Tag Archives: inspection

Emily Newton, Revolutionized Magazine
FST Soapbox

How Can Preventive Maintenance Save Food Processors Money?

By Emily Newton
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Emily Newton, Revolutionized Magazine

The right preventive maintenance approach can improve food safety while saving money. With the right plan, food processing professionals can prevent serious machine failure, decrease maintenance costs and get a better sense of which machines may be more trouble than they’re worth.

However, not every preventive maintenance plan is guaranteed to help processors cut costs. Investing in the right strategy and tools will be necessary for a business that wants to save money with effective maintenance.

How an Effective Preventive Maintenance Approach Can Save Money

To start, the food safety benefits of a preventive maintenance program can help food processors avoid significant troubles down the line. Contamination and recalls will cost time and money.

They can also damage the professional relationships that businesses have with buyers. Recalls are extraordinarily expensive for food and beverage companies, costing an average of $10 million per recall, according to one joint study from the Food Marketing Institute and the Consumer Brands Association (formerly the Grocery Manufacturers Association).

Preventive maintenance can also extend machines’ life spans, giving a company more time before they’ll need to completely replace or rebuild a piece of equipment. Over time, this will help a business prevent machine failure or injuries resulting from improper machine behavior or function. In some cases, it can also mean cheaper repairs and less downtime.

Improving Records With the Right Plan

An effective preventive maintenance plan also generates a significant and detailed archive of maintenance records.

If a plan is implemented correctly, technicians will create a record every time they inspect, repair or otherwise maintain a particular machine. These records will be an invaluable asset in the event of an in-house or third-party audit, as they can help prove that machines have been properly lubricated, calibrated and otherwise maintained.

If a food processing business needs to resell a particular piece of equipment, they’ll also have a full service record that can help them establish the machine’s value.

Over time, the records will also give a highly accurate sense of how expensive the machines really are across an entire business. If the staff records repairs performed, tools used and resources and time spent, professionals can quickly tabulate each machine’s cost concerning man-hours or resources needed. These logs can help single out machinery that may be more trouble than it’s worth and plan future buying decisions.

With a digital system, like a computerized maintenance management system (CMMS), managers can automate most of the administrative work that goes into a preventive maintenance plan.

Modern CMMS tech also provides a few additional benefits beyond streamlining recordkeeping. For example, if a business is up against a major maintenance backlog or trying to balance limited resources against necessary repairs and checkups, a CMMS can help optimize their use of resources. As a result, they can make the most of the time, money and tools they have.

Common Preventive Maintenance Pitfalls

Typically, an effective preventive maintenance plan starts with a catalog of facility equipment. This catalog includes basic information on every piece of equipment in the facility — such as location, name, serial number and vendor, as well as information on how frequently the machine should be inspected or maintained.

Keeping spotty or incomplete records can make a preventative maintenance plan both less effective and more expensive. For example, a partial service record may give an improper idea of how well-maintained certain equipment is. Missing machine information may also confuse service technicians, making it harder for them to properly inspect or maintain a machine.

Too-frequent maintenance checks can also become a problem over time. Every time a maintenance technician opens up a machine, they can potentially expose sensitive electronics to dust, humidity or facility contaminants, or risk damage to machine components.

A maintenance check also means some downtime, as it’s usually not safe or practical to inspect a running machine.

Using the wrong maintenance methods can also sometimes decrease a machine’s life span. For example, certain cleaning agents can damage door gaskets over time. This can eventually cause equipment like a freeze dryer to be unable to create a proper seal.

The equipment manufacturer and technicians can usually help a company know what kind of maintenance will work best and how often they should inspect or tune up a machine.

Going Beyond Preventive Maintenance

Preventive maintenance is the standard approach in most industries, but it’s no longer the cutting-edge of maintenance practices. New developments in the tech world, like new Industrial Internet of Things (IIoT) sensors and real-time artificial intelligence (AI) analysis, have enabled a new form of maintenance called predictive maintenance.

