Tag Archives: documentation

Melanie Neumann, Neumann Risk Services
FST Soapbox

The COVID-19 Record Retention Conundrum

By Melanie Neumann, JD, MS
2 Comments
Melanie Neumann, Neumann Risk Services

During this global pandemic, the U.S. Equal Employment Opportunity Commission (EEOC) green-lighted employers to take temperatures checks of employees and to administer COVID-19 testing for workers prior to returning to work without running afoul of the Americans with Disabilities Act (ADA). This appears straight-forward upon first reading, however, several practical uncertainties about implementation, including confidentiality, discrimination, and how long to retain records remain.

As such, deciding whether to take temperatures and/or require COVID- 19 testing as a return to work strategy is more complicated than it may seem.

Temperature Screening & Testing Considerations

Temperature screening and COVID-19 mandatory testing are both permitted medical examinations during this pandemic but are otherwise prohibited during non-pandemic times. Before adopting, employers should understand the requirements impacting the records these tests generate, including the need to protect confidentiality and to retain records for longer than one may expect.

Temperature Screens
Under normal circumstances, temperature checks are considered a prohibited medical examination under the ADA. During a pandemic, however, the Equal Employment Opportunity Commission (“EEOC”) makes an exception, allowing employers to take temperatures/use temperature checks and exclude employees from the workplace should temperatures exceed public health recommendations. If employers keep records of temperatures, they must retain these records per applicable regulations. This is important because an “employee medical record” would likely result if employers take employees’ temperatures or collect temperature related records. As we will see below, there are regulatory requirements that require how we conduct these screens, and where and for how long we must retain them.

COVID-19 Testing

COVID-19 testing also constitutes a permissible medical exam under ADA during this pandemic, per the EEOC-issued guidance regarding mandatory employee testing.

For medical examinations to be allowed under the ADA, the test must be “job related and consistent with business necessity,” and employers must treat information as a confidential medical exam.

The initial guidance acknowledged that the spread of COVID-19 is a “direct threat,” hence meeting the requirement that a medical exam be “job related and consistent with business necessity” and that temperature screenings were therefore appropriate. For the same reasons, in updated guidance released at the end of April 2020, the EEOC expanded that guidance to clarify that employers may choose to administer COVID-19 testing to employees before they enter the workplace to determine if they have the virus for the same reasons.

When reading the EEOC’s language closely, the permission granted by EEOC appears to be for diagnostic tests, as the guidance states testing is to determine if employees have the virus before allowing employees to return to work. It is unclear whether antibody testing is included in the above analysis because antibody tests do not determine if someone is currently infected.

In addition, there are other considerations employers should assess before adopting a testing protocol. EEOC reminds employers that they must review the accuracy and efficacy of the selected test per FDA and CDC recommendations. Moreover, pragmatic considerations, such as how to maintain social distancing and employee privacy, determining who will perform the testing and at what the frequency, not to mention evaluating whether there is enough test capacity to perform employee-wide testing at a meaningful cadence should be evaluated.

Records Management & Retention

There is another often over-looked question: What do employers do with documented test records? This question applies whether the employer conducts the test, requires tests from employee’s healthcare providers to be off work to self-isolate, or as a return to work requirement.

It was clearly outlined above that temperature records and COVID-19 test records constitute employee medical records. Why is this important? Because there are specific requirements relating to employee medical records, including what appears to be a surprisingly long retention requirement.

Where to retain: An employer should store all medical information related to COVID-19 in existing medical files, separate from the employee’s personnel file, per the ADA, limiting access to this employee confidential information. This includes an employee’s statement that he has COVID-19 or suspects he/she has the disease, or the employer’s notes or other documentation from questioning an employee about symptoms.

How long to retain: That is the 30-year question. The Department of Labor’s Occupational Safety and Health Agency (OSHA) provides retention requirements for employee medical records in certain situations for a period of an employee’s employment plus 30 years.

While COVID-19 test results and temperature screening documentation are deemed medical examinations under the applicable regulations, are the documented results deemed medical records? We turn to applicable EEOC OSHA regulations in section 1910.1020 for answers.

