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.
DuPont BAX System X5 PCR Assay for Salmonella detection
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.
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.
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?
From sanitation and processing to testing and analysis to transportation and imports, government requirements of companies in the food industry are changing. Many companies are already prepared for the transformation that FSMA will bring. Within food testing and analysis, expectations will be higher than ever. Companies should be able to more accurately and rapidly identify contamination in order to take immediate action. What are some of the biggest concerns in testing and analysis? What changes can we expect? In a roundtable discussion with Sample6 executives, Michael Koeris, Ph.D., founder and vice president of operations, Tim Curran, CEO, and Jim Godsey, vice president of research & development, share their perspective on the hurdles that industry is facing and how innovative technology plays an important role in the future of food safety.
Key trends:
Focus in testing shifts from not just testing and recording data, but also analyzing and communicating results. Having data analysis and reporting skills will be a critical function for the next generation of food safety professionals.
Be proactive, not reactive. If you’re finding problems at the finished product level, it’s too late.
The need for stronger partnerships between industry and government, especially relating to providing industry with the tools to effectively gather and analyze data in a timely manner.
Food Safety Tech: What are the current industry challenges, especially related to advances in pathogen detection technology?
Tim Curran, CEO of Sample6
Tim Curran: When I look at food companies and food safety managers, [their jobs] have become harder to do well, instead of easier. The environment in which they’re working is more challenging, and the pressures are increasing. There’s more regulatory scrutiny, whether we talk about FSMA or the regulatory environment [in general], and there are more testing and inspection [expectations].
Second, the nature of the foods that we need make for the U.S. population (and I think it is a trend around the world): Ready-to-eat products. We’re producing products that are more convenient for families where they won’t necessarily have a cook step down the road. The kinds of foods in demand have a higher risk profile.
Third is the globalization of food supplies. Raw materials are coming in from all different directions, and there is an increasing number of shipping points. That creates more pressure, and from a food safety perspective, that is a bad thing.
“It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there.” -Michael KoerisFinally, there’s social media. There’s a lot of scrutiny from the public. Information around any kind of fear or recall is rapidly disseminated.
These factors add up to higher pressure, a higher bar, and a harder job to accomplish—and the tools and methods available to keep the plant safe and food safe are not keeping pace.
Although I think food plants want to test more at the point of contamination, it’s just not possible. Unless they have a sophisticated lab, most food companies ship out samples because enrichment is required. As a result, they’re getting feedback on the safety of their plant and food in two, three, or four days, depending on where they fall as a priority to that outside lab.
Jim Godsey: With FSMA, testing is decentralizing from the larger lab, which is typically staffed with experienced personnel, to the facility where those personnel don’t exist. Having a test with a workflow that can be easily accommodated by someone with a high school education is absolutely critical for the field.
Michael Koeris, Ph.D., founder and vice president of operations
Michael Koeris: Visibility of data is generally extremely poor, because many people touch individual data points or pockets of data. The hand-off between the different groups is usually shaky, and the timeliness of delivering data to the operators has been a huge issue. This has been an opportunity for us: Our control offering is an operating system for environmental control. It’s an open system, so it accepts both our data and other people’s data, enabling visibility across an entire corporate infrastructure. Plant managers and other [users] of these systems can generate timely reports so they can see what is happening on a daily basis.
FST: In considering professional development, what skills are necessary to ensure that employees will be well equipped to address the issues discussed here?
Godsey: The role of the food safety manager becomes a much more critical and challenging role. To support that, they need better tools; they need to know with a high degree of confidence that their facility has been tested, that the testing was done at the proper times and intervals, and that the data has been analyzed in a timely manner. It’s not just assay/analysis [or] reporting results anymore; it’s the holistic review of those results and translating that [information] into whether or not the plant is safe at that point in time.
Koeris: The persona of the food safety manager is changing. They need to see themselves as the brand protection manager. If you have food safety issues, your brand is at risk. We need to empower the food safety manager at the local level to act, remediate and change processes.
