By Jennifer Allen

Like most people, you probably know that the FDA regulates food. But did you know that it also regulates food packaging? That’s because chemicals in packaging could migrate into our food under certain conditions. FDA defines a “food contact substance” at CFR 21, 170.3(e)(3) as “any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” This definition includes substances used in food packaging.

Generally speaking, regardless of the type of packaging involved or the specific component of that packaging, manufacturers are presumed to be following current good manufacturing practices. And, if no limit is specified, the quantity of any substance used in the packaging must not exceed the amount absolutely necessary to achieve the desired result. Provided the manufacturer adheres to those basic requirements, then it has a few different options for the type of materials it may use.

One option the manufacturer has is to use a material or component that is generally recognized as safe for use in food packaging (“GRAS”) under CFR 21, part 186, or that is used in accordance with a prior sanction or approval. Examples of GRAS substances include clay and Japan wax.

Or the manufacturer may use specific materials already approved by FDA. In CFR 21, parts 175, 176, and 177, the FDA has authorized the use of different types of adhesives/coatings, paper and paperboard, and polymers, respectively. Each of those types of product must be used in accordance with the strict conditions set forth in those parts. For example, synthetic paraffin is approved for use as a coating, but under CFR 21, 175.250, there are strict technical requirements for the congealing point, oil content, and absorptivity of the substance.

Alternatively, a manufacturer may submit a premarket notification for a food contact substance under CFR 21, 170.100-106, known more colloquially as an FCN. Unlike substances approved for use by all under the sections above, a substance approved via an FCN is only approved for use by the manufacturer that submitted the FCN, and only under the precise conditions of use set forth in the FCN. If another manufacturer wants to use the exact same substance in the exact same manner, it must nevertheless submit its own FCN.

Finally, under CFR 21, 170.39, manufacturers may seek an exemption for a particular substance that migrates from the food-packaging material into the food at minimal levels if they can show that the substance 1) has not been shown to be a carcinogen, and there is no reason to suspect it may be carcinogenic; 2) presents no other health and safety concerns; 3) has no technical effect on the food; and 4) has no significant adverse impact on the environment.

A word about per- and poly-fluoroalkyl substances, more commonly referred to as PFAS. PFAS are used in certain types of disposable dishware and in non-stick cookware. It is PFAS that allow you to enjoy that greasy piece of fried chicken on a paper plate without the grease soaking through the plate onto your clothes. But in recent years, PFAS have come under attack. That’s because the evidence suggests that these substances build up in the human body and in our water and soil, and may be harmful to human health and to the environment. Certain PFAS are currently approved for use by the FDA, but with mounting pressure from various stakeholders, that is rapidly changing.

May 8, 2025

Food Fraud Quick Bites

Sharp Rise in Fraud for Nuts, Dairy, and Cereals: Q1 2025

By Food Safety Tech Staff

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The Index—published quarterly—tracks verified food fraud cases reported by global food safety authorities. Findings from the first quarter of 2025 reveal volatile patterns in vulnerable commodities, impacting procurement, quality assurance, and supply chain integrity.

Key Q1 2025 Highlights:

Nuts, Seeds & Nut-Based Products: +358% rise in incidents, mostly due to species substitution, allergen risks, and origin fraud.
Dairy Products: Though incident numbers remain low, cases involving counterfeit butter and milk adulteration are rising, indicating early escalation.
Cereals & Bakery Products: 23% increase, driven by mislabeling, illegal additives, and pesticide-related compliance failures.
New Risks: Garlic and non-alcoholic beverages appeared as emerging fraud targets for the first time in the Index.

“It is extremely important for the food industry to identify the commodities most at risk from food fraud globally,” says Professor Chris Elliott, Founder of the Institute for Global Food Security at Queen’s University Belfast. “FOODAKAI’s Global Food Fraud Index has identified some new threats I was unaware of, while others were high on my radar.”

