Tag Archives: hazards

Brett Madden, Aviaway
Bug Bytes

Bird Problems and Control Methods for Food Production Facilities

By R. Brett Madden
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Brett Madden, Aviaway

Various types of pest birds can impact food plant structures and facility surroundings. Even a single bird that finds its way into a food plant can trigger a host of concerns. Such as, failed audits, product contamination, plant closure, production stoppage, lost revenues, fines, structural damage, health hazards to occupants and fire hazards.

In most cases, a food plant operation has a bulletproof pest control plan; however, in most cases, birds are always an afterthought in most pest management plans. After inspecting and consulting numerous food plants, I hear the same story over and over: “I have a person in the warehouse that can chase them out” or, “are birds really a big deal?” or, “why do I have to be concerned about birds?” and on and on. Despite what you may think, birds are a big deal, and you should take them seriously!

Pest management, pigeon droppings HVAC
Larger birds, such as pigeons, can cause more problems around the exterior of a facility on HVAC units as seen here. (Image courtesy of Aviaway Bird Control Services & Consulting)

Since food processing plants contain areas that have very sensitive environments, birds can introduce various adulterants and harmful contaminants. Birds can cause potential harm to humans due to foodborne illness.

Pest Bird Species

There are four main pest birds: Pigeon, Starling, Sparrow and Seagull. Each one of these birds can cause a host of concerns and issues for food processing facilities. Just one bird can cause catastrophic damage. In most cases, small pest birds such as Sparrows and Starlings can gain access into a facility through a variety of ways:

  • Damaged bumpers around truck bay loading dock doors.
  • Open doors (seems obvious, but I always find doors wide open during audits).
  • General building deficiencies.

Larger birds, such as Pigeons and Seagulls, typically cause more problems around the exterior of a facility on ledges, rooftops, HVAC units, loading docks and related areas.

In either case, these various types of pest birds can cause significant problems on the interior and exterior of food plants.

Conducive Conditions

In most cases, facilities want to reduce as many conducive conditions as they can around and within the facility in a timely fashion. A conducive condition is one whereby due to a building condition, structural design, equipment operation, food or water source, or surrounding conditions (i.e., near a public landfill, raw materials mill or body of water) can attract pest birds to a facility. With each of these conditions, great care must be taken to reduce as many conducive conditions as possible.

Examples of Conducive Conditions

Structural Conditions

  • Loading docks/canopies with open beams and rafters
  • HVAC equipment
  • Pooling water (roof and landscaping)
  • Structural overhangs and ledges
  • Open access points
  • Landscaping (types of plantings)
  • Damaged truck bay bumpers
  • Gaps and opening around the structure
  • Doors with improper sealing

Human Conditions

  • Open dumpsters
  • Overflowing dumpsters
  • Dirty dumpsters
  • Product spillage
  • Employees feeding birds
  • Doors left open

All these conducive conditions, if left unresolved, can lead to significant bird problems. Reducing as many conducive conditions as possible will be the first step of any bird management program.

Bird Control Methods

From the start, your facility should have a bird management plan of action. For the most part, bird problems should not be left to be handled internally, unless your staff has been properly trained and has a bird management plan in place.
Most birds are protected by the Federal Migratory Bird Treaty Act of 1918. However, Pigeons, Sparrows, and Starlings are considered non-migratory birds and are not protected under this Act. Even though these three bird species are not protected, control methods still need to be humane. More specifically, your bird control program must also comply with is the American Veterinary Medical Association (“AVMA”) Guidelines for the Euthanasia of Animals if this is the control method selected. The AVMA considers the House Sparrows, Feral Pigeon, and the Common Starling “Free-Ranging Wildlife.” And Free-Ranging Wildlife may only be humanely euthanized by specifically proscribed methodology.

In addition to the above-mentioned regulations, various regulations regarding the relocation of birds/nests may also apply. I also always recommend checking with local and state agencies to ensure that there are no local regulations that may apply. Bottom line: Don’t rely on untrained internal practices; one misstep could result in heavy financial fines and penalties.

Bird Management Strategies

First Line Defense

  • Stop any bird feeding around the facility immediately
    • Any bird management plan should have a clear policy prohibiting employees from feeding birds. Once birds have been accustomed to routine feeding, the birds will continue to return.
  • Eliminate Standing Water Sources
    • All standing or pooled water needs to be eliminated. Thus, routine roof inspections need to be conducted to ensure drains are working properly.
    • Landscape irrigation needs to be calibrated to ensure no puddling of water in areas of low sun exposure.
  • Proper Sanitation Practices
    • Ensure that dumpster lids are closed when not in use.
    • Trash removal frequency adequate.
    • Routine cleaning of trash receptacles.
    • Immediate removal of spilled food.
  • Eliminate Entry Points
  • Survey the facility to ensure that all holes are properly sealed.
    • Around truck bay bumpers and doors
  • Exhaust vents are properly screened.
  • Windows are closed and have screens when in use.

