Tag Archives: FDA

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part III)

By Frank Pisciotta, Spence Lane
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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. Part II reviewed access, subject matter experts, mitigation strategies and community drinking water. This final article reviews broad mitigation strategies, feasibility assessments, food defense plans, partial ingredient security and the “Three Element” approach through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities, but which can also be applied to the smaller facilities that are currently in the process of readying for the next deadline of July 26.

Lesson 14: When the final rule was released, the concept of using broad mitigation strategies was eliminated. That notwithstanding and realizing that many companies seek to operate at a stricter standard for food defense with a clear focus on brand protection, versus only those process steps that potentially could result in a “wide scale public health impact.” Broad or facility-wide mitigation strategies should not be abandoned, but are less likely to get you a lot of credit for IA compliance. Including existing food safety prerequisite programs (PRP), programs and practices that are put in place to maintain a sanitary environment and minimize the risk of introducing a food safety hazard, can, in some cases, also be included as security mitigation. PRP’s with slight modifications can also contribute to a good “food defense” posture. For example, one PRP addresses hazardous chemicals and toxic substances. In some cases, non-food grade substances that could result in product contamination (not necessarily wide-scale public health impact) might be available to a disgruntled insider. It is obvious companies are concerned about contaminants being brought into the plants, but please do not overlook contaminants that are already there and ensure that they are properly secured when not in use.

Other facility-wide programs (broad mitigation) that contribute to effective food defense might include site perimeter or building security, visitor and contractor management, pre-employment background checks, employee security awareness and food defense training and sanitation chemical management.

Lesson 15: If you are using the three elements approach (Guidance Chapter 2 Section G) or the hybrid approach (Guidance Chapter 2 Section H), you will be required to make an assessment on feasibility. In the early VA’s conducted, prior to the second installment of the guidance in March of 2019, feasibility was essentially an all or nothing proposition. One could argue that a judgment call was required as to whether an intentional adulteration incident could be accomplished given the inherent conditions. Those conditions might include a lot of coworkers who might be able to observe and serve as witnesses to deter the act. With the release of the second installment of the guidance from the FDA, a new tool was made available which would allow food and beverage companies to run a calculation and make a more accurate prediction of how much of an unnamed “representative contaminant” which is assumed to be highly lethal and heat stable it might take to contaminate a product batch. Typically, the larger the batch size, the higher the quantity of the “representative contaminant” would be required to achieve a lethal dose (LD) in a serving size. So, to provide an additional level of validation with identified actionable process steps, the use of the LD calculation might be considered to provide more realistic insight into the feasibility element. For instance, if it would require one hundred pounds of the “representative contaminant,” you might feel justified in concluding that it is not realistic to get that amount of contaminant into the batch at the process step and rule out the point, step or procedure as an APS. This can save money and ensure limited food defense resources can be channeled to the areas where legitimate risk can be reduced.

Lesson 16: After an APS is identified, sites will need to determine, as the rule states, whether the existing “mitigation strategies can be applied…to significantly minimize or prevent the significant vulnerability.” Simply stated, what is in place today for food safety, and the broad-based security measures in use, may or may not be enough when you consider an insider motivated to contaminate the product. The FDA’s mitigation strategies database may offer some insights into additional food defense measures to consider. Where additional mitigation strategies are identified, from the time of completion of the VA until a site’s regulatory compliance deadline arrives (next one is July 26, 2020), that change must be incorporated into the food defense plan and fully implemented. We recommend that a site make a list of new mitigation strategies after the VA is complete for tracking purposes during the implementation phase. No mitigation strategies should be included in the food defense plan that are not fully implemented and where records cannot be adequately produced.

Lesson 17: In the second installment of the guidance, the concept of partial ingredients was introduced. The key activity types (KAT) of secondary ingredients is now considered to include the storage of partially used, open containers of secondary ingredients where the tamper-evident packaging has been breached. Tamper evident tape looked to have promising benefits, but several of our clients have abandoned the use of this mitigation strategy, which has been proven repeatedly to be defeated without detection. It appears that using containers that can be secured with numbered seals might be a better option and even better if the seals would be metal detectable in the event one went astray in a product stream.

