Steve Ardagh
FST Soapbox

What’s in Your Glove?

By Steve Ardagh
2 Comments
Steve Ardagh

In the food processing and food service industry, glove wearing is meant to protect, not infect. That’s the theory, but not necessarily the reality.

Over 100 billion protective gloves—over 90% of the national supply—are imported into the U.S. each year from factories scattered throughout Asia. A good proportion of the gloves are destined for a substantial proportion of the 700,000 workers in meat and poultry processing and fresh produce sectors, as well as a proportion of the 14 million workers in the food service sector.

The FDA recently specifically classified gloves as Zone 1 Food Contact Surfaces, meaning in direct contact with ready to eat (RTE) ingredients or finished food products, and at the highest risk for product contamination.

The Food Safety Gap

However, there is a vital and contradictory gap in the oversight of quality assurance within FDA regulations. Here’s how the gap occurs. The FDA Compliance (21CFR177) for a glove to be called food-compliant involves a one-time single glove test conducted by overseas factories with an FDA-approved lab. The test is focused solely on chemical migration from the glove to food, and unless the manufacturer changes material ingredients, the test has no expiry date. “Food Compliant” gloves are not tested for bioburden, cleanliness or performance.

Complementary regulations also listed under FDA Title 21 Part 110 – Good Manufacturing Practice (GMP 21 CFR 110.10) require gloves to be “intact, clean, and sanitary” and “impermeable.” Upon arrival in the U.S. however, there is no requirement from the FDA for gloves to arrive “intact, clean, and sanitary” and “impermeable.” Gloves with FDA (21 CFR 177) compliance are imported “without the benefit of inspection.”

Why Does This Matter?

If you went down a food processing line and told every glove wearer that there was a 46% chance that the gloves they were wearing contained human fecal indicators, or potentially contained more than 250 unique and viable pathogens, what do you imagine the reaction would be? What would consumers think knowing the food on their dinner table might have been handled by potentially contaminated gloves?

The findings of a five-year study commissioned by Eagle Protect and undertaken by the B. Michaels Group revealed widespread risk of contamination in the disposable glove industry. The findings were presented at the 2019, 2021 and 2022 International Association for Food Protection (IAFP) annual meetings. Results found human fecal indicators on 46% of new and unused off-the-shelf gloves along with other foodborne pathogens and microbes including E. coli, Bacillus cereus, Bacillus anthracis, Listeria monocytogenes, Clostridiales difficile, Staphylococcus, Salmonella, Pseudomonas aeruginosa, Streptococcus pneumonia, and various fungi including Aspergillus.

Michaels, a leading microbiologist, ran the study, which involved independently testing 2,800 new and unused U.S. glove imports representing 26 different brands (approximately 25% of the ~100 SE Asian glove factories). Over 250 different viable microbial species were found on both the interior and exterior surfaces of the tested gloves.

Based on both observed conditions and events at SE Asian glove factories, as well as characteristics of microorganisms identified on or in disposable gloves, it was ascertained that microbes originate from contaminated water sources (rivers, drainage ditches and ponds). Once introduced into glove manufacturing facilities, contaminated rinse water circulates in and out of leaching or wash tanks, often not heated sufficiently, that are responsible for removing soluble chemical residues from glove surfaces.

In addition, gloves made of poor-quality materials can rip and tear, with particles finding their way into food products. Glove toxins can also contribute to a range of potential health issues including carcinogenicity, endocrine disruption, fertility impairment, metabolic disorders and skin diseases including dermatitis. For companies, there are issues with potential recalls, liability, worker compensation and consumer health.

How Can This Be?

In addition to dirty, polluted, contaminated water sources at factories, poor filtration, poor raw materials, unhygienic packing, poor hygiene practices by factory staff, lack of oversight and care by factory owners and, most important, lack of procurement standards on the part of U.S. corporate, business and institutional glove purchasers allow this to go on.

What Is the Solution?

There is little pressure on foreign glove manufacturers to self-regulate and improve their practices, unless businesses refuse to purchase from companies that cannot demonstrate acceptable standards. Therefore, the onus is on corporate and business purchasers of gloves. They need to be better educated about glove safety, including the risks of billions of potentially contaminated gloves on the hands of their workers in factories and plants, the potential risks to end consumers, and the value of adopting of clear standards for procurement that supersede the overwhelming criteria of “how cheap can we get them?”

Ask 1: Do manufacturers use Safe Ingredients? Are the raw materials tested to ensure consistency of manufacturing and to ensure the gloves are free of potentially toxic chemicals that might impact user and consumer health or contaminate food?

Ask 2: What is the Performance of the glove? Strength and durability tests and Acceptable Quality Level (AQL) further ensure consistent glove performance. AQL (maximum pinhole defects per 100 gloves) levels are required for medical and sterile gloves. There are no stated requirements by the FDA for Food Compliant Gloves. However, the standard should be at 2.5 (examination grade) or lower for food safety.

Ask 3: Are the gloves Clean? Bioburden on both the inside (skin contact) and outside (food and patient contact) can be tested to identify fungal and microbial contaminants that could pose a threat to the glove wearer, and the product handled.

