Tag Archives: monitoring

Chelle Hartzer, Orkin
Bug Bytes

Stored Product Insects Are Costly Consumers

By Chelle Hartzer
No Comments
Chelle Hartzer, Orkin

How much can pest issues cost? The truth is, it changes based on the pest, the size of the population and the prevalence throughout your food processing facility and products. If you want to protect your bottom line, you need to know which pests are the biggest threat and take steps to prevent them. Let’s focus on one major threat to food processing facilities: Stored product insects.

Believed by some pest control providers to be the costliest pests for food manufacturing and processing businesses, stored product insects can put a huge dent in your profits. What’s worse, these pests can be tough to discover by an untrained eye, and they’re incredibly difficult to control without the help of a pest management professional.

According to the USDA and the University of Wisconsin, “stored product pests can damage, contaminate, or consume as much as 10% of the total food produced in the U.S. alone, while in developing countries that rate has been estimated at 50% or more.”

That’s an astronomical figure for such small insects! Can you imagine the impact on your bottom line if 10% of your product was ruined?

For any business in need of an updated prevention plan, the first step is to review the current integrated pest management (IPM) program to ensure a proactive approach has been implemented to monitor for, and react quickly to, any pest issues around the facility. There’s no one-size-fits-all strategy for an IPM program; each program should be customized to meet the needs of the individual business. Different geography, construction and food products being produced can all create different pest pressures.

According to another study conducted by CEBR on the impact of pests on the global food supply, disruptions caused by pest infestations resulted in $9.6 billion in operating costs in the countries surveyed and 84% of U.S. businesses reported a net impact on revenue due to pest infestation across a five-year period. Diving deeper, 28% of food manufacturers and processors reported pest-related costs associated with contamination of raw materials leading to replacement costs.

In other words, having stored product insects around is expensive. If there were ever any doubts about the value of a proactive IPM program, these statistics prove it. So, let’s take a closer look at how you can work to protect your business against stored product insect—some of the most likely and costly invaders.

Types of Stored Product Insects

The term stored product insect covers a range of insect species that can be broken up into three main subcategories: External feeders, internal developers and secondary feeders. Each category has its own distinct characteristics, which are important to know for detection and proper identification.

External Feeders

This group develops on the outside of products, including damaged grains and processed foods. As they feed, they damage product and leave behind frass (insect droppings) as they make their way through.

Some of the most common external feeders include Indian meal moths and flour beetles.

Adult Indian meal moths are roughly 9 mm long and have a wingspan of 14–20 mm. The front wings on the adults are bicolored, with two main tones: Reddish-brown at the wing tip and silver-grey at the base. If you don’t see the pest itself, you may notice a messy silk webbing spun by the larvae.

Red and confused flour beetles, two of the most common beetle species, are 3–4 mm in length and also have a reddish-brown color. They’re rectangular-shaped beetles and can often be found in grain bins infested with internal developers. This is because flour beetles like to feed on the kernels other stored product insects, like borers, have already broken up. They can also be found in processing lines and finished products.

Internal Feeders

Internal feeders lay eggs inside or outside of kernels of grain but develop entirely inside those kernels. As they develop, they hollow out the kernel, then the adults can go on to damage other kernels.

Some of the most commonly encountered internal developers are lesser grain borers and rice, maize and granary weevils. Weevils measure about 5 mm in length and are usually brown in color with a distinct elongated “snout.” Lesser grain borers, the most common internal feeder across the United States infesting wheat, are a bit smaller and don’t have the snout that weevils do. Both weevils and lesser grain borers have pitted patterns on their bodies, and all can fly except the granary weevil. As the larvae and pupae develop inside grain kernels, damage becomes especially evident when the adult chews out and leaves a distinctive perfectly round hole.

Secondary Feeders

This group typically eats from the outside in and feeds on the mold and fungus that can grow on out-of-condition grain and damp product.

Two of the most common secondary feeders are the foreign grain beetle and sawtoothed grain beetle. Foreign grain beetles love mold, and resemble flour beetles in size and color. To tell them apart, look for two “bumps” on the top corners of the thorax. Eliminating molds and damp conditions that facilitate mold growth is generally enough to help prevent infestations from secondary feeders.

Sawtoothed grain beetles can feed on many types of products and while they can’t physically penetrate packaging, the adults will find holes less than 1 mm in diameter, lay eggs, and the larvae will squeeze through the tiny openings to get to the product. They prefer processed food products like bran, chocolate, oatmeal and even pet foods, but will feed on whatever they can access. Sawtoothed grain beetles are smaller than flour beetles (3 mm) and have distinctive “teeth” on the margins of the thorax.

Prevention, Monitoring & Detection, and Removal

The best way to protect a facility from stored product insects is to employ numerous different tactics. Specifically, it’s important to proactively mitigate pest attractants, monitor for activity in key areas around the facility, and establish thresholds and action plans when pests are detected.

First and foremost, educate all employees about the pests most common around your facility and what to do should they spot one. Your pest sighting log is a great tool, but only if people use it! Have a clear escalation plan for any pest issues spotted. In addition, create a sanitation schedule to ensure all areas and equipment are cleaned to remove food and moisture buildup attractive to pests on a regular basis. While you can’t possibly eliminate all food (you are of course storing and processing food!), the aim is to minimize the amount and the access these insects have to that food source.

Next, make sure all incoming shipments and packages are inspected closely in a sealed off unloading area away from other products. Make sure employees know to check for signs of damage, especially holes caused by boring pests. Taking the time to inspect anything entering your facility in this way will give you a chance to spot pests before they have the chance to spread to your other products. Use the first-in, first-out (FIFO) approach for all goods to ensure older product doesn’t sit. The longer product sits, the more chance it can be infested and it may start deteriorating, and this is especially attractive to stored product insects.

