Tag Archives: Focus Article

By Sanjay K. Singh, Douglas Marshall, Ph.D., Gregory Siragusa, Ph.D.

Here is a prediction. Within the next year or years, at some time in your daily work life as a food safety professional you will be called upon to either use genomic tools or to understand and relay information based on genomic tools for making important decisions about food safety and quality. Molecular biologists love to use what often seems like a foreign or secret language. Rest assured dear reader, these are mostly just vernacular and are easily understood once you get comfortable with a bit of the vocabulary. In this the fourth installment of our column we progress to give you another tool for your food genomics tool kit. We have called upon a colleague and sequencing expert, Dr. Sanjay Singh, to be a guest co-author for this topic on sequencing and guide us through the genomics language barrier.

The first report of the annotated (labeled) sequence of the human genome occurred in 2003, 50 years after the discovery of the structure of DNA. In this genome document all the genetic information required to create and sustain a human being was provided. The discovery of the structure of DNA has provided a foundation for a deeper understanding of all life forms, with DNA as a core molecule of genetic information. Of course that includes our food and our tiny friends of the microbial world. Further molecular technological advances in the fields of agriculture, food science, forensics, epidemiology, comparative genomics, medicine, diagnostics and therapeutics are providing stunning examples of the power of genomics in our daily lives. We are only now beginning to harvest the fruits of sequencing and using that knowledge routinely in our respective professions.

In our first column we wrote, “DNA sequencing can be used to determine the names, types, and proportions of microorganisms, the component species in a food sample, and track foodborne diseases agents.” In this month’s column, we present a basic guide to how DNA sequencing chemistry works.

Image courtesy of US Human Genome Project Knowledge base

DNA sequencing is the process of determining the precise order of four nucleotide bases, adenine or A, cytosine or C, guanine or G, and thymine or T in a DNA molecule. By knowing the linear sequence of A, C, G, and T in a DNA molecule, the genetic information carried in that particular DNA molecule can be determined.

DNA sequencing happened from the intersections of different fields including biology, chemistry, mathematics, and physics.^1,2 The critical breakthrough was provided in 1953 by James Watson, Francis Crick, Maurice Wlkins and Rosalind Franklin when they resolved the now familiar double helix structure of DNA.³ Each helical strand was a polynucleotide, which consists of repeating monomeric units called nucleotides. A nucleotide consists of a sugar (deoxyribose), a phosphate moiety, and one of the four nitrogenous bases—the aforementioned A, C, G, and T. In the double helix, the strands run opposite to each other, commonly referred as anti-parallel. Repeating units of base-pairs (bp), where A always pairs with T and C always pairs with G, are arranged within the double helix so that they are slightly offset from each other like steps in a winding staircase. On a piece of paper, the double helix is often represented by scientists as a flat ladder-like structure, where the base pairs (bp) form the rungs of the ladder while the sugar-phosphate backbone form the antiparallel rails (see Figure 1).

Artistic representation of DNA Double Helix. Source: Eurofins

The two ends of each polynucleotide strand are called 5′ or 3′-end, a nomenclature that represents the chemical structure of the deoxyribose sugar at that terminus. The lengths of a single- or double-stranded DNA are often measured in bases (b) or bases pairs (bp), respectively. The two polynucleotide strands can be readily unzipped by heating, and on cooling, the initial double-helix structure is re-formed or re-annealed. The ability to rezip the initial ladder-like structure can be attributed to the phenomenon of base pairing, which merits repetition—the base A always pairs with T and the base G always with C. This rather innocuous phenomenon of base pairing is the basis for the mechanism by which DNA is copied when cells divide and is also the theoretical basis on which most traditional and modern DNA sequencing methodologies have been developed.

