Tag Archives: mitigation

Mike Edgett, Sage

COVID-19 Leads Food Companies and Meat Processors to Explore AI and Robotics, Emphasize Sanitation, and Work from Home

By Maria Fontanazza
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Mike Edgett, Sage

The coronavirus pandemic has turned so many aspects of businesses upside down; it is changing how companies approach and execute their strategy. The issue touches all aspects of business and operations, and in a brief Q&A with Food Safety Tech, Mike Edgett of Sage touches on just a few areas in which the future of food manufacturing looks different.

Food Safety Tech: How are food manufacturers and meat processors using AI and robotics to mitigate risks posed by COVID-19?

Mike Edgett: Many food manufacturers and meat processors have had to look to new technologies to account for the disruptions caused by the COVID-19 pandemic. While most of these measures have been vital in preventing further spread of the virus (or any virus/disease that may present itself in the future), they’ve also given many food manufacturers insight into how these technologies could have a longer-term impact on their operations.

For instance, the mindset that certain jobs needed to be manual have been reconsidered. Companies are embracing automation (e.g., the boning and chopping of meat in a meatpacking plant) to replace historically manual processes. While it may take a while for innovations like this to be incorporated fully, COVID-19 has certainly increased appetite amongst executives who are trying to avoid shutdowns and expedited the potential for future adoption.

FST: What sanitation procedures should be in place to minimize the spread of pathogens and viruses?

Edgett: In the post-COVID-19 era, manufacturers must expand their view of sanitation requirements. It is more than whether the processing equipment is clean. Companies must be diligent and critical of themselves at every juncture—especially when it comes to how staff and equipment are utilized.

While working from home wasn’t a common practice in the manufacturing industry prior to March 2020, it will be increasingly popular moving forward. Such a setup will allow for a less congested workplace, as well as more space and time for bolstered sanitation practices to take place. Now and in the future, third-party cleaning crews will be used onsite and for machinery on a daily basis, with many corporations also experimenting with new ways to maintain the highest cleanliness standards.

This includes the potential for UV sterilization (a tactic that is being experimented with across industries), new ways to sterilize airflow (which is particularly important in meatpacking plants, where stagnant air is the enemy) and the inclusion of robotics (which could be used overnight to avoid overlap with human employees). These all have the potential to minimize the spread of pathogens and, ultimately, all viruses that may arise.

Mike Edgett, Sage
Mike Edgett is an enterprise technology and process manufacturing expert with 20+ years leading business strategy for brands such as Infor, Quaker Oats and Bunge Foods. At Sage, he leads the U.S. product marketing team focused on the medium segment.

FST: How is the food industry adjusting to the remote working environment?

Edgett: While the pandemic has changed the ways businesses and employees work across most industries, F&B manufacturers did face some unique challenges in shifting to a remote working environment.

Manufacturing as a whole has always relied on the work of humans, overseeing systems, machinery and technology to finalize production—but COVID-19 has changed who and how many people can be present in a plant at once. Naturally, at the start of the pandemic, this meant that schedules and shifts had to be altered, and certain portions of managerial oversight had to be completed virtually.

Of course, with employee and consumer safety of paramount concern, cleaning crews and sanitation practices have taken precedent, and have been woven effectively and efficiently into altered schedules.

While workers that are essential to the manufacturing process have been continuing to work in many facilities, there will likely be expanded and extended work-from-home policies for other functions within the F&B manufacturing industry moving forward. This will result in companies needed to embrace technology that can support this work environment.

FST: Can you briefly explain how traceability is playing an even larger role during the pandemic?

Edgett: The importance of complete traceability for food manufacturers has never been greater. While traceability is by no means a new concept, COVID-19 has not only made it the number one purchasing decision for your customers, but [it is also] a vital public health consideration.

The good news is that much of the industry recognizes this. In fact, according to a survey conducted by Sage and IDC, manufacturing executives said a key goal of theirs is to achieve 100% traceability over production and supply chain, which serves as a large part of their holistic digital mission.

Traceability was already a critical concern for most manufacturers—especially those with a younger customer base. However, the current environment has shone an even greater spotlight on the importance of having a complete picture of not only where our food comes from—but [also] the facilities and machinery used in its production. Major budget allocations will surely be directed toward traceability over the next 5–10 years.

food safety tech

Food Labs/Cannabis Labs Virtual Conference Includes FDA Comments on Proposed Lab Accreditation Rule

By Food Safety Tech Staff
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food safety tech

Next month join Food Safety Tech and Cannabis Industry Journal for the virtual conference, Food Labs / Cannabis Labs. The event is complimentary for attendees and will be held Tuesday, June 2 through Friday, June 5 (each day the event begins at 11 am ET). The event was originally planned as an in-person event but was converted to a virtual conference as a result of the COVID-19 pandemic.

