Toxicology Reports 9 (2022) 238–249

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Toxicology Reports
journal homepage: www.elsevier.com/locate/toxrep

Human health risk assessment of arsenic, cadmium, lead, and mercury

ingestion from baby foods
Gwendolyn H. Parker a, Caroline E. Gillie b, 1, Julie V. Miller b, Deanna E. Badger c, Marisa
L. Kreider b, *
a
Cardno ChemRisk now Stantec, Houston, TX, USA
b
Cardno ChemRisk now Stantec, Pittsburgh, PA, USA
c
Department of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA

A R T I C L E I N F O A B S T R A C T

Handling Editor: Dr. Aristidis Tsatsakis Recently, the U.S. House of Representatives reported on the presence of heavy metals in raw ingredients used in
baby foods and in finished baby food products themselves. In light of these concerns, this study aimed to evaluate
Keywords: potential risks associated with the presence of heavy metals in baby food products. We analyzed 36 baby food
Heavy metal samples representing four ingredient categories (fruit; leguminous vegetable; root vegetable; or grain) for arsenic
Baby food
(As), cadmium (Cd), mercury (Hg), and lead (Pb). We assessed the potential lifetime cancer and non-cancer
Risk assessment
health risks posed to infants and toddlers following daily consumption of these chemicals in each food type,
Arsenic
Cadmium based on established daily food-specific ingestion rates. Daily doses were compared against selected reference
Mercury values and oral slope factors to determine non-cancer hazard indices (HIs) and lifetime cancer risks. Hazard
Lead indices indicated a potential for non-cancer risk (e.g., HIs > 1.0) under only a few exposure scenarios, including
for As and Pb under selected product type and age/concentration assumptions. Increases in lifetime cancer risks
for all analytes across the ingredient categories evaluated ranged from 3.75 × 10− 5 to 5.54 × 10− 5; cancer risks
were primarily driven by As from grain products. Though a limited set of exposure scenarios indicated a potential
for health risk, the exposure assumptions in this assessment were conservative, and the heavy metal concen­
trations we found in baby foods are similar to those observed in similar whole foods. Based on these findings and
the limited scenarios under which risks were identified, this study indicates that an infant’s typical intake of baby
food is unlikely to pose health risks from heavy metals above accepted tolerable risk levels under most exposure
scenarios.

1. Introduction may be introduced into the food supply via plant uptake, livestock
consumption of contaminated water or food, and/or agricultural or
In recent years, concerns have been raised about the presence of manufacturing processes [5].
heavy metals and metalloids in baby foods sold in the United States [1, The term “heavy metals” is widely used in the scientific community,
2]. More recently, multiple federal lawsuits have been brought against but lacks a standardized, authoritative definition. The U.S. Food and
baby food manufacturers, alleging that exposure to “heavy metals” can Drug Administration (FDA) defines and regulates the metals Hg Pb, and
negatively impact children’s development [3]. These lawsuits were filed the metalloid As as “heavy metals” in food additive provisions [6]. These
shortly after the release of a 2021 U.S. House of Representatives Sub­ elements are also commonly referred to as “heavy metals” in the sci­
committee on Economic and Consumer Policy report indicating that entific literature [7–9]. In this publication, we refer to the metals Cd, Hg,
baby foods manufactured in the U.S. contain “elevated levels” of “heavy Pb, and the metalloid As collectively as heavy metals.
metals,” such as arsenic (As), cadmium (Cd), mercury (Hg), and lead Multiple organizations have detected heavy metals at varying con­
(Pb) [3,4]. These “heavy metals” occur naturally in the environment, centrations in baby and toddler foods sold in the U.S. As part of the Total
and may also enter the environment as industrial pollutants. They also Diet Study (TDS), the FDA samples key foods, including various baby

* Corresponding author at: 20 Stanwix Street, Suite 505, Pittsburgh, PA, 15222, USA.
E-mail address: [email protected] (M.L. Kreider).
1
Current affiliation: Braskem, Pittsburgh, PA, USA.

https://doi.org/10.1016/j.toxrep.2022.02.001
Received 12 August 2021; Received in revised form 28 January 2022; Accepted 2 February 2022
Available online 4 February 2022
2214-7500/© 2022 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
G.H. Parker et al. Toxicology Reports 9 (2022) 238–249