For ongoing monitoring, talk to a pest management professional about deploying pheromone traps strategically around your facility. Pheromone traps are the best tool to monitor for stored product insects, as they will give you an idea of which pests are present, in what numbers, where they are, and they can help you track trends in pest activity over time. If any stored product insects are ever spotted, contact your pest management professional immediately. If there’s a chance of having stored product insects on your product, you absolutely should have pheromone trap monitoring in place.

The Total Cost of Stored Product Pest Problems

The impact of pest issues caused by stored product insects isn’t limited to the cost of paused operations and replacing contaminated product. These pests are tough to spot, and could be passed along to partners further down the supply chain. Naturally this could hurt the trust between supply chain partners, which is never a good thing!

If your facility gets a reputation of having problems with stored product insects, it’s going to hurt your brand—and that’s going to be another knock to your bottom line. Stored product insects can spread quickly between products placed closely together. So, if pests are mistakenly shipped to a partner’s facility or a store and then on to a customer, now THEY are going to have to deal with stored product insects, too. Being proactive is the best approach, and careful documentation can help you and your supply chain partners track pest issues to the source so they can be resolved quickly and minimize the impact on profits.

It becomes easy to see stored product insects can cause both short-term and long-term effects on the profitability of a business. Don’t let that be your facility and your reputation! Be proactive and partner with a pest management provider to help ensure your facility operations run smoothly and your customers stay happy.

Glen Ramsey, Orkin
Bug Bytes

Using Monitoring Devices to Protect Products from Pests

By Glen Ramsey
No Comments
Glen Ramsey, Orkin

They’re sneaking in through your windows, crawling through your front door when nobody is looking and squeezing through tiny openings to steal your food. They’re tough to catch, and even tougher to spot.

Naturally, we’re talking about pests. They come in all shapes and sizes, but have the same goal: To find a reliable, safe place to call home where they have abundant access to food, water and shelter. Unfortunately, food processing facilities offer pests all three of these things, making them susceptible to infestations that can compromise products and hurt the bottom line.

You probably already have an integrated pest management (IPM) program in place to mitigate the risk of pests inside your facility. While these programs are great for offering proactive, preventive solutions that use chemical solutions as a last resort, they shouldn’t be the beginning and end of your pest management efforts.

First and foremost, facility staff should always be familiar with the warning signs of pest issues and what to do if they spot something crawling around the building. Most pest management companies will offer complimentary training sessions for you and your staff, which is a great first step. Then, during your weekly/monthly staff meetings, let your employees know which pests are most likely to cause a problem and include some images of warning signs. Empower them to call out problems, explain the risks of pest damage to your products, and you’ll have a better chance of catching pest problems early.

But your staff can’t be expected to spot everything, and there are always pests that slip through the cracks.

That’s why pest management professionals frequently recommend using a variety of tools to closely watch pest activity and detect emerging hot spots around facilities. Tools like IR thermometers, moisture meters and telescoping cameras help pest management professionals identify these high-risk areas. Once these areas have been identified, your pest management professional can take the next step in advanced detection using monitoring devices to paint the picture of pest activity around your facility.

Monitoring devices make it easier to see where pests are traveling and give an idea for how many may be present. These devices capture pests for identification, assist in early detection and will help to mitigate the risk of infestation through early warning. If you’re particularly worried about an upcoming audit or the recent enforcement deadlines for FSMA, these devices will give you a better chance of scoring well and can help you demonstrate compliance by shifting your pest management plan to a more proactive approach as mandated by these new regulations.

There could be quite a few of these monitoring devices you’d like to start using around your facility today.

Fly Lights

A popular device found in many food processing facilities, fly lights attract flying pests by emitting strong UV lights that draws insects in, at which point they become trapped on a sticky glue board in the back of the light—out of sight and away from your products. They work best when placed inside near doorways and windows where pests might be able to squeeze inside, but they’re effective just about anywhere. Discuss placement with your pest management provider.

Why does it work?

The leading theory on why flying pests are attracted to lights has to do with their reliance on the sun and moon as navigational guides. In the past, insects could use the sun and moon as a guide because it stayed at a constant angle, allowing them to move in a consistent direction. However, artificial light confuses them and causes them to circle around the light source. Insects that move towards light in this way are called positively phototactic, while pests like cockroaches who move away from light are called negatively phototactic.

Mechanical Traps

Most commonly used for rodents, mechanical traps can allow for the humane capture and removal of rats and mice. These traps sound simple, and that’s because it is; the concept hasn’t changed for years. Why? Because it’s effective! Rodent curiosity or bait can draw the rodent inside one of these stations, which have a mechanical door ready to close as soon as it enters. There is also new technology on the way that will instantly notify both customer and pest management professional when this occurs, so the creature can be removed immediately. These stations are most frequently used around the interior perimeter of a facility to keep rodents from getting further than the exterior walls.

Why does it work?
Simply put, rodents will often run along walls. They’re extremely athletic and very clever, which is why it’s never recommended to try to place traps yourself. They can learn from close calls with unsuccessful trapping techniques, which is why it isn’t worth the risk to handle rodent issues alone. With proper knowledge and placement, they can be outsmarted.

Sticky Traps and Glue Boards

Perhaps the simplest tools in the pest professional’s shed, sticky traps and glue boards are meant to reduce the population of crawling insects around a facility. Because they’re not very large, they can be used just about anywhere inside a facility.

Why does it work?

These are usually used for small population control in areas where crawling pests are already present. Sticky traps and glue boards are generally coated with a substance that attract pests, which then ensnares them when they step on the surface of the trap. These are great for catching pests like cockroaches, and give you a sense of how many pests are coming through an area over a period of time. Over time, you’ll be able to see if the population is trending downwards or if the problem is getting worse based on the number of pests captured.

Pheromone Traps

Great for combating the stored product pests that pose a huge threat to food processing facilities with large inventories, pheromone traps trick pests into getting trapped. While sticky traps can be used all over, pheromone traps are more effectively used by placing them strategically around storage areas to help monitor for any stored product pests.