OSHA Requirements

The OSHA general duty clause, section 5(a)(1) requires employers to furnish to each of its employees a workplace free from recognized hazards that are causing or likely to cause death or serious physical harm. COVID-19 appears to rise to this threat level. But is that fact alone dispositive to falling under the applicable OSHA retention requirements?

OSHA regulation section 1910.1020 requires employers to retain employee exposure or employee medical records relating to employee exposure to certain hazards. This section applies to each general industry, maritime and construction employer who makes, maintains, contracts for, or has access to employee exposure or medical records, or analyses thereof, pertaining to employees exposed to toxic substances or harmful physical agents (Emphasis added).

Is SARS-CoV-2, the virus that causes COVID-19, considered a “toxic substance or harmful physical agent?”

Most would quickly assume the answer is ‘yes’. But it may not be as clear as the black and white letter of the law would hope. Let’s review some key definitions in the applicable regulation to help shed more light on this question.

What are Toxic Substances or Harmful Physical Agents?

The record retention requirement pivots on the last phrase of 1910.1020, that is “…pertaining to employees exposed to toxic substances or harmful physical agents.”

Toxic substances or harmful physical agents are defined as follows;

  • 1910.1020(c)(13) “Toxic substance or harmful physical agent” means any chemical substance, biological agent (bacteria, virus, fungus, etc.), or physical stress (noise, heat, cold, vibration, repetitive motion, ionizing and non-ionizing radiation, hypo – or hyperbaric pressure, etc.) which:
    • 1910.1020(c)(13)(i) is listed in the latest printed edition of the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS) which is incorporated by reference as specified in Sec. 1910.6; or
    • 1910.1020(c)(13)(ii) has yielded positive evidence of an acute or chronic health hazard in testing conducted by, or known to, the employer; or
    • 1910.1020(c)(13)(iii) is the subject of a material safety data sheet kept by or known to the employer indicating that the material may pose a hazard to human health. (Emphasis added by author).

The use of “or” clarifies that only one of the criteria need to be met. Based on the above, while subsections (c)(13)(i) and (c)(13)(iii) do not appear relevant, subsection (c)(13)(ii) appears to apply as SARS-CoV-2 has shown to result in acute health hazard, resulting in the disease COVID-19. Whether there is a chronic health impact remains to be seen given the novelty of this virus. That said, acute health impact appears sufficient to determine SARS-CoV-2 as a “toxic substance or harmful physical agent” for purposes of this analysis.

This alone doesn’t automatically place an employer in a 30-plus year requirement to retain employee medical records. What constitutes an “employee medical record” and “employee exposure record” for purposes of this regulation must be further understood before determining appropriate retention.

What are Employee Medical Records and Employee Exposure Records?

“Employee medical records” are defined in section 1910.1020(c)(6), and means a record concerning the health status of an employee that is made or maintained by a physician, nurse or other healthcare personnel, or technician, including: Medical and employment questionnaires or histories, the results of medical exams, lab test results, medical opinions/doctor’s recommendations, first aid records, employee medical complaints, and descriptions of treatment or prescriptions.

Section 1910.1020(d)(1)(i) goes on to specifically prescribes a minimum of a 30-plus year retention period as follows: “The medical record for each employee shall be preserved and maintained for at least the duration of employment plus thirty (30) years.”

“Employee exposure records,” are defined in subsection 1910.1020(d)(1)(ii), as: “Each employee exposure record shall be preserved and maintained for at least thirty (30) years,…”. Some exceptions are listed in this subsection for records relating to health insurance claims, first aid records and records relating to employees working less than one year.

What Constitutes Employee Exposure?

One must also look at what “employee exposure” means in light of this regulatory requirement to determine applicability of the 30-plus year retention.

1910.1020(c)(8) defines “exposure” or “exposed” to mean that an employee is subjected to a toxic substance or harmful physical agent in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorption, etc.), and includes past exposure and potential (e.g., accidental or possible) exposure, but does not include situations where the employer can demonstrate that the toxic substance or harmful physical agent is not used, handled, stored, generated, or present in the workplace in any manner different from typical non-occupational situations.