foods, in the U.S. and tests them for various elements, including As, Cd, threat” in baby food [1]. The EDF did not evaluate human health risk,
Hg, and Pb [10]. Additionally, non-governmental organizations, such as however, but instead characterized the hazard presence (i.e., the
Consumer Reports and Healthy Babies Bright Futures (HBBF), tested baby detection of one or more heavy metals). In its 2019 study, HBBF
and toddler food samples collected in the U.S. for heavy metals in 2017 benchmarked the these metal concentrations in baby foods against FDA
and 2019, respectively, focusing specifically on As, Cd, Hg, and Pb [2, guidance when possible [11]. In addition, metal concentrations were
11]. A total of 50 packaged foods were sampled in the Consumer Reports benchmarked against these non-authoritative limits established by
study, all of which had detectable concentrations of one or more of these advocacy groups: 1 μg/kg Pb in all categories of food tested (EDF);
heavy metals. Similarly, the HBBF study detected at least one heavy 1 μg/kg Pb in fruit juices (American Academy of Pediatrics (AAP));
metal in 95 % of the 168 baby foods tested. Gardener et al. [12] tested 1 μg/kg Cd and 3 μg/kg As in fruit juices (Consumer Reports); and
564 baby and toddler formulas and foods and found that 37 % and 57 % 25 μg/kg As in infant rice cereal (HBBF). Most recently, in 2021, the U.S.
of products had detectable levels of Pb and Cd, respectively, with the House of Representatives Subcommittee on Economic and Consumer
highest levels of each metal detected in cereals, snacks, and kids’ meals. Policy released a report analyzing data provided by commercial baby
Chronic oral exposures to the heavy metals highlighted by these food manufacturers, and found that the As, Cd, Hg, and Pb concentra­
studies (As, Cd, Hg, and Pb)are associated with cancer and adverse non- tions detected in baby foods or their raw ingredients were multiple times
cancer health effects. Both As and Pb are designated as known human higher than the FDA’s bottled water standards [4]. This analysis,
carcinogens when ingested. Oral exposures to As, Cd, Hg, and Pb have though, did not characterize children’s potential exposures to these
also been shown to induce non-cancer systemic and target organ hazards based on use patterns, but instead compared them to water
toxicity, including neurological, reproductive, developmental, cardio­ intake benchmarks, which are inappropriate for characterizing risks
vascular, hematological, gastrointestinal, renal, musculoskeletal, and associated with food. Additionally, in its 2018 analysis, Consumer Re­
dermal adverse health effects, depending on the element [13–16]. ports identified “troubling” findings, including the detection of “worri­
The FDA has issued import alerts and draft and final guidance doc­ some” levels of at least one of the heavy metals in the products tested. It
uments to industry detailing Pb and inorganic As levels not to be noted that 15 of the sampled products would pose potential health risks
exceeded in select food products (e.g., infant rice cereal; juice; dried to a child regularly eating one serving or fewer per day [2]. Consumer
fruits; candy; and spices). More comprehensive guidance or regulations Reports, however, has not made its dataset publicly available in order to
limiting heavy metal levels in food, however, have not been established allow for an independent risk assessment.
or promulgated to date [17–22]. Absent any authoritative limits for Based on the available literature to date, few studies have evaluated
exposure to As and heavy metals in many foods transparently evaluating health risk to children from multiple heavy metals across a variety of
any health risk potential associated with these elements detected in food food types. The objective of this study was to understand potential
becomes critically important. Many studies have evaluated the presence health risks associated with heavy metals in specific food product cat­
of heavy metals in food and their associated health risks in general, but egories, including fruits, grains, leguminous vegetables, and root vege­
only a limited number of peer-reviewed studies have evaluated the tables, with the understanding that potential risks are likely to differ by
exposure and subsequent health risks of select heavy metals in baby food type. In this study, we performed a risk assessment of As, Cd, Hg,
foods sold in the U.S. Using probabilistic risk assessment methods to and Pb in purchased baby foods within these categories. We purchased
evaluate the health risks of inorganic As in rice cereal consumed by U.S. food products, analyzed them for heavy metal concentrations, and
infants and toddlers, Shibata et al. [23] concluded that median and conducted a complete risk assessment for consuming these foods during
upper bound consumption of rice cereal exceeded tolerable chronic early childhood using the resulting concentrations and food type-
non-cancer risk levels, but was within an acceptable cancer risk range. specific intake rates. This study’s aim is to provide complete and
Gardener et al. [12] indicated that fewer than 7% of total solid baby food transparent information on the health risks associated with consuming
samples collected exceeded FDA and World Health Organization (WHO) baby foods via established, authoritative risk assessment methods, so as
limits for both Pb and Cd under high-consumption scenarios, and 0% to comprehensively address the recent and emerging concerns emerging
and 14 % of the infant formulas exceeded the Pb and Cd limits, about this issue.
respectively. Similarly, in an analysis of FDA TDS Cd and Pb concen­
tration data from 2014 to 2016, Spungen [24] demonstrated that dietary 2. Methods
Pb exposure typically exceeds toxicity criteria when the upper bound of
the data were used, whereas Cd exposures exceed toxicity criteria across 2.1. Selection of samples
upper and lower bounds using conservative toxicity criteria. Additional
peer-reviewed publications have evaluated heavy metal exposures and For this study, we selected infant and toddler foods made by three
their associated health risks from baby and toddler foods outside the U.S. different manufacturers. Our inclusion criteria included foods that were
Martins et al. [25], for example, assessed exposure of infants to total Hg both targeted toward children between the ages of four months and
concentrations in infant foods commercially available in Portugal, and three years (i.e., stages one through four) and that also contained one or
found that its provisional tolerable weekly intake (PWTI) in foods other more primary ingredient(s) in the following categories: fruit (e.g., pear,
than fish and shellfish was not exceeded under any exposure condition. peach, apple, and/or strawberry); leguminous vegetable (e.g., peas and/
In their recent study, Gu et al. [26] measured concentrations of inor­ or green beans); root vegetable (e.g., sweet potatoes and/or carrots); and
ganic and total As in rice-based baby foods to estimate infant dietary grain (e.g. rice and/or whole wheat). While dietary exposure to the
exposure to As. They found that 75 % of samples exceeded maximum analytes of interest is not limited to the specific food products or cate­
levels for As in the EU. Further, under high-consumption scenarios, gories described herein, we concentrated on products within these
exposure to As exceeded the benchmark dose lower confidence limit ingredient categories because of their ubiquity in infant and young
(BMDL), indicating potential for increased health risks associated with children’s diets [28]. Because one likely origin of heavy metal
excess consumption of As in rice products. In a study of weaning formula contamination in foods is plant uptake from water and soil, we identified
in Spain, Camara-Martos et al. [27] performed a probabilistic assess­ the primary ingredient category as the variable of interest.
ment of Cd exposure, and determined that all exposure scenarios were We purchased baby and toddler foods from five supermarket chain
below the associated PWTI. locations in and around Pittsburgh, Pennsylvania between December,
Multiple non-peer-reviewed publications have also contributed to 2018 and March, 2019. Purchased products included both organic and
the current public understanding of this issue. In 2017, the Environ­ non-organic foods packaged in jars and pouches. We collected a total of
mental Defense Fund (EDF) raised concerns about Pb in its analysis of 36 baby and toddler food samples. We procured three different organic
11 years of data from the FDA TDS, describing it as a “hidden health or non-organic baby food products for each of four primary ingredient