The report also confirms persistent threats in seafood, with a 74% year-on-year increase due to species substitution and antibiotic misuse in aquaculture.

February 16, 2025

Food Safety Attorney

The Ins and Outs of FSMA’s Foreign Supplier Verification Program

By Jennifer Allen

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In recent years, through regulations created under the Food Safety Modernization Act, the FDA has adopted a preventive approach to food safety, in contrast to the Whack-A-Mole strategy of dealing with foodborne illness that proceeded the FSMA. Thus, an alphabet soup of new processes, such as HACCP and HARPC, have taken center stage. But with so much food being imported from other countries, these regulations could very easily be undermined. Enter the Foreign Supplier Verification Program, or FSVP (found at 21 CFR 1.500 et seq.).

The FSVP’s purpose is to ensure that importers of foods from outside of the United States have adequate assurance that these foods were harvested, grown, manufactured, processed and/or packaged using protections equivalent to those imposed by the FDA on U.S. foods. The regulations define a foreign supplier as the establishment that manufactures, processes or grows the food, or raises the animal, for export to the United States, without further manufacturing or processing by others (besides labeling or other similar de minimis activities). Absent an exemption, importers of foreign foods and the foreign suppliers themselves must comply with the FSVP.

Under the FSVP, importers must conduct a hazard analysis for each type of food they import. They must then approve each foreign supplier they use, taking into consideration the results of that analysis; the identity of the entity that will be minimizing or preventing any hazards; the foreign supplier’s performance; and any other relevant factors. And importers must document this process and their approval of each foreign supplier. This process should take place every three years or whenever circumstances change. And since having an approved foreign supplier has limited effect if importers don’t limit their food imports to those approved suppliers, importers must also have written processes in place to ensure that they import foods only from approved suppliers.

The FSVP is not a one-and-done process. After approving a particular foreign supplier, and before actually importing food for the first time, importers must determine which verification activities they will conduct to provide assurance that any identified hazards have either been significantly minimized or prevented, as well as the frequency of those activities. Depending on the particular food and the type of hazard, the importer must decide whether to conduct onsite audits, sampling and testing of food, a review of the foreign supplier’s relevant food safety records, any other appropriate activity, or a combination of these activities. And if the foreign supplier at any time fails to significantly minimize or prevent any identified hazards, then the importer must have steps in place to take corrective measures.

There are some foods that are exempt from the FSVP’s requirements. The requirements do not apply to juice and fish, food imported for research or personal consumption, alcoholic beverages, foods regulated by the USDA (meat, poultry, egg products), food that is merely shipped through the United States, and food that is manufactured, grown or raised in the United States, exported, and returned. In addition, imported canned foods are exempt, but only if the importer verifies and documents the foreign supplier’s compliance with the requirements of 21 CFR 113. There is also a partial exemption if the imported food will be incorporated into a canned product that complies with part 113. And importers are deemed to be in compliance with the FSVP if they are considered a “receiving facility” under 21 CFR 117 or 507 (hazard planning for human and animal food respectively) and if they either implement preventive controls for the imported food, are not required to do so, or have established and implemented a risk-based supply-chain program.

Last but not least, under 21 CFR 1.512, very small importers and those who import food from certain types of small foreign suppliers are required to adhere to a less burdensome set of regulations. A very small importer is one whose sales of human or animal food, in the previous three years, adjusted for inflation, totaled less than $1 million or $2.5 million per year respectively, when combined with the U.S. market value of any human or animal food imported, manufactured, processed, packed, or held without sale. Foreign suppliers are considered small if they are a qualified facility under parts 117 or 507, are a farm that is not considered to be a covered farm under 21 CFR 112, or if they export shell eggs and have fewer than 3,000 laying hens. Importers must keep records showing that part 1.512 applies.

Very small importers must obtain written assurance from their foreign suppliers before importing any food and every two years thereafter that the supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as U.S. regulations provide. Those importing food from certain small foreign suppliers must obtain written assurances from those suppliers that generally provide assurance that the food is safe.

