Chelle Hartzer, Orkin
Bug Bytes

Don’t Let Pests Wreck Your Supply Chain

By Chelle Hartzer
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Chelle Hartzer, Orkin

In today’s global marketplace, it has become necessary for facility managers to implement more detailed inspection and documentation policies for incoming shipments as part of the larger food safety plan. But plan as you might, pests are adept at infiltrating food products and contaminating shipments. Their resilience and persistence will make you pay, literally, if you’re not paying close attention.

Pest management is a key component of any facility manager’s food safety plan, but understanding how best to prevent pests from compromising shipments—and by extension the supply chain—takes diligence. An integrated pest management (IPM) program is the best way to ensure that insects and rodents are kept away from processing, packaging and storing food products. Again, this information shouldn’t be anything new if you’re a food processing facility manager, but it’s important to note that IPM focuses on proactive prevention of pests, to align with FSMA’s Hazard Analysis and Risk-Based Preventive Control (HARPC) regulations. These newer regulations shift the focus from reacting to potential contamination concerns to preventing as many issues as possible. Being proactive is a must.

Aside from the legal backlash a facility could face if found if violating these rules, pest issues can also have a major negative impact on a business’ bottom line. Imagine the cost of even one of your outgoing shipments being contaminated by cockroaches or stored product pests. Now, imagine the impact on your business from consumer backlash if the pest-ridden shipment travels further down the line. Simply put, it’s never good if the pest problems are traced back to your facility.

So, what’s the best way to protect your supply chain from potential pest issues and remain compliant under FSMA and HARPC?

All food safety plans should have considerations in place based on a review from a Preventive Controls Qualified Individual (PCQI). This individual is responsible for preparing the document, with the input of as many departments and people as possible, such as QA/QC, maintenance, production teams, and more. Since pests are a common potential hazard, a pest management program should be included in the plan.

That being said, it’s important to inspect all incoming shipments. Even if suppliers have implemented measures to help keep pests away from their sites and products, pests are tough to entirely prevent and it’s always a possibility some have slipped through the cracks (literally!). Pests are attracted by food, water and shelter, so a truck transporting products to your facility is going to be chock-full of attractants! Carefully inspecting incoming shipments will not only help ensure pests don’t enter your facility, but it will help you and your supply chain partners target exactly where problems may be occurring. Forming good relationships with your suppliers, and keeping communication open can help to manage any issues that may pop up.

The faster pest issues are detected, the better. It’s easier to address a pest problem and more accurately pinpoint where it originated if it can be caught early. Otherwise, pests can reproduce quickly and spread, making it harder to pin down the source of an infestation and to treat it. It’s tough to overstate the importance of open lines of communicated between supply chain partners!

To avoid allowing pests into your facility or sending them to a supply chain partner, implement the following processes:

  • Inspect shipments for pest activity, especially incoming shipments. Some common signs include live or dead insects, droppings and damage to the product and packaging.
  • Ensure packaged products are properly sealed and undamaged before transport, and then check the transportation vehicle before loading product for shipping.
  • If there is a pest sighting, remove any compromised product to avoid allowing pests to spread to other goods or find a way into the facility. If it can’t be removed from the facility, isolate it in a contained area and call your pest management provider immediately.
  • Empower employees to call out pest issues as well by implementing a “see something, say something” policy. Don’t forget to have a pest sighting log, and let the employees know where it is and what to record.
  • Use monitoring devices to detect pest activity levels. Devices like insect light traps, pheromone monitors, and glue boards can be easily placed in shipping and receiving areas as an early warning sign of pest activity.

With an untrained eye, pest issues can be difficult to notice. Ask your pest control professional about a free training session for employees. Most pest management companies offer this service free of charge, and it can be a big help. There’s no reason you shouldn’t take advantage.

The pest pressure a facility faces is dependent on a variety of factors including location, geography and the type of product being produced and stored. No two facilities are the same, which is why every pest management program should be customized to meet the needs of the business.

As a start, the following pests are the most common to find in the food processing industry.

  • Rodents: Rats and mice can carry disease-causing pathogens that can be deposited onto other surfaces by simply making contact with equipment or products. Both are capable of fitting through tiny gaps (mice can fit through a hole the size of a dime, while rats can fit through a hole the size of a quarter), meaning any openings on the exterior of a building serve as a welcome mat to a curious rodent. To spot the signs of rodent activity, look for droppings and yellowish-brown grease marks around corners and along baseboards, as these marks can be caused as a rodent rubs against these areas. In addition, look for gnaw marks around any gaps or openings in walls and on products.
  • Cockroaches: Able to squeeze their bodies through miniscule gaps, cockroaches will feed on just about anything. With a good food source, they can reproduce quickly. A couple cockroaches can become an infestation in a matter of months, especially with an abundant food supply. Cockroaches are most active at night, so if you see one during the day it’s a good sign that it’s time to act quickly!
  • Flies: While less likely to find their way into packaged products, flies can spread dangerous, potentially disease-spreading pathogens on everything they touch. They usually don’t travel too far from their larval food source, but their ability to reproduce quickly can make them a nightmare to get rid of if steps aren’t taken to remove them immediately.
  • Stored Product Pests: There are numerous kinds of stored product pests, but all are adept at thriving in and around products undetected. The Indian meal moth, for example, is a moth with small, cream colored larvae that will eat just about anything. Stored product pests are some of the most likely pests you’ll find on incoming shipments and in storage areas, as they’re right at home breaking into and surviving within product packaging.