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categories: fruits, leguminous vegetables, root vegetables, and grains. Consistent with EPA guidance, non-detects (ND), or samples with con­
Three samples of each product type from three distinct lots were ob­ centrations below the LOD, were assumed to have concentrations of the
tained in order to ensure that we captured potential variability in heavy analyte of interest at one-half of the LOD (0.0015 mg/kg, or 1.5 μg/kg)
metal concentrations within a product type. Table 1 provides additional for risk assessment purposes [31]. Samples that were non-quantifiable
detail on the samples, including primary ingredient categorization, (NQ), with instrument detections between the LOD and lower limit of
brand, organic designation, packaging material, and sample size. quantitation (LLOQ, 0.010 mg/kg, or 10 μg/kg), were assumed to have
concentrations of the analyte of interest equal to one-half of the LLOQ
(0.005 mg/kg or 5 μg/kg). The uncertainty, which accounts for error in
2.2. Analysis and quantification of As, Cd, Hg, and Pb in baby foods
calibration, accuracy, precision, and percent recovery parameters, for
As, Cd, Pb, and Hg were 6 %, 15 %, 8 %, and 15 %, respectively. For
To determine which elements to evaluate in baby foods, we consid­
method validation, analysts at AGQ Labs USA followed the US FDA EAM
ered common metals and metalloids characterized by laboratories, and
guidance for method validation. The validation included the demon­
narrowed the list by identifying specific hazards to which children may
stration of several figures of merit, including accuracy, precision,
be sensitive, including reproductive and developmental hazards, carci­
sensitivity, selectivity, limit of detection, limit of quantification, line­
nogenicity, and mutagenicity. For this screening, we specifically iden­
arity, range, and ruggedness of the method. The method used for this
tified metals and metalloids on the California Office of Environmental
study was validated by the US FDA and a multi-laboratory validation.
Health Hazard Assessment (Cal/OEHHA) Proposition 65 list, as well as
those that the European Chemicals Agency (ECHA) has designated as
Category 1 or 2 carcinogens, mutagens, or reproductive toxicants. Upon 2.3. Data analysis
identifying the metals and metalloids subset, we further excluded
essential minerals (e.g., cobalt; chromium; nickel) and/or elements only In order to calculate exposure point concentrations for As, Cd, Hg,
identified as carcinogens due to inhalation effects (e.g., antimony; and Pb in each ingredient category, summary statistics (mean, median,
beryllium; selenium; vanadium). The resulting identified elements were and maximum concentrations as well as standard deviation) were
As, Cd, Hg, and Pb. Previous studies have identified these elements and generated. Figures for As, Cd, Hg, and Pb concentrations in baby food
the importance of characterizing their risks to infants and young chil­ samples were prepared in GraphPad Prism version 9.1.2 (San Diego,
dren [2,4,29]. CA). All ingredient categories were characterized by a relatively small
After purchase, the 36 baby food samples were stored under sample size (N = 9), and across all analyzed elements and ingredient
temperature-controlled conditions in an office setting. In March, 2019, categories a majority of samples fell below the LOD. For these reasons,
all samples were sent in their original, sealed packaging to AGQ Labs we were not able to fit a distribution to the data to identify the best
USA (Oxnard, CA, USA), an ISO-17025 accredited laboratory. Food central tendency measure for the risk assessment. Both mean and me­
samples were analyzed for total As, Cd, Hg, and Pb, using a heat-block dian concentrations were therefore used to calculate exposure point
assisted acid digestion and inductively-coupled plasma mass spectrom­ concentrations as central tendency measures. Similarly, the sample size
etry (ICP-MS) method per the FDA Elemental Analysis Manual (EAM for and number below the LOD precluded us from calculating a valid 95 %
Food and Related Products, Method 4.7 [30]). Briefly, samples were acid upper confidence level. As such, we used maximum analyte concentra­
digested and heated using a heat block with half volume acid, and then tions to estimate potential upper-bound exposure concentrations.
subsequently diluted to 50 mL total volume. Samples were then
analyzed for total As, Cd, Hg, and Pb via ICP-MS. The quantification 2.4. Exposure and risk assessment
range for As, Cd, and Pb was 0.010–25.0 mg/kg (or 10–25,000 μg/kg)
and 0.010–2.50 mg/kg (or 10–2500 μg/kg) for Hg. The limit of detec­ 2.4.1. Exposure estimate
tion (LOD) for As, Cd, Pb, and Hg was 0.003 mg/kg (or 3 μg/kg). We estimated exposure to As, Cd, Hg, and Pb via baby food ingestion
using deterministic methods for three different age groups: birth to
Table 1 <1 year; 1 year to <2 years; and 2 years to <3 years. Mean, median, and
Baby and Toddler Food Samples. maximum analyte concentrations in each food category were used to
Sample Primary Brand Organic/ Packaging Size
calculate an average daily dose (ADD) in order to evaluate non-cancer
ID Ingredient Nonorganic Material health effects, using the following Eq. (1):
Category
ADD = C × IR (1)
1 Fruit Brand Organic Plastic pouch 3.5
1 oz. where ADD is the average daily dose (mg/kg-day), C is the respective
2 Fruit Brand Organic Plastic pouch 3.5
1 oz.
mean, median, or maximum concentration of heavy metals in each food
3 Fruit Brand Nonorganic Plastic 2 oz. category (mg/g; see Table 4), and IR is the average daily intake rate for
1 container each ingredient category (g/kg-day; see Table 2).
4 Grain Brand Organic Cardboard 8 oz. In addition, we calculated a lifetime average daily dose (LADD) to
3 box
assess lifetime cancer risk, using mean, median, and maximum analyte
5 Grain Brand Nonorganic Plastic 8 oz.
1 container concentrations according to the following Eq. (2):
6 Grain Brand Nonorganic Plastic 8 oz.
C × IR × ED
1 container LADD = (2)
7 Leguminous Brand Organic Glass jar 2.5 AT
Vegetable 3 oz.
8 Leguminous Brand Nonorganic Plastic 2 oz. where LADD is the lifetime average daily dose (mg/kg-day); C is the
Vegetable 1 container respective mean, median, or maximum heavy metal concentration (mg/
9 Leguminous Brand Nonorganic Plastic 2 oz. g; see Table 4); IR is the average daily intake rate for the respective
Vegetable 1 container
ingredient category (g/kg-day; see Table 2); ED is the exposure duration
10 Root Vegetable Brand Nonorganic Glass jar 4 oz.
2 over which the infant/child in each age group consumed baby foods
11 Root Vegetable Brand Organic Glass jar 4 oz. (days); and AT is the averaging time (i.e., the period over which the
3 exposure is averaged (a 70-year lifetime equates to 25,550 days)).
12 Root Vegetable Brand Organic Plastic pouch 3.5 Age- and mean ingredient-specific intake rates, compiled from the U.
1 oz.
S. Environmental Protection Agency’s (EPA) Exposure Factors Handbook,

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Table 2 heavy metal analyses estimated the total elemental concentrations, and
Mean Baby Food Ingestion Exposure Parameters. did not distinguish between organic and inorganic chemical forms The
Age Group toxicity criteria for both As and Hg, however, are differentiated by
Parameter Reference chemical form (i.e., organic and inorganic). Both the organic and inor­
<1 1-<2 2-<3
year years years ganic forms of As and Hg are found in various foodstuffs. Organic As and
Hg are more commonly found in fish and aquatic plants, representing a
BW: Body Weight (kg) 6.825 11.4 13.8 Table 8–1 [32]
ED: Exposure Duration (days) 365 –
major route of human exposure to these forms. Comparatively, inor­
AT: Averaging Time (days) 25,550 – ganic As and Hg are the predominant types found in foods other than
Table 9–1: Mean seafood [40–43]. As such, we selected toxicity criteria associated with
Fruit 9.9 9.8 7.7 values for Total the inorganic forms of these elements. In the case of As, applying inor­
Fruits [33]
ganic As toxicity criteria yields conservative risk estimates, in the event
Table 12-1:
Grain 3.9 6.4 6.4 Mean values for that both types are present in the sample concentrations. Table 3 depicts
IR: Consumer-
Total Grains [34] the selected cancer and non-cancer toxicity criteria for each heavy
Only Mean
Intake Rate Leguminous
Table 9–6: Mean metal, including the issuing agency and tumor type or most sensitive
2.73 3.31 1.49 values for target organ or system, as applicable.
(g/kg-day) Vegetable
Legumes [33]
Table 9–6: Mean
Root values for Root 2.4.3. Non-cancer risk
3.62 2.9 2.64
Vegetable Tuber To estimate the non-cancer health risk of ingesting heavy metals via
Vegetables [33] baby food consumption, we calculated a hazard quotient (HQ) for As,
Cd, and Hg using the standard EPA methodology, as depicted in the
following Eq. (3) [48]:
are based on U.S. dietary survey data collected between 2005 and 2010
[32–34]. Considerable variability exists in the timing of the transition ADD
HQ = (3)
from breast milk or formula to solid foods among infants and young RfD or TDI
children between <1 and 3 years old, particularly within the first year
[35–37]. As such, consumer-only mean intake rates, representing only where ADD is the average daily dose (mg/kg-day), the RfD is the
those individuals who reported eating the food item during the survey reference dose (mg/kg-day), and the TDI is the tolerable daily intake
period, were selected as conservative food consumption estimates not (mg/kg-day). For Pb, we calculated the HQ using the Eq. (4) below, to
biased downward by survey participants who did not consume the foods account for body weight:
of interest. These exposure parameters are presented by age group and ADD × BW
ingredient category in Table 2 below. HQ = (4)
MADL

