By R. Brett Madden

Bird droppings and nesting materials, if allowed to accumulate over time, can cause severe damage to building facades, ledges, loading docks, walkways, roofs and more. Building materials such as stone, wood and metal can be damaged due to the acidity of the bird droppings. And in extreme cases, a buildup of bird droppings can impact the structural integrity of a structure. Also, roof drains can become clogged, and fire hazards from packed nesting materials around electrical fixtures can develop. Not to mention all the possible diseases that can result from disturbing bird droppings! Rather than waiting until these bird problems develop and result in potentially expensive remediation, in most cases, it will be cheaper to consider bird prevention design elements beforehand—specifically, in the design-build stage (ideally) or the retrofit stage (alternatively).

Before we can review the building design elements, it is best to review the types of areas that birds prefer to land, roost and nest. This way, when considering a design element, considering the kinds of spaces they prefer to set up camp will make more sense.

90-Degree Ledges
- Building ledges
- Decorative elements
- Truck bay bumpers
Knee Walls (parapet ledges)
- Typical construction around most commercial buildings
- Roof structure types
- Flat based surface areas
Covered Overhangs
- Loading docks
- Building canopies
- Interior building structures
Roofing Equipment
- Under HVAC units
- Ductwork
- Roof equipment
Water Sources
- Retention ponds
- Decorative fountains
- Any water source (natural or otherwise)
Food Sources
- Fruit trees
- Trash removal
- Container practices
- Proximity to building
Light Fixtures and Electrical Items
- These items provide warmth
- These items provide elevated areas to survey area and avoid predators

In the design-build phase of the project, when we work with architects, we always recommend decreasing the number of 90-degree ledges or reducing the ledge depth surface area as much as possible. In those areas that we are not able to reduce or eliminate the ledge, we would recommend a landing-based deterrent product such as a bird spike, bird wire, ledge exclusion system or electrified shock-based bird control product. Each of these types of bird deterrent items has different pros and cons.

Bird Spikes

Bird spikes are a type of bird deterrent/and anti-roosting device that will make it hard for a bird to land on a leading ledge and close its wings as it walks onto the ledge surface. When a bird’s landing process is made more difficult, combined with a reduction of the surface landing area, the birds will be deterred from the leading ledge area. Most types of bird spikes have thin metal/plastic rods that are attached to a solid base that point in an upward direction. Bird spikes come in various widths depending upon the surface ledge width area. Bird spikes can be mounted to just about any ledge/surface. Bird spikes can be installed on numerous types of building ledge types and sizes. Bird spikes can be an effective deterrent on gutters, signs, rooflines, cameras, pipes, parapet/knee walls, and related building surfaces.

A con of using bird spikes is that bird spikes are primarily designed to deter larger birds like pigeons. Smaller birds such as sparrows or starlings will not be deterred with bird spikes. A smaller bird can move within and around the rods to use the rods to hold nesting materials within the strands of rods to hold their nesting materials within the bird spike to create a nest. Another con is that larger quantities of bird spikes are unappealing to the building aesthetics.

Bird wire

A bird wire system is a combination of stainless-steel posts that are either epoxied or tapped and drilled into the surface area (typically mortar lines/joints). After the stainless-steel post is mounted, a thin monofilament stainless steel wire is secured between the posts with a micro-spring. The wire is tensioned between the two posts. As pigeons or larger birds attempt to land on treated areas, they will not be able to close their wings and thus will be deterred from landing on treated areas.

A con of using bird wire is that it is typically only effective against larger birds.

Ledge Exclusion

The goal is to turn a 90-degree angle into a 45-degree angle. When you have a ledge that has a base landing area and a return wall area, this allows birds a great shelter area and an ability to survey surroundings. By creating a 45-degree angle, you take a bird’s ability to land and get a foothold and land on the surface. The product is effective for larger birds such as pigeons and smaller birds, too.

The only real con of the changing the ledge structure is matching the building finish. However, this is the best bird exclusion method that is effective against all bird species.

Shock Track

Shock track is a low-profile shock track system with a minimalist low profile, and virtually invisible solution to deter and prevent birds from landing, roosting or nesting on building ledge-based surfaces. The shock track system will deliver a mild/startling electric shock when the bird contacts the strip. Shock track systems are a great option when building/structural aesthetics are a key factor for the facility.

