Cecile Camerlynck, Transparency One

Why We Buy: The New Era of Transparency

By Cécile Camerlynck
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Cecile Camerlynck, Transparency One

Supply chains are getting increasingly more complex. Add to this the fact that consumers want more and more information about the products they buy. How can we obtain and store the information we want (and need), when we interact with hundreds of suppliers? Transparency in your supply chain is no longer a “nice to have”, but has become a must-have.

Product, price and quality used to be enough. Brands created products with good, better and best strategies targeting specific customer segments based on price and quality differences. Classifying customers and products allowed for more targeted offers—and a closer connection to the consumer.

And then Apple and Amazon reinvented the shopping experience. Digital and mobile took off. The customer experience became a point of differentiation in the store, online and on devices. As a result, the customer experience and omni-channel retailing have been core values for the past decade.

Today, a new value is emerging: Transparency. It is no longer enough to have a high-quality product, at a good price and with a rewarding shopping experience. The rise in health-conscious consumers, a highly interconnected society (transparency in the digital era), and a greater frequency of recalls and social responsibility issues has increased consumer demand for transparency. They want to know where and how products are made, what they are made of, and who made them.

Unsurprisingly, shoppers are very concerned by news about food safety issues such a Listeria and food fraud, which have become increasingly well publicized. Experience shows that these events have a significant impact on consumer confidence in brands and in certain types of products, which can take a long time to overcome.

According to a report released this year by World Vision Canada, consumers want to make ethical buying decisions.1 However, they are kept in the dark and don’t have enough information about products to do so. The organization is pushing for a new law, such as those already passed in the United States and the UK, to ensure that factories in foreign countries supplying the Canadian market don’t use minors to make products.

Every brand will need to determine the right level of transparency for their company and customers (consumer trust drivers like country of origin, label accuracy, etc.). Only 1% of consumers will want to know everything. For the other 99%, what they really want to know is that the brand they are buying from has a safe and responsible supply chain. They want to trust the brand promise. However, many brands still only know their immediate suppliers—and to ensure this trust, they need to dig deeper.

Providing transparency in your entire supply chain will reduce what we call the “visibility barrier” and give you access to all the information that you need and that your customer wants. Rather than simply reacting when a crisis emerges, you will proactively know your entire supply chain identity.

In 2016, technology and business practices exist to truly create brand trust by ensuring a safe and responsible supply chain. Yes, supply chains are complex and global. Yes, they represent thousands of companies, some of whom may not want to share information. But if more than a billion people can connect on Facebook, when it comes to knowing the supply chain, it’s simply not enough to say “I don’t know.”

Reference

  1. Press, J. (June 9, 2016). “New report on child labour raises call for supply chain transparency law”, Times Colonist, Accessed August 12, 2016. Retrieved from: http://www.timescolonist.com/new-report-on-child-labour-raises-call-for-supply-chain-transparency-law-1.2274235
Elise Forward, Forward Food Solutions
FST Soapbox

Embracing the New Direction

By Elise Forward
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Elise Forward, Forward Food Solutions

Food safety and quality assurance professionals are called upon to be change agents and leaders. It is important to embrace change, growth and continuous improvement, as these are the keys to success. With the arrival of FSMA, the culture of the food industry as a whole is going to get a boost, and we need to embrace the change that is coming. We are called to be cheerleaders for change and to encourage others to assist as changes are made. The food safety culture of an organization is reflected in how a company responds to necessary changes.  However, it is often more than the systems that can use improvement; the culture could use some reinforcement as well.

Elise Forward will be speaking at the 2016 Food Safety Consortium, December 6–7 in Schaumburg, IL | LEARN MOREIn part two of a series on food safety culture, we continue to look at how food safety professionals can positively influence the food safety and quality culture of our respective organizations. In Part I, the people of the organization were recognized as critical to the food safety culture. In Part II, we will discuss the remaining items that affect food safety: access to resources, systems and opportunities for growth.

