Verifying Engineering Controls: The Critical Role of Emerging Technology

Featured in the AIHA Blog

Written by Erik Malmstrom, CEO of SafeTraces | December 22, 2020

A ceiling vent

2020 has been a wake-up call for the built environment. For years, indoor air quality has been a problem hidden in plain sight. Scientific research has detailed the scale and extent of this challenge, as well as the real human consequences evidenced in degraded cognitive function, illnesses, and absenteeism.

However, the current pandemic has elevated indoor air quality to an urgent matter of life and death. Infectious disease experts, including the CDC, have arrived at consensus regarding the significance of airborne and aerosol-based transmission of SARS-CoV-2. Moreover, viral infection has shown to be 18 times more likely indoors than outdoors, leading to a state of paralysis in much of the built environment.

The good news is that we know that air ventilation and filtration can make a major difference in mitigating airborne exposure risk indoors. According to the AIHA’s Guidance Document “Reducing the Risk of COVID-19 Using Engineering Controls” (PDF), “Engineering controls (including ventilation and filtration) that can keep infectious aerosols at very low levels indoors offer the greatest promise to protect non-healthcare workers and other vulnerable populations as we reopen our businesses and workplaces.”

The bad news is that the pandemic has exposed a critical gap in the toolbox of industrial hygienists and mechanical engineers—a science-based, data-driven diagnostic solution for verifying engineering controls in real-world indoor environments. Today, many rely on carbon dioxide monitors, computational fluid dynamic modeling, mathematical calculations, and even smoke and bubble testing, none of which accurately approximate the risk of infectious aerosols.

Our company offers the first diagnostic solution for verifying ventilation and filtration-focused engineering controls, specifically for infection control, through a novel methodology that safely mimics aerosol mobility and exposure levels with DNA-tagged tracer particles. During the pandemic, we have supported clients spanning commercial real estate, industrial plant operations, and public infrastructure, providing us the following key insights:

  • Assumptions vs. ground truth: Similar to traditional building commissioning studies, our test results invariably reveal important discrepancies between our client’s assumed understanding of airflow patterns, airborne exposure levels, and HVAC system performance in their facilities relative to our assessment findings. Frequently, we detect unanticipated airflow between building areas, mechanical faults in the HVAC system, among other surprising findings that would otherwise be unknown to the client and that increase occupational health and safety risk.
  • Multiplier effect of airborne interventions: Our test results indicate a valuable multiplier effect of ventilation and filtration, evidenced by lower detection levels of our tracer particles in both air and surface swab samples. In other words, effective ventilation and filtration not only can reduce airborne exposures by removing infectious aerosols in the air; it also can reduce fomite exposures by preventing infectious aerosols from depositing on surfaces and infecting building occupants.
  • Importance of in-room interventions: Our test results clearly and consistently indicate greater efficacy in reducing airborne exposures with in-room interventions like portable HEPA filters relative to HVAC system interventions like MERV-level upgrades. Our tracer particles often don’t make it to in-system filters, whereas portable HEPA filters remove our tracer particles closer to the point of risk where infected occupants are likely to infect others. Thus, several clients have reevaluated the soundness of proceeding with MERV-level upgrades when considering their occupational health and safety benefit relative to their financial cost.

In conclusion, it is paramount for all occupants and professionals to understand if the HVAC system and engineering controls are actually helping or not in preventing the spread of COVID-19. Emerging technologies have tremendous potential to provide a more accurate understanding of real-world occupational health and safety risk and mitigate this risk based on science and data.

 

– Erik Malmstrom

Erik Malmstrom is CEO of SafeTraces, a Bay Area technology company and provider of DNA-enabled diagnostic solutions for indoor air quality. Further information can be found at www.safetraces.com.

This content originally appeared on the AIHA Blog. Read it here.

Is Your Supply Chain Putting Your Company at Risk?

