Contains Nonbinding Recommendations 
 
 
Action Level for Inorganic Arsenic in 
Apple Juice: Guidance for Industry 
 
 
 
 
Additional copies are available from: 
Office of Food Safety, HFS-300 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740  
(Tel) 240-402-1700  
http://www.fda.gov/FoodGuidances 
 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to http://www.regulations.gov.  Submit written comments on the guidance 
to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket 
number [FDA-2012-D-0322] listed in the notice of availability that publishes in the Federal 
Register.   
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
June 2023   
 
 
 
 
Table of Contents 
 
 
 
 
I. Introduction ............................................................................................................................. 3 
II. Background ............................................................................................................................ 3 
III. Data on Arsenic in Apple Juice .......................................................................................... 5 
IV. Risk Assessment, Achievability Assessment, and Exposure Assessment ........................ 6 
V. Action Level ............................................................................................................................ 7 
VI. Conclusion ............................................................................................................................. 9 
VII. References ........................................................................................................................... 9 
 
 
 
  2   
 
Action Level for Inorganic Arsenic in 
Apple Juice: Guidance for Industry1 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible for 
this guidance as listed on the title page. 
 
I. Introduction 
 
This guidance provides information to manufacturers on the action level2 of 10 parts per billion 
(ppb) or 10 micrograms/kilogram (g/kg) for inorganic arsenic in apple juice3 that is intended to 
help protect public health by reducing exposure to inorganic arsenic and that is achievable by 
industry with the use of current good manufacturing practices.  This guidance presents the 
background and rationale for FDAs action level. 
 
Consistent with 21 CFR 109.6(d), this action level reflects the level of inorganic arsenic at which 
FDA may regard apple juice as adulterated within the meaning of section 402(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(1)).  We intend to consider this 
action level, in addition to other factors, such as our confidence in a measured analytical value, 
when considering whether to bring enforcement action in a particular case. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe our current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited.  The use of the 
word should in FDA guidances means that something is suggested or recommended, but not 
required. 
 
II. Background 
 
Arsenic is an element that occurs in the environment from both natural and manmade sources, 
 
1 This guidance has been prepared by the Division of Plant Products and Beverages, Office of Food Safety, in the Center 
for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
2 Under 21 CFR 109.4, when certain conditions are met, FDA may establish an action level for an added poisonous or 
deleterious substance to define a level of contamination at which a food may be regarded as adulterated, within the 
meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  In this context, added 
does not mean added by the manufacturer, but rather resulting from the hand of man; for example, from previous 
pesticide use (see United States vs. Anderson Seafood, Inc. 622 F.2d 157 (5th Cir. 1980)).  Action levels serve as 
guidance to FDA field staff and industry.  We will establish an action level, as opposed to a tolerance or regulatory limit 
(which must be established by rulemaking), when technological or other changes that might affect the appropriateness 
of the tolerance are foreseeable in the near future (21 CFR 109.6(d)).  Consistent with 21 CFR 109.6, we will consider 
action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case. 
3 Including apple cider. 
 
  3   
including erosion of arsenic-containing rocks, volcanic eruptions, contamination from mining and 
  
smelting ores, and previous or current use of arsenic-containing pesticides (Ref. 1).4 Arsenic is 
found in both inorganic and organic forms (together referred to as total arsenic), and inorganic 
arsenic is generally considered more toxic than organic arsenic (Ref. 4).5  Consumption of 
inorganic arsenic has been associated with cancer, skin lesions, cardiovascular disease, and 
diabetes in humans (Refs. 4-5).  A report by the National Research Council (NRC) (Ref. 5) also 
listed adverse pregnancy outcomes and neurodevelopmental toxicity as adverse health effects of 
concern for exposure to inorganic arsenic.  The Joint Food and Agriculture Organization/World 
Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA) (Ref. 4), which 
includes participation by FDA scientists, concluded that food can be a major contributor to 
inorganic arsenic exposure, and the European Food Safety Authority (EFSA) (Ref. 6) concluded 
that dietary exposure to inorganic arsenic should be reduced.6 
 
