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FDA Report on E. Coli Outbreak in Romaine Lettuce Points to “Significant” Finding of Strain in Sediment of Water Reservoir

By Maria Fontanazza
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The November 2018 outbreak of E.coli O157:H7 infections linked to romaine lettuce caused 62 illnesses across 16 states. The FDA zeroed in on the Central Coast growing regions of northern and Central California as being responsible for the contamination. The outbreak was declared over on January 9 and yesterday FDA released the report, “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”, which provides an overview of the investigation.

The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.

“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.

(left to right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Greens Marketing Agreement discuss the first E.coli outbreak involving romaine lettuce during a panel at the 2018 Food Safety Consortium. Read the article about the discussion.

Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.

The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.

Although FDA did not directly name the farm in the report, it provided a link about the recall that was initiated by the farm, Adam Bros. Farming, Inc., in December.

Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:

For growers:

  • Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
  • Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
  • Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
  • Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
  • Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce

For the broader industry:

  • The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
  • All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
  • The adoption of best practices in supply chain traceability

Resources

  1. FDA report: “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”
  2. FDA statement from Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas
  3.  FDA investigation of source of E.coli O157:H7 outbreak linked to romaine lettuce
Karen Everstine, Decernis
Food Fraud Quick Bites

How Food Fraud Happens

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

The food industry has been hard at work over the past few years implementing food fraud mitigation plans in response to Global Food Safety Initiative (GFSI) certification program requirements. GFSI defines food fraud as:

“A collective term encompassing the deliberate and intentional substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, labelling, product information or false or misleading statements made about a product for economic gain that could impact consumer health.” (GFSI Benchmarking Requirements, 2017)

GFSI then further defines the terminology of food fraud by citing seven categories (shown in the following diagram).

GFSI, Food Fraud
Used with permission from GFSI

In the Food Fraud Database, we categorize food fraud records using the following terminology (with examples):

  • Dilution/substitution
    • Substitution of an entire fish fillet or partial dilution of olive oil with another oil
  • Artificial enhancement
    • Addition of melamine to artificially increase the apparent protein content of milk or the addition of coloring agents to spices
  • Use of undeclared, unapproved, or banned biocides
    • The use of chloramphenicol in honeybee populations (where not permitted) or the addition of hydrogen peroxide to milk
  • Removal of authentic constituents
    • The sale of “spent” spice powder (used in the production of an oleoresin) as a whole spice powder
  • Misrepresentation of nutritional value
    • Infant formula that does not contain the required nutritional content
  • Fraudulent labeling claims
    • Misrepresentation of label attributes related to production method (organic, kosher, halal, etc.)
  • Formulation of an entirely fraudulent product (using multiple adulterants and methods)
    • The sale of “100% apple juice” that consists of sugar, water, malic acid, flavor, and color
  • Other
    • This includes counterfeits, theft, overruns, etc.

Harmonization of food fraud terminology is frequently discussed, so I thought it might be useful to provide information on how our definitions relate to the GFSI terminology:

GFSI category “Dilution”: This category maps directly to our category dilution/substitution. The reason we combine these into one category is that the intent is the same: To replace the weight or volume of a product. This can occur either through partial or full substitution of a liquid product, a granulated product, or swapping an entire intact product such as a fish filet. One of the GFSI examples for substitution is “sunflower oil partially substituted with mineral oil”, which could just as accurately be described as dilution.

GFSI category “Substitution”: As noted above, this category maps directly to our category dilution/substitution. However, we would not consider the use of hydrolyzed leather protein in milk (one of the cited examples) to be dilution/substitution because it is not used to replace weight or volume. We would view that as artificial enhancement of the protein content of milk.

GFSI category “Concealment”: We do not include a category focused on concealment because all food fraud involves concealing some aspect of the true contents of the food. One of the examples cited in this category is “poultry injected with hormones to conceal disease.” The use of antibiotics, anti-fungal agents or other substances to reduce bacterial load or mask deterioration would be classified, in our system, as the use of undeclared, unapproved or banned biocides. The use of coloring agents on fruit to improve appearance would also be classified as artificial enhancement.

GFSI category “Mislabeling”: Since all food fraud is, to some extent, mislabeling, we reserve the use of the term fraudulent labeling claims to those label attributes that describe production processes (organic, kosher, etc.). With the exception of falsification of expiration dates, the other examples cited would not be classified by us as mislabeling. The sale of Japanese star anise, which is potentially toxic, as Chinese star anise (a different species) is dilution/substitution and a health risk to consumers. The sale of cooking oil that has been recovered from waste streams and illegally produced is also a form of substitution that poses a potential health risk to consumers.

GFSI category “Unapproved enhancements”: This GFSI category aligns nicely with our category artificial enhancement, and both examples cited are nicely illustrative of the concept, which involves the fraudulent addition of a substance specifically for its function (not as a replacement for weight or volume).

GFSI Category “Gray market production/theft/diversion”: The production and sale of food products through unregulated channels would all be classified in our category called other. Because these forms of food fraud involve the sale of food outside of regulatory control, prevention measures will generally be substantially different from the prevention of fraud within legitimate supply chains.

