New FDA staff Manual Guides, Volume I- Organizations and functions Food and Drug Administration

Approved new objectives for the Research Division of Microbiology

1. DIVISION OF MICROBIOLOGY (DAECCD)

A. Advises the Deputy Director for Research in the planning and implementation of strategies for achieving annual and long-range plans for research and research support in the area of microbiology

B. Conducts independent or collaborative applied research and development in the various fields of microbiology as they relate to programs involving biochemical toxicology, genetic and reproductive toxicology, developmental toxicology, neurotoxicology, molecular epidemiology and toxicity evaluations

C. Develops, modifies, and validates microbial testing procedures which contribute to the assessment to toxic industrial chemical, drugs, food additives, or naturally occurring and potentially toxic materials in the environment

D. Directs and implements a microbiological surveillance program, providing quality assurance for all laboratory animal operations and toxicology experiments involving animal systems

E. Investigates and implements quality assurance tests to ensure that toxicological experimentation is not interrupted or confounded by microbiological entities. Develops techniques to detect food-borne pathogens

F. Defines the role of microorganisms in degradation and detoxification of potentially hazardous compounds

G. Determines the kinetics of biodegradation using environmental models

H. Defines the role of intestinal microflora in activation or detoxification of xenobiotics

I. Uses microorganisms as models to predict metabolic pathways of drugs in mammals

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary of Health and Human Services, effective July 8, 2011.

Source: http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/ucm278665.htm

Verifying Listeria killing via an innocuous indicator in foods

Verifying Listeria killing via an innocuous indicator in foods.has the same rate of degradation when subjected to heat as Listeria.

 Manufacturers can test the Listeria-killing potential of heat treatments in factories by using the enzyme amylase to simulate the behavior of the pathogen, scientists have discovered.

The industry uses heat treatment as an additional safeguard to kill off pathogens in products such as ready-to-eat foods, which involve minimal cooking after processing. Amylase has the same rate of degradation when subjected to heat as Listeria and is harmless if ingested.

A Norwegian food researcher devised the method as one of two ways to test the reliability of heat treatment methods in eliminating Listeria monocytogenes in food. The other procedure involved examining the effect of heat treatments on actual Listeria cells encapsulated in alginate beads. However, because this involves the use of a pathogen, food safety rules dictate that it can’t be used on production lines.

By contrast, the simulation method could be and consequently provided a more trustworthy picture of Listeria control under plant conditions. The organization partnered a fish cake manufacturer on the research.

Burgers and fish cakes were often fried or grilled on both sides, but this was still not sufficient to completely kill all Listeria pathogens. It is known that manufacturers validate their own lines in an incomplete way. Many measure the core temperature at the end of the line, but that may not be enough, you need to see if there are cold spots in some of the burgers.

Researchers had also been testing the survival rate of Listeria monocytogenes encapsulated in alginate beads after microwave heat treatment in a lab context through this method you  can introduce Listeria directly in line. It is easier to use a harmless enzyme when conducting research in real production lines, as this avoids contamination of the processing equipment and foods.

This method was tested in full-scale production of grilled fish cakes, and showed that this type of TTI (time temperature indicator) was simple to use and is useful in documenting that secure targets are achieved for heat treatment in complicated heat processes.

Source: FoodProductionDaily.com

Descubren carne de equino en hamburguesas de bovino de importante empresa multinacional

La acción no representa un peligro para el consumidor, sin embargo afecta gravemente la credibilidad de la empresa.

A través de un muestreo aleatorio realizado en el retail por la Food Safety Authority of Ireland (FSAI), tres productos vendidos por la cadena Tesco contenían carne de caballo. Esto fue pesquisado a través de un análisis de ADN donde se encontró que los tres productos señalados tenían al menos un 37% de carne equina, donde además se descubrió en los productos ADN de cerdo.

Las autoridades fueron claras al señalar que esto no representa un peligro para el consumidor, sin embargo representa un grave caso de adulteración, ya que entre los ingredientes de los productos solo se mencionaba carne de origen bovino, siendo la principal consecuencia de este hallazgo, la caída en la credibilidad de los consumidores hacia la empresa.

La empresa no tardó en realizar un recall de todos los productos involucrados en el retail, adicionalmente pidió disculpas a todos los consumidores afectados a través de una carta pública. Aquellas personas que adquirieron los productos afectados pueden devolverlos y acceder a un rembolso.

Tesco es la tercera tienda de retail más importante a nivel mundial con su sede principal ubicada en el Reino Unido. La empresa abarca 14 países principalmente en Europa, Asia y América del Norte. No posee tiendas en América Latina.

