OUTBREAK & ROOT CAUSE ANALYSIS INVESTIGATION
Food Outbreaks and Appropriate Responses
When a major food production outbreak or food safety failure occurs, what would does management do?
What is a proper investigation?
What can be done to prevent future failures?
A properly executed accident/incident investigation drives to the root causes of the food production failure to prevent a repeat occurrence. A valid incident investigation process includes identifying the investigation team, establishing/reviewing written procedures, identifying root causes, and tracking of all hazards found to the generation of a completion report and corrective actions and new SOPs.
What is all of the above worth an organization?
EVERYTHING or cease to exist also known as an existential threat.
Root Cause Analysis Investigation
A root cause analysis (RCA) is a method of problem solving engaged to identify the root causes of faults or causation of production problems. Root case analysis is widely used in food production operations to determine the underlying causes of the variance from designed performance standards in order to identify appropriate solutions to the issues. Ideally, the RCA team should have extensive experience gained from prior, similar situations combined with immediate and economic solutions.
The RCA team should also consider that there can be, and often are, multiple root causes contributing to the failure(s).
Investigative focus should also be on HOW and WHY the events occurred, rather than WHO was responsible for the causation.
Evidence gleaned from methodical and concrete data points should be used to back up root cause claims.
Sufficient, valid information must be presented to decision-makers to allow them to engage the best corrective course(s) of action.
Comprehensive and holistic approach(es) are the most supportable to prevent future occurrences.
Ultimately, timely, accurate, and economically implementable actionable analysis is the need of every decision-maker faced with an incident or food safety failure.
US FDA Food Outbreak Investigations
FDA initiated traceback and testing investigations are initiated when food is the subject harm to the public. The government investigation examines where the food was grown, processed, transported, and stored prior to the humans ingesting the suspect products. Additionally, the government's traceback, sample collection and onsite inspection(s) should be mirrored by the inspected food production organization. Mirroring refers to the suspect organization's double-testing all government sites.
The goal for the government and the food production organization is that no human will ever become sick or die from consuming food products. All food safety efforts should focus on this goal.
A Product Market Withdrawal
A "Market Withdrawal" is an action taken by a supplier to hold a food product for inspection, dumping or return.
A Market Withdrawal is not a recall and does not necessarily require a trace-back.
A supplier may engage a Market Withdrawal for product quality issues, or while checking other quality issues. If it becomes a food safety issue then the Market Recall becomes a Food Recall.
A supplier may request that a buyer "Hold" the product until disposition can be determined. Alternatively, a client may be asked to dispose of the product. The client may request to be reimbursed for the disposal action.
The supplier may issue a credit and normally ships replacement product.
Buyers have choices with a "Market Withdrawal" that are not available in a Recall situation.
RELIABILITY ANALYSIS METHODS TO PREVENT PATHOGEN OUTBREAKS
Powerful Statistical Tools to Prevent Outbreaks
AME Certified PCR Laboratories develops fresh food product pathogen contamination studies employing Reliability Analysis Methods.
The following Reliability Analysis methods support in predicting fresh food product pathogen contamination events:
· Failure Mode Effects Analysis (FMEA)
· Fault Tree Analysis (FTA)
· Reliability Block Diagrams (RBD)
These methods analyze a food production system’s components and the possible failure points to identify potential sources of contamination.
By understanding the system components and potential failure points, measures can be taken to reduce the risk of contamination.
These measures can involve implementing quality control protocols, testing the system components, and more.
Additionally, these methods can help to identify potential sources of contamination before the product is shipped to the customer, reducing the risk of contamination.
financial losses due to pathogen contamination outbreak
$10 to $100 Million USD Losses
Pathogen contamination in food products is a major concern for the food industry as it can lead to foodborne illness outbreaks.
In addition to the negative impact on consumer health, foodborne illness outbreaks also have a significant financial impact on food companies. In this report, we will discuss the financial losses that food companies suffer after their products are detected to have a pathogen contamination, with references and links to relevant sources.
Financial losses due to pathogen contamination:
Pathogen contamination in food products can result in food recalls, which can be costly for food companies.
According to a study by the Grocery Manufacturers Association (GMA), the average cost of a food recall is $10 million, with some recalls costing up to $100 million.
This includes the cost of recalling the product from the market, investigating the cause of contamination, and disposing of contaminated products.