The most appropriate bird control strategy will be determined based on the severity of the bird pressure. For example, if the bird pressure is high (birds have nested), then in most cases, you will only be able to use bird exclusion methods. Whereas, if the bird pressure is light to moderate (birds have not nested), bird deterrent methods can be used. This is an important distinction. Bird exclusion is physically changing the area to permanently exclude said pest birds. Whereas, bird deterrent devices inhibit birds from landing on treated areas.

Bird Deterrent Methods

After the previously mentioned first-line strategies have been implemented, the next step would be to install bird deterrent products (birds have not nested).

  • Bird Spikes
  • Bird Wire
  • Electrified Shock Track
  • Bird Gel
  • Sonic & Ultra Sonic Devices
  • Lasers and Optical Deterrents
  • Hazing & Misting Devices
  • Pyrotechnics
  • Live Capture

Bird Exclusion Methods

If the birds have nested in or around the facility, the next step would be to install bird exclusion products (birds have nested).

  • Bird Netting
  • Ledge Exclusion (AviAngle)
  • Architectural modifying structural
  • Aggressive Harvesting (Targeting)

Prevention Strategies

The best prevention strategy is planning and knowledge. Conduct a bird audit and develop a bird management plan before birds get near or inside the facility. The key is to act quickly, as soon as an incident occurs. I find countless times when I am called in to consult or service a food plant, that the birds got into the facility and no one knew what to do, and as a result, the birds remained within the facility for an extended period, thus increasing the risk of exposure. It is always much easier to remove a bird when they are unfamiliar with their surroundings. Whereas, it is much more difficult to remove birds from a facility that has had a long-standing bird problem.

Once you have a plan, who oversees the bird management plan? Are thresholds determined and set for various areas of the facility? For example, a zero threshold in production areas? Threshold levels will be set based upon by location and sensitivity of the said location. What steps are going to be taken to remove the bird? For how long is each step conducted? These questions need to be answered and developed to stay ahead of bird problems.

Reduce as many conducive conditions as possible. The longer a conducive condition stays active, the more likely birds, as well as other wildlife or rodents, will be attracted to the site and find a way into the facility.

Pathogen Contamination & Hazards

Birds present a host of problems, whether they are inside or outside of a facility. Birds can roost by air vents, and the accumulation of bird feces can enter the facility air system. Bird droppings on walkways and related areas allow for the possibility of vectoring of said dropping when employees step on droppings. Thus, spreading fecal matter/spores and other contaminants to areas throughout the facility.

If birds are within the facility, droppings can spread on product lines, raw materials, stored products, equipment and more, thus, causing contamination. Because of a bird’s ability to fly, they are perfect creatures to spread various diseases, pathogens, ectoparasites and fungal materials. Diseases such as Histoplasmosis, Salmonella, Encephalitis, E-coli, Listeria, and more. Birds have been known to transmit more than 60 infectious diseases!

Besides the spread of potentially harmful contaminants throughout the facility, bird droppings and nesting materials can also create a host of additional problems:

  • The acidity in bird droppings can damage building finishes, façade signs, lighting and more.
  • Wet bird droppings can create a slip and fall hazard.
  • Bird nesting materials can create a fire hazard around façade signs, exit signs and light fixtures.
  • Bird nesting and debris can clog roof drains and cause roof leaks from standing water.
  • Introduction of ectoparasites into the facility such as bird mites, lice, fleas, ticks and more.

Conclusion

In summary, taking a proactive approach to bird control is the best practice. Reduce food, water and shelter sources (aka conducive conditions) promptly. Pest management programs need to implement a more in-depth section of the program for bird control. Like integrated pest management, bird control should be based upon an integrated method. Each facility will have its unique challenges. As such, each bird management plan needs to be tailored to the specific site. A well designed and balanced, integrated bird management program will provide long-term and cost-efficient bird control.

The next article in this series will take a closer look at how to prepare an integrated bird management audit program.

Don Groover, DEKRA OSR
FST Soapbox

Why Changing Workplace Safety Culture Must Start From the Top

By Don Groover
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Don Groover, DEKRA OSR

Workplace safety in the food industry can be challenging. The precision required of workers in slaughter, meat packing or wholesale processing facilities can lead to serious harm or worse. The Bureau of Labor Statistics reports that the potential hazards in this industry are many: Knife cuts to the hands and the torso, falls, back injuries, exposure to toxic substances, carpal tunnel syndrome, and even infectious diseases.

This industry may have more challenges in safety than any other industry. Yet, there are companies that excel in safety performance, even given these challenges.

Organizations that are serious about protecting their workers must do far more than react after an injury or rely on awareness-based safety efforts. Typically this approach only delays the next injury. Safety is not just about responding to injuries, but is about the ongoing identification of exposure, the implementation of control systems, and assuring these controls are used to neutralize the exposure.