With predictive maintenance, a food processing plant can outfit their machines with an array of special sensors. These sensors track information like vibration, lubrication levels, temperature and even noise. A digital maintenance system will record that information, establishing baselines and data about normal operating levels.

Once the baseline is established, the predictive technology can use fluctuations or extreme variables to predict improper operation or machine failure. If some machine variable exceeds safe operating thresholds, the predictive maintenance system can alert facility supervisors — or, depending on what kind of control the system has, shut down a machine altogether.

The predictive approach can catch issues that may arise in-between checks in a preventive schedule. This can help reduce the frequency of maintenance checks — possibly preventing further machine damage and saving the business money on technician labor.

The data a predictive maintenance system collects can also help optimize equipment for maximum efficiency.

Implementing a predictive maintenance plan will require a bit of a tech investment, however.

Food Processors Can Save Money With the Right Maintenance Approach

Preventive maintenance isn’t just essential for food safety — done well, it can also be a major cost-saving measure for food processors.

Good recordkeeping, a regular maintenance schedule and new technology can all help a business decrease maintenance and equipment costs. For processors that want to invest more in their maintenance plans, a predictive approach can provide even better results.

Checklist

2020 FSC Episode 6 Wrap: Lessons in Sanitation

By Maria Fontanazza
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Checklist

COVID-19 has put a spotlight on the importance of proper handwashing and overall hygiene. In addition to focusing on worker and operational safety, it has also pushed food manufacturers and processors to pay more attention to the location of high-touch areas and how they should be cleaned, sanitized, disinfected and sterilized. During last week’s Food Safety Consortium episode on sanitation, there was discussion about the need to have the right sanitation plan and properly trained people in place. “When it comes to food safety, who are the most important people in the plant? It’s the sanitation crew and employees. They are on the frontlines, ” said Shawn Stevens, founder of Food Industry Counsel, LLC. “If they don’t do their job or are not given the tools to do their jobs, that’s where the failures occur. We need to empower them. We have to invest in sanitation and not be complacent.”

Investing in a sanitation plan is where it all begins, said Elise Forward, president of Forward Food Solutions. Within the plan, companies need to include items such as PPE and sanitation equipment, along with what resources will be needed and what chemicals will be required. “What would it look like in our manufacturing facilities if we had a plan for the pandemic?” asked Forward. “There was so much scrambling: ‘How do we do this and what do we do’. We need to plan for these events.” Forward, along with David Shelep, microbiologist and consultant for Paramount Sciences and Bill Leverich, president of Microbiologics, Inc., offered a strong overview of the right components of a sanitation plan and the common products and technologies used in the process (quaternary ammoniums, sodium hypochlorite, ethyl alcohol, peracetic acid, hydrogen peroxide, and chlorine dioxide). They also provided insight on some of the products and technologies that are being explored in the face of COVID-19—UV-C and hypochlorous acid, which has applications in cleaning biofilms, hand sanitizing, fogging, and surface application (i.e., electrostatic spraying, mopping).

“Cleaning and sanitizing is setting up your production team(s) for success.” – Elise Forward, Forward Food Solutions

View the list of EPA-registered COVID-19 disinfectants.

Beyond sanitation methods, companies need to invest in employee training and be committed to their safety. This means giving employees sick days and not incentivizing them to come to work when they are sick.

Rob Mommsen, senior director, global quality assurance and food safety for Sabra Dipping Company, shared a candid perspective on how Sabra developed an effective and validated Listeria environmental monitoring program (LEMP) following an FDA inspection that led to a swab-a-thon, findings of resident Listeria in the plant, and a huge product recall as a result of the Listeria contamination in the plant (Mommsen stated that Listeria was never found in product samples). “We had to severely alter the way we cleaned our plant,” he said. And the company did, with a number of changes that included taking the plant apart and cleaning it; removing all high pressure water nozzles; changing areas in the plant from low care to high care; keeping movable equipment to certain areas in the plant; changing employee and equipment traffic patterns; and retraining staff on GMPs. The company also changed its microbiological strategy, conducting daily swabbing in certain zones, increasing testing on samples, and implementing a weekly environmental meeting that was attended by senior and department managers. “Fast forward” to 2019: FDA conducted an unannounced audit and noted that Sabra’s environmental monitoring program was one of the best they’ve seen and that the company’s culture was clearly driven by food safety, according to Mommsen.