Fuente: http://newhope360.com/

Aporte: Eduardo Castillo Franzoy

Emergence of New Norovirus Strain GII.4 Sydney — United States, 2012

Long-term–care facilities and restaurants were the most frequently reported settings

Noroviruses are the leading cause of epidemic gastroenteritis, including foodborne outbreaks, in the United States (1). Hospitalization and mortality associated with Norovirus infection occur most frequently among elderly persons, young children, and immunocompromised patients. Noroviruses belong to the family Caliciviridae and can be grouped into five genogroups (GI through GV), which are further divided into at least 34 genotypes. Human disease primarily is caused by GI and GII noroviruses, with most outbreaks caused by GII.4 strains (1).

During the past decade, new GII.4 strains have emerged every 2–3 years, replacing previously predominant GII.4 strains. Emergence of these new Norovirus strains has often, but not always, led to increased outbreak activity. For example, the previously dominant GII.4 New Orleans strain was not associated with increased norovirus outbreak activity in the United States (2). CDC collects information on norovirus strains associated with outbreaks in the United States through an electronic laboratory surveillance network called CaliciNet (3).

This report documents the recent emergence of a new GII.4 strain, GII.4 Sydney, which caused most (53%) of the Norovirus outbreaks, reported through CaliciNet during September–December 2012. Continued surveillance will enable further assessment of the public health implications and significance of this new strain.

In March 2012, a new GII.4 Norovirus strain was identified in Australia. Named GII.4 Sydney, this emergent strain has since caused acute gastroenteritis outbreaks in multiple countries (4). In the United Kingdom, an early onset of the 2012 winter Norovirus season was reported in association with emergence of GII.4 Sydney as the dominant strain implicated in outbreaks.*

In the United States, GII.4 Sydney has spread rapidly nationwide, causing an increasing number of outbreaks. During September–December 2012, a total of 141 (53%) of the 266 Norovirus outbreaks reported to CaliciNet were caused by GII.4 Sydney. The other outbreaks were caused by 10 different GI and GII genotypes, including GII.4 New Orleans. A statistically significant increase in the proportion of outbreaks caused by GII.4 Sydney was noted: four (19%) of 21 outbreaks in September 2012; 22 (46%) of 48 in October 2012; 70 (58%) of 120 in November 2012; and 45 (58%) of 77 in December 2012.

Source: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6203a4.htm

New Campylobacter screening method improve outbreak detection

porA gene seems to be a good indicator of the uniqueness of a specific strain.

In a new study, a team of California-based scientists shows that by targeting and analyzing a specific gene in Campylobacter jejuni, labs can screen dozens of isolates of the bacteria to find the handful most likely to be the source of an outbreak.

Unlike other enteric bacteria, such as E. coli O157:H7, Campylobacter is so diverse in a farm environment that many different strains can be present in just a few samples.

This genetic diversity makes it hard for scientists to link a human Campylobacter infection to its source, since the leading method of bacterial analysis — pulsed-field gel electrophoresis (PFGE) — is time-consuming and labor intensive, and therefore difficult to perform on more than a few isolates at a time.

For this study, researchers zeroed in on one gene in Campylobacter, called porA, which has been suggested to be a good indicator of the uniqueness of a specific strain.

The team collected samples from two different California dairies that were the sources of Campylobacter jejuni outbreaks linked to milk, and conducted porA sequencing on over 100 isolates found in cow feces and water runoff at these locations.

Campylobacter outbreaks are rare. The majority of Campylobacter infections occur as sporadic cases not linked to other illnesses; thus opportunities to study a Campylobacter outbreak are none too common.

Through porA analysis, the researchers narrowed this set down to a group of 8 most likely to match the outbreak strain.

At the second farm, which was ground zero for a 2007 Campylobacter outbreak raw milk that sickened 11 people, a total of 34 C. jejuni isolates were collected. These were narrowed down to a set of 17 likely candidates by porA sequencing. Using this screening method to prioritize isolates, knowing that it was going to be too expensive for the state to test many Campylobacter isolates using PFGE,” explained Jay-Russell.

The study was conducted by researchers at the University of California, Davis; the California Department of Public Health; USDA’s Agricultural Research Service and CDC’s Epidemic Intelligence Service. It appears in this month’s issue of the Journal of Clinical Microbiology.

Source:  Food Safety News

In Canada, 29 Cases of E. coli 0157:H7 associated with KFC and Taco Bell

Contaminated lettuce originally came from California.

The Public Health Agency of Canada (CFIA) is investigating an E. coli outbreak that has now sickened at least 29 people. The outbreak is located in the eastern of Canada in the Maritimes province  and Ontario,  and the latest evidence in the Public Health Agency of Canada’s food-borne illness investigation indicates that the most probable cause of the E. coli O157:H7 is shredded lettuce distributed by FreshPoint Inc. primarily to some KFC and KFC-Taco Bell restaurants. The products were not distributed to grocery stores.