In addition to the cost of the recall, food companies also face financial losses due to the damage to their brand reputation.
Consumers are less likely to buy products from a company that has been involved in a food recall, and this can lead to a significant decrease in sales.
A study by the Harris Poll found that 44% of consumers avoid products from companies that have been involved in a food recall.
Moreover, food companies may also face legal action from customers who have been affected by the contaminated product.
The cost of legal fees and settlements can be significant and further damage the company's financial position.
Examples:
One example of a food company that suffered significant financial losses due to pathogen contamination is Chipotle Mexican Grill. In 2015, an outbreak of E. coli was linked to Chipotle's restaurants, leading to 55 reported cases across 11 states.
The company had to temporarily close 43 restaurants and saw a 30% decrease in sales in the fourth quarter of 2015. The outbreak cost the company an estimated $10 million in direct costs, including the cost of the recall and increased marketing and public relations expenses.
Another example is the 2008 Salmonella outbreak linked to peanut butter products manufactured by Peanut Corporation of America (PCA).
The outbreak resulted in nine deaths and over 700 reported cases of illness. PCA filed for bankruptcy in 2009, and the total cost of the outbreak, including lawsuits and settlements, was estimated to be $1.2 billion.
Conclusion:
Pathogen contamination in food products can have a significant financial impact on food companies.
The cost of recalls, damage to brand reputation, and legal fees can result in significant financial losses. It is therefore essential for food companies to implement effective food safety measures to prevent pathogen contamination and ensure the safety of their products.
loss of consumer confidence after outbreak & Recall
Food Brands Lose Consumer Confidence
In recent years, there have been several high-profile food recalls due to pathogen outbreaks, which have led to a loss of consumer confidence in the affected brands. This article will explore the reasons behind this loss of trust, and the impact it can have on businesses.
When a food product is recalled due to a pathogen outbreak, it can create negative media attention and public concern about the safety of the brand's products. In addition, consumers may associate the brand with the illness or injury that resulted from consuming the contaminated food, which can cause them to lose trust in the brand's ability to ensure the safety of their products.
Studies have shown that food recalls can have a significant impact on consumer trust and confidence in food brands. For example, a survey conducted by the Food Marketing Institute found that 21% of consumers said they would never purchase a product again if it was associated with a recall. In addition, a study published in the Journal of Food Protection found that consumers were more likely to perceive a food recall as a sign of poor quality control and a lack of concern for consumer safety.
Furthermore, consumers tend to associate pathogen outbreaks with certain types of food, such as meat, poultry, and produce. This can lead to a broader loss of confidence in the entire industry, not just the affected brand. This can be particularly damaging for small businesses or niche brands that operate within a specific industry, as they may struggle to regain consumer trust even if they were not directly involved in the outbreak.
So, what can businesses do to regain consumer trust after a pathogen outbreak and recall? The first step is to take swift action to address the issue and communicate with customers about what steps are being taken to prevent a similar issue from occurring in the future. It's important to be transparent and honest with consumers, and to provide regular updates on the progress being made.
In addition, businesses can take proactive steps to prevent future outbreaks by implementing food safety measures, such as regular testing and inspection of their products and facilities. This can help demonstrate to consumers that the business takes their safety seriously and is committed to providing safe, high-quality products.
In conclusion, a pathogen outbreak and recall can have a significant impact on consumer confidence in a food brand. Businesses must take swift action to address the issue and communicate effectively with customers in order to regain their trust. By implementing proactive food safety measures, businesses can demonstrate their commitment to consumer safety and prevent future outbreaks from occurring.
Predicting Food Product Bacterial Safety Life
Reliability Analysis Methods Offer a Way to Predict
Food safety is a crucial concern for businesses in the food industry, as well as for consumers. Ensuring that food products are free from harmful bacteria is essential to protect public health and maintain consumer trust.
Reliability analysis methods offer a way to predict the bacterial safety life of food products, and in-house pathogen testing can provide a more comprehensive and efficient approach to monitoring food safety.
The benefits of reliability analysis methods and in-house pathogen testing for predicting and ensuring food product bacterial safety life.
Reliability analysis methods involve collecting data on the performance of food products and analyzing that data to identify potential contamination points.
This information can be used to predict how long a food product is likely to remain safe from harmful bacteria and what factors may cause it to become contaminated.