As always, the devil is in the details. Before importing any food, importers should carefully review the regulations, preferably with legal assistance, to ensure that they do not run afoul of the law and inadvertently undermine the safety measures in place here in the U.S.

Frank Yiannas, VP of Food Safety, Walmart

February 13, 2025

Biros' Blog

Brands We Trust Use a New Food Safety Playbook

By Rick Biros

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Today, my daughter-in-law dropped off our five month old granddaughter along with a bottle of Abbott Nutrition’s Similac baby formula to supplement the breast milk she pumps. You may remember three years ago, the Similac brand had a major food safety recall due to Cronobacter sakazakii contamination that killed two babies. My wife raised a proverbial red flag questioning whether to feed our granddaughter that brand of formula. Should we trust that brand?

So, I reached out to my some of my food safety network of friends and asked the question “would you feed that brand of formula to your family?” The responses I received were evenly divided with these two being fairly representative :

“Yes – I would – but everyone’s entitled to their opinion / feelings. I get it. We’ve got to TRUST the system is working.
“No – I would not. Too many companies give lip service to food safety and just go back to business as usual.”

My effort to get guidance from my food safety network was of no help. Neither answer gave us much confidence or trust in the brand.

Continuing the discussion, I challenged my wife, why do still you buy Boar’s Head cold cuts, even after the Listeria outbreak? She replied “because I know that Boar’s Head set up a Food Safety Council, lead by people we know really well. I trust them.”

I’m not making this up, literally, three hours later I receive a Linked In notification of a post from Frank Yiannas, “Today, Boar’s Head paused production at all of their plants to hold what they’re calling Food Safety Promise Day. Yes, they had a tragic incident &, of course, our thoughts will always remain with those hurt & harmed and their families. I agreed to help investigate the root cause & find solutions to prevent something like this from happening again – not to serve as a defense expert witness. And they’ve allowed me to do just that. In many outbreaks, the reality of what occurred remains elusive & substantive corrective actions are rarely shared with the public. Here’s an attempt to do things differently. ”

Frank and I messaged each other and he told me “While prevention must always be our primary focus, if significant events do occur, I hope what we’ve done serves as the new playbook and expectation – conduct a proper and thorough root cause investigation to determine with specificity what happened, implement science-based and effective controls, and tell that public what you’ve done to prevent it from ever happening again.”

Frank is right and the food industry should learn from this. I would add that the transparency Boar’s Head has demonstrated today will significantly increase consumer’s trust of the brand. Boar’s Head posted this page to their company’s website: https://boarshead.com/foodsafety

Post Script, my daughter-in-law decided against the formula and bought their competitor’s brand. It’s all about trust.

Frank Yiannas, FDA, Rick Biros, Innovative Publishing, Food Safety Tech, Food Safety Consortium — Frank Yiannas and Rick Biros at the Food Safety Consortium Conference.

December 18, 2024

Biros' Blog

It’s Five O’Clock Somewhere! Episode 3 Recording: Partnership for Food Traceability

By Food Safety Tech Staff

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What do a little old lady’s checkbook from 2000, a 5-pound tub of peanut butter, and a delivery truck in Iowa all have in common? It’s not the setup for a joke – it’s a story of food safety evolution.

Join host Rick Biros as he welcomes Dr. Ben Miller from The Acheson Group and Eric Marshall from Leavitt Partners on the “It’s Five O’clock Somewhere” webinar. They’ll unpack the FDA’s FSMA 204 Traceability Rule and explore how the groundbreaking Partnership for Food Traceability (PFT) is leading the way in helping companies and regulators prepare for the new rule.

From historical context to emerging solutions, this candid conversation will dive into the technical challenges facing the industry and reveal how a unique public-private collaboration is shaping the future of food traceability.

