Environmental Monitoring Programs and The Cost of Failure

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What happens when a food company does not have an effective environmental monitoring program in place? The cost of failure can be significant, warns Prof. Ann Draughon, ranging from placing contaminated food in the markets, to managing product recalls, and businesses getting shut down.

Effective Environmental Monitoring, Sampling and Testing (EMS) Programs are absolutely necessary to protect our consumers, and make safe food, and are also required from a regulatory and food safety point of view, and to verify that our food safety programs are working.

In a recent webinar, Prof. Ann Draughon offered some insights on what happens when such an EMS program is not set in place – the cost of failure is much greater, and the repercussions can be severe, she warns.

What is on the horizon with EMS given the new regulatory landscape under the Food Safety Modernization Act and the proposed rules? Prof. Draughon talked about the Mandatory Preventive Controls described in Section 103 of the Act that lists the following controls that FDA will require:

  • Environmental monitoring programs;
  • Sanitation and cleaning requirements;
  • Allergen control;
  • Mitigation of hazards; and
  • Supplier verification.

How will FSMA affect FDA’s regulatory sampling of food facilities and products? The volume of environmental samples will increase at a much higher rate than sampling for allergens or ingredients, she adds. And in order to meet such a high demand for environmental inspection and sampling, it will be important to have in place effective EMS programs. Prevention will be cost-effective and give companies the ability to detect and destroy the microorganism before they cause any issues. Prof. Draughon provided the following numbers as cost of reinspection: $224 per hour for domestic inspections, $325 per hour for foreign inspections, and cost of FDA reinspection in FY 2012 estimated to be around $21,000.

She described two case studies of companies that suffered bankruptcy, and business losses due to massive food safety related recalls, caused by inadequate or lack of environmental monitoring programs.

3M-Envi-Monitoring_March2015-1

“This company is currently bankrupt due to a massive recall. While they had a great food safety plan, they did not back it up with a strong EMS program,” Prof. Draughon explained.

Speaking about the second company, she explained that the strong and capable leadership had done everything right for the company, but what went wrong? “There was a:

  • 3M-Envi-Monitoring_March2015-2Lack of trend analysis of environmental data;
  • Lack of communication within company about any positives Listeria results;
  • Sporadic Listeria positives occurred – while the problem was fixed, they continue to reoccur and the source was never detected or fixed;
  • The company had a reactive EMS, but not proactive,” she explained.

What are some of the recurring problems due to ineffective EMS programs? Prof. Draughon listed these as:

  • Increased risk of recall;
  • Increase loss of product;
  • Increased liability exposure;
  • Build-up of pathogens and spoilage agents or chemicals in environment;
  • Lack of regulatory compliance; and
  • Reaction to problems, not prevention.

Based on this high cost of compliance, Prof. Draughon strongly recommended establishing an effective EMS program, which has the following attributes:

  • Focus on having the appropriate indicators and hazards;
  • Ensure the best procedures selected and validated;
  • Strong sampling plan, which is well-designed and dynamic;
  • Data analysis and data management; and
  • Education and training.

Learn more by listening to the series of webinars on Environmental Monitoring, presented by 3M Food Safety. Click here for more details.

Color Choices When It Comes to Food

By Chelsey Davis
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When it comes to getting your product off the shelf and into consumers’ homes, color has a lot to do with first impressions. So when deciding on packaging or even food coloring, what colors should food manufacturers choose?

Color plays a huge role in how we decide what to eat. It’s often the first element noticed in the appearance of a food product and as humans, we begin to associate certain colors with various food types from birth. We then attribute these colors to certain tastes. For example, if something is bright red, we might assume it will taste like cherry or cinnamon. If something is bright green, we might expect that food product to taste like lime or apple. And when it comes to fresh foods, like fruits and vegetables, we rely on the color to determine the ripeness or freshness. So aside from expected taste, what else do colors mean when it comes to food?

Red – Appetizing: According to research, the color red is not only eye-catching, but also triggers appetite and is used on a majority of packaging designs. This is perhaps because the color, when found in natural foods like berries, indicates ripeness or sweetness.

Blue – Appetite Suppressant: Surprisingly, there are no true blue foods found in nature, and no, blueberries are actually a shade of purple! Blue, in relation to foods, is actually an appetite suppressant. This is why some weight loss plans suggest placing your food on a blue plate, or even dying your food blue to avoid overindulgence.

Yellow – Happiness: Yellow is perceived as the happiest color and is used widely in various food products. As such, yellow tends to evoke optimism and general good feelings. There are, however, speculations and disagreements when it comes to the artificial color of yellow in food products.