The challenge is that the root of why an exposure exists or can even thrive in an organization maybe due to culture, organizational urgency, operational instability or a lack of understanding about the concept of exposure, to mention a few. Because the issue is bigger than safety programs, safety excellence requires all levels of an organization, from the C-Suite to the frontline worker, committing to a process that focuses on exposure. This needs to be done in a way that creates trust that safety is a value and if there is a values conflict, that safety has top priority.

Ultimately, it’s about shifting culture by making a safety excellence a priority.

Oftentimes leaders articulate that they want a safe culture, but they may not fully understand their role in creating the culture they desire and how they sustain the change. Senior leaders must go beyond a catch phrase approach to safety and actually articulate what are the cultural attributes they want to see firmly embedded in their organization.

These may be:

  • Workers watching out for each other and a willingness to step in if somebody is at risk.
  • Excellent housekeeping.
  • Workers stepping up to address physical hazards without being asked.
  • A willingness to report safety concerns and incidents.

Once the attributes are defined, then the organization is ready to understand what it takes to support that culture.
However, senior leadership needs to drive that change. Once upper management understands that accountability starts with them and not with the worker, they can move forward and create a culture that reinforces practices that identify potential exposure before incidents take place and not after. Doing so not only has the potential to lower incident rates, but it also:

  • Boosts morale. Workers believe the company has their backs and will commit to safety principles.
  • Strengthens trust between workers and management. Workers believe that safety excellence is a shared responsibility.
  • Increases commitment to all organizational objectives. Social theory research has shown that if you do something for someone else, they experience a pull to reciprocate. The more we do, the stronger the pull. When management shows that they can be trusted with employee safety, employees are free to reciprocate in other areas.

Our strongest and deepest relationships are built on a foundation of safety—not just physical safety but also psychological safety. If we come to believe that another person is interested in our physical or mental wellbeing, the foundation strengthens.

When leadership uses the power of safety they will see employee engagement increase. And the safety implications of worker engagement are profound: Disengaged workers are focused on their own safety. Involved workers are concerned with their own safety but are likely also concerned with the safety of their workmates and perhaps certain other people they interact with. Fully engaged workers are concerned with the safety of everyone around them and without prompting take proactive actions to help others.

Engaged workers are more likely to follow rules and procedures, be more receptive to change, and give discretionary effort. It seems like all companies are doing some type of engagement survey, yet the actions they develop to try and raise their scores are often lacking. Organizations that are serious about having an engaged workforce must fully understand how safety is foundational to engagement. More importantly, safety involvement activities need to be designed and implemented in a way that moves employees beyond mere involvement to full on engagement.

When a company demonstrates it values safety, workers will volunteer to get involved. Leadership must carefully consider what safety involvement activity is right for the culture. When employees participate in a successful and rewarding involvement activity, their personal level of engagement will move upward. Leadership must then figure out how to expand safety involvement. This isn’t done by demanding involvement. It requires purposeful planning and patience.

Melody Ge, Corvium
FST Soapbox

Compliance with the Intentional Adulteration Rule: Using FMEA for Your Vulnerability Assessment

By Melody Ge
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Melody Ge, Corvium

What is FMEA? What is a vulnerability assessment (VA)? How can these two be linked? Despite what you may think, there are similarities between these two methods. FMEA (Failure Modes and Effects Analysis) methods can be utilized to help objectively assess the vulnerable steps within your process.

After July 26, 2019, businesses other than small and very small businesses (defined by FDA) must comply with the FSMA Intentional Adulteration (IA) Rule. The rule is intended to enforce industry regulation to conduct vulnerability assessments and address proper mitigation plans to prevent any potential fraud risks within the food defense plan. For small businesses, the compliance date is July 27, 2020; for very small businesses, the compliance date is July 26, 2021.

Although the IA rule does not specify a particular method that you must use to conduct your VA and address proper mitigation plans, the following elements must be considered during your evaluation and mitigation strategy and must be implemented at each actionable step afterwards:

  • The potential public health impact (e.g., severity and scale) if a contaminant were added (21 CFR 121.130(a)(1))
  • The degree of physical access to the product (21 CFR 121.130(a)(2))
  • The ability of an attacker to successfully contaminate the product (21 CFR 121.130(a)(3))

During the 2019 Food Safety Consortium, Melody Ge will present: How to prepare ourselves in this data-driven transitioning time for the smart food safety era? | October 2 @ 10 am FMEA is a Six Sigma method widely used in operations when implementing a new process. It is a structured approach to discover potential failures that may exist within the design of a product or process. Within FMEA, the RPN (Risk Priority Number) score is used to prioritize risks and is calculated by Severity × Occurrence × Detection. RPN is a quantified number that helps you prioritize risks when determining actions. If we employ the same mentality, FMEA is a useful method in helping to identify vulnerable steps based on the risk within your process. Take a close look at how the RPN is generated; the following three components are also important during the vulnerability assessment.

Severity or the potential public health impact (e.g., severity and scale) if a contaminant were added.
Severity is identified when considering the consequence of when a processing step goes out of control; or thinking about the severity of the health impact. We can consider those impacts or consequences using four common categories:

  • Biological contaminants
  • Chemical contaminants
  • Physical contaminants
  • Intentional adulteration for economic gain contaminants

Occurrence or the degree of physical access to the product.