Why does it work?

This type of trap uses synthetically replicated versions of insect pheromones, which are secreted chemicals that insects put out to communicate with each other. In this case, the pheromone traps lure pests out from their hiding/feeding areas. There are also probe-type pheromone traps that are best used in bulk grain storage if necessary.

Now this isn’t an exclusive list of all the monitoring devices a pest management professional can recommend around your facility, but it does give you an idea of the most common, effective devices out there. Keep in mind that sanitation and exclusion must also be a big part of any IPM program, but monitoring devices (along with detailed documentation) can take your program to the next level and give you a better feel for the pest issues your facility deals with the most.

Any time you’re using these tools and devices to detect pest hot spots, it’s important to record the results over time. Your pest management professional will keep a logbook of findings on site, and you should reference that regularly. Also, consider requesting or creating a trend map of pest activity over time to help you see which pests are plaguing your facility the most. That way, it will be easy to work towards improving the pest management program you have in place, which in turn will help protect your products from contamination and protect your bottom line.

Megan Nichols
FST Soapbox

Blockchain Improves Visibility In the Food Supply Chain

By Megan Ray Nichols
2 Comments
Megan Nichols

Cryptocurrency is a favorite topic in the business world currently, but it’s not the coins or currency that are the star of the show. Bitcoin in and of itself is exciting and promising from several perspectives. However, the foundation of what these technologies run on is much more important. You likely already know what we’re going to talk about next: Blockchain.

To understand why blockchain is considered so crucial, you first need to delve into the core components of the technology. It’s basically a digital ledger, except it has some incredibly useful properties that make it uniquely lucrative. For starters, it’s public and transparent, so anyone with access to the network can see what’s happening in the moment, or what has been happening while they were away. However, the parties involved in a transaction or entry remain private, as do the materials or items exchanging hands.

Finally, because of the nature of blockchain, it’s secured and valid. The ledger itself is thoroughly protected, and no one can alter data save the parties involved. Even then, the relevant parties only weigh in with pertinent information such as time and date of the transaction and the amount transferred.

Most of what we’re talking about here is in reference to currencies and more traditional transactions. But it’s important to remember that we’re merely scratching the surface. As we speak, various organizations are working to adapt this technology for alternate industries and applications.

Still, what does any of this have to do with your average food supply chain?

Blockchain May Evolve the Food Supply Chain As We Know It

Believe it or not, blockchain can help improve the transparency and management of the food supply chain. It’s definitely needed. The world’s population continues to grow, and it’s expected to reach 10 billion by 2050. In food requirements, that means we’ll need to be increasing food production by as much as 70% to keep up. This puts a demand on the food supply chain to evolve and become more efficient, more accurate and more reliable.

The following are several ways blockchain can help achieve better transparency in and management of the food supply chain.

Preventing Foodborne Outbreaks, Enabling Fresher Goods

IBM has teamed up with several major suppliers including Wal-Mart, Dole and Nestle to come up with a blockchain-powered system that can be used to track a product’s journey from farm to store shelves. The goal is to create a more transparent deployment and transportation process so that interested parties can see exactly when and where certain foods might become contaminated.

Tracking this information will achieve a couple of things. For starters, public health officials, suppliers and management teams can help limit and prevent contagions from spreading. After the detection of Salmonella, for instance, they could mark all related goods as a risk and stop both stores from selling them and consumers from buying faster than ever before.

Second, it will help identify problematic systems and processes, hopefully cutting down on the risk of contamination in the future. If they know certain foods are going bad in transport, they can discern that it’s something to do with how they’re handled or stored along that segment of the journey. This would further enable them to identify and fix or optimize the issue. In other words, suppliers and retailers will use blockchain to keep food fresh. This is especially important since FSMA calls for reliable hygiene and storage methods during transportation.

More Accurate Inventory Tracking for Distributors

Unexpected shortages pose significant challenges to the food supply chain. A variety of external factors can contribute to a supply block, including inclement weather, poor soil, insect infestations, equipment failures and much more. When this happens, distributors are left to pick up the slack, but sadly, they often can’t do much to fix the problem.

Blockchain technologies, however, make the supply chain more transparent, which helps distributors get the information they need to address shortages. Through the use of blockchain, they’ll know exactly how much supply is available and what they need to do to ramp up their offerings.

For example, in the event of a shortage, they might connect with local farmers to make up the difference. Gathering the information needed to find the right partner, however, can take a long time when using traditional methods. Through blockchain, though, distributors could easily see product types, farming practices, harvest dates and amounts, treatment info, fair-trade certifications and other information. This would allow them ample time to find a suitable replacement or additional partner.

Transparent Safety Protocols

The food supply chain is lengthy, includes a lot of different parties and involves a lot of metrics and details that need to be recorded and monitored. The problem with having so many factors is that it can muddy the waters. It’s hard to keep track of what every party is doing, where problems exist and what improvements can be made.

Many modern food supply providers are as transparent as they can be with partners and colleagues, but it’s not an element you would describe as streamlined or accessible to all. Blockchain can completely alter and disrupt this for the better.

Since food safety is an enormous concern for suppliers, distributors and retailers, blockchain can offer more than just peace of mind. It can help organizations perfect the entire process, improving safety for consumers and even enhancing the freshness or quality of the products provided. Improper storage or transport, for instance, can have a detrimental effect on quality, before the goods even reach store shelves. Blockchain will enable better tracking and monitoring, and make the resulting details much more accessible and transparent.

It’s Time for the Food Supply Chain to Evolve

The coming change is warranted and welcomed by many. A more transparent process means a much more accessible system. Suppliers can better communicate with farmers and food sources. Distributors and retailers can keep a close eye on the goods they’re acquiring and offering to consumers. Furthermore, safety, quality and quantity can be more accurately monitored and measured by everyone along the way. It’s time for the food supply chain to evolve in this way — it’s been a long time coming.