2.4.2. Toxicity criteria identification where ADD is the average daily dose (mg/kg-day), BW is the age-specific
We compared the estimated daily exposure for each analyte to body weight (kg; see Table 2), and MADL is the Maximum Allowable
available cancer and non-cancer-based oral toxicity criteria or health Dose Level (mg/day) established by Cal/OEHHA.
guidelines. The cancer criteria result from applying low-dose extrapo­ We used hazard indices (HIs) to evaluate the exposure effect from
lation procedures, and are presented as the cancer risk per mg/kg/day multiple ingredient categories. HIs were calculated by summing HQs for
[38]. The non-cancer criteria are estimates of daily exposure likely to be each analyte and age group across ingredient categories, using the Eq.
without an appreciable risk of deleterious health effects, based on the (5) below. Because the RfDs for As, Cd, Hg, and Pb are based on adverse
most sensitive endpoint(s) [38]. effects on different target organs (Table 3), HQs were not summed across
In accordance with EPA recommendations for selecting toxicity analytes, since the resulting health risks may not be cumulative. HQs
criteria, cancer and non-cancer criteria from EPA’s Integrated Risk In­ and cumulative HIs exceeding 1.0 indicate a potential for human health
formation System (IRIS) were selected when available. When IRIS values risk from the associated exposure(s).
were not available, we selected current, transparent, peer-reviewed
HI = HQ1 + HQ2 + … + HQn (5)
toxicity criteria from authoritative sources, such as the European Food
Safety Authority (EFSA) or Cal/OEHHA [39]. As described herein, the

Table 3
Oral Toxicity Criteria for As, Cd, Hg, and Pb.
Cancer Non-Cancer
Heavy
Metal Criterion Value Unit Tumor Type Reference Criterion Value Unit Most Sensitive Target Reference
Organ/ System

As, EPA IRIS OSF 1.50E+00 (mg/kg/ Splenic [38] EPA IRIS RfD 3.00E- mg/kg/ Cardiovasculara, Dermalb [38]
inorganic day)− 1 sarcoma 04 day
Cd NA NA NA NA NA EPA IRIS RfD 1.00E- mg/kg/ Urinaryc [44]
03 day
Hg, NA NA NA NA NA EFSA TDI 5.70E- mg/kg/ Kidneyd [45]
inorganic 04 day
Pb Cal/ OEHHA 8.50E-03 (mg/kg/ Kidney [46] Cal/OEHHA 5.00E- mg/day Reproductive [47]
OSF day)− 1 tumors MADL 04

Key: EPA = U.S. Environmental Protection Agency; IRIS = Integrated Risk Information System; OSF = Oral Slope Factor; RfD = Reference Dose; EFSA = European
Food Safety Authority; TDI = Tolerable Daily Intake, calculated by dividing the Tolerable Weekly Intake (TWI) by 7 days/week; Cal/OEHHA = California Office of
Environmental Health Hazard Assessment; MADL = Maximum Allowable Dose Level.
a
Possible vascular complications.
b
Hyperpigmentation and keratosis.
c
Significant proteinuria.
d
Kidney weight change.

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2.4.4. Cancer risk and 48.0 μg/kg. The mean and maximum concentrations in the grain
Cancer health risks represent the probability of developing cancer product samples were 9.7 μg/kg and 20.0 μg/kg, respectively. Median
from exposure to a given chemical at a given concentration [48]. The Pb concentrations in both ingredient categories were non-detected
incremental probability of developing cancer (i.e., the theoretical excess (1.5 μg/kg) or non-quantifiable (5.0 μg/kg). Pb was also detected in
cancer risk, or increased lifetime cancer risk) is the additional risk above the fruit (33 %) and leguminous vegetable (22 %) products. The mean
the cancer risk an individual would face absent the exposures charac­ and maximum Pb concentrations in the fruit product samples were
terized in this study. We calculated the lifetime cancer risks (LCRs) for 2.7 μg/kg and 5.0 μg/kg, respectively, and the mean and maximum Pb
As and Pb from consuming these foods using the following Eq. (6): concentrations in the leguminous vegetable product samples were
2.3 μg/kg and 5.0 μg/kg, respectively. The minimum and median Pb
LCR = LADD × OSF (6)
concentrations in fruit and leguminous vegetable products were non-
where LADD is the lifetime average daily dose (mg/kg-day) and OSF is detected (1.5 μg/kg) or non-quantifiable (5.0 μg/kg).
the oral slope factor (mg/kg-day)− 1. LCRs were summed across all age Fig. 1A illustrates the distribution of each heavy metal in each
groups, analytes, and ingredient categories in order to calculate cumu­ ingredient category. Specifically, this figure demonstrates that grain and
lative lifetime cancer risks associated with baby food consumption. root vegetable ingredient categories had higher median concentrations,
with larger ranges relative to fruit and leguminous vegetable ingredient
3. Results categories for As, Cd, and Pb. Additional detail is provided for the grain
(Fig. 1B), fruit (Fig. 1C), and root vegetable (Fig. 1D) ingredient
3.1. Metal and Metalloid Analyses and Exposure Estimates for Baby categories.
Foods Tables 5 and 6 present the heavy metal ADDs and LADDs for each age
group and ingredient category, calculated using mean, median, and
Table 4 presents heavy metal detection frequencies, as well as min­ maximum metal concentrations.
imum, mean, median, and maximum concentrations across food cate­
gories. As, Cd, and Pb were each detected in samples within at least two 3.2. Non-cancer risk
ingredient categories, while Hg was not detected in any samples. As was
detected in 100 % of grain samples, and had the highest reported mean Table 7 presents the As, Cd, Hg, and Pb non-cancer HQs and HIs for
(90.4 μg/kg), median (126.0 μg/kg), and maximum (132.0 μg/kg) each ingredient category and age range. We calculated HQs (unitless)
concentrations as compared to the other ingredient categories. As was using the mean, median, and maximum analyte concentrations reported
also detected in 100 %, 67 % and 78 % of the root vegetable, fruit and in Table 4, in accordance with Eqs. (3) and (4) above. HQs for As
leguminous vegetable product samples, respectively. Cd was detected in exceeded 1.0 for children in all age groups consuming grain products
100 % of grain product samples, resulting in mean and median con­ represented by mean, median, and maximum concentrations. For each
centrations of 25.8 μg/kg and 20.0 μg/kg, respectively (range: concentration, As HQs were lower for children <1 year old, compared to
12.0–61.0 μg/kg). Cd was detected 33 % of fruit product samples and 67 the two older age groups, which had identical HQs. Across age groups,
% of root vegetable samples. The mean and maximum Cd concentrations consuming grain products represented by mean As concentrations
in the fruit product samples were 4.4 μg/kg and 16.0 μg/kg, respec­ resulted in lower HQs than median concentrations. In children <1 year
tively, and the mean and maximum Cd concentrations in the root old, the HQs ranged from 1.18 (based on the mean As concentration) to
vegetable product samples were 3.8 μg/kg and 5.0 μg/kg, respectively. 1.72 (based on the maximum As concentration). HQs ranged from 1.93
The minimum and median Cd concentrations in fruit and root vegetable to 2.82 for the two older age groups. Regarding As non-cancer health
products were non-detected (1.5 μg/kg) or non-quantifiable (5.0 μg/ risks from consuming all ingredient category products, HIs ranged from
kg). No Cd detections were reported in the leguminous vegetable 1.47 in children <1 year (based on the mean As concentration) to 3.25
samples. in children ages 1 to <2 years (based on the maximum As concentra­
Pb was detected in both grain (100 %) and root vegetable products tion). Cumulative HIs for As were driven by HQs for grain products.
(88 %). The mean and maximum Pb concentrations were highest in the Pb HQs exceeded 1.0 for a subset of age ranges for fruit, grain, and
root vegetable ingredient category, with respective values of 15.8 μg/kg root vegetable products under at least one scenario (e.g., mean or

Table 4
As, Cd, Hg, and Pb Concentrations (μg/kg) in Baby Food Samples by Ingredient Category.
Concentration (μg/kg)a
Heavy Metal Ingredient Category No. of Samples Detection Frequency n (%)
Minimum Mean Median Maximum Error (±SD)b