Keep these pests on the radar, and make sure to take note of where pests are found and how many are spotted. The more information, the better, as it helps pest management professionals get to the root of pest problems.

Documentation is always a major key. It shows an auditor that careful planning and proactive prevention are points of emphasis, which will be important. Although there are numerous documents to keep on hand, add the following to your list in order to more easily demonstrate compliance with pest related FSMA regulations:

  1. Supply chain program, including suppliers and ingredients.
  2. Receiving procedures, including the pest management program that helps prevent pests from entering the facility on products or through loading areas.
  3. Receiving records, or, in other words, documentation of shipments received from suppliers.
  4. Monitoring records of any captured pests in or around the facility and any corrective actions.
  5. Application records for treatments used in and around the facility.

If suppliers are located in another country, note the requirements differ from facilities located in the United States. The FDA breaks this down on their website, but importing products from another country means a facility must follow the Foreign Supplier Verification Program. This comes with a different set of compliance documents and means the importing facility must monitor foreign suppliers’ food safety plans.

Remember: Preventing pests needs to be a proactive process included in the food safety plan. If you want your supply chain to remain pest free, partner with a pest management company and talk to your supply partners to establish standards for documentation and communication. All will benefit, as you’ll be able to catch problems early and have a better chance of keeping pests from wrecking your supply chain.

Read on for more articles by Chelle Hartzer.

How to Prepare for an Audit at Any Time

Minimize the Risk of Pests by Maximizing Your Staff

 

Richard Wilson, AuditComply
FST Soapbox

Why SaaS and Food Safety Are A Perfect Match

By Richard Wilson
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Richard Wilson, AuditComply

Food manufacturers, what’s keeping you up at night? What’s the one issue that could damage your reputation so badly that you lose customers? The answer: A food safety crisis that at best, requires your products to be recalled and at worst, puts valued consumers at risk.

Similarly, if you’re a global supply chain manager, what’s your number one worry? The answer: Maintaining continuous compliance with industry standards, meeting increased regulation requirements, or maybe it’s a key supplier failing their BRC audit?

Whatever it is, we all know food manufacturers are under increased pressure, facing multiple internal and external challenges in an ever-changing complex environment. Challenges such as price volatility, stronger competition, increasing customer demands, complex supply chains and globalization are all taking their toll.

Furthermore, to add to this increasing pressure, organizations are still relying on paper-based systems and manual processes to help manage their risk, quality and compliance, and even their environmental health and safety (EHS)! This approach is inefficient, makes the audit and compliance process costly and difficult to scale, while compromising quality and complicating traceability. It’s time to take advantage of the digital age and relieve the pain and pressure of traditional risk and compliance management with a SaaS (software as a service) solution.

What is SaaS (Software as a Service)?

SaaS providers use the internet to deliver their bespoke software offering, usually in the form of a subscription-based service with a monthly or annual fee. The main benefit of SaaS is the cloud, being cloud-based software, upgrades and fixes are managed by the software provider, reducing or eliminating the need for an IT infrastructure—all your data is readily available in real time, on one centralized platform. SaaS is delivering more visibility and mobility without hassling organizations with the details and streamlining software integration across the globe.

SaaS solutions have become a game changer in modern risk management, and the following points illustrate why.

Speed of Deployment

Food and beverage manufacturers require a SaaS solution for multi-site global deployment with complete local management. A SaaS solution will graft onto your business processes immediately. No additional IT hardware should be needed, which means you don’t waste your time procuring and installing an IT infrastructure for multiple sites to benefit. It’s important to remember that the food and beverage industry is moving fast, so if your chosen SaaS solution requires months or years to implement, you’re talking to the wrong people. There is a common saying at my company: “We don’t count in months or years, we count in hours and minutes”.

Providers that offer traditional, on-premise solutions, require extensive configuration and bespoke coding to map to the client’s needs. Long rollout and deployment cycles are inherently expensive to maintain and have poor user experience. This is the reason most consumers revert to Excel/Word and Sharepoint, ultimately losing the ability to manage consistently at scale across their real estate. With an RPM (risk and performance management) SaaS solution you can expect a fast deployment with a comprehensive and configurable enterprise workflow from day one.