For larger areas such as loading docks, canopies, and related covered structures, netting is the main bird exclusion method.

A few cons for a shock system are that at times, you may have some arcing with heavy snow or water collection when connection area of the strips make contact, and this system is typically only effective against larger birds.

Bird Netting

Bird netting is an exclusion method of bird control. It is intended to be installed on buildings, loading docks, warehouses, airport hangers, transportation facilities, barns, food silos, over building exteriors, balconies, parking garages, rooftops, HVAC units, bridges, agricultural crop applications, ponds, and any other surface that netting hardware can be installed. Bird netting is the best method for excluding all pest bird types. Specifically, seagulls, pigeons, sparrows, starlings, and crows can all be excluded from bird netting.

Bird exclusion netting will prevent birds from gaining entry above any areas that are netted off. It excludes pest birds from roosting and nesting. There are various types of netting and mesh sizes. When selecting the type of netting and mesh size, it is critical to both the target pest bird and where the netting is being installed.

By far, bird netting the best bird exclusion method to control all bird species. The only con of bird netting is that depending upon the application, and the cost can be expensive.

In conclusion, when considering the design-build phase or a retrofit project, the aforesaid areas that are attractive to birds to land, roost and nest should be considered. In most cases, birds can be prevented with a bit of planning.

Remember to also consider surrounding areas (proximity of birds), acceptable pest bird threshold levels, reducing all food and water sources, and closing off all possible entry points. The goal is to not only prevent the birds from setting up shop on the building, but we want to try to keep them an acceptable distance away, too.

December 23, 2019

Food Fraud Quick Bites

How Not To Spice Up Your Life

By Susanne Kuehne

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Food fraud, Spices — Find records of fraud such as those discussed in this column and more in the Food Fraud Database.
Image credit: Susanne Kuehne.

Spices claim high prices and are a popular target for food fraud. The Khyber Pakhtunkhwa (KP) Food Autority discarded 5,000 kg of adulterated spices in a Pakistan, and legal action will be taken against the perpetrators. The fraudulent additions included inedible items and unauthorized food colors.

Resource

1. Fahad Shabbir, UrduPoint (December 10, 2019). “KP Food Authority Discarded 5,000 Kg Adulterated Spices”. Pakistan Point News.

December 18, 2019

Food Fraud Quick Bites

Another Seafood Fraud: The Cephalopod Edition

By Susanne Kuehne

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Squid, Portugal — Find records of fraud such as those discussed in this column and more in the Food Fraud Database.
Image credit: Susanne Kuehne.

For more than three years, more than 100,000 pounds of giant squid from Peru was imported into the United States by a father-son duo who owned two Long Island food processing and distribution companies, and then marketed the squid as the more expensive octopus. The mislabeled seafood was worth over $1 million, and 10 grocery stores were defrauded during this time period. This kind of fraud carries steep fines and a possible five-year prison sentence.

Resource

The United States Department of Justice (November 25, 2019). “New York Food Processing and Distribution Companies and Owners Plead Guilty to Seafood Sales Fraud”. Retrieved from Department of Justice, Office of Public Affairs, Press Release Number 19-1307.

December 11, 2019

Food Fraud Quick Bites

Sweet Things, Adulterated

By Susanne Kuehne

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Food fraud, lavendar, honey — Find records of fraud such as those discussed in this column and more in the Food Fraud Database.
Image credit: Susanne Kuehne.

Honey is a popular item for adulteration, and honey with a specific botanical source is seen as a more valuable product. The Czech Agriculture and Food Inspection Authority took samples of organic Spanish lavender honey in a Czech supermarket, and analyzed the pollen. The analysis showed that the honey was from alternative botanical sources and certainly not lavender.

Resources

Czech Agriculture and Food Inspection Authority (May 2, 2019). “Med z mořské levandule BIO tekutý”.

December 4, 2019

Food Fraud Quick Bites

Things Are Smelling Fishy Yet Again

By Susanne Kuehne

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Food Fraud, Decernis — Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.