The source of contamination has not been determined, but the lettuce originally came from California. U.S. officials have been notified of this outbreak. Public health officials are investigating to see if food safety controls were followed at each step along the production and supply chain. The reported illnesses occurred between late December and early January. 

The CFIA continues to lead the coordination of the investigation into this outbreak in close collaboration with its health and food safety partners. There are 6 cases in New Brunswick, 10 in Nova Scotia and 13 in Ontario. The majorities of cases has recovered or are recovering. Additional cases of illness may be identified and linked to this outbreak in the future.

The E. coli O157 food-borne illnesses are not uncommon in Canada. In recent years, an average of about 440 cases of this type of E. coli infection was reported annually in Canada. In April 2012, 18 sick with E. coli O157:H7 from romaine lettuce in Canada and California from Amazing Coachella Inc. out of California. In October 2009: 4 sick with E. coli O157:H7 from lettuce served at a Wendy’s in Ontario. October 2008: E. coli O157:H7 in romaine lettuce in Ontario at 3 restaurants Johnathan’s Family Restaurant, Little Red Rooster and M.T. Bellies. August 2008: Aunt Mid’s iceberg lettuce sickens 3 with E. coli O157:H7. September 2006:  Dole Baby Spinach sickens 1 with E. coli O157:H7.

The CFIA recommend always remember the proper hygiene and safe food handling and preparation practices are key to preventing the spread of all foodborne illnesses, including E. coli. Hand washing is one of the best ways to prevent the spread of foodborne illness.

Contaminated foods may look and smell normal. It is important to ensure that you wash your fruits and vegetables before eating them, and cook meat to a safe internal temperature.   

Source: CFIA www.publichealth.gc.ca

Aporte: Pedro Valenzuela G.

FDA releases two long-awaited Food Safety Rules

The public will have 120 days to comment the two rules mandated by the FSMA

After a year-long delay, two sweeping new food safety rules that will for the first time mandate produce safety standards and preventive controls nationwide will be released today and published to the Federal Register on Monday, according to the U.S. Food and Drug Administration.

“It’s a big deal that these two are coming out because it’s the central framework for prevention,” said Michael Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, in an interview with Food Safety News. “We’re eager to get to the next phase of the process.”

The two rules were mandated by the Food Safety Modernization Act (FSMA) — a law that aims to shift the U.S. food safety system from being primarily reactive to focusing on prevention — which President Obama signed into law, with broad bipartisan support, exactly two years ago.

Since the law was enacted, the FDA has failed to keep up with the multiple deadlines set by Congress, in large part because the measures proposed by the agency were under review at the White House Office of Management and Budget’s Office of International and Regulatory Affairs for more than a year — a delay many stakeholders blamed on election politics.

It is still not clear exactly why the Obama administration’s review took so long (OMB officials have long maintained the rules are just complex and take time). According to Taylor, the OMB’s cost-benefit analysis, which will soon be posted online, found that the economic benefits from the two new rules are much greater than the expected costs to the food industry.

“There are significant benefits that well exceed the estimated costs,” said Taylor, adding that preventing outbreaks and the health care costs associated with them is actually one small part of the expected economic benefit. “There’s a great benefit in reducing the disruption to the markets, the loss of sales, and the loss of consumer confidence each time a major foodborne illness outbreak strikes.”

The agency has made full drafts of the proposed rules, which are lengthy, available online. The public will have 120 days to comment and then the rule will go through the normal rulemaking process, which could take several months.

It will likely take time for stakeholders to review the proposed rules, as the agency has not yet released an overview of what exactly would be required under the proposal, but the early reactions were unanimously positive.

One of the key elements of the proposed rule for produce focuses on water. If a farm is applying water to the edible part of the crop, it will likely have to meet a microbial standard, or explain why such a standard isn’t relevant to that specific product.

Source: FoodSafetyNews

Listeria blamed for US smoked salmon recalls

L. monocytogenes contamination continues to drive a wave of US smoked salmon recalls.

The latest incident concerned Chilean supplier Procesadora de Productos Marinos Delifish. On December 31, the company voluntarily recalled cold smoked salmon products marketed in the US, produced from lots 249 to 291 and manufactured between September 5 and October 17 2012.

Fortunately, no complaints or illnesses were reported. However, this is merely the last in a long line of recalls, all linked to Listeria monocytogenes. On December 23, Multiexport Foods recalled smoked salmon sold in Wal-Mart retail subsidiary Sam’s Club’s stores in 42 US states and Puerto Rico.

USA Ocean Beauty Seafoods: Just nine days before this, Ocean Beauty Seafoods recalled 371 cases of ready-to-eat cold smoked salmon after internal samples tested positive for Listeria contamination. The product, which was imported from Chile, was sold in 12 US states.

