This week, FDA issued an import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. The Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, gives the agency the ability to help prevent entry of human food products into the U.S. if they are found to be contaminated with a broad range of human-made chemicals including benzene, dioxins and polychlorinated biphenyls (PCBs), and per- and polyfluoroalkyl substances (PFAS), among others.

PFAS are a diverse group of thousands of chemicals used in many different types of products. PFAS in the environment can enter the food supply through plants and animals grown, raised, or processed in contaminated areas. It is also possible for very small amounts of certain PFAS to enter foods through food packaging, processing, and cookware.

In 2022, FDA initiated a targeted survey for PFAS in 81 seafood samples collected at retail and determined that the estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from certain samples of canned clams from China is likely a health concern. The 81 samples in the survey consisted of clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia, most of which were imported to the U.S. The agency plans an additional targeted survey of molluscan shellfish this year, and this new import alert could be used to refuse entry of foods such as seafood contaminated with PFAS.

Specific firms and their food products found with levels of chemical contaminants that may pose a risk to human health may be subject to detention without physical examination under the new alert.

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The Biden Administration announced on October 18, 2021, that Environmental Protection Agency (EPA) regulators will set enforceable limits on per- and polyfluoroalkyl substances (PFAS). The chemicals have been manufactured since the 1950s and are now widely detected in nearly every human. However, there are still a lot of unknowns regarding how they get into the body and what harm they cause.

The EPA’s PFAS Strategic Roadmap is a three-year plan detailing actions to help prevent PFAS from being released into the air and food supply and to expand cleanup efforts. The agency wants to implement the roadmap prior to the 2024 Presidential election.

Craig Butt, PhD, staff application scientist in the Americas for SCIEX, believes the new roadmap is a broad and ambitious plan to tackle PFAS contamination thanks to three main objectives—research, restrict, and remediate. “The approach considers the entire lifecycle assessment of PFAS from manufacture to use in commercial and industrial products to final disposal, which helps to ensure a more comprehensive and protective strategy,” he tells Food Quality & Safety. “The roadmap also emphasizes a strong investment in scientific, evidence-based decision-making through supporting research to fill key knowledge gaps, such as exposure pathways, toxicity assessment, and remediation.”

Specific plans include testing drinking water nationwide, implementing drinking water regulations and health advisories, assessing exposure and toxicity, developing new analytical testing methods, and monitoring PFAS in fish tissues and air emissions.

“The roadmap commits to monitoring PFAS levels in fish, an important food source for many people,” Butt says. “But, more holistically, the strategy will evaluate the importance of food ingestion as a source of PFAS exposure to humans. Presumably, this will answer questions such as, is food ingestion a significant source of PFAS exposure and which foods contribute the most to our exposure? Further, monitoring PFAS in biosolids and air will help ensure that farms and the entire food system is better protected from PFAS contamination.”

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When you hear the words “food contamination” your mind makes an immediate connection to unpleasant words such as: illness, disease, unsafe, etc. However, it’s very unlikely that the word “chromatography” comes to mind. One dictionary definition of “contamination” has it as “the action of making something impure by polluting or poisoning.” In other words, the “pure” becomes “impure” by the introduction of something bad that isn’t supposed to be there. Narrowing the definition to the subject of “food contamination,” one definition describes it as “the presence in food of harmful chemicals or microorganisms which can cause consumer illness.” Again something bad has been introduced that shouldn’t be there, which is making the wholesome unwholesome. Food contamination is often divided into two categories: chemical and microbiological. This article will deal only with the chemical contamination of food.*

Chemical Contamination

It is impossible to deal seriously with the subject of the chemical contamination of food without drilling down on some questions, such as the following.

1. What is the potential contaminant?
2. How much is there?
3. Where did it come from?
4. How did it get in the food?
5. What is the specific danger or health risk?
6. How can potential contamination be prevented?

The chemical contamination of food is usually (but not always) quite subtle. Unlike the urgent potato salad incident described in the footnote, the chemical contamination of food is often manifested as trace level exposure to toxic chemicals over long periods of time (i.e., chronic exposure). Potential health effects may not to be realized until many years later, perhaps in the form of carcinogenicity, teratogenicity, and/or metabolic disturbances. And, unlike microbial contamination that can be reversed by such techniques as heating, the chemical contamination of food is generally not reversible. Chemical contamination can only be “cured” by prevention, and prevention is impossible without deep, scientific knowledge about the chemical system associated with the potential for contamination. If you can’t identify, detect, and measure the potential chemical contaminant, you can’t prevent it from happening. You are relying on luck, not science.