Ask 4: Are the gloves Skin Tolerant? Poor quality gloves are often the cause of skin irritation. FDA Food Compliance does not ask for cleanliness, physical standards or toxicity tests. Gloves can be tested for a wide variety of chemicals and toxic exposure that could result in dermal or systemic toxicity, ensuring against skin irritation and occupational skin diseases of the wearer.

Ask 5: Is the factory making your gloves independently certified and does it use child or forced labor? Does your supplier or distributor have credentials such as being a registered B-Corp or accreditation by WRAP (Worldwide Responsible Accredited Production) organization, SEDEX (Supplier Ethical Data Exchange) or similar independent labor and quality verifications?

Ask 6: Is the product traceable? Does your glove box come with a QR code in which manufacturing activity is captured, secured and shared across the supply chain?

Consortium of Agreement to be Better Informed

The sight of blue gloves on a production line is universal. So too is the assumption that these gloves are safe by being “intact, clean, and sanitary.” Yet, we have learned that this is not always true. The only realistic action that can improve glove safety is for corporations to adopt standards, for glove wearers to demand quality gloves and for consumers to start asking “What’s in your gloves?”

Although regulators can set the tone that encourages industry to do the right thing, ensuring glove safety really does come down to suppliers and buyers uniting in a full-throated demand that there be a reduction in the risk of glove contamination in the U.S.

There needs to be a consortium of agreement from purchasers of protective gloves to shift from the lowest common cost denominator (cost) to a higher standard. The top 15 food producing companies in the U.S. have a combined market capitalization of $1.4 trillion so there is room to take some extra safety steps to implement a Supplier Code of Conduct using a system to conduct assessments and lab tests and to monitor outcomes.

Better and more informed decisions can be made by procurement departments. Food processing and food service companies all have safety and sustainability criteria; glove safety should be among the standards to adhere to.

We should be able to feel more at ease knowing that the gloves our food processing and service personnel put on are of the highest standards. This should be a paramount concern, not just to experts, but also the public who remain mostly unaware of the risks and dangers in glove manufacturing. Therefore, it is incumbent on all the industries involved in the making, selling and purchasing of gloves to adopt and advocate for a robust system for the manufacturing, tracking and quality assurance of gloves.

Jennifer McEntire
Women in Food Safety

Building a Satisfying Career in Food Safety

By Food Safety Tech Staff
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Jennifer McEntire

With so many potential paths available to food safety and quality assurance professionals, how do you narrow your career path goals, and when is it time to move on to a new opportunity? These were two of the themes of last month’s Women in Food Safety gathering. Featured speaker, Jennifer McEntire, Ph.D., founder of Food Safety Strategy and former Chief Food Safety & Regulatory Officer at the International Fresh Produce Association (IFPA), discussed her 25-year career path and why she chose to step out on her own as an independent food safety consultant.

The keys to a long and satisfying career are to keep an open mind and explore opportunities, said McEntire. Having trained as a food microbiologist, her career was heavily influenced by an early internship at the National Food Processors Association (later to become the Grocery Manufacturers Association) in Washington, DC. She later worked with IFPA and regulatory consultancies including the Acheson Group and Leavitt Group. Her experiences in DC instilled in her an appreciation for regulations and an interest in what she referred to as “being in front of the debate in forming legislation.”

“I love reading regulations, I love DC and I enjoy learning how decisions are made, the debate of a bill and finally how it gets passed,” said McEntire. “So I have always worked in the regulatory area.” However, as she moved up the ladder, she realized that she was spending more time in meetings than rolling up her sleeves and working and decided to go out on her own as a consultant. “I am naturally risk adverse,” said McEntire. “So, I made this transition very cautiously.”

Questions to Ask

The questions that have guided her career decisions, which she encourages other professionals to ask themselves are, “What am I good at? What do I like to do?”

Although she has a very strong background in regulations and compliance, when launching her own company she wanted to take the opportunity to broaden that scope and work with companies in building better food safety management systems. “I didn’t want to focus just on audit compliance as these clients are often just compliance focused. Instead, I wanted to work with companies that wanted to be better, build and improve their operations,” said McEntire. Key questions she encourages companies to ask (that she asks clients) are, “Where do we go from here? What does success look like?”

Owning and managing her own company gave her the opportunity to build her skill set outside of food safety regulation. “Owning my own business isn’t easy, but at each stage I learn something new. For example, how to build a website and how to manage my company email accounts,” said McEntire. “Although there are many new things, I enjoy being responsible for my own schedule. I don’t have to ask anyone for permission and I actually don’t miss working for an employer anymore.”

Tips for Success

McEntire shared several tips that contributed to her success, including:

  • surround yourself with the right people.
  • stay informed and keep up-to-date
  • take advantage of the opportunities that arise

“Throughout your career, it’s important to let your opinion be heard,” she said. As you move into leadership positions, “I ask everyone what they think, then gather all information and make sure I understand it. If you have to make the decision, make a decision that you are confident in based on the information available. You may get challenged, but be strong, defend it and don’t hesitate in making the final decision.”