More Questions than Answers

This analysis may leave more questions than answers, as several questions remain after looking closely at the regulatory requirements. For example:

  • How can an employee prove that exposure to SARS-CoV-2 occurred in the course of employment?
  • Does the employee even have to? The regulation clearly states that it is the employer’s burden, in that the “employer demonstrate that a toxic substance or harmful physical agent was not present in the workplace in any manner different from typical, non-occupational situations”.
  • How can an “employer demonstrate” that the harmful physical agent was not present? In other words, how can employers demonstrate that its employees are at any greater exposure by coming to work than they are in their every day lives, like going to the grocery store?
  • How do employers prove absence? Is it even possible given several people are asymptomatic?
  • Does this analysis differ by food industry sectors? What about meat and poultry processors with known high rates of infection in their workplace? Would the analysis differ?

Conclusion

Short of additional guidance issued by Department of Labor’s OSHA, ultimately this will likely be decided by the courts when the first lawsuit on this topic arises, known as decision via case law. What do employers do in the interim while these shades of gray are not yet adjudicated? It is recommended to err on the side of caution. Find ways to adjust your company’s record retention procedures and systems to be able to accurately retain these records for the duration of your employee’s employment plus 30 years.

Resources

  1. OSHA Laws & Regulations. OSH Act of 1970. SEC 5. Duties. Retrieved from https://www.osha.gov/laws-regs/oshact/section5-duties
  2. OSHA Standards. Part 1910, Standard 1910.1020. Retrieved from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020
  3. OSHA. Access to Medical and Exposure Records. (2001). U.S. Department of Labor, OSHA. Retrieved from https://www.osha.gov/Publications/pub3110text.html
  4.  U.S. Equal Employment Opportunity Commission. “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws”. (Updated May 7, 2020). Retrieved from https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. See A. 6 and B.1.
Michelle Lombardo Smith, The Wenger Group
FST Soapbox

Top of the Pecking Order: How We Transformed Our Processes

By Michelle Lombardo Smith
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Michelle Lombardo Smith, The Wenger Group

A 75-year-old feed manufacturer making more than 2,000 feed formulas is bound to have a lot of business complexities. Add to that several years of rapid growth combined with outdated, manual processes. Several years ago, this was the situation we faced at our family-owned feed manufacturer and egg/poultry provider in the mid-Atlantic region.

We needed a way to simplify and streamline key processes, such as activities involved with safety and compliance. After evaluating several enterprise content management systems in 2015, we eventually selected Laserfiche to digitize records, implement electronic forms and automate manual workflows. While we completed an initial Laserfiche software install in 2016, we were still tasked with the process of building out solutions the company wanted to use in house, and we therefore continue to work closely with the company today.

Meeting Regulations With Data Sheets

Our initial project focused on digitizing our collection of safety data sheets, standardized documents that contain occupational safety and health data. Prior to implementing this software, we relied on paper manuals across different locations. Managing the creation of new data sheets and ensuring old ones were removed became quite the task. This project couldn’t have come at a better time, as the Occupational Health and Safety Administration (OSHA) had recently mandated changes to the data sheets.

By digitizing data sheets and storing them in a central repository, the documents were made more accessible and searchable for mill managers, and compliant to the new mandated standard. Additionally, data sheets were easily retrieved for any first responders seeking to understand what chemicals were in a facility in the event of a fire. It now takes just minutes to search for and retrieve documents, helping the organization stay in compliance with state reporting. Having the ability to create and add new sheets immediately is a tremendous benefits as well. These new capabilities allow us to help keep employees safer than ever before.

Shortened Delivery Processes

The next process that needed to be targeted was deliveries. Delivery tickets at the feed mills were billed based on production weight in the company’s enterprise resource planning software, and delivery weight was entered manually when the physical tickets were returned to the office, which could sometimes be days after the product was shipped. When the shipped weight showed a different amount than the production weight, the finance team had to issue the customer a credit leading to more inefficiency and a wrinkle in customer confidence.

Laserfiche allowed the company to develop delivery tickets to be scanned at the mill. Tickets are now available in 24 hours, and the processing time for invoicing has gone from six hours to just three. Warranty costs have decreased while customer confidence has increased.