GFSI Category Counterfeiting: This GFSI category is similar to the gray market production/theft/diversion category in that it involves intellectual property infringement and production outside of regulatory control. It would similarly be classified in our other category.

Megan Nichols
Retail Food Safety Forum

How Can We Make Food Labeling More Consistent?

By Megan Ray Nichols
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Megan Nichols

Consistent Inconsistencies

Current food labels may seem to possess a wealth of information, but they’re often challenging to read even if you know what you’re looking for. Additionally, studies have shown that even accurate food labels don’t work —they lead to no significant dietary changes. Even posting the calorie counts on fast food menus did little to change people’s eating habits.

It might sound as simple as telling consumers to read the ingredients labels on the items that they’re purchasing. The problem with this—aside from the fact that ingredients are often printed in a painfully small font—is that you almost need a degree in chemistry to understand the components. This confusion is a big issue with processed foods that contain a variety of chemicals to protect the flavor of the food and preserve it during storage.

When it comes down to it, choosing healthy foods isn’t the problem—or at least, not the only problem. Picking a healthy option isn’t as complicated as doing your taxes or choosing a mortgage when you purchase a home. We as consumers have plenty of information available to us when it comes to eating healthy. The problem is the fact that it’s easier and usually cheaper to choose the unhealthy option. You can buy a can of soda for $0.50, while a bottle of water often costs more than $1 at a soda machine or convenience store.

No One Reads Them Anymore

Another big issue with nutrition labels is that no one bothers to read them anymore. One survey found that two-thirds of young adults in the Minneapolis-St. Paul area don’t bother reading nutrition labels or worry about the nutrition content of what they’re eating.

While the survey didn’t explore why adults were no longer utilizing nutrition labeling, it’s likely due to a combination of consumer distrust and confusion. People either don’t trust that the labels contain accurate information, or they’re merely confused by the information presented in that format.

The Healthwashing Dilemma

How many times have you walked into the grocery store and chosen a brand based on whether or not it had “All-Natural” or “Organic” labels? Even if these phrases are written on the label, that doesn’t necessarily mean that the food contained within falls under either of those categories. That’s where the problem of healthwashing occurs.

Food packages will slap these labels on their product even if it doesn’t apply—a company can claim that their product is “all natural” and still use pesticides on it. Some businesses use products like pyrethrins, which are potentially dangerous pesticides derived from natural sources—specifically, the chrysanthemum flower.

Food companies don’t typically like to advertise this information because it might discourage potential consumers from choosing their brand, especially if the user is concerned about their health and is trying to remove all chemicals and pesticides from their food chain.

Fixing the Labeling Problem

What can we do to encourage consumers to pay attention to nutrition labels? The biggest challenge lies in making these labels more consistent and transparent. That task is more complicated than it sounds since there is no regulation or standardization in nutrition labeling. Clean labeling could be the solution.

Five key facets define clean labels — Simple ingredients lists, transparency in ingredients and packaging, no flowery language, accurate images and fresh food—are top priorities for consumers, with transparency being in the highest demand. However, these labels face the same problems as current nutrition labels—a lack of standardization. When asking more than 27,000 people in 31 countries what they thought clean labeling meant, more than a third had no idea, according to a report from Packaged Facts.

Many companies have started to transition to clean labels, but no law currently requires businesses to do so.

The Need for Change in Food Labeling Consistency

Food labeling could potentially help consumers make healthier choices if they were more accurate and easier to understand. Eliminating the flowery language that currently defines food labeling is one step in the right direction. The federal government— or, more specifically, the FDA— may need to step in as well to create standards that each company can be held to so that consumers know what exactly is in their food, no matter the brand.

Food labels are on nearly everything that we buy, except for fresh meat and produce. It’s time to create a standard and transparent label that everyone can understand.

Karen Everstine, Decernis
Food Fraud Quick Bites

“Natural Flavor” Claims

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

The company that produces the very popular flavored sparkling water brand LaCroix is facing a class action lawsuit that alleges false claims of the product being “all natural.” The suit alleges that certain flavor chemicals used in the beverage are, in fact, artificial ingredients. These flavor chemicals include limonene, linalyl propionate (linalool propionate), linalool and ethyl butyrate (ethyl butanoate). While these flavor chemicals can be synthesized, they are naturally occurring chemical constituents and can therefore be derived from natural sources.

The safety of the beverages is not at issue; this is a labeling question. The suit states that linalool is “used in cockroach insecticide,” which is inflammatory and misleading. Chemical compounds, including those used as food ingredients, naturally have multiple applications and this does not have any bearing on the question of whether they are safe to use in foods.

Presumably, the labeling issue of whether these flavor chemicals were naturally or synthetically derived will be addressed as the suit progresses. This suit does, however, highlight some of the challenges we have in tracking food fraud information related to flavors.

Flavors are big business. Appealing flavors enabled LaCroix to make unsweetened sparkling water explode in popularity. If you have been on the Institute of Food Technologists Annual Meeting expo floor, you have seen the prominent displays and creative food samples offered up by the big flavor houses. It is a competitive business and very proprietary. The FDA labeling requirements for flavors allow them to be listed generally as “spice,” “natural flavor,” or “artificial flavor” (or a combination of those). This makes tracking and standardizing public records of food fraud related to flavors challenging.

