Listeria monocytogenes is a ubiquitous pathogen with a high mortality rate that can become persistent in the retail food environment, says Janet Buffer, MPH, of the Center for Foodborne Illness Research and Prevention, Ohio State University. During her presentation “Listeria monocytogenes and sanitation in the retail environment,” at the “Food Safety Hazards Series” virtual event, she discussed areas in retail food service environments most likely to harbor the pathogen as well as the best-proven methods to reduce the prevalence of listeria in your facility.
Areas that are more likely to harbor listeria monocytogenes in the retail food environment include:
Cracks and crevices in the floor
The floor/wall juncture, especially under sinks
On touchpoints of cooler handles and deli slicers
In front of deep fryers
In front of deli slicers and on slicer blades
Drains
Sink interiors
Areas where raw chicken is stored or transported
“Listeria monocytogenes is hardy. It tolerates salt, grows in cold environments and is moderately resistant to acids,” said Buffer. “It is also ubiquitous. We find it in soil, water, silage, manure and sewage. We bring it in on our shoes. We can carry it on our clothes, and it can become a persistent pathogen in our retail spaces.”
A recent study by Briana C. Britton, et al, published in Food Control Journal, identified the most effective sanitation and customer service strategies correlated with lower listeria prevalence in retail delicatessens. These include:
When the deli is cleaned two-to-three hours/day
Changing gloves after touching nonfood surfaces
Keeping sanitation records
Using foam to clean and sanitize
“All chemicals work and all work very well,” said Buffer. “But, they must be used at the correct concentrations and they will require some elbow grease.”
Inga Hansen is the new managing editor of Food Safety Tech. She has more than 20 years’ experience in business-to-business healthcare media. Inga previously served as executive editor of MedEsthetics magazine and associate editor of Dialysis & Transplantation.
“Inga will be a strong addition to our team and will be responsible for growing our delivery of original in-depth reporting on important industry issues, helping curate content for our virtual and live conferences, develop and expand our Advisory Board and expand our reach on social media,” says Rick Biros, president and publisher of Innovative Publishing.
“The safety and integrity of our food from farm to table is vital to our communities. Rick Biros and Food Safety Tech have been integral resources for the professionals who grow, produce, package, serve and regulate our food. I am excited to help continue Food Safety Tech’s mission in providing the knowledge, education and forums for collaboration that support their work,” said Hansen.
About Food Safety Tech: Food Safety Tech is a digital media community for food industry professionals interested in food safety and quality. We inform, educate and connect food manufacturers and processors, retail & food service, food laboratories, growers, suppliers and vendors, and regulatory agencies with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an environment that fosters safer food for consumers.
The U.S. Department of Health and Human Services, Office of the Inspector General (OIG) has announced an audit of the FDA over its actions regarding the Abbott infant formula recall. The audit, announced on June 2, will “determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements.”
The OIG is specifically examining the FDA’s actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures related to conducting inspections of the manufacturing facility and overseeing Abbott’s initiation of the infant formula recall.
The FDA released a timeline of its infant formula-related activities, showing that inspectors first became aware of issues including standing water and inadequate handwashing during a routine inspection at Abbott Nutrition’s Sturgis, Michigan, facility in September 2021—the same month that the FDA received the first consumer complaint report of Cronobacter illness in an infant from the Minnesota Department of Health.
One key area of frustration during Congressional hearings in May was the delay of action on a whistleblower report filed with the FDA Detroit District Office in October 2021. The complaint was not reviewed by FDA leadership until February 2002, “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the FDA.
Additional inspections of the facility between January and March 2022 found “significant, fundamental sanitation, building and equipment issues.” Swabs taken during the inspections revealed six confirmed samples of Cronobacter. These findings led Abbott, on the recommendation of the FDA, to voluntarily cease production at the facility and recall potentially contaminated products. The contaminated formula has been linked to four hospitalizations and two deaths.
The OIG audit is scheduled to be completed in 2023.
Over the last 20 years, I have helped thousands of companies prepare for food safety audits. You can only imagine the plethora of questions that my team and I are asked by the food companies as they build their food safety programs. Many revolve around the basics of building an initial food safety plan. Here are the top five food safety plan questions I am asked regularly that I will address within this article:
What are the foundations of a good food safety plan?
Who should be involved in the process of building the food safety plan?
