Following the report released by Congress in February regarding an alarming amount of toxic heavy metals found in baby food, the FDA has released an action plan that aims to reduce the presence of those dangerous metals to the “lowest possible levels” in common foods consumed by babies and young children. The “Closer to Zero” plan takes research, regulatory and outreach into consideration and will use the following approach:
Evaluating the scientific basis for action levels. FDA will evaluate existing data from routine testing of food, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.
Proposing action levels for specific toxic elements in baby food categories that include cereal, formula, and pureed fruits and vegetables.
Working with stakeholders and federal partners on proposed action levels— including collecting data and information from workshops and scientific meetings—and assessing the feasibility of the proposed action levels and timeframes for achieving them. The FDA will use and monitor the information to finalize the action levels.
“Our action plan will start with prioritizing our work on those elements for which we have the most data and information – arsenic and lead – while research continues on other elements, progressing through each element over time across various categories of foods consumed by babies and young children,” stated Janet Woodcock, M.D., acting FDA commissioner and Susan Mayne, Ph.D., director of CFSAN. “During the plan’s first year (phase one), we will be proposing action levels for lead in categories of foods consumed by babies and young children, consulting with and gathering data from stakeholders and federal partners on issues such as the feasibility of meeting action levels for lead, and sharing resources with industry on best practices for reducing or preventing lead contamination. We will also complete updated sampling assignments testing toxic element levels in baby foods and evaluate the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three and beyond are outlined in our plan.” Phase 2 runs from April 2022 until April 2024 and will expand the agency’s work into cadmium and mercury, as well as finalize action levels for lead. Phase three and beyond begins in April 2024 and will finalize action levels for arsenic.
A report released last month by the Subcommittee on Economic and Consumer Policy revealed dangerous levels of toxic heavy metals in baby food. It stirred up quite a bit of controversy and concern, and raised questions over whether baby food manufacturers were hiding dangerous levels of toxic heavy metals in food, and whether FDA was doing enough to ensure the safety of food.
In an effort to assure the public that FDA is taking the issue seriously, the agency published a constituent update about its actions to further prevent or reduce toxic elements in foods for babies and young children. It also issued a letter to manufacturers and processors of baby and toddler foods as a reminder of the “responsibility under the rulemaking to consider chemical hazards that may be present in foods when conducting your hazard analysis,” which is part of the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food FSMA rule.
“FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air,” stated CFSAN Director Susan Mayne in the letter. “Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.”
The agency also stated that it is finalizing a plan to reduce levels of toxic elements in baby foods, including:
“Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
Focused compliance and enforcement activities, including inspections.
Providing guidance to industry on how to meet their obligations under current regulations.”
The agency will also continue its surveillance sampling assignment that focuses on these products.
Following a report released nearly two weeks ago about the potential danger posed by toxic heavy metals found in baby foods manufactured by several major companies, FDA has issued a response. The report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, was released by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy on February 4. The Subcommittee stated that FDA should require baby food manufacturers to test their finished products for toxic heavy metals and require any toxic heavy metals be reported on food labeling. It also stated that FDA should set maximum levels of toxic heavy metals allowed in baby foods.
“The FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study,” the agency stated in a CFSAN update. “Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.”
FDA cited its work in sampling infant rice cereal for arsenic, which it says has resulted in safer products on the market, along with its recent court order to stop a U.S. company from distributing adulterated juice that had potentially harmful levels of inorganic arsenic and patulin (a mycotoxin).
The CFSAN update, however, did not specifically address the companies or baby foods called out in the Subcommittee’s report.
Last week a report released by Congress cited dangerous levels of toxic heavy metals in several brands of baby food. Back in November 2019, the Subcommittee on Economic and Consumer Policy asked for internal documents and test results from baby food manufacturers Nurture, Inc. (Happy Family Organics), Beech-Nut Nutrition Company, Hain Celestial Group, Inc., Gerber, Campbell Soup Company, Walmart, Inc., and Sprout Foods. According to the staff report, Nurture, Beech-Nut, Hain and Gerber responded to the requests, while Walmart, Campbell and Sprout Organic Foods did not.
The findings indicate that significant levels of arsenic, lead, cadmium and mercury were found in the baby foods of the four manufacturers who responded to the Subcommittee’s requests (Nurture, Beech-Nut, Hain and Gerber). It also stated the alarming point that, “Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.”
The Subcommittee voiced “grave concerns” that the baby food made by Walmart, Sprout Organic Foods and Campbell was “obscuring the presence of even higher levels of toxic heavy metals in their baby food products than their competitors’ products” due to their lack of cooperation.
In addition, the report states that the Trump administration “ignored a secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods” in August 2019.