Fast forward again to 2020 and the pandemic: With work-from-home orders in place and other frontline workers staying home for various reasons, the company saw a change GMP adherence, employee training and the frequency of environmental monitoring, said Mommsen. So Sabra had some work to do once again to re-right the ship, and Mommsen presented it as a lessons learned for folks in the food industry: In addition to employee safety, food safety must be the number one priority, and having the support of senior management is critical; the turnaround time for environmental swabs is also critical and an effective LEMP should consist of both conventional testing as well as rapid detection technology; and an environmental monitoring program requires persistence—it is not self sustaining and there are no shortcuts.

The watch the presentations discussed in this article, register for the 2020 Food Safety Consortium Virtual Conference Series, and view the session on demand.

Gary Smith, FoodChain ID
FST Soapbox

Are Remote Audits Here to Stay?

By Gary Smith
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Gary Smith, FoodChain ID

Starting in late March, based on travel restrictions and the risk of COVID-19 infection transmission, GFSI released direction to the food industry on the possibility of recertification extensions. The extensions enabled a one-time, six-month grace period to prevent certification loss.

In June GFSI updated guidance to allow up to half of the recertification process to be completed off-site using remote technology, while requiring completion of an audit’s on-site inspection within 28 to 30 days. In exceptional circumstances, a certification program could allow a maximum of 90 days for the on-site audit portion. As these “blended” audits began, fewer facilities sought extensions.

The remote portion of an audit, which includes program and record review as well as interviews, may increase audit time compared to pre-COVID audits, as all involved adjust to the use of technology and accessible electronic formats for records and programs.

After COVID-19, it is conceivable to predict that a portion of the audit could remain virtual. However, in food production, auditing requires the use of sight, touch and smell, not yet replicated without human observation. And, while COVID-19 has forced an audit evolution by pushing “virtual” adoption based on business needs, remote capabilities will still require a significant investment in technology, time and re-education of the industry. In the meantime, expect audit schedules to be disrupted for the next 9 to 12 months.

As the industry seeks to adapt for the future, we will likely see an acceleration in terms of digitized quality management systems. In the short term, manufacturers are putting their energy and focus into keeping employees safe, maintaining production and meeting customer commitments.

Several leading food safety groups have issued guidance on best practices for blended audits and the use of technology. And while the answer to “Are blended audits are here to stay?” appears to be “yes” for the immediate future, audits are expected to evolve over time. Although certain sections within audits are better adapted to remote capabilities, facilities will continue to use on-site auditors until new technologies enable them to do otherwise.

Alex Kinne, Thermo Fisher Scientific
In the Food Lab

Ensuring Food Safety in Meat Processing Through Foreign Object Detection

By Alex Kinne
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Alex Kinne, Thermo Fisher Scientific

The USDA estimates that foodborne illnesses cost more than $15.6 billion each year. However, biological contamination isn’t the only risk to the safety and quality of food. Food safety can also be compromised by foreign objects at virtually any stage in the production process, from contaminants in raw materials to metal shavings from the wear of equipment on the line, and even from human error. While the risk of foreign object contamination may seem easy to avoid, in 2019 alone the USDA reported 34 food recalls, impacting 17 million pounds of food due to ‘extraneous material’ which can include metal, plastic and even glass.

When FSMA went into effect, the focus shifted to preventing food safety problems, necessitating that food processors implement preventive controls to shift the focus from recovery and quarantine to proactive risk mitigation. Food producers developed Hazard Analysis and Critical Control Point (HACCP) plans focused on identifying potential areas of risk and placement of appropriate inspection equipment at these key locations within the processing line.