These findings support our initiatives to assess and reduce exposure to inorganic arsenic in food.  
For example, in April 2016, we released a risk assessment on arsenic in rice and rice products (Ref. 
7) and a draft guidance for industry with an action level for inorganic arsenic in infant rice cereal 
(81 FR 19976).  In August 2020, we finalized the approach presented in the 2016 draft guidance 
(85 FR 47797).  We also conducted surveys in 2013, 2016, and 2018 of arsenic in other foods 
(Refs. 8-10), focusing primarily on rice and rice products, and released consumer information on 
consumption of rice and rice products, available online at 
https://www.fda.gov/consumers/consumer-updates/consumers-seven-things-pregnant-women-and-
parents-need-know-about-arsenic-rice-and-rice-cereal.  We also posted analytical results for 
arsenic in foods intended for babies and young children sampled under the FDAs Toxic 
Elements in Food and Foodware, and Radionuclides in Food Program from FY2008-FY2021 
(Ref. 11). 
 
On July 15, 2013, we published in the Federal Register (78 FR 42086) a notice of availability for a 
draft guidance for industry entitled Arsenic in Apple Juice: Action Level, a supporting document 
entitled Supporting Document for Action Level for Arsenic in Apple Juice, and a risk assessment 
report entitled A Quantitative Assessment of Inorganic Arsenic in Apple Juice (Ref. 12).  The 
2013 risk assessment focused on cancer effects, but a growing body of literature suggests an 
association with adverse neurodevelopmental effects in infants and children from exposure to 
inorganic arsenic (Refs. 5, 7).  
 
4 Generally, it is not possible for FDA to identify the specific source of any arsenic that may be found in a particular 
type of food, including apple juice.  Therefore, for purposes of this guidance, FDA is not distinguishing the 
presence of arsenic that may be due to prior pesticide use, such that the residues are pesticide chemical residues 
subject to a tolerance or tolerance exemption by the Environmental Protection Agency (EPA) under section 408 of 
the FD&C Act (21 U.S.C. 346a), or other environmental contamination.  Our understanding from EPA information 
is that currently arsenical pesticide use in the United States is limited to the organic arsenical monosodium 
methanearsonate (MSMA) for use on sod farms, golf courses, highway rights-of-way, and to control weeds in 
cotton fields (Ref. 2), and to chromated copper arsenate (CCA) for use by certified pesticide applicators using 
specialized high-pressure equipment in wood treatment facilities (Ref. 3). 
5 Organic in this sentence refers to arsenic molecules that contain carbon.  Inorganic arsenic molecules do not contain 
carbon.  Use of the term organic here does not refer to organically grown food. 
6 The Codex Alimentarius Commission (Codex), an international food standards organization, has established 
maximum levels (MLs) for toxic elements, including inorganic arsenic, in certain foods in international trade.  At this 
time, Codex has not established a ML for inorganic arsenic in apple juice. 
 
 
  4   
 
Apple juice is one source of exposure to inorganic arsenic from food.  Apple juice is a greater 
potential source of dietary inorganic arsenic exposure for children than for adults, because 
childrens dietary patterns are often less varied than those of adults, and they consume more apple 
juice relative to their body weight than do adults (Ref. 13).   
 
FDA has conducted routine surveillance for total arsenic in apple juice for many years; 
surveillance results are described in Section III below.  Total arsenic levels in apple juice samples 
have routinely been below 10 ppb; for example, more than 95 percent of total arsenic levels in a set 
of 94 apple juice samples collected at retail as part of a fiscal year (FY) 2011 assignment were 
below 10 ppb (Ref. 14).  The remaining four samples in that assignment with total arsenic levels 
above 10 ppb had inorganic arsenic levels below 10 ppb.  However, we occasionally find apple 
juice samples with inorganic arsenic levels above 10 ppb as part of our surveillance efforts.   
 
FDA considers that it is possible to further reduce public exposure to inorganic arsenic from apple 
juice in general, and specifically from apple juice that currently may contain inorganic arsenic at 
levels above 10 ppb.  Therefore, we are issuing this final guidance to manufacturers on an action 
level for inorganic arsenic in apple juice of 10 g/kg or 10 ppb.  This guidance finalizes the 
approach presented in the July 2013 draft guidance.   
 