Mobile App to the Rescue

Finally, with the mobile app the organization was able to decrease the complexity for one of its farming divisions, Dutchland Farms, all while staying in legal compliance. This specific division contracts egg production and pullet growing. The FDA published its Veterinary Feed Directive (VFD) regulations in 2015, a regulation that directly applied to Dutchland’s this team of growers and producer. The directive added to the list of antibiotics that required a veterinarian’s prescription to administer. In addition, flock owners now had to have a flock health plan and an established relationship with a veterinarian. We initially had a manual process to write and store the plans, but that process was digitized and automated with Laserfiche in 2017. Service technicians can now get electronic forms signed at the farm and be immediately transmitted to the company’s consulting veterinary practician, who lives out of the country. As a result, we were able to significantly reduce the time from farm signature to vet approval/signature of the Flock Health Plans, and saved on a huge amount of paper copies and mail costs.

What’s next? These days, we’re searching for a new ERP system, a multi-year journey that will include scanning capabilities and an expanded role for Laserfiche. Meanwhile, all the products developed are still a work in progress even as the software expands to teams like quality assurance and human resources.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

What a Waste

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

The Netherlands Food and Consumer Product Safety Authority NVWA closed down an animal feed company that generated €4 million revenue selling contaminated feed with forged documents. Several thousand tons of waste, unsuitable to use in animal feed, was found at the facility, and three employees have been arrested.

Resources

  1. Byrne, J. (February 6, 2020). “Arrests in feed fraud cases in the Netherlands”. Feed Navigator.
  2. Also see Inval bij veevoederbedrijf in omgeving van Tilburg.

Technical Writing Workshop Focuses on Key Skills Needed for Writing Up Non-Conformances and CAPAs

By Food Safety Tech Staff
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Technical writing is not as simple as it sounds—especially as it relates to writing non-conformances and CAPAs. Innovative Publishing is offering a Technical Writing Virtual Workshop that takes place over two two-hour sessions on March 3 and 10. The event is being hosted by Food Safety Tech’s sister publication, MedTech Intelligence, but the content is applicable to the food industry as well.

The course will be instructed by world-class, international quality and regulatory consultant Mark Proulx, president of MLB Consulting Services. Proulx has more than 25 years of direct manufacturing, auditing, and FDA experience and is a certified quality auditor and Six Sigma Black Belt.

The workshop was developed for the following industry professionals:

  • Engineers responsible for writing up investigations and reports
  • Tech writers who must communicate the results of testing in reports, write up papers, produce arguments for or against an issue
  • Middle-level managers who are attempting to make arguments or show results
  • Laboratory staff who document results and write reports
  • Technicians who must write up test protocols, non-conformance reports, corrective actions, reports to upper management, etc.
  • Quality Assurance/Quality Control and Regulatory Compliance people who must document clearly the purpose of investigations and produce final reports that clearly state actions to be performed or the results of testing

Learn more about this special Technical Writing Virtual Workshop now! Register by February 11 for a special discount.

Paperstack

Taking Your Operations Digital? Bring in the Stakeholders Early

By Maria Fontanazza
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Paperstack

Going digital is a hot topic in the food industry, but making the investment can be a tough choice for organizations. Jeremy Schneider, business development director, food safety and quality assurance at Controlant, reviews some of the factors that food companies should consider when making the decision, along with the value that digital technologies can bring from the perspective of ROI and improving food safety culture.

Food Safety Tech: For businesses that have been historically paper-driven, where do they start on the technology adoption journey?

Jeremy Schneider, Controlant
Jeremy Schneider, business development director, food safety and quality assurance at Controlant

Schneider: There are a number of questions that firms, both small and large, should consider when deciding to move to a paperless operation. Have you considered what moving away from a paper-based system would mean for your enterprise? What are the perceived challenges to making this move? Or perhaps, what are the risks of not moving to digital? How would utilizing systems provide your organization with the ability to access data in transformative ways?

For organizations that are making the transition from paper documentation to digital, it is critical to develop a roadmap with tangible milestones and objectives. Although there are a variety of reasons to make the switch to digital, what is most important for your organization will determine what those are, as they will play a critical role in developing a roadmap of priorities. We often find that organizations identify a ‘’pain-point’’ in their current process, and this is a leading driver to wanting to make a change in their process. Perhaps this is the inability to easily access information in a timely manner, or the challenges with making sense of the data that you are currently collecting. Whatever your challenges may be, begin by developing a plan, and prioritize this, as it will provide you with early positive results that will keep you working towards the goal. As you experience these early benefits from going digital, you will begin to see the value that this will bring your organization at scale.