Fruit 9 6 (67) 1.5 3.8 5.0 5.0 1.8

Grain 9 9 (100) 10.0 90.4 126.0 132.0 54.4
As
Leguminous Vegetable 9 7 (78) 1.5 4.2 5.0 5.0 1.5
Root Vegetable 9 9 (100) 5.0 10.8 12.0 22.0 5.4
Fruit 9 3 (33) 1.5 4.4 1.5 16.0 5.2
Grain 9 9 (100) 12.0 25.8 20.0 61.0 16.9
Cd
Leguminous Vegetable 9 0 (0) 1.5 1.5 1.5 1.5 0.0
Root Vegetable 9 6 (67) 1.5 3.8 5.0 5.0 1.8
Fruit 9 0 (0) 1.5 1.5 1.5 1.5 0.0
Grain 9 0 (0) 1.5 1.5 1.5 1.5 0.0
Hg
Leguminous Vegetable 9 0 (0) 1.5 1.5 1.5 1.5 0.0
Root Vegetable 9 0 (0) 1.5 1.5 1.5 1.5 0.0
Fruit 9 3 (33) 1.5 2.7 1.5 5.0 1.8
Grain 9 9 (100) 5.0 9.7 5.0 20.0 7.0
Pb
Leguminous Vegetable 9 2 (22) 1.5 2.3 1.5 5.0 1.5
Root Vegetable 9 8 (88) 1.5 15.8 5.0 48.0 15.6

Values below the lower limit of quantitation (LLOQ) were replaced with ½ the LLOQ (10 μg/kg), 5 μg/kg.
a
Values below the limit of detection (LOD) were replaced with ½ the LOD (3 μg/kg), 1.5 μg/kg.
b
SD = Standard Deviation.

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Fig. 1. Determination of As, Cd, Pb, and Hg in Baby Foods. Heavy metal concentrations depicted by (A) All Ingredient Categories, (B) Grain Products, (C) Fruit
Products, and (D) Root Vegetable Products. Individual concentrations are plotted for each ingredient category (A) or subcategory (B-D), with mean concentrations
depicted by a black horizontal bar. The Leguminous Vegetable Ingredient Category was not depicted, as all detections (n = 9) were between the LOD and LLOQ.

Table 5
As, Cd, Hg, and Pb Average Daily Doses (μg/kg-day) for Children Ages <1 to <3 Years Consuming Baby Foods.
Age Categories

Heavy Ingredient <1 year 1-<2 years 2-<3 years

Metal Category
Mean (μg/ Median (μg/ Max (μg/kg- Mean (μg/ Median (μg/ Max (μg/kg- Mean (μg/ Median (μg/ Max (μg/kg-
kg-day) kg-day) day) kg-day) kg-day) day) kg-day) kg-day) day)

Fruit 2.59E-01 3.38E-01 3.38E-01 4.28E-01 5.59E-01 5.59E-01 4.07E-01 5.31E-01 5.31E-01
Grain 2.41E+00 3.35E+00 3.51E+00 6.60E+00 9.19E+00 9.63E+00 7.99E+00 1.11E+01 1.17E+01
As Leguminous
7.87E-02 9.32E-02 9.32E-02 1.59E-01 1.89E-01 1.89E-01 8.68E-02 1.03E-01 1.03E-01
Vegetable
Root Vegetable 2.66E-01 2.96E-01 5.44E-01 3.56E-01 3.97E-01 7.27E-01 3.93E-01 4.37E-01 8.02E-01
Fruit 3.00E-01 1.01E-01 1.08E+00 4.97E-01 1.68E-01 1.79E+00 4.72E-01 1.59E-01 1.70E+00
Grain 6.86E-01 5.32E-01 1.62E+00 1.88E+00 1.46E+00 4.45E+00 2.28E+00 1.77E+00 5.39E+00
Cd Leguminous
2.79E-02 2.79E-02 2.79E-02 5.66E-02 5.66E-02 5.66E-02 3.08E-02 3.08E-02 3.08E-02
Vegetable
Root Vegetable 9.47E-02 1.24E-01 1.24E-01 1.27E-01 1.65E-01 1.65E-01 1.40E-01 1.82E-01 1.82E-01
Fruit 1.01E-01 1.01E-01 1.01E-01 1.68E-01 1.68E-01 1.68E-01 1.59E-01 1.59E-01 1.59E-01
Grain 3.99E-02 3.99E-02 3.99E-02 1.09E-01 1.09E-01 1.09E-01 1.32E-01 1.32E-01 1.32E-01
Hg Leguminous
2.79E-02 2.79E-02 2.79E-02 5.66E-02 5.66E-02 5.66E-02 3.08E-02 3.08E-02 3.08E-02
Vegetable
Root Vegetable 3.71E-02 3.71E-02 3.71E-02 4.96E-02 4.96E-02 4.96E-02 5.46E-02 5.46E-02 5.46E-02
Fruit 1.80E-01 1.01E-01 3.38E-01 2.98E-01 1.68E-01 5.59E-01 2.83E-01 1.59E-01 5.31E-01
Grain 2.57E-01 1.33E-01 5.32E-01 7.05E-01 3.65E-01 1.46E+00 8.54E-01 4.42E-01 1.77E+00
Pb Leguminous
4.24E-02 2.79E-02 9.32E-02 8.59E-02 5.66E-02 1.89E-01 4.68E-02 3.08E-02 1.03E-01
Vegetable
Root Vegetable 3.91E-01 1.24E-01 1.19E+00 5.23E-01 1.65E-01 1.59E+00 5.77E-01 1.82E-01 1.75E+00

maximum concentration). HQ exceedances ranged from 1.06 to 1.12 for the older population. Comparatively, consuming grain and root vege­
children ages 1 to <3 years consuming only fruit products containing the table products represented by median Pb concentrations resulted in HQs
maximum Pb concentrations. The lower HQ was reported for the older less than 1.0 for these ages. For children <1 year, HQs only exceeded 1.0
age group. The fruit product HQs were calculated using only Pb con­ for consuming grain and root vegetable products containing the
centrations below the LLOQ. HQs calculated for children consuming maximum Pb concentrations. Pb HI exceedances, accounting for
grain and root vegetable products demonstrated a contrasting trend of consuming all ingredient category products, ranged from 1.51 for chil­
higher HQs reported for the older age group. Grain and root vegetable dren 1 to <2 years (based on the median Pb concentration) to 8.30 for
product HQs derived using mean and maximum Pb concentrations were children 2 to <3 years (based on the maximum Pb concentration).
greater than 1.0 for children ages 1 to <3 years old, and were higher in Consuming Cd- and Hg-containing baby foods across all ingredient

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Table 6
As, Cd, Hg, and Pb Lifetime Average Daily Doses (μg/kg-day) for Children Ages <1 to <3 Years Consuming Baby Foods.
Age Categories

Heavy Ingredient <1 year 1-<2 years 2-<3 years

Metal Category
Mean (μg/ Median (μg/ Max (μg/ Mean (μg/ Median (μg/ Max (μg/ Mean (μg/ Median (μg/ Max (μg/
kg-day) kg-day) kg-day) kg-day) kg-day) kg-day) kg-day) kg-day) kg-day)