Green – Natural/Healthy: With sustainability and organic being at the top of mind for a large amount of consumers, green is making its way to becoming one of the more popular colors in the food supply chain (think green juice). The color green is now almost synonymous with health and well-being when it comes to food.

Orange – Satisfying/Energizing: One article states that orange is associated with foods that are hearty and satisfying, like breads, soups and potato products, but can also be seen as a source of energy.

Color choices when it comes to packaging

As mentioned above, color is the first thing we notice when it comes to appearance. In fact, more than 90% of purchase decisions are influenced by visual factors, and 85% of shoppers say that color is the primary reason for buying a product. With that in mind, understanding how color on packages dictates purchasing behavior is important to food manufacturers. While the descriptions of colors above represent how we feel towards food items, the colors on the packaging of those food items elicit completely different feelings. For example, seeing blue eggs on a plate versus purchasing eggs in blue packaging will evoke different emotions. Here’s how a few colors break down in terms of packaging:

Red – Energy: Red is a very bold color and using it in your packaging helps to draw attention to you product. Not only does it spark appetite, but it’s also the color we tend to look at first. This is why red is so popular among food packages.

Blue – Trust: Unlike the food color of blue, using blue in your packaging helps to portray trust and dependability in your product. It should be noted, however, that darker blues are considered more professional and serious, whereas lighter blues help to give the perception of softness and creativity.

Yellow – Optimistic: Yellow in packaging is very similar to yellow in food coloring. It helps to suggest that something is original or innovative, or that the product is cheaper/fun. With the positive energy of this color, we typically see it used to help attract children and young adolescents.

Green – Healthy: As with green in food coloring, green in packaging is also associated with healthy and organic products. With the increase in consumers being more aware of their health and what goes into their bodies, we are seeing green used in more and more product packaging.

Purple – Uniqueness: Using purple in your packaging helps to imply that your product is unique or original, and with purple being attributed to spirituality, it is often used in holistic products. It should also be noted that purple tends to be more attractive to females and the youth market, but is slowly making its way into acceptance within the male audience.

Orange – Affordability: Orange is often times used to portray value and affordability, and for food marketers, using orange on packaging helps to give the item a more affordable feel.

Black – Luxury: Black typically stands out on packaging and tends to appear heavier and more expensive, which transmits a higher perceived value. You can see this color used on items like premium ice creams and chip packages. And depending on what colors you choose to pair it with, black can give off various feelings.

Brown – Earthy: Brown tends to be used in products that want to portray a natural, wholesome or organic feel, as well as comfort and simplicity. We often see brown packaging in products that promote sustainability, proclaiming that the materials used to make the package were recycled.

White – Simple: White is viewed as simple, pure and basic, and is a good choice when attempting to create the impression of cleanliness, purity, efficiency or, of course, simplicity. And depending on the additional colors chosen to pair with white, you can give your packaging, or product, a completely different feel.

When it comes to getting your product off the shelf and into consumers’ homes, color has a lot to do with first impressions. So when deciding on packaging or even food coloring, make sure to pay close attention to the psychology behind color when it comes to purchasing behavior. Do you have additional tips on choosing colors for food items and packaging? Leave a comment below and let us know!

Expanding GMO Labeling Requirements in the U.S.

By James Cook
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In November 2014, the people of Oregon and Colorado voted for mandatory labeling of foods produced from genetically modified organisms (GMO). These initiatives from Maine, Connecticut, Vermont, and subsequently Oregon and Colorado speak of the public’s desire to know what they are eating, a mistrust of the industry, and a lack of action from the Federal government.

Currently in the U.S.. there is no Federal law that requires the labeling of GMO derived products, providing the product is not significantly different to the non-GMO product, or different in use, nutrition, or includes an unexpected allergen. However, FDA has produced voluntary labeling guidance on GMO and non-GMO. While many companies have option to label their products as non-GMO, there hasn’t been the same desire by the industry to label their products as GMO.

Unwanted events have caused the public to believe that the industry cannot be trusted and that the government is not doing everything it can to protect the public. One case involved a strain of GMO corn (Starlink) that was only approved for animal feed and fuel, because it cause a reaction in people. Unfortunately, this strain of corn did end up in the human food supply chain, causing the U.S. price of corn to plummet on the world market, and dozens of products to be recalled.