“To this day, baby foods containing toxic heavy metals bear no label or warning to parents. Manufacturers are free to test only ingredients, or, for the vast majority of baby foods, to conduct no testing at all,” the report stated (infant rice cereal is the only baby food held to a stringent standard regarding the presence of inorganic arsenic).
As a result of the findings, the Subcommittee has made several recommendations:
FDA should require baby food manufacturers to test their finished products for toxic heavy metals.
FDA should require manufacturers to report toxic heavy metals on food labels.
Manufacturers should find substitutes for ingredients that are high in toxic heavy metals or phase out the ingredients that are high in toxic heavy metals.
FDA should set maximum levels of toxic heavy metals allowed in baby foods.
Parents should avoid baby foods that contain ingredients that test high in toxic heavy metals.
There are more than 1000 different pesticides in use around the world. While these chemicals are designed to target insects, weeds and other pests, residual amounts can remain on food that is subsequently eaten by consumers. The effects of pesticides on the population can be acute or chronic depending on the exposure. Acute over-exposure can cause poisoning and result in long-term effects such as cancer or reproductive issues. Chronic, lower dose exposure to pesticides has been associated with health issues such as respiratory problems, skin conditions, depression, birth defects, cancer and neurological disorders such as Parkinson’s disease.
People who face the greatest risk for adverse health outcomes from pesticide exposure are those in agricultural roles, who are more likely to come into direct contact with these chemicals. However, developing fetuses, infants and children, as well as pregnant and nursing mothers and women of childbearing age are at increased risk of experiencing negative health effects due to the presence of unsafe levels of pesticides in food. Exposure throughout a child’s development¬–including in the womb, infancy, early childhood, and puberty–can be particularly dangerous, affecting hormone regulation and brain development.
To minimize adverse health effects, the United States Environmental Protection Agency (EPA) and the European Union (EU) impose strict regulations on the amount of pesticides that can be applied to a crop, in order to limit the residue exposure downstream. Pesticides are assigned maximum residue levels (MRLs) depending on their toxicity, with the majority typically set at 10 µg/kg. However, due to the greater risk of certain compounds affecting the healthy development of infants and young children, some pesticides are controlled further: For instance, in the EU, specific pesticides are restricted in baby foods with MRLs of between 3–8 µg/kg.
Triple Quadrupole GC-MS/MS: Meeting the Needs of Pesticide Analysis
In order to test foods for pesticide residues at these very low levels, food safety laboratories require sophisticated analyte detection technologies. Gas chromatography-tandem mass spectrometry (GC-MS/MS) is a powerful analytical technique that offers the sensitivity and selectivity required to detect and identify pesticide residues at levels that often go beyond those mandated by regulatory authorities, even in complex sample matrices such as baby food. Indeed, GC-MS/MS can detect multiple residues within samples at levels as low as 0.025 µg/kg, much lower than the MRLs of regulated pesticides.
The sensitivity of the latest triple quadrupole GC-MS/MS systems is enabling levels of detection so low that many food testing laboratories have been able to adopt more efficient and universally-applicable sample preparation procedures based on QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) methods. Combining these modern GC-MS/MS systems with QuEChERS sample preparation techniques allows food samples to be analyzed directly, significantly reducing workflow complexity. Furthermore, the specificity of triple quadrupole GC-MS/MS can easily compensate for the additional matrix components or residual acetonitrile carried over from sample preparation.
EU SANTE Criteria for Pesticide Residue Quantitation
When it comes to the detection of pesticides in baby foods, workflows must comply with rigorous quality control and method validation standards. The EU SANTE/11813/2017 criteria outline three specific requirements that pesticide residue analysis methods must satisfy to achieve compliance.
Firstly, a minimum of two product ions must be detected for each pesticide with a peak signal-to-noise ratio greater than 3 (or in case noise is absent, a signal must be present in at least five subsequent scans), and the mass resolution for precursor ion isolation must be equal to or better than unit mass resolution. Secondly, the retention time of an analyte within a sample must not differ by more than 0.1 minutes compared with standards in the same sequence. Finally, the relative ion ratio for each analyte must remain within 30% of the average of calibration standards from the same sequence.
Fortunately, modern triple quadrupole GC-MS/MS systems are ensuring food safety testing laboratories comply with these criteria. In terms of peak detection and resolution, the specificities achieved using the latest triple quadrupole instruments meet or exceed the EU SANTE requirements by providing consistent data points regardless of sample preparation approach or matrix type. Precise detection at the ultra-low concentrations required for pesticide residue quantitation is routinely achieved using modern triple quadrupole GC-MS/MS systems, with analyses offering qualitative identification of each analyte among a large group of residues. Furthermore, the latest systems deliver stable ion ratios that are well within the required 30% range at the default 10 µg/kg MRL across multiple injections.
