Inorganic Arsenic in Rice Cereals for 
Infants: Action Level 
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 https://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-2016-D-1099 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 
 
August 2020 Contains Nonbinding Recommendations 
 
 
 
 
 
Table of Contents 
 
 
 
 
I.  Introduction 
 
 
II.  Background 
 
III.   Discussion 
 
IV.  Action Level 
 
V.   Conclusion 
 
 
VI.  References 
  2  Contains Nonbinding Recommendations 
 
 
Inorganic Arsenic in Rice Cereals for 
Infants: Action Level1 
Guidance for Industry 
 
 
 
 
 
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 level2for inorganic arsenic in 
rice cereals for infants (hereafter referred to as infant rice cereals) that is intended to help protect 
public health by reducing infants dietary exposure to inorganic arsenic and is achievable by 
industry with the use of current good manufacturing practices.  This guidance applies to all types 
of infant rice cereals.  
 
FDAs guidance documents, including this guidance, 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.  
                                                            
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 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)).  These 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 (21 CFR 109.4)), 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  Contains Nonbinding Recommendations 
 
II. Background 
 
Arsenic is an element that occurs in the environment from both natural and manmade sources, 
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).3 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. 5).4  Consumption of 
inorganic arsenic has been associated with cancer, skin lesions, cardiovascular disease and 
diabetes in humans (Refs. 5-6).  A report by the National Research Council (NRC) (Ref. 6) 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. 5), 
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. 7) concluded 
that dietary exposure to inorganic arsenic should be reduced. 
 
These findings support our initiatives to assess and reduce exposure to inorganic arsenic in food.  
For example, in July 2013, we announced the availability of a draft quantitative assessment of 
lifetime risk of certain cancers associated with exposure to inorganic arsenic in apple juice (Ref. 
8) and a draft guidance for industry with an action level for inorganic arsenic in apple juice (78 
FR 42086).  We also conducted surveys in 2013, 2016, and 2018 of arsenic in other foods (Refs. 
9-11), focusing primarily on rice and rice products, and released consumer advice 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.  On April 6, 2016, FDA published in 
the Federal Register (81 FR 19976) a notice of availability for a draft guidance for industry 
entitled Inorganic Arsenic in Rice Cereals for Infants: Action Level, a supporting document 
entitled Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for 
Infants, and a risk assessment report entitled Arsenic in Rice and Rice Products Risk 
Assessment: Report.  This guidance finalizes the approach presented in the April 2016 draft 
guidance.  
 
                                                            
3 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 infant rice cereal.  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 Federal Food, Drug, and Cosmetic 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 arsenicals monosodium methanearsonate (MSMA) for use on sod farms, golf 
courses, highway rights-of-way, and to control weeds in cotton fields (Ref. 2) and 10,10'-Oxybisphenoxarsine 
(OBPA) to prevent microorganism growth in plastics and as a material preservative in adhesives and coatings (Ref. 
3), and to chromated arsenicals for use by certified pesticide applicators using specialized high-pressure equipment 
in wood treatment facilities (Ref. 4).  
4 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. 
  4  Contains Nonbinding Recommendations 
III. Discussion 
 
Exposure to Inorganic Arsenic in Rice and Rice Products 
Because it is in the environment, inorganic arsenic is found in some foods.  Rice and rice-based 
food products have higher levels of inorganic arsenic than do other foods tested by FDA, and 
given their widespread consumption, are a major food source of inorganic arsenic (Ref. 12).  
Rice also tends to have higher arsenic concentrations than other cereal crops (such as wheat and 
barley), because of its ability to take up arsenic from soil and water and because it is typically 
grown under flooded conditions, which increases the potential for arsenic uptake (Ref. 12).  
Evidence from FDAs Total Diet Study (Ref. 13)  an ongoing survey and analysis of the 
average American diet  revealed that total arsenic levels, although varying, tend to be higher in 
rice and rice products than in other foods.  Our follow-up sampling also revealed significant 
levels of inorganic arsenic in rice and rice products, including rice cereals for infants (Refs. 9-
11).  Rice is commonly served to infants, primarily in the form of infant rice cereal (Ref. 12), 
which is the most commonly consumed infant instant cereal in the U.S.5   Rice and rice products 
are a greater potential source of dietary inorganic arsenic exposure for infants and children than 
for adults, because the dietary patterns of infants and children are often less varied than those of 
adults, and because infants and children consume more food relative to their body weight than do 
adults (Ref. 15).  Therefore, elevated levels of inorganic arsenic in foods that infants eat, such as 
rice cereals, may represent a significant source of exposure for infants (Ref. 12).  In addition, 
infants and children may be particularly susceptible to adverse neurodevelopmental effects of 
exposure to inorganic arsenic (Refs. 6, 12).  We think that it is possible to reduce dietary 
exposure to inorganic arsenic from infant rice cereals through industrys use of current good 
manufacturing practices, in particular selection of sources of rice or rice-derived ingredients with 
lower inorganic arsenic levels and testing these incoming rice and rice-derived ingredients.  
Using rice with lower levels of inorganic arsenic will result in lower levels of inorganic arsenic 
in the infant rice cereal because the main ingredient (rice) will have lower levels of inorganic 
arsenic.  Therefore, we are issuing this guidance on an action level for inorganic arsenic in rice 
cereal for infants. 
 