Fruit 3.70E-03 4.83E-03 4.83E-03 6.12E-03 7.98E-03 7.98E-03 5.82E-03 7.59E-03 7.59E-03
Grain 3.44E-02 4.79E-02 5.02E-02 9.43E-02 1.31E-01 1.38E-01 1.14E-01 1.59E-01 1.67E-01
As Leguminous
1.12E-03 1.33E-03 1.33E-03 2.28E-03 2.70E-03 2.70E-03 1.24E-03 1.47E-03 1.47E-03
Vegetable
Root Vegetable 3.80E-03 4.24E-03 7.76E-03 5.09E-03 5.67E-03 1.04E-02 5.61E-03 6.25E-03 1.15E-02
Fruit 4.29E-03 1.45E-03 1.54E-02 7.09E-03 2.39E-03 2.55E-02 6.75E-03 2.28E-03 2.43E-02
Grain 9.80E-03 7.61E-03 2.32E-02 2.69E-02 2.08E-02 6.36E-02 3.25E-02 2.52E-02 7.70E-02
Cd Leguminous
3.99E-04 3.99E-04 3.99E-04 8.09E-04 8.09E-04 8.09E-04 4.41E-04 4.41E-04 4.41E-04
Vegetable
Root Vegetable 1.35E-03 1.76E-03 1.76E-03 1.81E-03 2.36E-03 2.36E-03 2.00E-03 2.60E-03 2.60E-03
Fruit 1.45E-03 1.45E-03 1.45E-03 2.39E-03 2.39E-03 2.39E-03 2.28E-03 2.28E-03 2.28E-03
Grain 5.70E-04 5.70E-04 5.70E-04 1.56E-03 1.56E-03 1.56E-03 1.89E-03 1.89E-03 1.89E-03
Hg Leguminous
3.99E-04 3.99E-04 3.99E-04 8.09E-04 8.09E-04 8.09E-04 4.41E-04 4.41E-04 4.41E-04
Vegetable
Root Vegetable 5.29E-04 5.29E-04 5.29E-04 7.08E-04 7.08E-04 7.08E-04 7.81E-04 7.81E-04 7.81E-04
Fruit 2.57E-03 1.45E-03 4.83E-03 4.26E-03 2.39E-03 7.98E-03 4.05E-03 2.28E-03 7.59E-03
Grain 3.68E-03 1.90E-03 7.61E-03 1.01E-02 5.21E-03 2.08E-02 1.22E-02 6.31E-03 2.52E-02
Pb Leguminous
6.06E-04 3.99E-04 1.33E-03 1.23E-03 8.09E-04 2.70E-03 6.69E-04 4.41E-04 1.47E-03
Vegetable
Root Vegetable 5.59E-03 1.76E-03 1.69E-02 7.48E-03 2.36E-03 2.27E-02 8.24E-03 2.60E-03 2.50E-02

Table 7
Non-Cancer Hazard Quotients for Children Ages <1 to <3 Years Consuming Baby Foods Containing As, Cd, Hg, and Pb.

Note: HQs and HIs >1 are shaded in grey; HQs and HIs derived from mean, median, and max concentrations are provided in the table.

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categories did not result in increased non-cancer risks for any age group concentrations measured in these baby food types. This finding is
at even the maximum concentrations. consistent with the existing available literature regarding these metals
[12,25,27,49,50]. The As and Pb concentrations reported in certain
3.3. Cancer risk product types, however, may represent potential health risks under the
exposure assumptions used in this assessment.
Table 8 summarizes lifetime cancer risks for children ages <1 to <3
years from consuming As- and Pb-containing baby foods. We calculated 4.1. Arsenic
lifetime cancer risks using the mean, median, and maximum metal
concentrations reported in Table 4, in accordance with Eq. (6). Increased Health risks associated with As were not identified from exposure to
cancer risk for general population exposures is typically characterized as fruit or vegetable (root or leguminous) products. Overall, non-cancer
cumulative cancer risk above 1 in 1,000,000, or 10− 6 (unitless). and cancer risks from As are driven by its presence in grain products.
Consuming mean, median, and maximum As concentrations in fruit, This finding is consistent with the published literature, which indicates
grain, and root vegetable products resulted in cancer risks greater than that both non-cancer and cancer risks are associated with arsenic in rice-
10− 6. Total cancer risks from As across all ingredient categories ranged based products [51–54]. Such conclusions, though, may differ by rice
from 3.74 × 10-5 (based on the mean As concentration) to 5.53 × 10-5 type and source, and/or the risk assessment’s underlying assumptions
(based on the maximum As concentration). Comparatively, cancer risks [53,55]. Elevated concentrations of As in grain products, particularly
from consuming Pb across all food categories were well below the rice-based products, is common, owing to its natural occurrence in soil
threshold of 10− 6, ranging from 2.21 × 10-8 to 1.15 × 10-7. Combined [26,53,54,56–59]. In the most recent FDA TDS, rice and rice-based
lifetime cancer risks from consuming As and Pb across all ingredient products were among the products listed with the highest measured
categories were driven by As concentrations, and ranged from As concentrations [10]. As was detected in all white rice samples and in
3.75 × 10-5 (based on the mean concentrations) to 5.54 × 10-5 (based 97 % of crisped rice cereal samples, with mean concentrations of
on the maximum concentrations). 66 μg/kg and 159 μg/kg, respectively. Of the three grain-based baby
foods evaluated in this study, two were rice-based. The rice-based
4. Discussion products in this study contained much higher As concentrations than
did the wheat-based product (Fig. 1B), and therefore accounted for the
Recently, public interest concerning heavy metals in baby foods has increased risk from As associated with the grain-based products. As
grown, thanks in part to widely publicized studies from Consumer Re­ concentrations in these rice products exceed the guidance value estab­
ports and the U.S. House of Representatives [2,4]. These studies, how­ lished by the FDA for rice-based cereal and baby food of 100 μg/kg [19].
ever, have been limited in their interpretation by: 1) reporting only Gu et al. [26] found that 75 % of all rice-based baby foods had As
concentrations in ingredients or finished products, and not calculating concentrations above 100 μg/kg in Australia, indicating this phenome­
health risk; 2) comparing measured concentrations to inappropriate non is common. Although both non-cancer and cancer risks associated
screening values in an effort to estimate risk (e.g., comparing food with As could be anticipated based on other studies of As in rice-based
concentrations to drinking water limits); or 3) not providing details on products, the risks herein are likely overestimated because of the
risk assessment assumptions, preventing transparency. This risk assess­ selected exposure assumptions and guidance values. The assumptions
ment provides a transparent and conservative estimate of potential regarding daily intake of grains used in this assessment are based on
health risk to enhance understanding of this issue. total grain consumption [34]. In its risk assessment of rice and rice
The analyses in this study focused on measuring As, Cd, Hg, and Pb products for <1 year olds, the FDA assumed ingestion rates of 0.664 and
levels in different baby food types (e.g., fruits, grains, root vegetables, 0.925 g/kg/d for rice-based cereal and all rice products, respectively
and leguminous vegetables). Previous studies identified these heavy [60]. Comparatively, we assumed that a child’s consumption of
metals as chemicals of concern for children’s exposures, owing either to grain-based baby foods was equivalent to his or her total daily grain
their concentrations in foods or to childhood-specific hazards [2,4,11, consumption across grain products (e.g., 3.9 g/kg-d for < 1 year olds).
29]. We used results of these analyses to estimate non-cancer and cancer Because the selected grain products were primarily rice-based cereals
health risks for children <1 year, 1 to <2 years, and 2 to <3 years, along that represented the highest As concentrations in grain-based baby
with cumulative cancer risks across all ages. Based on these analyses, foods, using consumption rates for all grains will overestimate daily As
human health risks, including non-cancer and cancer (where appli­ exposure associated with any specific grain product type (including
cable), are not expected from Cd or Hg exposure, based on the rice). In addition to overestimating the mass of consumption for any

Table 8
Lifetime Cancer Risks (LCRs) for Children Ages <1 to <3 Years Consuming Baby Foods Containing As, Cd, Hg, and Pb.

