Tag Archives: facility design

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part III)

By Frank Pisciotta, Spence Lane
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Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series addressed the importance of a physical security expert, insider threat detection programs, actionable process steps (APS) and varying approaches to a VA. Part II reviewed access, subject matter experts, mitigation strategies and community drinking water. This final article reviews broad mitigation strategies, feasibility assessments, food defense plans, partial ingredient security and the “Three Element” approach through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities, but which can also be applied to the smaller facilities that are currently in the process of readying for the next deadline of July 26.

Lesson 14: When the final rule was released, the concept of using broad mitigation strategies was eliminated. That notwithstanding and realizing that many companies seek to operate at a stricter standard for food defense with a clear focus on brand protection, versus only those process steps that potentially could result in a “wide scale public health impact.” Broad or facility-wide mitigation strategies should not be abandoned, but are less likely to get you a lot of credit for IA compliance. Including existing food safety prerequisite programs (PRP), programs and practices that are put in place to maintain a sanitary environment and minimize the risk of introducing a food safety hazard, can, in some cases, also be included as security mitigation. PRP’s with slight modifications can also contribute to a good “food defense” posture. For example, one PRP addresses hazardous chemicals and toxic substances. In some cases, non-food grade substances that could result in product contamination (not necessarily wide-scale public health impact) might be available to a disgruntled insider. It is obvious companies are concerned about contaminants being brought into the plants, but please do not overlook contaminants that are already there and ensure that they are properly secured when not in use.

Other facility-wide programs (broad mitigation) that contribute to effective food defense might include site perimeter or building security, visitor and contractor management, pre-employment background checks, employee security awareness and food defense training and sanitation chemical management.

Lesson 15: If you are using the three elements approach (Guidance Chapter 2 Section G) or the hybrid approach (Guidance Chapter 2 Section H), you will be required to make an assessment on feasibility. In the early VA’s conducted, prior to the second installment of the guidance in March of 2019, feasibility was essentially an all or nothing proposition. One could argue that a judgment call was required as to whether an intentional adulteration incident could be accomplished given the inherent conditions. Those conditions might include a lot of coworkers who might be able to observe and serve as witnesses to deter the act. With the release of the second installment of the guidance from the FDA, a new tool was made available which would allow food and beverage companies to run a calculation and make a more accurate prediction of how much of an unnamed “representative contaminant” which is assumed to be highly lethal and heat stable it might take to contaminate a product batch. Typically, the larger the batch size, the higher the quantity of the “representative contaminant” would be required to achieve a lethal dose (LD) in a serving size. So, to provide an additional level of validation with identified actionable process steps, the use of the LD calculation might be considered to provide more realistic insight into the feasibility element. For instance, if it would require one hundred pounds of the “representative contaminant,” you might feel justified in concluding that it is not realistic to get that amount of contaminant into the batch at the process step and rule out the point, step or procedure as an APS. This can save money and ensure limited food defense resources can be channeled to the areas where legitimate risk can be reduced.

Lesson 16: After an APS is identified, sites will need to determine, as the rule states, whether the existing “mitigation strategies can be applied…to significantly minimize or prevent the significant vulnerability.” Simply stated, what is in place today for food safety, and the broad-based security measures in use, may or may not be enough when you consider an insider motivated to contaminate the product. The FDA’s mitigation strategies database may offer some insights into additional food defense measures to consider. Where additional mitigation strategies are identified, from the time of completion of the VA until a site’s regulatory compliance deadline arrives (next one is July 26, 2020), that change must be incorporated into the food defense plan and fully implemented. We recommend that a site make a list of new mitigation strategies after the VA is complete for tracking purposes during the implementation phase. No mitigation strategies should be included in the food defense plan that are not fully implemented and where records cannot be adequately produced.

Lesson 17: In the second installment of the guidance, the concept of partial ingredients was introduced. The key activity types (KAT) of secondary ingredients is now considered to include the storage of partially used, open containers of secondary ingredients where the tamper-evident packaging has been breached. Tamper evident tape looked to have promising benefits, but several of our clients have abandoned the use of this mitigation strategy, which has been proven repeatedly to be defeated without detection. It appears that using containers that can be secured with numbered seals might be a better option and even better if the seals would be metal detectable in the event one went astray in a product stream.

Lesson 18: Food defense plan unification. Facilities regulated under the IA rule are likely to already have a food defense plan for other initiates such as SQF or BRC. The IA Rule is not unlike other counter-terrorism regulations in potential to create challenges to meet voluntary and regulatory requirements without having multiple food defense plans. The IA Rule based on its modeling after HACCP creates some very specific requirements in terms of how data needs to be presented and records maintained. Sites may be doing other things to support food defense, and one strategy that might keep auditors in their lane would be to include any non-IA Rule food defense content (e.g., for SQF or BRC) in an appendix to the IA Rule Food Defense Plan.