Can I convert my HACCP Plan into a food safety plan?
Are there resources and tools available to help build my food safety plan?
Should I add food safety culture to my food safety plan?
What Are the Foundations of a Good Food Safety Plan?
FDA dictates that a food safety plan is a set of written documents that are based on food safety principles and incorporates:
Hazard analysis
Preventive controls
Supply-chain programs
Recall plan
Written procedures to be followed for:
Monitoring
Corrective actions
Verification and validation
A food safety plan is developed for every individual facility based on the unique issues at each facility. For example, if a company has multiple processing plants processing the exact same product in multiple areas throughout the country, each facility will need their own unique plan. The reason for that is each facility may have different risks based on process flow layout, equipment used, suppliers and even employee and management cultures.
Each facility will have a separate HACCP plan detailing each chemical, biological and physical risk for the layout of the operation and equipment used. Recall plans will need to be created for each facility’s unique customers. Supplier monitoring will need to be developed for each facility’s unique suppliers.
Who Should be Involved in the Process of Building the Food Safety Plan?
Creating the team to build your food safety plan is one of the most important steps in the process and probably the most overlooked. Most teams I have seen include the QA and/or food safety person, the operations manager and the maintenance manager. This is too limited and often leads to risks being missed and processes that are either too simple or over complicated. A food safety team should have a member from each of the following departments:
Food Safety/QA
Operations
Maintenance
Crew or shift lead
Executive management (preferably the CEO)
Sanitation
A line worker or two
Why the CEO, a shift supervisor and line worker(s)? The CEO creates the company culture and should be funneling information down from the top. If the CEO is part of the team, the whole organization will see the importance of the food safety plan.
Line workers and crew leads are on the floor working the processes day in and out. They will be key to implementation of the plan. As processes are created, the line workers and crew chiefs can provide amazing insight on the processes and reporting tools that will be most effective on the floor. Having this information before implementation will save hours of time and minimize the risk of having to alter processes that don’t work in reality.
Can I Convert my HACCP Plan into a Food Safety Plan?
Many companies have a basic HACCP plan for their facilities. Often the question is, “Isn’t my HACCP plan a food safety plan?” The answer is yes and no. Basically, you can have an HACCP plan and not have a food safety plan, but you cannot have a food safety plan without an HACCP plan.
A food safety plan is more encompassing than an HACCP Plan. Looking at your facility floor plan and analyzing chemical, biological and physical risks is a key part of a food safety plan. The food safety plan adds another layer of monitoring for all risks and provides added processes for preventative controls, recalls and supplier monitoring.
Also, companies that have only an HACCP plan often have not been keeping that plan up to date with an all encompassing team described above. Once the new, more robust teams are created and they start building the food safety plan, many find they need to significantly alter their HACCP plans.
Are There Resources and Tools Available To Help Build My Food Safety Plan?
Luckily, we live in a technical world full of inexpensive or free tools. There are many very smart people that have services available to assist in creating a food safety plan as well. Here is a list of some free and low cost solutions:
Free Solutions:
The FDA created a free solution, the “FDA Food Safety Plan Builder.” This solution walks you through the process of creating a food safety plan step-by-step.
If you need a food safety plan for a specific GFSI Standard, walking through the individual check lists provided by the standards you choose will lead you to the creation of a food safety plan, albeit a very robust one.
If you do not need full certification, building a food safety plan based on GFSI Global Markets is a great stepping stone and they have a free toolkit.
Paid Solutions:
There are many software tools that you can purchase. The pricing and features will vary based on the company. Google “Food Safety Plan Software” and you will see the many options available.
Working with a consultant is a great option if you don’t have the time to learn the process of creating, building and implementing a food safety plan. There are many great and not so great consultants in the industry. If you decide to go this route make sure you interview at least three consultants and ask the following questions:
“Are you going to coach us on how to own and maintain our food safety program or do you do everything on your own?” Many consultants think they “own” the programs they develop, as if they are proprietary systems. Some will charge you year after year to use their program. Avoid these consultants.
“How long have you been consulting?”
“May I talk with a couple of your past clients?” If they are unwilling to provide testimonials that may be a red flag.
Should I Add Food Safety Culture to My Food Safety Plan?