Written by Krista Earl of TagOne | December 7, 2020

Ingredient traceability. Once merely a concern for select consumers and extraordinarily transparent brands, has become a more frequent concern of consumers and has been highlighted in the FDA’s “New Era of Smarter Food Safety” initiative.  The FDA, retailers and consumers are increasingly invested in the safety, efficacy and quality of the ingredients and their source that are the foundation of what we are putting in our bodies.  This foundation is built on one of the key components in “The New Era of Smarter Food”: Tech Traceability.  Tech traceability will combine a culture, best practices and technology to enable your organization to know, at a minimum, who provided your ingredients, and who purchased your ingredients. Sounds simple, right? Well, it depends. Let’s look further at the steps which will help you effectively manage your supply chain.

It Starts with Culture

Implementing a company culture that is focused on quality is critical to ensure that you have a safe, detailed process that keeps your consumers safe. The problem, however, is that many companies are not living up to these standards, and do not have the proper process in place to capture and analyze critical data and documents throughout their supply chain.  As recently as August 2020, a salmonella outbreak in onions caused 167 hospitalizations nationally. A study by Countless investigations around the globe have uncovered mislabeled ingredients and unsafe handling of consumable food products. A study by the Journal of American Medicine identified that less than 50% of CBD products had accurate labeling. The result? Consumers aren’t trusting food and supplement companies anymore. Additionally, this drives up legal fees and insurance premiums.

So, what can you do to protect yourself now?

  • Develop standard operating procedures. Identify and document your key process areas. And equally important, assign named individuals to own them. When something is assigned to everyone, it’s assigned to no one.
  • Get GMP/ GAP certified. This is a long, challenging process, but this will build in the discipline necessary to scale your operation and reduce your risks while you push out a quality product. Additionally, any major retailer or enterprise partner is going to require GMP certification prior to conducting business with you.
  • Know your Suppliers and Buyers. You should have a clean database of each of your suppliers (and have documentation of their respective certifications) and also each of your buyers and the products they delivered or purchased (respectively). All documentation needs to be up to date and verified (yes, companies fake their paperwork). Start with a spreadsheet and move to a cloud-based system when you have the budget.
  • One up and one back. Once you have your supplier and buyer list locked down (and an approval process to ensure you are working with safe suppliers), make sure you track EVERY transaction that occurs (date, item, lot #, location, CofA’s, etc). If your business is early stage, a spreadsheet and shared cloud drive may suffice, but as you expand, a more sophisticated technology will be required.
  • Inactive ingredients matter too. In fact, your packaging could be a risk to your product. Remember, every item that touches your product- adds risk.
  • Inspect your processor or contract manufacturer. Many of you may be thinking “I use a partner, and they say they are certified” and then stop. Well, don’t assume. You need to collect and keep all documentation, conduct an audit to ensure that they are meeting your quality standards. Remember, it is your label on the package, so you are liable in the event of an incident.

Taking it to the Next Level

  • Risk reduction. Class action lawsuits and civil disputes can put us in court, which is a significant distraction from growth, an undue financial burden and can destroy your reputation. Don’t risk it.
  • Product provenance. If you have taken the time to ensure that you have the best quality product on the market (organic, no-GMO, etc) how can you validate this claim? Blockchain traceability systems can help you differentiate your product and increase sales.
  • Chain of custody. Having proper documentation, CofA’s and buyer/seller information isn’t only for your records, it is extremely important to illustrate who was in possession of specific ingredients at what time period. This is especially critical with foreign imported items.
  • Tech traceability. Consumers want to know where the product they are putting in and on their body came from. Domestic? Organic? Allergens? And equally important, in the event there is a recall, a quick, surgical action can make the difference in lives, and millions in lost revenue. The only way to achieve this is with both a tight supply chain process and a technology system which can “connect” the data from your suppliers, ingredients, products and track to your buyers.
  • Get digital. It is time to move on from paper, spreadsheets, dropbox and your accounting system and invest in a digital platform that consolidates, organizes, and measures all of your supply chain and inventory information.
  • Predictive Analytics. Anything that is measured improves. Imagine if you could identify your more reliable suppliers based on a graph? Or which seed is going to perform better in a different climate? Being able to track your data and analytics will keep you ahead of the competition.

