FOOD SAFETY

Federal Efforts to 

Manage the Risk of 

Arsenic in Rice

Report to the Ranking Member, 

Subcommittee on Labor, Health and 

Human Services, Education, and Related 

Agencies, Committee on Appropriations, 

House of Representatives

March 2018

GAO-18-199

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-18-199, a report to the 

Ranking Member, Subcommittee on Labor, 

Health and Human Services, Education, and 

Related Agencies, Committee on 

Appropriations, House of Representatives

March 2018

FOOD SAFETY

Federal Efforts to Manage the Risk of Arsenic in Rice

What GAO Found

The National Research Council (NRC) of the National Academy of Sciences, in 

2013, and more recent key scientific reviews reported evidence of associations 

between long-term ingestion of arsenic and adverse human health effects, such 

as cardiovascular disease. Many of the studies NRC reviewed as part of its 

survey of the scientific literature examined the ingestion of arsenic in drinking 

water, but others looked at arsenic from all sources, including dietary sources

such as rice. NRC stated that evidence suggests that food, particularly rice, may 

be a significant source of inorganic arsenic, the more toxic of the two forms of 

arsenic; however, consumption of rice and levels of arsenic in rice vary widely, 

making it difficult to estimate arsenic intake from rice. NRC identified stronger 

evidence for some health effects at higher levels of arsenic—defined by NRC as 

100 parts per billion or higher in drinking water—than at lower levels, which are 

more common in the United States, and noted that research on the health effects 

of ingesting lower levels of arsenic is ongoing.

The Food and Drug Administration (FDA) and the U.S. Department of Agriculture 

(USDA) have taken actions to manage the risk of arsenic in rice to human health,

including assessing the type and prevalence of health effects that may result 

from long-term ingestion of arsenic in rice. FDA also has taken action to publicly 

communicate and report on the risk. In 2016, FDA issued a risk assessment 

about the human health effects from long-term ingestion of arsenic in rice and 

draft guidance recommending industry not exceed a level of 100 parts per billion 

of inorganic arsenic in infant rice cereal. FDA noted it issued this guidance 

because infants face a higher risk owing to their less-varied diets. However, FDA 

has not updated the risk assessment, which was informed by a review of 

scientific studies published before February 2015, or finalized the draft guidance.

In prior work, GAO has found that sharing risk information and incorporating 

stakeholder feedback can help organizations identify and better manage risks, as 

well as increase transparency and accountability to Congress and taxpayers. 

FDA officials stated that they may update the risk assessment based on newlyavailable information and consider public comments before finalizing the draft 

guidance. However, FDA officials could not provide a specific timeline for either.

By developing such a timeline, FDA could help clarify when it will take action and 

improve the transparency of its decisions.

FDA coordinated with USDA and other federal agencies on actions to manage 

the risk of arsenic in rice to varying extents. For example, FDA and USDA 

coordinated on developing arsenic detection methods for rice to a limited extent, 

although both agencies have crosscutting strategic goals for developing 

detection methods for foodborne contaminants, including arsenic. GAO has 

noted in prior work that developing interagency mechanisms to coordinate 

crosscutting issues may reduce potentially duplicative efforts. FDA and USDA 

officials stated that they coordinated on an informal basis but have no 

mechanism for coordinating more formally. By developing a coordination 

mechanism, FDA and USDA could enhance their ability to use their resources 

View GAO-18-199. For more information, efficiently and avoid potentially duplicative efforts.

contact Steve Morris at (202) 512-3841 or 

morriss@gao.gov.

Why GAO Did This Study

Arsenic, an element in the earth's 

crust, can be harmful to human health 

and may be present in water and 

certain foods, such as rice. Rice may 

be more susceptible to arsenic 

contamination than other crops due to 

the flooded conditions in which it is 

typically grown. FDA and USDA work 

to address food safety risks. FDA’s

responsibilities for rice include 

regulatory and research programs;

USDA’s include research programs. 

GAO was asked to review issues 

related to arsenic and rice. GAO 

examined (1) what NRC and recent 

key scientific reviews have reported 

about the effects of ingestion of arsenic 

on human health, (2) the extent to 

which FDA and USDA have managed 

the risk to human health from arsenic 

in rice, and (3) the extent to which FDA 

has coordinated with USDA and other 

federal agencies on actions to manage 

the risk. GAO analyzed a 2013 NRC 

report on inorganic arsenic, 14 reviews 

of scientific studies on the human 

health effects of ingesting arsenic

published from January 2015 to June 

2017, and agency documents;

interviewed agency officials; and 

compared good practices with actions 

FDA and USDA took to manage risk 

and that FDA took to coordinate.