Our data includes more than 60 of food fraud related to flavors represented as “natural.” Most of these records are linked to vanilla extract or various essential oils. However, we have also captured a handful of records that address misrepresentation of synthetic flavor chemicals as naturally-derived. This includes records for linalool and ethyl butyrate, among others such as vanillin and linalyl acetate. However, none of these records describe publicly reported incidents of fraud for naturally-derived flavor chemicals. The records are based on peer-reviewed publications aimed at method development for authentication of natural flavors.

Added value claims such as “natural” tend to increase food fraud risk because the costs of production can be so much higher. While an ingredient like vanilla extract is certainly one example of this, we do not tend to see the same level of evidence of food fraud potential for naturally-derived flavor chemicals in public records. When our users need to conduct a food fraud vulnerability assessment for a natural flavor that is a proprietary blend of flavor chemicals, we suggest that they incorporate information from the entire natural flavors group into their assessment. Given the proprietary nature of flavor blends and FDA labeling requirements, it is not feasible for us to track every individual flavor blend in our database.

Fortunately, given the importance of flavors to the food industry, flavor companies have a vested interest in preserving their client relationships and public reputation by ensuring flavors labeled as “natural” qualify for that label claim.

Resources

  1. The Decernis Food Fraud Database is a continuously updated collection of food fraud records curated specifically to support vulnerability assessments. Information is gathered from the scientific literature, regulatory reports, media publications, judicial records, and trade associations from around the world and is searchable by ingredient, adulterant, country, and hazard classification.
Jessia Burke, Allergen Control Group
Allergen Alley

Allergen Detection & Control: Challenges & Strategies

By Jessica Burke
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Jessia Burke, Allergen Control Group

While global market demand for “free-from” food products is increasing, undeclared and mislabelled allergens, sulphites and gluten, throughout the supply chain, continue to be the number one cause of consumer product recalls. This is of major concern since the number of individuals affected by life-threatening allergies is on the rise, especially in children. Unfortunately, there is no cure for a food allergy; avoidance of allergenic food(s) is the only way to prevent an allergic reaction.

It is clear that allergen recalls negatively affect the consumer, however, they also result in huge financial implications and loss of brand credibility to all organizations involved. Businesses and brands may take a significant hit to their reputation since consumer perception plays a key role in the success of a business. With the increased use of the internet and social media, it is even more important to stay out of the spotlight and avoid recalls.

Among the reasons allergens hold the #1 position for product recalls may be lack of knowledge, insufficient supplier and raw material information, packaging errors, and accidental cross-contact. Cross-contact may be the result of poor cleaning practices, inadequate handling and storage procedures, employee traffic, and improper identification and assessments of risks. In addition, from a regulatory perspective, priority allergen lists and ingredient labeling laws vary from country to country, causing confusion for both manufacturers and consumers.

The good news is, implementing a strong allergen control plan can help to prevent recalls, protecting consumers and your business.

It starts with conducting a thorough risk assessment of each step in your process to determine where procedures and controls need to be implemented. A process flow diagram is very useful in understanding where allergenic ingredients and foods exist in the plant and where they are introduced into the process.

Control measures must be implemented even before raw materials enter the facility. The importance of understanding the incoming ingredients, inputs and suppliers cannot be overstated. The allergen status of every raw material handled or present in a food business needs to be identified and effective risk assessment tools applied. This involves identifying and documenting the food allergens present in each raw material, including non-food items like maintenance and cleaning chemicals. It’s imperative to recognize suppliers and backup suppliers’ vulnerabilities to ensure the success of the program. This should include identifying all allergens handled in the facility, as this might not be obvious based on ingredient declarations or product specification documents. Ensure supplier ingredient specification documents are current and routinely reviewed so accurate assessments can be made about the level of allergen risk.

Ensure there is segregation of allergenic foods or ingredients at every step of the process, from receiving raw materials through to shipping finished product. It is important to review labels at receiving to confirm the allergen status of raw materials. This serves as verification that ingredients have not been modified and the allergen status is still accurate. It also provides the basis upon which to determine storage and handling requirements. Visual tools are great for displaying the allergen status of each raw material. This can be done through applying color coded stickers or tape, unique tags or some other method, and should be done immediately at receiving. To avoid the potential for cross contamination from one ingredient to another, each allergen and/or group of allergens should have its own designated storage area or space. In addition, never store allergenic ingredients above ingredients that do not contain the same allergen.