III. Data on Arsenic in Apple Juice 
 
FDA routinely monitors total arsenic in apple juice through its Toxic Elements in Food and 
Foodware, and Radionuclides in Food Program (TEP).7  The TEP is a targeted monitoring program 
that monitors levels of certain toxic elements, including arsenic, in foods and foodware in domestic 
and imported products.  Foods selected for analysis include those that are suspected of having 
elevated levels of toxic elements based on historical data or other information available to us. 
Apple juice is one of the foods sampled under the TEP program.  FDA has published TEP data on 
arsenic in apple juice from 2005-2011 (Ref. 15) and 2013-2022 (Refs. 16-17).  In October 2011, 
FDA issued a supplemental assignment to the TEP resulting in the collection of 94 retail apple 
juice samples.  FDA published these data in 2013 (Ref. 14). 
 
Table 1 summarizes results from the FY2011 retail sample survey.  These samples, all of which 
were speciated for inorganic arsenic, had a mean of 4.4 ppb inorganic arsenic and a standard 
deviation of 2.4 ppb inorganic arsenic, with a range of 0 to 9.8 ppb inorganic arsenic.  Of the 94 
samples, 90 had total arsenic levels of 10 ppb or less; the other four samples had total arsenic 
levels ranging from 11 to 36 ppb.  All samples had inorganic arsenic levels below 10 ppb and 51 
samples had inorganic arsenic levels below 5 ppb.8   
 
Table 2 summarizes TEP data collected from FY2013-2022, consisting of 160 single-strength 
apple juice samples (Ref. 16).  These samples had a mean of 4.6 ppb total arsenic and a standard 
deviation of 6.6 ppb total arsenic, with a range of 0 to 44 ppb total arsenic.  Of the 160 samples, 
 
7 https://www.fda.gov/food/chemical-contaminants-pesticides/toxic-elements-foods-and-foodware.  
8 In addition to inorganic arsenic, methods for speciating arsenic can also quantify organic arsenic species including 
monomethylarsonic acid (MMA) and dimethylarsinic acid (DMA).  Because only three of the 94 samples had levels of 
MMA or DMA above trace amounts (i.e., above 2 ppb, Ref. 14) and because inorganic arsenic is considered more 
toxic than organic arsenic (see Section II), FDA concluded that the action level for arsenic in apple juice should be 
based on inorganic arsenic.  
 
  5   
143 samples had total arsenic levels of 10 ppb or less, and 125 samples had total arsenic levels of 5 
ppb or less.  Speciation analysis was conducted on 14 of these 160 TEP samples, and these 
speciated samples had a mean of 20.6 ppb inorganic arsenic and a standard deviation of 10.1 ppb 
inorganic arsenic, with a range of 8.3 to 39 ppb inorganic arsenic (Ref 17).9  Of the 14 speciated 
samples, 12 were confirmed to have inorganic arsenic levels above 10 ppb. 
 
FDA also monitors apple juice through the Total Diet Study (TDS) (Ref. 18).  The TDS is an 
ongoing market basket study representative of the U.S. diet that includes analysis of toxic elements 
such as arsenic.  Table 2 summarizes TDS data on arsenic in apple juice collected from FY2013-
2020, consisting of 47 single-strength apple juice samples for babies and for general consumption.  
The TDS data had a mean of 2.7 ppb total arsenic with a standard deviation of 2.0 ppb total arsenic 
and ranged in concentration from 0 to 10 ppb total arsenic.  Most TDS samples are not samples of 
individual foods; they are composites (averages) of three retail samples, all from different cities.  
Because the compositing provides an average result, and our achievability assessment is based 
on percentiles of arsenic concentrations in individual samples, we did not use the TDS data in the 
achievability assessment or other assessments in Section IV. 
 
Because FDA analyses indicate the majority of arsenic in apple juice is inorganic arsenic, total 
arsenic can closely approximate inorganic arsenic in apple juice (Ref. 14).  FDA used the total 
arsenic data collected from FY2013-2022 to recalculate the disease rate and achievability estimates 
from FY2011, as well as to estimate the reduction in inorganic arsenic exposure from apple juice to 
children based on the 10 ppb action level.  We discuss our evaluation in the next section.  
 