The nose knows: In case fish smells “fishy”, it is no longer fit for human consumption. A Canadian fish importing company pleaded guilty to the import of 9,000 pounds of rotten and partially decomposed fish into the United States. The potentially adulterated fish was sampled by the FDA, who declared it to be too spoiled to be sold in the country, hence refused its entry into the United States—but the fish was imported via a wrong shipment declaration anyway. The crime of importing refused food carries a prison sentence of up to a year.

Resource

Department of Justice, The United States Attorney’s Office, Western District of Washington (October 18, 2019). “Canadian seafood wholesaler, and owner, plead guilty to illegally importing fish into U.S.”

December 3, 2019

FST Soapbox

Prevention Takes Center Stage to Address Food Recalls

By Colleen Costello

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In the complex food supply chain, a single product travels a long journey before reaching consumers’ plates. It’s no wonder that it has become so difficult to control the quality and safety of food. As food moves from trucks to conveyor belts and through grocery store shelves and shopping carts, the risk for harmful bacteria to contaminate products rises immensely. What’s worse is pinpointing the source of contamination can be nearly impossible, leaving food manufacturers scrambling to “fix” the error without even knowing the cause.

In recent recalls, processing plants completely shut down operations in an effort to resolve the issue and thoroughly sanitize their entire facilities. While this is good news for consumers, this type of reactive response will undoubtedly have a long-term, irreversible impact on the business—both financially and potentially for the brand’s reputation. Consumers remember the name of the company they heard on the evening news that had to pull thousands of pounds of products from shelves in their city or region. Then, when they make their weekly trip to the grocery store, they likely make sure to avoid that company’s products in fear of potential quality issues that could make them and their families sick. It’s a deadly cycle for consumers and public health, as well as business livelihood.

Product and consumer safety must continue to be the top priority for the food industry. The success of these companies literally depends on it. With so much on the line, the food industry must come together to spark a shift in how they operate to prevent food recalls rather than having to respond to them.

Stopping Recalls to Save Lives and Businesses

To move in the direction of mitigating pathogens from ever coming into contact with food and therefore preventing recalls altogether, processors must develop and deploy new strategies that keep facilities consistently clean. The U.S. government is stepping in with regulations such as FSMA that urge companies to shift from reactively responding to safety issues, to proactively working to prevent them. This is the fundamental shift that is needed across the food supply chain in order to protect consumers and food producing businesses.

Important new technologies have emerged in recent years that can add new layers of meaningful protection to continuously combat contamination across the supply chain. When coupled with existing disinfection and cleaning practices, these new technologies can help mitigate the introduction of harmful pathogens as food moves from point A to point B, with all the stops made in between.

One example is the advent of a new class of technology that incorporates antimicrobial LED lighting, which enables food processors to take an “always on” approach to keeping surfaces free of harmful pathogens. Since these lights meet international standards for unrestricted and continuous use around people, they’re able to irradiate large places and the smallest of spaces, all while workers are present.

However, simply deploying these new technologies isn’t enough. For new prevention strategies to be truly successful, food processors should consider the bigger picture. A large percentage of food processors focus primarily on bolstering their sanitation approaches in the areas that have the highest likelihood of coming into contact with food products. This is logical, as Zone 1 and Zone 2 are typically the highest risk for contracting and spreading harmful pathogens.

Environmental Safety Zones — Environmental safety zones. Figure courtesy of Vital Vio.

However, processors are leaving holes in their sanitation strategies by not taking measures to keep areas, such as Zone 3 and Zone 4, also well protected. To ensure food remains free of contaminants, plant managers must ensure the entire environment is fully protected, including the belts and vessels that the food touches, as well as the break rooms where employees rest and offices where management holds meetings. If these areas aren’t kept equally as clean, facilities are risking outside contaminants to enter Zone 1 that can ultimately compromise their food products.

Food recalls have become eerily common, putting a strain on public health and businesses. To stop what seems to be rising to crisis level, all companies involved in the food supply chain need to take a proactive stance toward prevention. This means deploying advanced technologies that continuously prevent harmful pathogens from taking root anywhere in their facilities. Simple yet thoughtful solutions, such as antimicrobial LED lighting, ensure food companies are one step closer to keeping all of us and their businesses safe.

November 29, 2019

Retail Food Safety Forum

To Protect Food Quality, Start With the Data

By Doug Macdonald

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Last month, the FDA held a public meeting to discuss its New Era of Smarter Food Safety initiative, with a rallying call to create a more “digital, traceable and safer food system.”