One significant issue that many organizations face when beginning this journey is not bringing the appropriate stakeholders into a program early enough. It is critical for the success of new supply chain programs to make sure you bring in members of purchasing, logistics, quality, finance, IT, and others as early as possible so that any questions or concerns are properly vetted early in the process. In addition to this, getting buy-in from these teams at the earliest phase of a project will allow others to vet the system in their own way, potentially helping them solve challenges they have been

FST: Talk about measuring the success of a technology: How do the metrics translate into ROI?

Schneider: A question that is often raised is how to measure the success of the technology. Simply put, does the program make your life easier and solve the problem you set out to, or not? Does it meet the concise objectives that you outlined in the beginning of the process, or does it fall short in some way? If your answer to any of these questions is yes, and it does meet the objectives, then you are well on your way to defining success of your program.

Read Food Safety Tech’s previous discussion with Schneider, Using Technology for Traceability Adds Dimension to Supply Chain, Promises ROIIt is critical that programs are able to show their value through their return on investment, but how do you measure this? If you have recently implemented a real-time supply chain temperature monitoring program, for instance, you may want to consider metrics such as reduced loss, spoilage, shortages, or restaurant-level outages as metrics of success. Or perhaps you would want to translate this into a dollar figure. For instance, in the previous year, your organization counted 10 rejected shipments due to suspected temperature abuse, at a loss of $500,000. In the year following your implementation, your new system was able to help the organization intervene and minimize that loss to just one rejected shipment at a cost of $50,000, thus leading to a reduced loss rate of $450,000.

In collaboration with other stakeholders in your organization, you may be able to identify additional metrics, such as reduced freight rates from optimized shipping lanes, reduced insurance premiums from reduced losses, or reduced quantities of on-hand inventories as you are able to truly manage a just-in-time supply chain. If your organization actively measures your Cost to Serve, savings within your supply chain would likely be an important data point to consider.
Beyond the identifiable money savings, consider some of the soft ROI attributes, such as enhanced collaboration with supply chain and supplier partners, improved customer loyalty, brand protection generally, and sustainability initiatives. Does your organization have goals to reduce food waste? If so, perhaps waste minimization is an important attribute to measure. When evaluated holistically, significant savings can be realized.

FST: How does technology facilitate a more effective food safety culture?

Schneider: Building an effective food safety culture is a process that requires commitment from every level of your organization. The ways that we promote food safety culture within each organization differs, from rewarding team members when they identify an unsafe practice, to actively promoting food safety throughout the organization, to encouraging quality assurance teams to identify state-of-the-art technologies and implementing them to improve the systems, programs, and processes throughout the company.

As food safety professionals, our toolboxes are filled with a variety of tools for the job, and technology as a tool is no exception. Technology should enable our organizations to be more efficient, allowing them to focus their attention on high-priority projects while minimizing work that can be automated. An example of this is setting parameters to allow organizations to work based on exception instead of requiring a review of all documentation.

As we enter the New Era of Smarter Food Safety, and the tenants of it being people-led, technology-enabled, and FSMA-based, we have a mandate to try new technologies to help solve previously unsolvable supply chain challenges. Organizations are actively pursuing real-time supply chain temperature monitoring as a way to provide insights into their cold chain and allowing them to move from reaction to a position of prevention.

Organizations are finding that investments in food safety technologies pay dividends in customer commitment over the long term. It is no longer acceptable to only meet regulatory standards. It is now an expectation that companies do anything possible within their power to assure customer safety and, per the FDA’s new mandate, to help create a more digital, traceable, and safer food system.

Nuts, tree nuts

Q3 Hazard Beat: Nuts, Nut Products and Seeds

By Food Safety Tech Staff
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Nuts, tree nuts

The following infographic is a snapshot of the hazard trends in nuts, nut products and seeds from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. For the past several weeks, Food Safety Tech has provided readers with hazard trends from various food categories included in this report. This week’s hazard snapshot concludes the series.

Nut hazards, HorizonScan
2019 Data from HorizonScan by FeraScience, Ltd.

View last week’s hazards in Milk & Dairy Products.