Risk Assessment and Achievability 
To facilitate development of an action level for inorganic arsenic in rice cereal for infants, we 
conducted a risk assessment on arsenic in rice and rice products (Ref. 12).  The risk assessment 
includes a qualitative component that addresses the risk of certain non-cancer adverse health 
effects to infants, to young children, and during pregnancy from dietary exposure to inorganic 
arsenic in rice and rice products.  The risk assessment also includes a quantitative component that 
provides estimates of exposure to inorganic arsenic from rice and rice products and estimates of 
lifetime cancer risk from this exposure.  Finally, the risk assessment estimates potential 
reductions in inorganic arsenic exposure and cancer risk from possible mitigation actions, 
including limiting the maximum level of inorganic arsenic in infant rice cereals. 
                                                            
5 Based on data from the U.S. National Health and Nutrition Examination Survey (NHANES), What We Eat In 
America (WWEIA), for the years 2003-2010 (Ref. 14), the mean per capita daily intake of dry instant infant 
cereals (not containing fruit) for the first year of life is as follows: rice, 4.8 g/d; oatmeal 2.8 g/d; barley, 0.1 g/d; 
and mixed grains, 0.8 g/d.   
 
  5  Contains Nonbinding Recommendations 
 
The qualitative component of the risk assessment concluded that exposure to inorganic arsenic 
during pregnancy, infancy, and early childhood may increase the risk of neurodevelopmental 
toxicity and/or adverse pregnancy outcomes.  The quantitative component of the risk assessment 
found that exposure to inorganic arsenic in rice and rice products may increase lung and bladder 
cancer cases in later life, whether exposure occurs only during infancy (through infant rice 
cereals) or throughout life.  The quantitative assessment also showed that establishing an action 
level will reduce inorganic arsenic exposure and risk (Ref. 16).  More information can be found 
in the Arsenic in Rice and Rice Products Risk Assessment Report (Ref. 12) and the Supporting 
Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants (Ref. 16). 
 
To assess achievability, or manufacturers ability to achieve hypothetical maximum limits on 
inorganic arsenic in infant rice cereals, we used results of surveys from three data sets of rice 
cereals to determine the percentage of samples of infant rice cereals that would fall below each of 
the hypothetical maximum limits.6   More information on achievability and arsenic data can be 
found in the Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for 
Infants (Ref. 16).  FDA used the information in the supporting document and risk assessment 
document to identify an action level for inorganic arsenic in infant rice cereals. 
 
IV. Action Level 
 
Because of the potential for human health risks associated with exposure to inorganic arsenic, 
human exposure to inorganic arsenic in rice cereal for infants should not exceed levels achievable 
with the use of current good manufacturing practices, in particular selective sourcing of rice or 
rice-derived ingredients with lower levels of inorganic arsenic and testing these incoming rice 
and rice-derived ingredients.  The action level for inorganic arsenic in infant rice cereals that 
FDA considers achievable with the use of such practices is 100 microgram per kilogram (g/kg), 
or 100 parts per billion (ppb) (see Ref. 16).  FDA has made the determination that this level is 
achievable based on sampling and testing results.  Based upon our risk assessment and 
achievability assessment, we consider that this reduction in inorganic arsenic in rice cereal will 
lead to a predicted quantifiable reduction in the lifetime risk of certain cancers associated with 
exposure to inorganic arsenic, as well as an unquantifiable reduction in the risk of certain non-
cancer adverse health outcomes reviewed in the risk assessment, including neurodevelopmental 
effects in infants.  This guidance applies to all types of infant rice cereals (e.g., white-rice, 
brown-rice, organically grown, and conventionally grown).  Though not binding, the action level 
for inorganic arsenic in infant rice cereals is intended to encourage manufacturers to reduce levels 
of inorganic arsenic in their products, thus reducing the possible risk for infants fed rice cereal.   
 