Pour yourself a drink and discover how three seemingly unrelated items transformed how we track food on its journey from farm to fork. Watch the Recorded Webinar

August 14, 2024

FST Soapbox

Transforming Food Safety Testing: Designing the Modern Lab

By Daniel Aubert, Ph.D., Grant Hedblom, Ph.D.

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Food safety professionals must be always focused on continuous improvement. This includes transforming labs into modern spaces and utilizing innovative methods that make the industry more efficient.

In the age of AI and automation, we are all focused on efficiency. When saving time and resources is the name of the game, as professionals, we must regularly assess new methods and processes, looking for solutions that make our labs run more effectively.

Across the food safety testing industry, we continuously look for ways to improve our laboratory spaces and teams. How can we test more quickly? How can we work more effectively as a team? How can we build resiliency within our labs and throughout the industry?

When we look at the history of our industry, we see the traditional, tried-and-true reference methods as the gold standard—we know that they work, and they are widely trusted and accepted. However, when we look at these methods in a modern context, we notice several areas in which they could be improved.

These traditional methods are often slow to produce results and highly labor intensive. When compounded by the ever-present issue of staff hiring and retention, it becomes increasingly apparent that labs need to streamline and simplify testing methods.

The fact is that the modern lab is no longer only a space for traditional testing methods but a hub for innovative, cutting-edge technologies.

In a time when consistency, speed, and accuracy are paramount, it’s important we, as food safety professionals, look for methods, equipment, and processes that are easy to use, easy to replicate, and easy to interpret.

So, what does a modern lab involve?

When thinking of building a modern lab, the need is to address three key issues:

How can we speed up our decision-making? Using rapid, easy-to-use technologies allows labs to receive feedback on environmental testing and harmonize result interpretation quickly. Advanced technologies with ready-to-use and straightforward assays and automated procedures also speed up processes and allow faster, more reliable processing speeds and confident decision-making.
How can we demonstrate our ability to comply with food safety standards?The answer is simple: digitalization, proactivity, and traceability. By utilizing enhanced data management and integration systems, labs can manage a high volume of data, turning it into actionable insights. That data is then, used to demonstrate compliance across a variety of standards and specifications.
How can we feel confident in our results?Implementing new, more modern technology can be intimidating, and given the pressure that high turnover rates place on labs, we must trust the results we share. Automation, standardization in result interpretation, and enhanced data management can help lab managers and decision-makers make the best decisions for the enterprise, knowing that each laboratory analyst is measuring the same metrics, no matter their tenure. Implementing modern solutions makes standardizing testing methods and result interpretation easy, so you can feel comfortable and confident in your data.

Another critical aspect of building a modern lab is networking with our peers across the food safety industry. Attend conferences and webinars, read articles, ask questions, and find out what modern solutions are working for other labs in the industry. Recognizing the value that we get from listening and learning from other experts helps our industry grow.

As the food safety testing industry moves into a more modern era of operations, we must remember that change is good. Change moves us forward, enhances efficiency, and increases confidence while creating sustainable and reliable systems and processes.

Creating modern labs within our various entities around the world will take the food safety testing industry to a new frontier as we all work toward the same goal — keeping people around the world safe and healthy.

August 13, 2024

Biros' Blog

It’s 5 o’clock somewhere!

By Rick Biros

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Join me in a happy hour conversation with David Acheson, President and CEO of TAG called “It’s 5 o’clock somewhere!” Podinar Broadcast: Thursday, August 22 at 5 o’clock EST.

In 2012, David Acheson of TAG was an early advisor in the launch of Food Safety Tech and the Food Safety Consortium conference. Back then, many things were new and evolving including the proposed Food Safety Modernization Act (FSMA). David and I will look back at FSMA, how it has evolved and discuss the future FSQA risks and challenges.

This is the premiere of a new podinar series. What’s a podinar? Simply, a podcast using a webinar platform. It’s a conversation. Unscripted. No slides. Just talk… over an adult beverage.

