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12/14. Microbiology/QA Lab Analyst - Tifton, GA
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12/17  2018 ISSUE:839


Get the Facts Food Safety – Preventing Food Poisoning
Source :
By (Dec 14, 2018)
The holidays are noted for an abundance of food. However, it is also a time when persons are more vulnerable and susceptible to food poisoning, which can lead to hospitalisation. Food poisoning refers to illness as a result of eating contaminated food.
How Food Poisoning is Contracted
Food poisoning is caused by excessive bacteria in food, whether raw or cooked. Food can be poisoned from any stage of production – growing, harvesting, storing, shipping or preparing.
Common contaminants of food include: Hepatitis A, (E.coli) and Listeria among others. These can be transmitted by an infected food handler, unclean surfaces, storing foods at the incorrect temperature, using contaminated water in the preparation of food or storing raw and fresh food in the same container or location.
Food Poisoning Symptoms
Persons experiencing the following symptoms in excess should seek medical attention immediately.
• Nausea
• Vomiting
• Diarrhoea, which may be bloody
• Abdominal pains and cramps
• Fever
How to Minimise Food Poisoning Risk:
Persons can take the following steps to minimise food poisoning.
• Wash fruits and vegetables properly before preparing them.
• Wash hands constantly during cooking.
• Store food in the refrigerator not more than two hours after cooking.
• Have a separate cutting boards for meat and vegetables.
• Ensure that street food is from a reputable place.
For additional information contact:
Ministry of Health
10-16 Grenada Way
Kingston 5
Tel: 876 – 633-8103/633-7433
Fax: 876 – 622-8364

You May Be the Food Supply’s First Line of Defense
Source :
By Lisa Lupo (Dec 13, 2018)
Fulfilling FSMA’s IA training requirements.
Along with the requirement that food facilities develop a written Food Defense Plan for the first time ever, FSMA’s Mitigation Strategies to Protect Food Against Intentional Adulteration (IA Rule) requires that individuals assigned to work at actionable process steps and their supervisors be trained in food defense awareness. Why is this so critical? As is stated in the Food Safety Preventive Controls Alliance (FSPCA) course designed for these personnel: “You may be the food supply’s first line of defense.”
To determine what FDA-authorized training involves, QA Editor Lisa Lupo took two online courses. One was developed by FDA, the other by FSPCA and the International Food Protection Training Institute with FDA funding. The FSPCA course was updated more recently and includes more information on the IA rule.
Both courses are free and fulfill the training requirement of the IA rule. Like other aspects of FSMA, the requirement is flexible, and other similar food defense awareness training may be chosen to satisfy the requirement. Currently neither course is available in Spanish, and FDA is unaware of any alternative Spanish courses. In both courses, each module includes an overview of what participants will learn and brief “Knowledge Check” quizzes. Upon completion, the participant is instructed on the printing of a Certificate of Completion to be filed in the facility’s Food Defense Plan.
Following are overviews of each course to provide an idea of what FDA deems important and what participants will learn.
FSPCA. Food Defense Awareness for the Intentional Adulteration Rule ( This is an interactive, recorded audio/slide presentation. The estimated completion time of 20-30 minutes was accurate for me, and there is accountability: clicking too quickly through the course will freeze it, requiring the participant to restart at the module where the quick-clicking began. There is a four-hour inactivity time-out, after which the course must be started from the beginning. With the objectives of introducing participants to food defense and discussing the IA rule, the course covers the importance of food defense, ways to protect food from intentional adulteration, and recognition and reporting of suspicious activity. It is divided into three modules:
Intentional Adulteration and Food Defense Overview. Includes explanations of intentional adulteration and food defense; distinguishing food defense from food safety; and the consequences of IA.
Implementation of Food Defense at a Facility. Focuses on the importance of a Food Defense Plan, and provides further detail on actionable process steps, mitigation strategies, and the importance of training.
Roles and Responsibilities. Details personnel roles in food defense and reporting of suspicious activity. Noting the diligence required of regulators and the industry in ensuring safe, unadulterated food, the importance of the course participant also is highlighted.
FDA. Food Defense 101 — Food Defense Awareness for Front-Line Employees ( This IA course is completely written, with no accompanying audio, although, like the FSPCA course, it includes interactive slides. Unlike that course, it has no checks to ensure the participant doesn’t click through to the certificate page. This course can be left at any time, simply clicking the navigation bar to return to the last viewed slide. With three sections, the objectives are for the participant to be able to define food defense and explain the differences between food safety and food defense; recognize the importance of the front-line employee in food defense; identify threats the front-line employee may encounter and how to respond; and understand FDA’s Employee FIRST acronym as an easy way to recall their responsibilities in food defense. The sections include:
Front-Line Employee’s Role in Food Defense. Following a brief discussion of the industry’s role in and requirements for producing safe food, the differences between food defense and food safety are stated, general protection measures described, and potential causes and motivations for adulteration listed.
