Yesterday the CDC reported that the E.coli outbreak linked to romaine lettucegrown in the Salinas, CA growing region is over. The contaminated lettuce should no longer be available, and FDA states that consumers do not need to avoid romaine lettuce from Salinas. The agency will continue its investigation into the potential factors and sources that led to the outbreak.
The FDA did identify a common grower link to the E.coli O157:H7 contamination as a result of its traceback investigation. However, a statement released yesterday by FDA Deputy Commissioner for Food Policy and Response Frank Yiannas points out that “this grower does not explain all of the illnesses seen in these outbreaks.”
To be specific, the FDA, CDC and other public health agencies were tracking three outbreaks involving three separate strains of E.coli O157:H7 linked to romaine lettuce. During the course of the investigation FDA, CDC, the California Department of Food and Agriculture and the California Department of Public Health conducted sampling of the water, soil and compost of several of the fields in the lower Salinas Valley that were connected to the outbreak. “So far, sample results have come back negative for all of the three outbreak strains of E. coli O157:H7. However, we did find a strain of E. coli that is unrelated to any illnesses in a soil sample taken near a run-off point in a buffer zone between a field where product was harvested and where cattle are known to occasionally graze,” Yiannas said in the agency statement. “This could be an important clue that will be further examined as our investigation continues. However, this clue does not explain the illnesses seen in these outbreaks.”
Finding the contamination source(s) is critical, as it will aid romaine growers in putting safeguards in place to help prevent future contamination.
As for the final case count (with last illness onset on December 21, 2019) of this outbreak, there were 167 total illnesses and 85 hospitalizations across the United States. No deaths were reported.
Food processing is a multi-trillion dollar industry that encompasses facilities such as bakeries, meat and poultry plants, bottling lines, dairies, canneries and breweries. For all of these food processing plants a commercial flooring system is essential for maintaining a hygienic environment. Few areas of a plant provide as much opportunity for the spread of bacteria, mold, fungi and dust as the floor. Hazardous materials from a contaminated floor can easily be spread from worker’s shoes and mobile equipment. Food processing plants present a unique set of challenges that require careful consideration of floor properties and installation.
Food processing plants floors are subjected to constant, high concentrations of salt, alkaline and oil compounds that substantially degrade the floor and thereby risk food contamination and facility shutdown. These compounds can come from common food production by-products like oils, fats, dairy products, sugar solutions, blood, and natural acids or from harsh cleaners and disinfectants. Even with frequent and thorough cleaning these substances can—and will—result in microbial growth and the spread of bacteria in untreated concrete or poorly installed resinous flooring.
Cleaning floors is an essential part of maintaining food processing operations to keep up with government standards. A proper floor coating is a necessity for dealing with the vigorous, harsh cleaning procedures that typically include very hot water and aggressive cleaning chemicals. Depending on the exposure to corrosive, temperature and moisture conditions a thin film coating may suffice; however, in most cases, a thick, durable floor coating is needed to endure the cleaning operations. If too thin of a coating is used the repeated barrage of high pressure, high-temperature hot water and steam will strip the floor coating. Only an experienced flooring professional can determine the proper floor coating for a facility.
In addition to the properties of the floor coating, proper installation is essential for maintaining a hygienic, safe facility. If a floor is not seamless even the best floor coatings are vulnerable to germ buildup within gaps and cracks. To prevent harmful substance accumulation, a seamless coving transition from the floor to the wall is needed. Not only does that make the floors unsanitary, but it also can spread to other parts of the facility, equipment and product. Coving also aids in the cleaning process by allowing for hosing around the sides and corners of the room where germ buildup is most common.
An often-overlooked—yet critical—aspect of floor installation is having the proper pitch to promote water drainage. Having pools of water is not only dangerous for workers but for product safety. Such an examples of this issue is the Listeria outbreak at cantaloupe producer Jensen Farms, which led to 33 fatalities, 143 hospitalized victims, and ultimately, the end of their business. In the 2011 FDA released a report that focused on “Factors Potentially Contributing to the Contamination of Fresh, Whole Cantaloupe Implicated in the Multi-State Listeria monocytogenes Foodborne Illness Outbreak”. The conclusion was reached that the leading cause of Listeria spreading was due to a poorly constructed packing facility floor that was difficult to clean and allowed water to pool. The best way to prevent a similar situation at your plant is to make sure you get an experienced flooring expert, who understands your facility’s needs, to choose a floor with the right properties and to properly install it.
Using whole genome sequencing (WGS), FDA has confirmed 96 illnesses in 11 states that were caused by Salmonella Javiana. Thus far, traceback evidence indicates that a fruit mix from New Jersey-based Tailor Cut Produce is the possible source of the outbreak.