Access to Resources

Doing a job properly, efficiently and well is very difficult without the proper resources. One of the greatest challenges is to convince upper management that there is a need for additional labor, equipment and/or resources. Food safety culture is not about being the best; it is about going above and beyond and thinking outside of the box. Do not let the customers, FDA or CDC’s Pulsenet “catch” an issue. It is imperative to be proactive, look for problems and be innovative. This is part of the food safety/QA job, and support is needed from upper management. People, equipment and infrastructure must be connected to food safety issues and have a dollar amount put on them. The focus should not be on how much these activities or resources cost, but rather the savings that will occur because these food safety measures are preventing problems.

Considerations: Could a lack of resources lead to less cleaning? Could this cause a build-up of biofilms of unwanted and problematic bacteria, leading to a recall? Often production resources can be quantified as lost product produced. If production and quality have a new person, make sure that drains get extra scrubbing during downtime or that the walls and corners where the extra hoses are stored get added attention. What about any peeling paint? Or, dust on the overhead pipes? Who is attending to these items? Do you need a quality management system to manage the flow of information? Could a lack of this be severely detrimental in the event of a supplier withdrawal or recall? What is the value of time spent versus the benefits that a company-wide system could bring?

Systems

All food safety systems are under the microscope and getting an overhaul thanks to FSMA. As with any time that change is in the air, having a plan of action is helpful. The Plan-Do-Check-Act (PDCA) cycle is an easy-to-remember resource that can be useful when managing changing systems. Using this method provides the backbone to assist in the documentation of the change as well as evaluating the change and ensuring effectiveness.

  1. Plan. Create and document a plan for the changes. Include who, what, where, when, why and how in the plan.
  2. Do. Execute the plan and remember to document the actions.
  3. Check. Make observations, conduct interviews and audit the changes that were made. Document your findings.
  4. Act. Make any modifications to the system based on audits, interviews and observations. Document the actions taken and any required follow-up.
  5. Repeat the cycle until the results are satisfactory. Keep in mind that the goal is continuous improvement and should not be considered a one-time task.

In all things food safety and quality related, documentation of your efforts is critically important. The old adage, “if it is not documented, it was not done” rings true. The systems will be enhanced and people in the organization will see the importance of the changes and their role in the improvement of the systems if these items are documented.

Embracing Opportunities for Growth

Many people balk at change, probably because they cannot see the opportunities on the other side. Food safety and quality professionals also need to be able to communicate to all levels of the organization when change needs to happen. We need to talk about the changes, and whether they are required or desired. It is important to talk about the benefits, which help employees see beyond the uncomfortable time during the change. Do this through meetings with executives, doughnut days with shift employees, and pizza lunches with middle management. Implement incentive programs to reward people who are making good decisions and showing food safety leadership.

Since everyone will be impacted, it means that as quality professionals we need to band together. We are each other’s best customers. Let’s rise to the top, work together and expect the best of each other. If your customers are asking for stronger food safety systems than what is currently in place, use this to support your efforts in bettering the organization’s programs. If your organization cannot meet your customer’s food safety and quality requirements, will you have adequate sales? Probably not.

Being a cheerleader for change and improvement can be tough! Create a support group for yourself. Being the problem solver, leader and change agent can be draining at times, especially with a very small team. Ensure the renewal of the food safety team and yourself by connecting with other professionals through trainings, conferences, trade associations, etc. At a minimum, read leadership blogs in addition to the food safety and quality blogs and groups that are available. All of these avenues can provide support, encouragement and connection to others in the industry as well as serve as a resource for best practices.