Ultra-low-level Quantification of Pesticides Using Triple Quadrupole GC-MS/MS
In a recent study that put the capabilities of the latest triple quadrupole GC-MS/MS systems to the test, samples of baby food (carrot/potato and apple/pear/banana) spiked with a mixture of more than 200 pesticides at three concentrations (1.0, 2.5 and 10.0 μg/kg) were analyzed using the Thermo Scientific TSQ 9000 triple quadrupole GC-MS/MS system fitted with an Advanced Electron Ionization (AEI) source. Prior to injection into the instrument, the homogenized spiked samples were prepared for analysis using a QuEChERS method that included an acetonitrile extraction step, a clean-up step involving primary secondary amine (PSA) and dispersive solid phase extraction (dSPE), followed by acidification with 5% formic acid in acetonitrile.
The triple quadrupole GC-MS/MS system met all SANTE criteria at the three spiking concentrations in both food matrices. More than 97% of the target pesticide residues in the 1 μg/kg spiked sample had recoveries in the range of 70%–120%, highlighting the broad applicability of the method. The recoveries of the target pesticides from the apple/pear/banana sample spiked at 10 μg/kg are shown in Figure 1.
Figure 1. Recovery and precision data for apple/pear/banana extractions (n=6) at a concentration of 10 μg/kg, obtained using TSQ 9000 triple quadrupole GC-MS/MS system fitted with an advanced electron ionization (AEI) source.(Figure 1 continued)
Triple Quadrupole GC-MS/MS: Supporting Exceptional Limits of Detection
To determine the limits of detection of the system, baby food samples prepared by the previously-described QuEChERS method were spiked with the same mixture of pesticides at 14 concentrations ranging from 0.025 to 250 μg/kg. Using the triple quadrupole GC-MS/MS system, the SANTE criteria were met for all of the pesticides targeted at the default MRL of 10 μg/kg. Additionally, more than 90% of the target compounds had a limit of identification (LOI) satisfying all SANTE requirements below 0.5 µg/kg, and more than 60% of the target residues met these criteria below 0.1 µg/kg (Figure 2).
Figure 2. Number of target residues satisfying the EU SANTE requirements (carrot/potato sample matrix). IDL, instrumental detection limit; LOI, limit of identification.
Instrumental detection limits (IDLs) were also determined for each pesticide residue by performing 10 replicate injections of the lowest matrix-matched standard of carrot/potato that met all SANTE criteria. IDLs were then evaluated using one-tailed student t-tests, taking into account the concentration and absolute peak area %RSD for each compound. The evaluated IDLs ranged from approximately 5 fg (for chlorobenzilate) to 2.0 pg (for bioallethrin), with over 95% of the residues exhibiting an IDL of less than 500 fg on the column (equivalent to 0.5 µg/kg in each sample extract). These results highlight the exceptional performance of the system, offering quantitative analysis of more than 200 pesticides over up to five orders of magnitude.
Conclusion
Enforcing regulations on the amounts and types of pesticides used is essential to limit our exposure to safe levels. The latest GC-MS/MS systems are capable of detecting and identifying pesticide residues at levels far beyond those required under regulatory standards, helping food testing laboratories efficiently ensure the food our children eat is always safe to consume.
Whole Foods Market voluntarily recalls packaged raw macadamia nuts due to possible Salmonella contamination. Recalled items were sold in AR, AZ, CA, CO, HI, KS, LA, NM, NV, OK, TX, and UT Whole Foods Market Stores. No illnesses have been reported to-date. Based upon routine testing conducted by an FDA-contracted laboratory, it was determined that the raw macadamia nuts tested positive for Salmonella.
Beech-Nut Nutrition recalls approximately 1,920 pounds of baby food products that may be contaminated with small pieces of glass… The baby food product was produced on December 12, 2014: 4-oz. glass jars containing “Stage 2 Beech-Nut CLASSICS sweet potato & chicken. The problem was discovered after the firm received a complaint from a consumer who found a small piece of glass in the product. The company has received a report of an oral injury associated with consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products.
Beech-Nut responds: “At Beech-Nut, we strive to make baby food with the best ingredients nature has to offer – freshly prepared and packaged in clean, safe and environmentally-friendly packaging. So, when any product of ours falls short of those standards, we take swift action to correct it.”
The cured and uncured pork items were produced on various dates between August 7, 2014 and April 1, 2015… The problem was discovered when an FSIS inspector was conducting a Food Safety Assessment and observed a processing deviation.
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