6
Note: CRs >10− are shaded in grey. LCRs using the mean, median, and max sample concentrations are provided in the table.

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specific grain product, this risk assessment also conservatively assumed substantially overestimated for fruits (the exceedance was already small,
all As measured in the samples was inorganic, as no differentiation of with HQs ranging from 1.06 to 1.12). For grain-based baby foods, Pb was
organic and inorganic As was conducted. Previous researchers have measured above the LLOQ in one product (an organic rice-based cereal),
demonstrated that inorganic As represents only a fraction of total As in and screening values were exceeded only when assuming mean or
grain products, including rice-based products, though the fraction of maximum Pb concentrations for all grains (Fig. 1B). As with As, this risk
inorganic As ranges widely, depending on the study [51,56–58,61,62]. assessment assumed that ingesting only grain-based baby foods
FDA estimated that inorganic As could range from 12 % to 100 % of total accounted for a child’s total daily grain consumption. Pb was not
As in rice and rice products [62]. Because organic As offers different detected in most rice cereal samples in the TDS (non-detect in 94 %).
hazard and dose response profiles than inorganic forms, and because Maximum Pb concentrations in TDS products was 13 μg/kg. The
only inorganic As screening values were used in this risk assessment, this maximum Pb concentration detected in grain products in this study was
risk assessment offers a worst-case prediction of human health risk from 20 μg/kg, while the mean concentration for all grain products was
inorganic As. Risks would be reduced if some As in the products were 9.7 μg/kg (approximating the LLOQ in this study and the range of TDS
organic. LODs).
In addition to the uncertainties regarding the estimated exposure to For root vegetable products, Pb was detectable in selected sweet
As, uncertainties also exist regarding selecting screening values to use in potato and carrot-based product samples, and screening values were
As-based risk assessments. For cancer-based risk assessments, we relied exceeded only when assuming Pb concentrations at the mean or
on an oral slope factor from EPA IRIS, which is more conservative than maximum (HQs ranged from 1.05 to 3.5). Pb was not detected in all lots
those used by the EPA to establish drinking water standards, or by the. of these products (Fig. 1D), suggesting variability in Pb concentration,
FDA to evaluate risk associated with rice and rice products [60]. In even within one product. Risk estimates based on the maximum
establishing the slope factor under IRIS, EPA acknowledged that un­ measured concentration are therefore likely to overestimate risk, even in
certainty exists regarding the potency of As carcinogenicity [38]. One instances in which parents feed their children a single product brand.
primary uncertainty associated with the slope factor is related to as­ Risk estimates based on mean concentration are more likely to
sumptions regarding consuming As in food. The underlying study approximate actual risk to children. Although exposures at the mean
providing the basis for the slope factor involves exposure to contami­ concentration may exceed the screening value in this risk assessment,
nated drinking water. In modeling the data, the. EPA assumed that the exceedance is quite small (HQs ranged from 1.05 to 1.15). Given the
2 μg/d of As from food contributed to the overall As exposure. These conservative assumptions used in this risk assessment, then, this risk is
data, however, were not based on empirical information provided in the unlikely to be appreciable.
study, and therefore have a high level of uncertainty. EFSA relies on an The Cal/OEHHA MADL of 0.5 μg/d was used to evaluate non-cancer
alternate screening value to determine inorganic As risk from foods of health risk for Pb. In the 1990s, the FDA established a provisional
0.3 to 8 μg/kg/d. Average daily As exposure from baby food in the tolerable total daily intake (PTTDI) level of 6 μg/d for Pb in young
current study was comparable to the EFSA screening range, estimated to children [67]. In 2018, the FDA reduced its daily intake level for Pb in
range from 0.1 to 11.7 μg/kg/d [63]. This result is consistent with food from 6 μg/d to an interim limit of 3 μg/d for children, corre­
several other studies that indicate exposures to As in rice products are at sponding to the Pb level that would result in a blood Pb level of 5 μg/dL,
or below the EFSA screening range [51,52,64]. the level at which clinical monitoring is recommended [67]. All daily
Collectively, these inherent conservatisms in the risk assessment are dose estimates in this study were well below the FDA limit of 3 μg/d. The
likely to overpredict non-cancer and cancer risks associated with As highest daily dose predicted by this study from Pb in baby food is
exposure in baby foods. Overall, exceedances of non-cancer screening 1.77 μg/d. Because it uses the most sensitive screening value available,
values for As were modest. HIs for all scenarios, including risks based on this risk assessment may overestimate Pb risk from baby foods. The FDA
maximum As concentration in any sample, were 3.25 or lower. For does not have recommended or enforceable Pb limits in vegetables,
cancer risk, cumulative risks from As ranged from 3.74 × 10− 5 to although it has provided recommendations for other food products,
5.53 × 10− 5, which would be considered an increased risk for general including candy, dried fruits (for import), and fruit juices. These guid­
population exposures by most agencies. Although both non-cancer and ance values are all 50 μg/kg or higher, and the Pb concentrations in all
cancer risk estimates for As in grain-based baby foods are likely to be baby products tested herein are below 50 μg/kg. This study is also
overestimated, and daily exposure estimates are within acceptable consistent with Gardener et al. [12], who identified that Pb exposures
ranges as defined by EFSA, this study provides additional evidence that from concentrations in baby food products typically do not exceed the
further investigating As in rice-based baby foods may be warranted. In FDA limits that were in place at the time of publication (either 6 μg/d or
response to EU imposed As limits in rice-based baby foods (100 μg/kg, 50 μg/kg). Daily doses, however, can occasionally exceed the Cal/O­
similar to FDA’s guideline), the presence of mixed cereal types (con­ EHHA MADL. Further, our findings are consistent with Spungen [24],
taining rice and another grain) has increased in the UK market [65]. At who determined that Pb exposures from baby food products typically do
the time of its 2016 risk assessment, FDA reported that 53%–62% of not exceed the interim FDA limit (3 μg/d), except under upper bound
infant rice cereal products exceeded the 100 μg/kg limit [60]. For con­ exposure conditions.
cerned parents, limiting children’s rice-based product consumption re­ The collective, inherent conservatisms in this risk assessment are
mains a possible mitigation strategy. The. FDA has recommended likely to overpredict risks associated with current Pb exposure from
feeding infants a variety of grain-based cereals in order to limit heavy baby foods. Within the context of this study, exceedances of non-cancer
metal exposure from food [66]. screening values for Pb were modest. HQs for all scenarios, including
risks based on maximum Pb concentration in any sample, were 3.53 or
4.2. Lead lower. Data variability further indicates that even within a brand, a
range of potential exposures to Pb exist, indicating that daily exposure at
For Pb, potential non-cancer health risks were observed in fruit, the maximum concentration is highly unlikely. Cancer risk associated
grain, and root vegetable ingredient categories. Across all product cat­ with Pb was not found to increase in this study. Estimated daily Pb
egories, Pb was only detected in selected products (mostly grains and exposure from these products remains below daily dose limits estab­
root vegetables), consistent with Gardener et al. [12], who reported 37 lished by the FDA for Pb. Although this study likely overestimates non-
% detection frequency for Pb across all baby food products, with the cancer Pb risk estimates (and thus consuming these foods may not
highest concentrations found in rice products. Pb was not detected in represent health risks to children), Pb should, however, remain a focus
any evaluated fruit-based baby foods, and risks were therefore deter­ of ongoing testing for food companies, so as to ensure children’s safety,
mined based only on the LOD and LLOQ. As such, the HQs may be owing to children’s sensitivity to Pb’s effects.