Lesson 18: Food defense plan unification. Facilities regulated under the IA rule are likely to already have a food defense plan for other initiates such as SQF or BRC. The IA Rule is not unlike other counter-terrorism regulations in potential to create challenges to meet voluntary and regulatory requirements without having multiple food defense plans. The IA Rule based on its modeling after HACCP creates some very specific requirements in terms of how data needs to be presented and records maintained. Sites may be doing other things to support food defense, and one strategy that might keep auditors in their lane would be to include any non-IA Rule food defense content (e.g., for SQF or BRC) in an appendix to the IA Rule Food Defense Plan.

Lesson 19: Under the VA method the FDA refers to as “the “Three Element” approach, suggestion is made in the guidance released in March 2019 that regulated facilities might consider creating stratified categories for each element of public health impact, degree of physical access and ability of the attacker to successfully contaminate product. This is asking regulated facilities to engineer their own vulnerability assessment methodology. It is our opinion that this is asking a lot from a food and beverage facility and that creating categories for each element (e.g., refer to Table 3 on page 54) will extend the time it takes to complete a vulnerability assessment, create a lot more uncertainty in the process and does not necessarily help companies to identify the areas where intentional adulteration risk is highest.

Conclusion

Organizations who have yet to execute vulnerability assessments (due July 26) or those who have already completed vulnerability assessments who may wish to reflect back on their existing VAs in an effort to eliminate unnecessary APS’s should find these strategies helpful in focusing limited resources to the areas where they can have the greatest effect. Since the initiation of this article series, the FDA has released its third installment of the guidance. Once we reflect on this new installment, we will address our thoughts in a future article.

April Kates, EAS Consulting
Retail Food Safety Forum

Labeling Impact of FDA’s Nutrition Innovation Strategy

By April Kates
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April Kates, EAS Consulting

On March 29, 2018, FDA announced the Nutrition Innovation Strategy, which signaled their intention to take a fresh look at what can be done to “reduce the burden of chronic disease through improved public nutrition.” The agency wants to facilitate consumers making better food choices to improve their health. At the same time, FDA has acknowledged that in many cases, changes in food processing technology has rendered outdated certain provisions of the regulations once written to both inform and protect the public. Therefore, FDA has developed a plan to move ahead to update its policy toolkit.

This multi-pronged approach includes modernizing food labeling, including food standards, health claims policy, ingredient labeling requirements and continuing implementation of the updated nutrition facts label, menu labeling, and reducing sodium in processed food products.

In particular, in trying to gather information to help determine the best approach to revising food standards of identity, FDA held a public meeting on September 27, 2019. FDA is attempting to provide room in the regulations for industry to be able to use modern and hopefully more healthful manufacturing methods while at the same time retaining the traditional characteristics and nutritional value of standardized food products.

During the public meeting, consumer advocacy groups, food industry trade groups and medical associations expressed many points of view as to what FDA should do to make the more than 250 food standards of identity more applicable to the modern food supply. FDA also took comments on updating food ingredient labeling requirements, including simplifying terms for ingredients such as vitamins. Because each food standard of identity is a regulation, it will be no small effort for the agency to update, remove or add standards of identity as needed. This meeting was a way to get input to help guide their decisions and priority—making for food standards and ingredient labeling revisions.

Obviously, with such a broad-based effort, the revisions and changes will be incremental. But the thing to keep in mind is that it all points to an effort to improve public health through the food supply as well as an effort to impactfully modernize the regulations. What follows is a very brief summary of some of FDA’s recent actions in this regard.

On December 30, 2019, FDA announced the final guidance on Serving Sizes, Dual-Column Labeling, which provided additional information about when dual column labeling for nutrition is required and what exemptions are in place to provide relief for certain products or package sizes.