Other biological advancements also paved the way towards the development of sequencing technologies. Prominent amongst these were the discovery of enzymes that allowed a scientist to manipulate the DNA. For example, restriction enzymes that recognize and cleave DNA at specific short nucleotide sequences can be used to fragment a long duplex strand of DNA.⁴ The DNA polymerase enzyme, in the presence of the deoxyribose nucleotide triphosphates (dNTPs: Chemically reactive forms of the nucleotide monomers), can use a single DNA strand to fill in the complementary bases and extend a shorter rail strand (primer extension) of a partial DNA ladder.⁵ A critical part of the primer extension is the ‘primer’, which are short single-stranded DNA pieces (15 to 30 bases long) that are complementary to a segment of the target DNA. These primers are made using automated high-throughput synthesizer machines. Today, such primers can be rapidly manufactured and delivered on the following day. When the primer and the target DNA are combined through a process called annealing (heat and then cool), they form a structure that shows a ladder-like head and a long single-stranded tail. In 1983, Kary Mullis developed an enzyme-based process called Polymerase Chain Reaction (PCR). Using this protocol, one can pick a single copy of DNA and amplify the same sequence an enormous number of times. One can think of PCR as molecular photocopier in which a single piece of DNA is amplified up to approximately 30 billion copies!

The other critical event that changed the course of DNA sequencing efforts was the publication of the ‘dideoxy chain termination’ method by Dr. Frederick Sanger in December 1977.⁶ This marked the beginning of the first generation of DNA sequencing techniques. Most next-generation sequencing methods are refinements of the chain termination, or “Sanger method” of sequencing.

Frederick Sanger chemically modified each base so that when it was incorporated into a growing DNA chain, the chain was forcibly terminated. By setting up a primer extension reaction where in one of the chemically modified ‘inactive’ base in smaller quantity is mixed with four active bases, Sanger obtained a series of DNA strands, which when separated based on their size indicated the positions of that particular base in the DNA sequence. By analyzing the results from four such reactions run in parallel, each containing a different ‘inactive’ base, Sanger could piece together the complete sequence of the DNA. Subsequent modifications to the method allowed for the determination of the sequence using dye-labeled termination bases in a single reaction. Since, a sequence of less than <1000 bases can be determined from a single such reaction, the sequence of longer DNA molecules have to be pieced together from many such reads.

Using technologies available in the mid-1990’s, as many as 1 million bases of sequence could be determined per day. However, at this rate, determining the sequence of the 3 billion bp human genome required years of sequencing work. By analogy, this is equivalent to reading the Sunday issue of The New York Times, about 300,000 words, at a pace of 100 words per day. The cost of sequencing the human genome was a whopping $70 million. The human genome project clearly brought forth a need for technologies that could deliver fast, inexpensive and accurate genome sequences. In response, the field initially exploded with modifications to the Sanger method. The impetus for these modifications was provided by advances in enzymology, fluorescent detection dyes and capillary-array electrophoresis. Using the Sanger method of sequencing, one can read up to ~1,000 bp in a single reaction, and either 96 or 384 such reactions (in a 96 or 384 well plate) can be performed in parallel using DNA sequencers. More recently a new wave of technological sequencing advances, termed NGS or next-generation sequencing, have been commercialized. NGS is fast, automated, massively parallel and highly reproducible. NGS platforms can read more than 4 billion DNA strands and generate about a terabyte of sequence data in about six days! The whole 3 billion base pairs of the human genome can be sequenced and annotated in a mere month or less.

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March 13, 2017

Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens

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Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that the final testing results are confidential.
Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

March 9, 2017

FST Soapbox

Dispelling the Myth that Food Safety is Not a Competitive Advantage

By Dana Johnson Downing

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“Food safety is not a competitive advantage” is one of the barf-worthy “feel good” messages you hear from food industry executives during speeches and public forums. Last week at the Global Food Safety Initiative (GFSI) conference in Houston, an audience of more than 1,150 from 54 countries heard this tired mantra repeated during a panel discussion featuring CEOs from Mondelez, Cargill, Tysons and Wegmans. The common theme espoused by the CEOs was that food safety is a given and it’s just the right thing to do. Under their flawed rationale, because food safety is mandated, it cannot be a differentiator. Huh? That’s like saying monogamy in marriage is a given. Sure, most brides and grooms pledge faithfulness, but hey, we all know cheaters gonna cheat.

I wasn’t the only one who didn’t buy the food safety kumbaya message the CEOs were peddling. BBC business journalist Adam Shaw was the moderator for the panel and he grilled the CEOs to try to expose the fallacy that food safety is not a competitive advantage as nothing more than high-mindedness with altruistic notions, but the CEOs deflected his pointed questions and stayed on-message. I thought the song from the Lego movie, “Everything is Awesome” might start blaring from the sound system at any moment. What I cannot discern is if the CEOs really believe that food safety is not a competitive advantage, or do they feel compelled to say it to bolster confidence in the food supply.