Staying Up to Date Is Automatic

Your chosen SaaS provider manage your entire solution from their side, which means upgrades, fixes and customization requests are immediate and automatic. Again, reducing or eliminating, the resource needs of an IT infrastructure. Organizations will have the advantage of immediately being able to utilize the latest features the SaaS solution has to offer. These upgrades will often be driven by feedback from users as organizational and industry requirements change. On-going system development will be crucial to staying in, and assuring, compliance and risk mitigation.

As a food manufacturer, it is important that your SaaS solution comes with a comprehensive document control library—a feature that will always be automatically updated by your SaaS provider. When you are conducting assessments in the field, many users require the ability to refer back to specific document types such as manuals, procedures, work instructions and the latest standards or regulations. These documents should be all managed by your SaaS provider, with teams consistently reviewing and updating important industry documentation on the platform for any user out in the field.

Ease of Use

Proofs of concept are crucial. Living in a world where we have an abundant amount of choice, organizations need to know their chosen SaaS solution has the ability to meet requirements and demands of both the organization and industry. This is made easy with SaaS, allowing organizations to test the software functionality in advance of purchase. Even for large food manufacturers, SaaS offerings can be used to test the software before it is purchased, and there should be no limit to the amount of trial users. The right risk and performance platform will also allow your team to upload specific templates, allowing new users to be familiar with assessments provided on the platform, easing your transition to a digital format.

Mobility and 360o Visibility

For further flexibility, popular SaaS providers will offer their solution in mobile format. Assessments conducted on the platform should be seamlessly synchronized between smartphone, tablet and desktop, allowing you to start an assessment on one platform and then pick it up on another. Users are no longer restricted to one location and can access their robust platform from any device, online or offline. We know that many companies are operating in

harsh environments, whether it’s the scorching temperatures of the Sahara desert or the blistering wind chills of northern Canada—your SaaS solution needs to come equipped with the right tools. By utilizing SaaS mobile offerings, organizations gain full visibility of their risk profile, making room for a culture of continuous compliance whether they’re in the field or back at the office.

Scalability at a Lower Cost

Implementing a SaaS solution means all your data is securely stored in the cloud. This provides scalability to match organizational growth strategies. Food manufacturers can add more users as their business grows without ever thinking about changing the hardware or requiring a full IT department for assistance. However, although SaaS offerings are provided at a lower cost than traditional solutions, each platform has its own rates, so shop around for a solution that will best suit your budget and requirements.

Bottom Line

Cloud-based software models have made risk, quality and compliance more affordable and flexible, considerably improving and streamlining business processes worldwide. Next time you are evaluating a SaaS solution for your food and beverage organizations, remember, the providers are staking their own survival on the software platform working. Whether it’s the protection, security, availability or performance of your data. Providers want to make their platforms a hassle-free and secure option for any food manufacturer looking to thrive in this demanding industry.

Relieve the pain and pressure of traditional risk and compliance management: Realize your investment from day one.

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.
Michael Koeris, Ph.D. and vice president of operations, Sample6, pathogen detection
FST Soapbox

The True Costs You Endure During a Food Recall

By Michael Koeris, Ph.D.
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Michael Koeris, Ph.D. and vice president of operations, Sample6, pathogen detection

When you think about the expense of a recall, you probably automatically focus on the costs to pull the affected product from shelves and reimburse customers. Yes, this can be an expensive undertaking. But the true, comprehensive cost of a recall involves immensely more than these obvious financial tolls. Do you fully understand the price to be paid when your organization is up against a food recall?

The recall process in the food manufacturing industry is a highly expensive one, averaging more than $10 million in costs to cover activities such as communicating the recall across the supply chain, retrieving and handling the recalled product, investigating the event and implementing corrective actions to prevent reoccurrence.

Of course, this average doesn’t address the possibility of litigation costs, decreased sales, reputational damage or brand crisis management, which can add up to millions—even billions— of dollars more. The public has become much more informed and aware of food safety events, and a single breach of trust could result in resounding losses to your brand. This makes it critical to understand the true costs you endure when faced with a food recall.

Immediate, Direct Costs

A recall can be a company-defining event. The vast majority of recalls are voluntary and a reflection of conscientious behavior by the retailers, wholesalers and producers, but that doesn’t mean you won’t incur serious expenses. The most obvious, immediate and direct ones include:

  • Pausing production to carry out recall response initiatives
  • Alerting necessary parties within and outside the organization, including regulatory agencies and relevant retailers
  • Managing the logistics of removing affected or mislabeled products
  • Examining the source of the recall, including issues with suppliers, equipment, processes or contamination prevention plans
  • Remediating the identified problems to prevent similar occurrences
  • Planning for expanded human resources to handle recall tasks in addition to routine operations

Again, these expenses could equate to millions of dollars from your bottom line, but the truth is they may be the most minor of your concerns in the face of a food recall.

Compliance Penalties

As you likely know by now, there’s a monumental shift happening in the regulatory arena. FSMA has enacted strict laws that place a greater emphasis on proactive and preventive approaches to food safety. In addition, the USDA has been focusing on strong enforcement of its guidelines for years.