By identifying these factors, businesses can take steps to improve food product design, reduce contamination risks, and ensure customer safety.
In-house pathogen testing is another valuable tool for businesses looking to improve food safety.
By testing raw, processed, and finished products, as well as environmental samples, businesses can quickly identify potential sources of contamination and take corrective actions before any harmful bacteria reaches consumers. In-house pathogen testing can be conducted on-site, allowing for more rapid results and a quicker response to any issues that arise.
One of the key benefits of in-house pathogen testing is that it can help businesses reduce the risk of contamination and improve food safety.
By conducting regular testing, businesses can identify potential sources of contamination and take corrective actions to prevent the spread of harmful bacteria.
This can reduce the need for costly recalls and help businesses maintain consumer trust.
In addition, in-house pathogen testing can improve food product design. By identifying potential contamination points, businesses can take steps to improve food product design and reduce the risk of contamination.
This is particularly important in industries such as food manufacturing, where product contamination can have serious consequences.
To conduct in-house pathogen testing, businesses need to have the proper equipment and trained personnel. However, the investment in these resources can pay off in the long run by reducing the risk of contamination and improving food safety.
In conclusion, reliability analysis methods and in-house pathogen testing offer valuable tools for businesses looking to improve food product design, reduce contamination risks, and ensure customer safety.
By collecting and analyzing performance data and conducting regular in-house pathogen testing, food production organizations can identify potential contamination points and take steps to minimize the risk of product contamination.
This can help food production organizations improve food safety, maintain consumer trust, and stay competitive in today's market.
Hidden losses a food production company suffers in a Recall
Financial Losses due to an Outbreak & Recall
Increased insurance premiums: After a food pathogen outbreak, insurance companies may increase the company's premiums to reflect the increased risk of future outbreaks.
- Product recalls: A food pathogen outbreak can result in a recall of the affected products, which can lead to significant costs for the company. This can include the cost of retrieving the products, the cost of disposing of the products, and the cost of lost sales.
- Legal costs: If consumers become ill or die as a result of consuming contaminated products, the company may face legal action. This can result in significant legal costs, including attorney fees and settlement payments.
- Damage to brand reputation: A food pathogen outbreak can damage the company's brand reputation, resulting in lost sales and reduced consumer trust. Rebuilding the company's reputation can be a lengthy and costly process.
- Increased insurance premiums: After a food pathogen outbreak, insurance companies may increase the company's premiums to reflect the increased risk of future outbreaks.
- Loss of customers: Consumers may switch to other brands or products following a food pathogen outbreak, resulting in a loss of customers and revenue for the company.
- Damage to relationships with suppliers: A food pathogen outbreak can damage the company's relationships with its suppliers, who may be hesitant to work with the company in the future.
FOOD PRODUCTION COMPANY OWNERS FEAR LOSSES FROM OUTBREAKS
Reliability Analysis mMethods Offer a Way to Predict
Food production company owners fear the most about a food pathogen outbreak is the potential for significant financial losses as well as reputational damage.
In addition, there is the potential for legal action from customers, suppliers, and shareholders if a pathogen outbreak is linked to the company's products. As a result, food production companies must take the necessary precautions to prevent the spread of foodborne illness, including implementing food safety measures, regularly monitoring food safety protocols, and responding quickly to any reported illnesses or outbreaks.
FDA Notification is Not Required if food Product unshipped
FDA Notification is Not Required
The Food and Drug Administration (FDA) of the United States is responsible for regulating the safety and labeling of food products.
One of the regulations set by the FDA is the requirement for manufacturers to provide notification to the agency before introducing certain types of food products into interstate commerce.
However, there are exceptions to this requirement, particularly when the product is not shipped to buyers.
That is, US FDA notification is not required if the food product is not shipped to buyers according to the Code of Federal Regulations.
Regulations:
The Code of Federal Regulations (CFR) states that manufacturers are required to provide notification to the FDA before introducing a new food product into interstate commerce (21 CFR 170.36).
This notification is known as a pre-market notification ( PMN), which provides the FDA with information about the food product, including its ingredients, manufacturing process, and safety data.
However, if the food product is not shipped to buyers, then the PMN requirement does not apply.
Exceptions:
This is because the purpose of the PMN is to allow the FDA to review the safety of the food product before it is sold to consumers. If the food product is not going to be sold, then there is no need for the FDA to review its safety.