I think we can all agree that consumers expect their products to be safe. Objectively, I think we must also agree that there are some companies in the food industry that simply do a better job of managing risk in their food safety system. As Warren Buffet once said, “Risk comes from not knowing what you’re doing.” Have you ever read the warning letters issues by the FDA? There are plenty of food operators who either do not know what they are doing or their profits are more important to them than the safety of the products they produce.

Perhaps the real reason these CEOs say food safety is not a competitive advantage is because they are trying to trick us with some twisted reverse psychology technique. More likely they avoid positioning their company as having an extraordinary food safety system because you can never eliminate all risk, and a recall or foodborne illness outbreak could be lurking just around the corner. That logic is a little lost on me, but okay.

What about food safety as a competitive advantage in the business-to-business (B2B) environment? With all the transactions between ingredient suppliers, brokers, distributors, co-packers and manufacturers, there is often friction between vendor and customer over food safety standards and the underlying documentation. Who you do business with matters more than ever before, especially now that there is greater supply chain transparency and process control mandated by FSMA. According to Brian Perry, senior vice president, food safety & quality at TreeHouse Foods, he has had to drop suppliers who are not FSMA-compliant because they pose too much risk. Meanwhile, companies are willing to pay a premium for suppliers who have their food safety documentation in order and routinely deliver on time and within specifications. So at least in the B2B marketplace, we can see that food safety can definitely provide a competitive advantage.

Pesky undeclared allergens and foreign material find a way to sneak into food production. Unsanitary conditions are sometimes permitted and product is adulterated. Mistakes are made, stuff happens, and sometimes food makes people and animals sick or even leads to death. So please don’t tell me that food safety is a given! If you want consumers to have confidence in our food supply, then tell them what your company does to try to prevent stuff from happening. Consumers’ appetite for information and knowledge about the food they consume is at an all time high. If consumers care about GMOs or how ethically-raised, humanely-treated, or sustainably-produced their food is, isn’t it logical to think they care about how companies develop a culture of food safety, the technology they use, and how strictly they monitor their suppliers? In order to make food safety a competitive advantage, food companies need to show supply chain partners and consumers that transparency isn’t just a buzzword. They need to show how they are operationalizing transparency to elevate food safety as a corporate imperative. Share your food safety story and respect your consumers enough to make up their own minds about whether your food safety system sets your brand apart.

March 7, 2017

How One Company Eliminated Listeria Using Chlorine Dioxide Gas

By Kevin Lorcheim

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The previous article discussed the various decontamination options available to eliminate Listeria. It was explained why the physical properties of gaseous chlorine dioxide make it so effective. This article focuses on one company’s use of chlorine dioxide gas decontamination for both contamination response and for preventive control.

The summer of 2015 saw multiple ice cream manufacturers affected by Listeria monocytogenes. The ice cream facility detailed in this article never had a supply outage, but ceased production for a short amount of time in order to investigate and correct their contamination. After a plant-wide review of procedures, workflows, equipment design and product testing, multiple corrective actions were put into place to eliminate Listeria from the facility and help prevent it from returning. One such corrective action was to decontaminate the production area and cold storage rooms using chlorine dioxide gas. This process took place after the rest of the corrective actions, so as to decontaminate the entire facility immediately before production was set to resume.

Responsive Decontamination

The initial decontamination was in response to the Listeria monocytogenes found at various locations throughout the facility. A food safety investigation and microbiological review took place to find the source of the contamination within the facility in order to create a corrective action plan in place. Listeria was found in a number of locations including the dairy brick flooring that ran throughout the production area. A decision was made to replace the flooring, among other equipment upgrades and procedural changes in order to provide a safer food manufacturing environment once production resumed. Once the lengthy repair and upgrade list was completed, the chlorine dioxide gas decontamination was initiated.