Robert Rogers
FST Soapbox

Validating Your Foreign Material Inspection System

By Robert Rogers
No Comments
Robert Rogers

The Food Safety Modernization Act (FSMA) requires that food manufacturing and processing companies identify potential hazards within their production systems and then:

  • Put in place preventive controls to address those hazards,
  • Monitor those preventive controls to ensure their effectiveness &
  • Provide documentation proving compliance with these requirements.

There are also requirements for each company to develop and establish its own plan identifying potential food safety hazards and preventive controls to counter them, and to establish the monitoring procedures that will verify the efficacy and reliability of the preventive controls.

Validating, verifying and monitoring the performance of the systems that ensure that only safe food enters the market enables food manufacturers and processors to meet the specific regulatory standards mandated by the countries where they operate and sell. This enables them to avoid product recalls that are costly and that severely damage brand identity. But these processes, in addition to satisfying regulators, also play a valuable part in protecting the companies from potential liability lawsuits, which can often be even more damaging.

The preventive controls most often used to effectively deal with such identified hazards are inspection systems (checkweighers and metal detection, X-ray and machine vision inspection systems) that quickly and efficiently detect non-standard and contaminated products and defective packaging and reject them from production lines before they can enter the marketplace. The performance of these systems must be validated, verified and monitored on an ongoing basis to ensure that they are performing as intended.

These terms–validation, verification and monitoring–are often used interchangeably, creating confusion within organizations and across industries because people interpret and use these terms in different ways. In fact, each term identifies a distinct process that has a clear purpose and role to play at different points throughout the equipment lifecycle. It is important to understand the purpose of each process to make sure that validation, verification and routine performance monitoring tests are performed to comply with regulatory requirements, particularly where the equipment is designated as a Critical Control Point (CCP).

Validation

The fundamental act of “validation,” when applied to inspection systems that are part of a food manufacturing or processing production line, is conducting an objective, data-based confirmation that the system does what it was designed, manufactured and installed to do. The International Featured Standards (IFS) organization defines validation as “confirmation through the provision of objective evidences, that the requirements for the specific intended use or application have been fulfilled.” In 2008, the Codex Alimentarius Commission defined validation as, “Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.” An important part of the validation procedure is the production of detailed data that demonstrates to line managers and to regulators that the system is operating as designed.

The manufacturer of each inspection system will validate its performance before delivery, testing it with generic products and packaging similar to what the customer will be producing. But that is only the beginning of the validation process. Onsite, that same system needs to be validated when inspecting the specific products that the production line where it will operate will be processing and/or packaging. This is ideally done at the time the system is originally installed in a production line, and then becomes one element of a complete program of validation, periodic verification and ongoing monitoring that will keep the system operating as intended and ensure that products are adequately and accurately inspected, and that accurate records of those inspections are kept.

It is critical for producers to remember, however, that the original onsite validation relates only to the specific products tested at the time. As new or additional sizes of products are developed and run on the production line, or packaging (including labeling) changes, the system will need to be re-validated for each change.

Verification

Verification is the process of periodically confirming that the inspection equipment continues to be as effective as when it was first validated. The verification process uses standard, established tests to determine whether the inspection system is still under control and continuing to operate as originally demonstrated. This verification process is conducted periodically at regular intervals to provide evidence-based confirmation that the system continues to be effective as specified. Formal performance verification is typically an annual process, to support audit requirements. It should continue throughout the productive life of the system.

Both validation of an installed system and periodic verification of operating systems can be conducted either internally by the end-user, or by the supplier of the equipment. Validation and verification services are often included as part of equipment purchase contracts.

Monitoring

Routine performance monitoring, as distinct from periodic verification, consists of a series of frequent, regular performance checks, during production, completed to determine whether processes are under control and to confirm that there has not been a significant change in the system’s performance level since the last successful test. The monitoring frequency may be as often as every two hours, depending on company standards, industry standards and/or retailer codes of practice.

If the monitoring process finds that a particular device is out of specification, all product that has passed through the production line since the last successful routine performance-monitoring event must be considered suspect and re-inspected.

In many cases, it is line operators that conduct online performance monitoring. However, many of today’s more sophisticated product inspection systems incorporate built-in performance monitoring software that automates this process and alerts operators when deviations occur. This valuable software feature removes any human error factor from the monitoring activity to help ensure that inspection processes are still being performed properly. It also provides documentation that will guide the end-user company’s QA groups in their continuous improvement efforts, and that will also be a valuable asset in the event of an inspection visit from regulators.

Routine performance monitoring can also have a direct impact on the production line’s OEE. Installing a system with built-in condition monitoring capability that automatically detects when the system may need correction and communicates that information directly to line operators reduces the frequency needed for verification testing, maximizing the line’s production uptime.

Reliance on the experts

Finally, food manufacturers and processors should remember that, while they are knowledgeable experts regarding their products, it is their equipment suppliers that are the experts on the capabilities and qualification procedures of their equipment. That expertise makes them the best source of reliable recommendations on questions from the most effective inspection equipment type for specific product needs, where to place that equipment on the production line for optimum results and how to validate, verify and monitor its performance.

Relying on these experts to conduct onsite validation and to advise on conducting periodic verification and ongoing performance monitoring can reduce both the time needed for the original onsite validation time and that needed for verification and ongoing monitoring procedures, increasing productivity.

Companies can also rely on these experts to be knowledgeable on the most current food safety regulations and the technology that affect equipment validation. It is critical for their success that they stay current on those topics, and sharing that knowledge is a valuable part of their service.

8 Food Industry Trends Fueled by FSMA

By Lori Carlson
No Comments

FSMA is fostering a surge in technology solutions, analytical tools and training products marketed to the food industry in the name of achieving FSMA compliance. And while many of these products were available pre-FSMA (especially in other industries like the life sciences), FSMA’s momentum has fueled the adaptation of solutions to meet the specific needs of the food industry for achieving and maintaining regulatory compliance. This article is a summary of emerging trends in food safety management by producers, manufacturers, distributors and retailers through the application of technology, educational tools, monitoring and detection systems, and other support mechanisms.