Conclusion

How do you implement the changes that need to occur with FSMA? Slowly and surely. Plan the strategy for implementation. Be persistent. Communicate with all levels of the organization by being a teacher, coach and leader; avoid being a cop. FSMA requires changes to the food safety programs of every food company that supplies products to the U.S. food market. We must not sit by the wayside but rather constantly teach, mold and shape the leaders who are in current management as well as the future managers who are just starting their careers. Before we know it, we have again been change agents, not in the bold and loud way, but in the soft and subtle way that can create a lasting effect and will forever positively influence the food safety and quality decisions in our organization.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

Motivating the Culture Shift

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

At the 2016 Food Safety Consortium, STOP Foodborne Illness will have a fundraiser to honor heroes in food safety. |December  6, 2016, 7–9 pm | LEARN MOREIn 2012 STOP Foodborne Illness established a relationship, which evolved into a partnership, with the California Leafy Green Marketing Agreement (LGMA) organization. On my first visit to LGMA, I met key staff members and observed a mock audit. We had good initial conversations. Scott Horsfall, CEO of LGMA, and I continued to talk and a second visit ensued, this time with individuals who had been ill with E-Coli from Leafy Greens. Everyone was a bit nervous, but it was a productive and even healing experience. We visited farms and processing plants, heard from farmers and shared a lovely meal outdoors with the farmers. On the last day, we sat in a room with tables configured in a large square and each person took turns introducing themselves, talking about why they were at the table, what roles they had in the leafy green business, and the visitors shared personal heart wrenching stories of illness and death from foodborne illness.  There was not a dry eye in the room during and after this encounter. Every farmer vowed to do everything possible to prevent pathogens from making their way into the market place. This was a profound experience for everyone involved.

The following year, Scott proposed that STOP Foodborne Illness and LGMA jointly create a video for training purposes. That project came to life in the summer of 2014. It is a video and a project that LGMA and STOP Foodborne Illness professionals are deeply proud of and love to share with others (the video comes in several versions and is available in Spanish). Scott and I continue to speak about the partnership and look for additional ways to collaborate.

Food safety is about collaboration and finding solutions and preventing illness and death from foodborne pathogens. This week I spoke with a mother whose daughter died a year ago from foodborne illness (not from produce). I told her that I so badly wish that we could have prevented her beautiful daughter’s death and vowed to continue this important work. We are not there yet: Each of us must be completely committed to getting to a place where we don’t hear these stories.  And we will get there by keeping the “why” at the forefront and continuing to develop critical strategies that reduce and work to eliminate the problem. Thank you to all who are dedicated to creating and sustaining a safe food supply and a special thanks to LGMA. You can see the LGMA video, “Video: The Why Behind Food Safety”, on our homepage.

Elise Forward, Forward Food Solutions
FST Soapbox

How to Build, Change and Mold Food Safety Culture

By Elise Forward
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Elise Forward, Forward Food Solutions

Food safety and quality professionals are change agents and problem solvers. It is what we do. The manner in which people within an organization respond to change, problems and opportunities for improvement is a reflection of the food safety culture of the organization. Does your organization celebrate when someone correctly decides to shut production down or put a product on hold? Obviously, it is always best to prevent any issues before they arise, but stopping a line to prevent bad product from being produced or catching out-of-specification product before it leaves the facility is better than continuing to produce and ship bad product. These events are often viewed as negative occurrences, and, therefore, many do not see the value of the Food Safety/Quality Assurance department.

Elise Forward will be speaking at the 2016 Food Safety Consortium, December 6–7 in Schuamburg, IL | LEARN MOREHow can we change this viewpoint and positively affect the food safety and quality culture of the organization? A few key factors have a great impact on the culture of an organization. People, systems, access to resources and opportunities for growth are all integral pieces of a stellar food safety culture. In this column, the first of a two-part series, we will explore how people build, change and mold the culture.

First and foremost, people are the number one asset and provide the greatest impact to change. Not only are personnel the eyes and ears of an organization, but they also provide the logic required to make good decisions. Computer technology is amazing, but it cannot fully replace the human ability to process the information. People need to be used to their fullest potential in order to obtain the greatest impact. The following are some ways people can be used to boost the food safety culture of an organization.