FDA provided its latest update about the ongoing investigation today: Of the 96 illnesses, 27 have been hospitalized, and no deaths have been reported. The highest number of illnesses have been reported in Delaware (39), Pennsylvania (34) and New Jersey (12). The agency stated its inspection at Tailor Cut Produce continues and it is collecting records to support a traceback investigation.
As of December 17, seven infections were reported, with four hospitalizations and one death across five states. The hard-boiled eggs were sold both in bulk pails to food processors, restaurants and retailers, as well as directly to consumers at the retail level, and have “Best If Used By Dates” through March 2, 2020.
FDA used whole genome sequencing to find a genetic match in the outbreak strain from samples collected at Almark’s facility during agency inspections in February and December of this year.
Going digital is a hot topic in the food industry, but making the investment can be a tough choice for organizations. Jeremy Schneider, business development director, food safety and quality assurance at Controlant, reviews some of the factors that food companies should consider when making the decision, along with the value that digital technologies can bring from the perspective of ROI and improving food safety culture.
Food Safety Tech: For businesses that have been historically paper-driven, where do they start on the technology adoption journey?
Schneider: There are a number of questions that firms, both small and large, should consider when deciding to move to a paperless operation. Have you considered what moving away from a paper-based system would mean for your enterprise? What are the perceived challenges to making this move? Or perhaps, what are the risks of not moving to digital? How would utilizing systems provide your organization with the ability to access data in transformative ways?
For organizations that are making the transition from paper documentation to digital, it is critical to develop a roadmap with tangible milestones and objectives. Although there are a variety of reasons to make the switch to digital, what is most important for your organization will determine what those are, as they will play a critical role in developing a roadmap of priorities. We often find that organizations identify a ‘’pain-point’’ in their current process, and this is a leading driver to wanting to make a change in their process. Perhaps this is the inability to easily access information in a timely manner, or the challenges with making sense of the data that you are currently collecting. Whatever your challenges may be, begin by developing a plan, and prioritize this, as it will provide you with early positive results that will keep you working towards the goal. As you experience these early benefits from going digital, you will begin to see the value that this will bring your organization at scale.
One significant issue that many organizations face when beginning this journey is not bringing the appropriate stakeholders into a program early enough. It is critical for the success of new supply chain programs to make sure you bring in members of purchasing, logistics, quality, finance, IT, and others as early as possible so that any questions or concerns are properly vetted early in the process. In addition to this, getting buy-in from these teams at the earliest phase of a project will allow others to vet the system in their own way, potentially helping them solve challenges they have been
FST: Talk about measuring the success of a technology: How do the metrics translate into ROI?
Schneider: A question that is often raised is how to measure the success of the technology. Simply put, does the program make your life easier and solve the problem you set out to, or not? Does it meet the concise objectives that you outlined in the beginning of the process, or does it fall short in some way? If your answer to any of these questions is yes, and it does meet the objectives, then you are well on your way to defining success of your program.
Read Food Safety Tech’s previous discussion with Schneider, Using Technology for Traceability Adds Dimension to Supply Chain, Promises ROIIt is critical that programs are able to show their value through their return on investment, but how do you measure this? If you have recently implemented a real-time supply chain temperature monitoring program, for instance, you may want to consider metrics such as reduced loss, spoilage, shortages, or restaurant-level outages as metrics of success. Or perhaps you would want to translate this into a dollar figure. For instance, in the previous year, your organization counted 10 rejected shipments due to suspected temperature abuse, at a loss of $500,000. In the year following your implementation, your new system was able to help the organization intervene and minimize that loss to just one rejected shipment at a cost of $50,000, thus leading to a reduced loss rate of $450,000.
In collaboration with other stakeholders in your organization, you may be able to identify additional metrics, such as reduced freight rates from optimized shipping lanes, reduced insurance premiums from reduced losses, or reduced quantities of on-hand inventories as you are able to truly manage a just-in-time supply chain. If your organization actively measures your Cost to Serve, savings within your supply chain would likely be an important data point to consider.
Beyond the identifiable money savings, consider some of the soft ROI attributes, such as enhanced collaboration with supply chain and supplier partners, improved customer loyalty, brand protection generally, and sustainability initiatives. Does your organization have goals to reduce food waste? If so, perhaps waste minimization is an important attribute to measure. When evaluated holistically, significant savings can be realized.
FST: How does technology facilitate a more effective food safety culture?