The facility in question was approximately 620,000 cubic feet in volume, spanning multiple rooms as well as a tank alley located on a different floor. The timeline to complete the decontamination was 2.5 days. The first half-day consisted of safety training, a plant orientation tour, a meeting with plant supervisors, and the unpacking of equipment. The second day involved the setup of all equipment, which included chlorine dioxide gas generators, air distribution blowers, and a chlorine dioxide gas concentration monitor. Gas injection tubing was run from the chlorine dioxide gas generators throughout the facility to approximately 30 locations within the production area. The injection points were selected to aid its natural gaseous distribution by placing them apart from one another. Gas sample tubing was run to various points throughout the facility in locations away from the injection locations to sample gas concentrations furthest away from injection points where concentrations would be higher. Sample locations were also placed in locations known to be positive for Listeria monocytogenes to provide a more complete record of treatment for those locations. In total, 14 sample locations were selected between plant supervisors and the decontamination team. Throughout the entire decontamination, the gas concentration monitor would be used to continuously pull samples from those locations to monitor the concentration of chlorine dioxide gas and ensure that the proper dosage is reached.

As a final means of process control, 61 biological indicators were brought to validate that the decontamination process was effective at achieving a 6-log sporicidal reduction. 60 would be placed at various challenging locations within the facility, while one would be randomly selected to act as a positive control that would not be exposed to chlorine dioxide gas. Biological indicators provide a reliable method to validate decontamination, as they are produced in a laboratory to be highly consistent and contain more than a million bacterial spores impregnated on a paper substrate and wrapped in a Tyvek pouch. Bacterial spores are considered to be the hardest microorganism to kill, so validating that the process was able to kill all million spores on the biological indicator in effect also proves the process was able to eliminate Listeria from surfaces. The biological indicators were placed at locations known to be positive for Listeria, as well as other hard-to-reach locations such as the interior of production equipment, underneath equipment and inside some piping systems.

In order to prepare the facility for decontamination, all doors, air handling systems, and penetrations into the space were sealed off to keep the gas within the production area. After a safety sweep for personnel, the decontamination was performed to eliminate Listeria from all locations within the production area.

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March 6, 2017

FST Soapbox

Foreign Supplier Verification Rule: Top 5 Questions Answered

By Randy Fields

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The Foreign Supplier Verification Rule, part of FSMA, requires the importer of food to meet the same stringent guidelines found within FSMA’s Preventive Controls rule. Companies defined as the importer are now required to deploy a Foreign Supplier Verification Program (FSVP) that ensures their foreign supply partners are producing the imported food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Register for the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | in-person or virtualAnd now, the questions:

1. Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the United States from any other country at the time of U.S. entry. If you are still unsure as to whether you are the importer, try answering the three questions below. If you answer “me” to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

Who controls the finances of the imported food?
Who controls the agent?
Who controls the goods? Whose truck picks it up or in whose DC is the product stored?

2. What comprises a FSVP?

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file. (Hint: It’s a good idea to trust but verify in this situation.)

3. Can you meet the FSVP challenge?

Any record requested by the FDA must be available within 24 hours and could date two years back. If you don’t have an automated system, it’s time to consider one, as it’s really the only way to manage the range of documents required by a FSVP across a retailer’s or wholesaler’s vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. What is the CEO’s responsibility under FSVP?

Senior executives in the extended retail food supply chain are personally responsible not only for their company’s compliance with FSVP, but also for verifying the compliance of their upstream supply chain.

5. Why is Now the Time to Take Action?

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While we like to think of food safety as not being a competitive advantage, it can be used as leverage against the competition. So it’s critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.

March 3, 2017

Three Practices for Supply Chain Management in the Food Industry

By Kevin Hill

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While building an effective logistics strategy, the end goal of supply chain management (SCM) needs to be kept in mind (i.e., allowing each member of the supply chain to achieve efficient inventory management as well as reach its customer service goals). To this end, it’s important to share information that will help each member achieve success. This includes data relating to demand forecasts, anticipated lead times and safety stock quantities. Let’s look at SCM best practices for food manufacturing and supply, and how this information plays a role.

Effective SCM: Best Practices for the Food Industry

Here’s an overview of SCM best practices in food supply and manufacturing:

Learn more about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MOREDemand Forecasts. This is generally based on demand, sales or usage patterns in the past. However, future demand can be affected by changing situations such as:

Gaining/losing customers
Increased/decreased product popularity
Introduction of new products
Short-term increase in demand through promotions, etc.