The event kicks off with FDA’s comments on the proposed FSMA laboratory accreditation rule, which will be presented by FDA’s Timothy McGrath and Donald Burr. Other session highlights include FSMA’s impact on labs; navigating the regulatory pitfalls of cannabis lab testing; the evolution of the lab testing market; documentary standards and reference materials; and vulnerability assessment frameworks and food fraud mitigation strategies. Many of the educational sessions will be followed by Tech Talks, which will be provided by sponsors in the laboratory technology or service provider fields, who will educate attendees about solutions that can assist in the food lab and/or cannabis lab environment.

More than 500 people have already registered to attend! Don’t miss this unique opportunity and register now. Please note that only registrants who attend the live event will have access to the recording.

For companies interested in Tech Talk opportunities, Contact RJ Palermo (203-667-2212). Tuesday and Wednesday are sold out.

Coronavirus, COVID-19

Webinar this Friday: Supply Chain Issues Related to COVID-19

By Food Safety Tech Staff
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Coronavirus, COVID-19

Visit Food Safety Tech’s COVID-19 Resource CenterAs the coronavirus pandemic disrupts personal lives and business, the food industry must continue to operate under very different conditions. This Friday, Food Safety Tech is hosting the third webinar in its series of COVID-19 in the Food Industry. Experts will discuss how to prepare for supply chain issues and disruptions. Sponsored by Intelex, this is a complimentary webinar event.

Event

COVID-19 in the Food Industry: Mitigating and Preparing for Supply Chain Disruptions

When

Friday, April 24, 2020 at 12 pm ET

Panelists

Steven Sklare, President, The Food Safety Academy (Moderator)
Kermit Nash, Partner at Saul Ewing Arnstein & Lehr
Steven M. Gendel, Ph.D., Senior Director for Food Science, Food Chemicals Codex

Register now

Megan Nichols
FST Soapbox

Four Ways To Improve Your Food Safety Management System

By Megan Ray Nichols
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Megan Nichols

Foodborne illnesses cost billions of dollars each year in the United States. A lack of standards can lead to severe consequences, including loss of customers, negative impact on brand reputation and employees missing work due to illness. As a result, safety is vital for any brand that is committed to high-quality food and maintaining a positive brand image.

Food safety management systems—the processes and procedures that companies set up to prevent contamination—are essential in reducing the risk of foodborne illness and ensuring the safest products possible.

By FDA regulation, most food processors must have HACCP as well as corrective actions/preventive action (CAPAs) plans in place. Even with the right safety guidelines, however, contamination or exposure to food hazards can still occur. The following are four ways to improve the quality of your food safety management system.

1. Conduct Regular Audits

Even if your business’s HACCP is highly effective in theory, it won’t prevent contamination unless actual practice lines up with documentation. Regular audits can ensure employee practice complies.

HACCPs are structured around identifying both potential food hazards and critical control points (CCPs) where your system has the opportunity to prevent, mitigate or eliminate a potential issue. Usually, this means storing food items or performing some biological, physical or chemical action to a target limit— like a specific temperature—to prevent or mitigate contamination.

For example, in the manufacturing of chicken products, cooking and hot-holding are critical control points at which the product needs to be heated to a certain temperature to eliminate or prevent potential hazards. Here, an audit would be a chance to ensure employees cooked and hot-held foods at the proper temperatures. If they aren’t, the food safety management team can make policy changes that ensure practice lines up with planning.

The audit process should be consistent and occur regularly. It should also cover every aspect of your HACCP strategy and place a particular focus on potential hazards and CCPs. These audits can be a way to uncover the strengths and weaknesses of your current HACCP strategy. Companies can use this information to build upon existing practices or demonstrate how procedures could be more effective.

Stainless steel
Stainless steel is popular in food handling due to impermeable surface and resistance to corrosion, two characteristics that help reduce the risk of food contamination. (free image from Splash)

2. Consider a CCP Monitoring System

You can use automated or digital systems to ensure that CCPs aren’t deviating from control limits. With the right sensors, it’s possible to ensure that food remains between target limits at each CCP. For example, automated sensors can quickly alert plant staff if the temperature of food in cold storage rises above a certain threshold, or if there is a deviation from a given CCP.

These alerts can help staff quickly respond to deviations, ensuring compliance, and reducing the risk of contamination by food hazards.

3. Review and Maintain Equipment

An thorough equipment program can be highly effective in reducing the risk of food contamination. To minimize risk, your plan should look at the equipment needed in your plant, as well as how it’s constructed and maintained. For example, choosing industry-standard or food-safe materials can help prevent contamination. Investing in the right kind of stainless steel can both improve operating costs and help reduce the risk of food exposed to hazards.

Preventive maintenance plans for food safety equipment can also reduce the risk of contamination by ensuring the proper functioning of site equipment.