Another case involved the development of GMO wheat. T his was a product that foreign markets had no desire for. There, after field trials from 2000 to 2003, the company that created the GMO wheat dropped the project despite FDA completing its food safety consultation on it in 2004.

In 2013, this strain of GMO wheat was found growing in a field in Oregon. After extensive review, the USDA completed an investigation and published its findings on September 26, 2014, concluding that it was the same GMO variety created by the aforementioned company. The report added that the wheat had not come from local field trials, and that they were “unable to determine exactly how the GMO wheat was found growing in Montana. That investigation is still ongoing.

Oregon mandatory labeling

One of the counties of Oregon, Jackson County, has banned GMO crops. Oregon was one of the states involved in the unwanted GMO wheat event, and has voted no to changing its existing law to require the labeling of raw and packaged foods produced entirely, or partially by genetic engineering. This law would have required retailers to properly label raw product as “genetically engineered.”

Manufacturers of pre-packaged foods would have to place labels clearly and conspicuously stating “produced with genetic engineering” or “partially produced with genetic engineering” on the front or back of the package. These phrases did not have to be part of the product name, nor did the manufacturer have to identify which ingredient or ingredients are derived from genetic engineering. No company would have been subject to injunction or fines, if the pre-packaged foods have less than 0.9 percent genetic engineered materials by the total weight of the package or were unknowingly, or unintentionally, contaminated with genetically engineered material. For pre-packaged products, retails would have been only responsible for their own labeled products. This would not apply to animal feed or food served in restaurants.

Colorado Right to Know Act

A law proposed in Colorado but also not passed, dealt with labeling requirements for products derived for genetic modification. Had it been passed, it would have been effective from July 1, 2016. Its main aim was that packaged and raw agriculture products derived from GM would have to have been labelled as “produced with genetic engineering.” The exemptions from the labeling requirements were:

  • Animal food or drink,
  • Chewing gum,
  • Alcoholic beverages,
  • Food containing one or more processing aids,
  • Enzymes produced or derived from genetic engineering,
  • Food in restaurants and food produced for immediate consumption not packaged for resale,
  • Food for animals not derived from genetic engineering but fed feed or injected with a drug derived from genetic engineering, and
  • Medically prescribed food. 

Food would not have been considered misbranded if it had been produced by someone unaware that the seed or food was derived from genetic engineering, or that it was either unknowingly or unintentionally co-mingled with genetically engineering seed or food.

The Grocery Manufacturers’ Association (GMA), a major U.S. industry association that is against the individual state laws regarding GMO labeling, supports the HR 4432 Safe and Accurate Food Labeling Act introduced by the House of Representatives’ Mike Pompeo and G. K. Butterfield. This proposed law would not require products with GMO ingredients to be labelled as such, unless there are safety issues or substantial differences between them and the non-GMO ingredient, but it will set specific requirements for GMO free claims and require FDA to develop requirements for Natural claims. While this law was introduced into Congress in April 2014, it hasn’t progressed to the point that anyone believes that it will signed into law anytime soon. Vermont is still the only state to have passed an unencumbered GMO law. Currently, laws in Maine and Connecticut with there requirements still not met, will not be enacted, at least, at this time. The state of Vermont is being sued with the GMO labeling debate in the U.S. still continuing even though the European Union has required labeling of GMOs since 1997. To date, there are more than 60 countries, as well as the EU, requiring labeling of GMOs.

This article originally appeared in SGS Hot Source Food Newsletter 6. For further information, please visit www.FoodSafety.SGS.com.

Want to learn more about GMO Labeling? Register for this complimentary webinar, on April 16, 2015, which will discuss

  • Next steps for state and federal labeling laws,
  • An update on the status of the non-GMO supply chain and certification programs,
  • Where organic fits in the non-GMO discussion, and
  • What are the marketplace challenges of going non-GMO?

CAPA and Root Cause Analysis for the Food Industry

By Dr. Bob Strong
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A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

Why do a Root Cause Analysis? Because unless you identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed.

Often times, it may seem that a Correction conceived on the fly solves the nonconformity. However, manufacturing processes—especially in the food industry—can involve a huge number of variables. As a result, problems that arise can involve multiple levels of causal relationships that must be followed in order to locate the true root cause of a nonconformity. This is why performing an RCA is essential; we may think we’re addressing the root cause of a non-conformity with a Correction, but in fact, we are only treating a symptom of a larger (and often more costly) issue.