Identifying Possible Threats. Presenting potential food defense situations a front-line employee may encounter, it includes interactive screens on which the participant clicks on topics for information on areas of concern, then finds potential threats in a food processing photo.
Who to Contact. Through discussion of intentional adulteration, the importance of the front-line employee, and key areas of potential threat, this lesson puts food defense directly in the participant’s hands stating: “You may be the only one to observe an unusual or suspicious situation, and the success of the food defense measures depend on you!”
IN SUMMARY. Both courses fulfill the IA training requirement, making it a matter of preference for facilities. Both impart food defense awareness and portray the importance of employee action; provide certification of the training; and provide free food defense education that can increase the awareness of all employees — whether required by regulation or not.
The author is Editor of QA magazine. She can be reached at

Managing Food Safety Risk in a Foreign Supplier Verification Program
Source :
By Dr. John W. Raede
Managing Food Safety Risk in a Foreign Supplier Verification Program
My introduction to a foreign supplier verification program (FSVP) was in 2013 by way of a coworker, Tim Jackson, Ph.D., who said, “Hey, Raede, your world is about to get more interesting” as he chuckled and walked away. At the time, I was working in a global supply chain quality management capacity. I did quite a bit of international travel to perform focused risk assessments, creating business relationships, building trust, and eliminating process variation. My worldview was all about walking the factory floor, watching processes, collecting data, analyzing, identifying issues, creating collaborative corrective actions, implementing them, and validating if they accomplished what we intended. Boom—done. Little did I know how prophetic Tim’s words would be 5 years later when an opportunity presented itself that I knew I had to pursue.
I had been searching for a challenging, faster-paced environment that required my experience and process knowledge in an expanded role. In March of 2018, I came to an agreement with an importer of record (IOR) that supplies an array of imported and domestic food ingredients for the U.S. industrial market. I had the pleasure of working with this family firm for 15 years in my previous role because they were one of my suppliers. Switching from a corporate-based “silo” structure to a “many hats” format was tough enough, and add to that the challenge of working from a remote location with a 3-hour time difference. The FSVP was in the forefront of this position, and I had to jump in and gain an understanding immediately. Fortunately for me, the program was set up by a very competent and capable individual, Breanna Neff. She was a recent graduate of the Cornell University Food Science Department and had to start from scratch to build the program.
Importance of the Document Exchange Process
Document management was not in my circle of responsibility in my previous role. I really had no idea of the volume of documents that were required at the time and what the future regulatory requirements would eventually generate. Once in, I began to realize quickly how providing documentation in a timely manner is a critical component of the customer service capability for this type of organization. Especially in a new ingredient/product introduction that is on a tight implementation schedule. You do not want to be the reason a potential piece of business is lost in any-size organization.
The technical folks need the backup documents to begin the process, and if they are not received in a timely manner, the process comes to a halt. The goal should be to keep that process running smoothly and be considered as the best IOR to work with. The challenge is how to keep the updated version of the documents that have expiration dates (most are annual) available when requested.
Document management services are becoming popular; there are two main choices in the marketplace to my knowledge. I’ll let you do your own research to determine which is the best fit for your operation. If you are supplying to a large-scale operation, you are already engaged in the process with a supplier portal and receive the barrage of notification emails regarding expired and/or new document requests. There are least-cost options available that require a database-to-database transfer from your supplier to your customer, or the often more expensive “pass through” option.
Caution: Although a web-based system is an efficient method to control the document management portion of the FSVP, you must be careful not to lose the personal side of this operation. Numerous times, I receive document requests, turn them around quickly, and receive a sincere note back thanking me for the speed of the response. You cannot ignore the importance of that interaction. Remember, business is personal: It is all about relationships based on trust through verification.
Supplier Risk Assessments
I’ve always believed that the way we conduct ourselves in our professional life is basically how we are in our personal lives. If you like to travel, learn about different cultures, learn different languages, eat different foods, sleep in airports, continuously request documents, and send documents, you too can be an FSVP professional!
One of my favorite phrases is: “Everything I’ve experienced in my life has prepared me for the challenges I am facing today.” It is a guiding principle that allows me to have the mental fortitude to walk into a situation with confidence, prepared to handle whatever will be encountered and be prepared for the next challenge.