 

Don't Eat Poop logo
Food Safety Culture Club

Making Recalls Faster and More Efficient

By Food Safety Tech Staff
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Don't Eat Poop logo

Recall—it’s a word that strikes fear in the hearts of CEOs, food safety professionals and the general public. At the 2023 Food Safety Consortium, Roger Hancock, CEO of Recall InfoLink, joined Matt Regusci and Francine Shaw, co-hosts of the “Don’t Eat Poop” podcast, to discuss the challenges in handling food recalls and the importance of taking steps now to make the recall process faster and more efficient.

Hancock launched Recall InfoLink, a supply chain process management system, after spending 15 years leading food safety and quality at Albertson’s, where he managed roughly 250 recalls per year. His goal was to improve how companies manage recalls, making the process easier and faster, and ensuring that the right message gets to the right people at the right time.

“Faster is better,” said Hancock. “For a CEO, the brand isn’t as exposed in the media, the cost will be fairly low and liability contained. For the consumer, faster means maybe I didn’t buy it because it was already pulled from the shelves or, if I bought it, I took it out of my pantry before I ate it.”

When recalls happen slowly or over time, the problem isn’t typically with individual companies and how they perform the recall. “The problem is between companies,” said Hancock. “The bigger the recall, the more companies that get involved in passing data from place to place, and that tends to slow things down. And you can imagine a game of telephone where the message consistency changes and problems start to escalate.”

He seeks to solve this problem by building what he calls a “recall-ready community.” “Our concept is if preparedness is done as a community—or as a supply chain—then those gaps can be identified ahead of time,” said Hancock. “So, when everybody’s hair is on fire and a recall is happening, they’re not having to solve problems that they’ve already identified and solved…Every recall is unexpected and unplanned, so to make them fast and easy requires practice and being ready.”

During the conversation, Hancock shared the most challenging recall he was involved in during his 30-year career. “It was the first and only mad cow disease (BSE) recall in the U.S.,” he said. On December 23, 2002, Albertson’s found out that a BSE-positive cow was in its supply chain. “I spent from December 23 to end of January documenting the recall. It was nightmare,” said Hancock. “There was a lot of concern/fear about mad cow disease at the time and there was a cow that had tested positive for BSE in our supply chain. There were no protocols for how to handle it. There were no regulations around how to handle it. So, it was very complex.”

Hancock did point out that, despite the high number of food recalls happening every year, very few pose a risk to human health. “Most recalls remove products that have a problem or defect that isn’t really going to hurt anyone, but for business or compliance reasons probably needs to get out of the supply chain. So only a fraction of recalls that happen actually pose a risk to people,” he said.

This raised the question of recall fatigue and whether businesses and consumers have become complacent. “Some of our clients choose to notify their customers out of courtesy that they didn’t buy the recalled product. And what we find is that too many of those courtesy notifications end up creating a habit of, ‘I don’t need to look at this.’ So, there is a risk there. And as I’m listening to all of the focus on consumer notification, I worry about that same risk. As we think about consumer notification and even streamlining business communication, it takes a savvy person to know how to do it correctly, so that you don’t have unintended consequences of either people ignoring the notification or of creating a panic.”

Listen to the full episode here and join us October 20-22 at the 2024 Food Safety Consortium in Washington, DC.:

 

Cronobacter
Ask The Expert

Cronobacter Regulation and Detection

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Cronobacter

As we saw with the recent large scale recalls of infant formula, Cronobacter has become a pathogen of growing public health concern for vulnerable populations. Our guest experts, Sally Powell Price, Regulatory Expert Food and Beverage Safety at MilliporeSigma, and Andrew Lienau, Food Regulatory and Validation Senior Expert at MilliporeSigma, detail the importance of Cronobacter in food manufacturing, summarize detection solutions and provide a glimpse into the future of this potentially deadly pathogen.

Why is Cronobacter detection important?

Cronobacter are ubiquitous pathogens that have been isolated from a wide variety of sources including dried herbs and spices, soil, starches and milk products. They are found naturally in the environment, for example, in our yards, kitchens and living rooms. They even can live on surfaces including kitchen counters, sinks and food facility manufacturing equipment.

Andrew Lienau
Andrew Lienau

Infant formula, as we have seen in recent years, can be contaminated by this type of bacteria. While Cronobacter infections are rare, they can be fatal to newborns and immunocompromised individuals. When these infections are diagnosed in infants, they are often linked to consumption of powdered formula.

According to CDC, the potential mortality rate for Cronobacter infection is 40%. It has high risks for newborns, especially low-birth weight infants. Cronobacter is highly resistant to stress and can survive in products such as powdered infant formula for more than two years, which is the major risk factor. Almost all Cronobacter species are linked to human infections (adults and infants).

How is MilliporeSigma’s Assurance® GDS method fit-for-purpose for detection of Cronobacter?