For manufacturers, this means adjusting processes and procedures to comply with legal requirements for monitoring, testing, documentation, risk assessment and more. It is not enough for companies to have a plan for taking corrective action on contaminated products; they must also have a strong preventive plan in place to identify pathogens in the production environment before they affect the product and/or leave the facility. If your company undergoes an FDA or USDA audit or investigation that reveals noncompliance with government-mandated prevention efforts, you could be looking at significant consequences like criminal fines and forfeitures to the U.S. government.

FSMA laws and USDA regulations stipulate that depending on the nature of the violation, and whether the food is adulterated or misbranded, the FDA or USDA may consider regulatory actions, including:

  • Issuing advisory letters
  • Initiating court actions, such as seizure or injunction
  • Implementing administrative detention to gain control of adulterated or misbranded products
  • Mandating a recall of violative food
  • Suspending a facility’s food registration to prevent the shipment of food

Lawsuits and Litigation

According to the CDC, 48 million people get sick from foodborne illness each year, 128,000 are hospitalized and 3,000 die. If your organization is sued on the basis of a contaminated or unsafe product, you can expect to deal with attorney fees, court costs and settlements. In the worst cases, you may even need to pay damages to harmed consumers.

Yes, prosecutions are rare. But they are a reflection of a failure to protect consumers, as well as potential negligence or (in the rarest of cases) malicious intent. The financial effects of these reputational scars go well beyond obvious litigation expenses.

Lost Sales

Once a recall is ordered, a series of actions unfold that drastically impact your income. Manufacturers halt production, and retailers pull products from their shelves. Worse, a loss in consumer trust can initiate a long-lasting sales depression. Your customers want to know that the products they’re buying are safe. In response to a recall, they may change their purchasing, food preparation and consumption practices, or they may avoid the product for months or years after the recall has ended.

Insurance Impacts

Most food companies have recall insurance to protect their assets if a recall occurs. But, are you fully informed on what it means to work through a recall with your underwriter or how a recall affects your premiums? Is there a possibility of losing your insurance? It’s crucial to understand how your insurance is affected by a recall and what is contractually covered under your plan.

Brand Deterioration

Recalls are happening more frequently today than ever before, for reasons including stricter compliance regulations and supercharged government testing regimes using novel technologies like next-generation sequencing. This increased focus on testing by the government has led to a greater discovery rate of contamination, which is a good thing for the public. It means that improvements will be made to yield an even safer food production environment.

Nonetheless, recalls are alarming to your customers, and the last thing you want to risk is their trust in your brand. At the end of the day, your brand is your primary asset. It is a representation of who you are and how you do business. When recalls happen, customers lose faith in your brand, which comes with a hefty price tag for your company. If your brand deteriorates due to consumer mistrust, you’re risking business failure.

Unfortunately for the food industry, stories exposing scandals are a proven way to catch the public’s eye. Therefore, any news of a recall receives immediate and aggressive media coverage from both traditional and social media platforms. In the event of a recall, publicity is inevitable, and it’s an expense that spans every aspect from public relations management to eroded sales.

Karen Everstine, Decernis
Food Fraud Quick Bites

A Look at the Latest Targets

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

Recent food fraud news includes the seizure of a million bags of fraudulently labeled and expired rice in Kenya, fraudulent spices found in a warehouse in India, and a U.S. grocery store chain sued for selling manuka honey that wasn’t 100% manuka. In Spain, tuna intended for canning was dyed and diverted to be sold as fresh and in China, 8,000 bottles of counterfeit wine were seized by the local food and drug administration. In Greece, 17 teenagers became ill after drinking alcoholic beverages containing methanol. Recently published journal articles on detection methods have looked at adulteration of honey with sugar syrups, meat adulteration with other species, authentication of products containing truffles, and Arabica coffee authenticity. One group of researchers evaluated a method to authenticate the botanical and geographic origin of hops.

Vanilla prices have been high, increasing the incentive to substitute natural vanilla extracts with similar flavors. A search of the Food Fraud Database shows a range of fraudulent adulterants associated with vanilla extract: Coumarin, ethyl maltol, ethyl vanillin, maltol, vanillic alcohol, and vanillin (natural or synthetic). Recently published authentication methods include GC-VUV and analysis of stable isotopes of carbon and hydrogen (with GC-IRMS).

In 2004 (another period of high vanilla prices), a company that sourced vanilla beans from Indonesia for use in manufacturing vanilla extract identified mercury contamination in two lots of beans they had received. Mercury was presumably added to increase the weight of the beans. The company quarantined all beans and products that had been manufactured from them. They also had to shut down flavor production to clean and decontaminate the processing equipment.

Due to their high value and physical form (they are often sold in ground or liquid extract form), herbs and spices have a long history of fraudulent adulteration. Many countries have publicly reported being affected by food fraud in herbs and spices over the past 10 years.