FDA Deputy Commissioner for Food Policy and Response Frank Yiannas made it clear that the FDA is not replacing FSMA. Rather, the goal is to build on it, recognizing changes in the food industry over the last 10 years and the technologies available to tackle new challenges.

This isn’t surprising given continuing quality issues resulting in food recalls and shelf withdrawals. Last year, two major outbreaks of E. coli that were tied to consumption of romaine lettuce made a mark on industry perceptions, impacting customer trust, brand loyalty and the bottom line of companies involved were affected. Research by Allianz found recall costs could reach $10,000,000 for significant events.

To achieve the FDA’s goal of end-to-end traceability, the amount of information carried by every food item needs to increase, as will information about its location and condition in the supply chain. Grocers are at the sharp end of the food chain, meaning everything the FDA is proposing will impact them. As well as being merchandisers, they are brand-owners in their own right. They work directly with farmers and growers, they are directly involved in food safety, storage and distribution, and they feel the impact of recalls more than most. Unlike others in the food chain, they interact with consumers daily. This is important to note, since consumers are expecting communication on recalls immediately. In a recent study of more than 15,800 global consumers, 66% of respondents noted that they expect immediate notification of a product recall and another 28% stated they expect notification within a week.¹ Furthermore, 88% said if a retailer immediately informed them of an issue, they would be more likely or slightly likely to trust them. The study also found that only 16% of consumers completely trust the product information provided to them from retailers today. In short, the impact of recalls extends far beyond the empty store shelf, and gives the industry even more reason to strive for safety.

High-Tech Next Steps

The FDA plans to publish a strategic blueprint early in 2020 of planned actions to meet its goal, but food brands and grocers need not wait to act. Proven technologies like brand compliance solutions, combined with emerging blockchain track and trace solutions and Internet of Things (IoT) sensors can add new depth and detail to traceability in the food supply chain, and these new technologies are already helping grocers and retailers keep consumers safe.

As retailers have sought a better means to track supply chain movements, blockchain technology has emerged as a potential way forward. Originally developed to manage financial transactions involving cryptocurrency, blockchain has proven to be capable of providing a verifiable record of the movement of goods through a supply chain. In fact, one major retailer has been piloting blockchain for more than a year and has already proven its value on produce items, cutting traceability times from more than a week to a matter of seconds. Some want to go even further and use IoT sensors to monitor the condition (e.g., temperature) of food products in the supply chain. Together, blockchain can help trace the path a product took through the supply chain and IoT can monitor the environmental conditions en route, providing a more cohesive picture of its supply chain journey.

But while supporting a few simple products with one ingredient and a one-step supply chain, such as fruits or vegetables, is one thing, scaling to address the needs of the average private brand retailer—now handling more than 10,000 active products from 2,000 production sites globally—is another. Managing the complexity of a product like tiramisu or a ready-made meal with dozens of ingredients, all coming from different sources, needs a different approach. To address the complexity, many are turning to brand compliance solutions—trusted, real-time repositories of information spanning the entire supply chain. For example, those using brand compliance solutions now have complete visibility of the ingredients in their private label products, helping them ensure labeling accuracy and transparency for consumers. Brand compliance tools also bring improved visibility of the food supply chain, enabling them to verify the status of manufacturing sites and respond quickly to food quality issues.

This combination of detailed product and supplier information makes brand compliance a foundational enabler for any blockchain/IoT-based initiative to improve supply chain visibility and traceability. For example, using brand compliance solutions, grocers can:

Confirm the ethical compliance of the supply chain at the point of selection or review, while using blockchain/IoT to monitor the ongoing conformance to these standards
Validate shelf life claims during formulation, while blockchain/IoT monitors logistical movement and environments to optimise products’ freshness
Record products’ formulation and ingredients to ensure safety, legal compliance and labeling accuracy, with blockchain/IoT monitoring the ongoing conformance to these standards
Rapidly identify potential risks across the entire formulation and supply chain, while tracking the affected batches to stores using blockchain and IoT

This convergence of static factual data (e.g., formulation, nutrition and allergens) linked to near real-time traceability and checking offers grocers confidence in the data and supports the consumer’s confidence of an actual product in their basket.

