Tag Archives: salmonella

By Shawn K. Stevens

There was been a significant uptick in the amount of foodborne illness outbreaks and food product recalls (there were more than 500 food product recalls last year), many of which have been caused by dangerous pathogens. As FSMA plays a role in addressing this alarming trend, FDA is making several policy changes that will only continue to intensify. The agency is conducting microbiological profiling both inside food processing facilities during routine inspections and testing large amounts of food at the retail level. In addition, it has launched criminal investigations against food companies distributing products that have the potential to cause human illness. In many of these cases, company executives did not have direct knowledge that their products were causing, or had the potential to cause, illness. Many investigations involve Listeria monocytogenes (LM) found in food processing environments or in food products in commerce. Under FDA’s new approach, the failure to eliminate sporadic LM findings in the environment can subject companies to criminal liability. The immediate challenge to the food industry is to find a more effective solution to identify and reduce pervasive pathogens in the processing environment using pathogen-reduction technologies, while simultaneously employing written food safety protocols that can provide additional protection against criminal sanctions.

PulseNet Makes Foodborne Illness Link

Following the conclusion of the infamous the Jack-In-The Box outbreak that sickened 600 and killed four people more than two decades ago, the federal government recognized that similar outbreaks were probably occurring throughout the country, but there were no viable means of detection. As a result, the CDC created the PulseNet database, a mandatory foodborne illness reporting system to detect and track outbreaks in real time. From there, when a patient tested positive for a pathogen of concern (such as Listeria Monocytogenes, Salmonella or E. coli O157:H7), his or her doctor had to report that finding to the state health department. Each state requests copies of the isolates and tests them for the specific genetic DNA fingerprint of the pathogen of interest. These fingerprints are uploaded to PulseNet, and when indistinguishable genetic DNA fingerprints are uploaded from multiple victims, the CDC can recognize that an outbreak is emerging. The agency shares this information with FDA and other federal, state and local health departments as they work to determine a common source. Despite the fact that most illnesses uploaded to PulseNet remain unsolved, the database has helped CDC and FDA solve hundreds of outbreaks that have affected thousands of victims.

My subsequent columns will look at the emerging challenges faced by the food industry, including recent federal criminal investigations, some solutions designed to assess environmental contamination and reduce pathogens, and strategies that you can employ to reduce criminal liability.

February 8, 2016

USDA Poultry Standards Could Reduce Illnesses by 50,000 Annually

By Food Safety Tech Staff

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The USDA has finalized federal standards to lower the incidence of Salmonella and Campylobacter in ground chicken and poultry (including raw chicken breasts, legs and wings, which comprise about 80% of the chicken that American’s purchase). FSIS updated its microbial testing schedule at poultry facilities and will also start posting food safety performance about companies online.

“This approach to poultry inspection is based on science, supported by strong data, and will truly improve public health,” said USDA Deputy Under Secretary for Food Safety Al Almanza in an agency press release. “The new performance standards will complement the many other proactive, prevention-based food policies that we’ve put in place in recent years to make America’s supply of meat and poultry safer to eat.”

Intended to achieve at least a 30% reduction in Salmonella illnesses, a pathogen reduction performance standard for chicken parts, ground chicken and ground turkey is being finalized by FSIS. It is doing the same to achieve a 32% reduction in illnesses from Campylobacter in chicken parts and ground chicken. FSIS estimates a low prevalence of Campylobacter in ground turkey and is thus aiming for a 19% reduction.

“Over the past seven years, USDA has put in place tighter and more strategic food safety measures than ever before for meat and poultry products. We have made strides in modernizing every aspect of food safety inspection, from company record keeping, to labeling requirements, to the way we perform testing in our labs,” said Agriculture Secretary Tom Vilsack in the release. “These new standards, in combination with greater transparency about poultry companies’ food safety performance and better testing procedures, will help prevent tens of thousands of foodborne illnesses every year, reaching our Healthy People 2020 goals.”