Want to learn more about FSMA trends and compliance? Attend the 2016 Food Safety Consortium in Schaumburg, IL | December 7–8 | LEARN MOREWhether by the spark of FSMA or because it makes practical sense (and most likely, a bit of both), businesses are integrating their food safety programs with enterprise initiatives and systems for managing compliance and risk to achieve increased visibility and harmonization across the organization.  The most popular trends fueled by FSMA largely reflect technology solutions to achieve this integration.

Subsequently, solutions that support risk assessment, supply chain management, real-time monitoring, corrective action, self-assessment, traceability, and training management are most attractive and lucrative from an ROI perspective. And while it may be hard to find a one-size-fits-all technology solution depending upon the needs of the organization, technology service providers are quickly raising the bar to meet these growing needs as organizations strive to reduce risk and increase compliance. Other top trends at the periphery of technology solutions include the mobilization of food safety personnel and increased availability of on-demand training and detection tools to bring the FSMA movement full circle.

1. Software-as-a-service (SaaS) technology solutions quickly gained a following in the food industry in recent years to achieve an automated food safety and quality management system (FSQMS) solution.

The substantial management components and recordkeeping requirements of the FSMA rules has accelerated the food industry’s need for automated solutions to document program management, queue workflows and distribute notifications for corrective and preventive action (CAPA). Understanding this need, many SaaS providers evolved with FSMA to provide functionality that dovetails with new regulatory requirements.

2. Increased availability of risk and vulnerability assessment tools is of significant importance in meeting many requirements of FSMA’s rules.

The regulatory language of all FSMA rules is steeped in risk analysis to support the prevention of food safety hazards and threats. This creates a demand for user-friendly tools and training courses to help food businesses analyze and update their management systems within the context of these new requirements. Risk and vulnerability assessment tools currently available to the food industry are diverse in functionality and vary in scope and cost.

For example, FDA’s free online tool, FDA-iRISK 2.0, assesses chemical and microbiological hazards in foods through process models, which quantify risk across scenarios and predict the effectiveness of control strategies.  Commercially available food hazard assessment tools based on HACCP/ HARPC principles include Safefood 360° and EtQ, which provide risk assessment modules as a part of their SaaS platform.

Universities, trade associations, and commercial risk management and consulting firms came together to produce two very different food fraud vulnerability tools to support the industry. SSAFE by the University of Wageningen RIKILT, Vrije Universiteit Amsterdam and PricewaterhouseCoopers (PwC) is a free online tool and mobile app, which guides users through a decision tree and assessment questionnaire to determine fraud opportunities, motivators and gaps in existing controls. EMAlert by the Grocery Manufacturers Association (GMA) and Battelle is a subscription-based online tool to assess vulnerability from economically motivated adulterants (EMA’s). Individuals conducting vulnerability assessments are recommended to periodically access food risk databases such as the U.S. Pharmacopeial Convention’s (USP) food fraud database to stay informed of historical and emerging threats to the supply chain.

And in support of FSMA’s Food Defense rule, the FDA developed a free food defense software tool, Food Defense Plan Builder (FDPB), to help food businesses identify vulnerability to intentional adulterants and terrorist attacks on the food supply chain.

3. SaaS platforms, app-friendly assessment tools and FSMA recordkeeping requirements are creating a natural pathway for the increased use of mobile devices and electronic recordkeeping and verification.

From supply chain management to effective traceability to regulatory compliance, efficient document management and on-demand data retrieval is a must have of the modern FSQMS. Food businesses recognize the inherent obstacles of paper-based systems and increasingly trend towards rugged mobile devices and electronic recordkeeping to make better use of personnel resources, technology solutions and data. FSMA is helping leverage this trend two-fold through increased requirements for documentation and verification of food safety management activities and by not requiring electronic records to additionally meet the provisions of 21 CFR part 11 (electronic recordkeeping).

4. An increased demand for more effective, frequent and accessible training must be met across an organization to maintain an adequately trained workforce responsible for implementing FSMA.

To keep up with this demand—as well as the training demand imparted by GFSI schemes and fact that a company’s FSQMS is only as good as those who develop and operate it—food businesses are turning to online and blended learning courses to increase training frequency and effectiveness. In Campden BRI’s 2016 Global Food Safety Training Survey, 70% of food processors and manufacturers responded that they received training deficiencies during audits as the result of a lack of refresher training and/or lack of employee understanding.

In an effort to help close this gap and meet new implementation requirements of FSMA, food safety training providers are increasing offerings of eLearning courses, which provide targeted content in shorter duration to meet users’ needs in an interactive (and often multilingual) format. Shorter and more frequent targeted training is proven to increase knowledge retention and job performance. E-Learning training solutions can be found through dedicated training service providers as well as universities, trade associations, regulatory agencies, scheme owners, certification bodies, and other compliance organizations.

Depending upon the training provider, online training may be distributed through a learning management system (LMS) to provide additional training tools, assess training effectiveness and manage the training activities and competencies of all participants.

5. Targeted monitoring and verification activities such as product testing, environmental monitoring or water quality testing are helping to increase the demand for pathogen testing and push the frontier of improved rapid pathogen detection methods.

In a recent Food Safety Tech article, Strategic Consulting, Inc. noted more than a 13% annual increase in pathogen testing by contract food laboratories as determined by a recent industry study conducted by the group. The study additionally identified turn-around-time as the second most important factor for suppliers when choosing a contract lab. Increased access to rapid pathogen testing—and in particular, detection without time-dependent cultural enrichment—are primary needs of food businesses as regulators and customers push for enhanced monitoring and verification via testing mechanisms.