Looking Ahead

It seems clear that the food business is moving in the same direction as airlines and banks and becoming much more data driven. For grocers looking to keep pace, they will need to:

Treat data as a core competency. This means hiring information experts, investing for the future, and using data to identify ways to deliver better, safer products.
Create a customer-centric value promise. Grocers must go beyond regulatory compliance and use data to improve consumer transparency, support ethical sourcing initiatives, expand sustainable packaging and speed innovation.
Go above and beyond. Rather than waiting for FDA direction or simply complying with requirements, brands should take matters into their own hands, hold themselves to high markers and get started now.

In the future, improving the way that we manage the food supply chain is not just about how well we work with trucks and warehouses; it’s about how use information. The FDA’s initiative makes a clear statement that now is the time to modernize our food supply chains. As we look ahead to a new decade, the industry can come together to improve food safety and protect consumers, and we need not wait for the FDA’s blueprint or even the new year to get started.

Reference

Setting the Bar: Global Customer Experience Trends 2019. (2019). Oracle Retail. Retrieved from https://go.oracle.com/LP=86024.

November 27, 2019

Food Fraud Quick Bites

It Is Natural, So It Is Good For You – Or Not?

By Susanne Kuehne

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Pills, food fraud — Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.

In a large study of nearly 6000 products, more than a quarter (27%) of herbal medicines and foods sold in 37 countries on six continents was found to be deliberately or accidentally adulterated. In this study, the products, which came in a variety of forms such as softgels, tea and more, were analyzed with high throughput DNA sequencing and showed mislabeling, added fillers, substituted ingredients or contaminants. Such fraud can be a harmful to consumer health and safety, and must be monitored and tracked closely.

Resource

Ichim, M.C. (October 24, 2019). “The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally Widespread Adulteration”. “Stejarul” Research Centre for Biological Sciences, National Institute of Research and Development for Biological Sciences, Piatra Neamt, Romania. Frontiers in Pharmacology. Retrieved from https://www.frontiersin.org/articles/10.3389/fphar.2019.01227/full.

November 25, 2019

FST Soapbox

How Will AR and VR Improve Safety in the Food Industry?

By Megan Ray Nichols

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The food and beverage sector is a huge presence in the U.S. economy. As of 2017, the industry employed 1.46 million people across 27,000 different establishments. Total food and beverage sales stand at around $1.4 trillion and add $164 billion in value to the economy as a whole.¹ This presents significant opportunities and risks alike. Companies that trade in food products are held to some of the highest regulatory standards. With globalization ongoing and a higher demand than ever for variety and niche products, companies find they need to expand the mobility of their services. They must also broaden their product choices without missing a beat when it comes to quality.

Augmented reality (AR) and virtual reality (VR) have emerged as unlikely allies in that quest. These technologies are already having a positive impact on food and worker safety in the industry.

Improves New Employee Training

Onboarding and training new employees is a costly and time-consuming endeavor in any industry. Moreover, failure by companies to impart the necessary skills, and failure by employees to retain them, can have ghastly consequences. Errors on assembly lines may result in faulty products, recalls, worker and customer injuries, and worse.

The stakes in the food and beverage sector are just as high as they are in other labor- and detail-oriented industries. VR provides an entirely new kind of training experience for employees, whether they’re working on mastering their pizza cutting technique or brewing the perfect cappuccino. Other times, “getting it right” is about much more than aesthetic appeal and immediate customer satisfaction.

Animal slaughtering and processing facilities represent some of the more extreme examples of potentially dangerous workplaces in the larger food and beverage industry. Between 2011 and 2015, this U.S. sector experienced 73 fatal workplace injuries. Excepting poultry processing, 2015 saw 9,800 recordable incidents in animal processing, or 7.2 cases for every 100 full-time employees.

Some adopters of VR-based employee training claim that virtual reality yields up to an 80% retention rate one year after an employee has been trained. This compares extremely favorably to the estimated 20% retention rate of traditional training techniques.

Training via VR headset can help companies get new hires up to speed faster in a safe, detailed and immersive environment. Food processing and service are high-turnover employment sectors. The right training technology can help workers feel better prepared and more engaged with their work, potentially reducing employee churn.