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

January 10, 2016

From the Editor’s Desk

Will It All Come Tumbling Down for Chipotle?

By Maria Fontanazza

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As of late, the problems for Chipotle have been endless. 2015 was a year of several Salmonella, norovirus and E. coli outbreaks for the restaurant chain. With the first full week of the new year wrapped up, 2016 is off to perhaps an even rockier start, with news of the company being hit with both a class action lawsuit and a federal grand jury subpoena.

Company stockholder Susie Ong filed a civil complaint against Chipotle on January 8, stating that the company made false or misleading statements and failed to disclose that its “quality controls were inadequate to safeguard consumer and employee health.” Filed in the U.S. District Court for the Southern District of New York, the complaint calls out a norovirus outbreak that occurred in August in Simi Valley, California; a Salmonella outbreak in Minnesota that sickened 64 people; the closure of all company restaurants in Portland, Oregon and Seattle, Washington in November following an E.coli outbreak; and the highly-publicized norovirus outbreak that sickened more than 140 students from Boston College in Brighton, Massachusetts last month.

Ong’s complaint also mentions the federal grand jury subpoena, which Chipotle made public two days prior (January 6) in an SEC filing. Served in December, the subpoena is part of a criminal investigation by FDA and the U.S. Attorney’s Office for the Central District of California into the Simi Valley norovirus outbreak, which sickened about 100 patrons and employees (some reports state that more than 200 people fell ill). Ong’s lawsuit states that health inspectors found “dirty and inoperative equipment, equipment directly linked to the sewer, and other sanitary and health violations” at the Simi Valley restaurant.

With December’s norovirus outbreak in Brighton and the CDC’s announcement that it was further investigating five new cases of E. coli that were reported the month prior, restaurant sales were down 30% for the month, according to the SEC filing. Ong adds up all of these unfortunate events in the lawsuit, stating, “As a result of defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.”

Chipotle has not yet publicly commented on the lawsuit.

Earlier in December, Chipotle called attention to improvements it was making to its food safety program by bringing in IEH Laboratories and Consulting Group to reevaluate its processes in an effort to prevent future outbreaks. Clearly that was not enough.

Food companies take heed. 2016 is off with a bang, and not in a good way. Last week industry was also buzzing about the DOJ’s investigation into Blue Bell Creameries over the deadly Listeria outbreak. FDA and the other federal powers-that-be are making it very clear that negligence will no longer be tolerated (Or should I say, alleged negligence, in this case). Compliance, accountability, and above all, ethical behavior are at the heart of the matter.

Will it all come tumbling down for Chipotle? It remains to be seen whether the company will be able to recover from these issues. And maybe an even bigger question is, who will be next?

December 29, 2015

Food Safety Testing Market to Hit $6.4 Billion by 2020

By Food Safety Tech Staff

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As a result of the rising incidence of food contamination and foodborne illness outbreaks such as Listeria, Salmonella and E.coli, the North American market for food safety testing is expected to hit $6.4 billion within the next four years. According to a recent report by Markets and Markets, the 7.4% compound annual growth rate will also be fueled by the following factors:

Actions taken by food manufacturers to implement more testing at different stages of the chain in order to strengthen food safety standards
Increased concern to reduce the amount of product recalls
Increased consumer interest in ingredients and food safety
FSMA and the regulatory effort to reduce the presence of pathogens or contaminants in food

Learn more about how food laboratories are working to detect dangerous pathogens.

The Markets and Markets report:“North American Food Safety Market by Contaminant , Technology, Food Tested (Meat & Poultry, Dairy, Fruit & Vegetable, Processed Food), & by Country – Trend & Forecast to 2020″

Update: (1/14/2016): According to a report released by Research and Markets on January 14, the global food safety testing market can expect to achieve a 7.1% CAGR over the next five years, hitting $16.2 billion by 2020.