Ensuring an assay is robust is a lengthy process. Microbiology methods are reviewed and approved by standards or certification bodies. Certification organizations for food microbiology include AOAC International and Health Canada in North America and AFNOR Groupe and MicroVal in Europe. Approved testing methods undergo rigorous, systematic scientific scrutiny and validation to ensure they are credible and legally defensible and thus can be used with confidence by industry, regulatory agencies, research organizations, testing laboratories and academic institutions. It is important during this validation process to demonstrate that the methods are reproducible and provide consistent results across a variety of sites and users.

MilliporeSigma logo

During the certification process, methods are compared against standard reference methods or a “gold standard.” For example, there is a reference method developed by ISO for enrichment of Cronobacter from foods. Through the certification process, the MilliporeSigma Assurance® GDS method performed as well as the reference method. But the GDS Cronobacter method requires less time, materials and personnel to obtain comparable results. This certification improves both industry confidence and access to a rapid, reliable method for detection of Cronobacter in food.

The GDS for Cronobacter method has been reviewed and approved by both MicroVal (MicroVal 2017LR77) and AOAC International (AOAC PTM 121903; AOAC OMA 2021.08). These review processes can take more than one year from initial submission of protocol to generation of the validation data, including final review of the results by the certification organization. Outside expert peers also review the method for approval.

This year MilliporeSigma was honored that the Assurance® GDS Cronobacter method was recognized as the Method of the Year Award in Microbiology by AOAC International.

What are the regulatory implications and outlook for Cronobacter & infant formula?

The recent move towards restructuring the FDA and Human Foods Program was in part driven by the high-profile recalls and subsequent infant formula shortages due to Cronobacter contamination. Over the next year, we can expect to see continued regulatory scrutiny of Cronobacter and similar pathogens or analytes that put infants and other vulnerable populations at risk.

Sally Powell Price
Sally Powell Price

Last year, the U.S. FDA released a strategy to help prevent Cronobacter illnesses, and in 2023, they expanded their approach by increasing inspection capacity and updating the Infant Formula Compliance program.

Beginning in 2024, Cronobacter infection will be a nationally notifiable disease as recognized by the US Centers for Disease Control (CDC). The FDA will collaborate with states and public health labs to bolster testing efforts. This will provide more clinical isolates, complementing the FDA’s environmental and product sample collection and sequencing strategies. It will also increase sequencing data available in the NCBI database in hopes of bridging scientific gaps related to Cronobacter.

Furthermore, the FDA is reviewing existing testing criteria to potentially enhance finished product safety with a focus on infant formula regulations led by the Office of Critical Foods. The Agency is collaborating with Congress to explore legal avenues to require firms to report Cronobacter-positive product test results, among other requirements.

For infant formula manufacturers it’s not all about regulation, however. Manufacturers and stakeholders now have expanded opportunities for collaboration with the FDA and related working groups like the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). These partnerships offer a unique chance for productive dialogue and the potential to engage in valuable initiatives aimed at providing scientific insights into Cronobacter and its prevention, including elective surveillance programs. Additionally, stakeholders in the infant formula industry can strengthen efforts to be transparent with consumers. They may actively participate in public meetings and engage with industry associations such as the Association of Food and Drug Officials (AFDO) or The Partnership for Food Safety Education (PFSE), fostering open discussions and sharing best practices to enhance safety and quality standards in the production and preparation of powdered infant formula. This proactive engagement not only fosters consumer confidence but also contributes to a safer environment for infants and vulnerable populations.

 

Resources:

https://www.sigmaaldrich.com/US/en/product/sial/71038bc

https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/296/685/71038bc-dfu-ug5695en-ms.pdf

https://www.youtube.com/watch?v=JyANKbGPeJQ

https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/microbiological-testing/pathogen-and-spoilage-testing/assurance-gds-genetic-detection

https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/214/623/assurance-gds-system-br2694en-ms.pdf

 

 

 

 

 

 

 

Jennifer Allen
Food Safety Attorney

Food Labeling Requirements for Natural Flavors

By Jennifer Allen
1 Comment
Jennifer Allen

Natural flavors are ubiquitous in foods today, and chances are, at least one of the products that your company manufactures contains them. But what are they, and how should they be identified on your packaging?

Natural flavors are defined at 21 CFR 101.22(a)(3) as “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.” In short, a natural flavor is a substance the purpose of which is simply to add flavor, which is extracted from a food through one of a certain number of processes.

The astute among you may be asking yourself right now, “Why are so many consumers critical of natural flavors? From this definition, they seem pretty natural to me.” Well, consider that the above regulation applies only to the flavor. But when you take a natural flavor off the shelf to incorporate it into your product, that flavor is contained in some kind of solvent, with certain additives for functionality. The solvent and additives are not required to be in any way “natural.” This may be why some consumers are skeptical about how “natural” natural flavors really are.

Labeling Nuances

As with all ingredients, natural flavors must be identified as such on your product’s ingredients panel. If those flavors don’t make up the primary characterizing flavor of the product, but are included simply to make your product juicier, to enhance mouth-feel or to supplement the flavor imparted by the other food ingredients, then identifying them as “natural flavors” on the ingredients panel is sufficient.