IV. Risk Assessment, Achievability Assessment, and Exposure 
Assessment 
 
a. Risk Assessment: In 2008, we established a level of concern (Ref. 19) of 23 ppb for inorganic 
arsenic in single-strength (ready-to-drink) apple juice as part of a hazard assessment.  This level of 
concern, which is no longer in use, focused on non-cancer endpoints and average consumption of 
apple juice with higher levels of arsenic for a limited (not lifetime) period of time.  
 
In 2011, to facilitate development of an action level for inorganic arsenic in apple juice, FDA 
conducted a quantitative assessment of the risk for cancer associated with exposure to inorganic 
arsenic in apple juice.  Detailed information on the risk assessment process can be found in the risk 
assessment document (Ref. 12).  Briefly, FDA used data on lung and urinary tract cancer cases 
from a Taiwanese population exposed to high levels of inorganic arsenic in drinking water (Ref. 
20-21) to develop a dose-response model for inorganic arsenic and cancer.  FDA used data from 
the National Health and Nutrition Examination Survey to estimate apple juice consumption rates 
for children (ages 0-6 years) and for all persons (ages 0-50 years and for lifetime), both for average 
consumption and for high consumption (three times average consumption).  The dose-response 
 
9 FDA uses an inductively coupled plasma mass spectrometry (ICPMS) method for total arsenic 
 
(https://www.fda.gov/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM377005.pdf) and a high 
performance liquid chromatography-inductively coupled plasma mass spectrometry (HPLC-ICPMS) method for 
speciation analysis (https://www.fda.gov/media/86499/download).  Measurement of total arsenic is considered simpler 
and easier to perform than speciation analysis, in which the inorganic and organic forms of arsenic present in a sample 
are identified and quantified.  Therefore, in the past, FDA has screened apple juice samples for total arsenic, and then 
speciated samples with elevated total arsenic to determine inorganic arsenic levels.  We intend to continue this 
practice. 
 
  6   
model was then used to model disease rates based on the estimated average inorganic arsenic 
concentrations in apple juice collected by FDA in FY2011 (Table 3). 
 
To update the disease rate calculations in the risk assessment, FDA estimated total arsenic 
concentrations in apple juice from FY2013-2022 TEP data (Ref. 16).  We modeled average total 
arsenic concentrations in juice at or below hypothetical inorganic arsenic maximum limits (3, 5, 
and 10 ppb), where juices with arsenic concentrations exceeding these maximum limits were 
hypothetically eliminated from the food supply.   
 
Based on FY2013-2022 sampling data and assuming chronic exposure (0-50 years), the modeled 
bladder and lung cancer disease rates at the hypothetical maximum limits ranged from 2.5 to 4.2 
cases per million people for the average consumer and 7.5 to 12.8 cases per million people for 
high-level consumers (see Table 4).  Comparison of risk estimates between lifetime exposure and 
childhood exposure indicate that much of the risk from apple juice is incurred during childhood 
because the majority of exposure occurs during childhood (Ref. 12). 
 
b. Achievability Assessment: To assess achievability, or manufacturers ability to achieve the 
hypothetical maximum limits on inorganic arsenic, we used survey results to determine the 
percentage of apple juice samples in the market that would fall at or below each of the hypothetical 
maximum limits.  The initial analysis from samples collected in FY2011 (Table 3) demonstrated 
that at 3, 5, and 10 ppb, achievability was 31, 54, and 100 percent, respectively.   
 
We repeated this analysis on the 160 single-strength TEP samples collected from FY2013-2022 to 
examine arsenic levels in apple juice since the 2013 draft guidance (Ref. 16).  Table 4 shows that 
63, 78, and 89 percent of TEP samples had total arsenic levels below 3, 5, and 10 ppb, respectively.  
These results reflect a trend toward improved achievability at lower levels (i.e., 3 and 5 ppb) since 
the FY2011 survey, but decreased achievability at 10 ppb.    
 
c. Exposure Assessment: To examine the effect of a 10 ppb action level for apple juice on 
inorganic arsenic exposure in children, we compared estimated dietary exposure for total arsenic 
from apple juice with and without a 10 ppb action level.  To estimate dietary exposure, we used the 
mean concentration of total arsenic in apple juice and the 90th percentile consumption 
(representing an upper bound) for children.  This upper bound percentile (90th percentile) was 
chosen as a health protective measure to account for children who consume larger amounts of 
apple juice and would therefore have higher exposures.  For the FY2013-2022 dataset, an action 
level of 10 ppb for single-strength (ready-to-drink) apple juice reduces dietary exposure to total 
arsenic for children by 42% at the 90th percentile consumption level.   
 