Currently, there are numerous rapid methods based on DNA, immunological or biosensor techniques. These methods can detect foodborne pathogens in relatively short amounts of time ranging from a few minutes to a few hours. But they often require pre-processing strategies to reduce matrix interference or concentrate pathogens to meet the level of detection (LOD) of the assay.1 These strategies increase the overall time of the assay and are largely the next hurdle for improved rapid detection.

6.  Food businesses are experiencing a wave of self-assessment followed by CAPA as organizations work to analyze and update their food safety systems and protocols within the context of applicable FSMA rules.

This trend has the potential to be the most beneficial to the supply chain and consumers as it provides a distinct opportunity for food businesses to reconsider previously overlooked hazards and vulnerabilities and upgrade food safety controls along with the management system. Seeing the FSQMS with fresh eyes—outside of the framework of a familiar standard—can lead to significant improvements in food safety management, product safety and quality, and even operational efficiency.

7.  For many food businesses, heightened regulation has spurned the need for dedicated staff to support compliance efforts.

Many food businesses are subject to multiple rules—some of which require a dedicated individual such as the Preventive Controls Qualified Individual (PCQI) to assume responsibility for the implementation of various provisions. And food businesses are not exempt from the acute need for qualified individuals with a food safety skill set. Across the industry, from service providers to retailers and everyone in between or at the fringe, executives understand that it takes tireless leadership and knowledgeable staff to produce safe food.

8. More than any other trend, communication on FSMA, food safety and related topics is easily the most prevalent exhibiting exponential activity over the past five years.

Whether in support or contention with the proposed (now final) rules, FSMA promulgates constant dialogue about food safety, what it means and how it should be implemented. The constant flurry of communication provides both benefits and deterrents to understanding the new regulations and identifying effective solutions for compliance. This dichotomy creates a significant need for authoritative and easy-to-understand information from consolidated sources within the industry such as trade associations, risk management organizations and food safety schemes. The divide has also helped fuel the need for information hubs like the Global Food Safety Resource (GFSR) that aggregate critical regulatory information, food safety solutions and best practices to reach a global community.

Reference

  1. Wang, Y. and Salazar, J.K. Culture-Independent Rapid Detection Methods for Bacterial Pathogens and Toxins in Food Matrices. Comprehensive Reviews in Food Science and Food Safety. 2016; 15(1): 183-205.
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

FSMA Preventive Controls: Are You Prepared?

By Bill Bremer
No Comments
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Compliance to FSMA has presented a new and difficult challenge for industry, the public and the FDA since it passed on January 4, 2011. With compliance dates for the initial FSMA rule—Preventive Controls—coming in September 2016, food sites must establish plans now to meet the impending deadline.

Complying with the Preventive Controls Rule

The Preventive Controls Rule was published September 17, 2015, with the compliance date for registered companies (more than 500 employees) scheduled for September 19, 2016. The compliance date is one year later for companies with fewer than 500 employees, unless otherwise specified under FSMA.

Under the FSMA rules, registered food facilities must evaluate and implement preventive control provisions and meet the requirements and the approaching deadline. The most urgent concerns for companies subject to the Preventive Controls Rule include developing a Preventive Controls Program, identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.

The following areas are all included under the FSMA Preventive Controls Rule:

  • Hazard Analysis. Companies must identify and evaluate known and reasonably foreseeable hazards.
  • Preventive Controls. Preventive controls must be implemented to significantly minimize or prevent the occurrence of hazards.
  • Monitoring. Preventive controls must be monitored for effectiveness.
  • Corrective Actions. Procedures for addressing failures of preventive controls and prevention of affected food from entering commerce are required.
  • Verification. Facilities are required to verify that preventive controls, monitoring and corrective actions are adequate.
  • Recordkeeping. Records must be kept for two years.
  • Written Plan and Documentation. A written plan must document and describe procedures used to comply with requirements.
  • Qualified Individual. A Qualified Individual who has been adequately trained must be present at the facility to manage the preventive controls for the site and the products processed and distributed at/from the site.

Failure to implement Preventive Controls (a.k.a., Hazard Analysis and Risk-based Preventive Controls (HARPC)) for qualified sites may result in fines and possible jail sentences.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning for FSMA compliance (see Table I). To complete your own planning assessment, review your progress compared to the questions below.

Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of preparedness for FSMA compliance.
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have their training, planning and development underway to comply, or face possible violations, fines, and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage the preventive controls program—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

Tim Curran, Sample6
FST Soapbox

Putting FSMA Into Practice

By Tim Curran
1 Comment
Tim Curran, Sample6

High-profile food recalls and food-borne illnesses continue to keep food safety top of mind. Yet, many in the industry are still struggling to put the best practices we’ve learned over the years about how to properly secure our global food chain into practice. Put simply: The focus needs to be on prevention rather than reaction.

Food safety procedures must be strengthened across the board to meet increasing regulatory pressures and prevent massive recalls and illness outbreaks. FSMA puts the principles of prevention into law. The first major update of federal food safety laws since 1938, it was signed into law by President Obama at the start of 2011. After years of debate, it is now finalized and implementation can begin. The objective of FSMA is to ensure that the U.S. food supply is safe by shifting the focus from reaction to prevention. Now, who can argue with that?

FSMA also pushes the FDA to extend beyond its traditional reactive role. For the first time, the FDA has the power to stop unsafe and possibly contaminated food from entering the food supply.

Let’s take a quick step back so we can explore how to best put it into action. FSMA is made up of five primary provisions:

  • Preventive controls
  • Inspection and compliance
  • Imported food safety
  • Response
  • Enhanced partnerships

I’d argue that the first provision is the true heart of FSMA: Prevention. The first provision focuses on preventative controls and provides a framework for an effective food safety program. In FSMA, this is broken into five key parts, including hazard analysis, preventative controls, monitoring, corrective action and verification. But what does that mean to you? You can best comply with these requirements by implementing better visualization, documentation and communication tools. Let’s walk through each section and the types of tools that you should consider.