Occurrence is identified when considering how frequently a process step is expected to go out of defined controls. Is it once a week or once a month? Depending on how often the step goes out of defined controls, this will trigger different action steps as well as mitigation plans.

Detection or the ability of an attacker to successfully contaminate the product.

Detection is considered by how easy it can be detected when the failure occurs. For example, within the food production operation, mixing steps is relatively easier than a CIP step to be detected. More references could be found in FDA’s definition of KAT (Key Activity Types, as discussed in the draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration”), such as:

  • Bulk and liquid receiving and storage
  • Liquid storage and handling
  • Secondary ingredient handling
  • Mixing and similar activities

Once the RPN is identified, then the vulnerable steps can be sorted based on the RPN. To utilize this approach, Table 1 provides a template to be considered using FMEA for the vulnerability assessment.

Process Step Description Is it KAT? (Y/N) RPN Action Process Step Mitigation Strategy Explanation
Sev Occ Det RPN
Table 1: Determine the vulnerable steps (for reference)

As IA rules regulate, a mitigation plan must be generated once a vulnerable step is identified. The intention of the plan shall ensure those risks identified are mitigated and controlled so that the final finished products are not impacted or contaminated. One tip to begin this process is to start with reviewing your current control plan for potential food safety risks. As FSMA Preventive Controls are fully implemented, all food plants shall have a food safety plan in place with validated control plans that are intended to reduce risks for potential physical, chemical, biological and adulteration for economic gain. Sometimes, these risks are highly associated with potential vulnerable steps for intentional adulteration, especially those processing steps associated with potential economic gain hazards. If those controls are not working properly, then we can seek out other mitigation plans. Nevertheless, regardless of what steps are taken, they have to be validated to show that the IA risks are effectively mitigated. Monitoring and verification shall be conducted as well once the mitigation plan is implemented.

Of course, like all food safety management systems, every food plant should have its own designated plans based on the products being produced, operations implemented and the nature of the production. Ultimately, it will be your choice to find an effective method that fits your production culture. However, the intention should always be in compliance with the IA rules: Identify the vulnerable steps within the process, and conduct mitigation plans to control the risks of intentional adulteration.

Erika Miller
FST Soapbox

Does the Sanitary Transportation Regulation Require Seals for LTL Shipments?

By Erika Miller
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Erika Miller

This question has come up frequently in our FSMA Sanitary Transportation workshop. Just as with all the parts of FSMA, the focus of the Sanitary Transportation of Human and Animal Food regulation is on addressing hazards that may be present throughout the food chain and assigning responsibility (liability) for preventing those hazards. There are very few specific requirements—most of it is couched in very general language, for flexibility on both sides (FDA’s and industry’s).

While the regulation does not specifically address locks or seals on trailers, the FDA has stated publicly that they intend to enforce the adherence of industry to generally accepted best practices. Sometimes, as in the case of certain animal food applications, the FDA has stated they will accept mild steel transports instead of stainless (as would typically be required for hauling food) because it’s all about the risk, and mild steel is not a risk in those applications. What is the risk of an unlocked load to the food being hauled, and to the business being conducted? Maybe a seal or lock on an LTL can protect a significant investment from an identified hazard.

Generally, in most food hauling operations, seals or locks are required on trailers by businesses in order to protect their investments. They are also expected under GFSI-approved food safety management systems, used by most food manufacturers (which are private, voluntary standards, not regulatory). They are definitely required if you want to haul 100% juice under Juice HACCP and the JPA guidelines.

There are so few straightforward answers with FSMA. You must always look at your operation, your risks, and decide if controls are necessary. Document the basis for your decision, ensuring it is based on facts. If the FDA inquires, you must make your case for your decision. Do you feel comfortable defending it, all the way to a court of law if need be? If so, then stand by it.

If there are potential risks to food that is being hauled (don’t forget about defense-type risks as well, like the truck being stolen or misrepresented) then you must take reasonable, industry-standard precautions to prevent those hazards from occurring.

Of course, you want to do this anyway because it is smart business.

Gabriela Lopez, 3M Food Safety
Allergen Alley

Five Steps to Creating a Successful Validation Study

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

Manufacturing large volumes of food product that must be safe for human consumption with finite resources is, simply put, a demanding responsibility. For many food brands, having dedicated production lines is not always an option, so lines are often shared amongst a variety of food products. A potential problem arises when products containing allergenic foods are manufactured on the same equipment as other products, and those allergenic foods are not meant to be declared in the product label. As a result, residues of the first product manufactured may move to the next product. Known as direct cross-contact contamination, this issue can have a severe adverse impact on allergic consumers.

