CURSOS 2016

The five Biggest U.S. Foodborne Illness Outbreaks of 2015

Salmonella caused six out of ten larger outbreaks

5. Shigella from Mariscos San Juan, 194 sickened. The Santa Clara County Public Health Department reported on Nov. 9 that 194 people were sickened with Shigella. Nearly all of the cases reported that they ate at Mariscos San Juan restaurant on Oct. 16 or 17. [News Report]

4. Salmonella Typhimurium from Tarheel Q, 1 death and 280 sickened. Those who fell ill after eating at the Lexington, NC barbeque restaurant came from 16 North Carolina counties and five states. Laboratory testing indicated that the BBQ sample and a sample from a patient who became ill during the beginning of the outbreak were both positive for Salmonella. [News report]

3. Salmonella from the Boise Co-op, 290 sickened. Approximately 290 people were sickened with Salmonella linked to food purchased from the Boise Co-op deli after June 1, 2015. Preliminary test results showed Salmonella growth in raw turkey, tomatoes and onion. [News report]

2. Cyclospora from Mexcan-grown cilantro, 546 sickened.For the third year in a row, Cyclospora-contaminated cilantro grown in Mexico caused a massive outbreak. This year, there were 31 states affected but Texans bore the most with 179 illnesses. The bulk of the illnesses hit at the end of May and throughout June.[CDC outbreak information]

1. Salmonella Poona from Cucumbers, 4 deaths and 838 sickened. This enormous outbreak hospitalized 165 people and four deaths were reported in Arizona, California, Oklahoma and Texas. The outbreak hit California the hardest where 232 people were sickened, but 38 states were affected in total. Investigators identified cucumbers imported from Mexico and distributed by Andrew & Williamson Fresh Produce as a likely source of the infections and there were two recalls of potentially contaminated cucumbers. The number of reported illnesses has declined substantially since the peak of illnesses in August and September, but it hasn’t returned to the number of reported illnesses expected each month (about five). [CDC outbreak information]


t is also interesting to mention the Listeria outbreak connected with Blue Bell Creameries. There were three deaths and 10 illnesses connected to the ice cream and reported as early as 2010. On April 20, 2015, Blue Bell recalled all of its products and began distributing its ice cream again at the end of August. Although the outbreak was fairly small and only one connected illness was reported in 2015, we thought it important to note on this list because of the unusual food product and the national coverage it sparked this year.

Source:http://www.cdc.gov/foodsafety/outbreaks/multistate-outbreaks/outbreaks-list.html

New E. coli O26 causing an extensive outbreak

What is the Problem and What is Being Done About It?  

The FDA, CDC, and state and local officials began investigating an outbreak of a different Shiga toxin-producing Escherichia coli O26 (STEC O26) linked to Chipotle Mexican Grill restaurants during December 2015. This outbreak has a rare DNA fingerprint, which is different from the larger, previously reported outbreak.

During the firs outbreak Chipotle Mexican Grill closed 43 restaurants in Washington and Oregon in early November 2015 in response to the initial outbreak. All these restaurants reopened in November 2015. Chipotle Mexican Grill worked in close consultation and collaboration with health officials throughout the investigation to determine whether it was appropriate to reopen these restaurants. Chipotle reports taking the following actions, among others, prior to opening:

Interviews were conducted with five ill people, who all reported eating at Chipotle Mexican Grill restaurants. Whole genome sequencing is being used to see this strain is genetically related to the STEC O26 that caused the larger outbreak. This investigation is ongoing.

The FDA continues to work with Chipotle Mexican Grill restaurants as well as federal, state and local agencies to gather information about the supply chain(s). The FDA will continue to provide updates on the investigation as they become available

The FDA and the Centers for Disease Control and Prevention (CDC) along with state and local officials are investigating two separate outbreaks of E. coli O26 infections that have been linked to food served at Chipotle Mexican Grill restaurants in several states.

Earlier in December 4, 2015, the CDC reports a total of 52 people infected with the outbreak strain of STEC O26 from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27).

There have been 20 reported hospitalizations. There have been no reports of hemolytic uremic syndrome (HUS) and no deaths. Of the three most recent illnesses reported in November, only one ill person, whose illness started on November 10, reported eating at Chipotle Mexican Grill in the week before their illness began. The majority of these cases were reported from Oregon and Washington during October 2015.

To date, whole genome sequencing has been performed on STEC O26 isolates from 21 ill people from California (2), Minnesota (2), New York (1), and Washington (16). All 21 isolates were highly related genetically to one another. On the contrary all microbial testing performed by the company did not yield E. coli (more than 2,500 tests of Chipotle's food, restaurant surfaces, and equipment all showed no E. coli).