Metal detection is the most common detection technology used to find ferrous, non-ferrous, and stainless steel foreign objects in food. In order to increase levels of food safety and better protect brand reputation, food processors need detection technologies that can find increasingly smaller metal foreign objects. Leading retailers are echoing that need and more often stipulate specific detection performance in their codes of practice, which processors must meet in order to sell them product.

As food processors face increased consumer demand and continued price-per-unit pressures, they must meet the challenges of greater throughput demands while concurrently driving out waste to ensure maximum operational efficiencies.

Challenges Inherent in Meat Metal Detection

While some food products are easier to inspect, such as dry, inert products like pasta or grains, metal foreign object detection in meat is particularly challenging. This is due to the high moisture and salt content common in ready-to-eat, frozen and processed, often spicy, meat products that have high “product effect.” Bloody whole muscle cuts can also create high product effect.

The conductive properties of meat can mimic a foreign object and cause metal detectors to incorrectly signal the presence of a physical contaminant even when it is nonexistent. Food metal detectors must be intelligent enough to ignore these signals and recognize them as product effect to avoid false rejection. Otherwise, they can signal metal when it is not present, thus rejecting good product and thereby increasing costs through scrap or re-work.

Equipping for Success

When evaluating metal detection technologies, food processors should request a product test, which allows the processor to see how various options perform for their application. The gold standard is for the food processor to send in samples of their product and provide information about the processing environment so that the companies under consideration can as closely as possible simulate the manufacturing environment. These tests are typically provided at no charge, but care should be taken upfront to fully understand the comprehensiveness of the testing methodologies and reporting.

Among the options to explore are new technologies such as multiscan metal detection, which enables meat processors to achieve a new level of food safety and quality. This technology utilizes five user-adjustable frequencies at once, essentially doing the work of five metal detectors back-to-back in the production line and yielding the highest probability of detecting metal foreign objects in food. When running, multiscan technology allows inspectors to view all the selected frequencies in real time and pull up a report of the last 20 rejects to see what caused them, allowing them to quickly make appropriate adjustments to the production line.

Such innovations are designed for ease of use and to meet even the most rigorous retailer codes of practice. Brands, their retail and wholesale customers, and consumers all benefit from carefully considered, application-specific, food safety inspection.

Ensuring Safety

The food processing industry is necessarily highly regulated. Implementing the right food safety program needs to be a top priority to ensure consumer safety and brand protection. Innovative new approaches address these safety concerns for regulatory requirements and at the same time are designed to support increased productivity and operational efficiency.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

No Celebration During These Days Of The Dead

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

One of the worst suspected alcoholic beverage poisoning incidents has claimed dozens of lives in Mexico. A possible cause may be tainted liquor from illegal bootleg sources; the suspicion is pointing to methanol as a contaminant, which can lead to blindness and even death. Due to the coronavirus crisis, some Mexican states banned alcohol production and sales, which may have promoted the sales of illicit alcoholic beverages. An Euromonitor report mentions that about 25% of alcohol beverages in developing markets are illicit and may endanger consumers’ health and lives.

Resource

Taylor, P. (May 14, 2020). “Another illicit alcohol tragedy as dozens killed in Mexico”. Securing Industry.

Peter Jardine, Bayer
Bug Bytes

Sanitation and IPM Inspection

By Peter Jardine
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Peter Jardine, Bayer

Register to attend the complimentary webinar: New Technology’s Impact on Pest Management in a FSMA Regulated World | March 5, 2020 | 12 pm ETMillions of pounds of food are lost every year due to pest activity. A lot of those lost food products could have been prevented through a quality sanitation program. One of the best ways to protect your facility from the potential damage and pathogen spread caused pests like rodents is to maintain a quality sanitation program.

Every sanitation program should take into consideration conditions that are conducive to attracting and supporting unwanted visitors. As rodents are incredibly agile and intelligent creatures, one of the best ways to keep them out of a facility is to give them no reason to be interested in coming in. This means eliminating access to each of their basic needs: Food, water and harborage—in any amount. Remember, they are small, scrappy creatures and only need crumbs and droplets of water to survive. Once you change your perspective from that of a human being to that of a rodent you may be surprised by the bountiful conditions that are at your feet.