4. Provide Employee Support and Encourage Buy-In

Training programs are an essential component of any HACCP. If your employees don’t know how to handle food properly or aren’t aware of HACCP documentation or the CCPs in the food processing pipeline, they won’t be able to execute the plan and prevent contamination.

While training programs are crucial, they don’t necessarily guarantee compliance. Common pitfalls exist that can discourage employees from following the plan. To encourage employee buy-in, training should begin by discussing the importance of food safety and the potential risks of contamination.

The training should also be robust enough that employees feel confident when executing the HACCP. Training staff should be sure to provide visual demonstrations and opportunities for employees to practice before they become responsible for food safety. Tests or evaluations both during and after training can be useful tools in determining how well your employees understand your business’s HACCP strategy. Regular follow-ups on training can also ensure compliance and reduce the risk of contamination.

Improving Food Safety Management Systems

For any business that works with food, safety programs are essential in ensuring the safest and highest quality product possible. Existing food safety management systems can often improve with the right methods. For example, automated monitoring systems can reduce the risk of deviating from CCP limits. Employee training and regular audits can also ensure that a plant’s food safety practices line up with the documented plan.

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.

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.

FDA

FDA Updates Food Defense Plan Builder to Support Compliance with Intentional Adulteration FSMA Rule

By Food Safety Tech Staff
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FDA

Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:

  • Facility Information
  • Process/Product Description
  • Vulnerability Assessment
  • Mitigation Strategies
  • Food Defense Monitoring Procedures
  • Food Defense Corrective Action Procedures
  • Food Defense Verification Procedures
  • Supporting Documents
  • Signature

The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.

The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.

FDA

FDA Says Routine Intentional Adulteration Inspections Will Start March 2020

By Food Safety Tech Staff
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FDA

Learn more about food fraud  at the Food Labs Conference | June 2–4, 2020 | Rockville, MDThis week FDA made an announcement during a public meeting that the agency’s routine inspection to verify compliance with the FSMA Intentional Adulteration rule will start next March.

The first compliance date for the rule is this July. It is a requirement for food facilities covered under this rule to develop and implement a food defense plan that identifies vulnerabilities and the consequent mitigation plan.

FDA stated that it has received feedback on the “novel nature” of the rule’s requirements and that stakeholders want more time to develop their food defense plans. “ To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020,” FDA stated and added that it is working on developing more resources as well as the final part of draft guidance to continue to assist industry.

food safety tech

Food Hazards Web Seminar Addresses Detection, Mitigation and Control

By Food Safety Tech Staff
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food safety tech

On June 1, Food Safety Tech is hosting a web seminar (also penned a “virtual conference”) about food hazards in the realm of pathogens and allergens. “Food Hazards: Detection, Mitigation & Control” begins at 11 am ET, kicking off with a presentation from Mickey Parish, Ph.D., senior science advisor at CFSAN, about the agency’s policy on Listeria monocytogenes. The following is a preview of what you’ll learn during the complimentary event (that’s right, it’s free for all attendees).

Critical Elements for a Successful Pathogen Environmental Monitoring Program

Nearly every segment of the food and pet food industries are either working on implementing pathogen environmental monitoring programs (PEMPs), or are working to optimize programs already in existence. Programs are increasing in complexity with many now covering multiple environmental pathogens, hygienic facility zones and sampling zones. Regulators and customers are stepping up requirements for aggressive, science-based PEMPs. The seven most critical elements for a successful PEMP will be discussed. These elements include: management commitment, determining the need for and stringency of the program, risk evaluation, sampling plan, sampling methods, data management and corrective actions.

Allergen Detection & Control

While global market demand for free-from food products is increasing, undeclared and mislabelled allergens, sulphites and gluten, throughout the supply chain, continue to be the number one cause of consumer product recalls.

To meet the varied regulatory landscape and protect consumers, effective preventative management systems must be implemented, verified and validated. What are the challenges, risks and opportunities for manufacturers and retailers to protect their brands? This informative session will provide insights into:

  • Government regulations and how management systems can align with the Food Safety Modernization Act (FSMA) and the Safe Food for Canadians Act
  • Successful interventions and protocols to reduce the risk of gluten and allergen related recalls
  • Differences between Management System/ Process and Product Third-Party Certifications

Pathogen Mitigation: Sanitary Design in Facilities and Sanitation Methods

This presentation will go into detail regarding pathogen mitigation strategies for food processing facilities. The relationship between hygienic design and sanitation as they factor into pathogen mitigation will also be discussed. The presentation will then examine various sanitation methods and how they can be applied within the food industry to help eliminate and control pathogens.

Each educational session will be followed by a technology spotlight and an interactive Q&A between attendees and speakers. Don’t miss out on this event—Register here!