Everyone is involved in food safety. A team is always stronger than individuals. Everyone, from the C-suite to the third-shift person in charge of the employee refrigerator and taking out the trash, to the office staff that answers the phones and opens the mail, needs to have responsibility for food safety. In addition, contractors and subcontractors are not immune to providing a significant role in protecting the food safety of your product. All relevant staff must have the appropriate training to understand that what they do affects the food safety of the product as well as the entire facility. Having everyone trained means that many then share the food safety mentality and, therefore, there are stopgaps in the system. As with many issues, it is not one breakdown of the system that leads to a failure but a culmination of many breakdowns. People are still the strongest asset to food safety, so having multiple stopgaps (i.e., people), involved in protecting the process will help ensure that the product remains safe.

Executive responsibility. The responsibility of the overall food safety of products leaving the facility now lies with the executives, as seen by the recent cases involving Peanut Corporation of America, DeCosters and Jensen brothers. Executives and decision makers are accountable for the presence of or lack of appropriate food safety measures. Therefore, when making changes, executives need to understand that these are personal decisions that could affect themselves and their family, in addition to customer confidence as well as profits and losses. Questions such as, “What happens if their name is plastered on the evening news?” and “How will your customers, investors, consumers react if the company has a problem?” should be asked.

Evaluate any decision for food safety consequences. Food safety and quality is directly related to profits and losses. Any issue or change that arises must be evaluated to determine if there are any impacts to food safety. For example, the purchasing department must understand that the items purchased and used on the production floor impact food safety. Therefore, food safety should be on every agenda and part of every decision. This can be as simple as adding to the bottom of every agenda the question, “Is there any way that food safety will be impacted?” The C-suite members should be included in management meetings where additional food safety discussions occur.

Employee trust. Employees must be trusted to keep the product safe in order to safeguard the business and the products. It is human nature to take pride in the work that we are assigned and to strive for excellence. People feel rewarded when they are trusted and will continue to add value to the organization by striving for continuous improvement. This translates to greater attention to food safety and quality.

If an employee cannot be trusted, this person should not be on the payroll. The Food Defense rules specifically require a company to address intentional adulteration from an internal entity. To ensure quality, background checks should be completed on every employee, contractor or sub-contractor who has access to critical areas of the facility.

Food safety should be in every job description. Food safety is everyone’s job, so update job descriptions to include pertinent responsibilities to food safety. At a minimum, everyone should have the “See something, say something” responsibility in his or her job description, in addition to anything specifically related to his or her job. Likewise, it can be valuable to have an independent set of eyes to evaluate a system. Therefore, train and use all personnel that do not have a background in food safety and quality. Departments such as accounting, warehouse, maintenance and personnel should be trained to perform GMP and sanitation audits. Spread these tasks around and your systems will benefit. The people performing the tasks will take pride at being trusted with these important responsibilities and tasks.

While a company or organization may start in an undesirable situation, it is possible to change the environment. Remember, the people you work with are your greatest asset. Value these people; uplift, teach and coach them in the ways of food safety and quality. Your efforts will produce astounding results! In the second half of the discussion on food safety culture, we will discuss other facets that influence food safety culture.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

Managing GFSI Certification a New FSMA Requirement

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Compliance to FSMA requires companies to meet existing program requirements and new ones being published or face regulatory consequences. A part of FSMA also requires that companies follow established food safety plans, which includes GFSI certification.

With these changes, GFSI-level programs must integrate into an aligned Food Safety Management System (FSMS) and strategy. Key considerations include sustainability, multi-year planning, effective organizational structures and expectations, well-defined roles and expectations, compliance, and business objectives.

The value of GFSI certification depends on how the company uses its organizational resources to maximize return on investment, while meeting the changing FDA requirements. Effective management of a GFSI-certified FSMS can have a significant impact on FDA/FSMA compliance. The risk of not meeting established programs while implementing new FSMA programs must be measured, and attention must be given to addressing FSMA compliance, while maintaining established programs.