Source: http://www.cdc.gov/ecoli/2015/o26-11-15/index.html

FSMA Update: Importing Food under the Foreign Supplier Verification Program

Potential hazards may include any biological, chemical or physical hazards related to the food which are reasonably likely to cause illness or injury

The FSVP rule first looks to the importer. An importer is the U.S. owner or consignee of a food offered for import into the U.S. If the importer is a food manufacturer otherwise subject to the preventive controls rules, no FSVP program is necessary because the hazard is identified and managed under their preventive controls processes. If the importer is not a U.S. manufacturer subject to the preventive controls rules and does not meet one of the other enumerated exceptions, the importer must create and implement an FSVP.An FSVP requires the importer to vouch for the foreign supplier of an article of food. The foreign supplier is generally the foreign entity that manufacturers and processes the food being exported to the United States. If a foreign food passes through an intermediary packer, holder or re-labeler, the original manufacturer is still deemed to be the foreign supplier.
  
An importer’s FSVP must be a written plan which provides for three separate processes: 1) an evaluation of the potential hazards of the imported food; 2) an evaluation of the performance of the particular foreign supplier; and 3) a plan for the performance of periodic and appropriate supplier verification activities.

Potential hazards may include any biological, chemical or physical hazards related to the food which are reasonably likely to cause illness or injury. If potential hazards are identified, the foreign supplier’s performance in controlling hazards must be evaluated.

Once a foreign supplier is initially evaluated and approved, the supplier’s performance must be verified on a regular basis. If the potential hazard could cause serious adverse health consequences or death, the minimum standard is that a verification audit must be conducted at least annually.

If an importer utilizes several foreign suppliers, a separate FSVP must be developed for each. If an importer obtains more than one food product from any foreign supplier, an FSVP analysis must be performed for each food product, although there may be some overlap making the process easier. The type and method of foreign supplier verification processes is flexible and may include on-site audits, sampling and testing, and/or reviews of the suppliers’ relevant food safety records.

The three processes referred to above in an FSVP may be conducted by the importer itself or the importer may rely upon other specified types of entities so long as the importer itself reviews and assesses the verification records, including the results of supplier verification activities.  

Source: https://www.registrarcorp.com/monitor/index.jsp?gclid=CjwKEAiAkb-zBRC2upezwuyguQ4SJADZG08vjZVo-jK6WgjoFDhRCHKpnEmp44u3irGSiRBszmHAOBoCV1Tw_wcB

WHO Releases First Global Estimates of Foodborne Disease

One in 10 sickened annually around the world each year

About one in every 10 people around the world are affected by foodborne disease each year. Of those 600 million people, 420,000 die as a result.
These numbers are the first global estimates — conservative ones — of foodborne illnesses and were calculated by the World Health Organization (WHO). The comprehensive report, published Thursday, Dec. 3, incorporated 31 foodborne hazards, including bacteria, viruses, parasites, toxins and chemicals.
Diarrheal diseases were responsible for most of the global burden, causing 550 million illnesses and 230,000 deaths, WHO reported. In addition, children younger than 5 years old carried 40 percent of the foodborne disease burden, despite representing only 9 percent of the global population.

31 Foodborne Hazards in WHO Global Estimates
Diarrheal Disease Agents	Campylobacter spp., Cryptosporidium spp., Entamoeba histolytica, Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC), Giardia spp., Norovirus, Salmonella enterica (non-invasive infections) non-typhoidal, Shigella spp., Shiga toxin-producing E. coli (STEC), Vibrio cholerae
Invasive Infectious Disease Agents	Brucella spp., Hepatitis A virus, Listeria spp., Mycobacterium bovis, Salmonella enterica (invasive infections) non-typhoidal, Salmonella enterica Paratyphi A, Salmonella enterica Typhi
Helminths	Ascaris spp., Echinococcus multilocularis, Echinococcus granulosus, Clonorchis sinensis, Fasciola spp., Intestinal flukes, Opisthorchis spp., Paragonimus spp., Taenia solium, Toxoplasma gondii, Trichinella spp.
Chemicals	Aflatoxin, Cassava cyanide, Dioxin

Source: http://www.who.int/foodsafety/areas_work/foodborne-diseases/ferg/en/

Multistate Outbreak of Shiga toxin-producing Escherichia coli O26.

Chipotle Mexican Grill restaurants at several states is a likely source of this outbreak.