Lesson 19: Under the VA method the FDA refers to as “the “Three Element” approach, suggestion is made in the guidance released in March 2019 that regulated facilities might consider creating stratified categories for each element of public health impact, degree of physical access and ability of the attacker to successfully contaminate product. This is asking regulated facilities to engineer their own vulnerability assessment methodology. It is our opinion that this is asking a lot from a food and beverage facility and that creating categories for each element (e.g., refer to Table 3 on page 54) will extend the time it takes to complete a vulnerability assessment, create a lot more uncertainty in the process and does not necessarily help companies to identify the areas where intentional adulteration risk is highest.

Conclusion

Organizations who have yet to execute vulnerability assessments (due July 26) or those who have already completed vulnerability assessments who may wish to reflect back on their existing VAs in an effort to eliminate unnecessary APS’s should find these strategies helpful in focusing limited resources to the areas where they can have the greatest effect. Since the initiation of this article series, the FDA has released its third installment of the guidance. Once we reflect on this new installment, we will address our thoughts in a future article.

Brett Madden, Aviaway
Bug Bytes

Strategies and Building Design Improvements to Help Prevent Birds

By R. Brett Madden
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Brett Madden, Aviaway

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

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

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

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

Bird spikes, Aviaway
Bird spikes (All images courtesy of Aviaway Bird Control Services & Consulting)

Bird Spikes

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

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

Bird wire

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

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

Ledge exclusion
Ledge exclusion

Ledge Exclusion

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

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

Shock Track

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

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

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

Bird netting
Bird netting

Bird Netting

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

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

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

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

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

Mark Your Calendars: Pathogens Web Seminar on December 5

By Food Safety Tech Staff
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Next month Food Safety Tech is hosting a complimentary virtual event, “Pathogens: Getting to the Source, Prevention Strategies that Work“, which takes on Thursday, December 5 from 1–4 pm ET. The web seminar brings together subject matter experts who will share their perspectives on pathogen contamination, smarter facility design and operational hygiene, and important prevention strategies.

Speakers include:

  • Larry Cohen, Principal Microbiologist, Food Safety Department, TreeHouse Foods, Inc.
  • David Pirrung, Owner, DCP Consulting
  • Dave Evanson, Technical Consultant, Merieux NutriSciences

Attendees will have the opportunity to ask speakers questions during the live Q&A session that follows each presentation. Register now for this special Pathogens Web Seminar.

This event is sponsored by Millipore Sigma and Bayer Digital Pest Management.

Brett Madden, Aviaway
Bug Bytes

How to Prepare an Integrated Bird Management Audit Program

By R. Brett Madden
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Brett Madden, Aviaway

Birds of different species can become a pest problem depending upon where they are landing, roosting or nesting. In terms of food facilities, birds can cause various concerns: Product safety risks, possible contamination (bird droppings/feathers), poor audit grades, inspection failure, secondary insect pest problems, vectoring of foodborne illness pathogens, plant closures or fines. It is for these reasons that it is essential that food, beverage and product manufacturers (FBP) establish an integrated bird management (IBM) program.

An IBM program will ensure that every essential team member is on the same page in terms of the protocols for managing pest birds within and around the facility. Even if a facility has taken a proactive approach to bird control, the potential exists for birds to enter a facility. Especially considering bird pressures around adjacent properties, buildings, bodies of water and food sources near the facility.

Read Part I of this series: Bird Problems and Control Methods for Food Production FacilitiesIBM for food industry facilities is a systematic approach to preventing birds from gaining access within a facility and reducing the length of time birds remain within a facility. Nuisance birds, depending upon how severe the bird pressure—i.e., how many birds are landing, roosting and/or nesting within a given area—can cause severe damage to equipment, property, food products, displays, vegetation, façade signage, ledges, roofs, HVAC equipment, drains, fire suppression, electrical equipment and more. The longer that birds are permitted to remain within and around a facility, the more damage they can cause, and the harder it is to remedy the problem. Thus, it is critical to remove any birds that have gained entry as soon as possible to prevent possible FBP contamination and the birds getting comfortable within the facility.

There are several components to developing an IBM program. First, you need to conduct a complete inspection of the interior/exterior of the facility, followed by a review of the current data as well as any historical bird data. Now that you have all the raw data, you can begin developing the site-specific IBM plan for the FBP facility. Now that you have the program designed, the program can be implemented. Finally, after a defined timeframe that the IBM program has been active, the program needs to be evaluated to determine if any adjustments need to be made to the program.

Inspection

The first step in developing an IBM program is to conduct an initial site inspection audit of the interior and exterior of the facility.

Integrated bird management, audits, food safety
An example of an integrated bird management food safety audit checklist. Credit: Aviaway

The following various elements need to be inspected and with said findings documented.