Complying with FSMA Food Safety Programs
The implementation of FSMA-compliant programs requires having an established GFSI FSMS and demonstrating conformance with one’s own policies. Programs must be maintained and improved as the FSMA requirements are developed and implemented. Each of the GFSI schemes has been vetted to meet a significant level of FDA/FSMA requirements—a key benefit to these industry programs.

Developing a compliant FSMS with proper alignment of your existing programs to FSMA must be assessed. For example, companies with more than 500 employees must include requirements in their programs for the FSMA Preventive Controls rule, which is set for compliance September 19, 2016. In this regard, registered food facilities must evaluate and implement preventive control provisions and meet the requirements by the approaching deadline. This requires effectively updating current programs, establishing key imperatives including cGMPs (Section 117), identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.

The following areas are all included under the FSMA requirements:

  • cGMP, Controls and Preventive Controls. Must be identified, modified, and implemented to further minimize or prevent the occurrence of hazards based on Section 117 requirements.
  • Food Safety Plan, Hazard Analysis, and HACCP. Companies must identify and evaluate changes in their existing programs to include FSMA Preventive Controls.
  • Qualified Individual. Must be trained with authority to oversee Preventive Control program aspects, developments and impacts.
  • Written Programs and Documentation. Up-to-date GFSI-level FSMS provides documented programs, procedures, and records for meeting requirements under FDA/FSMA.
  • Management & Monitoring. All controls, including under FSMA and existing GFSI-level, must be monitored, validated, and verified for effectiveness.
  • Management of Corrective Actions. Procedures including traceability response for addressing failures of procedures, GMPs and controls must be under management review and confirmed for prevention of adulterated food from entering commerce.
  • Recordkeeping. Records must be complete and accurate for all food production and safety activities and kept for two years, including the testing level verification of all programs under FSMA and GFSI-level programs.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to GFSI-level programs meeting FSMA. To complete your own planning assessment, review your progress compared to the questions in Table I.

FSMA, GFSI
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of FSMS and GFSI preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have their existing food compliance and GFSI programs in good standing to comply with FSMA or face possible violations, fines and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage GFSI certification—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

Randy Fields, Repositrak
FST Soapbox

Sanitary Transportation Rule: Ignore at Your Own Peril

By Randy Fields
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Randy Fields, Repositrak

FDA posted the FSMA rule on the Sanitary Transportation of Human and Animal Food in April. The majority of retailers, wholesalers, suppliers and carriers will have one year to comply with this new rule. The sanitary transportation rule sets out to prevent practices that would introduce contamination risk during the transportation of food through the supply chain.

For retailers, wholesalers, suppliers and carriers, the final rule is really the sleeper regulation among the new FSMA laws. You probably have your HAACP plans and preventative control procedures in place, but do you have the necessary documents in place with your carriers to meet the FDA’s requirements?  And, are those documents easily accessible?

Under FSMA, you must address all FDA record inquiries within 24 hours, and these inquiries can go back two years, plus 12 months beyond the expiration of related service agreements. Failure to respond to an FDA records inquiry is considered a “prohibited act” and can land you in hot water with both the FDA and Department of Justice, which acknowledged they will enforce FSMA through civil and criminal penalties. That’s a game changer.

You are now required to ensure that transportation equipment does not cause the food it is carrying to become unsafe. You must also maintain adequate temperatures throughout your portion of the supply chain and prevent cross contamination. And, you must train your personnel in sanitary practices. All of these factors—processes and procedures, agreements and formal training of personnel—must be documented and made available to the FDA. Put simply, compliance with FSMA is proven through documentation because according to the FDA, if it is not documented, it did not happen!