I remember 25 years ago how I kept repeating that mantra the first time I disembarked the Boeing 747 in a country that required a business visa and generated personal safety warning documents from our in-house travel agents. Didn’t know the language, culture, the airport, or even if our contact had arranged transportation. After receiving scrutinizing stares through the maze of customs agents, I received the stamps of approval on my passport and stepped into the cacophony of awaiting loved ones, vocal tour guides, and taxi services. Much to my delight, a gentleman was holding a piece of paper with my name on it, and after an awkward hug (from me to him), off we went.
The assessment went better than expected, the factory programs exceeded my expectations, and the translation challenge was minimal. The important factor that was recognized by all the parties involved was the development of a rapport. We dined together for lunch and dinner. We spoke of our families and shared similar experiences that narrowed the cultural differences. When I left, I knew I had connected with the managers, and they understood why I asked the questions I did, pushed for verification, and left them with a list of items to mitigate risk for our customers.
We were a company with one emerging brand that had a robust internal prevention program, and we needed to implement those risk-mitigation strategies in our supply chain. My boss at the time, Dale R. Rice (who is now Dale R. Rice, D.V.M.), coined a phrase, “Realistic specifications, rigidly enforced.” He encouraged me to audit to the specification for each ingredient at the supplier locations. A thorough ingredient specification will cover the quality and food safety attributes important to the customer.
My previous experiences with implementing a supplier management program for a single brand and multiple product variations grew into multiple brands and select ingredient categories via an acquisition by a global corporation. I spent the subsequent years managing domestic and foreign supplier performance. This advancement over a period of 25 years increased supplier knowledge into currently implementing an FSVP for an IOR with approximately 70 products from an international supplier base.
An FSVP is not about performing multiple desk audits. While document and procedure review are crucial to a baseline understanding, the real learnings are derived from walking out to that factory floor and seeing it for yourself. You need to meet the line managers, line workers, maintenance technicians, and sanitation crew. They need to see what their customers look like and think about. Make it personal.
Business is about relationships, and relationships are personal. Your suppliers need to know you, understand what your concerns are, and what you can do to help them. In my current role, we are focused on traveling to our suppliers’ locations, having discussions with the factory professionals about practices and procedures, walking the factory floor, concluding the assessment with a closing discussion, and then enjoying a meal together while sharing our professional and personal experiences. Again, the personal side of business is important. I want my suppliers to care about our company, customers, and our customers’ consumers.
The key to understanding any process is to deconstruct it and look at the parts individually while keeping in mind how they will all fit back together and function. Below is a list of the requirements of an FSVP and a summary of how I recommend addressing each one:
Use a qualified individual to develop an FSVP and perform FSVP activities: At a minimum, your designate should successfully complete FSVP training. Ms. Neff successfully completed a Preventive Controls-Qualified Individual (PCQI) training and an FSVP prior to setting up the structure, and I successfully completed the PCQI, PCQI Instructor, and FSVP courses.
Perform a Hazard Analysis that includes identifying known or reasonably foreseeable hazards associated with each type of food and determining whether they require a control: The intent of this item in the final rule is to ensure the IOR understands the risks associated with the ingredient they are bringing into the country. We prioritized the Hazard Analysis by product volume and lethality step control (supplier or customer), and performed an annual risk assessment focusing on preventive controls for biological, chemical, and physical hazards at our high-volume/high-risk suppliers.
Evaluate risks posed by the food and the performance of the foreign supplier: This requirement is ingredient-shipment specific. To quote President Ronald Reagan: “Trust but verify.” Ask for supporting documents, go to the supplier’s location, ask pointed questions, and gain a detailed understanding of your supplier’s processes and procedures. We evaluate the process flowchart, Hazard Analysis document for the ingredient(s), validation studies for the lethality steps (if identified as a Critical Control Point), food safety plan, certificates of analysis per shipment, and supporting documents such as pesticide residue lab results.
Conduct appropriate supplier verification activities to provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented: This step is also focused on the validation of procedures and verification that the procedures are followed. Low-risk supplier verification activities may include reviewing updated third-party audits, conducting supplier meetings at trade shows, and reviewing corrective actions identified in the third-party audit and/or corrective actions for issues identified by our customers. Spending extra time on corrective actions is very important because it provides an insight into the management commitment of the supplier. I will address this further later.