December 28, 2015

Worst Foodborne Illness Outbreaks of 2015

By Food Safety Tech Staff

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The CDC highlighted the following cases of contaminated food that resulted in foodborne illness outbreaks for 2015.

Pathogen	Company and/or Product	Cases	States	Hospitalizations	Deaths	Status
*Listeria*	Blue Bell Ice Cream	10	4	10	3	Investigation complete
*Listeria*	Karoun Dairies, Inc. (soft cheese)	30	10	28	3	Investigation complete
E.coli O26	Chipotle Mexican Grill	53	9	20	0	Investigation ongoing
*Salmonella*	Cucumbers	838	38	165	4	CDC provided last update 11/2015
*Salmonella*	Pork	192	5	30	0	CDC says outbreak “appears” to be over

December 18, 2015

Are You Ready for the Produce Rule? You Just Might Be

By Marsha Madrigal

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At last the new Produce Rule is out, issued on November 13, 2015. For the first time in FDA history, the rule establishes a science-based minimum standard for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The rule can be found in Part 112 of the Code of Federal Regulations (CFR). It applies to both domestic and imported produce.

The new rule provides assurance that produce on the market is not adulterated under the Food, Drug, and Cosmetic Act. It will accomplish this by establishing procedures, processes and practices that are known to minimize the risks of serious adverse health consequences or death to humans, and to prevent the introduction of known biological hazards into and or on produce.

The definition for a farm, covered under the rule, includes two kinds of farming operations, primary production farm and secondary activities farm. The primary production farm operates under one management, and the secondary activities farm is an operation. Where as the primary production farm owns, or jointly owns, a majority of interest in the secondary activities farm.

Food Safety Consortium — During the FDA Town Hall, an audience member asks about the Produce Rule and the work being done with Mexico. Watch the video

For the most part, the new mandated FDA Produce Rules, mirror what farmers, packers and others in the farm business have been doing all along. For years now, produce buyers have required some kind of written guarantee from their suppliers such as a third-party audit certificate showing that the supplying farm or packing shed is complying with the farm food safety standards. Most farms and packing sheds have already undergone, if not one, but perhaps two or more third-party audits such as a Good Agricultural Practices (GAP) or, one of the Harmonized GAP audits, or a Good Manufacturing Practices (GMP) audit, or one of the Global Food Safety Initiative (GFSI) audits such as GlobalGAP, Safe Quality Foods (SQF) or BRC Global Standards (BRC).

This means that those covered under the Produce Rule for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption and have received a third-party audit should have no trouble achieving compliance with the new Produce Rule.

The above-mentioned third-party standards cover most aspects of the key requirements of the Produce Rule regarding agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools, and buildings.

However, some key requirements of the new rule not noted in existing third-party standards include:

Water testing of untreated water, sample collection and survey creation for agricultural water.
Microbial standard limits for detectable amounts of microorganisms to include Listeria monocytogenes, Salmonella species, and E. coli 0157:H7 for the treatment process of soil amendments, including manure.
The final Produce Rule includes requirements to help prevent the contamination of sprouts. For example, requires testing of spent sprout irrigation water for pathogens and requires environmental monitoring for Listeria. Documentation or letters from seed and/or bean supplier for the prior treatment of seed and beans are acceptable.
The requirements of Domesticated and Wild Animals relies more on monitoring and assessing conditions during growing season. If you find evidence of potential contamination like animal excreta, you must take action and evaluate whether produce can be harvested or if there is a likelihood of contamination. The produce must not be harvested.

This rule does not apply to:

Farms that have an average annual value of produce sold during the previous three year period of $25,000/yea
Produce for personal or on-the farm consumption
If the produce is on the list of “rarely consumed raw commodities” such as sweet potatoes and
A food grain such as wheat or oats

The rule provides also for exemptions:

Produce that will receive commercial processing (kill-step) to reduce microorganisms of public health concerns.
Provides a qualified exemption and modification requirement for farms that meet certain requirements based on monetary value and direct sales to qualified end users such as consumers or restaurants. The farm must also meet associated modified requirements like establishing and maintaining certain documentation.