Ensure there is segregation of allergenic foods or ingredients at every step of the process, from receiving raw materials through to shipping finished product. (Shutterstock image)

Controlling allergen risk throughout processing can be a major challenge since there are so many opportunities for cross contact. Ideally, physically segregate production of foods containing allergens from the production of non-allergenic foods. When physical segregation is not possible, dedicated production lines and equipment is best practice. Barring this, scheduling production runs appropriately can reduce the risk of cross contact and minimize sanitation and changeover activities. Where possible, schedule non-allergenic production before processing allergen-containing products. In addition, dedicate and identify tools and utensils for allergenic ingredients and products. Providing a visual aide can help ensure appropriate practices, and one way to do this is through color coding. Similarly, use dedicated employees on non-allergenic production lines and/or allergenic production lines. Make the employees easy to identify by implementing colored uniforms, hairnets or smocks. Identify allergenic materials by labelling or color coding throughout the manufacturing process. This should include rework, which should only be added to work in progress containing the same allergens.

Control of allergens does not stop at processing; the Maintenance department also plays a big role. Sanitary design needs to be considered when purchasing any piece of equipment. The equipment must be easily and fully washable to ensure proper sanitation. Positioning of equipment is also important in terms of cleanability and the potential of cross contact from an allergenic production line to a non-allergenic production line. Airflow and the potential for contamination of air borne allergenic dust to non-allergenic ingredients, products and equipment also should to be considered. Lastly, maintenance procedures must be put in place to prevent cross contact. This includes processes for repairing or maintaining equipment, cleaning tools and changing work apparel between repairs, as appropriate.

Consumers rely heavily on ingredient declarations and allergen statements on packaging to make purchasing decisions. “For those living with the medical condition of food allergy, the simple act of eating is complicated; avoiding their allergen is the only tool they have to manage the risk of a potential allergic reaction. These consumers require accurate labeling information to help them stay safe while still having sufficient food choices,” states Jennifer Gerdts, executive director at Food Allergy Canada. As such, it is imperative that the information on finished product labels and packaging is accurate. A solid allergen control program includes processes for reviewing labels for new and modified products to ensure they are reflective of the ingredients in the product. Labels and packaging should also be verified for accuracy prior to receipt, and at the beginning of a production run or at changeover. Outdated labels and packaging should be discarded immediately to prevent the chance of accidental usage. Inventory control procedures and label/packaging reconciliation is imperative to ensure the correct labels/packaging have been applied to the appropriate finished product.

It is crucial to develop and implement robust procedures for effectively cleaning equipment, utensils, food contact surfaces and non-food contact surfaces. This must include cleaning between batches of allergenic and non-allergenic production and responding to allergen spills. Carefully consider the tools and cleaning chemicals used for each the task, as this can make a significant difference in the success of the sanitation program. Verification and validation of cleaning practices must be undertaken to confirm that cleaning activities are effective in removing the allergens in the facility. This can be done through visual inspections, swabbing after sanitation and trending results.

One of the most important tools for ensuring the success of any allergen control program is educated employees. All foods handlers, regardless of their position, should undertake training in food allergens. Employees are the eyes and ears of the plant floor, the more knowledgeable they are, the more likely proper procedures will be followed, and potential risks identified.

Complete regular reviews of the allergen management program to ensure that it remains current, effective, and continues to assist in the production of a safe and legal food product. The program should be reviewed, at a minimum, whenever a customer complaint is received regarding allergic reactions, there is a change to raw materials or suppliers, there is a change in manufacturing processes, there has been an introduction of new machinery, or there is a change to cleaning practices and procedures.

An important aspect of an allergen control program is allergen testing. Testing can be used to confirm the allergen status of raw materials at receipt, to verify cleaning processes, and to evaluate finished products. An array of test methods exist for this purpose, including but not limited to, immunochemical methods such as ELISA or lateral flow devices, DNA-based methods, such as Polymerase Chain Reaction (PCR), Mass spectrometry (MS), and other non-specific methods such as Protein tests, ATP and visual inspection to verify cleaning. The choice of test method is very important and depends on the purpose of the test, the type of sample, food matrix, processing effects, desired turn-around time, availability of equipment, skill level of person doing the analysis and cost. ELISA and lateral flow devices are often used on-site at the production facility because results can be obtained quickly, costs are relatively low, and personnel can be easily trained to use these tests. In some circumstances of highly processed samples, PCR may be a better choice. However, PCR testing requires specialized equipment and skilled technicians so is usually performed in a third-party testing lab. Mass spectrometry is yet another option but can be costly and like PCR, this method requires specialized equipment and skilled personnel to perform the analysis.

As you can see, there are many factors to consider when developing an effective allergen control program. While it may seem daunting, it is critical understand how to identify and assess all allergen risks and develop a plan to control, verify and validate each one. The upfront work may be challenging, however once implemented, an effective allergen control program will protect allergenic consumers from the potentially life-threatening effects of inadvertently consuming and allergenic product, and will protect your business from financial loss and a tainted brand reputation.

Karen Everstine, Decernis
Food Fraud Quick Bites

A Look at Fraudulent Labeling Practices

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

Food fraud happens in many ways, and it can be challenging to categorize the various methods of fraud. Dilution and/or substitution involves the intentional addition of an alternate product with the intent to replace weight or volume (olive oil, juices and fish are prone to this type of fraud). Artificial enhancement is the addition of a substance that is not intended to replace weight or volume, but to have a functional effect (such as the use of industrial dyes in spices). Certain forms of food fraud, such as theft/resale, counterfeit packaging, or overruns may not involve the addition of alternate ingredients. However, as customers and consumers, we would be taking a risk to trust the safety of any foods that are intentionally misrepresented.