For example, if a food manufacturer is conducting a taste test of a new product and the product will not be sold to consumers, then the PMN requirement does not apply.
Similarly, if a food manufacturer is producing a food product solely for research purposes and the product will not be sold to consumers, then the PMN requirement does not apply.
Other Regulations:
It is important to note that there are other FDA regulations that may still apply to food products that are not shipped to buyers. For example, food products that are used in animal feed may still be subject to FDA regulations even if they are not sold to consumers.
Additionally, if a food product is shipped to buyers outside of the United States, then it may still be subject to FDA regulations, as the agency has the authority to regulate the importation of food products.
Summary:
The FDA pre-market notification requirement does not apply to food products that are not shipped to buyers.
This exemption is designed to allow manufacturers to conduct taste tests, research, and other activities without being burdened by unnecessary regulation.
However, it is important for manufacturers to be aware of other FDA regulations that may still apply to their food products.
FSMA’s Loophole in Food Safety Reporting for Producers
FSMA's Reporting Requirements
The United States Food Safety Modernization Act (FSMA) of 2011 was enacted to improve food safety in the US and prevent foodborne illnesses. While the act is comprehensive, it has a reporting loophole that exempts food producers from reporting to the US Food and Drug Administration (FDA) if the product is not shipped to the market. This article explores the implications of this regulatory gap on food safety in the US.
Overview of the FSMA of 2011
The FSMA was enacted in 2011 to enhance the safety of the US food supply by emphasizing prevention over response to contamination incidents.
The act mandates preventive controls, increased inspections, and enhanced recall authority for tainted products (FDA, 2021).
The law also requires facilities to implement preventive controls and develop a written food safety plan, which must be available for FDA inspection (FDA, 2021).
The Loophole in Reporting Requirements
The FSMA mandates that facilities report to the FDA if they produce, pack, or hold food that may cause serious adverse health consequences or death to humans or animals.
However, the act does not require food producers to report to the FDA if the food product is not shipped to the market (FDA, 2021).
This loophole allows producers that identify a safety issue in their products to avoid reporting to the FDA by not shipping the affected products to the market.
Implications for Food Safety
The reporting loophole may have significant implications for food safety in the US. It could lead food producers to dispose of contaminated products quietly without informing the FDA to avoid the financial and reputational consequences of a public recall.
This practice would undermine the FSMA's goal of preventing foodborne illnesses by compromising transparency and accountability.
The FDA may not be able to identify trends or common issues in food production without accurate reporting from food producers.
This limitation may affect the agency's ability to improve food safety regulations and practices, leading to continued foodborne illness outbreaks.
Summary
The FSMA of 2011 has made significant strides in enhancing food safety in the US. However, the reporting loophole for food products not shipped to the market remains a concern. Policymakers and the FDA should address this gap to ensure that all aspects of the food production process are subject to appropriate oversight and regulation, maintaining the safety and integrity of the US food supply.
Detect Food Pathogens in Large Food Lots via qRT-PCR methods
Pathogen Detection In Large Food Lots
AME Certified PCR Laboratories, an in-house food safety testing support service, "PCR and PCR-based methods can be used to test for pathogens in large lots of food" (AME, 2023, para. 2).
qRT-PCR have been widely used in food microbiology for decades and have demonstrated high specificity and sensitivity in detecting a wide range of bacterial, viral, and parasitic pathogens (Jayarao, 2018; Rossi et al., 2021).
qRT-PCR works by amplifying a target DNA sequence using a pair of primers that flank the region of interest, and detecting the amplicons by fluorescence, or hybridization (Gelaw et al., 2018).
qRT-PCR can detect a single pathogen cell in a complex food matrix if the DNA extraction, purification, and amplification steps are optimized and validated (Gibson et al., 2018).
There is a claim that qRT-PCR is inherently unable to detect pathogens in large food lots is misleading and unsupported by scientific evidence because qRT-PCR-based methods have evolved and diversified over time to address various challenges and opportunities in food safety testing.
Quantitative, Real-Time PCR, also known as qRT-PCR allows for the detection and quantification of pathogens in a rapid and quantitative method, and can be used to monitor food safety in real-time during production and distribution (Wang et al., 2020; Zhang et al., 2021).