Jim Godsey, vice president of research & development
There also has to be fundamental change in the industry in how results are viewed. Not all tests are created equal. It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there. This is not a pharmaceutical production facility. Setting the wrong goals at the corporate level of zero positives disincentivizes operators to not look hard enough. You have to actually understand the plant and then make sure that you’re safe with regards to your control plan.
FST: How do you expect the final FSMA rules and implementation process will impact industry?
Koeris: Most of the larger food players are already doing what FSMA mandates or will mandate. The medium and smaller processors will have to adapt and change. They have to implement better standards and more standards, more surveillance, and implement more rigorous processes. The [key] is to help them do this on a tight budget.
FSMA has increased awareness of food safety across the supply chain. It is still focused on the processors, but we know it doesn’t stop there; it doesn’t stop at the distributor or the retailer. Food safety has to be throughout that supply chain.
Having an understanding and awareness of all of the challenges that exist downstream—that will [lead to] the real innovation and increase in foods safety.
UPDATE: September 9: According to the CDC, 341 people have been reportedly infected with Salmonella from 30 states. Since September 3, the number of cases has increased by 56. Two deaths have now been reported (California and Texas). Andrew & Williamson Fresh Produce has voluntarily recalled all cucumbers sold under the “Limited Edition” label (between August 1 through September 3, 2015).
More information has been posted on the CDC website.
Across 27 states, an outbreak of Salmonella Poona linked to cucumbers grown in Mexico has led to one death and 53 reported hospitalizations, according to FDA. The agency released an update on Friday with the latest figures and information related to the outbreak and the product.
The product:
Cucumbers supplied by Andrew and William Fresh Produce of San Diego
Cucumbers grown in Baja, Mexico
Referred to as a “slicer” or “American” cucumber
Shipped in black, green, yellow cartons that read “Limited Edition Pole Grown Cucumbers”
The Salmonella outbreak (as of 9/3):
Where: Alaska (8), Arizona (60), Arkansas (6), California (51), Colorado (14), Idaho (8), Illinois (5), Kansas (1), Louisiana (3), Minnesota (12), Missouri (7), Montana (11), Nebraska (2), Nevada (7), New Mexico (15), New York (4), North Dakota (1), Ohio (2), Oklahoma (5), Oregon (3), South Carolina (6), Texas (9), Utah (30), Virginia (1), Washington (9), Wisconsin (2), and Wyoming (3)
Date range: July 3 to August 26, 2015
1 death
53 reported hospitalizations
Additional details are available on FDA’s website, and the agency will provide an update when new information is available.
As with any potential health hazard related to consumption of a food product, FDA is advising consumers not to eat the cucumbers. They are also urging restaurants to ask their suppliers what company supplied their cucumbers.
Next month Stewart Parnell, the former CEO of Peanut Corporation of America (PCA), is scheduled to be sentenced for his role in a deadly salmonella outbreak involving shipping contaminated peanut products nationwide. Parnell, who could spend the rest of his life in jail, was found guilty on 71 counts, including conspiracy, obstruction of justice and wire fraud. This landmark case sends a strong message about accountability to both industry and consumers, said Darin Detwiler, senior policy coordinator for food safety at STOP Foodborne Illness, at the IAFP 2015 conference in July.
“His actions resulted in technically more deaths than that of Charles Manson,” said Detwiler, who indicated that Parnell is still very much in denial over his role in the salmonella outbreak. “This might be one snapshot—one look at one person in one industry, in one business—but think about how many companies are out there [and] of this mindset—the idea that they’ll never get caught.”
Food companies should be held strictly liable when it comes to consumer safety, ensuring that they take preventive measures so that illness and death never happen. The sentencing of Parnell next month could set a precedent for how future cases involving companies responsible for foodborne illnesses and outbreaks are handled.