Better estimates can be achieved with an effective derived demand or a CPFR (collaborative planning, forecasting and replenishment) system. This can be done through automated data collection, or by the following process:

Identifying customers who can predict future demand (i.e., what they may use or sell in the future)
Collecting demand forecasts about specific products from them
Comparing these forecasts against their actual purchases on a monthly basis
Helping them improve future predictions by sharing this data with them

Customers may overestimate demand, but you might consider offering a discount based on accurate forecasts to encourage better results. In addition, you should also consider these five elements:

Usage patterns in the past, not including CPFR data
Increasing/decreasing product popularity trends
Higher/lower seasonal usage or demand
Events/promotions in the near future
Market and industry data from sources such as management, sales, etc.

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February 28, 2017

FST Soapbox

Employee Buy-in to Ensure FSMA Compliance

By Erika Miller

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Getting employees on board can be one of the most difficult parts of any major change within a company. When things are operating just fine from the perspective of the employee, the cries of, “but we’ve always done it this way!” can be deafening. As a manager, it is our job to explain the new requirements in a way that encourages buy-in from employees at all levels of the organization, and to always present a united front with the company, even if we do not fully understand why a change is important. It is almost a guarantee a business would not spend money implementing a major change if there was not an impetus behind it. One crack in the façade can lead to an entire shift becoming demoralized and disheartened.

Compliance with FSMA is no exception. Although the aim of the act is to reduce food safety risks to the population of the United States, the added paperwork and regulatory requirements can seem onerous to the employees responsible for doing the work. I would encourage any managers who are experiencing some feelings of “why me?” to search YouTube for the videos made by families touched by major foodborne illness outbreaks. The pregnant mothers whose babies are infected with Listeria from deli meat sandwiches are particularly heartbreaking for those who have children.

Once a manager has convinced him or herself of the importance of compliance with the new food safety regulations, it’s time to get your employees on board as well. If you can, show them the same videos you saw to encourage their buy-in. Listeria is a danger in any plant handling a ready-to-eat product or one that could be improperly cooked by the end user. Remember, cooking instructions do not absolve the manufacturer of the responsibility to produce food free of hazards! With the internet, impactful videos are only a click away. Just remember to always fully vet the video before attempting an at-work viewing party—lots of people on the internet have senses of humor that may not translate well to the workplace.

Making the issue personal also works well. This is a great way to get the message home about allergens. In any group of associates, chances are good that at least one of them will have a close friend or family member who is affected by a food allergy. Ask people to raise their hands if they know anyone who is allergic to food. Ask them what that person must do to protect themselves. Frequently, the answer is that the allergic consumer can only read the label. This is a great teaching tool for the importance of proper labeling and can be used as a lead-in to the introduction of a new Allergen Preventive Control, if one is required. Ask the employees to visualize the people they know with food allergies when completing the required records, or performing the onerous tasks, and imagine themselves as the last line of defense.

Many companies employ the services of temporary agencies. These companies can offer a great solution for a company that is concerned about the exposure to litigation that can occur through employee separation. Some industries have high levels of turnover or seasonal operations, which can prove difficult to manage for busy HR departments. Turnover can lead to a loss of accountability as well, such as when an employee informs you that their training was deficient (leading to a major snafu). If their predecessor was not in the position long enough and the chain of training was broken, it can take a substantial investment of time and energy from a senior individual to train that relatively low-paid position back to base minimum level. Outsourcing some of the work to a temporary agency can seem like a godsend at first. They find them, they train them, and all the hiring company must do is eliminate downtime. Who wouldn’t?

However, over time, many companies find the time and money they saved at the outset comes back around to bite them in the end. Temp agencies often do not keep good records, and if you are relying on them to deliver crucial introductory food safety training before they send candidates to you to begin, you may end up in a bind when your auditor or FDA investigator asks to see your training records. The obvious solution is to bring all training back in-house, but that can partly defeat the purpose of having the temp agency in the first place.