Cross-contact contamination can occur at various stages of production, but it’s direct food cross-contact in shared production lines that is often found as a particularly significant food safety hazard. Addressing cross-contact through effective cleaning procedures is one of the most critical allergen management activities in establishing preventive controls and minimizing the potential of unintentional presence of food allergens. Allergen cleaning validation enables food manufacturers to evaluate that their cleaning procedure is adequate when it comes to removing ingredients from direct food contact surfaces.

Cleaning validation consists of generating data to demonstrate that allergenic foods are removed from direct food contact areas to a pre-defined acceptable level. A basic cleaning validation design consists of determining the residual level or presence of allergenic food before cleaning (baseline), and then assessing the level of the allergenic food after cleaning.

If the cleaning procedure exists in several steps (i.e., more than one rinse or purge, as with dry cleaning) additional testing to assess the level of allergens between cleaning stages and in the final product can also be incorporated. It is important to remember that a single validation study may not be applicable for an entire site operation. Different production lines within a food production site may require an individualized validation analysis. This determination will depend on the cleaning process as well as the formulation of the products being manufactured.

There are five important considerations for establishing a successful validation study:

  1. Set up a team and assign a leader to carry out the design of the validation. Involving relevant personnel with knowledge in the product formulation, manufacturing process, equipment design and cleaning and sanitation regimes may provide valuable insight to identify processes that should be included in the validation. It may also bring to light critical sampling points in the equipment that should be considered.
  2. Determine the scope of the study. This is where you describe and justify which equipment, utensils, cleaning regime and production processes will be validated. It may be wise to group different processes or select the worst-case scenario. For example, you might choose to focus on food production equipment regarded as hard to clean or equipment that contains the highest concentration of the allergenic food.
  3. Design a sampling plan. This is a critical prerequisite before starting a validation study. The plan should be clearly defined, with critical sampling points and locations prescribed to challenge the effectiveness of the cleaning regime and to find evidence of allergenic food presence. In both open equipment and equipment that will be dismantled as part of the cleaning regime, it is important to select sites where food can get trapped, as well as other sites that are hard to clean. Also consider other surfaces that can be a source of direct cross-contact like protective clothing and utensils. For clean-in-place (CIP) systems, wash water should be collected from the onset of cleaning and then at intervals leading up to the final rinse water. This helps to demonstrate that allergen food levels are diminishing, thereby validating the use of CIP analysis as a verification method. Note that it is important to consider that the sampling plan for the validation should also reflect the sampling plan that will be used during routine verification. Support from a statistician may facilitate the decision to define how many samples and type of samples (swabs, CIP or final product) should be collected for the validation and how many cleaning runs should be performed to demonstrate validity.
  4. Select a method of analysis. Validation and verification involve the use of a specific method to detect allergenic foods. The selected method should be validated as well, an undertaking most often done by the commercial supplier. Then it should be verified by the food processor that the method is fit for purpose, such that the allergenic food will be recovered and detected under the conditions in which samples are routinely collected. This ensures there will not be interference due to the food itself or due to cleaning chemicals. There are a variety of different analytical methods; most are based in technologies designed to detect proteins. Enzyme-linked immunosorbent assays (ELISA) and immune-based lateral flow devices (LFDs) offer detection of specific protein targets (i.e., egg proteins, milk proteins, peanut proteins) and are ideal for a validation study. ELISA can provide quantitative data from pre-cleaning, at various intervals during the cleaning process, at post-cleaning and at final product, offering a measurable level of the allergenic food during the cleaning process. Rapid detection through LFDs also allows food processors to assess the presence or absence of a specific protein or group of proteins, but different from ELISA, the result is only qualitative. In either case, these rapid tests may be used for both validation and routine verification. In addition, there are non-specific tests that can detect total protein that may be selected for a cleaning validation study. These tests do not provide specific information about the allergen to be managed, and thus may be more suitable for routine verification. During a cleaning validation study, it is important to include the test that will be utilized for verification and ensure it is also fit for purpose and detects the allergenic food to an appropriate pre-defined sensitivity. This is particularly important if the test is different from the analytical method chosen for cleaning validation.
  5. Establish acceptance criteria. Proteins from allergenic foods may cause an adverse reaction at very low levels. To date, there are very few regions in the world in which threshold or permitted levels for allergens in food are established. Each individual food manufacturer should define a criterion to establish when a surface is clean from allergens after routine cleaning. The limits that are set up should be practical but also measurable and verifiable, thus it is important to define a level with knowledge of the sampling and analytical method selected. The sensitivity of the analytical methods currently available may be used as a criterion to verify that levels of an allergen are under control if they fall below the limit of detection of the analytical method.

Once a cleaning regime has been validated and documented, routine allergen cleaning verification should be performed as part of a monitoring program to demonstrate that the cleaning process in place is effective and that the risk of direct cross-contact is consequently being controlled. The validation should be repeated at defined intervals, often once a year. However, it is expected that a cleaning verification will be performed after each production run and cleaning procedure in order to reflect that the validated cleaning process is still effective. Cleaning verification, along with other allergen management activities, strengthens implemented food safety programs and helps to protect consumers.