Schneider: Building an effective food safety culture is a process that requires commitment from every level of your organization. The ways that we promote food safety culture within each organization differs, from rewarding team members when they identify an unsafe practice, to actively promoting food safety throughout the organization, to encouraging quality assurance teams to identify state-of-the-art technologies and implementing them to improve the systems, programs, and processes throughout the company.
As food safety professionals, our toolboxes are filled with a variety of tools for the job, and technology as a tool is no exception. Technology should enable our organizations to be more efficient, allowing them to focus their attention on high-priority projects while minimizing work that can be automated. An example of this is setting parameters to allow organizations to work based on exception instead of requiring a review of all documentation.
As we enter the New Era of Smarter Food Safety, and the tenants of it being people-led, technology-enabled, and FSMA-based, we have a mandate to try new technologies to help solve previously unsolvable supply chain challenges. Organizations are actively pursuing real-time supply chain temperature monitoring as a way to provide insights into their cold chain and allowing them to move from reaction to a position of prevention.
Organizations are finding that investments in food safety technologies pay dividends in customer commitment over the long term. It is no longer acceptable to only meet regulatory standards. It is now an expectation that companies do anything possible within their power to assure customer safety and, per the FDA’s new mandate, to help create a more digital, traceable, and safer food system.
In the latest FDA update about the E. coli O157:H7 outbreak involving romaine lettuce, the agency has stated that consumers should not eat romaine lettuce that has been harvested from Salinas, California. Traceback investigations related to three different E. coli outbreaks (three different strains, all of which involve romaine lettuce) have pointed to a common grower located in Salinas. Frank Yiannas, deputy commissioner for food policy and response, called the identification of a common grower a “notable development” but also stated in a press announcement, “Because of the expansive nature of these outbreaks, our investigation remains a complicated work in progress, and it is too soon to draw definitive conclusions.”
FDA, CDC and California partners have sent out a team to conduct new investigations at ranches used by the grower as part of the process in finding the contamination source, according to an FDA update.
Thus far, 102 illnesses have been reported across 23 states, with 58 hospitalizations. No deaths have been reported. The last illness onset was reported on November 18.
Thus far Swedesboro, NJ-based Missa Bay, LLC has recalled more than 75,000 pounds of salad products because of a lettuce ingredient that might be contaminated with E. coli O157:H7. This lettuce was also found to be in packaged salad that the Maryland Department of Health said contained E. coli.
FDA states that thus far lettuce grown indoors has not been indicated in the outbreak.
Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series addressed the importance of a physical security expert, insider threat detection programs, actionable process steps (APS) and varying approaches to a VA. To further assist facilities with reviewing old or conducting new VAs, Part II will touch on access, subject matter experts, mitigation strategies and community drinking water through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.
Lesson 6: Utilization of Card Access. The FDA costs of implementing electronic access control, as reported in the Regulatory Impact Analysis document (page 25) are shown in Table 1.
Average Cost Per Covered Facility
Prohibit after hours key drop deliveries of raw materials
Electronic access controls for employees
Secured storage of finished products
Secured storage of raw materials
Cameras with video recording in storage rooms
Peer monitoring of access to exposed product (not used)
Physical inspection of cleaned equipment
Prohibit staff from bringing personal equipment
Table I. Costs of Mitigation
In our opinion, these costs may be underreported by a factor of five or more. A more realistic number for implementing access control at an opening is $5,000 or more depending on whether the wire needs to be run in conduit, which it typically would. While there are wireless devices available, food and beverage organizations should be mindful that the use of wireless devices may in some cases result in the loss of up to 50% of electronic access control benefits. This happens because doors using this approach may not result in monitored-for-alarm conditions, such as when doors are held open too long or are forced open. Some wireless devices may be able to report these conditions, but not always as reliable as hardwired solutions. Using electronic access control without the door position monitoring capability is a mistake. From a cost standpoint, even a wireless access control device would likely be upwards of $2,000 per opening.
Lesson 7: In the interest of time, and in facilities with more complex processes (which increases the work associated with the VA), plan to have quality, food safety and physical security personnel present for the duration of the VA. But also bring in operational specialists to assess each point, step or procedure for the respective operational areas. You may wish to have a quick high-level briefing for each operational group when it’s their turn to deliberate on their portion of the manufacturing operation. Proper planning can get a hybrid style VA done in one-and-a-half to three days maximum for the most complex of operations.
Lesson 8: Conduct a thorough site tour during the assessment process; do not limit your vulnerability activity to a conference room. Both internal and external tours are important in the assessment process by all members of the team. The external tour is needed to evaluate existing measures and identify vulnerabilities by answering questions such as:
Is the perimeter maintained?
Are cameras pointed correctly?
Are doors secure?
Are vehicles screened?
Are guards and guard tours effective?