V. Action Level 
 
FDA previously identified 23 ppb as the level of concern for inorganic arsenic in apple juice for the 
purpose of a hazard assessment based on short-term exposure and non-cancer endpoints.  Based on 
the quantitative risk assessment using chronic exposure (0-50 years) and cancer endpoints, as well 
as considerations including additional information on neurodevelopmental effects, data on total and 
inorganic arsenic levels, manufacturer achievability, and reduction in exposure, FDA is setting an 
action level for inorganic arsenic in single-strength apple juice of 10 g/kg or 10 ppb.  The action 
level of 10 g/kg or 10 ppb, based on chronic exposure, will be protective against adverse effects 
associated with short-term exposure that were the basis for the level of concern of 23 ppb. 
 
  7   
 
Because of the potential for human health risks associated with exposure to inorganic arsenic, 
human exposure to inorganic arsenic in apple juice should not exceed levels achievable with the 
use of good manufacturing practices.  FDA considers that it is possible to further reduce public 
exposure to inorganic arsenic from apple juice in general, and specifically from apple juice that 
currently may contain inorganic arsenic at levels above 10 ppb.   
 
Possible sources of inorganic arsenic in apple juice include processing aids, prior use of arsenic- 
based pesticides on land currently used for apple orchards, current use of arsenic-based pesticides 
in other countries, naturally high levels of arsenic in soil or water, and atmospheric deposition from 
industrial activities.  It may be possible in some cases for manufacturers who have found elevated 
inorganic arsenic in sources of apples or apple juice concentrate to reduce or limit inorganic arsenic 
in apple juice by choosing sources of apples or apple juice concentrate with lower inorganic arsenic 
levels or no detectable inorganic arsenic. 
 
Another potential source of inorganic arsenic in apple juice is water used by manufacturers to 
dilute concentrate to prepare ready-to-drink juice.  Municipal water supplies in the United States 
are required to meet a maximum contaminant level of 10 ppb arsenic established by EPA (40 CFR 
141.62).  However, well water from areas of the U.S. with naturally high arsenic levels in 
groundwater could contain higher levels of arsenic.10  It may be possible in some cases for 
manufacturers who have found arsenic in water used to dilute concentrate to reduce or limit levels 
of inorganic arsenic in ready-to-drink apple juice by examining and controlling arsenic levels in 
water used for dilution of juice concentrate. 
 
With regard to processing aids, recent research by FDA shows that the use of some filtering aids to 
remove sediments in juice can contribute to elevated arsenic levels.  Changing or treating filtering 
aids may reduce the levels of arsenic in filtered juices (Refs. 22-23). 
 
FDA has made the determination that a level of 10 g/kg or 10 ppb inorganic arsenic is 
achievable under good manufacturing practices based on evaluation of recent FDA data on arsenic 
levels in apple juice samples.  FDA considers the action level for inorganic arsenic in apple juice to 
be protective of public health.  The action level can reduce human exposure to inorganic arsenic 
that may be found in apple juice. 
 
We note that achievability at lower levels has been increasing rapidly in recent years.  For instance, 
achievability at 5 ppb improved from 54 percent for samples collected in FY2011 (based on 
inorganic arsenic) to 78 percent for samples collected from FY2013 to FY2022 (based on total 
arsenic).  Continued improvement with respect to achievability is likely possible over the next 
several years.  We further note that lower arsenic levels are more protective of public 
health.  Modeled cancer rates based on average juice consumption decline from 4.2 cases per 
million at 10 ppb to 3.2 cases per million at 5 ppb based on FY2013-2022 data.  As we collect 
additional data with respect to achievability and dietary exposure, we expect to revisit action levels 
as part of FDAs Closer to Zero action plan11 (Ref. 24). 
 
 
10 Water used for dilution must be of safe and sanitary quality (21 CFR 117.37(a)). 
11 FDAs Closer to Zero action plan is a science-based, iterative approach to decreasing levels of toxic 
elements, including arsenic, in foods over time, including by setting action levels. 
 