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4.3. Uncertainties and limitations Table 10

95th Percentile Baby Food Ingestion Exposure Parameters.
Although this study provides a transparent and conservative risk Age Group
assessment of the selected heavy metals in baby foods in order to aid Parameter Reference
<1 year 1-<2 2-<3
understanding of whether these products pose risks to children, it is not years years
without some limitations and/or uncertainties. In addition to the un­
BW: Body Weight (kg) 8.475 14 17.1 Table 8–3 [32]
certainties and limitations in specific risk assessments associated with Pb Table 9–1: 95th
and As exposure, this study only evaluated a small subset of available percentile
Fruit 27.2 24.0 20.5
products on the market. Though these products were selected from na­ values for Total
tional suppliers in order to include a range of foods that babies may eat, Fruits [33]
Table 12-1: 95th
their representativeness of the entire market as a whole is unknown.
percentile
Identifying specific risks (and, contrastingly, the elements identified as IR: Consumer- Grain 8.7 12.7 11.7
values for Total
Only 95th
unlikely to be a risk) are consistent with the published literature, indi­ Grains [34]
Percentile
cating that these results might actually be representative of other Intake Rate
Table 9–1: 95th
products [12,24–27,50,68]. Furthermore, the As and Pb concentrations Leguminous percentile
(g/kg-day) 18.7 16.3 14.0
Vegetablea values for Total
found in the sampled baby foods in this study and identified as potential Vegetables [33]
health risks are consistent with concentrations found in many whole Table 9–1: 95th
foods and non-baby food products reported in the TDS, as depicted in Root percentile
18.7 16.3 14.0
Table 9. In spite of the similarities to existing data on these elements in Vegetablea values for Total
Vegetables [33]
both baby food products and whole foods, more comprehensive analyses
could bolster these conclusions. Follow-up studies with more robust a
Age-specific intake rates were not available for leguminous or root vegeta­
sample sizes could elucidate the relationship between heavy metal bles. Age-specific consumer-only upper bound intake rates for total vegetables
concentrations in baby foods and brand-specific manufacture processes were therefore assigned to each vegetable category.
and formulations, including variables such as specific ingredients,
source location, agricultural practices, and/or production methods. Furthermore, children with higher consumption rates could reasonably
Further, heavy metals were not present above limits of detection and be expected to have higher body weights. Collectively, then, although
quantitation in most product samples. Pb and As were detected in <75 % this risk assessment did not consider all combinations of intake rate,
of all products tested. Uncertainty therefore remains regarding actual body weight, and concentration, the results presented herein represent
concentrations of the elements in the products tested. For the purposes the most typical exposure scenarios for children exposed to heavy metals
of this risk assessment, we assumed that non-detected element concen­ via food products.
trations were present in the food at one-half of the LOD, which may over-
or under-estimate the actual metal concentration in the product. 5. Conclusions
Lastly, this risk assessment relies on inherent assumptions regarding
food intake and body weight that are intended to represent typical use Overall, this risk assessment indicates that, except for select exposure
conditions, but may not represent all children’s food consumption pat­ scenarios and products, when consumed, baby foods are unlikely to pose
terns and body weights. In an effort to understand potential risk vari­ risks from heavy metals. The primary exception, however, is As in rice-
ability related to food intake rate variation, Table 10 presents the upper based foods, a recognized issue worldwide because of the natural
bound (95th percentile) ingredient-specific consumer-only intake rates occurrence of As in soil and its high uptake into rice. Though Pb risks
and body weights, compiled from the EPA Exposure Factors Handbook. were potentially identified for some product categories, Pb exposures
The upper-bound food intake rates are approximately 1.8- to 9.4-fold routinely were below FDA guidelines, and daily doses were very close to
higher than the intake rates used in this risk assessment. Correspond­ the Cal/OEHHA MADL of 0.5 μg/d, if not below. This study can provide
ingly, for children with very high food consumption rates, calculated additional information and support for decision-makers regarding con­
risk estimates would be approximately 1.8- to 6.8-fold higher than this cerns about dietary heavy metal exposures to children, particularly in
risk assessment reports (with high-end estimates based on total vege­ terms of understanding potential risks by baby food product type.
table consumption, rather than type-specific consumption). Contrast­
ingly, upper bound body weights are approximately 25 % higher than Conflict of interest
those used in this risk assessment, which would reduce the estimated
daily dose and corresponding risk estimates in a similar fashion. The authors declare no conflict of interest.

Table 9
TDS As and Pb Concentrations in Whole Foods Compared to Current Study Baby Food Samples.
As Concentration (μg/kg) Pb Concentration (μg/kg)
Food Type
Minimum Mean Maximum Minimum Mean Maximum

Current Study: Grain 10.0 90.4 132 5.0 9.7 20.0

TDS: Rice, white, enriched, cooked 36 66 111 0 0 0
TDS: Shredded wheat cereal 0 1 18 0 0.3 11
Current Study: Fruit 1.5 3.8 5.0 1.5 2.7 5.0
TDS: Orange (navel/Valencia), raw 0 0 0 0 1 21
TDS: Pineapple, canned in juice 0 0 0 0 7 46
Current Study: Leguminous Vegetable 1.5 4.2 5.0 1.5 2.3 5.0
TDS: Peas, green, fresh/frozen, boiled 0 0 0 0 0 0
TDS: Pinto beans, dry, boiled 0 0 0 0 0.3 11
Current Study: Root Vegetable 5.0 10.8 22.0 1.5 15.8 48.0
TDS: Sweet potatoes, canned 0 0.3 11 0 12 23
TDS: Carrot, fresh, peeled, boiled 0 0 0 0 2 19
TDS: Carrot, baby, raw 0 0.4 13 0 1 9

Note: Current study ND = 1.5 μg/kg, NQ = 5 μg/kg; TDS ND = 0 μg/kg.

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Funding [9] M. Jaishankar, T. Tseten, N. Anbalagan, B.B. Mathew, K.N. Beeregowda, Toxicity,
mechanism and health effects of some heavy metals, Interdiscip. Tox. 7 (2) (2014)
60–72.
This research was not funded by any grants from any agencies in the [10] FDA, Total Diet Study: Elements Results Summary Statistics. Market Baskets 2006
public, commercial, or not-for-profit sectors. Through 2013, April 15, 2014. Revised April, 2017, U.S. Food and Drug
Administration (FDA)-Center for Food Safety and Applied Nutrition-Office of
Analytics and Outreach-Exposure Assessment Branch, College Park, MD, 2017.
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