Science-Based Prevention

The above concept illustrates why the Food Safety Modernization Act (FSMA) represents such a revolutionary advance in the area of making food safe from chemical contamination. FSMA is wholly anticipatory, not reactionary. You are not allowed to wait decades for a subtle carcinogenic effect to manifest itself before taking action; you must reasonably anticipate the threat of contamination and take proactive measures to prevent it. In other words, you must answer question number 6, mentioned previously. However, you can’t begin to answer this question without reliably answering questions number 1 and 2. For effective prevention, you need to use analytical testing methods that are both qualitatively and quantitatively reliable. The FDA consistently uses the term “scientifically-valid” to describe this basic requirement. Therefore, if prevention is the heart and soul of FSMA then scientifically-valid food testing methods are the means to effective prevention. However, the term “scientifically-valid method” is not a static definition, but a fluid concept.

Food Testing Method Modernization Movement

As technology has advanced, the ability to identify, detect, and measure chemical substances in environmental samples (such as food) has increased exponentially. Arguably, the advance of analytical testing capabilities in the past two decades has exceeded the advance of the prior 100 years. Consequently, food testing methods that may have been the pinnacle of scientific-validity when they were developed 20 years ago may now be quite dated in terms of analytical capability. This is particularly manifested in the inability of many older test methods to adequately differentiate and quantify specific chemical species. This has increased the risk of chemical contamination, particularly in light of the globalization of food supplies that has complicated the tracking of food ingredient origins.

This is probably best illustrated by the unfortunate incident of 2007-2008 where ingredients used in the manufacture of pet food and infant formula were intentionally contaminated (i.e., adulterated) with melamine to fraudulently increase the measured protein content. The scheme initially succeeded because the prescribed test used to measure the protein content (the 100+ year-old Kjeldahl test for total organic nitrogen) can’t distinguish between the nitrogen content of protein and melamine. The Kjeldahl test lacks the ability to speciate specific organic nitrogen compounds and is not fit for the purpose of measuring the protein content of food, at least in the face of a chemical contamination threat from melamine. A sophisticated high performance liquid chromatography (HPLC) test for melamine was subsequently developed, which put an end to that particular contamination threat.

The melamine tragedy brought rapid realization of the vulnerability of many older food testing methods for preventing chemical contamination, whether accidental or intentional. This vulnerability arises from an inherent lack of specificity of older food testing methods—the inability to accurately speciate individual toxic chemical species in a complex food matrix. This inability is particularly stark when one compares the technology underlying the older methods to the much greater capabilities of modern analytical technology. This has led to a broad-based, method modernization effort on the part of government agencies (FDA, NIOSH, EFSA, etc.) and standard setting institutions (AOAC, USP, etc.) to enable the ability to measure, and therefore prevent, the chemical contamination of food. Modern chromatography has played a major role in this food method modernization movement and the ability to prevent food contamination.

Impact of Modern Chromatography

In the introduction to this article, I stated that the term “chromatography” probably isn’t the first thing that comes to mind when considering the subject of food contamination. But, perhaps it should be; at least in the case of chemical contamination. Modern chromatography has an unsurpassed ability to isolate, differentiate, and identify diverse potential contaminants in food. There are many diverse opportunities for food to become chemically contaminated. One needs only to consider the great number of toxic compounds in commerce and the many potential exposure routes from farm to table. The potential for contamination is so diverse, it is impossible to generalize the power of chromatography to prevent food contamination. Instead, I will present a series of thumbnail sketches that illustrate the breadth and depth of recent chromatographic method developments.

The following images are all examples taken from the recently published Phenomenex Food Testing Applications Guide that contains over 150 liquid chromatography (LC), gas chromatography (GC) and solid phase extraction (SPE) applications.

Diversity of Potential Chemical Contamination Scenarios

(click to enlarge)

Mycotoxins: Mycotoxins from cereal based goods by SPE and LC/MS/MS. Produced by certain molds that can grow on grains, mycotoxins are a class of compounds that are highly toxic and carcinogenic.

PAHs: Polycyclic aromatic hydrocarbons (PAHs) in water by GC/MS. PAHs are a class of carcinogenic compounds that arise from the inefficient combustion of petroleum-based products and can contaminate the environment and foods.

PFASs: 23 per-polyfluoronated alkyl substances (PFAS) by UHPLC/MS/MS. PFAS compounds have been widely used in food packaging; they are able to leach into food at trace levels, and since they are extremely bioaccumulative, they can build up in the fat tissue of the consumer.

Melamine: Melamine and cyanuric acid in milk and baby formula products by SPE, LC/MS, and GC/MS. This relates directly to the melamine contamination/adulteration crisis of 2007-8.

Acrylamide: Acrylamide from coffee by SLE and LC/MS/MS. Acrylamide can be found in certain starch-containing foods that have been exposed to heat. Acrylamide is classified as a carcinogen so its presence in food, even at low concentrations, is a concern.

Pesticides in Poultry: Chlorinated pesticides in poultry tissue by SPE & GC/ECD. Chlorinated pesticides are highly persistent in the environment and are also highly bioaccumulative in animal fat.