So what’s the best way to comply with the new rules? Having the information on paper in filing cabinets simply won’t do. Can you imagine searching for specific confirmation that an employee received the proper training in a bank of file cabinets? Even with an efficient system, that could be like looking for a needle in a haystack. Collecting the information in spreadsheets is only slightly better, as it simply digitizes the disorganization.

Retailers, wholesalers, suppliers and carriers need to start their compliance process by reviewing and understanding all of the FSMA rules, guidance procedures and responsibilities. You ignore them at your own peril.

Then, consider automating your recording keeping system.  It is really the only way to efficiently collect and manage the documentation needed to comply with the new law.  When reviewing technology options, make sure you choose a system that is not only easy to use by frontline workers, but also provides sophisticated reporting and alerts to point out potential problems in real time. And, if possible, the solution should do more than just report on food safety activities. As long as you’re investing in a technology to meet FSMA requirements, you might as well implement a system that can potentially save money in other areas such as managing business or training documentation, new vendor approvals, or carrier optimization.

The bottom line is that the sanitary transportation rule will require that you devote additional resources to make the entire extended grocery channel more risk free for consumers and companies alike. And the best way to do that is to implement new technology that gives visibility to product transfers from point of production or processing to the point of purchase, and documents each step along the way.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

We Know the Why

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

Food safety culture is not just a catchy phrase or the right thing to say. It is the right thing to embrace and the right thing to implement. But how is it achieved? It is relevant to start with understanding “The Why” behind food safety. Why is it important?  Do people really get sick and die? Why does that happen, and what is our role in preventing it?  How do we integrate aspects of FSMA with a culture that embraces a robust food safety culture, and how do we create passion around the culture?  I continue to address this issue, because at nearly every meeting I attend, in committees in which I serve and in simple conversations with colleagues, I hear the frantic voices of those who have so much to do, results to produce, bosses to please, and staff to supervise, and the why behind food safety is rarely mentioned.

STOP Foodborne Illness, Why Behind Food Safety
We need to truly understand the “why: behind food safety.

I speak to and read about individuals daily who have been sick or lost children or parents to this preventable problem. I see the photos of their children and hear about their loving attributes, yet this aspect is often neglected in the equation of the busy lives of those involved in growing, producing and distributing our food. I get it—who wants to talk about the problem when there is a product to promote and sell? But in reality, the only reason any of us live this frantic life with a long to-do list is because people get sick and die from foodborne illnesses, and because it is our job to do what we can to prevent the illnesses. And while consumers can practice safe food handling, there is nothing they can do about Salmonella in peanut butter, or Listeria in ice cream, cantaloupe or caramel apples. Let’s start the conversation of HOW to change and sustain a strong food safety culture and include the why as our rationale in the conversation.  STOP Foodborne Illness is interested and will devote more time to the how, and I hope you will join us in this conversation and endeavor. I would love to hear your thoughts.

David Chambliss, IBM Research
In the Food Lab

Scientific Breakthrough May Change Food Safety Forever

By David Chambliss
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David Chambliss, IBM Research

How safe is a raw diet? Could sterilizing our food actually make us more prone to sickness? Are vegans healthier than carnivores? In the last few decades, global food poisoning scares from beef to peanut butter have kept food scientists and researchers around the world asking these questions and searching for improved methods of handling and testing what we eat.

It’s been more than 150 years since Louis Pasteur introduced the idea of germ theory—that bacteria cause sickness—fundamentally changing the way we think about what makes our food safe to eat. While we’ve advanced in so many other industrial practices, we’re still using pasteurization as the standard for the global food industry today.

Although pasteurization effectively controls most organisms and keeps the food supply largely safe, we continue to have foodborne outbreaks despite additional testing and more sophisticated techniques. The potential health promise of genomics, and the gut microbiome genetics and bacterial ecosystems, could be the key to the next frontier in food safety.

The scientific community is once again at the cusp of a new era with the advent of metagenomics and its application to food safety.