Recently, I wrote an article for FoodSafetyTech.com titled “The Costs Of Food Safety: Correction vs. Prevention,” and the opening sentence is “Every company that grows, produces, packs, processes, distributes and serves food has a food safety culture. In the food industry, when looking at food safety culture there are essentially two groups: The correction and the prevention groups.”
By starting the process of creating a food safety plan, you are already crossing the chasm into the “prevention group.” Adding elements of food safety employee training, recognition and food safety behavior management into your food safety plan and implementing those elements will alter your organization in some of the most positive ways.
Every food company has a food safety culture, some are toxic and others are refreshingly positive. If you have read this article to the end I assume you either have a positive food safety culture or would like to create one. Incorporating key teams members in your planning and taking advantage of the resources available will place you on the path to developing an effective food safety plan and a company culture that embraces food safety.
The U.S. Food & Drug Administration will be hosting a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to discuss the recent draft guidance on lead action levels for juice. The draft guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” issued in April provides action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends.
These draft action levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods, and advance the FDA’s goals in the Closer to Zero action plan.
During the webinar the FDA will provide an overview of the draft guidance and additional information, as well as answer stakeholder questions.
Featured speakers include Dr. Susan Mayne, director of the Center for Food Safety & Applied Nutrition (CFSAN), Dr. Conrad Choiniere, director of the Office of Analytics and Outreach, CFSAN, and Dr. Paul South, director of Division of Plant Products and Beverages, Office of Food Safety, CFSAN.
To register for the webinar, visit the registration page. The webinar will be recorded and posted to the FDA website.
GFSI notes that while there is some existing guidance that addresses fraudulent activities, there is a significant need for CCFICS, which deals with ‘horizontal’ issues, to develop definitions and update its guidance to better reflect current food fraud initiatives.
To support this work, Codex has created a dedicated working group, Chaired by the United States with co-chairs from China, the European Union, the Islamic Republic of Iran and the United Kingdom. GFSI acts as an official observer to Codex, providing input and recommendations on this work through its GFSI Codex Working Group. The group, which currently consists of representatives from Nestlé, PepsiCo, The Coca-Cola Company and Danone, plays a key role in underpinning GFSI’s Benchmarking Requirements and reinforcing Codex’s mandate of valuing collaboration, inclusiveness, consensus building and transparency.
The group is also observing to help ensure this work does not reinvent the wheel, but identifies, collects and utilizes existing work from experts within the scientific and academic industries and regulatory community that have been working on this topic for the past decade.
In regard to the feedback provided on the Codex Guidance on Food Fraud, the GFSI Codex Working Group stressed:
The importance of including industry as a key partner in managing food fraud
The need for clarity around the roles of respective Codex committees in the prevention and detection of food fraud, specifically around analytical and testing guidance to prioritize the detection of food fraud (i.e. the role of CCMAS – Codex Committee on Methods of Analysis and Sampling vs. the role of CCFICS in food fraud)
The importance of collaboration between all relevant stakeholders to manage food safety risks in the event of genuine food fraud incidents
The absolute need to include ‘feed for food producing animals’ in the scope of this work
The view that existing food safety processes and networks provide a good basis for managing communication of food fraud incidents and share good practices
To define numerous terms that are also being proposed, defined and considered with the development of agreed terms and conditions.
Codex is hoping to finish this work in 2024/2025. Between now and the last final draft, which is planned to be submitted for final approval to the Codex Alimentarius Commission, there will be multiple draft versions developed.
This week’s episode of the 2021 Food Safety Consortium Virtual Conference Series will examine The New Normal: COVID-19’s Lasting Impact on the Food Industry. The following are highlights for this Thursday’s session:
COVID & Manufacturing, with April Bishop, Treehouse Foods
Impact of COVID-19 on Food Safety & Quality Teams, and Strategies for Moving Forward, with Jill Stuber, The Food Safety Coach
The Intersection of COVID, Technology and Consumer Changes, with Darin Detwiler, Northeastern University
COVID & Business Continuity Planning, with Douglas Marshall, Ph.D., Eurofins
TechTalks from RizePoint and Bayer
This year’s event occurs as a Spring program and a Fall program. Haven’t registered? Follow this link to the 2021 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! Registration includes access to both the Spring and the Fall events. We look forward to your joining us virtually.
The 20th annual GFSI Conference convened yesterday, but instead of bringing together an international group of food industry stakeholders in one central location, the event was held online, streamed throughout offices and homes across the globe.