Multiplex PCR, which uses multiple primer pairs to detect different pathogens simultaneously, can save time and resources compared to single-target PCR (Kumar et al., 2018).
Other PCR-based methods, such as loop-mediated isothermal amplification (LAMP) and nucleic acid sequence-based amplification (NASBA), have also been developed and applied in food safety testing (Liu et al., 2021; Park et al., 2019).
Therefore, the claim that qRT-PCR is too slow, too expensive, and too unreliable to be practical for food safety testing ignores the advancements and potentials of qRT-PCR-based methods and protocols.
The feasibility and effectiveness of qRT-PCR-based methods in detecting food pathogens in large lots depend on various factors, such as the type and level of contamination, the nature and complexity of the food matrix, and the sampling and testing strategy (Chang et al., 2019; Jin et al., 2020).
qRT-PCR-based methods can be applied to different types of food samples, such as raw and processed meat, poultry, seafood, dairy, fruits, vegetables, and grains, and can detect various foodborne pathogens, such as Salmonella, Listeria, E. coli, Campylobacter, Norovirus, and Hepatitis A (Gibson et al., 2018; Jayarao, 2018).
In addition, PCR-based methods
qRT-PCR-based methods have become increasingly more affordable and accessible in recent years, thanks to the development of portable and automated PCR instruments, miniaturization of PCR reaction volumes, and cost-effective reagents and consumables (Wang et al., 2020; Chen et al., 2021; Hoffmann et al., 2017).
AME Certified PCR Laboratories supports the claim that qRT-PCR methods can be used to test for pathogens in large lots of food is valid in the evolving field of food safety testing.
While qRT-PCR-based methods have their limitations and challenges, they have also demonstrated high specificity, sensitivity, rapidity, and affordability in detecting a wide range of foodborne pathogens in various food matrices.
Testing Large Volumes of LETTUCE in WASH FLUME with qRT-PCR
2018 E. coli Outbreak in Lettuce could have been avoided
Lettuce is a popular salad green that is enjoyed by people all over the world.
However, lettuce can also be a source of foodborne illness.
In recent years, there have been several outbreaks of foodborne illness linked to lettuce, including an outbreak of E. coli in 2018 that sickened over 200 people.
To help prevent foodborne illness, it is important to test lettuce for harmful bacteria.
One way to test lettuce is to use quantitative, real-time polymerase chain reaction (qRT-PCR) technologies, which a molecular biology method that can be used to amplify and quantify DNA.
This makes it a valuable tool for food safety testing, as it can be used to detect the presence of pathogenic DNA of the bacteria quickly and accurately in lettuce wash flumes.
AME Certified PCR Laboratories (AME) specializes in qRT-PCR-based food safety testing.
AME offers a variety of qRT-PCR-based tests for lettuce, including tests for E. coli (EHEC), Salmonella spp., and Listeria spp.
AME's DNA tests are designed to be used in a HACCP (Hazard Analysis and Critical Control Points) program, which is a system that is used to identify and control hazards that could cause foodborne illness.
AME's qRT-PCR-based tests can be used to test large volumes of lettuce in a wash flume.
This is important because it allows food producers to test lettuce for harmful bacteria at the point of production.
Testing lettuce at the point of production helps to ensure that lettuce is safe to eat and helps to prevent foodborne illness.
AME's qRT-PCR-based tests are a valuable tool for food safety testing.
They are quick, accurate, and easy to use.
AME's tests can be used to test large volumes of lettuce in a wash flume, which helps to ensure that lettuce is safe to eat and helps to prevent foodborne illness.
Benefits of Using qRT-PCR-Based Testing for Lettuce There are several benefits to using qRT-PCR-based testing for lettuce.
These benefits include:
-Quick and accurate results: qRT-PCR is a very sensitive and accurate technique, which means that it can detect even low levels of harmful bacteria.
--This is important for food safety, as it allows food producers to identify and remove contaminated lettuce before it is shipped to consumers.
-Easy to use: qRT-PCR is a relatively easy technique to use, which means that it can be used by food producers with little or no training.
--This makes it a cost-effective option for food safety testing.
-Versatile: qRT-PCR can be used to test for a variety of harmful bacteria, including E. coli (EHEC), Salmonella spp., and Listeria spp.
--This makes it a valuable tool for food safety testing, as it allows food producers to test for the most common foodborne pathogens.