Food Fraud incidents, spices
Incidents of food fraud reported in the Food Fraud Database for the past ten years in the category “Herbs, Spices, and Seasonings” (68 total).1

Mitigation measures for products at high risk for fraud include putting in place raw material specifications that include authenticity criteria, implementing analytical surveillance, establishing strong supplier relationships and audit programs, and increasing supply chain transparency.

Resource

  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.
Melody Ge, Kestrel Management
FST Soapbox

Supply Chain Management 101

By Melody Ge
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Melody Ge, Kestrel Management

Supply chain management is becoming more and more relevant to small and entrepreneurial food businesses, particularly related to FSMA requirements that are required to be fully implemented by this September. To meet these requirements, it is important for small businesses to understand:

  • Applicable FSMA requirements
  • How to develop a supplier approval program
  • What challenges companies may encounter and tips to overcome them
  • How to find an appropriate starting point to develop a supply chain management program

Supply Chain Management Program

1. Receiving facility: A facility that is subject to preventive controls and supply-chain program and that manufacturers/processes raw materials or ingredients that it receives from a supplier.
2. Supplier: The establishment that manufacturers/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.Food manufacturers need to develop and implement a supply chain management program, including supply chain preventive control, to control those potential hazards identified that shall be controlled by the suppliers when receiving all raw materials and ingredients. As defined in the actual FDA regulation, a supply management program will only be considered as a preventive control when it is linked to a potential food safety hazard in the raw materials and incoming ingredients. It is the supply-chain-applied control (21 CFR 117.3). As a receiving facility, you have the right to ask your suppliers for all related information associated with the food safety hazards that you identified from your own food safety plan.

What should be in your supply chain management program or supply-chain-applied control?

  1. There needs to be a series of credentials for approval. This can be determined by you, depending on the hazards and product risks. For example, a third-party audit result or a certification from a reliable audit can serve this purpose.A few questions can be considered, including whether suppliers have a recall plan, whether suppliers have an existing food safety plan to control hazards, or whether suppliers have a non-conforming products control plan. Often these can be checked and verified when a third-party audit or third-party accredited audit is conducted. Once a supply chain management program becomes a preventive control, the raw materials can only be supplied by an approved supplier.
  2. Monitoring activities and verifications should be applied to those approved suppliers in your supply chain. This can be done throughout the business history and supplier performance. You need to demonstrate how you continue monitoring the supplier approval status, and suppliers must demonstrate how their products remain guaranteed. Public records (e.g., warning letters), sample testing incoming goods, and customer audits are commonly utilized in the industry. However, in FSMA, when an approved supplier is supplying a high-risk raw material, such as one with SAHCODHA (Serious Adverse Health Consequences or Death to Humans or Animal) risks, an onsite (your own audit or third-party (accredited) audit) is required to be conducted as the verification activity. This must be completed annually unless you can provide a risk-based justification of other types validated verification activities.
  3. Afterwards, as a receiving facility, you need to consider and develop procedures for non-conforming suppliers:
  • How do you require your suppliers maintain their “approval” status in your supply chain management program throughout the business years?
  • When one approved supplier is unapproved or experiencing unexpected incidents, how do you manage back-up suppliers?
  • What criteria do back-up suppliers need to meet prior to supplying the product(s)/ingredient(s)?

Melody Ge will be presenting “What Have We Learned After FSMA Implementation?” at the 2018 Food Safety ConsortiumDifferent products will have different approaches based on facility business operations. However, one thing remains the same. The justification must ensure that potential hazards identified from the original approved supplier are controlled when a back up supplier is used.

4. Last but not least, just like all other programs and controls, records and documentation are important! Records must be kept for all parts of the supply chain management program, including plan, monitoring, verification and any corrective actions that have been conducted. These data are precious to your facility over time, as supplier performance and trending could be a strong reference to see whether adjustment or modifications should be applied to your supply chain management.

There may be challenges collecting information or approving suppliers, but never forget the intention of a supply chain management program—to control the food safety hazards of incoming goods. Your supply chain management program will allow you to demonstrate that you have made all efforts to control the hazards that could potentially arise from your supply chain.

Resource

  1. FDA FSMA Preventive Controls to Human Foods. Retrieved from https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm
Kimberly Stuck, Allay Consulting
FST Soapbox

Cannabis Edibles and Food Safety: Buy At Your Own Risk

By Francine L. Shaw, Kimberly Stuck
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Kimberly Stuck, Allay Consulting

Cannabis edibles—i.e., capsules, chewable gummies, lollipops, cookies, etc. —are becoming more popular and commonplace as laws legalizing cannabis are passed in certain states. Some people are consuming these edibles simply for pleasure, while others are ingesting it for medical reasons, such as reliving epilepsy symptoms, easing chronic pain and combating nausea from chemotherapy. While safety regulations are in place for the foods we eat, who is responsible for the safety of these cannabis consumables?