What is metagenomics? Metagenomics is the study of the bacterial community using genetics by examining the entire DNA content at once. Whole genome sequencing of a single bacterium tells us about the DNA of a specific organism, whereas metagenomic testing tells us about the interaction of all the DNA of all the organisms within a sample or an environment. Think of the vast quantity of genetic material in the soil of a rice patty, a lettuce leaf, your hand, a chicken ready for cooking, or milk directly from a cow. All of them have thousands of bacteria that live together in a complex community called the microbiome that may contain bacteria that are sometimes harmful to humans—and possibly also other bacteria that help to keep the potentially harmful bacteria in check.

Metagenomics uses laboratory methods to break up cells and extract many millions of DNA molecular fragment, and sequencing instruments to measure the sequences of A’s, C’s, G’s, and T’s that represent the genetic information in each of those fragments. Then scientists use computer programs to take the information from millions or billions of fragments to determine from what bacteria they came. The process is a little like mixing up many jigsaws, grabbing some pieces from the mix, and figuring out what was in the original pictures. The “pictures” are the genomes of bacteria, which in some cases carry enough unique information to associate a given bacterium with a previously seen colony of the same species.

Genomics of single bacterial cultures, each from a single species, is well established as a way to connect samples of contaminated foods with reported cases of foodborne illnesses. With metagenomics, which essentially looks for all known species simultaneously, one hopes to do a better job of early detection and prevention. For example, if a machine malfunction causes pasteurization or cleaning to be incomplete, the metagenomics measurement will likely show compositional shifts in which bacterial phyla are abundant. This can make it possible to take remedial action even before there are signs of pathogens or spoilage that would have led to a costly recall.

Up until now, keeping food safe has meant limiting the amount of harmful bacteria in the community. That means using standard methods such as pasteurization, irradiation, sterilization, salt and cooking. To determine whether food is actually safe to eat, we test for the presence of a handful of specific dangerous organisms, including Listeria, E. coli, and Salmonella, to name a few. But what about all the “good” bacteria that is killed along with the “bad” bacteria in the process of making our food safe?

Nutritionists, doctors and food scientists understand that the human gut is well equipped to thrive unless threatened by particularly dangerous contaminants. The ability to determine the entire genetic makeup within a food could mean being able to know with certainty whether it contains any unwanted or unknown microbial hazards. Metagenomic testing of the food supply would usher in an entirely new approach to food safety—one in which we could detect the presence of all microbes in food, including previously unknown dangers. It could even mean less food processing that leaves more of the healthful bacteria intact.

More than 150 years ago, Pasteur pointed us in the right direction. Now the world’s brightest scientific minds are primed to take the food industry the next leap toward a safer food supply.

Patty Murray
FST Soapbox

Chilean Gourmet Food Companies Eager to Learn about FSMA

By Patty Murray
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Patty Murray

Whenever possible, I try to spread the word about food safety and share the knowledge gained from my years of experience in various sectors of the food industry, especially from my time managing the Food Safety Tech conferences and webinars. Recently, I even worked it into a presentation about social media marketing for a Pro-Chile Trade Board Event where food safety issues were hot topics throughout the day.

Representatives of more than 30 food manufacturers from Chile attended the event, which was held at the Summer Fancy Food Show in New York City and organized with The Food Institute and Grover Global Food Marketing.  Well established in Chile, these producers of gourmet specialty food products wanted to learn the intricacies of selling their cured meats, olive oils, edible flowers, teas, preserves, desserts and snacks in the United States.

(left to right) vent sponsor, Mauricio Banchieri, Trade Commissioner, Trade Commission of Chile in New York - ProChile, with speakers Lauren Handel, Janis Grover, Patty Murray and Andrea Sapag of the Trade Commission.
(Left to right) vent sponsor, Mauricio Banchieri, Trade Commissioner, Trade Commission of Chile in New York – ProChile, with speakers
Lauren Handel, Janis Grover, Patty Murray and Andrea Sapag of the Trade Commission.