Internal tours are important to validate documented HACCP points, steps or procedures.A tour also helps to validate process steps that are in multiple parts and may need to be further assessed as a KAT, for public health impact, accessibility and feasibility or to identify issues that have become “invisible” to site employees which might serve a security purpose.
Properly conducted tours measure the effectiveness of a variety of potential internal controls such as:
Use of identification measures
Use of GMP as a security measure (different colors, access to GMP equipment and clean rooms)
Effectiveness of buddy systems
Lesson 9: Do not forget the use of community drinking water in your processes. This is an easy way to introduce a variety of contaminants either in areas where water is being treated on site (even boiler rooms) or where water may sit in a bulk liquid tank with accessibility through ladders and ports. In our experience, water is listed on about half of the HACCP flow charts we assessed in the VA process.
Lesson 10: Some mitigation strategies may exist but may not be worth taking credit for in your food defense plan. Due to the record keeping requirements being modeled after HACCP, monitoring, corrective action and verification records are required for each mitigation strategy associated with an APS. This can often create more work than it is worth or result in a requirement to create a new form or record. Appropriate mitigation strategies should always be included in your food defense plan, but sometimes it produces diminishing returns if VA facilitators try to get too creative with mitigation strategies. Also, it is usually better to be able to modify an existing process or form than having to create a new one.
Lesson 11: In cases of multi-site assessments, teams at one plant may reach a different conclusion than another plant on whether an identical point, set or procedure is an APS. This is not necessarily a problem, as there may be different inherent conditions from one site to the next. However, we strongly suggest that there be a final overall review from a quality control standpoint to analyze such inconsistencies adjudicate accordingly where there is no basis for varying conclusions.
Lesson 12: If there is no person formally responsible for physical security at your site, you may have a potential gap in a critical subject matter area. Physical security measures will make at least a partial contribution to food defense. Over 30 years, we have seen many organizations deploy electronic access control, video surveillance and lock and key control systems ineffectively, which provides a false sense of security and results in unidentified vulnerability. It is as important to select the right physical security measures to deploy, but also critical to administer them in a manner that meets the intended outcome. Most companies do not have the luxury of a full-time security professional, but someone at the plant needs to be provided with a basic level of competency in physical security to optimize your food defense posture. We have developed several online training modules that can help someone who is new to security on key food defense processes and security system administration.
Lesson 13: As companies move into ongoing implementation and execution of the mitigation strategies, it is important to check that your mitigation strategies are working correctly. You will be required to have a monitoring component, correction action and verification intended for compliance assurance. However, one of the most effective programs we recommend for our clients’ food defense and physical security programs is the penetration test. The penetration test is intended to achieve continuous improvement when the program is regularly challenged. The Safe Quality Food (SQF) Institute may agree with this and now requires facilities that are SQF certified to challenge their food defense plan at least once annually. We believe that frequency should be higher. Simple challenge tests can be conducted in 10 minutes or less and provide substantial insight into whether your mitigation strategies are properly working or whether they represent food defense theater. For instance, if a stranger were sent through the plant, how long would it take for employees to recognize and either challenge or report the condition? Another test might include placing a sanitation chemical in the production area at the wrong time. Would employees recognize, remove and investigate that situation? Challenge tests are easy high impact activities; and regardless of the outcome, can be used to raise awareness and reinforce positive behaviors.
Whether training a new security officer, reviewing existing security plans or preparing for an upcoming vulnerability assessment (due July 26, 2020), these lessons learned from experienced security consultants should help to focus efforts and eliminate unnecessary steps at your facility. The final installment in this series will address broad mitigation strategies, the “Three Element” approach and food defense plan unification. Read the final installment of this series on Lessons Learned from Intentional Adulteration Vulnerability Assessments, Part III.
The nose knows: In case fish smells “fishy”, it is no longer fit for human consumption. A Canadian fish importing company pleaded guilty to the import of 9,000 pounds of rotten and partially decomposed fish into the United States. The potentially adulterated fish was sampled by the FDA, who declared it to be too spoiled to be sold in the country, hence refused its entry into the United States—but the fish was imported via a wrong shipment declaration anyway. The crime of importing refused food carries a prison sentence of up to a year.
FDA Deputy Commissioner for Food Policy and Response Frank Yiannas made it clear that the FDA is not replacing FSMA. Rather, the goal is to build on it, recognizing changes in the food industry over the last 10 years and the technologies available to tackle new challenges.
This isn’t surprising given continuing quality issues resulting in food recalls and shelf withdrawals. Last year, two major outbreaks of E. coli that were tied to consumption of romaine lettuce made a mark on industry perceptions, impacting customer trust, brand loyalty and the bottom line of companies involved were affected. Research by Allianz found recall costs could reach $10,000,000 for significant events.