On December 27, 2019, FDA reopened the comment period on the use of ultrafiltered (UF) milk in certain cheeses. When the proposed rule for UF milk in cheeses originally published in 2005, FDA received many comments. Essentially, ultrafiltration was a means to enhance the speed of cheese production, and the standard of identity cheeses were written before this technology was common and did not permit this type of process. FDA seeks to modernize the cheese standards while keeping intact the nature of these cheeses, and so the agency is eager to learn about what can be done to accommodate the new technology without losing the essence of the standards that consumers have come to expect. Because of the time lapse since the previous comment period, FDA is seeking more information to inform their rulemaking.

On October 25, 2019, FDA released a final rule revising the type size for calorie declarations on front of pack labeling for glass-front vending machines. The 2014 rule establishing calorie labeling for products sold from vending machines had provisions that were difficult for certain products to meet. This new rule recognizes those challenges and was an attempt by the agency to provide a middle ground for the industry to meet the requirements of visible calorie labeling on small packages sold in vending machines.

On August 15, 2019, FDA announced final guidance on converting units of measure for Folate, Niacin, and Vitamins A, D and E on the nutrition and supplement facts labels. The guidance provides help to the industry in meeting the requirements of the revised nutrition facts label.

Regarding updating the “healthy” claim on food products, when this term was originally defined by the agency, saturated fat was the nutrient of focus for these claims. However, since then, there are new focuses on health, such as added sugar and calories. In September 2016, FDA sought to modernize the claim, and provided an interim policy to guide its use.

In May 2019, FDA published a draft guidance to provide enforcement discretion for the use of the term “potassium chloride salt” on ingredient statements. In addition, in April 2019, FDA provided a draft guidance for the calculation of calories from a newer sweetener, Allulose.

As you can see, there are a lot of moving parts to FDA’s effort. What will be the impact on the food industry? Changes will most likely be gradual. Over time, there will be modifications to food standards of identity, and potentially claims, and both of these will cause label revisions. And, typically, there may be enforcement discretion by FDA to allow the industry time to revise their products and /or labeling as needed.

You will see FDA requests for information from the public and the industry on various related topics to the Nutrition Innovation Strategy, and guidance documents will be updated.

FDA

FDA Releases Supplemental Draft Guidance for Intentional Adulteration Rule

By Food Safety Tech Staff
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FDA

Read the series: Lessons Learned from Intentional Adulteration Vulnerability AssessmentsThis week FDA issued a supplemental draft guidance to aid in compliance with the FSMA Intentional Adulteration Rule. The draft, “Mitigation Strategies to Protect Food Against Intentional Adulteration”, includes chapters that address food defense corrective actions and verification, reanalysis and recordkeeping. It also includes appendices on FDA’s Mitigation Strategies Database, along with how business can assess their status as a small or very small business.

This is the third and final installment of the draft guidance for the IA rule.

The FDA is still on schedule to begin routine intentional adulteration inspections next month.

FDA

Drug to Mitigate Peanut Allergies in Kids Gets FDA OK

By Food Safety Tech Staff
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FDA

On Friday FDA announced the approval of a drug to mitigate allergic reactions to accidental peanut exposure in children. Manufactured by Aimmune Therapeutics, Palforzia is intended for use in children who are four years through 17 years old. FDA points out that there is no cure for a peanut allergy and so peanuts must continue to be avoided.

Palforzia is a powder made from peanuts and administered in capsule and sachet form via three phases, the first of which occurs under the supervision of a healthcare professional. This first phase, called “initial dose escalation”, involves administration of a single capsule. The second phase, “up-dosing”, is a phase of 11 increasing dose levels over a period of several months (the first dose of this phase is also administered under watch by a healthcare professional, while the remaining doses can be taken daily at home). Following completion of the second phase, a patient begins the “maintenance” treatment, which is delivered via a sachet (the powder can be mixed with foods such as applesauce and yogurt).

“Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in an agency press release.

Palforzia is available through healthcare providers, healthcare settings and pharmacies that receive special certification and are educated on the risk of anaphylaxis in using the drug. Patients interested in receiving the drug must be part of FDA’s risk evaluation and mitigation strategy program.

Frank Yiannas, FDA, food safety

2020 Food Safety Consortium Keynote Speaker Announced: Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response

By Food Safety Tech Staff
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Frank Yiannas, FDA, food safety

EDGARTOWN, MA, January 22, 2020 – Innovative Publishing Company Inc., publisher of Food Safety Tech, has announced that Frank Yiannas, deputy commissioner for food policy and response at FDA, will serve as the keynote speaker for the 2020 Food Safety Consortium Conference & Expo on October 21. The Consortium is the industry’s leading food safety event for networking and educational opportunities, and takes place October 21–23 in Schaumburg, IL (just outside Chicago).

“At last year’s Food Safety Consortium, Frank Yiannas spoke about the ‘sea change’ happening at FDA and the increased efforts on the part of the agency to drive more transparency and traceability. We look forward to his insights, as well as learning more about FDA’s progress on its initiatives, especially the New Era of Smarter Food Safety,” says Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference & Expo.

This year’s Food Safety Consortium Conference & Expo features three breakout tracks: Food Safety, chaired by Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation; Food Integrity, chaired by Steven Sklare, president of The Food Safety Academy; and Food Defense, chaired by Jason Bashura, senior manager, global food defense at PepsiCo.

The call for abstracts is open until March 2, 2020.

Food Safety Consortium, Frank Yiannas, FDA
Frank Yiannas, FDA deputy commissioner for food policy & response, addresses the ways that the public and private sector must work together as part of the agency’s initiative, the New Era of Smarter Food Safety during the 2019 Food Safety Consortium.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy. The Food Safety Consortium Conference and Expo is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

With the passage of the Farm Bill, there has been a great deal of interest from the food industry in cannabis-infused foods and beverages, which includes hemp and CBD. The Food Safety Consortium is co-located with The Cannabis Quality Conference & Expo, an educational and networking event for cannabis safety and quality solutions. Serving the Midwest market with a unique focus on science, technology and compliance, the Cannabis Quality Conference enables attendees to engage in conversations that are critical in finding solutions to improve regulatory compliance, quality, efficiency and cost effectiveness in a quickly evolving cannabis marketplace. Both conference programs run concurrently, thus, Food Safety Consortium registrants can attend any of the Cannabis Quality Conference presentations and vice versa. This year’s event takes place October 21–23 in Schaumburg, IL and is co-located with the Cannabis Quality Conference & Expo.

Lab grown meat

How Plant-Based Foods Are Changing the Supply Chain

By Maria Fontanazza
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Lab grown meat

The plant-based meat market is anticipated to be worth more than $320 million in the next five years, according to a report released last summer by Global Market Insights. As the popularity of meat-alternative products continues to rise, new challenges are being introduced to supply chain management. Joe Scioscia, vice president of sales at VAI explains some of these hurdles and proposes how technology can help.

Food Safety Tech: Is the growing popularity of plant-based foods introducing hazards or challenges to the supply chain?

Joe Scioscia, VAI
“The growing popularity of plant-based foods has presented a new set of challenges for the supply chain,” says Joe Scioscia of VAI.

Joe Scioscia: The growing popularity of plant-based foods has presented a new set of challenges for the supply chain, especially considering many of these organic items are being introduced by traditionally non-organic retailers. Impossible Foods received FDA approval for its plant-based burger in 2019, showing just how new the plant-based movement is to the industry.