Without an RCA, it’s anyone’s guess whether a Correction will hold. The nonconformity might be solved, or it might come back—and bring with it other issues related to the root cause.In any case, guessing is not sound strategy for dealing with non-conformities. This is why it is essential for organizations to be disciplined in their approach to investigating non-conformities. Sure, performing an RCA takes time, and nobody wants to waste time on something unnecessary. Nevertheless, organizations should understand that identifying the root cause of a nonconformity early could save a great deal of time and expense in the long run. Of course, you won’t know unless you perform the RCA, so it is always a better practice to invest time into an RCA upfront rather than get exposed to a more serious nonconformity at a later date that could threaten the safety and/or quality of product being produced or handled.

Who should perform the RCA?

Though it may be possible for a single person to perform an RCA, it is always better to have a team of minds working on the problem—people who are familiar with the relevant products, processes, equipment, and challenges of the working environment. A team also brings a greater pool of experience, knowledge, and perspectives, which can be extremely helpful in the investigative process of an RCA. It also makes sense for your RCA team to be comprised of people who canhelp represent the resulting CA or PA plan to other areas of the organization and help facilitate buy-in, consensus, and execution of the plan

CAPA: The process unpacked

A new white paper, published by SAI Global Assurance Services, describes in detail the various steps involved in CAPA. Broadly, these have been described as:

  1. Identify the problem: Before you can solve the problem, you must identify it plainly and clearly.
  2. Evaluate /Review: How big is the problem? What are the implications? What is the severity of the consequences?
  3. Investigate: Make a plan to research the problem.
  4. Analyze: Identify all possible causes using different methodologies such as It is/ It is not analysis, the 5 Why’s Method, and The Fishbone Diagram
  5. The Action Plan: Narrow the list of possible causes.
  6. Implement: Execute the action plan
  7. Review: Verify and assess effectiveness

CAPA benefits

A thorough and effective CAPA provides a lot of benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections, frequency of which will be based on on the robustness of your food safety programs.

This article is an excerpt from a white paper prepared by SAI Global Assurance Services, and has been published in Food Safety Tech with permission. Click here to download the white paper in its entirety.

Paul Dewsbury, B.Sc.

Honey Laundering: Food Fraud That’s Not So Sweet

By Paul Dewsbury
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Paul Dewsbury, B.Sc.

ThermoFisherpodcastAs a result of my research, I found two fantastic resources describing the background of food fraud, the first is an excellent 3-minute podcast on our website, titled, Food Fraud by Dr. Jennifer McEntire, who at the time was VP and Chief Science Officer at The Acheson Group and is now the newly appointed VP of Science Operations at the GMA. Dr. McEntire succinctly gets to the crux of the reasons pertaining to food fraud and it is well worth a listen.

The second is a 3-minute slide deck narrated by renowned food safety expert Professor Chris Elliot, Director of the Institute of Global Food Safety at Queens University Belfast. Professor Elliot highlights the impact of various food frauds including melamine adulteration in milk, spices, meat and he specifically expands on the topic of honey laundering.

There are too many honey adulteration frauds to list here and while some have resulted in huge fines and criminal charges, there is one that will not go away is the mislabeling of Manuka honey. This premium product (and premium price) is a rare honey from New Zealand produced by bees that pollinate the manuka bush and has numerous claimed medicinal properties that can be extremely profitable for the fraudsters through substitution with a basic product. As food fraud is an international issue, various organizations likeInterpol and Europol have food fraud units and here in the UK the government has committed to, and is setting up a dedicated Food Crime Unit.

Moving into the science, one of the best literature resources I would like to share is the Food Fraud Resources website which has some highly cited articles including reviews, thought leadership and analytical methods that are available for download. There are various techniques for honey analysis in the journals and I want to briefly focus on one of the most powerful for authentication, the use of isotope analysis. In our Application Note 30177, Detection of Honey Adulteration with FlashEA Elemental Analyzer and DELTA V Isotope Ratio Mass Spectrometer, we describe a fully automated system for the detection of honey adulteration with C4-syrups according to the AOAC 998.12 guidelines and is routinely used in many laboratories.

Is honey analysis or food fraud of interest to your laboratory? If so, share your thoughts and experiences in the comments below. 

Check out Thermo Fisher’s Food Community page for more resources, on-demand webinars, videos, and application notes.