The reason: Americans spend a lot on food—$1.5 trillion annually, which is 28% of all retail trade in the United States, according to Brian Todd, president and CEO of The Food Institute, a firm that provides industry news, data and trends. He shared that consumer spending was up 2.3% in 2014 to $6,759 per year per household. Products on the rise include fresh fruits and vegetables, dairy, olive oil, confections and beverages. Key qualities include grab-and-go/convenience, non-GMO, organic, all-natural, healthy, fortified, gluten-free and air-popped/baked.

Todd and other speakers addressed new U.S. government regulations including FSMA, food labeling (nutrition and front of package), bioterrorism, customs, facility registration and certifications.  Drilling down into many of the legal details was Lauren Handel, Esq., of Handel Food Law in New Jersey. Handel emphasized the importance of FSMA compliance, in particular, preventive controls, produce safety and foreign supplier verification.

Janis Grover, of Grover Global Food Marketing, who has more than 30 years experience in brand management, pointed out that non-U.S. food manufacturers have an extra hurdle to overcome with the new food safety laws. Grover explained that establishing food safety confidence in their brand with U.S. buyers is critical before they can begin negotiating any importing and distribution deals. According to Grover, to be successful, non-U.S. food manufacturers need to verify with U.S. buyers that they will comply will all U.S. food manufacturing and labeling laws, and that they have the required certifications and other quality control documentation to support their claims.

Sometimes at our FST conferences, speakers and attendees ask about the implementation of our new food safety laws. Will top management provide the funding for quality systems and traceability? Will companies be vigilant about the entire supply chain? Will there be significant and meaningful enforcement by government? Will foreign suppliers comply?  I was heartened by the tone and content of the Pro-Chile event and optimistic as I walked the Summer Fancy Food Show with another international client. One of the first statements made to us by a potential U.S. partner was “Do you have a GFSI certificate?” My client did.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

FSMA Preventive Controls: Are You Prepared?

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Compliance to FSMA has presented a new and difficult challenge for industry, the public and the FDA since it passed on January 4, 2011. With compliance dates for the initial FSMA rule—Preventive Controls—coming in September 2016, food sites must establish plans now to meet the impending deadline.

Complying with the Preventive Controls Rule

The Preventive Controls Rule was published September 17, 2015, with the compliance date for registered companies (more than 500 employees) scheduled for September 19, 2016. The compliance date is one year later for companies with fewer than 500 employees, unless otherwise specified under FSMA.

Under the FSMA rules, registered food facilities must evaluate and implement preventive control provisions and meet the requirements and the approaching deadline. The most urgent concerns for companies subject to the Preventive Controls Rule include developing a Preventive Controls Program, identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.

The following areas are all included under the FSMA Preventive Controls Rule:

  • Hazard Analysis. Companies must identify and evaluate known and reasonably foreseeable hazards.
  • Preventive Controls. Preventive controls must be implemented to significantly minimize or prevent the occurrence of hazards.
  • Monitoring. Preventive controls must be monitored for effectiveness.
  • Corrective Actions. Procedures for addressing failures of preventive controls and prevention of affected food from entering commerce are required.
  • Verification. Facilities are required to verify that preventive controls, monitoring and corrective actions are adequate.
  • Recordkeeping. Records must be kept for two years.
  • Written Plan and Documentation. A written plan must document and describe procedures used to comply with requirements.
  • Qualified Individual. A Qualified Individual who has been adequately trained must be present at the facility to manage the preventive controls for the site and the products processed and distributed at/from the site.

Failure to implement Preventive Controls (a.k.a., Hazard Analysis and Risk-based Preventive Controls (HARPC)) for qualified sites may result in fines and possible jail sentences.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning for FSMA compliance (see Table I). To complete your own planning assessment, review your progress compared to the questions below.

Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of preparedness for FSMA compliance.
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have their training, planning and development underway to comply, or face possible violations, fines, and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage the preventive controls program—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.