One month before that, Michael Gourmet Delicacies recalled its Wild Alaskan Sockeye Salmon sold in 

USA Florida Whole Foods stores after the Florida Department of Agriculture identified Listeria in one sample. And on November 9, 2012, Spence & Co, based in Brockton Massachusetts, recalled 1,563 packs of New York style Nova Lox after Listeria was discovered during routine product testing.

UK Two people sick: Two people were taken sick as a result, it is believed, of the contamination. Roy Betts, head of microbiology at UK food research and development firm Campden BRI, said the US zero tolerance policy to Listeria in food would have an effect on the frequency of recalls. By contrast, the EU allows tolerable safe levels of Listeria in product.

The pathogenic Listeria can generally be killed by thorough cooking and proper food preparation, but smoked salmon is often eaten raw, creating greater risk of transmitting the infective bacteria to consumers.

Heat treatment: Betts added: “Smoked salmon is treated with different types of heat process, which would have an effect on killing microorganisms.”

Survey results issued in September by Hutchison Scientific, the School of Natural and Computer Sciences,

University of Aberdeen and Chilled Food Associates pinpointed areas vulnerable to Listeria contamination in smoked fish factories. Drains, skinning machines, brine injection units and fish slicers were all listed as particularly susceptible. Plant workers could also spread the pathogen from area to area via their hands or equipment, the study found. It analyzed irradiation, high pressure processing and pulsed light technology as ways to remove L. monocytogenes contamination.

Source: Food Quality News

Nuevo Reglamento de la Ley de Etiquetado de los Alimentos

MINSAL lanza advertencias que deberán incluirse en  alimentos envasados

El subsecretario de Salud Pública, Jorge Díaz, dio a conocer este sábado 5 de enero el nuevo Reglamento de la Ley de Etiquetado de los Alimentos que establece cómo será la advertencia que deberá colocarse en los alimentos envasados que presenten altos niveles de nutrientes considerados críticos como sal, azúcares, grasa saturada y calorías.

Dicha normativa se someterá a consulta pública en la página web del Ministerio de Salud www.minsal.cl

La autoridad, junto a la directora del Instituto de Nutrición y Tecnología de los Alimentos de la Universidad de Chile (INTA), Magdalena Araya, presentaron modelos de envases de alimentos con la propuesta que se someterá a escrutinio, la que contempla un símbolo similar a un disco pare (octágono) con la leyenda Alto en Sal, Alto en Calorías, Alto en azúcares o Alto en Grasa Saturada, según corresponda. La elección del modelo se hizo sobre la base a un estudio de evaluación de mensajes de advertencia encargado por el Ministerio de Salud al INTA.

Asimismo el testeo concluyó que la figura del octágono se identifica de mejor manera por la población como advertencia. La propuesta de advertencia plantea que ocupe no menos del 20% de la cara principal del envase y que se ubique en el extremo superior derecho del mismo.

En la oportunidad el subsecretario Díaz explicó que el rotulado de alimentos tiene como objetivo fundamental la educación de la ciudadanía. “El mostrar a la población de una manera muy sencilla, didáctica y visual, aquellos elementos que le permiten tomar una decisión positiva”  especialmente para quienes son portadoras de alguna enfermedad crónica como los diabéticos, obesos, hipertensos,  o quienes tienen problemas con el colesterol.

Fuente: Foods News Latam

Delifish S.A. recalls product because of possible Listeria monocytogenes risk

No other products supplied by Delifish or Marine Harvest USA are involved in this case

Potential Listeria-positive products have been identified and we can confirm that Delifish S.A. has issued a voluntary recall of cold smoked salmon products potentially containing Listeria monocytogenes placed on the market in the USA produced from lots 249 through 291, manufactured between September 5 2012 and October 17, 2012.

There have been no complaints or illnesses reported. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can affect immune depressed individuals especially pregnant women can cause miscarriages and stillbirths.

Product was possibly distributed in the CA, VA, OH, IL, FL, GA, TX, DE, NJ, NY, PA, and Puerto Rico and reached consumers through retail stores. The voluntary recall is carried out as a precautionary measure in cooperation with the U.S. Food and Drug Administration and is based on Listeria detection in a few of the recalled batches. No other products supplied by Delifish or Marine Harvest USA are involved in this case.

The US FDA has a zero tolerance for Listeria in products intended to be eaten without prior heat treatment. In EU the tolerance limit for such products is up to 100 bacteria/gram.

Listeria control thus has a very high attention in our company with strict internal standards and routines. We therefore take this issue seriously and are taking these measures to assure that products supplied by Delifish are healthy and safe for our customers and consumers.

Consumers with questions may contact the company at 1-877-479-8085 for more information including how to return the product for a full refund.

Source: http://www.fda.gov/Safety/Recalls/ucm333681.htm