 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

What to do Now to Migrate from HACCP to HARPC

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

There is much talk about HARPC – Hazard analysis and risk-based preventive controls – and how food companies need to either elevate their existing Hazard Analysis at Critical Control Points (HACCP) program, or formulate a new HARPC-based food safety plan, in order to comply with proposed rules under the U.S. Food Safety Modernization Act in the

In a recent FSMA Fridays discussion, Dr. David Acheson and Melanie Neumann of The Acheson Group elaborated along with SafetyChain Software’s Barbara Levin, how HARPC differs from HACCP and what companies can start doing now to be prepared. We present below some excerpts.

How are HACCP and HARPC different?

The key term is that HARPC is risk –based. While HACCCP is more prescriptive, based on the seven-step process, the risk-based analysis requires moving outside of those seven steps to think of how else can I manage risk. Also, under HARPC, it’s no longer deemed sufficient to have a HACCP plan – you need to have a more exhaustive food safety plan.

How should F&B companies approach migrating HACCP to HARPC plans?

In the proposed FSMA rules, FDA has changed the language of defining how and which products should be monitored from ‘reasonably likely to occur,’ which is HACCP type terminology, to ‘significant.’ FDA is doing this in an attempt to differentiate the required HARPC-based food safety plan from traditional HACCP plans. This requires food companies to look at hazards along the whole supply chain – from when we are receiving food to when we are shipping it out (and not just at control points). For instance, environmental controls in a ready-to-eat foods processing area is covered now, which is beyond the traditional HACCP area. So look at those risks in the processing facility and ask if they are significant risks.

Who is the Qualified Individual and how does this impact the HARPC approach?

This is the million dollar question! FDA hasn’t come out with a clear definition yet – only vaguely referring to this person as ‘qualified by training or experience.’ However, this person has a lot of responsibility on their plate – they are responsible for preparing a robust food safety plan that identifies and controls risks, for putting in place corrective actions and validate these, and for doing a reanalysis of the food safety plan as needed. F&B companies need to ask if they have the right person driving this bus. You do need somebody in your business who is capable and qualified to do this, or FDA allows you to use an outside expert as the Qualified Individual.

What will FDA expect to see with HARPC when they come in to see FSMA being enforced?

Once FSMA is implemented (possibly) by August 2016, FDA inspectors can come into F&B facilities and ask to see food safety plans, and details of the HARPC plans. They would want to understand what the process is, what the hazards are, and how and if you are controlling these, and if you are thinking of these hazards from a risk-based preventive controls strategy.

What are top three things that companies should be doing to comply today?

As described often, HARPC is an evolution of HACCP or HACCP on steroids. The first thing you need to do is understand what you are being asked to do with HARPC. Make sure you get the strategy here. Step two, is to get together a team to do this to figure out where your risks are, if they are significant, and build these into food safety plan. Step 3 is look at your current systems and structure. Do you have these now identified significant risks controlled? Have you determined what the controlling steps are, and put in place these preventive controls? Ask yourself if you are controlling these risks, monitoring them, putting in place corrective actions and validating them?

Final point: we often hear people saying, ‘I am going to wait. We are going sit out and watch how the rules evolve.’ But our advice is Do Not Wait! We have a lot of insight on how the final rules are going to pan out and what the compliance requirements will be. So start working now.

For more on this discussion, click here.

Lessons Learned from the Implementation of Seafood HACCP for FSMA

By Tim Hansen
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While HACCP has been highly successful and truly promoted seafood safety and consumer confidence in these products, there are several useful lessons that may make your transition to FSMA compliance easier.

One of the tenets of FSMA is the requirement for preventive systems (AKA HACCP) for all food groups regulated by FDA. Up to the time of passage of FSMA, FDA wanted preventive systems only for seafood, fruit and vegetable juices and low-acid canned foods.

Since the requirement for preventive controls is about to be extended to all foods regulated by FDA, it may be instructive for affected food firms to consider some of the common problems experienced by the seafood industry during the implementation of HACCP. This regulation has been highly successful and truly promoted seafood safety and consumer confidence in these products. There are several useful lessons that may make your transition to compliance easier.

1. Unnecessary CCPs. Implementation of the Seafood HACCP regulation came with a great deal of uncertainty for the industry. Their response was to include a hazard as a CCP even when it did not meet the FDA “reasonably likely to occur” standard. This resulted in some cases overly complicated HACCP plans. Firms can avoid this problem through rigorous hazard analysis and following agency guidance for the commodity being processed.

2. Mixing sanitation controls with HACCP controls. The Seafood HACCP Regulation requires that certain aspects of sanitation be properly controlled, monitored and documented through records. While it is feasible to include these controls within the HACCP plan it is much simpler keep sanitation controls separate from HACCP controls. A sanitation SOP is highly recommended that show how sanitation is controlled, monitored and recorded.

