the FDA. It may also result in criminal charges for the company and owner.

Some frozen-food manufacturers and processors have already shifted focus to comply with HAACP recommendations. Though that won’t be sufficient for most, it is a step in the right direction and HARPC conversion may not be as challenging. Requirements are more-stringent, but the foundation is similar. The FDA has stated that educational programs will be made available, particularly to smaller organizations in need of HARPC plans.


jueves, 5 de noviembre de 2015

La FDA toma medidas para modernizar el sistema de inocuidad de los alimentos

Pone mayor énfasis en la prevención de enfermedades transmitidas por los alimentos.

La Administración de Alimentos y Medicamentos (FDA)  de los Estados Unidos finalizó dos de las siete normas fundamentales bajo la Ley de Modernización de la Inocuidad de los Alimentos (FSMA).  Las dos normas basadas principalmente en controles preventivos se centran en implementar procesos más modernos para la elaboración de alimentos de consumo animal y humano. Ello implica que las empresas alimentarias implementen medidas y trabajen conjuntamente con la FDA con el propósito de evitar posibles riesgos para los consumidores a partir de la elaboración del producto en lugar de esperar a actuar cuando se haya producido un brote.
Las nuevas normas de controles preventivos exigen a las empresas de alimentos desarrollar e implementar planes de inocuidad de sus productos por escrito, las cuales detallen todos los posibles riesgos que pudiesen afectar su inocuidad y además deben explicar los pasos que la empresa ha seleccionado para evitar o reducir considerablemente la probabilidad de que ellos ocurran.
Con estas normas las empresas alimentarias serán responsables de controlar sus propias instalaciones y procesos e identificar cualquier posible peligro para poder evitarlo.  Bajo estas normas la FDA evaluará directamente estos sistemas y sus resultados, y consecuentemente se podrá asegurar que se eviten los posibles problemas relacionados con la inocuidad de los alimentos.
Michael R. Taylor, subcomisionado para alimentos y medicamentos veterinarios de la FDA mencionó que se ha venido trabajando con los Estados, las empresas alimentarias, los granjeros y los consumidores para crear normas razonables, prácticas y significativas, para lo cual se ha asumido un firme compromiso en brindar asesoramiento, ayuda técnica y capacitación para mejorar el área de la inocuidad de los alimentos que pone a la prevención en primer lugar.
Una vez que las normas de la FSMA estén activadas en enero del año 2016, funcionarán juntas para fortalecer sistemáticamente el sistema de inocuidad de los alimentos y proteger de una mejor manera la Salud Pública.
Es tarea de las Empresas exportadoras de alimentos nacionales incorporarse y cumplir con estos nuevos requisitos a la brevedad.
Aporte: Gabriela García.

lunes, 2 de noviembre de 2015

FDA Investigates 2015 Outbreaks of Cyclosporiasis

The origin is cilantro from the state of Puebla, Mexico supplied to various restaurants.

Clusters of illness were identified in Texas, Wisconsin, and Georgia. Most (319, 58 percent of 546) ill people experienced onset of illness on or after May 1, 2015, and did not report international travel within two weeks before illness onset.  These 319 people were from the following states: Arkansas (3), California (2), Connecticut (5), Florida (13), Georgia (26), Illinois (9), Iowa (1), Kansas (2), Maryland (1), Massachusetts (12), Michigan (2), Missouri (1), Montana (3), Nebraska (1), New Jersey (7), New Mexico (2), New York (32), North Carolina (1), Texas (179), Utah (1), Virginia (3), Washington (2), Wisconsin (11).
Clusters of illnesses were identified in Texas, Wisconsin, and Georgia.  The FDA; the Texas Rapid Response Team; Texas Department of State Health Services; the Wisconsin Department of Health Services; the Wisconsin Department of Agriculture, Trade and Consumer Protection; the Georgia Rapid Response Team; and the Georgia Department of Public Health have collaborated on traceback investigations related to these illness clusters.  These investigations found that cilantro from the state of Puebla, Mexico was supplied to restaurants at which people identified in the illness clusters ate, indicating that some illnesses in these states were linked to fresh cilantro from Puebla, Mexico.  As of September 16, 2015, the CDC reported that case numbers have returned to baseline levels.
The CDC and state public health officials have identified annually recurring outbreaks (in 2013 and 2014) of cyclosporiasis in the United States which have been associated with fresh cilantro from the state of Puebla, Mexico. Although not confirmed by epidemiological means, the FDA reviewed a cluster of Cyclosporiasis illnesses from 2012 in which the state of Texas had previously identified cilantro as one of multiple possible suspect vehicles. The FDA determined that cilantro from the state of Puebla, Mexico, was supplied to the point of service implicated in that outbreak and was already found as the potential source of the 2012 outbreak.

miércoles, 21 de octubre de 2015

80 Illnesses Linked to Shigella Outbreak; CA Seafood Restaurant Closed

Shigella is generally transmitted through a fecal-oral route.

Mariscos San Juan at 205 N. 4th St. in downtown San Jose, CA, was closed Oct. 18 after the Santa Clara County Public Health Department connected the seafood restaurant with an outbreak of Shigella that reportedly may have sickened at least 80 people.

The restaurant remains closed, and Santa Clara health officials say 11 of the Shigella victims have been treated in intensive care units at area hospitals.

All of those stricken with the intestinal infection that causes fever, abdominal pain and diarrhea report dining at the San Jose restaurant on either the previous Friday or Saturday.

Shigella is an enteropathogen not frequently found in foods that affects humans. The clinical disease is a dysentery diarrhea that can be treated successfully with antibiotics. Local health officials said that they expect the number of those sickened will grow, and they issued a request for action by all clinicians in the area.

The disease is the result of bacteria that passes from improperly washed hands of one person to the mouth of another person, often through handling contaminated objects or food. The disease is easily passed among childcare professionals and food preparers.

Clinicians treating suspected Shigella patients are being asked to test stool cultures and order antimicrobial susceptibility testing and blood cultures if the person became hospitalized. Doctors were also asked to “tailor therapy based on results of susceptibility testing, recognizing that routine antimicrobial susceptibility tests for Shigella may not include some commonly available oral antibiotics.”

Area emergency rooms were reporting they were treating multiple patients with vomiting and fevers as high as 104ºF.

The downtown Mariscos San Juan is one of the restaurant chain’s three locations in San Jose. The Willow Street restaurant had its permit suspended in August. The third location on Senter Road in San Jose remains open. Santa Clara County has suspended the permits of 81 restaurants during the past six months for a variety of code violations.