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February 27, 2017

Food Transparency Movement Driving Changes in Labeling

By Maria Fontanazza

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Recently the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI) announced an initiative to reduce the amount of confusion that consumers experience regarding the “sell by”, “use by” and other date-specific labeling on food packaging. It is also part of an effort to reduce food waste.

The new initiative is completely voluntary, but GMA and FMI are hoping that retailers and manufacturers adopt the standard by the summer of 2018. It streamlines the labeling terminology to two simple phrases:

“BEST If Used By”. Describes product quality, indicating the date by which the product may not taste or perform as expected but it is still safe to consume
“USE By”. Applies to highly perishable products and/or products that have a food safety concern over a period of time that warrants a date by which the products should either be consumed or discarded

A variety of factors well beyond “sell by”/”use by” dates contribute to consumer confusion. The following Q&A is a brief discussion with Dagan Xavier, co-founder and vice president, customer intelligence at Label Insight on the impact of incorrectly labeling products (erosion of brand trust) and the challenge food companies face in providing transparent information on their products.

Food Safety Tech: How is the demand for transparency both from consumers and regulators changing the food product labeling landscape?

Dagan Xavier: Transparency sounds easy, but in reality, it is complex. For companies, managing compliance and consumer demands is not cut and dry.

Thankfully, brands and consumers are usually on the same page. But there are times when it’s not the case—and that causes trust issues. For one, brands need to use specific, compliant wording. That wording can sometimes be more complex than a preferred consumer-friendly phrasing. For example, USDA’s proposed labeling of GM-containing products refers to them as “genetically engineered.” Except, consumers are far more familiar with the term “genetically modified.”

Regardless of these nuances, regulations around transparency are in place to help consumers. The regulations set clear definitions about what products or ingredients can or cannot qualify for a labeling claim.

We currently live at a time where there is a general distrust of the food industry from consumers. Having strict regulations in place that add factual meaning behind claims is incredibly important. Meaningful and understandable claims, logos, and certifications are slowly beginning to help build trust back up from consumers.

FST: What challenges are food companies facing in labeling their products?

Xavier: One of the biggest hurdles companies face in labeling is fitting as much information as possible on the package. Between mandatory components (like allergens, nutrients, ingredients) and desired content (marketing copy and images), something almost always gets left off. What gets left off? It tends to be sourcing facts, “Made in America” logos, and other data that consumers find valuable but rank lower on a brand’s priority list.

In reality, 100% complete product information is nearly impossible to fit within the confined space of most product packaging.

The good news is that according to a recent study by Label Insight, most consumers (88%) say they would be interested in accessing a complete set of product information digitally.

SmartLabel (an initiative by the Grocery Manufacturers Association) is an easy solution. SmartLabels save companies space on their packaging, while still allowing them to communicate all product information with consumers digitally.

Most consumers (79%) say they are very likely or somewhat likely to use SmartLabel technology if it was offered by a brand. 44% say they would trust a brand more if it participated in the GMA SmartLabel initiative.

FST: Related to labeling, what are the complicating factors when a company is producing organic, GMO-free, gluten free, etc.—especially when working with suppliers?

Xavier: Having a trusting relationship and open communication with suppliers is key.

Because regulations around organic and gluten-free are so stringent here in the United States, brands need to rely on their suppliers to have ongoing robust certification audits, inspections, documentation and renewal programs.

We expect regulations around GMO-containing products to follow suit.

For companies with dozens of suppliers, it can get tricky managing the documentation of certifications. This is especially complicated if suppliers are overseas and their audits are not delivered through the same certifying agencies that retailers or importers would like.

Adding logos and certifications to packages can be expensive and add risk to brands if a supplier falls out of compliance. In the end, it is important for both brands and suppliers to have robust documentation and a good communication channel. This ensures that all information on-pack is always the most accurate information for consumers and retailers.

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February 23, 2017

FDA’s CAPT Palmer Orlandi Promoted for Public Health Leadership

By Food Safety Tech Staff

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Palmer A. Orlandi, Jr., Ph.D., senior science officer and research director in FDA’s Office of Foods and Veterinary Medicine, has been promoted to the rank of Rear Admiral and the U.S. Assistant Surgeon General. Orlandi received the flag-grade promotion during a ceremony held Thursday afternoon in the FDA Wiley Building.