But under certain circumstances, they must also be identified more prominently on the principal display panel. As the regulations explain at 21 CFR 101.22(i), if your product has a certain primary characterizing flavor (the example the regulations use is strawberry shortcake), and most or all of that characterizing flavor comes not from the food itself but from natural flavors derived from that food, then those flavors must be clearly identified. The name of the flavor must be included. It may have the word “natural” in front of it, but it must have the word “flavored” after it. So, to use the strawberry shortcake example, if your shortcake is predominantly flavored with actual strawberries, then your label would read “strawberry shortcake.” But if it is primarily or solely flavored by natural flavor derived from strawberries, then it must be labeled: “natural strawberry flavored shortcake,” or “strawberry flavored shortcake.

What if you are flavoring your product with natural flavors that are not derived from the food that is the characterizing flavor? For example, what if your product is a lemon pie, but you flavor it only with natural flavors derived from limes? In that case, you must either include by the product name the identity of the actual flavor (for example, “with natural lime flavor”), or you must identify it as being artificially flavored. You read that correctly. Even if you are using a natural flavor, if it isn’t from the food that is the characterizing ingredient in your product, then it is considered an artificial flavor. What about a lemon pie flavored with natural lemon flavor but also with natural lime flavor. In that case, your label would include the words “natural lemon flavor, with other natural flavors.”

As a rule of thumb, if your product’s principal display panel contains the name of a food item, or a picture of a piece of fruit or other food item that the consumer would understand to be the primary recognizable flavor in the product, but the product does not in fact contain that fruit or other food item, or is predominantly flavored with natural flavors, then you must comply with the labeling requirements above. But if your product is predominantly flavored by the food item itself, with the natural flavors simply enhancing the flavor or serving a secondary flavoring function, then you need only identify the presence of natural flavors in the ingredients panel.

 

Don't Eat Poop logo
Food Safety Culture Club

Human Skills: The Key Ingredient of Food Safety Culture

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Don't Eat Poop logo

Building relationships and trust with your team are the backbone of strong leadership. But these skills are seldom part of a food safety and quality assurance professionals training. At the 2023 Food Safety Consortium, Jill Stuber and Tia Glave, founders of Catalyst, a food safety consultancy that offers leadership training programs, sat down with Matt Regusci and Francine Shaw, co-hosts of the “Don’t Eat Poop” podcast to discuss strategies leaders can use to build their “human skills” as well as the lack of respect often seen in today’s workplace.

“The technical skills are very important in food safety, and we are consistently building them, but we are missing the human side,” said Glave. One danger of missing this human side is a lack of respect toward team members that translates to high turnover and low productivity.

You have to respect your people, which means saying “Please,” “Thank you,” working alongside them and understanding their unique goals and responsibilities. “If you want someone to work on Black Friday, you may have to work around a track schedule or a baseball schedule,” said Shaw. “If you want them to give up part of their Christmas, maybe you only have two-hour shifts. It is a give and take not a constant take, and leaders have forgotten that.”

One exercise Glave and Stuber use to help new leaders build their human skills is The Three Ps. “It’s all about learning what people are Passionate about Professionally and Personally,” said Stuber. “And we hear from attendees that their people are opening up to them because they started using this process and team members are working more cooperatively with them.”

One of the key frustrations of new leaders is that they feel bogged down by constantly having to deal with the “people stuff.” Welcome to leadership, says Stuber. “People will say to us, ‘I can’t get any work done because it’s all talking with people, and we say, ‘Your job is people now, welcome to the change!’”

Listen to full conversation here:

 

 

 

 

 

Rick Biros
Biros' Blog

The Rising FSQA Phoenix

By Rick Biros
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Rick Biros

Last month, the Food Safety Tech team wrapped up a very successful Food Safety Consortium Conference. While I could name drop many of the who’s who of food safety who presented this year, Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs, gave a great keynote address in tandem with Sandra Eskin, Deputy Undersecretary for Food Safety at USDA FSIS. Erik stayed for the full conference and participated in two additional panel discussions, one on Succession Planning and the second on Recalls. Sandy stayed for two days and made herself accessible to the delegates.

As the conference director I’m also the emcee. I introduce the speakers and panelists, but I also have the opportunity to be a participant and observe the interplay between delegates. What I observed at the Consortium was great networking, conversations and mentoring but what really stood out was a real energy among the delegates, something I haven’t seen at any food safety conference in the last few years. I believe that energy is an indicator that FSQA (food safety and quality assurance) is coming back from the devastation and impact of the Covid-19 pandemic.

For example, on the topic of FSQA auditing and inspections, Covid significantly reduced the amount and type of internal and supplier audits as well as FDA inspections. Many auditors who were independent contractors just quit. They moved on because there was no work. This left a huge void in trained and experienced auditors.

Our session on Succession Planning for Inspectors and Auditors included panelists from government, academia, industry and industry associations. They discussed the increase in inspections and audits coming in 2024 and thus, the real need to fill the void in inspectors and auditors left from the pandemic, as well as the need to train and nurture those folks.