The 2018 Food Safety Consortium features a Cannabis Quality track | November 13–15 | Learn MoreSince customers can order cannabis edibles online from just about anywhere (including Amazon), they assume these products must be safe. But, as it turns out, that’s not necessarily true. Currently, there’s no regulatory standard for edible cannabis products. Very few consumers realize that it is a “buy-at-your-own-risk” market.

The FDA makes certain that foods sold in the United States are safe and properly labeled. But, currently, they do not regulate cannabis edibles.

Cannabidiol (CBD) infused edibles seem to be more “socially acceptable” than smoking cannabis because they sidestep some of the stigmas, such as the odor. This makes them appealing to a wider audience.

It’s entirely possible that some of the edibles you purchase aren’t manufactured from food-grade ingredients. A document from the Denver Department of Public Health and Environment recently noted that some CBD products being sold in the United States are coming from unregulated, unsafe and unsanitary manufacturing facilities. Further, some of these edibles contain unapproved ingredients, have been produced in unsafe conditions, and had unsubstantiated health claims on their labels.

In many cases, the edibles being sold and consumed in the United States may:

  • Not have the desired effect that consumers are seeking.
  • Be dangerous for consumption, due to inappropriate levels of CBD.
  • Contain ingredients that are not food grade and are, therefore, unsafe to ingest.
  • Be hazardous due to cross-contamination or cross-contact issues.
  • Transmit foodborne illnesses due to poor sanitation and hygiene in the facilities where they were produced.

There have been a number of cases of foodborne illness (and potential hazards) in cannabis edibles recently. In August 2017, Dixie Brands voluntarily recalled six cannabis products after the Denver Department of Public Health and Environment discovered they were produced with potentially unsafe, non-food-grade oils. That same summer, The Growing Kitchen recalled MaryMint Tincture, a breath spray product, after a health inspector found it being stored on a shelf at room temperature (not refrigerated). There was concern about whether the oil was shelf stable, and the potential botulism risk from the unrefrigerated oil in this product.

Another company, At Home Baked, made bubble hash, a form of cannabis concentrates, in its cannabis edibles. Their recall included a variety of products, including their brownie mixes, blondie mixes, rice krispy treats, and Stixx candy. It seems they were manufacturing their products in a washing machine that was in poor working condition (eroding, rusted and containing substantial amount of mold.) Unregulated “facilities”— such as old, moldy, rusty washing machines—are dangerous and extremely concerning in terms of public health and safety.

Denver is one of a few areas in the United States that is regulating the production of edibles on a food safety level. And in Denver alone, there has been a tremendous number of cannabis investigations in recent years, many of them ending in recalls. However, most U.S. jurisdictions are choosing not to regulate food safety around the production of cannabis and edibles. As a result, many unsafe cannabis edibles are being produced and sold to the public, which presents a significant risk to consumers.

Since these products (and the cannabis industry in general) are not regulated, many people producing edibles have not had even the most basic food safety training. Numerous production facilities overlook the most basic food safety rules: They don’t wash their hands, they don’t prevent cross-contamination, and they don’t pay attention to critical items like time and temperature control, proper storage, pest control, sanitation, etc. Yet, they are preparing consumable products and selling them to the public, who believe the edibles are safe.

Because there’s no federal regulation, lab testing varies among each state that permits the use of medical and recreational cannabis. Unfortunately, that means there aren’t consistent safety standards in the cannabis industry, as there are in the food service industry.

The FDA requires a (HACCP) plan for most food manufacturing and food service industries. This means that food businesses will take great strides to only sell food that is safe for consumption, and will not cause injury or illness. As the cannabis industry continues to produce cannabis-infused edibles and other products, people in the business can learn from the existing food safety protocols and procedures. Particularly, they should look to maintain compliance with food safety regulations and take all necessary steps to ensure a safe product for consumers (e.g., clean facilities, food-grade ingredients, no cross-contamination, proper labeling, etc.)

Fortunately, there are a growing number of CBD and THC edible producers that are hiring food safety and cannabis experts to help them elevate their safety standards before the FDA starts to regulate. As with all industries, there are many producers that are ready, willing and trying to do the right thing.

As more people purchase and consume cannabis edibles, it’s becoming increasingly important to buy from reputable companies that follow proper safety protocols. Cannabis companies should produce and handle edibles like food businesses produce and handle food – with the utmost attention to safety.

Nick Recht, TEKLYNX
FST Soapbox

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.

Allen Sayler, EAS
FST Soapbox

Fast Track to FDA FURLS—Expediting or Impeding Access to Overseas Markets

By Allen Sayler
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Allen Sayler, EAS

Is the FDA Unified and Listing Systems (FURLS) system with its newly updated electronic Export Listing Module (ELM) a pathway to overseas markets or just one more regulatory hurdle that has been put in place by the U.S. government to impede export of U.S.-processed foods? A review of the new updates is needed to provide the answer to this question.