Under certain conditions the FDA may withdraw a farm’s qualified exemption.

The rule focuses on sources of produce contamination found in the past: Agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools and buildings.

This rule and others under FSMA such as Preventive Controls for Human Food, Preventive Controls for Animal Food, and the Foreign Supplier Verification Program are a long overdue yet great achievement for FDA. The agency now shifts its gear into focusing on preventing food safety problems instead of reacting to food safety outbreaks.

FDA estimates that about 348,000 illnesses per year will be prevented by the implementation of this rule.

The compliance dates for the new rule are staggered and based on business size.

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December 14, 2015

USDA Issues Best Practices for Minimizing Salmonella and Campylobacter in Poultry

By Food Safety Tech Staff

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As part of a federal goal to achieve a 25% reduction in Salmonella illnesses related to meat and poultry products by 2020, USDA’s FSIS has revised and published guidelines for poultry processors. The document, “FSIS Compliance Guideline for Controlling Salmonella and Campylobacter in Raw Poultry”, intends to provide best practices based on scientific and practical considerations for minimizing pathogen levels and meeting FSIS food safety requirements.

The guidance recommends preventive measures that poultry companies can make in the following areas:

Pre-harvest (on the farm)
Sanitary dressing procedures
Further processing practices
Antimicrobial interventions
Management practices

FSIS is also seeking comment on the fourth edition of the updated document.

There has been little change in the number of confirmed Salmonella cases, which sicken more than 1 million people annually in the United States. The guidance is part of FSIS’ Salmonella Action Plan, which was announced in December 2013.

December 9, 2015

PCR Assay for Salmonella Detection Gets AOAC-RI Certified

By Food Safety Tech Staff

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Today DuPont announced that the AOAC Research Institute (AOAC-RI) approved a method extension of Performance Tested Method #100201 to include the company’s BAX System X5 PCR Assay for Salmonella detection. Introduced this past July, the PCR assay provides next-day results for most sample types following a standard enrichment protocol and approximately 3.5 hours of automated processing. The lightweight system is smaller and designed to provide more flexibility in testing.

“Many customers rely on AOAC-RI and other third-party certifications as evidence that a pathogen detection method meets a well-defined set of accuracy and sensitivity requirements,” says Morgan Wallace, DuPont Nutrition & Health senior microbiologist and validations leader for diagnostics, in a company release. “Adopting a test method that has received these certifications allows them to use the method right away, minimizing a laboratory’s requirements for expensive, time-consuming in-house validation procedures before they can begin product testing.”

The validation covers a range of food types, including meat, poultry, dairy, fruits, vegetables, bakery products, pet food and environmental samples.

December 8, 2015

Make Your Data More Meaningful

By Maria Fontanazza

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Data can be a very powerful tool, but only if it is used in an effective manner. It needs to be easily consumable and understood by all levels within an organization. “It’s great to collect information, but if you don’t do something with it, you’re not doing yourself, your facility or your employees any favors,” says Holly Mockus, product manager at Alchemy Systems. “It can really trip you up during a regulatory inspection to have all of this information that you haven’t looked at, tracked, trended or reacted to.”

As FSMA places more importance on documentation and record keeping, FDA-regulated facilities will need to not only capture information but also translate data into easily digestible content for management and employees in order to drive continuous improvement. In a discussion with Food Safety Tech, Mockus shares some key points on how companies can transform their data from numbers and statistics into meaningful and actionable information.

Collect meaningful data from the start. From the beginning of the data collection process, be mindful of exactly what outcome the organization wants to achieve. Having an understanding that the data will be measured and acted upon encourages facilities to avoid gathering information just for the sake of collecting it.
Involve the employees who actually collect the data. Data is more meaningful when employees understand why they’re gathering information and are involved in the process from the beginning.
React to the data. If the information reveals a good or bad trend, or that a process or procedure is out of spec, take action. In addition, document how the business reacted to the issue and the corrections that were put in place.
Close the loop for continuous improvement. Establish a closed loop for data collection, focusing on how gaps were addressed, with an emphasis on continuously improving on the process.
Really examine the data collected. Whether collected for a product, process or equipment line, sit down and take a close look at the data. This exercise is intended to reveal redundancies across departments and help reduce record keeping tasks.