Another theme at the Consortium was the continued evolution of Food Safety Culture. Delegates were looking for ways to take Food Safety Culture to the next level and apply metrics to it. We did a post conference survey, and the feedback we received supports this. Here are some of the direct responses:

Q: What were your top takeaways from the Food Safety Consortium?

  • Transparency from regulators and ways to foster growth and culture.
  • Food Safety Culture is in the forefront, as evidenced by the numerous panels. I attended nearly every one pertaining to this subject. It is a difficult subject because it is subjective and difficult to measure and quantify.
  • Food Safety Culture is ever evolving and becoming a more important factor every year. We need a new system but are unwilling to scrap or majorly overhaul the current one … FSMA was supposed to drastically reduce foodborne illness incidents. It doesn’t seem to be working, and we are nearing the time for FSMA 2.0. While it doesn’t appear that we are getting better at reducing the number of incidents, we are getting better at detecting them.

Q: What Topics should we plan for next year’s Food Safety Consortium?

  • Updates from the FDA and USDA on current projects
  • How to demonstrate Food Safety Culture. How to build a program and maintain momentum was discussed this year. But how do we show results to auditors? We need guidance and expertise on proving a solid FSC to auditors.

My takeaway from this year’s Food Safety Consortium is that the FSQA community is on the cusp of a resurgence in activity, training and investments—like a Phoenix rising from the ashes of Covid. But even before the pandemic, there was an overall sense of FSMA and GFSI fatigue. I am seeing a collective increase in FSQA activity that has not been present in many years, and that’s a good thing!

In 2024, we will see accelerated digital transformation. Data analytics will play a greater role in FSQA strategies. Getting an entire industry and supply chain ready for FSMA 204 in two years will be a huge undertaking. Also, Food Safety Culture will evolve to provide metrics and data for accountability.

Food Safety Tech continues to publish original weekly articles on these emerging trends. We are introducing a new FSQA Auditor Training program in Q1, and next year’s Food Safety Consortium conference will be held October 20-22, 2024, in Washington, DC, continuing the conversations, debates and discussions.

You can be part of this new wave of FSQA energy by contributing an article to Food Safety Tech or submitting an abstract for the 2024 Food Safety Consortium conference.

This new wave of energy has inspired me. It’s been a while since I last wrote this column, way too long. And FSMA 2.0, that will be the subject of a future column. Also, I’ll share my thoughts on the new food safety agency, our new podcast partners from Don’t Eat Poop and many other topics. Until next time…

All the best!

Rick Biros, Founder, Publisher, Conference Director

 

 

peanuts, allergens
Allergen Alley

Allergen Advisory Labeling

By Food Safety Tech Staff
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peanuts, allergens

We’ve all seen the vague warnings on food labels, such as “May contain tree nuts” or “This product was made in facility that also processes dairy.” At the Food Safety Consortium in October, Steven Gendel, principal of Gendel Food Safety and former FDA Food Allergen Coordinator, offered guidance on when and how these advisory—also known as precautionary—labels should be used by food companies. In his presentation “Allergen Advisory Labeling,” Gendel made clear that these statements are not regulatory requirements and are not to be used for a company’s benefit (i.e, to shield the company from liability). They are for consumers and should be used only to protect consumers in situations where there is a potential risk of cross contamination that cannot be controlled through regulated cross contamination efforts and may cross the threshold of safe levels for allergic consumers.

Steve Gendel, USP
Steven Gendel

When to Use Allergen Advisory Labels

Advisory labels are to be used after a company has taken all necessary steps to eliminate allergen cross contamination and ensure the absence of allergens, and is unable to prevent the risk of cross contamination. “Companies should have a written justification for using an advisory label statement,” said Gendel.

How to Calibrate Risk

The risk to consumers with allergies is based on a combination of how much of the allergen is present and how much of the product is likely to be consumed. This means that risk should be based on how much of the product the consumer is likely to consume, not the labeled serving size. Take, for example, a small bag of chips that includes nutritional information for two servings per bag. If the consumer is more likely to eat the entire bag in one sitting, the allergen dose should be based on the exposure from one full bag of chips. “The dose can justify use of an allergen advisory label,” said Gendel. (For guidance on dose, the United Nations Food and Agriculture Organization (FAO) has established allergen threshold levels.)

It is also important to note that precautionary or advisory labels are for potential cross contamination risks only. “There is no minimum dose for an ingredient,” said Gendel. “If an allergen is an actual ingredient in the product, it must be on the ingredient label.”

 

 

Paul Bradley
Ask The Expert

Ask the Expert: Five Steps for Success in Digitization and Technology Selection

By Paul Bradley
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Paul Bradley

Across the food and beverage industry, organizations are undertaking a wide variety of data-oriented technology initiatives. There are a host of reasons for the trend, and indeed the convergence of multiple factors is likely behind the growing urgency for digitization within many food and beverage brands, manufacturers and supplier organizations. To be sure, ongoing supply chain instability over the last three or more years has put a focus on supply chain resilience and the need for more nimble and flexible supply networks. A dynamic and ever-changing global regulatory landscape is driving compliance and reporting requirements that are increasingly difficult to meet without a solid digital strategy in place. ESG initiatives are driving the need for increased visibility into global supply chains. Evolving consumer preferences create pressures on R&D organizations for continued product innovation, all of which needs to take place within acceptable safety, quality and risk management parameters. And of course, hovering over all of this is a tight (and increasingly costly) labor market, putting increased focus on opportunities for automation and increased efficiently.