  8   
VI. Conclusion 
 
For the reasons discussed above, we have concluded that a level of 10 g/kg or 10 ppb inorganic 
arsenic is achievable under good manufacturing practices based on evaluation of recent FDA data 
on arsenic levels in apple juice, which highlights industry progress in lowering levels of inorganic 
arsenic in apple juice.  We intend to take the following sampling and enforcement approach to 
arsenic in apple juice.  We intend to initially analyze apple juice samples for total arsenic.  We 
intend to speciate samples containing more than 10 g/kg or 10 ppb total arsenic to determine 
inorganic arsenic levels.  We intend to consider the action level of 10 g/kg or 10 ppb inorganic 
arsenic as an important source of information for determining whether apple juice is adulterated 
within the meaning of section 402(a)(1) of the FD&C Act (21 U.S.C. 342(a)(1)).  FDA considers 
on a case-by-case basis whether a food that contains a contaminant is adulterated.  When 
considering whether to bring an enforcement action in a particular case, we will consider whether 
the inorganic arsenic causes apple juice to be adulterated under section 402(a)(1) of the FD&C Act.  
 
VII. References 
 
The following references marked with an asterisk (*) are on display at the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday; they also are available electronically at https://www.regulations.gov.  References 
without asterisks are not on public display at https://www.regulations.gov because they have 
copyright restriction.  Some may be available at the website address, if listed.  References without 
asterisks are available for viewing only at the Dockets Management Staff. 
 
1. Agency for Toxic Substances and Disease Registry (ATSDR), 2007, Toxicological Profile for 
Arsenic, U.S. Department of Health and Human Services, Public Health Service, accessed online at 
https://www.atsdr.cdc.gov/toxprofiles/tp2.pdf. * 
 
2. U.S. Environmental Protection Agency (EPA), 2022, Monosodium Methanearsonate (MSMA), 
an Organic Arsenical, accessed online at https://www.epa.gov/ingredients-used-pesticide-
products/monosodium-methanearsonate-msma-organic-arsenical. * 
 
3. U.S. EPA, 2016, Chromated Arsenicals Final Work Plan. Registration Review. Case Number 
0132, accessed online at https://www.regulations.gov/document?D=EPA-HQ-OPP-2015-0349-
0005. * 
 
4. WHO/FAO Joint Expert Committee on Food Additives (JECFA), 2011, Evaluation of Certain 
Contaminants in Food, 72nd Report of the World Health Organization/Food and Agriculture 
Organization of the United Nations Joint Expert Committee on Food Additives, accessed online at 
https://www.who.int/publications/i/item/9789241209595.*  
 
5. National Research Council (NRC), 2013, Critical aspects of EPAs IRIS assessment of inorganic 
arsenic: interim report.  National Academies Press, Washington, D.C. accessed online at 
http://www.nap.edu. *  
 
6. European Food Safety Authority (EFSA), 2010, Scientific Opinion on Arsenic in Food, EFSA 
Journal 2009, 7(10): 1351, accessed online at https://www.efsa.europa.eu/en/efsajournal/pub/1351. * 
 
  9   
 
7. U.S. FDA, 2016a, Arsenic in Rice and Rice Products Risk Assessment Report, accessed online 
at https://www.fda.gov/food/cfsan-risk-safety-assessments/arsenic-rice-and-rice-products-risk-
assessment and at: https://www.fda.gov/science-research/peer-review-scientific-information-and-
assessments/completed-peer-reviews. * 
 
8. U.S. FDA, 2013a, Analytical Results from Inorganic Arsenic in Rice and Rice Products 
Sampling, accessed online at https://www.fda.gov/media/86074/download. * 
 
9. U.S. FDA, 2016b, Analytical Results from Inorganic Arsenic in Rice Cereals for Infants, Non- 
rice Infant Cereal and Other Foods Commonly Eaten by Infants and Toddlers, accessed online at 
https://www.fda.gov/food/cfsan-risk-safety-assessments/arsenic-rice-and-rice-products-risk-
assessment. * 
 