3. Monitoring need to be available in their original form in an organized fashion. Inadequate or poorly organized monitoring records were a big problem. Ideally, records should not be rewritten unless absolutely necessary. Rewritten records are a red flag to FDA investigators. If records are missing do not falsify information to fill the gaps. This could be the basis for a severe regulatory action. It is much better to perform a verification review and corrective action that is available to the investigator.

4. If a new product is introduced to your processing operation the HACCP plan should be amended immediately. Do not wait until a convenient time as a regulator could show up at any time. Also, do not assume that the hazard analysis and HACCP plan for a similar product will be the same. Either can result in a finding of failure to have a HACCP plan. You should start at the beginning with a proper hazard analysis and develop the plan for that product in accordance with the hazards you identify.

5. Scientific studies used to establish a critical limit for a CCP should be readily available to the investigator. For example, a study to show the necessary heat penetration time-temperature parameters of a cooked product to achieve sufficient bacterial kill or the proper mix of salt, water and exposure time to achieve a proper level of water phase salts in a cold smoked fish products are important information for the investigator to evaluate whether the critical limit of a CCP is adequate to control the hazard.

6. Generic HACCP plans should not be used. In the past some operations adopted a generic HACCP plan to cover their processing without performing a hazard analysis. This often resulted in hazards being missed and a faulty plan. FDA expects that each firm will conduct a hazard analysis. Not doing so could result in a serious charge.

This article originally appeared in EAS-e-News, March 2015 edition. 

 

Getting Ready for FSMA: How a Laboratory Information Management System Can Help

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Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required by FSMA.

Do you know where your food comes from? How sure are you that it was grown, processed or produced with your safety as the priority? Increasingly this issue is headline news as we struggle with managing the outbreak of food-borne illnesses caused by the very stuff of our daily lives: salmonella contaminated peanut butter; e-coli contaminated beef and pork; contaminated spinach, lettuce and strawberries; melamine in milk.

In each instance, the grower or producer had inadequate methods in place to trace the original source of the contamination. The Mexican tomato business was devastated in 2009 when tomatoes were wrongly blamed for an outbreak of salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to know the contamination source. Several people died, many more became ill and a major business was destroyed for lack of information. The ultimate price for those food producers is that not only have they lost revenue due to product recalls, but, more importantly, they have also lost the trust of the buying public – and governments around the world have taken notice.

In the United States, the oversight of food had fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fell under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contained a combination of meat, dairy and produce fell under the oversight of the Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections had been low compared to the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public.

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The result of this legislation for consumers should be greater safety of their grown and produced foods. The impact for food producers will be mandates for upgraded business and operations plans, investments in instrumentation, software and manpower, and a safer food supply chain. This white paper discusses how to respond to FSMA, the role that traceability plays in it, and how leading food producers have implemented best practice solutions.

Employing a LIMS to meet the demanding FSMA requirements

The most important common thread throughout the FSMA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:

  • Automated data collection from testing and delivering the records of proof that are required for regulatory compliance;
  • A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;
  • A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;
  • Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation; and
  • Assurance that all (standard, fast turnaround and condition sensitive) samples are handled and processed correctly.

Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording that data for any subsequent inspection. Auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS whenever required to confirm consumer safety.

Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning systems.

For some food testing laboratories, commercial LIMS have been too costly for the business to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. The new legislation will put enormous strain on these labs to remain compliant. Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required of the FSMA.

Case Studies: LIMS providing traceability for food worldwide

Chr. Hansen is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in the United States, Denmark, France and Germany to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data, and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system, so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities technicians and laboratory administrators.

Molkerei Alois Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production Quality Control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller UK selected Thermo Scientific LIMS to manage their QC data for raw materials, in -process, and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.

Sino Analytica in Qingdao City, China is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies, and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements for food exports to countries including the United States. The LIMS has helped laboratory managers achieve faster assembly, collation, and review of information and data relating to QA/QC activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.

This article has been adapted from a white paper presented by Thermo Fisher Scientific. Click here to access the white paper. For More Information about Thermo Scientific informatics solutions for the food and beverage industry, visit: www.thermoscientific.com/foodsafetyresources.

Millennials Are Changing the Food Industry

By Chelsey Davis
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Millennials are definitely changing the landscape of the food industry. What do they care about when it comes to food, and what does this mean for food manufacturers?