Day one kicked off with a welcome from Wai-Chan Chan, managing director of The Consumer Goods Forum, Qu Dongyu, Director-General of the Food and Agriculture Organisation of the United Nations, who addressed the humanitarian and consumer perspective of food safety. “We need a strong engagement of the private sector for our agrifood systems to become more efficient, more inclusive, more resilient and more sustainable,” Chan stated. The conversation about the global importance of sustainability continued with a conversation led by Erica Sheward, GFSI Director, and Howard Popoola, vice president, corporate food technology and regulatory compliance for The Kroger Company and Roy Kirby, global director, microbiology, food safety and toxicology for Mondelez International. They talked about GFSI’s program, Race to the Top, and the /global Markets Programme capability tool, which was established more than 10 years ago to help companies implement continuous improvement to develop an effective food safety management system, and its potential in developing markets. “Think about what this could do for farmers, think about what it could do for families in Africa, in those places described as countries of opportunity, producing niche products, who just need an opportunity to be able to sell their products into the world stage,” said Popoola, who is also a GFSI steering committee member.
During the course of the day, stakeholders also discussed pandemic-specific issues including supply chain disruptions, and the role of crisis communications and messaging to consumers related to the safety of the food supply.
Recent food scandals around the world have generated strong public concerns about the safety of the foods being consumed. Severe threats to food safety exist at all stages of the supply chain in the form of physical, chemical and biological contaminants. The current pandemic has escalated the public’s concern about cross contamination between people and food products and packaging. To eliminate food risks, manufacturers need robust technologies that allow for reliable monitoring of key contaminants, while also facilitating compliance with the ISO 17025 standard to prove the technical competence of food testing laboratories.
Without effective data and process management, manufacturers risk erroneous information, compromised product quality and regulatory noncompliance. In this article, we discuss how implementing a LIMS platform enables food manufacturers to meet regulatory requirements and ensure consumer confidence in their products.
Safeguarding Food Quality to Meet Industry Standards
Food testing laboratories are continually updated about foodborne illnesses making headlines. In addition to bacterial contamination in perishable foods and ingredient adulteration for economic gains, chemical contamination is also on the rise due to increased pesticide use. Whether it is Salmonella-contaminated peanut butter or undeclared horsemeat inside beef, each food-related scandal is a strong reminder of the importance of safeguarding food quality.
Food safety requires both preventive activities as well as food quality testing against set quality standards. Establishing standardized systems that address both food safety and quality makes it easier for manufacturers to comply with regulatory requirements, ultimately ensuring the food is safe for public consumption.
In response to food safety concerns, governing bodies have strengthened regulations. Food manufacturers are now required to ensure bacteria, drug residues and contaminant levels fall within published acceptable limits. In 2017, the ISO 17025 standard was updated to provide a risk-based approach, with an increased focus on information technology, such as the use of software systems and maintaining electronic records.
The FDA issued a notice that by February 2022, food testing, in certain circumstances, must be conducted in compliance with the ISO 17025 standard. This means that laboratories performing food safety testing will need to implement processes and systems to achieve and maintain compliance with the standard, confirming the competence, impartiality and consistent operation of the laboratory.
To meet the ISO 17025 standard, food testing laboratories will need a powerful LIMS platform that integrates into existing workflows and is built to drive and demonstrate compliance.
From Hazard Analysis to Record-Keeping: A Data-Led Approach
Incorporating LIMS into the entire workflow at a food manufacturing facility enables the standardization of processes across its laboratories. Laboratories can seamlessly integrate analytical and quality control workflows. Modern LIMS platforms provide out-of-the-box compliance options to set up food safety and quality control requirements as a preconfigured workflow.
The requirements set by the ISO 17025 standard build upon the critical points for food safety outlined in the Hazard Analysis and Critical Control Points (HACCP) methodology. HACCP, a risk-based safety management procedure, requires food manufacturers to identify, evaluate and address all risks associated with food safety.
LIMS can be used to visualize control points for HACCP analysis according to set limits. Graphic courtesy of Thermo Fisher Scientific.
The systematic HACCP approach involves seven core principles to control food safety hazards. Each of the following seven principles can be directly addressed using LIMS:
Principle 1. Conduct a hazard analysis: Using current and previous data, food safety risks are thoroughly assessed.