Reevaluate the food and foreign supplier every 3 years: No matter the size and/or budget of your operation, you must request an updated Hazard Analysis and Critical Control Points (HACCP)/Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan and risk assessment from your supply chain. We perform annual risk assessments at our high-volume suppliers. The benefits are twofold: First, we gain a visual perspective of process improvements from the previous year. Second, we strengthen the business-personal relationships with the management team by sharing meals and conversation. Document management systems come in handy when requesting the updated HACCP/HARPC risk assessments on a 3-year schedule.
Keys to Evaluating a Potential Supplier
A significant number of further processors retain their own in-house auditors or contract with third-party certification bodies. A recommendation is to conduct a targeted risk assessment for your customers to determine whether they want to invest the resources to move forward with the new ingredient on-boarding process. The purchasing, R&D, regulatory compliance, and food safety folks appreciate a heads-up, so to speak. Nobody wants to waste the substantial cost of sending an auditor to a location that will fail because of major deficiencies in their food safety plan.
In most cases, a certification body has audited the potential site, and a good idea is to carefully review the report. Another key component is a pre-site assessment, what some refer to as a desk audit. The HACCP flowchart for a review prior to each product is a standard item to have in hand when you are performing a desk audit and during the walk-through at the supplier location. It is your guide to what preventive controls have been identified as potential hazards by the factory management.
Risk Assessments
I have found that internal audits provide an insight into how a supplier manages their business. The internal audit identifies issues in the factory, and the corrective action completion data indicate the management commitment. Internal audits are a key component to an organization’s ability to identify potential hazards, conditions that can cause disruptions in throughput, and situations that can create employee safety risk. A supplier that has a robust internal auditing program can prevent issues that may contribute to a system failure. The critical component to an internal auditing program is implementing an effective corrective action and then verifying the corrective action solved the issue.
Document requests are an integral part of the FSVP. In my experience, our customers keep track of their own document requirements via document control programs. I recommend you perform your own due diligence if you employ a system to manage the volume of requests your business generates.
Corrective Actions
One of the key items I look for is management commitment. This is one of the few things that may indicate whether you will have a successful relationship with the supplier. If the resources are not provided to pay for and train capable employees, provide them with the equipment and tools they need. In my experience, resources are required to pay/train/develop/retain competent managerial staff, and when the resources are not provided, the opportunities for failure increase significantly.
Management commitment is a leading indicator of the overall sustainability of the business. Capable managers do not stay with an organization that cannot support their initiatives. Factory managers require competent support staff to fulfill the goals and objectives of the business. If there is a solid team in place, there is normally an experienced, cordial, capable factory manager, general manager, and/or owner. A supplier with a capable and competent factory manager is less likely to have significant failures that cause food safety issues. An exceptional factory manager will conduct him- or herself the same with their staff, family, friends, vendors, and even waitstaff at restaurants. In my opinion, you can learn a substantial amount about someone from the manner in which they address people that are paid to provide a service. Have you ever had to disembark an airplane because of a mechanical issue? Personally, I am happy the leading indicators worked (found before disaster) and not the lagging indicators (reason for the disaster). More than once, I have stood in line after we have walked off the aircraft and the person in front of me is yelling at the gate agent, who did not ground the plane. To me, the person yelling is not an exceptional manager.
Site Assessments
An FSVP requires international travel, bottom line. If you don’t like to travel, then you should pick another occupation.
Personally, I really enjoy traveling. It is in my DNA. My aunt managed a traveling circus tent show. I would join them during the summer months, work in the concession stand, help with setup/takedown, and travel a portion of the country for 2 months. We had a set schedule of towns we would visit and set up for 2 days, perform six shows (three each day), take the tent down after the third show on the second day, and drive all night to the next town. It could be hectic when the weather didn’t cooperate, the trucks broke down, or some of the crew would disappear on the way to the next location. The mantra was “The show must go on.” The idea being, the folks paid their money and we must fulfill our obligation to provide the product, no matter the hardship.
Business travel to me isn’t really that different from the circus days. Most of my assessments are scheduled by continent and require extensive scheduling. There are challenges to overcome, and unless I am completely incapacitated, I am going to show up. For example, while writing this article, I just completed the second week of a 5-week European trip performing risk assessments at 10 supplier manufacturing sites, involving nine hotels, six flights, and countless hours in a car or train.
In my opinion, to develop a successful FSVP, you must have a firm understanding of the products, process, people, and procedures. The more you are informed about the entire operation, the easier it becomes to speak or write cogently. Business is about personal relationships, and the stronger the relationship, the better the business. That means you must walk the factory floor. In the words of my good friend Chuck Regan: “If you’re going to buy meat, you better have bloody boots, and if you’re going to buy fish, you better stink.”
