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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To ensure that only the best and safest food products reach consumers, processors constantly test and monitor contaminants in their inbound raw materials, which is not an easy feat. That’s where high-sensitivity analysis and accurate data comes in, allowing decision makers at the quality management level to effectively screen raw materials to determine their suitability for use, and to ensure product value, safety, and compliance.

Proper screening ensures that contaminants don’t exceed the maximum residue levels (MRLs) in the food product. Compliance risk aside, food processors want to put their brand name on only the highest quality food products. Brand reputation suffers when a product’s quality does not line up with the brand promise stamped on its packaging. For example, “all natural” or “100% organic” claims may invite further scrutiny if it’s revealed the food contains higher levels of contaminants. The impact can be far reaching, leading to media attention, a loss of consumer trust, recalls, and costly litigation.

A New Way to Test for Residue

Processors know that early detection of contaminants, such as glyphosate and mycotoxins, within inbound products saves time and money; however, such testing historically requires sending samples to a qualified lab for analysis by liquid chromatography (LC), sometimes coupled with advanced detection using mass spectrometry (MS). It can take days or even weeks for the test results to come back from the lab.

Imagine this all-too-common experience for food and agricultural facilities: A supplier pulls up with a truckload of grain. You collect and send a sample of the grain off to a lab to be screened for mycotoxin or pesticide residue. In the meantime, the grain sits in storage, risking cross-contamination with other raw materials. While waiting for laboratory results to arrive, you are left wondering how much time—and money—you could save if you could screen the raw materials for contaminants before the supplier unloads or leaves the premises?

The good news is that on-site testing technologies are available that can produce precise results in minutes, not days or weeks. The aim of both a laboratory-based analytical technique, such as high-performance liquid chromatography (HPLC), and a rapid test is the same: to measure whether a sample contains certain compounds. That’s where the similarities end. LC requires an accomplished laboratory technician to extract the target analyte from the sample and perform the analysis with an organic solvent according to a well-documented standard operating protocol (SOP).

Everyone is familiar with lateral test strips, the same format used with COVID-19 diagnostic test kits. Quantitative lateral flow strip tests can, in a matter of minutes, alert test users to the presence or absence of a specific target, whether it is SARS-CoV-2, mycotoxins, or glyphosate. Further, unlike LC, rapid test strips employ a water-based extraction method that any company owner, quality control professional, USDA or FDA licensed inspectors, or factory worker can perform on site. Administering on-site testing with lateral test strips is less costly and increasingly more sustainable given that samples never leave the site, which eliminates the packaging, shipping costs, and transportation emissions necessary to send samples to a lab for analysis.

The benefits of rapid on-site testing are that data-informed decisions can be made in the moment, allowing time for action and remediation. Processors can decide sooner whether to use a particular batch of raw materials or to source a substitute or replacement ingredient instead. Quality control managers can make specific plans for each raw material based on its quality. Operational efficiency improves and quality teams can have greater confidence in the quality of the inbound materials faster, eliminating the worry and uncertainty that attends untested inbound raw materials until they are confirmed clean. All of these are reasons to turn to rapid test methods at the food manufacturing facility.

Out of the Lab

Still, as with any new form of technology, some will remain hesitant or skeptical about implementing a new, unfamiliar way of testing. After all, results so important to their business and human safety cannot be left to chance.

Continuous learning is a proactive way to ensure ongoing success with any monitoring tool. Implementing rapid test methods outside of the lab is no exception. Annual retraining and simple procedure posters hung around the facility with QR codes that lead straight to full guides or step-by-step videos online help to improve the confidence of test operators and help to ensure consistent, accurate data collection. Scientist or not, the user’s confidence in their ability to perform the test will make all the difference in day-to-day work satisfaction, as well as obtaining sensitive, and accurate results.

On-site testing is a first line of defense in keeping low quality raw materials out of the facility and out of the global food chain. Access to rapid strip test screening kits has the potential to change the way raw materials are cultivated, harvested, and processed. Being able to customize a cultivation plan or harvest crops in a way that minimizes worker exposure to contaminants or microfungal toxins enables producers to make data-informed decisions that impact how they perform their jobs. Ultimately, the highest value is to protect consumers by ensuring food is free of contamination. Rapid test technologies mitigate risk much earlier in the value chain, which bolster preventive strategies and offers a more holistic approach to food safety.

Jackson is VICAM market development manager for Waters Corporation. Reach her at patricia_jackson@waters.com.

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A new study by Clean Label Project, a national non-profit that analyzes consumer products for the purposes of public education, found that more than 25 percent of 500 infant formulas and baby foods it tested exceed state or federal safety guidelines. Lead, arsenic, mercury, bisphenol A (BPA), and acrylamide were among the contaminants.

“The World Health Organization reports that during the first 1,000 days of life, the foundation of optimal health, growth, and neurodevelopment across the entire lifespan are established, making the findings particularly alarming,” says Jaclyn Bowen, MPH, MS, executive director, Clean Label Project, Denver, Colo.

Disturbing Findings
The contamination found in the study was higher than anticipated, says Sean Callan, PhD, director of operations and quality for Denver, Colo.-based Ellipse Analytics, the third-party analytical chemistry laboratory that performed the testing. In fact, more than 35 percent of baby food products tested contained quantifiable levels of lead, a statistic more than 40 percent higher than the recent Environmental Defense Fund summary report of products published in June. “This is the most concerning finding because lead, in addition to being linked to cancer, impairs brain function,” he says. “Early life exposure to lead has been linked to a decline in IQ and other neurological contaminants.”

Furthermore, one in 10 tested products contained acrylamide, a neurotoxin and carcinogen. And over half of the products contained some level of arsenic. As many as one-third of the more than 500 products tested exceeded at least one state or federal guidance level.

While BPA was found in less than 5 percent of tested samples, the most interesting finding was that in 60 percent of BPA cases, the product in question made an on-pack claim of being BPA-free, Dr. Callan reports. BPA is an endocrine disrupter, meaning that it alters hormone levels.

Why Contamination Occurs
Bowen surmises that baby food products contain contaminants because heavy metals naturally occur in the environment. They may also be introduced into the environment as a result of human activity. Some foods pick up heavy metals during growth and as a result of harvesting, storage, and handling and manufacturing activities.

BPA, for example, has been used in a variety of plastic products since the 1960s. It is also present in the epoxy inner coating of many metal containers. “The main concern for exposure is based on the tendency of some acidic foods to leach BPA from the food packaging into the food,” Bowen says. “Heating food in plastic containers containing BPA may also result in BPA leaking into food.”

Possible Solutions
To prevent future contamination, the onus is on brands to do their own proactive due diligence before sourcing ingredients, Bowen says. Brands need to rethink product specifications on the maximum thresholds of contaminants such as heavy metals. Brands also need to consider whether their supplier should administer confirmation testing or if they will assume the time and expense of performing testing.

Furthermore, Bowen points out that it is especially critical to use a third-party analytical chemistry laboratory with very sensitive levels of detection to perform testing. If instrumentation doesn’t get into the single digit parts per billion (the threshold limits established by state guidelines like the California Office of Environmental Health Hazard Assessment), then test results won’t detect a contaminant and give brands a false sense of security. For brands that don’t have direct oversight of the sourcing, including brands that use co-packers, she recommends implementing strict quality assurance and control methods.

Bowen also says that strict supplier assurance programs and product specifications are needed; these elements need to be incorporated into Hazard Analysis Critical Control Point plans.

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