Principle 2. Determine the critical control points (CCPs): Each CCP can be entered into LIMS with contamination grades assigned.
Principle 3. Establish critical limits: Based on each CCP specification, analytical critical limits can be set in LIMS.
Principle 4. Establish monitoring procedures: By defining sampling schedules in LIMS and setting other parameters, such as frequency and data visualization, procedures can be closely monitored.
Principle 5. Establish corrective actions: LIMS identifies and reports incidents to drive corrective action. It also enables traceability of contamination and maintains audit trails to review the process.
Principle 6. Establish verification procedures: LIMS verifies procedures and preventive measures at the defined CCPs.
Principle 7. Establish record-keeping and documentation procedures: All data, processes, instrument reports and user details remain secured in LIMS. This information can never be lost or misplaced.
As food manufacturers enforce the safety standards set by HACCP, the process can generate thousands of data points per day. The collected data is only as useful as the system that manages it. Having LIMS manage the laboratory data automates the flow of quality data and simplifies product release.
How LIMS Enable Clear Compliance and Optimal Control
Modern LIMS platforms are built to comply with ISO 17025. Preconfigured processes include instrument and equipment calibration and maintenance management, traceability, record-keeping, validation and reporting, and enable laboratories to achieve compliance, standardize workflows and streamline data management.
The workflow-based functionality in LIMS allows researchers to map laboratory processes, automate decisions and actions based on set criteria, and reduce user intervention. LIMS validate protocols and maintain traceable data records with a clear audit history to remain compliant. Data workflows in LIMS preserve data integrity and provide records, according to the ALCOA+ principles. This framework ensures the data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) as well as complete, consistent and enduring. While the FDA created ALCOA+ for pharmaceutical drug manufacturers, these same principles can be applied to food manufacturers.
Environmental monitoring and quality control (QC) samples can be managed using LIMS and associated with the final product. To plan environmental monitoring, CCPs can be set up in the LIMS for specific locations, such as plants, rooms and laboratories, and the related samples can then be added to the test schedule. Each sample entering the LIMS is associated with the CCP test limits defined in the specification.
Near real-time data visualization and reporting tools can simplify hazard analysis. Managers can display information in different formats to monitor critical points in a process, flag unexpected or out-of-trend numbers, and immediately take corrective action to mitigate the error, meeting the requirements of Principles 4 and 5 of HACCP. LIMS dashboards can be optimized by product and facility to provide visibility into the complete process.
Rules that control sampling procedures are preconfigured in the LIMS along with specific testing rules based on the supplier. If a process is trending out of control, the system will notify laboratory personnel before the product fails specification. If required, incidents can be raised in the LIMS software to track the investigation of the issue while key performance indicators are used to track the overall laboratory performance.
Tasks that were once performed manually, such as maintaining staff training records or equipment calibration schedules, can now be managed directly in LIMS. Using LIMS, analysts can manage instrument maintenance down to its individual component parts. System alerts also ensure timely recalibration and regular servicing to maintain compliance without system downtime or unplanned interruptions. The system can prevent users from executing tests without the proper training records or if the instrument is due for calibration or maintenance work. Operators can approve and sign documents electronically, maintaining a permanent record, according to Principle 7 of HACCP.
LIMS allow seamless collaboration between teams spread across different locations. For instance, users from any facility or even internationally can securely use system dashboards and generate reports. When final testing is complete, Certificates of Analysis (CoAs) can be autogenerated with final results and showing that the product met specifications. All activities in the system are tracked and stored in the audit trail.
With features designed to address the HACCP principles and meet the ISO 17025 compliance requirements, modern LIMS enable manufacturers to optimize workflows and maintain traceability from individual batches of raw materials all the way through to the finished product.
Conclusion
To maintain the highest food quality and safeguard consumer health, laboratories need reliable data management systems. By complying with the ISO 17025 standard before the upcoming mandate by the FDA, food testing laboratories can ensure data integrity and effective process management. LIMS platforms provide laboratories with integrated workflows, automated procedures and electronic record-keeping, making the whole process more efficient and productive.
With even the slightest oversight, food manufacturers not only risk product recalls and lost revenue, but also losing the consumers’ trust. By upholding data integrity, LIMS play an important role in ensuring food safety and quality.
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