TraceGains_Millennials1

We’ve all heard the latest trends regarding that hard-to-reach audience we’ve dubbed the Millennials (those born roughly between the years 1980 and the early 2000s). And with so many how-to articles out there, it’s hard to really understand who these folks are and what they want. Here are just a few fun facts about this generation: 50 percent consider themselves politically unaffiliated, they have the highest average number of Facebook friends, 55 percent have posted a selfie or two to social media sites, and there are roughly 80 million of them. This makes Millennials the biggest generation thus far. And one thing is for certain, based on research, they are definitely changing the landscape of the food industry. So what do Millennials care about when it comes to food?

Millennials care about quality and sustainability

According to a 2014 study by the International Food Council (IFC), Millennials have the highest level of awareness out of any age group when it comes to food sustainability, and they are willing to pay more for it. And when it comes to quality vs. price, Millennials are more apt to be loyal to a brand deemed to have quality products as opposed to a brand that has a better price point.

Quality versus price for Millennials (Image courtesy of Bushiness Insider via Goldman Sachs)
Quality versus price for Millennials (Image courtesy of Business Insider via Goldman Sachs)

Take McDonald’s for example. In August of 2013, the fast-food chain reported a 13 percent decline in consumption for people between the ages of 19-21 since 2011. And while Millennials are still dinning out, they are opting for franchises like Chipotle and Five Guys. Why? These chains pride themselves on using local producers and sustainable food items, which makes paying that extra $2.00 for guacamole not so bad to this generation.

Additionally, Millennials are more apt to choose products that are socially responsible and produce lower carbon footprints. For example, Millennials are now paying attention to how much energy, water and effort it takes to grow, manufacture and transport food, including the packaging process. And as this environmentally friendly generation matures and moves into prime spending age, manufacturers will need to evolve the packaging of food products to ensure they are created with eco-friendly and recyclable materials if they wish to appeal to these folks.

Millennials care about their health

This generation, as research states, is more aware of their health than any other generation thus far, especially when it comes to what goes into their bodies. Locally grown, cage-free, all-natural, organic—these are all terms Millennials tend to gravitate towards when making food choices. As a result, organic coffee shops are popping up everywhere, farm-to-table restaurants are all the rage, and even private label brands are seeing increases in sales, with Millennials opting for those over national brands due to the perception that these labels are more innovative.

Millennials are also reading labels and are more aware of what the items on the labels mean—they understand the ingredients and what goes into their food more so than their parents and grandparents. As a result, we’re seeing an increase in natural and organic claims as we navigate through the grocery aisles.

Graphic showing wellness stats for Millennials (Image courtesy of Bushiness Insider via Goldman Sachs)
Graphic showing wellness stats for Millennials
(Image courtesy of Bushiness Insider via Goldman Sachs)

What this means for food manufacturers

Food manufacturers have an interesting challenge ahead, but also a great opportunity. The ones that will ultimately gain popularity among Millennials will be those that are willing to innovate while staying authentic. Millennials not only value the transparency of brands, they are also aware of shortcomings when it comes to unsubstantiated claims. Food manufacturers must now walk the line between making all-natural and sustainable product claims, and being 100 percent truthful in their statements. When it comes down to it, Millennials will do the research, read the labels and uncover the truth.

So how do you appeal to Millennials, while also mitigating the risks when it comes to labeling your product natural, organic or GMO-free? To answer tough questions like this, TraceGains got the inside scoop from Attorney Antonio Gallegos, who advises on compliance with regulations administered by the FDA, FTC, USDA and similar state-level agencies, and co-produced a guidance report. Use this free Natural Labeling Guidance Report to help you make informed decisions in the future for your products. Do you have additional tips for reaching Millennials? Leave a comment below and let us know!

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Implementing an Effective Listeria Control Plan for Dairy Products

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In the last three years, there have been four major foodborne illness outbreaks caused by Listeria monocytogenes in dairy products (Oasis fresh curd cheese; Roos raw hard cheese; Crave Brothers pasteurized farmstead cheese; and Frescolina Marte pasteurized ricotta cheese). Before 2012, there have been multiple outbreaks due to raw and pasteurized Mexican-style soft cheeses and in pasteurized milk in 2007.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology LaboratoriesDr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories , recently spoke about Implementing an effective Listeria control plan for Dairy Products in a recent presentation. He described the pathogen as “a gram-positive bacteria, which is facultatively anaerobic, psychotrophic (can even multiply at refrigeration temperatures – though at slower rates), sensitive to heat processing, even found in healthy cows, raw milk and dairy processing environments, and can survive most cheese ripening processes.”