“As the senior ranking officers in the Commissioned Corps, flag officers exemplify the core values for which Commissioned Officers of the U.S. Public Health Service are held in high esteem. Flag officers provide executive-level leadership within the Department and within the Agencies in which they serve. Our flag officers also carry the title of Assistant Surgeon General and, as such, we rely on them to support special initiatives and exhibit the highest caliber of public health leadership.” – Commissioned Corps of the U.S. Public Health Service

Palmer Orlandi, FDA, Food Safety Consortium — WATCH THE VIDEO: Palmer Orlandi discusses FSMA and laying the groundwork for data acceptance in lab partnerships at the Food Safety Consortium.

Orlandi joined FDA 20 years ago, beginning his work at a research lab for CFSAN. It was there that he developed rapid and molecular detection methods for Cyclospora and Cryptosporidia and the Microsporidia (emerging food-and waterborne protozoan parasites). In 2008 he became the science coordinator in the Division of Field Science in FDA’s Office of Regulatory Affairs (ORA) where he oversaw collaborative analytical methods programs for ORA and the Food Emergency Response Network. In 2012 Orlandi took on the role of senior science advisor to the chief scientist officer at the Office of Food and Veterinary Medicine. He played an active role in integrating science and research efforts across the agency’s foods program, and working to align research and lab programs to regulatory field lab needs.

Orlandi received a Commission as an officer in the U.S. Army in 1981. He has been an officer in the Commission Corps of the Public Health Service since 1991.

February 23, 2017

Achieving Transparency in Organic and Natural Product Claims

By Lori Carlson

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Consumer preference for organic and “all natural” foods remains on the rise, according to market trend research and retailer sales.^1,2 The Organic Trade Association (OTA) recorded $40 billion in U.S. organic food sales for 2015, stating that sales have nearly doubled since 2008.³ Pair this with $21 billion in sales for Q1 2016 for non-GMO labeled foods and $1.6 billion in 2015 gluten-free sales and, it is hard to ignore this thriving market sector, which seeks to support consumers in their quest for fresh, healthy and transparently-labeled foods.^4,5

As a result of these trends, the industry is experiencing a surge in natural food and beverage start-up companies as well as the acquisition of organic and natural product companies by manufacturing giants such as Campbell Soup Co., Danone and General Mills, Inc. But in complex—and especially global—supply chains, achieving transparency comes with hurdles for verifying product claims such as “all-natural”, non-GMO, antibiotic-free, and other nutrient content or functional claims.

Organic and other natural food manufacturers are under increasing regulatory and consumer scrutiny for tracing claims back to the source for all ingredients. Failing to verify the authenticity or identity preservation (IP) status of materials, maintain chain of custody and ensure the accuracy of labels can have devastating consequences for a manufacturer, including regulatory action and consumer fraud class action law suits.⁶ It’s not just consumers demanding the “right to know” where food comes from, but manufacturers must also push this sentiment back through their supply chain to drive transparency for ensuring safety, brand protection and verifying product claims.

With the goal of meeting consumer demands for healthy food products, improved transparency in food production and clean labels, how can organic, non-GMO and natural food manufacturers stay ahead of the curve when it comes to ensuring that product claims provide the value consumers seek?

Consider the following tasks for achieving transparency in organic and natural product claims.

Analyze Your Ingredients for Risk

Get to know the pitfalls, which can affect the integrity of product claims. Many of these stem from cross contamination, authenticity or mislabeling issues for sourced materials. To prevent these pitfalls, analyze each ingredient for supply chain risks. Identifying potential risks, which may affect the integrity of claims creating liability for misbranding, is a critical step in achieving transparency.

For example, is there a potential for cross contamination from a non-organic source? This is a common risk where a supplier engages in the co-production of organic and non-organic materials. A lack of segregation and clear product identification during transportation, storage and processing activities can lead to commingling or cross-contamination, which affects material integrity and thus, any downstream product claims. Ensuring suppliers and the manufacturer have clear measures in place for segregation is an important consideration when determining risk.