Our customers require the current third-party audit certificate and the portion of the report that details the corrective actions. As an added component to the corrective action list, we request the status of the corrective actions and the validation study of the corrective actions’ effectiveness. It’s good to have corrective actions; however, they are not so good if they don’t solve the issue. I highly recommend augmenting your suppliers’ third-party audits with an additional annual visit to their manufacturing location(s) to perform a targeted risk assessment based on your customers’ product specification(s).
Clarification: I am not saying that audits do not add value to the FSVP equation; however, as an FSVP practitioner, you must go to the location that produces the product you import and experience it for yourself.   
Third-party audits play an important role in program and procedure verification. A skilled lead auditor can provide a valuable assessment of the overall effectiveness of the food safety plan, management commitment, and physical condition of the factory. I created a customized, risk-based assessment of each type of commodity we import, based on the customers’ specifications and the inherent risk associated with the commodity type.
Meeting Customer Requirements
If you want to meet your customer’s requirements, follow Dr. Rice’s rule: “Realistic specifications, rigidly enforced.” Let’s expand on this. Sound easy? It can be when you work with a supplier that understands its process capability. This is where the relationship based on trust is essential. In my experience, we are presented with two specifications: what the customer requires and what the supplier can offer. Frequently, a supplier will generate a specification based on the parameters they consistently meet, and then they widen the upper and lower control limits to build in excess process variation. Understandable, and in some cases, the range is within the customer’s specification. In some situations, the supplier may require assistance in understanding either how to achieve the customer’s specification or why the parameters are in place. As an example, I had been working with European suppliers about Listeria spp. specification differences between their market and the U.S. market. Progress was slow until the European market recalls for individually quick-frozen (IQF) vegetables hit, and then the conversation changed from why should they comply to how can they comply.
There is a component within a food industry business that is not discussed to the extent I believe it should be. Food safety professionals play a vital role in the development of new business and maintenance of existing business, and should be recognized for doing so. I am truly blessed to work for an organization that recognizes the importance of my contribution to the business, and I reciprocate by doing everything I can to mitigate risk and promote the programs that we need to execute. While discussing what my role in the organization would entail, I proposed that we needed to make a bold statement that food safety was at the forefront of the operation. That is why my official title is Chief Food Safety Officer. We wanted our customers and suppliers to know what our focus is and how we would act upon it.
The Importance of Preventive Controls Validation
Food safety requirements are not getting easier because regulatory compliance and product liability are driving the demand for tighter product specifications. Processes that were partially ignored previously are coming under scrutiny for their contribution to risk mitigation. As the demand for reductions in pathogenic organisms increases, we are challenged to utilize existing processes to perform a lethality step that we were not originally intended to.
As mentioned above, IQF frozen vegetables are in the forefront lately with a focus on validating the blanching process to achieve a 5-log reduction for Listeria monocytogenes. One segment of our customer base is focused solely on the blancher, and other customers will accept a combination of validated process steps to achieve a total 5-log reduction. We are still working through the details of the study. Understandably, our suppliers do not want to have studies performed that use product inoculated with L. monocytogenes in their facility and would rather use a surrogate organism. As the IOR, we have the responsibility to offer solutions that meet the customer specifications and are within the capability of the supplier. Not always the easiest move to execute; however, with a “quiver” of professional experts and associations from which to draw knowledge, we were able to offer salient solutions.
Some of our European suppliers did not want to blanch to a 5-log reduction because of the negative effects on the organoleptic characteristics that the increased time/temperature ratio has on the product. Our task was to help them understand the reasoning behind the requirement. In the U.S. market, the mindset is to “kill all of it!” We walked them through the validation study guidelines, certified laboratories that could perform the studies, and options that met their comfort levels.
Working with foreign suppliers to help them understand the U.S. domestic market can be a challenge. Creating a working relationship with the management team of the foreign supplier is a positive means to gain an understanding of each other’s concerns and build trust.
If you’ve made it this far into the article, I want to thank you by leaving you with a brief summation of what I believe to be the pillars of a successful program. 1. Evaluate your suppliers’ preventive controls thoroughly in their factory. Remember Chuck Regan’s quote: “If you’re going to buy meat, you better have bloody boots, and if you’re going to buy fish, you better stink.” 2. Your supplier must have the capability to manufacture to your customers’ specifications. Remember the quote from Dale Rice, D.V.M.: “Realistic specifications, rigidly enforced.” 3. Finally, you must challenge the validation studies of lethality steps and require pertinent process documentation. Remember the quote from Ronald Reagan: “Trust but verify.”  