Food Fraud
Categories of methods by which food fraud happens (as defined in the Food Fraud Database1). Graphic courtesy of Decernis

While all forms of fraud can be considered “mislabeling” in one way or another, we consider fraudulent labeling claims to be defined as misrepresentation of a label attribute that implies a particular production technique. Examples include representing non-organic products as organically produced, the sale of foods as halal that do not meet the appropriate standards, changing poultry expiration dates, and labeling products such as eggs and Iberian ham as “free range.” In 2017, a company in Canada was fined for selling falsely labeled kosher cheese. More recently, in Malaysia, millions of products were seized based on the use of fraudulent halal labels.

We have compiled more than 300 records of food fraud involving the use of fraudulent labeling claims. The most common fraudulent claims identified in our records are shown in the chart below.

Fraudulent labeling claims
Fraudulent labeling claims based on records reported in the Food Fraud Database.1

Consumer interest in organic foods is increasing and NSF cites “added value claims” such as organic and free range as one of the important factors driving food fraud risk.2 There continues to be a need for robust analytical tools for the authentication of organic foods. However, recent research has indicated it may be unlikely that authentication of these food products can be can be achieved by a single analytical method or the measurement of a single marker.3,4 Given the technical complexity and cost of ensuring the authenticity of organic label claims through analytical testing, preventing this type of food fraud also requires strong supply chain management and trustworthy supplier relationships along with effective auditing programs.

References

  1. The Decernis Food Fraud Database is a continuously updated collection of food fraud records curated specifically to support vulnerability assessments. Information is gathered from the scientific literature, regulatory reports, media publications, judicial records, and trade associations from around the world and is searchable by ingredient, adulterant, country, and hazard classification.
  2. NSF, “Risk Modelling Of Food Fraud Motivation – ‘NSF Fraud Protection Model’ Intelligent Risk Model Scoping Project FS 246004.” (2014). Retrieved from https://www.food.gov.uk/sites/default/files/media/document/NSF%20Final%20report.pdf.
  3. Inacio, CT and Chalk, PM. (January 2017) Principles and limitations of stable isotopes in differentiating organic and conventional foodstuffs: 2. Animal products. Crit Rev Food Sci Nutr.. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25849871
  4. Capuano, E., et al. (September 11, 2012). Analytical authentication of organic products: an overview of markers. Journal of the Science of Food and Agriculture. (Vol. 93) No. 1. https://doi.org/10.1002/jsfa.5914
Gabriela Lopez, 3M Food Safety
Allergen Alley

Establishing an Effective Food Allergen Control Plan

By Gabriela Lopez-Velasco, Ph.D.
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Gabriela Lopez, 3M Food Safety

It’s nearly 2019: Do you know where your allergen control plan is? The need for food manufacturers to have a clearly defined allergen control plan in place has never been more essential. Today, as food allergies are a growing health problem around the world to both children and adults, control measures to prevent food allergenic reactions simply must be established and enforced within the food manufacturing environment.

How did we arrive here? After all, it wasn’t that long ago that the approach to prevent an allergic reaction caused by a particular food relied on avoidance of the consumption of that food by reading product labels. Allergic individuals would merely rely on the information provided on the label to determine whether the ingredients include a food that may be a source of a potential allergen.

That approach started to become more stringent in January 2006 when the Food Allergen Labeling and Consumer Protection Act (FALCPA) took effect in the United States. The law requires that food labels specifically and clearly declare the presence of what is commonly referred to as the Big 8 Food Allergens: Milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat and soy. (Outside the United States, the European Union, Canada, New Zealand, Japan and other countries have similar requirements for these and other known food allergens.) Despite U.S. law now requiring the declaration of allergens on food labels, estimates of food recalls due to mislabeling is at more than 40% in the United States—alarming evidence for the need for a strong and structured allergen control plan. According to the USDA, the number of recalls due to undeclared allergens and ingredients considered a public concern increased from 13% in 2008 to 35% in 2012. The most common causes of recalls stem from changes in product formulation, changes in supplier’s ingredient formulation, regulatory inspections or consumer complaints.

So, what should today’s food manufacturers do? They must declare any allergens in their food to consumers, and they should follow Good Manufacturing Practices (GMP) and keep ingredients segregated within the plant. However, with increased food demand, this is more challenging than ever. As more food and food varieties are produced, the practice of sharing lines for allergen-containing and allergen-free foods is now commonplace. If a company shares production lines within its plant, then it needs to take steps to minimize the risk of cross contact and the unintentional addition of allergens during food production.

The FSMA final rule for Preventive Controls for Human Foods requires facilities to have a food safety plan in place that should consider a risk-based analysis of hazards and preventive controls to minimize or eliminate chemical, physical and biological hazards in the food supply chain. Within these preventive controls, food allergen controls should be in place as written and implemented procedures to control cross contact and ensure proper labeling.