Helps Eliminate Errors in Food Processing

Augmented reality is already demonstrating great promise in manufacturing, maintenance and other sectors. For instance, an AR headset can give an assembly line worker in an automotive plant detailed, step-by-step breakdowns of their task in their peripheral vision through a digital overlay.

The same goes for food and beverage manufacturing. AR headsets can superimpose a list of inspection or processing tasks for workers to follow as they prepare food items in a manufacturing or distribution facility.

In 2018, there was an estimated 382 recalls involving food products. Augmented reality alone won’t bring that number down to zero. However, it does help reduce instances of line workers and inspectors missing critical steps in processing or packaging that might result in contamination or spoilage.

Eases the Learning Curve in Food Preparation

There are lots of food products in the culinary world that are downright dangerous if they’re not prepared properly and by following specific steps. Elderberries, various species of fish, multiple root vegetables, and even cashews and kidney beans can all induce illness and even death if the right steps aren’t taken to make them fit for consumption.

In early 2019, inspectors descended on a Michelin-starred and highly respected restaurant in Valencia, Spain. The problem? A total of 30 patrons reported falling ill after eating at El País, one of whom lost her life. Everyone reported symptoms similar to food poisoning.

The common element in each case appeared to be morel mushrooms. These are considered a luxury food item, but failure to cook them properly can result in gastric problems and worse. Augmented reality could greatly reduce the likelihood of incidents like this in the future by providing ongoing guidance and reminders to new and veteran chefs alike, without taking the bulk of their attention away from work.

Brings New Efficiencies to Warehousing and Pick-and-Pack

Consumers around the globe are getting used to ordering even highly perishable foodstuffs over the internet—and there’s no putting that genie back in the bottle. Amazon’s takeover of Whole Foods is an indicator of what’s to come: Hundreds of freezer-equipped and climate-controlled warehouses located within a stone’s throw from a majority of the American population.

Ensuring smooth operations in perishable food and beverage supply chains is a major and ongoing struggle. It’s not just a practical headache for companies—it’s something of a moral imperative, too. The World Health Organization finds that around 600 million individuals worldwide fall ill each year due to foodborne illnesses.

Augmented reality won’t completely solve this problem, but it may greatly reduce a major source of potential spoilage and contamination: Inefficiencies in picking and packing operations. Order pickers equipped with AR headsets can:

Receive visual prompts to quickly find their way to designated stow locations in refrigerated warehouses after receiving refrigerated freight.
Locate pick locations more efficiently while retrieving single items or when they already have a partial order of perishable goods picked.

In both cases, the visual cues provided by AR help employees navigate warehousing locations much more quickly and efficiently. This substantially lowers the likelihood that food products are stuck in limbo in unrefrigerated areas, potentially coming into contact with noncompliant temperatures or pathogens. The FDA recognizes mispackaged and mislabeled food products as a major public health risk.

For food and beverage companies, AR should be a welcome development and a worthy investment. FSMA recognized that 48 million Americans get sick each year from compromised foods. The act required these entities to be much more proactive in drawing up prevention plans for known sources of contamination and to be more deliberate in standardizing their processes for safety’s sake.

AR and VR Boost Food, Worker and Customer Safety

Augmented and virtual reality may seem like an unusual ally in an industry where most consumers are primarily focused on the aesthetic and sensory aspects of the experience. However, there’s a whole world that lives and dies according to the speed and attention to detail of employees and decision-makers alike. Augmented realities, and entirely new ones, point the way forward.

Reference

Committee for Economic Development of The Conference Board. (March 2017). “Economic Contribution of the Food and Beverage Industry. Retrieved from https://www.ced.org/pdf/Economic_Contribution_of_the_Food_and_Beverage_Industry.pdf.

November 20, 2019

Food Fraud Quick Bites

Keeping Food Safe, the U.S. Way

By Susanne Kuehne

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Food fraud — Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.

In the United States, the FDA is responsible for regulations and recommendations to protect public health, which includes the prevention of any type of food adulteration (unintentional contamination, intentional adulteration, and food fraud – or “economically motivated adulteration”). FSMA (the Food Safety Modernization Act) resulted in new regulations and guidance with strategies to reduce all types of risks in food facilities. It was the most comprehensive reform of FDA’s food safety regulations in more than 70 years.

Resource

FSMA Rules & Guidance for Industry.