10. U.S. FDA, 2020, Analytical Results: Testing for Inorganic Arsenic in Rice Cereal for Infants, 
accessed online at https://www.fda.gov/media/135552/download. * 
 
11. U.S. FDA, 2023, Analytical Results for Arsenic, Lead, Cadmium, and Mercury in Foods 
Intended for Babies and Young Children  TEP (FY2008-FY2021), accessed online at 
https://www.fda.gov/media/164564/download. * 
 
12. U.S. FDA, 2013b, A Quantitative Assessment of Inorganic Arsenic in Apple Juice. 
https://www.fda.gov/media/86075/download. * 
 
13. National Research Council (NRC), 1993, Pesticides in the Diets of Infants and Children, 
National Academy Press, Washington, D.C., accessed online at http://www.nap.edu. * 
 
14.  U.S. FDA, 2011, Results of Arsenic Analysis in Single-Strength Apple Juice, 2011 (ORA 
Sampling Assignment 2011102701), December 16, 2011 update, accessed online at 
https://www.fda.gov/food/environmental-contaminants-food/results-arsenic-analysis-single-strength-apple-
juice-2011-ora-sampling-assignment-2011102701. * 
 
15.  U.S. FDA, 2011, Arsenic in Apple Juice Analytical Results, 2005-2011 Toxic Elements Food 
and Foodware Program, December 16, 2011 update, accessed online at 
https://www.fda.gov/food/environmental-contaminants-food/arsenic-apple-juice-analytical-results-
2005-2011-toxic-elements-food-and-foodware-program. * 
 
16.  U.S. FDA, 2022, Analytical Results for Total Arsenic in Single-Strength Apple Juice Sampled 
under the FDAs Toxic Elements in Food and Foodware, and Radionuclides in Food  Import and 
Domestic Compliance Program, FY2013- FY2022, accessed online at 
https://www.fda.gov/media/164093/download. *  
 
17.   U.S. FDA, 2022, Analytical Results for Speciated Arsenic in Single-Strength Apple Juice 
Sampled under the FDAs Toxic Elements in Food and Foodware, and Radionuclides in Food  
Import and Domestic Compliance Program, FY2013-FY2022, accessed online at 
https://www.fda.gov/media/164091/download. * 
 
18. U.S. FDA Total Diet Study, Ongoing, accessed online at 
 
  10   
https://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/default.htm.* 
 
19. U.S. FDA, 2008, FDA Hazard Assessment and Level of Concern--Apple Juice, accessed online 
at http://wayback.archive-
it.org/7993/20170111011855/http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/uc
m277681.htm. * 
 
20. Chen C-L, et al., 2010, Arsenic in drinking water and risk of urinary tract cancer: a follow-up 
study from northeastern Taiwan. Cancer Epidemiology, Biomarkers & Prevention, 19(1):101110. 
 
21.  Chen C-L, et al., 2010, Ingested arsenic, characteristics of well water consumption and risk of 
different histological types of lung cancer in northeastern Taiwan. Environmental Research, 
110(5):455462. 
 
22. Wang, Z., Jackson, L.S., Jablonski, J.E., 2017, Factors affecting the levels of heavy metals in 
juices processed with filter aids. Journal of Food Protection. 80(6):892-902.  
 
23.  Redan, B.W., 2020, Processing aids in food and beverage manufacturing: potential source of 
elemental and trace metal contaminants. Journal of Agricultural and Food Chemistry. 68: 13001-
13007. 
 
24. FDA, 2021. Closer to Zero: Action Plan for Baby Foods, accessed online at 
https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods.* 
 
 
 
 
   
 
  11   
Table 1. Summary of Data on Total and Inorganic Arsenic in Apple Juice Collected in 
FY2011 Retail Sample Survey - Number of Samples: 94  
 
Meanstd.  Range (min-
Data Set  Fiscal Year  Arsenic  dev  max) 
(ppb)  (ppb) 
Retail survey  2011  Total Arsenic*  6.44.7  1.3-36 
Inorganic 
Retail survey  2011  4.42.4  0-9.8 
Arsenic 
* One retail survey was conducted and all of the total arsenic samples were speciated. 
 