For food and beverage manufacturers looking to establish a food allergen control plan, there are three key steps:

  1. Risk Assessment: Is there a chance that unintentional allergens could be present in the food or manufacturing equipment in your plant? Risk assessment involves a hazard analysis by a multifunctional team that includes members from such departments as manufacturing, quality, food safety, sanitation, research and development, and regulatory compliance. Risk assessment helps identify potential sources of food allergens and maps their path through each step of the manufacturing process. Once the path is identified, controls can be put in place in target areas such as reception and storage, scheduling of production runs, variations in production, equipment design and supply and cleaning materials. It is important to periodically review and reassess your risk assessment as new products, formulation changes or vendor changes may change production conditions.
  2. Risk Management: Now that risks have been identified, they need to be managed. The key to successful risk management is developing work instructions and standard operating procedures that control the possibility of unintentional allergen contamination. These procedures and instructions include quality requirements for vendors’ ingredients, segregation, production controls, manufacturing scheduling, equipment and plant design, as well as cleaning and sanitation procedures. It is important to validate that these procedures and practices are effective using a science-based approach. In addition, these activities should be routinely reviewed and evaluated for effectiveness. A successful allergen control plan relies on continuous training, clear explanation of procedures and documentation of the existence and effectiveness of the plan.
  3. Risk Communication: The next step after assessment and management is communication. If you have an allergenic food in your plant that could be unintentionally found in the finished food product, it is essential that this information appears on the food label. Risk assessment can help define the nature of the potential allergen. Is the final product manufactured from ingredients that contain allergens or is it manufactured on equipment that is in direct contact with allergenic ingredients? This analysis can ensure proper labeling, either in the food ingredients or as a precautionary allergen label (PAL).Ultimately, it is important to remember that food allergen control plans require management commitment to succeed. Continual communication and training increase the safety of manufactured products. Allergen control is but one of the many efforts to prevent and minimize foodborne illness in humans, but the development of and adherence to an effective allergen control plan will go far in protecting allergic consumers and reducing the food manufacturer’s risk to reputational and recall costs.
Prop 65 label

California Proposition 65 To Impact Food Labels

By Nick Recht
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Prop 65 label

The fast-approaching August 30th deadline for California’s Proposition 65 has food manufacturers of all sizes working to make sure affected labels comply with the new labeling requirements. According to the California Office of Environmental Health Hazard Assessment (OEHHA), Proposition 65:

“…requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. These chemicals can be in the products that Californians purchase, in their homes or workplaces, or that are released into the environment. By requiring that this information be provided, Proposition 65 enables Californians to make informed decisions about their exposures to these chemicals.”

Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act, is intended to help better equip Californians to make informed decisions about the products they purchase. The OEHHA is responsible for determining which chemicals meet the legal and scientific requirements for inclusion on the Proposition 65 list, a list which has grown to more than 900 chemicals since it was originally published in 1987.

The new law will be enforced by the California Attorney General’s Office as well as any district attorney or city attorney for cities whose population exceeds 750,000. Individuals acting in the public’s interest may also seek to enforce Proposition 65 by filing a lawsuit against companies alleged to be in violation. Companies that are found to be in violation may be fined as high as $2,500 per violation per day.

To ensure compliance with the new law, food manufacturers must reference the list of included chemicals to determine which of their products, if any, are impacted. Manufacturers must then provide “clear and reasonable warnings” that chemicals used in the production of their goods or products sold in California are known to cause cancer, birth defects and/or other reproductive harm. The ruling impacts goods sold in California as well as those sold via catalog or the internet.

Proposition 65 underscores the importance of an agile labeling environment for food manufacturers, particularly as it relates to their ability to adjust labels prior to compliance deadlines. It also implores manufacturers to look to automation to reduce the room for human error. For example, labeling software can be leveraged to create a table look up so if an impacted ingredient is included in a product and printed on a label, the required warning statement is also automatically included on the label.

Leveraging a database connection to apply such warnings can help businesses mitigate risk, as failing to include a required warning could result in fines, business disruption and lost revenue. It is also important to note that compliance with Proposition 65 will require food manufacturers to stay up to date on changes, as new chemicals may be added and/or revisions to law may continue to occur. Food retailers must also stay abreast of labeling changes required by Proposition 65 to ensure the products they sell are in compliance. Learn more about Proposition 65 at the OEHHA’s official website: https://www.p65warnings.ca.gov.

Prop 65 label
Label design products can help a company add a warning statement to a current label. Image courtesy of TEKLYNX.
Nick Recht, TEKLYNX
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Enterprise Label Management for Better Food Labeling

By Nick Recht
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Nick Recht, TEKLYNX

The concept of a food label is simple. Labels identify products, provide customers with necessary information and enable companies to receive and ship products worldwide. Yet growing customer demands, changing labeling regulations and an increasingly competitive global marketplace continue to have food and beverage manufacturers scrambling to maintain some semblance of simplicity in an increasingly complicated labeling environment. Furthermore, the stakes are high for managing labels. Food recalls continue to make headlines, and a growing number of consumers rely on identified allergens to be properly labeled so they can select food and beverages that are safe to consume.