Food Safety Tech: How do companies transform data into a meaningful tool for management?

Mockus: That’s such a challenge for us. It should be easily consumable, especially for management and the higher ups in organizations, because they don’t have as much time to sit down and digest a 20-page document that’s full of numbers and statistics. Work towards to summarizing the information in a way that allows executives and plant managers to look at a graph and know instantly what it means; they don’t need to get into the nitty-gritty. Simplifying the scientific data, whether environmental sampling, quality assurance data, or microtesting in general, and taking it down to base a level so that the non-scientist can understand it—I think that’s something we have to work on, especially for those coming under more regulation. Keep in mind that people who look at the tracking and trending [might not] understand graphs and scientific terms.

A lot of people put the data into a graphic format—it doesn’t have to be a line graph or pie chart, it can be a red, yellow, green [indicator] or a scale of justice. Look at the graphics that are meaningful to your specific organization and use those. Be creative, but keep it simple.

FST: When companies set metrics, how can they ensure that those metrics are taking them in the right direction from a food safety perspective?

Mockus: Especially when you have metrics that are tied to performance for a manufacturing facility, you want to be careful how you set them and how you reward them. For example, if your metric for environmental testing is very low or at zero, you’re encouraging your workforce not to find those Listeria niches or areas in which Salmonella can grow, because you’re telling them that they have to be at a zero rate to be incentivized. It’s more about measuring the outcomes of the activities—are we finding the niches and eliminating them so we don’t have those issues versus saying we want to be at “zero”? [It’s important] to work with upper management so that they understand the consequences of their expectations and the incentive programs that they put in place.

Steward Parnell, PCA, salmonella outbreak

September 22, 2015

PCA Executives Sentenced: Stewart Parnell Gets Virtually Life in Prison

By Maria Fontanazza

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In what is being called a groundbreaking decision, a federal judge sentenced three executives from the Peanut Corporation of America (PCA) to a combined 53 years in jail for their role in the 2008-2009 Salmonella outbreak. Stewart Parnell, former CEO of the no-longer-operating PCA, has been sentenced to 28 years; his brother, Michael Parnell, was handed 20 years; and Mary Wilkerson, quality assurance manager of the plant, was given 5 years. Convicted last year on 71 counts, Stewart Parnell was facing up to 803 years in prison, but at the age of 61, 28 years is essentially a life sentence.

The culprit of the fatal 2008 Salmonella outbreak was tainted peanut butter paste manufactured by PCA. Nine Americans died, and more than 700 people across 47 states were sickened. The outbreak led to the recall of more than 2,100 products. It was one of the largest food recalls in U.S. history, and the case has garnered national attention.

During yesterday’s sentencing, victims and their families asked U.S. District Court Judge W. Louis Sands to deliver a life sentence to Stewart Parnell; his daughter, Grey Adams, addressed the room, “My dad’s heart is genuine…” and said that her father and their family are “profoundly sorry” for the deadly outbreak. As Parnell addressed the victims in the Georgia courtroom, he made mention of the problems at the plant but did not comment on the emails and company records that indicate he had knowingly shipped tainted product or tampered with any lab records.

Earlier this year STOP Foodborne Illness’ Darin Detwiler commented on the significance of the sentencing in a video interview with Food Safety Tech, stating, “His actions resulted in technically more deaths than that of Charles Manson.”

Moving forward, the bar for accountability at the executive level has been set much higher. Victims, their families, and food safety advocates are applauding the sentencing. What do you think about the decision and its impact on the industry?

PulseNet Makes Foodborne Illness Link

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