Dr. John W. Raede is the chief food safety officer for National Cortina, an importer of record for grass-fed beef, IQF vegetables, and edible oils. Dr. Raede specializes in food safety supply chain process improvement, risk mitigation, and foreign materials assessment and prevention.

Food safety experts warn  fruit and vegetables sold in British shops could contain potentially deadly norovirus
Source :
By Telegraph Reporters (Dec 16, 2018)
Fruit and vegetables being sold in British supermarkets have been found to contain norovirus, food safety experts have announced.
The UK's Food Standards Agency (FSA) researchers discovered that one lettuce in every 20 contained the vomiting virus.
The bug, spread by human waste, was also detected in one in every 27 bags of frozen raspberries.
"Norovirus is the commonest cause of gastrointestinal disease in the UK causing millions of cases annually," said the researchers, who added that their findings indicated serious negligence by food suppliers and retailers.
"One should not expect to find a norovirus in one's lettuce or raspberry," scientists told The Sunday Times.
"When the virus is detected it is clear that guidance [on food hygiene] is not being adhered to and that in consequence the pathogen is entering the food supply chain."
The researchers tested 568 lettuces, which had been mostly grown in Britain, and found norovirus in 30 of them.
Seven out of 310 batches of fresh raspberries and 10 out of 274 samples of frozen raspberries also tested positive for the bug.
Sian Thomas of the Fresh Produce Consortium, which represents salad growers, said: "The fresh produce industry is committed to maintain high standards."
The FSA said the research was part of a wider study into the sources and spread of norovirus. It has already pinpointed shellfish, especially oysters, as a key risk because they pick up the virus from human sewage pumped into the sea.
Norovirus has become Britain's most common food poisoning bug that attacks about three million people a year, many of them children.
Up to 300 victims die every year, often because they have already been weakened by age or another illness.
Scientists have now raised concerns that the findings could suggest the bug will be prevalent in many other fresh food items.

Foreign Matter: What’s Your Liability?
Source :
By Lisa Lupo (Dec 13, 2018)
PCA defense attorney details manufacturer liability for foreign matter in food.
When foreign matter gets into food, the consequences can be significant, particularly if that food makes its way to a consumer’s plate without detection. What liability does the food manufacturer have in an occurrence? According to Attorney E. Scott Austin, a member of Gentry Locke’s Criminal & Government Investigations practice group, liability and its repercussions will vary based not only on the steps taken in prevention, but on the type of matter in the food.
Regardless of the type, however, if foreign matter is detected in food and a consumer, customer, or the Department of Justice (DOJ) itself, wishes to bring legal charges against the manufacturer or other businesses in the food chain, a civil or criminal suit can be filed. (Note: Because regulations vary by state, Austin’s comments are based on those of Virginia, but are not to be considered legal advice for a particular situation.)
There are three types of foreign matter that can be found in food:
Naturally Occurring Foreign Matter. This is something that is naturally occurring but should not be in the food, such as bone in hamburger. While it shouldn’t be in the final product, it is something a consumer could expect to occur, so, in Virginia, there’s no liability on the manufacturer if you are taking steps to prevent such occurrences.
Non-Natural Foreign Objects. A foreign object is something that is not natural and should not be in the food, such as metal fragments in hamburger. It’s not supposed to be there; it’s irresponsible of the food producer for it to be there; and no consumer would expect it to be there. In such instances, Austin said, “You are strictly liable.”
Pathogens. Although disease-causing pathogens, such as Salmonella, E. coli, and Listeriaare naturally occurring in the environment, no consumer would expect to get a foodborne illness from their food. “This is the tip of the spear for FDA and DOJ,” said Austin, who represented former Peanut Corporation of America (PCA) owner and CEO Stewart Parnell in the criminal case on the 2008-09 Salmonella outbreak linked to PCA.
LIABILITY. Thus, it is foreign objects and pathogens for which a manufacturer is most likely to be charged with liability.
Foreign objects have been a leading cause of food recalls in recent years — and the problem is often discovered because of a customer complaint or injury. If you receive a complaint, the first thing to do, Austin said, is to identify the lot number and any customers to whom that run may have been shipped. If the lot is still running, stop production, clean, and find the cause.
The positive aspect of foreign objects is that there is generally a finite amount of impact; you may have only one complaint, so it’s fairly easy to control. But if the foreign object causes injury, the cost can still be high as it does come with liability.