CDC is only reporting ill people that have been confirmed by PulseNet as being infected with the outbreak strain of Shiga toxin-producing Escherichia coli O26 (STEC O26). Forty-five people infected with the outbreak strain of STEC O26 have been reported from 6 states. The majority of illnesses have been reported from Washington and Oregon. The number of ill people reported from each state is as follows: California (2), Minnesota (2), New York (1), Ohio (1), Oregon (13), and Washington (26).

Among people for whom information is available, illnesses started on dates ranging from October 19, 2015 to November 8, 2015. Ill people range in age from 2 years to 94, with a median age of 22. Fifty-eight percent of ill people are female. Sixteen (36%) people reported being hospitalized. There have been no reports of hemolytic uremic syndrome and no deaths.

CDC and state and local public health partners are continuing laboratory surveillance through PulseNet to identify additional ill persons and to interview them.

Investigation Update: CDC, the U.S. Food and Drug Administration, and public health officials in several states are investigating an outbreak of Shiga toxin-producing Escherichia coli O26 (STEC O26) infections.

The epidemiologic evidence available to investigators at this time suggests that a meal item or ingredient served at Chipotle Mexican Grill restaurants at several states is a likely source of this outbreak. The investigation has not identified what specific food is linked to illness. Chipotle Mexican Grill is assisting public health officials with understanding the distribution of food items served at locations where ill people ate and this work is ongoing.

State and local public health officials are interviewing ill people to obtain information about foods they might have eaten and other exposures in the week before their illness started. Forty-three (96%) of 45 people interviewed reported eating at a Chipotle Mexican Grill restaurant. The investigation is ongoing to identify common meal items or ingredients causing illness.

Investigators are also using whole genome sequencing, an advanced laboratory technique, to get more information about the DNA fingerprint of the STEC O26 bacteria causing illness. To date, whole genome sequencing has been performed on STEC O26 isolates from 9 ill people in Washington and 1 ill person in Minnesota. All 10 isolates were highly related genetically to one another. This provides additional evidence that illnesses outside the Pacific Northwest are related to the illnesses in Oregon and Washington.

Source: http://www.cdc.gov/ecoli/2015/o26-11-15/index.html

FDA Approves GE Salmon, Voluntary Labeling of GE Ingredients

Salmon for human consumption would not have a significant impact on the environment.

The FDA scientists rigorously evaluated extensive data submitted by the manufacturer, AquaBounty Technologies, and other peer-reviewed data, to assess whether AquAdvantage salmon met the criteria for approval established by law; namely, safety and effectiveness. The data demonstrated that the inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals that the genetic engineering is safe for the fish, and the salmon meets the sponsor’s claim about faster growth.
In addition, FDA assessed the environmental impacts of approving this application and found that the approval would not have a significant impact on the environment of the United States. That is because the multiple containment measures the company will use in the land-based facilities in Panama and Canada make it extremely unlikely that the fish could escape and establish themselves in the wild.

The agency had made a preliminary finding in December 2012 that approving the AquAdvantage Salmon for human consumption would not have a significant impact on the environment if, as the company plans, it is raised in tanks away from the ocean to limit the impact on wild salmon stocks.
FDA has specified that the GE salmon only be raised in two places, one on Vancouver Island, Canada, and the other in Panama, where Aqua Bounty was fined by the government last year for reportedly not having the proper permits and for repeatedly violating regulations.
Alison Van Eenennaam, Ph.D., a specialist in animal genomics and biotechnology at the University of California, Davis, participated in FDA’s scientific review.
“Basically, nothing in the data suggested that these fish were in any way unsafe or different to the farm-raised salmon,” she said.
AquaBounty’s GE salmon contains a growth gene from the Chinook salmon, which the company says could allow its product to grow to market size in half the time of a conventional Atlantic salmon. Because it involves a recombinant DNA (rDNA) construct introduced into the animal, the GE salmon meets FDA’s definition of a drug.
The company stated Thursday that the FDA approval could mean an “economically viable domestic aquaculture industry while providing consumers a fresh and delicious product,” adding that more than 90 percent of the seafood, and more than 95 percent of the Atlantic salmon, consumed in the U.S. today is imported.

Source: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm472487.htm

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.

Source:http://www.foodonline.com/doc/complying-with-harpc-a-must-for-the-frozen-foods-sector-0001

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.

Fuente: https://seguridadalimentariasesal.wordpress.com/2015/09/21/la-fda-toma-medidas-importantes-para-modernizar-el-sistema-de-inocuidad-de-los-alimentos/

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.

Source: http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm456755.htm

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.

Source:  https://services.sccgov.org/facilityinspection/Home/ShowDetail/PR0300496