Melody Ge, Kestrel Management
FST Soapbox

Still Have Questions about FSMA Preventive Controls?

By Melody Ge
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Melody Ge, Kestrel Management

In September 2015, the FSMA Preventive Controls for Human Food Rule was published, requiring affected companies to comply with all FDA timelines. The last of these deadlines required that all very small businesses (less than $1 million per year) be in compliance with the FSMA rule by September 17, 2018.

With most companies having implemented FSMA preventive controls at this point, what have we learned? What’s still not clear? What major challenges remain? This article shares some questions that could help more companies on their journey to FSMA compliance.

What Is the Preventive Controls (PC) for Human Food Rule?

In plain language, under FSMA’s preventive controls for human food, FDA asks companies to identify any known and foreseeable potential hazards to finished products, and then apply control measures to prevent those hazards from happening and to ensure companies produce safe products. This rule changes the mentality from reactive to proactive.

Let’s break the term preventive control apart:

  1. What are we preventing? We are preventing any potential hazards that could occur. FDA identified four major categories of hazards. Food companies must look at their production processes and identify any foreseeable hazards within these categories:
    • Physical
    • Chemical
    • Biological
    • Intentional adulteration for economic gain
  2. What are we controlling? We are controlling the risks from all those hazards identified. Control measures should be identified for each risk from a particular hazard identified so they can be effectively applied.

Melody Ge will close out the 2018 Food Safety Consortium with the Plenary Session, “What Have We Learned After FSMA Implementation?” | November 15Where Do We Start?

A logical starting point involves understanding all hazards at your production facility. How can you ensure all hazards are assessed and evaluated? Consider mapping out the process line as one effective way. It is important to thoroughly understand your processes, as well as all raw materials, equipment, and personnel associated with each processing step. The more details gathered at the beginning, the easier it is to understand the hazards and risks as a foundation. A hazard can always be eliminated later if it is not applicable nor likely to occur.

Are All Control Measure or PRPs Considered Preventive Controls?

The short answer is not necessarily. Only those associated with a potential hazard will be considered a preventive control. For example, for an approved supplier program controlling incoming goods and suppliers, if an allergen is identified as a potential foreseeable hazard, the approved supplier program at the receiving step will be identified as a preventive control. Once a preventive control is determined, it must be evaluated to ensure it is proper and applicable to control and minimize the risks (117.420).

The same mentality should be applied for other control measures. Is there is a hazard and, if so, can this control measure actually control the risk? Once preventive controls are determined and identified, monitoring and validation are the next steps to ensure preventive controls are functioning effectively to control the risks as expected. If not, proper corrective actions should be identified.

Are Corrective Actions Always Required?

Not always—it depends! It is important to remember the intent of FSMA’s preventive controls, which is to prevent any potential hazards and control the risks to ensure safe products are produced. Per 117. 150, corrective action is a must when:

  • There is a potential pathogen threat in RTE products
  • There is a potential pathogen threat from the environmental monitoring program
  • A preventive control is not properly implemented and a corrective action procedure has not been established
  • A preventive control(s) or the food safety plan as a whole is not effective
  • Records are not completed after review

Other than the above-mentioned, corrections can be applied to address minor and isolated problems in a timely manner. As with all other food safety management systems (FSMS), once a corrective action is determined and implemented, a verification of its effectiveness shall be conducted. In addition, everything should be documented, as records are a vital component of the preventive control rule.

The FSMA Preventive Controls Rule is not scary. It is simply a series of requirements to assist the industry in proactively identifying the best control measure for operations. Foreseeable hazards must be controlled. As with all other management systems, knowledgeable and experienced personnel can help develop a valid food safety plan, including preventive controls, and ensure it is effectively implemented and maintained onsite.

FSMA Preventive Controls Corrective Action Requirements

Melody Ge, Kestrel Management
FST Soapbox

8 Tips to Food Safety Program Development for Small and Entrepreneurial Businesses

By Melody Ge
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Melody Ge, Kestrel Management

The FSMA HARPC regulation has been in the implementation phase for approximately a year. Many small and entrepreneurial businesses are in the process of starting or finalizing the development of a food safety plan to comply with FSMA requirements. This includes program development, operational awareness and employee training. Often, small companies find this development more challenging compared to mature companies for several reasons, including a lack of resources or simply not knowing where to start.

The following eight tips can help small businesses that are developing a food safety plan to comply with FSMA.

1. Don’t be scared.

FSMA Preventive Controls is nothing scary. It is simply a series of food safety protocols and related documentation. It might seem overwhelming at the beginning with many documents and changes; however, it is actually a good method and tool to help strengthen operation lines and management.

FSMA helps businesses sustain and streamline processes. It is helpful to first map out the production process from the very beginning (when raw materials are received) through the end (when finished products leave the facility). The more details that are documented on the process, the easier and less time consuming it will be later to prevent potential risks.