Allison Kopf, Artemis

How Technologies for Cultivation Management Help Growers Avoid Food Safety Issues

By Maria Fontanazza
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Allison Kopf, Artemis

Visibility, accountability and traceability are paramount in the agriculture industry, says Allison Kopf, founder and CEO of Artemis. In a Q&A with Food Safety Tech, Kopf explains how growers can take advantage of cultivation management platforms to better arm them with the tools they need to help prevent food safety issues within their operations and maintain compliance.

Food Safety Tech: What are the key challenges and risks that growers face in managing their operations?

Allison Kopf: One of the easiest challenges for growers to overcome is how they collect and utilize data. I’ve spent my entire career in agriculture, and it’s been painful to watch operations track all of their farm data on clipboards and spreadsheets. By not digitizing processes, growers become bogged down by the process of logging information and sifting through old notebooks for usable insights—if they even choose to do that.

Allison Kopf, Artemis
Allison Kopf is the founder and CEO of Artemis, a cultivation management platform serving the fruit, vegetable, floriculture, cannabis, and hemp industries. She is also is an investment partner at XFactor Ventures and serves on the boards of Cornell University’s Controlled Environment Agriculture program and Santa Clara University’s College of Arts and Sciences.

I was visiting a farm the other day and the grower pulled out a big binder. The binder contained all of his standard operating procedures and growing specifications for the varieties he’s grown over the past 20 years. Then he pulled out a pile of black notebooks. If you’ve ever worked on a farm, you’d recognize grower notebooks anywhere. They’re used to log data points such as yield, quality and notes on production. These notebooks sit in filing cabinets with the hopeful promise of becoming useful at some point in the future—to stop production from falling into the same pitfalls or to mirror successful outcomes. However, in reality, the notebooks never see the light of day again. The grower talked about the pain of this process—when he goes on vacation, no one can fill his shoes; when he retires, so does the information in his head; when auditors come in, they’ll have to duplicate work to create proper documentation; and worse, it’s impossible to determine what resources are needed proactively based on anything other than gut. Here’s the bigger issue: All of the solutions are there; they’re just filed away in notebooks sitting in the filing cabinet.

Labor is the number one expense for commercial growing operations. Unless you’re a data analyst and don’t have the full-time responsibilities of managing a complex growing operation, spreadsheets and notebooks won’t give you the details needed to figure out when and where you’re over- or under-staffing. Guessing labor needs day-to-day is horribly inefficient and expensive.

Another challenge is managing food safety and compliance. Food contamination remains a huge issue within the agriculture industry. E. coli, Listeria and other outbreaks (usually linked to leafy greens, berries and other specialty crops) happen regularly. If crops are not tracked, it can take months to follow the contamination up the chain to its source. Once identified, growers might have to destroy entire batches of crops rather than the specific culprit if they don’t have appropriate tracking methods in place. This is a time-consuming and expensive waste.

Existing solutions that growers use like ERPs are great for tracking payroll, billing, inventory, logistics, etc., but the downside is that they’re expensive, difficult to implement, and most importantly aren’t specific to the agriculture industry. The result is that growers can manage some data digitally, but not everything, and certainly not in one place. This is where a cultivation management platform (CMP) comes into play.

FST: How are technologies helping address these issues?

Kopf: More and more solutions are coming online to enable commercial growers to detect, prevent and trace food safety issues, and stay compliant with regulations. The key is making sure growers are not just tracking data but also ensuring the data becomes accessible and functional. A CMP can offer growers what ERPs and other farm management software can’t: Detailed and complete visibility of operations, labor accountability and crop traceability.

A CMP enables better product safety by keeping crop data easily traceable across the supply chain. Rather than having to destroy entire batches in the event of contamination, growers can simply trace it to the source and pinpoint the problem. A CMP greatly decreases the time it takes to log food safety data, which also helps growers’ bottom line.

CMPs also help growers manage regulatory compliance. This is true within the food industry as well as the cannabis industry. Regulations surrounding legal pesticides are changing all the time. It’s difficult keeping up with constantly shifting regulatory environment. In cannabis this is especially true. By keeping crops easily traceable, growers can seamlessly manage standard operating procedures across the operation (GAP, HACCP, SQF, FSMA, etc.) and streamline audits of all their permits, licenses, records and logs, which can be digitized and organized in one place.

FST: Where is the future headed regarding the use of technology that generates actionable data for growers? How is this changing the game in sustainability?