Peter Jardine, Bayer
Bug Bytes

What’s the Most Important Tool for Proper IPM Inspection?

By Peter Jardine
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Peter Jardine, Bayer

As technologies become more and more advanced, the best pest technicians are often those willing to use the latest and greatest, most advanced tools on the market to provide superior service. However, if your technician is not carrying this one basic item in their toolkit, there is a good chance you’re not getting the quality of service you deserve. Any guesses at what that tool might be?

Register now for the complimentary webinar: New Technology’s Impact on Pest Management in the FSMA Regulated World | March 5, 2020 | 12 pm ETIf you guessed flashlight, you’re correct. Whether or not your technician carries a flashlight with them when they perform the inspection speaks volumes about the quality of service you are getting. A flashlight tells you two important things. First, that your technician is not just checking traps, but performing an investigation. He or she is looking for conditions that attract and foster pests. Second, a flashlight sends the message that your technician is willing to inspect dark or difficult-to-reach places. This is the type of technician willing to get on hands and knees to check under equipment. They will climb and crouch in order to reach the places pests are likely hiding. They value a pest-free environment more than their own convenience.

In short, the most important work your pest technician can provide is a thorough investigation to help prevent pest problems before they occur. If your pest technician is not performing an investigation each time they enter your facility, you’re not getting the value you need and should expect from your service provider.

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.

Cori Goldberg, Reed Smith
FST Soapbox

USDA Publishes Hemp Rules: Will It Impact Food?

By Cori Goldberg, Adam Brownrout, John Kendzior
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Cori Goldberg, Reed Smith

On October 29, 2019, the USDA released its long-awaited draft rule establishing a domestic hemp production plan, providing clarity to growers and ancillary businesses about how the USDA will regulate the hemp crop. The USDA, under authority provided by the 2018 Agricultural Improvement Act (2018 Farm Bill), was tasked with promulgating regulations and guidelines to establish and administer a program for the production of hemp in the United States. This rule has now arrived and been published in the Federal Register. The rule provides requirements for all state and tribal hemp production plans including requirements for testing hemp, licensing growers, disposing of non-compliant hemp, and collecting and storing information related to hemp production. The USDA will now accept public comment on the rule until December 30, 2019.

Although the USDA rule will greatly contribute to the expansion of legally grown hemp in the United States, this rule does not alter the law regarding CBD foods and CBD dietary supplement products. This is because the 2018 Farm Bill left intact FDA’s authority to regulate the sale and marketing of CBD foods, dietary supplements, drugs, and cosmetics, as those product types fall under FDA’s purview generally. FDA has allowed the sale of CBD cosmetics, with certain restrictions, and companies may submit CBD products to FDA through FDA’s drug approval process. However, it has maintained that the addition of CBD to foods and dietary supplements is illegal. Under the federal Food, Drug, and Cosmetic Act (FDCA), once a substance is approved as an Active Pharmaceutical Ingredient (API) in an FDA-approved drug, that substance may not be placed into interstate commerce in a food. Also under the FDCA, once a substance is approved as an API in an FDA-approved drug, that substance is excluded from the definition of a dietary supplement. FDA approved the pediatric epilepsy drug, Epidiolex, whose API is CBD. Therefore, FDA has concluded that CBD may not be placed into foods in interstate commerce and that CBD products are excluded from the dietary supplement definition and therefore may not be sold as dietary supplements. The USDA rule does nothing to change the legal status of CBD food or dietary supplement products. Thus, despite the expected increase of hemp availability following the passage of the USDA rule, CBD companies must wait for the FDA green-light in order to manufacture or sell hemp-derived CBD food products lawfully.Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry Journal

However, the rule does state that additional hemp is necessary to support the growing CBD market, and it notably put pressure on FDA by stating that if “FDA does not provide clarity about their plans for future regulation of CBD, there will continue to be uncertainty and downward pressure on the CBD portion of the hemp market.”