Today FDA announced the winner of the 2014 Food Safety Challenge. The Purdue University team snagged the $300,000 grand prize for its physical method for concentrating Salmonella to detectable levels via automated microfiltration. The technique can potentially reduce sample preparation time from 24-48 hours to a two- to three-hour timeframe.
Runner-up Pronucleotein received $100,000 for its portable device that enables rapid pathogen screening via DNA aptamer-magnetic bead sandwich assays.
Rapid technologies address the trend toward environmental testing versus finished product testing.
During the past decade, incidences of Salmonella have failed to drop, and the pathogen continues to pose a serious problem to the food supply. Meredith Sutzko, Product Manager, Food Pathogens at Romer Labs North America discusses current technology needs for the food industry.
Q: What are processors looking for in Salmonella detection methods?
Sutzko: I think we will see an increase in testing related to the Food Safety Modernization Act, and there’s a trend toward environmental testing as opposed to finished product testing. Instead of waiting to test finished products at the end of a production cycle, we’re finding that processors are taking a lot of environmental samples from the production line in different areas in order to find contamination further upstream so that when they get to the product testing, they have a lot of confidence that the product is going to be pathogen-free.
Processors are looking to identify contamination very early in the process. To do that, they need simple and cost-effective methods, especially ones that will deliver a fast time-to-result and can be used at the production facility so they don’t have to wait to obtain test results. By using test methods on-site, they can immediately take action upon getting the test result.
Q: How is RapidChek® differentiated from other rapid methods currently available?
Sutzko: The RapidChek method is an innovative, simple and easy-to-use test. With this test, we typically focus on the enrichment portion of the rapid method, because if salmonella is present in the environment, it’s going to be present at very low levels. The enrichment portion (or the growth phase), is important to get that pathogen to higher concentrations for detection.
We use innovative bacteriophage technology in our enrichment media. The bacteriophage act as selective agents during enrichment to inhibit the growth of competing microorganisms, which could be present. The phages allow an optimal growth environment for Salmonella, if it’s present, by reducing the growth of these other competitors. It helps to provide a fast time to result. Then we combine the enrichment media with a state-of-the art-lateral flow test, which uses highly purified antibodies that have been optimized for the sensitive and specific detection of Salmonella.
The technology is simple and easy to use. The end user doesn’t need any expensive equipment to run it. The method comes all-inclusive with everything necessary to run it, so there are no additional expenditures on consumables. Producers are able to do a lot more testing using the RapidChek, because it’s so cost effective. If they find contamination or a growth-niche, they can sanitize, take action and do more testing to make sure they’ve gotten rid of the pathogen.
Q: What’s the significance of Salmonella detection right now as it relates to the risk that the pathogen poses to the food supply?
Sutzko: Historically, Salmonella has been associated with meat and poultry. Recently we’ve seen a lot more outbreaks in different types of food products and matrices that historically have not been associated with Salmonella. Also, the food supply is being globalized. We’re receiving a lot of foods from different countries, possibly where their food safety standards are not as stringent as we have in the United States. We’re seeing an increased level of awareness by producers. They look at their suppliers and their raw materials to make sure they’re testing the materials before they put it into their supply chain.
Also with regulations like FSMA, we see retailers driving food safety and quality systems through third-party certification bodies such as GFSI. Retailers are requiring their suppliers to have effective food safety quality management systems in place in order to do business. These practices will help to ensure safe food is being supplied to the consumer from farm-to-fork.
In less than two weeks, FDA is holding a Demo Day at the Center for Food Safety and Applied Nutrition in Maryland. The agency will be awarding $500,000 to the team that can develop a technique or technology that creates “significant improvements” in the speed at which FDA can detect Salmonella in fresh, minimally processed produce.
A few months ago, Capt. Palmer Orlandi, Ph.D., senior science advisor at FDA’s Office of Veterinary Medicine, describes exactly why FDA is offering such a hefty prize. It can take between three and five days to detect Salmonella in product, and with full serotyping, it can take as long as two to three weeks to obtain results.
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