Kopf: Technology such as artificial intelligence and the internet of things are changing just about every industry. This is true of agriculture as well. Some of these changes are already happening: Farmers use autonomous tractors, drones to monitor crops, and AI to optimize water usage.

As the agriculture industry becomes more connected, the more growers will be able to access meaningful and actionable information. Plugging into this data will be the key for growers who want to stay profitable. These technologies will give them up-to-the-second information about the health of their crops, but will also drive their pest, labor, and risk & compliance management strategies, all of which affect food safety.

When growers optimize their operations and production for profitability, naturally they are able to optimize for sustainability as well. More gain from fewer resources. It costs its customers less money, time and hassle to run their farms and it costs the planet less of its resources.

Technology innovation, including CMPs, enable cultivation that will provide food for a growing population despite decreasing resources. Technology that works both with outdoor and greenhouse growing operations will help fight food scarcity by keeping crops growing in areas where they might not be able to grow naturally. It also keeps production efficient, driving productivity as higher yields will be necessary.

Beyond scarcity, traceability capabilities enforce food security which is arguable the largest public health concern across the agricultural supply chain. More than 3,000 people die every year due to foodborne illness. By making a safer, traceable supply chain, new technology that enables growers to leverage their data will protect human life.

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.

Seafood

Q3 Hazard Beat: Seafood

By Food Safety Tech Staff
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Seafood

The following infographic is a snapshot of the hazard trends in seafood from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. Over the past and next few weeks, Food Safety Tech is providing readers with hazard trends from various food categories included in this report.

hazards, seafood, HorizonScan
2019 Data from HorizonScan by FeraScience, Ltd.

View last week’s hazards in herbs and spices.

Data protection, security

The Digital Transformation of Global Food Security

By Katie Evans
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Data protection, security

Modern food supply chains are inherently complex, with products typically passing through multiple suppliers and distributors, as well as countries and continents, before they end up on the supermarket shelf. While global supply chains offer consumers greater choice and convenience, they also make protecting the security of food products more challenging. With additional stakeholders between farm and fork, products are exposed to an elevated risk of biological or chemical contamination, as well as food counterfeiting and adulteration challenges—potentially putting consumer health and brand reputation in jeopardy.

Given the importance of maintaining the safety, quality and provenance of food products, global regulatory bodies are placing the integrity of supply chains under increased scrutiny. In the United States, for example, the adoption of FSMA moved the focus from responding to foodborne illnesses to preventing them by prioritizing comprehensive food testing measures, enforcing inspections and checks, and enabling authorities to react appropriately to safety issues through fines, recalls or permit suspensions.1 Similarly, China’s revised Food Safety Law (known as FSL 2015) is widely considered to be the strictest in the country’s history, and seeks to drive up quality standards by empowering regulators, and enhancing traceability and accountability through robust record-keeping. 2 The European Union continues to closely regulate and monitor food safety through its General Food Law, which is independently overseen by the European Food Safety Authority from a scientific perspective.

Achieving the Highest Standards of Food Security, Integrity and Traceability

For producers, manufacturers and distributors, the heightened regulatory focus on the security and integrity of the food supply chain has placed additional emphasis on accurate record-keeping, transparent accountability and end-to-end traceability. To meet the needs of the modern regulatory landscape, food chain stakeholders require robust systems and tools to manage their quality control (QC), environmental monitoring and chain of custody data. Despite this, many businesses still handle this information using paper-based approaches or localized spreadsheets, which can compromise operational efficiency and regulatory compliance.

The fundamental flaw of these traditional data management approaches is their reliance on manual data entry and transcription steps, leaving information vulnerable to human error. To ensure the accuracy of data, some companies implement resource-intensive verification or review checks. However, these steps inevitably extend workflows and delay decision-making, ultimately holding up the release of products at a high cost to businesses. Moreover, as paper and spreadsheet-based data management systems must be updated by hand, they often serve merely as a record of past events and are unable to provide insight into ongoing activities. The time lag associated with recording and accessing supply chain information means that vital insight is typically unavailable until the end of a process, and data cannot be used to optimize operations in real-time.