So what does the USDA rule do? Under the USDA rule, states and tribes will have the option of either submitting a proposed hemp regulation plan to the USDA for approval or agreeing to submit to the USDA’s general requirements. All state and tribal plans must include certain provisions, including but not limited to:

  1. Land used for production: State and tribal plans must identify a process for collecting, storing and maintaining relevant information regarding land used for growing hemp in the state. This includes information regarding the description, acreage, and boundaries of the farm land.
  2. Sampling and testing for delta-9 tetrahydrocannabinol (THC): State and tribal plans must implement testing procedures to ensure that plants do not exceed THC levels above 0.3% (as provided in the 2018 Farm Bill). All testing facilities must be DEA approved, as non-compliant product with THC levels over 0.3% would be considered “marihuana” and a schedule 1 substance under the Controlled Substances Act of 1970 (CSA). Additionally, laboratories will be required to report a “measure of uncertainty” in their testing, designed to provide a buffer for the potential variation in sampling and testing procedures. Accordingly, plants testing higher than 0.3% THC but still within the “measure of uncertainty” will be considered compliant.
  3. Disposal of non-compliant products: States and tribes must develop a procedure for destroying non-compliant cannabis containing more than 0.3% THC. Because non-compliant product is considered a controlled substance, all product must be disposed of in a manner consistent with the CSA. Therefore, product must be collected and destroyed by a DEA agent or law enforcement officer.
  4. Inspection of hemp producers: States and tribes must develop procedures for inspecting hemp producers on an annual basis and also for inspecting random samples. The state must also develop procedures to identify and attempt to correct certain negligent acts such as not obtaining licenses or producers exceeding acceptable hemp THC levels.
  5. Information sharing: State and tribal plans must include procedures for reporting information to the USDA. This information must be provided to the USDA within 30 days of receipt from the hemp producers and includes contact information for all hemp producers in the state, legal descriptions of the land used for hemp production, and the license status of all hemp producers in the state.
  6. In states and tribes without an approved or proposed plan, hemp producers will be subject to the USDA general plan. The general plan also provides similar requirements for the testing and sampling of hemp. The USDA will provide licenses directly to hemp producers in states without an approved or submitted plan as some states may not want to have primary regulatory authority of hemp. These states will essentially hand over regulatory responsibility to the USDA. These licenses will be available by application 30 days after the final rule is published. Notably, the draft USDA rule also provides that states and tribes are restricted from prohibiting the transportation or shipment of hemp or hemp products produced under a state plan, tribal plan or a license issued under the FDA. The interstate commerce provision should put an end to the arrests of those transporting legally produced hemp from one state to another. For example, in July 2019, a trucker was arrested and charged with felony possessions of marijuana and intent to distribute while transporting legally grown hemp through South Dakota (South Dakota still considers hemp a controlled substance).

So while the USDA rule is much anticipated and grabbed the attention of many when published, food and dietary supplement manufacturers, distributors, and retailers are still stuck where they were before. We will all continue to wait and see what FDA will do.

Resource

  1. “Establishment of a Domestic Hemp Production Program”. (October 31, 2019). Federal Register. Retrieved from https://www.federalregister.gov/documents/2019/10/31/2019-23749/establishment-of-a-domestic-hemp-production-program.
Recall

Simmons Prepared Foods Recalls More than 2 Million Pounds of Poultry Products

By Food Safety Tech Staff
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Recall

Yesterday Arkansas-based Simmons Prepared Foods, Inc. initiated a Class I recall of 2,071,397 pounds of poultry products over concern of foreign matter contamination. The products, which were produced between October 21 and November 4, were shipped to Alabama, Arizona, Arkansas, California, Georgia, Minnesota, Oklahoma and Pennsylvania.

Thus far there have been no confirmed reports of adverse reactions related to product consumption.

In an FSIS news release, the agency expressed concern that some of the products may be frozen at institutions and is advising that the products be thrown away or returned to where they were purchased.