Alongside these macro-level global trends, technology itself is moving forward at a rapid pace. The global food and beverage value chain has become more interconnected than ever before, with massive amounts of information moving around the world at remarkable speed. And of course, no discussion of technology is complete without a mention of artificial intelligence (AI). While by no means a new idea—many mature AI-based technologies have existed within the industry for years—AI is evolving quickly. Generative AI technologies, hardly known prior to 2023, are now appearing across the technology landscape, and dominating discussions around technology investment and strategy.

Confronted with all of this, food and beverage industry leaders could be forgiven for feeling a bit overwhelmed. Not only is more information (some valuable, some less so) available than ever before, but a profusion of technology solutions are vying for attention, nearly all promising new levels of insight and productivity. The landscape is complex, but there are a few basic steps that teams can take to help ensure that any potential technology investments are pointed in the right direction and are set up for long term success. Let’s examine five basic, but important steps that can help guide digitization efforts to a strong outcome.

TraceGains Five steps graphic

1. Starting with the end in mind. The objective of a technology implementation should never be to implement a platform. Usually, technology investments start with a business problem that needs to be solved. For food safety teams, this can encompass a range of possibilities, from a desire to reduce error and gain efficiencies in processes, to a need for better real-time monitoring of processes already in place, to a desire to decrease global risk exposure in an increasingly diverse supplier environment. Whatever the situation, teams can substantially de-risk technology investments by being crystal clear on the business objectives (not simply the implementation goals) of a given initiative. Clearly defining a “north star” in terms of expected business outcomes, and revisiting those goals often, can help keep projects focused, and avoid costly missteps and poor prioritization decisions along the way.

2. Defining stakeholders. Though seemingly obvious, it can be surprisingly easy for teams to launch an initiative without a clear view of impacted stakeholders. Typically, a given technology solution will have relatively well-understood functional owners within an organization. But it’s equally important to understand downstream groups that may have to interact with the solution or its outputs. Direct users, too, are a stakeholder community that can easily be overlooked. A solution that does its job on paper but doesn’t align with the working conditions of an end-user community is going to run into challenges. External stakeholders may also need to be considered, as suppliers, customers, contract manufacturers and other entities can all become obstacles to program success if their buy-in hasn’t been considered early in the process.

3. Supplementing (vs. replacing) human intelligence. With all the buzz around AI, it’s easy to get excited about the longer-term possibilities of the technology. And that’s appropriate – AI has already had notable effects on industry technologies and will continue to do so in the years to come. But it’s equally important to consider the current state of generative AI solutions, and be realistic about the limitations and risks of the technology as it exists today. A useful framework for this approach can be to think in terms of how AI can help supplement, even maximize, the intelligence and expertise of human users. Can it consolidate data that would be cumbersome to organize and collate? Can it scan information and flag likely priorities for further investigation?

In the high-stakes environment of food safety and quality, the overlay of hard-earned human knowledge and awareness is going to remain necessary for a long time to come. At the same time, AI-based solutions are already present in the space, and those who use them wisely may very well realize a significant market advantage over those who shy away entirely.

4. Getting real about data quality. Whether the discussion is about AI, data insights, analytics, compliance reporting or automation, most technologies run on data. Put another way, most technologies aren’t any better than the data they consume. The ancient saying, “garbage in, garbage out” remains depressingly current, many decades after the dawn of computing.  As a result, it’s important to take a hard look at the quality, completeness, consistency and structure of the information that a potential technology solution will need to access in order to deliver on its promise. On the positive side, qualified technology providers should be able to provide assistance and clear guidance through the data side of any implementation, and in an increasingly networked world, providers may even be able to come to the table with useful industry data and data management practices that make this part of the digitization journey easier and faster. But it’s important not to skip this step; many are the solutions that never lived up to their potential because the data they needed to consume wasn’t workable.

5. Lastly, as initiatives come together, it’s important to loop back to the original business objectives that were clarified in the first step. Have those objectives been met and, crucially, can that be measured? If it can, the project has likely succeeded, and is positioned to yield insights toward the next step in the technology journey.

The good news is that as digitization continues across the food and beverage industry, it creates a greater opportunity for brands, manufacturers and suppliers to move away from the antiquated model of static, linear supply chains, and toward a more interconnected future based both on shared data and shared values. Explore the world’s largest network of F&B brands and suppliers at TraceGains Gather™, and learn more about the growing community of committed safety professionals worldwide.

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Anthony Zapata
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High Pressure Processing Automation Improves Line Productivity, While Reducing Food Risks

By Anthony Zapata
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Anthony Zapata

High Pressure Processing (HPP), also known as high pressure pascalization or cold pasteurization, is a nonthermal (5ºC – 20ºC) food and beverage preservation method that reduces the risk of pathogen contamination and achieves an increased shelf life while maintaining the optimum attributes of fresh products.