Pathogen-contaminated food that makes it to market, however, can have significantly greater costs and consequences for both the business and individuals, particularly if there is an outbreak or if a death results.
Thus, the first thing that should be done if pathogenic contamination is detected by anyone or any means, is to immediately notify all your customers to stop selling product, and recall all affected lots. Although this can increase liability in the short-term because you are telling your customers of the contamination potential, Austin said, “You’re way better off, because a lot of this is avoiding something worse. That ‘something worse’ is doing nothing or not enough.” And that, he said, could lead to a criminal conviction.
Although criminal cases are rare, they become more prevalent when there is an outbreak. Ever since the publication of The Yates memo in 2015 (above), there has been a trend toward making it a criminal matter, Austin said. In fact, the memo’s statement, “Both criminal and civil corporate investigations should focus on individuals from the inception of the investigation,” makes it clear that employees would be prosecuted, not just companies.
The Yates Memo
On September 9, 2015, then-Deputy Attorney General  Sally Q. Yates  issued a memorandum entitled, “Individual Accountability for Corporate Wrongdoing.” The memo was intended to guide department attorneys when handling corporate matters.
The memo outlined six significant policy steps to ensure corporate investigations are handled consistently across the department:
To be eligible for any cooperation credit, corporations must provide the Department all relevant facts about individuals involved in corporate misconduct;
Both criminal and civil corporate investigations should focus on individuals from the inception of the investigation;
Criminal and civil attorneys handling corporate investigations should be in routine communication with one another;
Absent extraordinary circumstances, no corporate resolution should provide protection from criminal or civil liability for any individuals;
Corporate cases should not be resolved without a clear plan to resolve related individual cases; and
Civil attorneys should evaluate whether to bring suit against an individual based on considerations beyond that individual’s ability to pay.
(U.S. Department of Justice)
“That type of environment could be considered consumer protection or overzealousness,” Austin said. But either way, anyone who is high up in a company linked to an outbreak should immediately consider the possibility of it becoming a civil or criminal issue. “If you’re talking biological agents, contact FDA immediately,” he said. Stop producing product, clean, and get FDA in to see that you’ve done this. “It’s not enough to say you did it, you have to have documentation,” he said.
Additionally, the cleaning and inspection needs to be done by someone more than the quality assurance team who was in place at the time of the contamination. If you go to court, it’d be hard to say you had great people in charge of the clean-up, when it is the same people who were in charge when it happened, he said.
TESTING. One critical caution Austin noted from the PCA experience is that if you are testing for a pathogen, “you have to abide by the test results. It’s not okay to retest,” he said. For example, you don’t have to test for Salmonella, but if you do and the result is positive, you cannot retest to a negative.
Although there are false positives, a second negative test does not mean that there is no Salmonella because it is usually not homogeneous; it clusters, he said. In fact, this makes it unlikely that you will get a second positive.
In the PCA case, for example, only 12 (0.33%) of more than 3,500 samples tested in 2007-2008 came back positive for Salmonella.
“You cannot retest,” Austin reiterated. “Trust me, we learned that lesson the hard way.” PCA was, in fact, the first such criminal case tried, Austin said. “This is a new and burgeoning area of criminal law that the government is getting its hands around.”
Citing the 1982 intentional poisoning of Tylenol capsules, Austin said, “Tylenol set the standard when they pulled every Tylenol product off the market. That was the right thing to do. It is the safest thing to do from a company standpoint and an individual liability standpoint.”
PREVENTION. To keep from being held liable in a food contamination case — whether it be a foreign object or pathogen — you want to put in place quality assurance mechanisms that prevent it, Austin said.
Not only did he recommend that you have GMPs that cover pathogens, metal fragments, etc., Austin said you need to have FDA check them. The agency is required to check GMPs, but they don’t always read them, he said. “I encourage people to have FDA read and understand these.”
In the PCA case, Austin said, the company noted that their GMPs said they would retest positives, but FDA responded that they didn’t really read the GMPs.
Thus, Austin recommends three key steps for prevention:
Have FDA read your GMPs.
Get them approved.
Follow them.
If you remember nothing else,” Austin said, “Make sure you have your GMPs thoroughly vetted and complete. And if there‘s a problem, you’ve followed them to the letter.” You want to have them in order before FDA knocks at your door.
The author is Editor of QA magazine. She can be reached at

What's happening inside your body when you have food poisoning? A new study into Bacillus cereus has some clues
Source :
By Tegan Taylor (Dec 11, 2018)
You know the symptoms well enough. The clammy chill that washes over your body, the clenching in your stomach and then, finally, the dash to the bathroom, possibly accompanied by a split-second decision about which part of your body to aim at the toilet first.