Now, food and beverage manufacturers of all sizes are re-thinking how they manage their labeling environments to navigate this increasingly complicated labeling landscape. For these manufacturers, doing so often begins with a closer look at how labeling is viewed throughout their enterprise. When labeling is treated as a discrete operation within the food and beverage manufacturing process, the labeling environment often relies too heavily on manual processes and is prone to human error. By contrast, when labeling is viewed as an integrated component of the manufacturing process, food and beverage manufacturers greatly improve labeling accuracy, efficiency and agility.

So what does labeling look like as integrated component of the manufacturing process? Enter enterprise label management (ELM), a centralized approach to labeling that leverages existing business systems, eliminates manual process, and reduces IT overheard and the room for human error. It integrates label design, approval, security and print automation and holds the key to improving labeling speed, accuracy and agility.

ELM centralizes label management and integrates labeling with other business or ERP systems. It consists of these four primary label management components:

  1. The ability to create and print barcode labels used for shipping, inventory, products and more.
  2. Label approval, traceability, security, storage and version control for all labels created and printed.
  3. Print automation to remove human interaction from the printing process.
  4. A configurable browser printing interface for seamless label printing locally and around the globe.

Food and beverage manufacturers of all sizes can benefit from ELM. Typically, companies look to ELM when they are looking to reduce waste, mitigate risk or reduce disparate system management. ELM is also a natural fit within lean manufacturing initiatives because its integrated approach allows organizations to leverage existing business systems and often reduces IT overhead. And because ELM incorporates label approval, traceability, security and version control, food and beverage manufacturers that leverage it are better equipped to respond to and execute a food recall should that situation arise.

From an efficiency standpoint, food and beverage manufacturers realize many benefits from ELM implementations. ELM eliminates manual approval processes that often result in production delays. It also reduces manual, error-prone processes. The use of label templates allows food manufacturers to quickly adjust labels, making it easier to respond to changing label requirements such as the FDA’s new Nutrition Facts requirements or those items required by FSMA.

With ELM, the use of a configurable browser printing interface allows food and beverage manufacturers to manage labels at one location while enabling users to print labels at locations around the globe. This greatly improves a manufacturer’s ability to manage labels across its network of production facilities and distribution centers, and provides a labeling environment that can easily adjust as the company grows.

ELM can also serve as a competitive advantage for food and beverage manufacturers. For one leading consumer goods manufacturer, an ELM solution provided a way to become more competitive in the marketplace. The manufacturer was facing challenges, as its former labeling process relied too heavily on manual processes. Specifically, its manual data entry was time-consuming and error-prone. Its labeling environment was also unable to accommodate label changes without costly, custom development time. Labeling errors meant the company was at risk of losing customers and market share, and the inability to quickly accommodate label changes negatively impacted its ability to comply with changing customer requirements.

With ELM, the manufacturer realized a 75% reduction in label development time, resulting in an equal decrease in labor costs. In addition, access to label templates gave them complete flexibility to quickly respond to business and customer requirements. And because its label creation was now automated and integrated with its existing SAP system as part of the ELM implementation, the company was able to increase labeling efficiency while reducing errors.

For food and beverage manufacturers, the benefits of ELM are too compelling to ignore. Here are four signs your company may benefit from ELM:

  1. Your barcode label printing is manual and disjointed, with many clicks.
  2. Your label templates are decentralized and difficult to manage.
  3. You have manual label approval workflows and can’t apply securities and controls for design vs. print users.
  4. You have many local print installations.

If you’ve answered yes to one or more of these signs, ELM warrants a closer look. ELM implementations can run smoothly when you partner with an experienced barcode labeling solutions provider, and your company will be better positioned to navigate what has become a very complicated food and beverage labeling environment.

magnifying glass

Avoiding Total Recalls: Regulatory Labeling for the Food and Beverage Industry

By Josh Roffman
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In recent memory, no time has more effectively demonstrated the challenges facing the food and beverage industry than spring 2018. In addition to a widely publicized recall of romaine lettuce, several other companies have instituted noteworthy product recalls. For example:

While demoralizing for food and beverage manufacturers, these recalls may also be an unavoidable part of doing business. Plants are grown outdoors, livestock lives outdoors, and no method of sterilization or disinfection is perfect. This is why regulations exist, such as FSMA or EU 1169, so that when recalls do occur, companies can efficiently find and eliminate their contaminated products, and then find the point in the supply chain where the contaminants were introduced.

Despite their necessity, food labeling and packaging regulations represent a huge challenge for food and beverage (F&B) manufacturers—and these challenges don’t exist in a vacuum. The labeling and packaging process is already a huge challenge, which includes customer requirements such as branding, cultural and linguistic localization, 2-D barcodes, and more. How can F&B companies enmesh their regulatory requirements with these existing challenges without adding to the complexity and expense of the entire undertaking?

Challenges of the Regulatory Environment

Since 2011, FSMA has been changing the way that F&B manufacturers produce, package, ship and sell food. In a departure with previous tradition, government inspectors no longer form the first line of defense against contaminated or mislabeled food. Rather, food producers and manufacturers themselves must bear the responsibility to implement procedures that prevent foodborne illness.