Interior audit, pest management
An example of an interior audit spreadsheet. Source: Aviaway. (Click to enlarge)

On the interior of the facility, look at the following items:

  • Active Birds with the Facility
    • List the areas and locations of birds
      • Example: Location(s): Food prep area(s), warehouse, etc.
    • Any history of birds and related areas
  • Interior Landscaping
    • Type(s) and necessity
  • Food Processing Areas
    • Any active control measures in place
    • Assess the level of risk
  • Bay Doors
  • Location(s): Gaps
  • Location(s): Bumpers
  • General Doors
    • Location(s): Gaps
    • Location(s): Bumpers
    • Location(s): Structural
    • Location(s): Doors left open
  • Additional Access Point(s)
    • Check all equipment areas that enter/exit building
  • Pipe-Line Penetrations
  • Sanitation
  • Conductive Conditions
    • Location(s): Standing water
    • Location(s): Food Sources
    • Debris
  • Bird Droppings or Nesting Materials
  • Staff feeding birds
    • All access to food and water
Exterior audit, pest management
An example of an exterior audit spreadsheet. Source: Aviaway. (Click to enlarge)

On the exterior of the facility, look at the following items:

  • Active birds with the facility
    • List the areas and locations of birds
      • Example: Locations(s): Rear loading dock
    • Any history of birds around the exterior of the facility
  • Adjacent Structures
    • Accessory buildings and structures
  • Sanitation Practices (Exterior)
    • Location(s): Dumpsters
    • Exposed food sources and spillage
  • Trash Receptacles
  • Trash Removal Frequency
  • Food Waste on Ground
  • Cleaning Practices
  • Cleaning Practices Schedule
  • Cleaning Food Waste Bins
  • Motion Doors
  • Bay Doors (Exterior)
    • Location(s): Gaps
    • Location(s): Bumpers
    • Location(s): Structural
  • General Doors (Exterior)
    • Location(s) Doors Being Left Open
  • Additional Access Point(s)
  • Bodies of Water
  • Conductive Conditions
  • Structural (Exterior)
    • Location(s): Pipe-Line Penetrations
    • Location(s): Flashing
    • Location(s): Pipes
    • Location(s): Openings
    • Location(s): Roof
    • Location(s): Roof Hatches
    • Location(s): Windows
    • Location(s): Canopy (Front/Rear)
    • Location(s): Awnings (Front/Rear)
    • Location(s): Façade Signage (Front/Rear/Side)
  • Drainage
  • Standing Water
  • Clogged Drains
  • Landscaping
    • Retention ponds
  • Bird Droppings or Nesting Materials
  • Exterior Storage
  • Merchandise Displays
  • Existing Bird Control Devices

Review

Next, after all the above items have been inspected and findings recorded, all the data needs to be reviewed. In addtion, all the current bird management practices within the facility, documentation practices, and current audit/inspection findings should be all evaluated together. All this information is your road map for developing your IBM Program. Make sure that while you are collecting all the said raw data, you also speak with all necessary staff to get the most accurate information possible.

Documentation

Now that you have conducted your inspections and collected all the data, it’s time to create a site-specific IBM Policy & Plan for the facility. The development and implementation of the IBM plan will provide the appropriate procedures that are to be implemented to prevent, control and exclude birds from entering a facility and from keeping birds an acceptable distance away from the facility. With proper training and implementation of IBM procedures, there will be a reduced likelihood that birds will be able to enter the facility, and the length of time birds remain inside the facility will be reduced—thus, reducing the level of pest bird damage caused, reducing hazards to food sources, equipment, the public, and the facility environment.

Each facility is unique in its operation, location and potential for bird activity. The facility’s IBM plan will be designed to factor its control options when remedying and preventing bird pressure.

Implementation

Now that you have an IBM Plan, it’s time to implement the plan. First, make any necessary changes based upon findings of the audit and review of all data. Next, correct any conducive conditions that were discovered during the inspection. All the items that may require adjustment may need to be planned out depending upon budgetary constraints. Define staff roles regarding bird control efforts on a front-line facility level. Each member of the action team must fully understand their role and responsibility about the implementation and day-to-day operation of the plan.

The IBM Plan is the roadmap that should be followed for managing pest birds throughout the interior and exterior of the facility and related structures. It will set forth the facility’s bird threshold levels and site-specific facility needs. Furthermore, the IBM Plan will provide in detail how each phase of the plan will be implemented at each facility. The facility coordinator, in collaboration with the IBM coordinator, shall be responsible for the administration and implementation of the IBM plan. Each of their roles and responsibly should be thoroughly reviewed and understood.

Next, conduct staff training on proper bird control removal methods if handing live removal internally. Otherwise, what are the approved processes for third-party vendors who are providing removal services? Finally, conduct a review of the new documentation process to record all necessary data for the IBM program. Data collection is a critical component in evaluating the success of the plan and determining if any adjustments need to be made.

Evaluation

To ensure goal compliance, the IBM program should be evaluated at each site annually. The review must consist of all records, the number of birds that gained access into the store, corrective actions taken (at the facility level and outside efforts), and any plan adjustments. By reviewing all the data collected, the plan’s effectiveness can be determined, and whether alterations need to be made. Note that the IBM plan is not a static document that sits in a binder. The plan will have to evolve as operations change, or the set goals of the program are not met.

Conclusion

A proactive approach to reducing bird populations is critical for food industry facilities. As such, the IBM program will ensure that your entire staff is adequately trained on all the site-specific bird control methods, reduce the frequency of birds entering the facility and create a documented bird control program that is designed for your specific facility.