Join me and David in a casual but engaging conversation. Adult beverage is optional but encouraged!

Complimentary but advanced registration required. Click Here.

August 5, 2024

Food Safety Risk Assessments are “Data Hungry”

By David Hatch

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David Hatch — VP, Digital Solutions Marketing, Neogen explains that risk assessments are data hungry.

“I got to sit in a room with the food safety team from a global organization. They were looking at both a hazard analysis and a risk assessment. The hazard is the thing that causes danger. The risk assessment is determining how probable is this thing to happen? And, if it happens, at what frequency does it happen? And, then how severe is the problem, if it happens? So there’s multiple factors in a risk assessment and as the group went through this, it occurred to me just how data hungry this process really is! Right? Because for each different hazard, you have to understand things like, well, “How frequently could this happen?” And without data around the actual occurrences of how frequently it happens, you have to kind of guess at it.”

Click on image to watch full video:

July 3, 2024

Food Defense: Yesterday, Today and Tomorrow. 2021 FSC Episode 8

By Food Safety Tech Staff

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In this archived recording, experts in food defense and security address a range of important issues in this area, including risk-based approaches to food defense, threat intelligence, cyber vulnerabilities and critical infrastructure protection.

The session, Food Defense: Yesterday, Today and Tomorrow, discusses pre-FSMA IA Rule voluntary food defense programs, compliance timelines, and regulatory compliance vs. enterprise risk based approaches to food defense. Presenters will address the status of Food Defense plan quick checks and share insights on Food Defense Plan reanalysis. Participants gain insights on threat intelligence sources and food defense-based research updates. Other topics to be covered include a brief overview of recently released insider risk mitigation reference material, cyber/IT “vulnerabilities”, critical infrastructure protection and how an all-hazards mindset to “all of the above” can help to contribute to a Food Protection Culture.

The following is the line up of speakers for this episode,

Jason Bashura, PepsiCo (moderator)
Food Defense Yesterday with Raquel Maymir, General Mills
FBI HQ Perspectives of Food Defense with Helen S. Lawrence and Scott Mahloch, FBI
Food Defense Tomorrow with Frank Pisciotta, ASIS Food Defense & Ag Security Community and Cathy Baillie, Mars, Inc.
Risk-based Food Defense with Jessica Cox, Department of Homeland Security, Chemical Security Analysis Center
Food Defense & Supply Chain Perspectives: Regional Resilience Action Plan with Jose Dossantos, Department of Homeland Security/CISA

Watch On Demand video: https://attendee.gotowebinar.com/recording/2149120139973957136

June 27, 2024

Biros' Blog

Food Protection: Prepare for the Unexpected

By Rick Biros

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In a June 24 New York Times article, ‘It’s Happening Again’ the Supply Chain is Under Strain, the head of ocean freight for a logistics company said “I’m lovingly calling the (logistics) market now ‘Covid junior,’ because in a lot of ways we’re right back to where we were during the pandemic. It’s all happening again.”

The Covid supply chain disruptions hit the industry hard, forcing manufacturers to source new ingredient suppliers. Trying to quickly approve (or disapprove) new suppliers put a massive strain on food safety and quality assurance departments who were (are) tasked with doing more with less. Most of the industry really was not prepared for this magnitude of disruption. However, food and beverage industry will always face a myriad of threats to our FSQA organizations. How do we manage to reduce the risks of these threats from impacting our organizations? We evaluate, we assess, we PREPARE for the unexpected – through planning, workforce development and learning from the past. Pick your poison:supply chain disruptions, emerging and virulent pathogens, man-made and natural disasters, new regulations, bird flu, PFAS’, food fraud (think cinnamon tainted with lead and the cross-functional collaborations needed to protect the public’s health), just to name a few.