Regardless of the answer to this question, whether your company is already participating in this program or is looking for new markets outside the United States in countries that do not require the FDA listing of U.S. food companies, you must understand how the FURLS system works, how to electronically register and better understand the regulatory challenges of the importing country.

The FDA recently released a notification that their FDA Unified and Listing Systems (FURLS) system has been updated to include an Export Listing Module (ELM). This update allows U.S. food manufacturers to electronically submit, and for FDA to receive and process requests for inclusion on the export lists for FDA-regulated food products and present these lists to countries that require them, whether your company is already participating in this program or is looking for new markets outside the United States.

As background, the FDA has established and maintains export lists for countries that require some assurance that U.S. food manufacturers exporting to these countries, at a minimum, meet all applicable food safety regulations enforced by FDA. These lists, in an unofficial way, serve as a “certification” by the FDA, representing the U.S. government, that either included facilities have provided information to the FDA to assert they are in compliance with the importing country’s regulations and requirements or, more likely, that the U.S. food manufacturer is meeting the currently applicable U.S. laws and regulations.

Other options for U.S. food manufacturers that are interested or already exporting to countries that do not require the FDA lists, include the FDA’s export certificates, which give the agency’s official attestation concerning a product’s regulatory or marketing status. The fact that FDA has issued an export certificate does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate. CFSAN issues “certificates of export” for seafood, food additives and food contact substances. CFSAN issues “certificates of free sale” for land food, dietary supplements, infant formula, medical foods and foods for special dietary use. U.S. firms wishing to apply for an export certificate for a food product may log in to FDA Industry Systems and submit an online application through the Certificate Application Process.

TraceGains, verifying suppliers Need to learn more about supplier verification? TraceGains is here to help! Download our Foreign Supplier Verification Program Guidebook to learn the ins and outs of this complicated FSMA addition. TraceGains enlisted the help of Marc Sanchez, regulatory attorney specializing in FDA and USDA law, and Shawn Stevens, a global food safety lawyer, to provide insight and break down some of the confusion.

Back to the FDA list option. It is important to note that companies may request to be included on these lists at any time; however, updates to the lists are only published quarterly by the FDA. Additionally, final listing decisions are made by the competent authority of the importing country. This is to say, there can be a short or lengthy process between the time when FDA updates the list for a particular country and when that country formally accepts the updated list. Since there is no downside for a company to appear on one FDA list or many (lists maintained for each country), this potential delay in official acceptance of the list should drive U.S. food companies to apply to be on all of the country lists, before there is a specific need to do so. Remember the old adage, “When you are in a hurry, inevitably you end up standing in the slowest line.”

Market access for U.S.-manufactured dairy products to the EU, China and Chile, for example, are subject to these listing requirements in order to gain market access. Do ensure you have verified that your dairy product meets the standards and labeling requirements for the country to which you wish to export, as it is likely that a foreign country’s dairy product requirements will not necessarily be the same as what is found in the United States. Another example is that in order to export U.S.-manufactured collagen and gelatin products to the EU, companies must provide a laboratory report from an accredited, private laboratory demonstrating that the products comply with the established criteria. For exporters of U.S.-manufactured/processed seafood products to the EU or China, inclusion on the FDA-maintained list is required, as well as an export certificate which is provided by the National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program after FDA listing has been completed.

Finally, U.S.-manufactured infant formula exports to China are also subject to listing requirements. It should be noted that the China Certification and Accreditation Administration (CNCA) defines infant formula as food intended for children up to 36 months of age, known as “infant and young children formula”. This differs from the U.S. definition. Please be advised that CNCA requires new applicants to submit evidence of third-party certification of compliance with Chinese laws and regulations as part of the application process. CNCA also requires that infant formula manufacturers/processors submit an Establishment Registration Application with additional information to CNCA.

One of the most important keys to gaining access to overseas markets is to get your company enrolled on as many of these FDA lists as possible, obtain FDA certificates of free sale ahead of time, and make sure you update your information and keep it current within the various FDA electronic database systems.

Whether your company faces a foreign market access challenge via being a part of the FDA List or needing to get an FDA “Certificate of Free Sale” or just have questions related to moving product out of a U.S. port and into a foreign port, contact a reputable consulting firm for assistance.

Francine Shaw, Savvy Food Safety, Inc.
FST Soapbox

Would Your Team Know How to Handle a Crisis?

By Francine L. Shaw
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Francine Shaw, Savvy Food Safety, Inc.

In 1993, Jack in the Box put foodborne illnesses and food safety “on the map” when their undercooked burgers led to an E. coli outbreak that infected more than 700 people. 171 people were hospitalized and four children died.

Don’t miss the Plenary Discussion on Crisis Management at the 2018 Food Safety Consortium | Learn moreUnfortunately, this infamous outbreak wasn’t an isolated incident. Foodborne illness outbreaks are on the rise in the United States. The CDC reports that 48 million Americans become sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States.