Building a great brand starts with building a great product. Yes, we can drive sales and have nice packaging, but your product is a compilation of all the ingredients and critical events in your supply chain. The companies that master quality and their supply chain and know where all their ingredients came from, will win by developing a reputation of excellence leading to trust from consumers and retailers.

 

– Krista Earl, Marketing Coordinator at TagOne.

TagOne is a cloud based, blockchain enabled integrated supply chain technology solution delivering groundbreaking transparency to the food and natural products industry. Learn more at www.TagOne.com or subscribe to podcasts on natural product transparency visit www.GettingTransparent.com

Using the Power of DNA and On-Product Traceability to Exceed the Security of Conventional Packaging

Featured in TagOne’s BlogOne!

Written by Ulrike Hodges, COO of SafeTraces | December 4, 2020

With increasing urgency, consumers and regulators are demanding transparency and assurances from companies, manufacturers, and distributors regarding their safety practices and the authenticity of their products. To illustrate the magnitude of the issue, the U.S spends an average of $152 billion annually on foodborne illness related costs and an average of $10 million a year per food recall. The U.S. Food and Drug Administration responded by ushering in the New Era of Smarter Food Safety, highlighting critical shortcomings of the current system in rapidly tracking and tracing food: records being largely paper-based; lack of end-to-end product traceability; and limitations in data sufficiency, compatibility, and quality for identifying products along the supply chain. These shortcomings can result in loss of life, millions of dollars in avoidable product loss, and lasting damage to consumer trust.

There is a persistent gap between the physical product being tracked and traced, and paper and digital records in the supply chain, providing the opportunity for bad actors in the supply chain to manipulate paper-based records, product labeling and packaging, and to profit from the misrepresentation of products. Product integrity can also be compromised through unintentional adulteration of records and products, due to human error resulting from an overly manual, inefficient recordkeeping process.

The good news is that blockchain and other existing supply chain solutions and digital technologies have made significant advances toward enhancing traceability and ultimately product integrity and consumer safety. Yet, the question remains on how to link a product’s digital record directly to the product.

A groundbreaking technology that leverages the power of DNA addresses the gap between the physical product, packaging, and digital-based records. SafeTraces, an innovative technology company in Pleasanton, CA has patented and deployed the miniDART® solution in the food industry and pharmaceutical industry, where it integrates seamlessly into existing production and processing steps, such as bulk commodity transfer points at the farm-level, produce wax lines or automated bag-filling lines.

SafeTraces’ revolutionary process of DNA tagging combines short, non-coding, non-living DNA sequences into edible, invisible, FDA-Generally Recognized as Safe (FDA-GRAS), DNA tags that leverage GS1 standards. The flavorless DNA tags, called safeTracers®, are applied directly to food, an API, excipient, or finished dose, in parts per billion (ppb) or less. By adding safeTracers directly to a product, the miniDART provides an immutable, covert, physical link between the product and digital traceability solutions. Using a simple test kit, downstream partners can read lot-level information directly off the product in 25 minutes, thereby rapidly accelerating the time it takes to authenticate a product even after its packaging has been removed.

When compared to conventional traceability solutions, SafeTraces’ solution delivers superior performance, ease of use, and scalability. It enables manufacturers and downstream partners to empirically support farm-to-fork claims, strengthen transparency and sustainability stories with consumers, and mitigate cost and risk associated with recalls and adulteration.