 
Table 2. Summary of Data on Total Arsenic in Apple Juice Collected from FY2013-2022 
 
Number of  Meanstd. dev  Range (min-max) 
Data Set  Fiscal Year 
Samples  (ppb)  (ppb) 
Toxic Element 
2013-2022  160  4.66.6  0-44 
Program (TEP) 
Total Diet 
2013-2020  47  2.72.0  0-10 
Study (TDS) 
 
 
Table 3.  Effects of Three Hypothetical Limits on Arsenic in Apple Juice: Modeled 
Disease Rates and Manufacturer Achievability from FY2011 Dataset1 
 
Average  Percentage of 94 
Disease rates 
inorganic  FY11 retail 
Limit  Disease rates3  based on three 
arsenic level  samples 
(inorganic  based on average  times average 
in juices  with inorganic 
arsenic,  juice  juice 
below  arsenic levels at 
ppb)  consumption4  consumption 
specified  or below 
(high consumer) 
limit 2  specified limit 5 
3  1.4  2.5 (0.0, 6.8)  7.7 (0.0, 20.3)  31 % 
5  2.7  4.8 (0.0, 12.8)  14.9 (0.1, 38.5)  54 % 
10  4.4  8.0 (0.0, 21.3)  24.9 (0.2, 63.8)  100 % 
 
1 Disease rates for total lung and bladder cancer are from Ref. 12.  Disease rates are based on chronic (0-50 years) 
exposure.  Inorganic arsenic levels are based on FY11 retail apple juice data (Ref. 14). 
2 Average inorganic arsenic level based on 94 samples.  For the purpose of calculating average levels, levels 
below the limits of quantitation (LOQ, 2.8 ppb for each arsenic species) were set to 1.4 ppb. 
3 Number of cases per million.  Numbers in parentheses represent lower and upper bounds. 
4 Average per capita juice consumption for all persons aged 0-50 years is 0.83 g apple juice/kg bw/day (see Ref. 
12, pp. 17-19).  Consumption data are from the National Health and Nutrition Examination Survey, 2007-2008.  
5 Percentages calculated by dividing the number of samples with inorganic arsenic levels at or below the 
proposed limit by 94 total number of samples. 
 
 
 
 
 
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Table 4.  Effects of Three Hypothetical Limits on Arsenic in Apple Juice: Modeled Disease 
Rates and Manufacturer Achievability from FY2013-2022 Dataset1   
 
Percentage of 160 
FY13-FY22 
Average total 
Disease rates 
Limit  arsenic level in  Disease rates3,4  samples 
based on three 
(inorganic  juices below  based on average  with total arsenic 
times average  levels at or below 
arsenic,  specified  juice 
ppb)  inorganic  consumption5  juice consumption  specified 
arsenic limit2  (high consumer)  inorganic arsenic 
limit 6 
 
3  1.6  2.5 (0.0, 6.2)  7.5 (0.1, 18.6)  63 % 
5  2.1  3.2 (0.0, 8.1)  9.8 (0.1, 24.3)  78 % 
10  2.7  4.2 (0.0, 10.6)  12.8 (0.2, 31.7)  89 % 
 
 
1 In Table 4, disease rates for total lung and urinary tract cancer are calculated based on dose-response model from Ref. 
12.  Disease rates are based on chronic (0-50 years) exposure.  Arsenic levels are based on FY2013-2022 data. 
2 Average total arsenic level based on 160 samples.  For the purpose of calculating average levels, non-quantified levels 
below the LOQ were set to the LOQ (2 or 4 ppb) and levels below the LOD (limit of detection) were set to zero. 
3 The risk estimates presume that all of the arsenic is inorganic. This is a conservative approach, since based on the 
FY2011 94-sample survey, the median percentage of inorganic/total arsenic is 75 percent.  
4 Number of cases per million.  Numbers in parentheses represent lower and upper bounds. 
5 Average per capita juice consumption for all persons aged 0-50 years is 0.69 g apple juice/kg bw/day based on 
consumption data from What We Eat in America (WWEIA), the food consumption portion of the National Health and 
Nutrition Examination Survey (NHANES), 2003-2018. 
6 Percentages calculated by dividing the number of samples with total arsenic levels at or below the proposed limit by 
160, the total number of samples.  Most of these samples were not speciated because they contained  10 ppb total 
arsenic. 
 
 
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