Or, consider adulteration from a non-authentic material, which can affect the integrity of the claim. Identifying vulnerabilities within the supply chain is necessary to reduce opportunities for perpetrating food fraud. Materials such as organic products and some natural ingredients are at greater risk for fraud where limited availability is an issue and/or the material is a high-value commodity or product. Mislabeling, counterfeit production or economically motivated adulteration, such as the substitution or dilution of ingredients in a sourced material, has a significant impact on downstream product claims.

Unverified packaging and labels are other sources of risk with the potential to affect the integrity of product claims. Ensure your supplier’s labeling practices include controls to verify the correct packaging and labels when producing IP materials or other ingredients with nutrient content or functional claims.

With a clear understanding of material risks, what attributes of an ingredient should be prioritized, tested and/or verified when considering the integrity of finished product claims?

Once material risks are analyzed, establish clear specifications for raw materials, which are agreed upon between the supplier and manufacturer. This serves as the basis for verifying material claims and subsequently, downstream product claims. Where specifications are in place, material verification may be performed through a variety methods including: testing, mass balance, COA review and audits. Verifying materials against agreed upon specifications not only supports due diligence in product claims but also brings manufacturers closer to their suppliers, steering us towards the next task.

Get to Know Your Suppliers

At the heart of food production transparency is the relationship a manufacturer has with its suppliers. Even the simplest of manufactured foods have a handful of ingredients, which are typically sourced through a global supply chain network. Due to the seasonality of produce or supply chain risks such as market fluctuations, business disruptions, natural disasters, or transportation failures; manufacturers can’t rely on a single supplier for the sourcing of a particular ingredient.

This leads to reliance on multiple suppliers, which may be geographically dispersed. Sourcing from multiple suppliers—especially when this occurs for multiple ingredients across multiple products—can create hurdles to relationship building for enhanced transparency due to time and resource constraints for acquiring first-hand knowledge of a supplier’s operation. Thus, proactive supply chain management, which enables a manufacturer to learn about the supplier’s history and operation, is essential for transparency.

This can be accomplished by establishing supplier approval criteria to provide a baseline for getting to know your supplier and establish minimum criteria for sourcing. Building upon this, is the use of approved suppliers to solidify the relationship and develop out a stable supply chain network. And finally, it is best practice to visit the supplier’s site to learn more about operational practices and the people responsible for ensuring material specifications and identity status are consistently achieved.

Apply Supply Chain Management Best Practices

Effective management of suppliers to prevent or reduce risks, which can lead to mislabeling and false claims, relies on the risk assessment conducted for materials and suppliers, applied controls (e.g., segregation) and verification that the supplier’s controls consistently ensure material integrity.

GFSI benchmarked schemes paved the way for enhanced supply chain management and risk mitigation when it comes to sourcing materials to ensure food safety and legal status. Some schemes additionally require controls and verification activities such as the validation of health claims or verification of nutrient content to provide a framework for helping manufacturers develop a system, which ensures product integrity. For food sold in the United States, a GFSI-based system is now reinforced by the FSMA Preventive Controls rule, which requires supply chain-applied controls to mitigate material risks along with additional controls to ensure that food is not adulterated or misbranded under the U.S. Food, Drug and Cosmetic (FD&C) Act.

It is important to note that while the FSMA Preventive Controls rule regulates most processors and manufacturers, organic raw agricultural commodities (RAC’s), dietary supplements and unprocessed meats are not covered by the rule as they are covered by other U.S. food regulations. Since these products may be included in organic and natural product formulations, manufacturers may want to consider applying a Preventive Controls methodology to their supply chain or pursue certification to a recognized food safety standard such as a GFSI benchmarked scheme where this is not already in place.

Simplify Your Supply Chain

Complex supply chains reduce visibility, add latency into monitoring, and increase opportunities for contamination or fraud.^7,8

Simplifying your supply chain can take a variety of forms such as the sourcing of local or domestic materials.

Continue reading the article by clicking on page 2 below.

Pages: 1 2

Responsive Decontamination

1. Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

2. What comprises a FSVP?

3. Can you meet the FSVP challenge?

4. What is the CEO’s responsibility under FSVP?

5. Why is Now the Time to Take Action?

Effective SCM: Best Practices for the Food Industry

Analyze Your Ingredients for Risk

Get to Know Your Suppliers

Apply Supply Chain Management Best Practices

Simplify Your Supply Chain

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