A string of unprecedented outbreaks at Chipotle occurred at multiple locations, beginning in 2015. Recently, there was widespread concern when romaine lettuce tainted with E. coli was shipped, served and sold at restaurants, stores and institutions nationwide. Earlier this year, approximately 2,000 7-Eleven customers at a Utah location were exposed to hepatitis A due to an infected employee who worked (and handled the convenience store’s food) while sick. The state’s local health department announced that anyone who used the restrooms, drank a fountain drink, ate fresh fruit or any item from the store’s hot food case was at risk for infection from the highly contagious illness.

Keep in mind that a crisis isn’t necessarily a foodborne illness. Think about other unexpected crises that could impact your organization, staff and customers, like natural disasters (hurricanes, blizzards, tornados, etc.) What if there’s a robbery, shooting or bombing at your venue? What if a guest chokes and dies? Perhaps there’s an unexpected power outage or a fire? Yes, unfortunately, these are all real possibilities.

If a crisis were to occur at your establishment, would your team know what to do?

As the saying goes, if you fail to prepare, prepare to fail. It’s extremely important to be prepared for every type of crisis imaginable—before anything bad actually happens.

When developing a crisis plan, consider and implement the following:

  • Form a crisis management team. Assign roles and responsibilities. Ensure all designated crisis team members understand what’s expected of them in the event of a crisis. For most food businesses, the crisis team will consist of a corporate attorney, company leadership, food safety team, crisis management consultant, a public relations expert, a trained media spokesperson and applicable government agencies.
  • Know how your local health department operates. The role of the local health department varies from jurisdiction to jurisdiction, so get to know your local inspectors. Work with your regulatory agencies, who will want to help.
  • Create honest, authentic and apologetic messaging. This will, of course, need to be developed to meet the specifics of your situation. Regardless of what happened, honestly describe the situation and explain the solutions-focused plan you’ve created to move forward. Transparency is important, otherwise key audiences (customers, employees, media, investors, advertisers, etc.) will lose confidence and trust in your company.
  • Work with the media to disseminate information about the incident. The media want to report what has happened, and it’s in your best interest to be straightforward with them. If there was a breakdown in your process, identify it, whether you received tainted merchandise from a vendor or experienced an error in the kitchen. Explain the concrete steps you’re taking to fix it and prevent a reoccurrence (e.g., selecting different vendors, re-training your staff, adjusting your food allergy protocols, etc.).
  • Train (or re-train) your staff on food safety protocols. Be certain that everyone is knowledgeable about food safety (e.g., how to prevent cross-contamination, how to properly prepare allergy-friendly meals, how to cook foods to proper temperatures, etc.) to avoid similar crisis situations in the future.
  • Use social media wisely. Monitor social media (Facebook, Twitter, Instagram, etc.) and respond to negative and/or erroneous comments. Messages on social media (as well as in real life) should always be positive, professional and honest. Don’t get defensive and don’t allow yourself to get sucked into toxic, negative message spirals.
  • Communicate with your customers, employees and other key stakeholders to win back their trust. Be honest, sincere and apologetic. Explain how/why their loyalty is so important to you, and vow to earn their trust again.
  • Change vendors, if necessary. Did a vendor mislabel ingredients, causing an allergic reaction in one of your guests? Did they source tainted products and sell them to you? Change vendors, and be clear in your communications (to media, via social media platforms, etc.) that you identified the vendor as the source of the problem, explaining that you’ve cut ties to them to eliminate similar events in the future.
  • Thank the responders that helped. Perhaps your crisis wasn’t a foodborne illness –it was a customer dying of natural causes, a bomb threat, a weather emergency, or an electrical fire. Use the media and social media platforms to thank the police, fire department and/or paramedics—whichever responders helped defuse the situation.
  • Designate a media spokesperson. When facing a serious crisis, your restaurant’s CEO/owner/president should be the spokesperson. The public wants the head of the company to speak authoritatively about the incident and the concrete plans to resolve the problem. Practice your messages before going in front of the cameras, anticipate the most challenging questions you may receive, and determine how you’ll respond professionally, politely and non-defensively.
  • Stay calm. While it’s upsetting (and terrifying!) to be in a crisis situation, remain calm as you work to recover from the incident. Follow your crisis plan and communicate your key messages. Make certain that important audiences (including customers, prospects, employees, the media, vendors, health inspectors, etc.) recognize how hard you’re working to prevent similar incidents in the future.
  • Debrief after the crisis is over. Regardless of what happened and the severity of the situation, after any kind of incident, get the crisis management team together and debrief. Review your plan and see if there is any room for improvement.

It is critical to have a plan established just in case a crisis occurs. Hopefully, you’ll never have to use it, but it’s always wise to be prepared. A crisis can hit any business at any time—how well you handle the situation could make a monumental difference in the court of public opinion.