But what's happening inside your body when you have food poisoning?
Research published today has given us a slightly clearer idea, at least for one type of bacteria.
A team from the Australian National University looked at the way the body responds to the bacteria Bacillus cereus, which can cause food poisoning and sometimes lead to serious infections elsewhere in the body, including sepsis, pneumonia and meningitis.
They found a toxin secreted by the bacteria binds directly to cells in the human body and punches holes in the cells to kill them, triggering an immune response.
Understanding the way toxins produced by this bacteria provoke inflammation in the body is a key to understanding how to treat it, said lead researcher Anukriti Mathur.
"Our immune system acts as a double-edged sword in these kinds of cases," Ms Mathur said.
"In certain cases where you've got a bacterial infection it would be really essential to boost our immune system so that it is stronger.
"However in cases such as sepsis, where you've got unwanted inflammation happening in your body, you want to dampen the inflammatory responses.
"A very unique balance is required in protecting us against different kinds of infections."
But what is it about this bacteria punching holes in your cells that leaves you hunched over a toilet bowl?
It has to do with the parts of your nervous system being targeted by the toxins produced by the bacteria, according to Vincent Ho, a University of Western Sydney gastroenterologist and researcher who was not involved in the study.
Bacillus cereus produces more than 12 different toxins. One triggers vomiting and another diarrhea, Dr Ho explained.
The vomit-inducing toxin, called cereulide, binds to serotonin receptors in the stomach and small bowel and stimulates the vagus nerve, which controls muscle movement in the gut.
"That signals back up to the vomiting centres of the brain," he said.
"And in a very similar way that is how the diarrheal form also works too. It's causing direct stimulation of the small bowel, and that's triggering a reactive response of reflex mechanism called the gastro-colic reflex.
"The toxins are stimulating against receptors in the gut lining … triggering a lot more movement of the muscle in the gut and the colon."
Bacillus cereus can be found in vegetables, rice and pasta, as well as meat and fish, and will grow in these foods if they are stored at the wrong temperature.
'Tis the season to be food-safe
While Ms Mathur's study looked at just one of the toxins produced by Bacillus cereus, there are plenty more ways that bacteria in your food can make you sick.
Other microorganisms can cause you gut grief, including salmonella, campylobacter, listeria and Staphylococcus aureus, among others.
One thing all these nasties have in common is that they thrive in foods left at room temperature for too long — and summer brings increased risk.
Warmer weather and Christmas entertaining conspire to make food poisoning cases increase over the summer, said Lydia Buchtmann from Food Safety Information Australia.
"For every degree that the temperature goes up, food poisoning cases increase," Ms Buchtmann said.
Dr Ho explained bacteria tends to multiply most quickly at temperatures between 32 and 43 degrees Celsius — in other words, a hot Australian summer's day.
"If you have 100 bacteria on a bit of food — which is hardly anything — at 8:00am, and it can double, let's say, every 20 minutes, at 2:00pm you'll have more than 26 million bacteria on the piece of food," he said.
This is important because food poisoning tends to be dose dependent. That is, the more bacteria you ingest, the more likely you are to get sick.
Food safety basics
Clean: Wash and dry your hands thoroughly and wash and dry chopping boards and utensils, especially after handling raw meats, or vegetables with visible soil
Chill: Ensure your fridge is kept below 5 degrees Celsius, and keep cold foods cold
Cook: Cook chicken, mince and sausages and similar meats right through until they reach 75C using a meat thermometer. Serve hot food steaming hot above 60C
Separate: Keep raw and cooked foods separate when storing and preparing and don't put cooked food back on the surface raw meat was on
Source: Food Safety Information Council
Ms Buchtmann said other factors were at play when it came to food poisoning at this time of year.
"You also get more cases over the summer because you're entertaining more, so you're cooking for larger numbers of people, you're putting the fridge under stress, overloading it, and you're cooking for several generations of people.
"Some people have much more risk of food poisoning: the elderly, little kids, pregnant women."
She urged people not to be complacent about food safety over the festive season.
"If you've got leftovers, as soon as they've stopped steaming, divide them into small portions in small containers so they cool really quickly and put them straight in the fridge or straight in the freezer.
"Use the leftovers in the fridge within two to three days. And if you're at risk of listeria — so pregnant, elderly, immunocompromised — then you need to use leftovers within a day."




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