Hazard Analysis. Most companies have strong HACCP plans in place, taking account food safety hazards at all stages of production. Risk assessment and risk management must be taken into account and critical control points defined. However, to manage this going forward, consider tools that enable visibility into the current and historical situation at those control points to allow your team to see their proximity to each other, as well as to other components in the plant.

Preventive Controls. Preventative controls are also called out as part of the FSMA requirements. This includes food allergen, supply-chain and sanitation controls in place, as well as sound recall plans. Again, critical control points (CCPs) are the key to ensuring your controls are effective. Also, consider trying indicator test points to stay one step ahead! Indicator test points, as advocated by food safety leader, John Butts, are one or more steps removed from your CCPs. By testing in these areas, you can identify possible risk areas before they even reach control points. This enables a much more proactive approach.

Monitoring. Your plant should have a monitoring plan that includes written procedures for monitoring preventive controls and how frequently they should be performed. This plan should take into account zone coverage, randomization, test frequency, test timing and sampling order. Depending on the business and regulatory rules of a plant, testing should include non-food contact and food contact surfaces. In order to ensure that testing is representative of the conditions in the plant, randomization of test points is important. In addition, test frequency and test timing should be defined, and organizations should seek tools that help to automate these business rules.

Corrective Action. Hope for the best, but always plan for the worst. What is your corrective action plan? You must have a written procedure for identifying and correcting a problem. For both your plant and for regulators, a clear record of your plan and that the steps were followed to close out any issues is required. Make sure that the team understands the steps that are required, number of re-tests and any recall requirements. Look for tools that automatically alert the relevant team members of the situation and track response and testing so that you can easily share this level of detail as needed.

Verification. Trust but verify. Having a plan is only half the job. Using your environmental and finished product testing programs to ensure that controls and corrective actions are effective turns your plan into action. Rapid testing technologies keep the time between testing and results tight. Also, communication of verification results keeps the team coordinated around food safety.

The move to more preventative food safety procedures does not have to create massive headaches. Compliance with FSMA will ultimately help your business and guarantee that you are providing safe food for your customers to consume. Many food companies have been implementing these best-practice guidelines for years. Thanks to FMSA, we all now get an easy-to-follow checklist.

Shifting from reaction to prevention makes food safer—and now, it is also the law. The first step is to make sure you have a good understanding of the components. Only then can you find the best tools and technologies to support you. Lastly, make sure that your team is well aligned around the goals and objectives of your food safety program. Together, we can make food safer.

Lessons Learned from the Implementation of Seafood HACCP for FSMA

By Tim Hansen
No Comments

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

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

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

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

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

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

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

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

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

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

 

Developing an Effective Environmental Monitoring, Sampling and Testing Program

As the food industry is moving toward a more preventive food safety strategy, environmental monitoring is playing an increasingly critical role in testing. Hazard analysis is shifting the focus from finished product testing to proactively testing the environment and the processing as critical control points to continuously monitor and reduce risk. Today many facilities are adding or strengthening their environmental monitoring programs to enhance their food safety risk reduction efforts.

In a recent webinar, Ann Draughon, Emeritus Professor of Food Microbiology and Toxicology, University of Tennessee spoke about Developing an Effective Environmental Monitoring, Sampling and Testing (EMS) Program. We present some excerpts from her presentation.

What do you need to get started with an EMS program?

“You need to first identify the right team; think about what kind of food you are processing (raw products or ready-to-eat products) and if it has had any food safety outbreak associated with it; determine critical or hygiene zones in your facility; determine sample locations; finalize which indicator tests will be done, and in which zones; determine which pathogens you will test for; choose the right test methods; set a baseline, and link that with your sampling plan, and establish testing frequency once you have finalized the number of samples and zones,” explains Draughon.

To establish critical hygiene zones, she advises to:

  • Survey entire facility and have a map of that facility;
  • Study that map and identify traffic patterns to divide the facility into critical hygiene zones, GMP zones, and non-processing zones;
  • Put in place barriers between these zones and dedicate equipment to the critical hygiene zone, and restrict access between zones; and
  • Establish strict cleaning, sanitation and monitoring plans for these diff zones.

Sampling of zones should be based on risk of contamination and/ or transmission of pathogens to food from environment, says Draughon. The sampling should also take into account potential sources of product contamination by whatever means during food processing (see image 1 for examples of 4 zone and 3-zone hygiene systems).

Selecting the right assays for your EMS program

There are many options, and it can be confusing to select the right assay for your needs. Draughon advises that companies need to look their monitoring needs and consider both indicator bacteria and pathogenic bacteria to select the right assay.

For monitoring with indicator bacteria, most companies look at ATP for environmental sanitation, often before start-up to make sure facility is clean before processing begins. Protein assays are also used to pick up any allergen on equipment.

APC or total viable count is a simple assay offering many choices, which tests for the number of live bacteria on your equipment or in your environment that can grow under air or oxygen at room temperature.

Yeast/ mold count assays are good for two purposes: 1. Mold frequently is the cause of spoilage in food, so it’s useful to understand if there are any present to determine shelf life, and 2. It also helps us understand the number of particulates in the air.

We can also select specific microbial groups as indicators, such as total Enterobacteriacae, fecal coliform or E.coli or Listeria species.

Sample collection and prep

When we collect a sample, we have to clearly document the sample including information such as when it was taken, from where, by whom, what happened to that sample etc. Use clean SOPs to reduce error. Use the assays previously selected and do it as quickly as feasible. If you are working with an outside company, decide how they are going to handle the sample. Finally, always keep in mind plant safety and leave nothing behind after sampling, and avoid cross-contamination.

For characterizing pathogens, you may want to genetically fingerprint any pathogenic isolates from your facilities. This will allow you to see if you have a constant harborage of a particular pathogen or if it changes. Draughon recommends using a contract lab for characterizing pathogens, as they would be better suited, and have better resources to do this. Destroy the isolates after characterization – you don’t want any chance of the pathogen spreading into the product or the environment.