To achieve the FDA’s goal of end-to-end traceability, the amount of information carried by every food item needs to increase, as will information about its location and condition in the supply chain. Grocers are at the sharp end of the food chain, meaning everything the FDA is proposing will impact them. As well as being merchandisers, they are brand-owners in their own right. They work directly with farmers and growers, they are directly involved in food safety, storage and distribution, and they feel the impact of recalls more than most. Unlike others in the food chain, they interact with consumers daily. This is important to note, since consumers are expecting communication on recalls immediately. In a recent study of more than 15,800 global consumers, 66% of respondents noted that they expect immediate notification of a product recall and another 28% stated they expect notification within a week.1 Furthermore, 88% said if a retailer immediately informed them of an issue, they would be more likely or slightly likely to trust them. The study also found that only 16% of consumers completely trust the product information provided to them from retailers today. In short, the impact of recalls extends far beyond the empty store shelf, and gives the industry even more reason to strive for safety.
High-Tech Next Steps
The FDA plans to publish a strategic blueprint early in 2020 of planned actions to meet its goal, but food brands and grocers need not wait to act. Proven technologies like brand compliance solutions, combined with emerging blockchain track and trace solutions and Internet of Things (IoT) sensors can add new depth and detail to traceability in the food supply chain, and these new technologies are already helping grocers and retailers keep consumers safe.
As retailers have sought a better means to track supply chain movements, blockchain technology has emerged as a potential way forward. Originally developed to manage financial transactions involving cryptocurrency, blockchain has proven to be capable of providing a verifiable record of the movement of goods through a supply chain. In fact, one major retailer has been piloting blockchain for more than a year and has already proven its value on produce items, cutting traceability times from more than a week to a matter of seconds. Some want to go even further and use IoT sensors to monitor the condition (e.g., temperature) of food products in the supply chain. Together, blockchain can help trace the path a product took through the supply chain and IoT can monitor the environmental conditions en route, providing a more cohesive picture of its supply chain journey.
But while supporting a few simple products with one ingredient and a one-step supply chain, such as fruits or vegetables, is one thing, scaling to address the needs of the average private brand retailer—now handling more than 10,000 active products from 2,000 production sites globally—is another. Managing the complexity of a product like tiramisu or a ready-made meal with dozens of ingredients, all coming from different sources, needs a different approach. To address the complexity, many are turning to brand compliance solutions—trusted, real-time repositories of information spanning the entire supply chain. For example, those using brand compliance solutions now have complete visibility of the ingredients in their private label products, helping them ensure labeling accuracy and transparency for consumers. Brand compliance tools also bring improved visibility of the food supply chain, enabling them to verify the status of manufacturing sites and respond quickly to food quality issues.
This combination of detailed product and supplier information makes brand compliance a foundational enabler for any blockchain/IoT-based initiative to improve supply chain visibility and traceability. For example, using brand compliance solutions, grocers can:
Confirm the ethical compliance of the supply chain at the point of selection or review, while using blockchain/IoT to monitor the ongoing conformance to these standards
Validate shelf life claims during formulation, while blockchain/IoT monitors logistical movement and environments to optimise products’ freshness
Record products’ formulation and ingredients to ensure safety, legal compliance and labeling accuracy, with blockchain/IoT monitoring the ongoing conformance to these standards
Rapidly identify potential risks across the entire formulation and supply chain, while tracking the affected batches to stores using blockchain and IoT
This convergence of static factual data (e.g., formulation, nutrition and allergens) linked to near real-time traceability and checking offers grocers confidence in the data and supports the consumer’s confidence of an actual product in their basket.
It seems clear that the food business is moving in the same direction as airlines and banks and becoming much more data driven. For grocers looking to keep pace, they will need to:
Treat data as a core competency. This means hiring information experts, investing for the future, and using data to identify ways to deliver better, safer products.
Create a customer-centric value promise. Grocers must go beyond regulatory compliance and use data to improve consumer transparency, support ethical sourcing initiatives, expand sustainable packaging and speed innovation.
Go above and beyond. Rather than waiting for FDA direction or simply complying with requirements, brands should take matters into their own hands, hold themselves to high markers and get started now.
In the future, improving the way that we manage the food supply chain is not just about how well we work with trucks and warehouses; it’s about how use information. The FDA’s initiative makes a clear statement that now is the time to modernize our food supply chains. As we look ahead to a new decade, the industry can come together to improve food safety and protect consumers, and we need not wait for the FDA’s blueprint or even the new year to get started.
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