Furthermore, using traditional data management approaches, gathering information in the event of an audit or food safety incident can be extremely challenging. Trawling through paperwork or requesting information contained in spreadsheets saved on local computers is time-consuming and resource-intensive. When it comes to establishing accountability for actions, these systems are often unable to provide a complete audit trail of events.

Digital Solutions Transform Food Security and Compliance

Given the limitations of traditional workflows, food supply chain stakeholders are increasingly seeking more robust data management solutions that will allow them to drive efficiency, while meeting the latest regulatory expectations. For many businesses, laboratory information management systems (LIMS) are proving to be a highly effective solution for collecting, storing and sharing their QC, environmental monitoring and chain of custody data.

One of the most significant advantages of managing data using LIMS is the way in which they bring together people, instruments, workflows and data in a single integrated system. When it comes to managing the receipt of raw materials, for example, LIMS can improve overall workflow visibility, and help to make processes faster and more efficient. By using barcodes, radiofrequency identification (RFID) tags or near-field communication, samples can be tracked by the system throughout various laboratory and storage locations. With LIMS tracking samples at every stage, ingredients and other materials can be automatically released into production as soon as the QC results have been authorized, streamlining processes and eliminating costly delays.

By storing the standard operating procedures (SOPs) used for raw material testing or QC centrally in a LIMS, worklists, protocols and instrument methods can be automatically downloaded directly to equipment. In this way, LIMS are able to eliminate time-consuming data entry steps, reducing the potential for human error and improving data integrity. When integrated with laboratory execution systems (LES), these solutions can even guide operators step-by-step through procedures, ensuring SOPs are executed consistently, and in a regulatory compliant manner. Not only can these integrated solutions improve the reliability and consistency of data by making sure tests are performed in a standardized way across multiple sites and testing teams, they can also boost operational efficiency by simplifying set-up procedures and accelerating the delivery of results. What’s more, because LIMS can provide a detailed audit trail of all user interactions within the system, this centralized approach to data management is a robust way of ensuring full traceability and accountability.

This high level of operational efficiency and usability also extends to the way in which data is processed, analyzed and reported. LIMS platforms can support multi-level parameter review and can rapidly perform calculations and check results against specifications for relevant customers. In this way, LIMS can ensure pathogens, pesticides and veterinary drug residues are within specifications for specific markets. With all data stored centrally, certificates of analysis can be automatically delivered to enterprise resource planning (ERP) software or process information management systems (PIMS) to facilitate rapid decision-making and batch release. Furthermore, the sophisticated data analysis tools built into the most advanced LIMS software enable users to monitor the way in which instruments are used and how they are performing, helping businesses to manage their assets more efficiently. Using predictive algorithms to warn users when principal QC instruments are showing early signs of deterioration, the latest LIMS can help companies take preventative action before small issues turn into much bigger problems. As a result, these powerful tools can help to reduce unplanned maintenance, keep supply chains moving, and better maintain the quality and integrity of goods.

While LIMS are very effective at building more resilient supply chains and preventing food security issues, they also make responding to potential threats much faster, easier and more efficient. With real-time access to QC, environmental monitoring and chain of custody data, food contamination or adulteration issues can be detected early, triggering the prompt isolation of affected batches before they are released. And in the event of a recall or audit, batch traceability in modern LIMS enables the rapid retrieval of relevant results and metadata associated with suspect products through all stages of production. This allows the determination of affected batches and swift action to be taken, which can be instrumental in protecting consumer safety as well as brand value.

Using LIMS to Protect Security and Integrity of the Food Supply Chain

Increasingly, LIMS are helping businesses transform food security by bringing people, instruments and workflows into a single integrated system. By simplifying and automating processes, providing end-to-end visibility across the food supply chain, and protecting the integrity of data at every stage, these robust digital solutions are not only helping food supply chain stakeholders to ensure full compliance with the latest regulations; they are enabling businesses to operate more efficiently, too.

References

  1. FDA. (2011). FDA Food Safety Modernization Act. Accessed October 3, 2019. Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma.
  2. Balzano, J. (2015). “Revised Food Safety Law In China Signals Many Changes And Some Surprises”. Forbes. Accessed October 3, 2019. Retrieved from https://www.forbes.com/sites/johnbalzano/2015/05/03/revised-food-safety-law-in-china-signals-many-changes-and-some-surprises/#624b72db6e59.