In short, FSMA will force F&B manufacturers to implement full transparency and traceability within their supply chains. Artwork and product labeling must be used to support these endeavors—ideally, one would be able to scan the barcode on a food package to instantly determine its origin as well as the chain of distributors that it passed through in order to reach your hands. Right now, the industry standard is well below this benchmark.

Right now, a seven-day timeline is the best-case scenario for traceability throughout the F&B supply chain. Although the endpoints of the supply chain—grocery stores and restaurants—may use modern digital records, you’ll find growers and transportation companies still using Excel and paper records.

In the meantime, a new European Union regulation known as EU 1169 went into effect in December 2016. It made a number of changes to food labeling laws, creating a uniform standard for nutritional facts information. Manufacturers must meet minimum standards for legibility, attain a minimum font size, and notify consumers about potential allergens.

Purely by coincidence, a new FDA food labeling law has also recently gone into effect. Announced in May 2016, this rule will update serving sizes found on most food packaging, alert consumers to added sugars, and more. Although these rules were originally slated to take effect in 2018, they’ve been delayed to 2020 for companies with more than $10 million in revenue, and delayed to 2021 for smaller F&B manufacturers.

To encapsulate, F&B manufacturers must now adjust to the following factors:

  • The FDA is becoming much more serious about preventing foodborne illnesses
  • To this extent, it’s begun to demand instant traceability from F&B manufacturers
  • In addition, the EU will force manufacturers to update their nutritional labeling
  • Manufacturers must update their nutritional labels in the United States as well—but differently

Barcodes and labeling already pose a complicated challenge for manufacturers, causing product recalls and packaging write-offs. Putting additional regulation on top of that solves problems in one sense, by making recalls less likely, but also creates problems in another sense—by putting pressure on artwork and labeling departments that are already overworked. After all, regulations alone aren’t the only sources of change and challenge when it comes to labeling and packaging.

Other Stressors on Labeling and Packaging within F&B Manufacturers

Changing consumer tastes, changing marketing methods, and changing technologies all play their role in adding stress to the job of labeling and packaging within the F&B manufacturing industry.

  • New Branding Needs. Packaging drives 36% of purchase decisions, which means that new and eye-catching label designs are always a must. Good design is subjective, however, and tastes change. For example, most Americans are now driven towards brands that are driven towards social and environmental causes. In other words, many F&B manufacturers may soon reorient their product artwork design to reflect this new concern.
  • International Expansion. If EU 1169 is a concern for you, it probably means that you’re selling into countries where English isn’t the only language. It’s easy to make missteps in this realm. For example, it’s possible to accidentally approve poorly translated copy, or to approve copy that’s in the wrong language entirely.
  • New Technologies. In addition to the UPC, many brands are now incorporating 2-D barcodes (such as QR codes), which provide product information when scanned by a smartphone. Although these codes are supposed to provide more information to consumers, only 34% of consumers actually scanned them as of 2014. The challenge for the labeling department is to make these codes more useful and user-friendly.

These new techniques, regions and branding requirements pose challenges. Think about the possibility of approving the right logo for the wrong country, approving out-of-date artwork, or substituting an FDA-compliant label for one that should comply with EU-1199. These things will happen, and they will necessarily lead to recalls. Here’s the question: How do you structure your artwork and labeling departments to minimize these risks?

Minimize Risks with Standardized, Centralized Labeling and Artwork Management

The secret to producing compliant labeling with up-to-date branding and correct localization is to create a system that gives you as little choice as possible. In other words, you should not find yourself wandering through a nest of file folders wondering which asset is the most up-to-date or find yourself developing separate label templates for each separate region you sell into.

Instead, your labeling and packaging artwork should be able to integrate with other business applications and content libraries to ensure your accessing the correct, most up-to-date approved content and assets. In an ideal world, if you start creating a label and select “Spain” as your target market, your labeling solution would immediately retrieve the relevant content for that target market. With the right kind of integrated, dynamic, data-driven solution you can be confident that you’ll only be dealing with complete with approved Spanish-language content for your packaging and your labeling. You would have peace of mind that your solution would generate an EU 1199-compliant nutrition label template, auto-populated with the appropriate nutrition facts. Additionally, if this label is intended for food sold only by a particular supermarket chain, you would feel confident that your solution would retrieve all of the correct content, images and barcodes required for that brand.

Improve Traceability by Replacing Sources of Confusion with Sources of Truth

To ensure accuracy and consistency, your labeling solution should integrate with your “sources of truth,” namely your ERP systems, but also potentially including your manufacturing execution systems, warehouse management systems, and more. You should be able to leverage existing business processes and vital data sources to drive labeling—to avoid replication of data and potential error, and instead automate and streamline your processes.

Recalls may be a fact of life, but using the right labeling and packaging solution will let you narrow their scope—and trace contamination to its source within a much faster window. The fastest solve for this problem involves creating a true “closed loop” for artwork and labeling—a comprehensive, integrated and automated solution to provide accurate and consistent labeling.