Pesticides in Spinach: Pesticide residues in spinach by QuEChERS, LC/MS/MS, and GC/MS.

Antibiotics: Antibiotics in meat by LC/MS/MS. Another potential source of food contamination is the introduction of antibiotics and other veterinary products used in livestock production.

Fatty Acids: Fatty acids in powdered infant formula by GC/FID. The analysis of fats in food is generally considered a “nutritional” analysis, rather than a “contamination” analysis. However, with the FDA’s 2016 ban of unhealthy trans fat from processed food, the unlawful presence of trans fat in a processed food such as infant formula would be a case of food “contamination.”

Conclusion

The rapidly evolving science of chromatography has enabled ever more powerful, sophisticated, and effective food testing methods. In turn, these improved methods have greatly strengthened the ability to anticipate and prevent food contamination. Better science-based food testing methods have clearly served to make food safer. And, the science and practice of chromatography is certain to continue its advancement, thereby insuring future improvements in food safety.

Dr. Kennedy, business development manager at Phenomenex, has focused on food safety and environmental monitoring during his over 45-year career. Reach him at Davidk@phenomenex.com.

*Since I am a chemist, and not a microbiologist, I am not qualified to hold a professional opinion on the subject microbial contamination. My only direct experience with the microbiological contamination of food consists of having used my gastrointestinal tract as an indicator of having consumed contaminated potato salad at a family picnic years ago.

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Safe food is something we all take for granted; nobody expects to get sick from the food we eat. We place a great deal of trust in the people and companies that provide our food. In the old days, that trust extended down to the butcher shop or the fruit stand when it was a short ride from there to the source—the farm. In essence, our food chain had few links and was very manageable. Much has changed over the years.

Several times in recent memory, despite routine testing, chemical contamination outbreaks have occurred. The impact of some of these events was severe, but it could have been mitigated if there had been a resource that could rapidly develop an analytical method designed to detect the contaminant in the food matrix.

It was this thinking that led Thermo Fisher Scientific to develop its Global Food Safety Response Center in Dreieich, Germany, near Frankfurt. The key to the center is its ability to respond quickly during a crisis. Workloads do not have to be shuffled and resources do not have to be reallocated, because the center is not a contract-testing lab and will not engage in routine sample testing.

A Clear Need

The need for a center of this kind is clear. Over the course of time, as the world’s population has grown and we have developed greater varieties of food and the efficient means to distribute that food globally, we created a longer food chain with many links. Today, food is created from a variety of ingredients that come from an even wider variety of sources. Trust is still a part of the equation, but because the food chain is long and therefore vulnerable to contamination, whether accidental or deliberate, we have to test to verify the safety of our food.

Government agencies around the world are tasked to test food, inspect food and facilities, set standards, and insure compliance. Manufacturers themselves test the food they produce or process for consumer safety and to ensure the integrity and protection of their brands. Testing is critical and may either be done internally or outsourced to independent testing labs that are experts at high-volume food testing.

Thermo Fisher’s new 600-square-foot facility is staffed with three full-time chemists working with state-of-the-art equipment under the direction of an industry-leading consultant in food safety. The center has a wet lab and an instrument lab equipped with key systems for food analysis, including gas chromatography, liquid chromatography, mass spectrometry, ultra high-performance liquid chromatography, and inductively coupled plasma mass spectrometry. Nearly all of the other instruments, equipment, supplies, and consumables in the lab are sourced from either Thermo Scientific or Fisher Scientific, and many products are self-manufactured.

Method Development

Even with the right talent and tools in place, method development remains a formidable task. When we speak of methods for chemical analysis, we are talking about a logical, documented process to test a substance. This method has to be verified or validated and must be repeatable and reliable.

The method includes the actions required to prepare a sample for testing and the instruments and settings required to achieve the desired results. It has to be designed to detect the contaminant reliably without false positives or negatives. The method is the key to detection.

Once a chemical contamination of food has occurred and the threat has been identified, this lab will begin to develop a method that can be used to detect that chemical reliably in the suspected food. The center’s staff will take samples through the workflow, from sample prep to data analysis, and work diligently to develop the method. After the method is validated (single-lab validation), it will be made available to the public, along with a training protocol and supply list. Regulators, contract testing labs, and end users will be able to use the method to analyze their food for the specific chemical contaminant.

Nobody wants another food crisis, and the Global Food Safety Response Center has an operations schedule whether there is a crisis or not. It’s comforting to know that if something does come up, this lab is ready to swing into action and devote 100% of its time, talents, energy, and resources to solving a problem that has considerable impact all over the world.

Broski is food safety marketing director for Thermo Fisher Scientific. For more information about the global Food Safety Response Center, visit www.thermoscientific.com/fsrc.

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