Food Safety Tech advisor and friend of mine, Jason Bashura, MPH, RS, Sr. Manager, Global Food Defense, PepsiCo has shared with me for years concepts related to the development of a Food Protection mindset. Food and beverage manufacturers companies are naturally concerned about protecting the public’s health and well-being, their brands and their own company’s financial bottom line. The phrase “Food Protection” requires a company-wide culture that incorporates the concepts of quality, food safety, food integrity ,food defense, EH&S, physical and cybersecurity concepts into the company’s approach to the envelope of “Food Protection.” Prior to FSMA, in 2007, the FDA released the Food Protection Plan which was founded on the themes of prevention, education & response all of which are key underpinnings of not only FSMA today, but as embedded within the New Era of Smarter Food Safety, for tomorrow. Today, the FDA funds Food Protection Task Forces across the U.S., and the use of the phrase Food Protection is more ‘prevalent’ than you think: how many uses of this term do you hear regularly? How many other Food Protection ‘elements’ there are? Please add your thoughts in the comments section below.

In recognition of the theme for this year’s World Food Safety day – Prepare for the unexpected – underlines the importance of being prepared for food safety incidents, no matter how mild or severe they can be. Food Protection is all about being prepared. Many firms recognize, celebrate and embrace World Food Safety Day as a month long celebration.

Jason can both talk the preparedness talk and walk the preparedness walk! Prior to his work at PepsiCo where his full-time job is predicated on protecting PepsiCo’s worldwide consumers, , he also has organized the Food Defense Consortium, an informal working group of FSQA, physical security, academia and other Food Defense professionals who share best practices, lessons learned and simply share information amongst the group. The Food Defense Consortium meets regularly via zoom and once a year in person at the Food Safety Consortium conference. Jason has a history of “being prepared” as a Volunteer with the Storm Engine Company #2 & the Storm Ambulance Corps in Derby CT, having served as a public health emergency response coordinator at the Naugatuck Valley Health District (CT), and an avid volunteer with the Valley Chapter of the America Red Cross (CT). He is currently serves as a community volunteer member – with environmental health experience – of the Board of Health for the Howard County Health Department (MD).

Frank Pisciotta, Chair, ASIS Food Defense Community and Jason Bashura, Facilitator, Food Defense Consortium presenting me with a Certificate of Appreciation for hosting the Food Defense Consortium at the Food Safety Consortium conference as well as publishing the Food Defense Resource Center on Food Safety Tech.

Another example of preparedness is Rick Rescorla who was the epitome of thinking WHAT IF on the day to day, about how to prepare, educate and respond to a variety of situations that might arise. As director for security at Morgan Stanley in New York City on September 11^th 2001, he is credited with saving greater than 2,700 lives thanks to his relentless pursuits for countless hours of education and raising awareness of how to deal with adverse conditions in an evacuation environment.

I guess one should practice what you preach. I listen to Jason and am working to be better prepared for the unexpected. A few years ago, I was “volunteered” to be the Captain of the Chappaquiddick Island CERT (Community Emergency Response Team). We coordinate with the fire department in advance of storms like Nor’easters and have a plan in place for the power being out and no ferry service to get off the island.

As we close out World Food Safety month, we need to not only learn from the past to prevent future issues – so that “it” doesn’t happen again – we need to embrace the opportunities that we face every day that help us to be better prepared, for tomorrow. As Colonel John “Hannibal” Smith from the original 1980’s “A-Team” tv show used to say “I love it when a plan comes together.”

Food Protection Resources:

For more information on how you can PREPARE your business for the unexpected, visit READY.gov
For more information on the Food Defense Consortium, visit the Food Defense Resource Center on this website or contact Jason.Bashura@PepsiCo.com
Rick Rescorla Citizen Honors Reward
Jason Bashura will be co-presenting at the Food Safety Consortium Conference with Jon Woody, Director, Food Defense, CAPT, USPHS, FDA and Debby Newslow, President, D.L. Newslow & Associates on the critical importance of developing and implementing a food defense plan to comply with the FSMA rule 21 CFR Part 121 (IA Rule)

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