Though, listeriosis, the infection caused when a person is infected with LM, is relatively rare – only affecting about 1600 individuals a year – it has a high mortality rate, highest among foodborne illnesses, especially among high-risk individuals.

Dr. Marshall listed some of the contributing factors to a LM outbreak:

  • Inadequate thermal processing
  • Refrigeration temperature being too high
  • Inadequate product flow through processing plant
  • Inadequate personal hygiene
  • Product shelf-life too long
  • Inadequate cleaning and sanitation
  • Inadequate environmental monitoring and control
  • Inadequate end product testing

Thermal processing is a time-temperature process, and it can be inadequate if either the temperature is too low, or the process time is too short.

It is common knowledge that whether it’s during transportation, or at retail or at homes, often temperature of food storage is not adequately maintained. Dr. Marshall said that as high as 55 percent of household units and 32 of retail store units had refrigeration temperatures of greater than 9 °C. “And once you get past that temperature threshold of 10 °C, the bacteria reaches maximum population level within six days (average shelf life).”

Inadequate cleaning & sanitation is another major cause for LM contamination and this is often the battle between production & sanitation. Floor drains are a common culprit, responsible for 63 percent incidence of LM. Dr. Marshall also referred to other sources of inoculation that you are not getting effective control of such as filler heads and high pressure water sprays or air sprays, which can aerosolize bacteria and spread the contamination to other surfaces.

Inadequate product flow is usually due to the failure to segregate pasteurized product form raw product or the failure to segregate employees working in raw vs. pasteurized locations. Address this by mapping out product and employee flow (along with equipment) and look for areas where cross contamination can occur, advises Dr. Marshall, who cautions facilities to monitor and control the following direct food contact surfaces that can be cross-contaminated:

  • Fillers
  • Packaging stems
  • Conveyors
  • Chilling solutions
  • Slicers, dicers, shredders, blenders, hoops, molds
  • Collators, assemblers
  • Product movement items, such as racks, bins, tubs and buckets
  • Spiral coolers, blast freezers
  • Hand tools, gloves, aprons

Inadequate personal hygiene is another contributing factor and this can include clothing such as outerwear and gloves. Maintenance personnel should be thorough in their hand-washing and it’s recommended they use alcohol based wipes after hand-washing.

Address the issue of shelf-life being too long by determining the shelf life based on food safety, and not food quality. Also, run LM challenge test in each product, Dr. Marshall advises.

Eurofins-LM-in-Dairy-webinar-March2015

FDA, in their Preventive Controls rule proposed under the Food Safety Modernization Act, has a section on Environmental Monitoring, based on the rationale that that poor control of the environment can lead to LM cross contamination of finished product, explains Dr. Marshall, adding that inadequate environmental monitoring and control is a key component for LM contamination.

“Invest your testing dollars to find hot spots in your facility and ensure the control mechanisms are working every day,” he says, asking companies to “detect and control hot spots, measure effectiveness of general cleaning and sanitation programs, and test for Listeria species.”

Dr. Marshall asks, “If I were LM and wanted to hide, where would that be? Would it be on an easy to clean surface such as the floor, or would it be in a nook or cranny where it’s hard to reach and clean?” He lists the following as areas that commonly harbor the pathogen and advises extra caution and creativity to clean these spots:

  • Equipment framework – nuts, bolts, open tubing, spot welds
  • Floors and drains – standing water
  • Walls
  • Ceilings, overhead equipment, catwalks, pipes
  • Condensate
  • Exposed, wet insulation around pipes and walls
  • Fork lifts, trolleys
  • Cleaning tools – sponges, brushes, scrubbers
  • Maintenance tools
  • Conveyors, belts and rollers (need to be broken down and cleaned regularly)
  • Control panels and switches
  • Rubber seals (especially if they have cracks)
  • Trash cans
  • Air fillers
  • Motor/ pump housings
  • Cracked hoses
  • Ice makers

End product testing is an effective way for testing for LM, but Dr. Marshall points out that there are often arguments against this. “Companies often argue that their HACCP plan is working, their kill step is effective and that they have a history of doing end product testing, and they haven’t had any positive results so far. But this is not a convincing enough argument.” End product testing can address the failure to monitor and control high risk ingredients, and is very useful to detect gross contamination events. It should be used to assess risk of rework, and also test for LM, not just Listeria, Dr. Marshall advises.

Hear more about building an effective control plan for Listeria in your dairy processing environment, by listening to this archived webinar recording, presented by Eurofins.