It is based on the use of high isostatic pressure transmitted by water of up to 6,000 bar /600MPa /87,000 psi, held for a few minutes. This pressure is transmitted uniformly and instantaneously throughout the product, therefore achieving an effect equivalent to pasteurization, without the use of heat. A highly versatile technology, HPP can be applied to a wide range of foods.

As a post-packaging process, HPP requires the loading of packaged products into baskets, which is traditionally a manual process. After loading and processing, the baskets then exit through an outfeed conveyor, where then again, the packaged product needs to be manually retrieved.

This manual batch process has become a challenge for many processors operating HPP machines due to the difficulty of sourcing labor.

Streamlining Operations with HPP Automation

Hiperbaric Automation Systems provide operational efficiencies and substantial labor reduction, while increasing productivity and providing strict traceability.

An HPP automation line consists of specialized software and hardware that work together to automate key parts of the HPP treatment process:

  • Product Loading/Unloading: Automated systems use conveyors, robots and tilting stations to move product in and out of HPP vessels, avoiding the ergonomic strains and throughput bottlenecks of manual loading.
  • Material Handling Equipment: Material handling is known to be tedious and labor-intensive. Companies can optimize production, improve efficiency and promote operator safety by using custom carriers, carrier carts, elevators, turntables, tote-dumpers, pre-feeders and dryers.
  • Minute RFID & Data Matrix: RFID tags and Data Matrix codes placed on the HPP baskets can help manufacturers track inventory, automate setup, and provide strict traceability and reliability, ensuring that all products are processed.

Why HPP Automation?

Automating the HPP process offers many advantages including increased productivity, cost savings, traceability and operator safety.

Improved Efficiency & Throughput. Without automation, HPP processors struggle to maximize machine runtime. Manual loading/unloading and basket reconfiguration make it hard to start cycles quickly. This downtime curtails throughput. HPP automation helps maximize production productivity by increasing throughput, production line speed and efficiency.

Reduced Labor Requirements. Manual HPP requires extensive labor to keep the machine constantly loaded and running. An automated system can cut labor requirements by more than half. With machines doing the repetitive, heavy lifting, staff can be redeployed to more value-adding tasks.

Prevent Handling Errors. Manual loading/unloading leaves room for human error. Operators may improperly load products. Automation standardizes these processes and minimizes direct handling to prevent human error. Automated data capture also gives full traceability for quality assurance. Ultimately, automation can provide strict traceability and reliability ensuring that all products are processed correctly.

Improved Workplace Safety. Repetitive activities like loading heavy baskets subject workers to ergonomic strains and injury over time. By reducing direct human-machine interaction, automation protects worker health and safety. The facility is a more attractive workplace to retain talent.

Case Study: Evolution Fresh Advances HPP with Automation

Evolution Fresh, a Bolthouse Farms subsidiary, is a premier cold-pressed juice company. The company partnered with Hiperbaric, a high pressure processing equipment manufacturer, to produce juices with fresh quality, clean label and extended shelf life.

Bolthouse Farms acquired Evolution Fresh from Starbucks in May 2022, expanding its beverage offerings from “nutrient-dense, plant-powered juices and smoothies to include a full lineup of primarily organic cold-pressed, premium juices,” according to Bolthouse Farms.

The company is using HPP to keep its juice safe by inactivating foodborne pathogens. Since it is a non-thermal process, it also helps protect the nutrients and delicious, vibrant taste of the premium quality, cold-pressed juices.

The HPP process enables shelf life expansion from three to five days to 55+ days, without preservatives, allowing expanded distribution to grocery channels.

With manual HPP, the company saw multiple stress injuries each year due to lifting and repetitive motion. By moving to automation, the company reduced its reliance on manual labor and made the processes more ergonomic. They eliminated 16,000 lbs. of lifting per day per person. Automation also helped with social distancing requirements due to COVID-19, allowing employees to spread out. Eliminating waste from triple handling and staging also enabled a continuous system rather than a batch process.

Automating the HPP process through an automated solution has enabled Evolution Fresh to increase efficiencies, reduce costs and drive revenue:

  • Overall Equipment Effectiveness (OEE) increased 15%
  • Injuries reduced by more than 90%
  • Waste reduced by more than 50%
  • Line labor reduced more than 50%

Post-HPP automation equipment includes a fully automated robotic arm that empties baskets and robots that assist in sorting and placing bottles upright. Today, Evolution Fresh uses nine employees on the processing line per shift compared to about 19 previously, a more than 50% reduction.

The Future of HPP Automation

The next step in automation will incorporate big data and analytics to create models for predictive maintenance and auto diagnosis. Computing advances and apps will allow real-time control over the automation process. Lastly, augmented reality will enable remote assistance and mixed-reality learning experiences.

Automation for HPP technology addresses many of today’s production challenges by increasing production line speed and efficiency, improving safety, reducing labor costs and injuries, and delivering accountability.