2. Be familiar with the process and the FDA hazard types.

Once all processes are mapped, take time to study and get familiar with them. It will be helpful to have a team of individuals with different job functions review process maps together. The objectives are to identify the following:

  • Where is the weakness?
  • Where can weaknesses be controlled?
  • What should be monitored?
  • When is a good time to monitor each process step?

According to FDA, five hazard types need to be considered and prevented: Physical, chemical, biological, intentional adulteration and radiological. These five types should always be kept in mind when reviewing and analyzing the direct production and non-direct production processes.

3. Thoroughly understand the entire supply chain.

Supply chain management is one of the key preventive controls required by FSMA. Just like mapping out the process, FDA requires each business to have a thorough understanding and control of its supply chain to ensure the risks are minimized from raw materials to end consumers. Whether you have foreign suppliers, distribution centers or co-manufacturers, finished product safety must not be compromised by any party. If foreign suppliers are being used, FSVP (Foreign Supplier Verification Program) must be implemented and communicated to vendors.

4. Think in food safety mindset.

If your business has just been established, then congratulations! You have the opportunity to start everything right from the beginning. Take food safety into consideration throughout every step in the process and operation. Considering food safety aspects and preventing hazard types might help you make your next good business decision.

5. Get everyone involved!

Food safety is not only the food safety and quality departments’ responsibilities; it reflects the entire company’s operational structure—from building structure, security, production line, and supply chain to procurement, HR and finance. Get everyone involved, from top management to line workers. Their expertise, experiences and feedback will help the entire program’s implementation and execution. With the inputs from each department function, the food safety program will be more practical to the entire business operation and, therefore, will be more solid and sustained, especially when it comes to ongoing implementation.

6. Designate one project leader.

If FSMA program development is considered a project that the whole company engages in, a project leader is required to make the journey efficient and smooth. The leader needs to have both the company operational experience, as well as food safety knowledge. The leader plays an important role in leading the project, coordinating the timeline, prioritizing work across departments, and communicating with all levels of employees.

7. Keep everything documented and recorded.

Documentation and recordkeeping are core to the entire program. Say what you do by writing down all procedures, policies, programs and SOPs. Do what you say by demonstrating what is contained in all records kept onsite. This is not only for audit purposes, but also for your own business growth. Your own operation data is the best data to improve and modify your processes, if needed. Records can be used for trend study and analysis after years in business. Records can reveal whether methods or programs implemented are working effectively and helping the business. Records can also provide strong support/evidence when there is an unexpected event.

8. Utilize free third-party resources.

There are many technologies linking the entire world together—leverage them to learn from your peers. GFSI-recognized certification programs, such as SQF, FSSC22000 and IFS, are releasing a global market program to specifically help small business start their programs. Webinars and trainings are available on many program development and food safety hot topics to help address challenges, and there are many tools and templates available for download to assist with documentation and recordkeeping.

Although there are a lot of perspectives and aspects to be considered to comply with FSMA, compliance can be achieved one step at a time. Start by mapping out your own production process today.

What To Consider When Developing A Facility Food Safety Plan

By Adam Serfas
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No two facilities will have the same food safety plan, as each should address the specific needs of that facility. Before beginning your draft, there are several critical factors to consider. Use the guide below as a checklist to review before starting or revisiting your own food safety plan—the following tips can be applied to all food and beverage processors and manufacturers.

1. Review current legislation that applies to your industry

The food safety sector evolves rapidly. Keep your finger on the pulse of updates and changes, whether current or forthcoming, to ensure that your plan is current and up to code. You can quickly familiarize yourself with guidelines and regulatory bodies dealing with your industry with a handful of excellent resources. Generally, we recommend starting with the FDA website, and from there you can navigate to resources that are specific to your industry. We also recommend you make use of the FDA’s Food Safety Plan Builder to assist you in meeting requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation.

2. Identify current potential risks in your facility

Once familiar with your industry requirements and inspection standards, the next step is to identify any current potential food safety risks specific to your facility. Be sure to incorporate employees at all levels while detailing these potential hazards or concerns. Oftentimes, employees at the management level will make note of things different than employees working on the plant floor. And the delivery truck driver’s perspective will vary from those of your janitorial team. Aim to build a comprehensive list, noting everything from obvious high-risk areas, to what might be trivial or unlikely facility hazards. The more robust the list, the easier your food safety plan will be to form later on.

3. Consider your facility layout

Your facility’s physical layout often determines what type of food safety plan is necessary. Ask yourself:

  • Does your facility have natural zones?
  • Is it comprised of multiple buildings?
  • Are certain defined areas more high-risk than others?
    If you answered “yes” to any of these questions, you’ll most likely want to incorporate a zone-based color-coding plan as a part of your food safety plan to ensure that all of your tools remain in their proper location and are used correctly.

4. Review the quality of your current tools
Take stock of your current tools, that includes everything used to make or process your product and everything required to clean the facility itself. Consider the tool quality—are these presentable and acceptable for an inspector to see? Do your brushes have loose bristles? Has your mop seen better days? Tools that are made of low-quality materials or are not in top shape present potential risks for a food-safe environment. Note which tools need to be replaced and perhaps consider incorporating color-coded tools if you have not yet done so, as they are a great way to step up your food safety practices and safeguard against cross contamination.