Obviously, the organic supply chain and produce suppliers have long followed regulations for handling produce, such as temperature controls, cargo tracking, and supply and demand planning software, so the produce could be tracked from farm to table and in the case of a recall, be traced back to the source. But for meat alternatives that are combining multiple plant-based ingredients, organizations in the supply chain who are handling these products
have new food safety concerns. Considerations on how to store and process meat alternatives, how to treat each ingredient in the product and, most importantly, how to determine temperature controls or the source of contamination are all discussions the food industry is currently having.

FST: How are plant-based foods changing the dynamic of the supply chain from a food safety perspective?

Scioscia: The food supply chain has changed dramatically in recent years to become more complex, with food items traveling farther than ever before, containing more ingredients and required to follow stricter regulations. Many of the changes to the supply chain are for the better—organic and plant-based alternatives offer health benefits for consumers and are a move towards a more sustainable future. But the reality is that the supply chain isn’t quite there yet. Suppliers, retailers and producers at every part of the supply chain need to work together to ensure transparency and food safety compliance—including for plant-based products. Foodborne illnesses are still a real threat to the safety of consumers, and these same consumers are demanding transparency into the source of their food and sustainable practices from brands. All of these considerations are what’s making this next era of the food industry more complicated than ever before.

Because food safety compliance is always top of mind in the food industry to keep consumers safe, this new and complex supply chain has required companies to rely heavily on technology solutions to ensure plant-based products are equally as safe to consume as non-organic alternatives. These same solutions are also helping supply chains become more transparent for customers and streamline food processes to build a more sustainable future.

FST: What technologies can food companies and retailers use to better manage the supply chain risk while supporting the increased consumer demand for meat alternatives?

Scioscia: Utilizing a centralized software system is one tool many food suppliers and distributors can use to better visualize, trace and process products in the supply chain—including for plant-based alternatives. Having access to a central platform for business data to track assets and ensure food safety regulations are being met allows for companies to optimize processes and cut unnecessary costs along the way.

Heading into 2020, many organizations in the food supply chain are also looking at new applications like IoT, automation, and blockchain as ways to curb food safety issues. The FDA has taken steps to pilot blockchain and AI programs to better track drugs and food products, in conjunction with major food brands and technology companies. Other organizations are following suit with their own programs and many are looking at these solutions to improve their food tracking efforts. It’s clear technology has the most potential to make it easier on the industry to comply with food safety regulations while meeting customer demands for plant-based alternatives and organic options—all the while building a sustainable supply chain for the future.

FDA

E. Coli Outbreaks Linked to Salinas-Grown Romaine Lettuce Over, Deputy Commissioner Yiannas Releases Statement

By Food Safety Tech Staff
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FDA

Yesterday the CDC reported that the E.coli outbreak linked to romaine lettuce grown 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.

Kevin Smedley, High Performance Systems
FST Soapbox

Importance of Flooring for Food Processing Plant Hygiene

By Kevin Smedley
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Kevin Smedley, High Performance Systems

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.

Food processing plant hygiene, flooring
A commercial flooring system is critical to maintaining a hygienic environment in a food processing plant. (Image courtesy of High Performance Systems)

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.

Cantaloupe

Nearly 100 People Sick from Salmonella ‘Potentially Linked’ to Tailor Cut Produce Fruit Mix

By Food Safety Tech Staff
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Cantaloupe

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.

Tailor Cut Produce recalled the Fruit Luau fruit mix earlier in December, along with its cut honeydew, cantaloupe and pineapple products.

Recall

Almark Foods Expands Hard Boiled Egg Recall As Listeria Outbreak Continues

By Food Safety Tech Staff
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Recall

Today FDA provided an update about its outbreak investigation of Listeria monocytogenes linked to hard-boiled eggs manufactured by Almark Foods’ facility in Gainesville, Georgia. On December 23, Almark expanded its recall to include all eggs manufactured at the Gainesville plant. In addition, the company is not producing products at this facility.

Thus far, four companies have recalled products containing the eggs from Almark Foods, as they have the potential to be contaminated with Listeria monocytogenes:

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.

The agency investigation is ongoing.