Written SOPs for EMS programs

It’s critical to have clear written SOPs for EMS programs which include the following:

  • Frequency of sampling;
  • When, where , how and duration of sampling;
  • Procedure for recording data and coding;
  • Sample number, size or volume;
  • Specific sampling and analysis validated protocols;
  • Monitoring of incubators and use of equipment;
  • Handling and shipping of samples; and
  • Alert and action levels and appropriate response to deviations from alert or action levels.

It’s also important that we train and validate the personnel performing EMS. Each individual doing this needs to demonstrate proficiency of doing this. They need to understand proper recording of EMS program data, alert and action levels, and zero tolerance levels. The personnel should be comfortable and qualified for sampling protocol, and using all the equipment.

In summary, sampling plans should be adaptable, which highest risk sites being tested initially. Establish a baseline and modify sampling plan as needed. Establish your sampling and testing criteria and sample as needed with each zone to fully assess the environmental program.

Click here for more information 3M Food Safety global educational webinar series in collaboration with Dr. Ann Draughon, on Environmental Monitoring and Sampling (EMS) Programs.

Mitigate Food Contamination Risk

Whether mycotoxins or microbiological values, heavy metals or pesticides – independent sampling and testing provide an objective and comprehensive overview of what food products contain and help comply with food safety regulations.

Nuts containing mould, frozen strawberries contaminated with hepatitis pathogens, and pesticide-laden vegetables – more than 3,000 products were objected by EU authorities in 2013. With increasing government, industry and consumer concerns about the hazards of food contaminants, and the risks they pose, food manufacturers, governments and non-governmental agencies, are implementing policies and processes to monitor and reduce contaminants.

Key food contaminants

Food contaminants cover a wide range of potential substances including:

  • Dioxins: Produced as unintentional by-products of industrial processes such as waste incineration, chemical manufacturing and paper bleaching, dioxins can be found in the air, in water and contaminated soil.
  • Allergens: Virtually all of the known food allergens are proteins that can subsist in large quantities and often survive food processing.
  • Genetically modified organisms (GMOs): Banned in a number of countries, controversy still exists with regard to the use of GMOs. Selling food and/or feed that is non-GMO in restricted markets places the burden of proof on the supply chain.
  • Heavy metals: Whilst heavy metals, such as lead (Pb), cadmium (Cd), mercury (Hg) and arsenic (As), can be found in nature, industrial and environmental pollutants have resulted in their increased presence in food and feed.
  • Hormones: Commonly used in animal husbandry to promote growth, hormone residues can be found in the food supply.
  • Melamine: Harmful to animal and human health, melamine is not a permitted food additive.
  • Mycotoxins: Produced by several strains of fungi found on food and feed products, mycotoxins are often invisible, tasteless, and chemically stable both at high temperatures and during long periods of storage.
  • Pesticide residues: Over-use of pesticides can lead to dangerous levels of hazardous chemicals entering the food chain with fresh fruit and vegetables being most susceptible to pesticide residues.
  • Polychlorinated biphenyls (PCBs): Used in many products, some PCBs are toxic and stable enough to resist breaking down even when released into the environment.
  • Radiation contamination: There are three ways that foodstuffs can become contaminated by radiation: surface, ground and water contamination.
  • Veterinary drug residues: Used in the treatment of animals, veterinary drugs can leave residues in animals subsequently sent into the food chain. The impact of contaminants varies. Depending on their toxicity and the level of contamination their effects can range from causing skin allergies, to more serious illnesses (including cancers and neurological impairments) and, in the most extreme cases, death.

To ensure that your food and feed products are fit for consumption, you need to test for specific contaminants throughout the value chain. For example, in concentrated levels, melamine, antibiotics and hormones can be harmful to animals and humans. Only thorough contaminant testing will determine if the above-mentioned impurities, among others, are present. After identification the relevant goods can be eliminated from the production and distribution chain.

Maximum levels and regulations

In order to protect consumers, maximum levels permitted in food products have been set by food safety legislation in many countries. Disappointingly, and despite efforts in some product areas, maximum levels are rarely harmonized across national borders. This inconsistency places responsibility for compliance firmly with the food supply chain. A comprehensive testing program can verify that your products meet maximum levels and the safety standards they represent.

In the European Union (EU), it is the food business operator who carries primary responsibility for food safety and the General Food Law Regulation (EC) 178/20022 is the primary EC legislation on general food safety. More specific directives and regulations compliment this, for example, EU regulations concerning non-GMO/GMO products, include Directive 2001/18/EC and regulations 1829/2003 and 1830/2003.

The U.S. Food and Drugs Administration has overseen the development and signing into law of the Food Safety Modernization Act (FSMA). Within the U.S., state regulators retain the right to apply additional regulations and laws. As result, rules regarding maximum levels, for example, vary from state to state.

In China, the Food Safety Law (FSL) was passed into law by the Chinese government in 2009. It introduced enhanced provision for monitoring and supervision, improved safety standards, recalls for substandard products and dealing with compliance failures.

Brazil’s food safety agency, Anvisa, coordinates, supervises and controls activities to assure health surveillance over food, beverages, water, ingredients, packages, contamination limits, and veterinary residues for import. No specific restrictions have been established yet for export.

Monitoring

Monitoring programs are frequently used to identify any contamination issues. From seeds, through the growing process and harvest, transportation, collection, storing and processing to the market channel, independent monitoring delivers credible and independently collected data on both quality and contaminants.

With so many policies and standards, both nationally and internationally, anyone involved in the food industry needs to be sure of accurate and up-to date information on food contaminant regulations. Whether mycotoxins or microbiological values, heavy metals or pesticides – independent sampling and testing provide an objective and comprehensive overview of what grain and food products contain.

For more information, please visit: www.SGS.com/foodsafety.