5. Review and communicate the food safety plan and training procedures

Review your current employee training materials –in particular, your cleaning and sanitation measures and food handling procedures–and hold a meeting to go over current training protocols with your team. Consider the following questions:

  • Are the expectations made clear?
  • Are there references to procedures that are no longer up to date?
  • Is there appropriate signage that can be readily referenced?
  • Is information available for non-native speakers?
  • Are the appropriate channels in place for employees to voice concerns about these training procedures?

Be sure to take notes on each of these items that need to be addressed. One of the most important pieces of a food safety plan – and something inspectors pay close attention to – is that it is properly communicated to all employees. Taking detailed notes as you discuss these procedures will be helpful in documenting your training methodology for the food safety plan and, of course, will help you to ensure that the training procedures themselves are the best they can be.

6. Consider the documentation requirements for your industry.

Your industry might require certain specific documentation for your food safety plan, which can include facility policies, procedures, safety review records, maps and more. Additionally, some governing bodies require that the food safety plan is completed by a certified individual who doesn’t necessarily need to be an employee of the facility. Review all necessary requirements to ensure that you satisfy all of these standards for your next inspection.

Should you have any questions when getting ready to start on your plan, we suggest you reach out to a company that specializes in color-coding tools, as they have experience in creating plans to accommodate all kinds of identified risks and can be a great resource.

food safety tech

Food Hazards Web Seminar Addresses Detection, Mitigation and Control

By Food Safety Tech Staff
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food safety tech

On June 1, Food Safety Tech is hosting a web seminar (also penned a “virtual conference”) about food hazards in the realm of pathogens and allergens. “Food Hazards: Detection, Mitigation & Control” begins at 11 am ET, kicking off with a presentation from Mickey Parish, Ph.D., senior science advisor at CFSAN, about the agency’s policy on Listeria monocytogenes. The following is a preview of what you’ll learn during the complimentary event (that’s right, it’s free for all attendees).

Critical Elements for a Successful Pathogen Environmental Monitoring Program

Nearly every segment of the food and pet food industries are either working on implementing pathogen environmental monitoring programs (PEMPs), or are working to optimize programs already in existence. Programs are increasing in complexity with many now covering multiple environmental pathogens, hygienic facility zones and sampling zones. Regulators and customers are stepping up requirements for aggressive, science-based PEMPs. The seven most critical elements for a successful PEMP will be discussed. These elements include: management commitment, determining the need for and stringency of the program, risk evaluation, sampling plan, sampling methods, data management and corrective actions.

Allergen Detection & Control

While global market demand for free-from food products is increasing, undeclared and mislabelled allergens, sulphites and gluten, throughout the supply chain, continue to be the number one cause of consumer product recalls.

To meet the varied regulatory landscape and protect consumers, effective preventative management systems must be implemented, verified and validated. What are the challenges, risks and opportunities for manufacturers and retailers to protect their brands? This informative session will provide insights into:

  • Government regulations and how management systems can align with the Food Safety Modernization Act (FSMA) and the Safe Food for Canadians Act
  • Successful interventions and protocols to reduce the risk of gluten and allergen related recalls
  • Differences between Management System/ Process and Product Third-Party Certifications

Pathogen Mitigation: Sanitary Design in Facilities and Sanitation Methods

This presentation will go into detail regarding pathogen mitigation strategies for food processing facilities. The relationship between hygienic design and sanitation as they factor into pathogen mitigation will also be discussed. The presentation will then examine various sanitation methods and how they can be applied within the food industry to help eliminate and control pathogens.

Each educational session will be followed by a technology spotlight and an interactive Q&A between attendees and speakers. Don’t miss out on this event—Register here!

FDA

FDA Releases Five FSMA Guidance Documents

By Food Safety Tech Staff
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FDA

Today the FDA issued five guidance documents related to FSMA with the goal of assisting food importers and producers meet provisions in the regulation.

The first two documents are related to the Foreign Supplier Verification Program (FSVP) regulation. The FDA issued the draft guidance, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, along with a small entity compliance guide. The third draft guidance is related to whether a measure provides the same level of public health protection as the corresponding requirement in 21 CFR part 112 or the PC requirements in part 117 or 507 . “This draft guidance aims to provide a framework for determining the adequacy of a process, procedure, or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and for human or animal food,” according to FDA.

The FDA also released a final chapter in the draft guidance related to FSMA requirements for hazard analysis and risk-based PCs for human food. The chapter is intended to assist food facilities in complying with the supply chain program requirements.

The fifth guidance is an announcement of the FDA’s policy to exercise enforcement discretion related to the FSVP rule regarding certain grain importers that bring the product into the United States as raw agricultural commodities. “This enforcement discretion is meant to better align the FSVP rule with the exemption for non-produce RACs under the PC rules,” stated FDA.