 

– Ulrike Hodges, COO of SafeTraces

Ulrike Hodges is the COO of SafeTraces, a Bay Area-based technology company and leader in DNA-enabled solutions for safety, traceability, and environmental quality. By harnessing the power of DNA, SafeTraces’ solutions meet the increasing demands of customers in the built environment, pharmaceutical, and food industries. Visit safetraces.com or contact a representative at info@safetraces.com for more information.

 

This content originally appeared on TagOne’s BlogOne! Online. Read it here.

The Role of Aerosols in COVID-19 Transmission

Aerosols in COVID-19 Transmission

Written by Erik Malmstrom, CEO of SafeTraces |  May 27, 2020

Initial Answers to the “Trillion-Dollar Question”: The Role of Aerosols in COVID-19 Transmission and Implications for Safely Reopening Shared Spaces

In an April 14 New York Times article titled “Stay 6 Feet Apart, We’re Told. But How Far Can Air Carry the Coronavirus,” Dr. Michael Osterholm, Director of the Center for Infectious Disease Research and Policy at the University of Minnesota, posed a question with enormous implications for global health and safety as we return to shared spaces in the absence of a vaccine and reliable rapid testing: 

“The question is what does it take for you to get infected? And that I think is the trillion-dollar question we have…maybe all it takes is an aerosol. You don’t need any droplets at all.” 

Dr. Osterholm highlights one of the critical “known unknowns” of COVID-19 – the transmission role of aerosols, or particles under five microns in diameter that are emitted while talking and breathing, that can stay suspended in air for hours, and that can travel over 20 feet.

Currently, guidance from the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) of six feet separation in public assumes that large droplets from coughing and sneezing are the principal means of COVID-19 transmission and that most large droplets drop to the ground within six feet.

However, a chorus of prominent experts have emphasized the role of aerosols and air flow as a potentially important transmission vehicle for COVID-19, with emerging scientific research lending credence to their argument:

What does the potential for airborne transmission of COVID-19 via aerosols mean for the air that we breathe in shared spaces that many of us will be returning to? 

On this matter, the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), a leading professional association whose guidance is widely referred to by facility managers, published a position document on infectious aerosols in April stating:

“Transmission of SARS-CoV-2 through the air is sufficiently likely that airborne exposure to the virus should be controlled. Changes in building operations, including the operation of heating, ventilating, and air-conditioning systems, can reduce airborne exposures.”

Given the complexity, urgency, and our evolving understanding of the risk presented by COVID-19 aerosols, practical application of ASHRAE’s guidance is easier said than done. In our experience, the airborne transmission risk is not always well-understood by facility managers and therefore insufficiently accounted for in reopening plans. Moreover, there is a notable gap in diagnostic tools available for assessing the risk of airborne transmission of COVID-19 indoors.

Based on groundbreaking technology developed with the support of the National Institutes of Health (NIH), our veriDART solution for verifying safe indoor airflows fills this gap. veriDART leverages proprietary airborne tracers that safely mimic the mobility of airborne pathogens like COVID-19 in order to identify high-risk transmission vectors, assess the efficacy of filtration, ventilation, and anti-microbial solutions, and instill public trust and confidence in buildings for safe occupancy.

Joseph Allen, Director of the Healthy Buildings program at Harvard T.H. Chan School of Public Health said, “The evidence suggests that mitigating airborne transmission should be at the front of our disease-control strategies for COVID-19.” As facility managers gradually reopen buildings while preparing for a potential second wave of viral outbreak this fall, veriDART is a powerful tool in the fight against COVID-19  – and gets us a step closer to answering the trillion-dollar question.

Please follow up to learn more and become an early adopter.   

Safety & Traceability in New Industries

Expanding Traceability to New Industries

Date: May 18, 2020

We hope that you and your loved ones are staying safe amidst the ongoing COVID-19 pandemic.

We wanted to provide an update on exciting developments at SafeTraces. At our core, our company is a mission-driven organization committed to solving the biggest, toughest safety challenges in the world. Until recently, we have been exclusively focused on food and agriculture-based applications of our technology. And for good reason. There is tremendous need for technology-enabled solutions for food safety and authenticity – consumers demand it, regulators mandate it, and food companies invest in it as a key source of value and competitive advantage.