V. Conclusion 
 
For the reasons discussed above, we have concluded that a level of 100 g/kg or 100 ppb 
inorganic arsenic in infant rice cereals is achievable under current good manufacturing practices, 
based on evaluation of recent FDA data on inorganic arsenic levels in infant rice cereals.  We 
intend to analyze samples of infant rice cereals for total arsenic, and to speciate samples 
                                                            
6 The method used by FDA for analyzing inorganic arsenic in rice is posted on the FDA website at 
https://www.fda.gov/media/95197/download. 
  6  Contains Nonbinding Recommendations 
containing more than 100 g/kg or 100 ppb total arsenic to determine inorganic arsenic levels.  
We intend to consider the action level of 100 g/kg or 100 ppb inorganic arsenic as an important 
source of information for determining whether infant rice cereal 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 a particular infant rice cereal to be adulterated under section 402(a)(1) of the FD&C Act.  
 
VI. References 
 
We have placed the following references on display in the Dockets Management Staff, Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You may see them at 
that location between 9 a.m. and 4 p.m., Monday through Friday.  These are also available at 
https://www/regulations.gov. As of August 2020, FDA had verified the Web site address for the 
references it makes available as hyperlinks from the Internet copy of this guidance, but FDA is 
not responsible for any subsequent changes to Non-FDA Web site references after August 2020. 
 
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 http://www.atsdr.cdc.gov/toxprofiles/tp2.pdf. 
 
2.  U.S. Environmental Protection Agency (EPA), 2018, 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, 2012, OBPA Registration Review: 10,10-Oxybisphenoxarsine, accessed online at 
https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&
dct=SR&D=EPA-HQ-OPP-2009-0618. 
 
4.  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. 
 
5.  WHO/FAO Joint Expert Committee on Food Additives (JECFA), 2010, 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://apps.who.int/iris/bitstream/handle/10665/44514/WHO_TRS_959_eng.pdf;jsessionid=9B9
41773BD2EBDEE5F7674F982732C60?sequence=1. 
6.   National Research Council of the National Academies (NRC), 2013, Critical Aspects of 
EPAs IRIS Assessment of Inorganic Arsenic: Interim Report, accessed online at 
http://www.nap.edu. 
 
7.   European Food Safety Authority (EFSA), 2010, Scientific Opinion on Arsenic in Food, 
EFSA Journal 2009, 7(10): 1351, accessed online at 
  7  Contains Nonbinding Recommendations 
http://www.efsa.europa.eu/en/efsajournal/doc/1351.pdf. 
 
8.   U.S. Food and Drug Administration (FDA), 2013a, A Quantitative Assessment of Inorganic 
Arsenic in Apple Juice, accessed online at https://www.fda.gov/media/86075/download. 
    
9.   U.S. FDA, 2013b, Analytical Results from Inorganic Arsenic in Rice and Rice Products 
Sampling, accessed online at https://www.fda.gov/media/86074/download.  
 
10.   U.S. FDA, 2016a, 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. 
 
11. U.S. FDA, 2020a, Analytical Results from Inorganic Arsenic in Rice Cereals for Infants, 
accessed online at https://www.fda.gov/media/135552/download.  
 
12.   U.S. FDA, 2016b, Arsenic in Rice and Rice Products Risk Assessment Report, accessed 
online at https://www.fda.gov/media/96071/download. 
 
13.   U.S. FDA, 2016c, Total Diet Study, accessed online at https://www.fda.gov/food/science-
research-food/total-diet-study. 
 
14.   Centers for Disease Control and Prevention (CDC), 2013, National Center for Health 
Statistics (NCHS). National Health and Nutrition Examination Survey Data. Hyattsville, MD: 
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 
2013, accessed online at http://www.cdc.gov/nchs/nhanes.htm. 
 
15. National Research Council (NRC), 1993, Pesticides in the Diets of Infants and Children, 
National Academy Press, Washington, D.C. 
 
16. U.S. FDA, 2020b, Supporting Document for Action Level for Inorganic Arsenic in Rice 
Cereals for Infants, accessed online at https://www.fda.gov/media/97121/download.  
 
 
 
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