Our miniDART and saniDART solutions represent major technological breakthroughs for food safety. miniDART is the first and only on-food traceability solution, leveraging edible, invisible DNA-based barcodes (FDA GRAS) that are applied directly to the food or ingredient and that a downstream purchaser can read with a rapid, inexpensive, on-site test to verify product source and authenticity. saniDART is the first rapid solution for verifying sanitation effectiveness at a microbial level to receive approval from AOAC-International, the gold standard for proprietary testing methods in food safety.

However, in recent months, opportunities beyond food and agriculture have increasingly demanded our attention for three important reasons. First, COVID-19 has created seismic global health and economic challenges that our technology is uniquely suited to help mitigate. Second, many companies outside of food and agriculture have sought our support, seeing our technology as a valuable solution to safety and security challenges confronting their operations. Third, our technology is highly versatile, enabling deployment in a wide variety of applications at scale. And that is why we have been compelled to support two other global industries facing enormous, urgent challenges:

Verifying Safe Airflow in the Built Environment

COVID-19 represents an unprecedented threat to public health and the global economy. As of mid-May 2020, Johns Hopkins counts nearly 300,000 deaths and four and a half million confirmed cases of COVID-19 globally in less than six months, sadly with these statistics forecasted to continue increasing until a vaccine is successfully developed.

Ranging from office buildings to nursing homes to food processing plants, the virus presents a major safety and health risk to the built environment given the complexity of airflows and the risk of airborne transmission. Currently, property managers lack adequate tools for assessing and mitigating this risk safely.

In response, we are excited to launch veriDART, our groundbreaking solution that leverages airborne tracers that safely mimic the mobility of pathogens like COVID-19 in order to verify safe airflows for building occupancy and re-occupancy. veriDART empowers property managers with a powerful tool to identify high-risk transmission vectors, ensure effective filtration, ventilation, and other protective measures, and target remediation actions. veriDART draws on SafeTraces’ deep expertise in surrogate particle development, built over years with support from leading institutions like the National Institutes of Health (NIH).

Anti-Counterfeiting for Pharmaceuticals & Nutraceuticals

The World Health Organization (WHO) estimates that the $200 billion global market for counterfeit drugs, touching nearly every therapeutic class, kill hundreds of thousands of people annually. Additionally, counterfeit nutraceuticals pose a serious threat to consumers as more than 50% of FDA Class I recalls between 2004 and 2012 were for dietary supplements. Product security stops at the unit of sale level, enabling significant risk of fraud, adulteration, and diversion during manufacturing and distribution.

To meet this growing need, we have introduced our on-dose traceability solution that leverages edible, invisible, FDA-GRAS, DNA barcodes that are mixed with coating or ingredients and applied to directly to pharmaceutical and nutraceutical pills during regular production. In turn, downstream supply chain partners can verify the authenticity, origin, and safety of a dose or its ingredients within 25 minutes more accurately and reliably than with traditional packaging-based serialization.

In closing, broadening our mission to ensure the highest safety standards of the food we eat, the medicine we take, and the air we breathe is an exciting and natural evolution of our company. Now more than ever, people demand transparency and assurances from food companies, drug manufacturers, and property managers regarding their safety practices. We are honored to tirelessly support our customers in making a better, safer world.

Sincerely,

Erik

 

 

Erik Malmstrom


Erik has been a leader at the intersection of agriculture and technology in senior roles at Farmers Business Network, Cargill, and the White House. He is a co-founder of CrossBoundary, a leading frontier market investment advisor, and is a combat veteran and graduate of U.S. Army Ranger and Airborne Schools. He received his undergraduate degree from the University of Pennsylvania and a joint M.B.A. – M.P.P. from Harvard Business and Kennedy Schools.

 

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