What GAO Recommends

GAO is making five recommendations, 

including that FDA develop a timeline 

for updating its risk assessment and 

finalizing its draft guidance and that 

FDA and USDA develop a coordination 

mechanism for developing methods to 

detect foodborne contaminants, 

including arsenic. FDA and USDA 

generally agreed with the 

recommendations.
Page i GAO-18-199 Food Safety

Letter 1

Background 5

NRC and Recent Key Scientific Reviews Reported Evidence of 

Associations between Ingestion of Arsenic and Adverse Human 

Health Effects 13

FDA and USDA Have Taken Actions to Manage the Risk to 

Human Health from Arsenic in Rice 16

FDA Coordinated Several Risk Management Actions with USDA 

and Other Federal Agencies to Varying Extents 27

Conclusions 32

Recommendations for Executive Action 33

Agency Comments and Our Evaluation 33

Appendix I Objectives, Scope, and Methodology 36

Appendix II Recent Reviews of the Health Effects of Ingestion of Arsenic 41

Appendix III Comments from the Department of Health and Human Services 43

Appendix IV Comments from the U.S. Department of Agriculture 47

Appendix V GAO Contact and Staff Acknowledgments 50

Table

Table 1: Information about Selected Stakeholders 38

Figures

Figure 1: Levels of Arsenic in the Soil Surface of the Contiguous 

United States, with Rice-Growing Counties Outlined 7

Figure 2: Rice Grain Before and After Milling 8

Figure 3: Alternate Wetting and Drying Water Management 

Practice in Arkansas Rice Fields 23

Contents
Page ii GAO-18-199 Food Safety

Abbreviations

ARS Agricultural Research Service

CDC Centers for Disease Control and Prevention

EPA Environmental Protection Agency 

FDA Food and Drug Administration

FGIS Federal Grain Inspection Service

HHS Department of Health and Human Services

NIFA National Institute of Food and Agriculture

NIH National Institutes of Health 

NRC National Research Council

ppb parts per billion

OMB Office of Management and Budget

USDA U.S. Department of Agriculture

This is a work of the U.S. government and is not subject to copyright protection in the 

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Page 1 GAO-18-199 Food Safety

441 G St. N.W.

Washington, DC 20548

March 16, 2018

The Honorable Rosa L. DeLauro

Ranking Member

Subcommittee on Labor, Health and Human Services, Education, and 

Related Agencies

Committee on Appropriations

House of Representatives

Dear Ms. DeLauro:

Arsenic, an element in the earth’s crust, is present in the environment, 

including water, air, and soil, because of both natural occurrence and 

human activity. It exists in two general forms, organic and inorganic.1

Both can be harmful to human health, but inorganic arsenic is generally 

considered to be the more toxic form.2 Inorganic arsenic has been 

classified as carcinogenic to humans by the International Agency for 

Research on Cancer.3 According to the Department of Health and Human 

Services’ (HHS) Agency for Toxic Substances and Disease Registry, 

exposure to arsenic generally occurs through contaminated groundwater 

and the ingestion of foods containing arsenic compounds.4 The Agency 

for Toxic Substances and Disease Registry identified rice as a 

predominant dietary source of arsenic.5 Partly because of the flooded 

conditions under which rice is typically grown, rice may be more 

 1

The organic form of arsenic consists of arsenic compounds that include carbon. The 

inorganic form of arsenic consists of arsenic compounds that include elements other than 

carbon.

2

Most data reported for arsenic in food describe the levels of total arsenic (the sum of both 

forms). In this report, we use the term “arsenic” to refer to either total arsenic or inorganic 

arsenic only. 

3

The International Agency for Research on Cancer is the World Health Organization’s 

agency that promotes international collaboration in cancer research. For additional 

information on its classifications, see International Agency for Research on Cancer, 

Agents Classified by the IARC Monographs, Volumes 1-120, accessed November 9, 

2017, http://monographs.iarc.fr/ENG/Classification/index.php. 

4

Agency for Toxic Substances and Disease Registry, Addendum to the Toxicological 

Profile for Arsenic (Atlanta, GA: 2016). 

5

The Agency for Toxic Substances and Disease Registry noted that as a dietary source of 

arsenic, including inorganic arsenic, rice is second to seafood, which mostly contains the 

organic form of arsenic. 

Letter
Page 2 GAO-18-199 Food Safety

susceptible to arsenic contamination than other crops. In 2009, the 

European Food Safety Authority noted that exposure of infants to arsenic 

in rice products is a concern because such products are often used in 

foods for infants and because infants and young children have a higher 

food intake relative to their body weight than adults.6

The safety and quality of the U.S. food supply, both domestic and 

imported, are governed by a complex system stemming from at least 30 

federal laws that are administered by 15 federal agencies. HHS’s Food 

and Drug Administration (FDA) and the U.S. Department of Agriculture 

(USDA) are the principal agencies working to protect the food supply from 

risks, such as contamination. FDA is responsible for ensuring the safety 

of virtually all domestic and imported food products, with the exception of 

meat and poultry, processed egg products, and catfish, which are the 

responsibility of USDA’s Food Safety and Inspection Service. Other 

agencies within USDA also play a role in food safety. For example, 

USDA’s Agricultural Research Service (ARS) and National Institute of 

Food and Agriculture (NIFA) sponsor food safety research. In addition, 

the Environmental Protection Agency (EPA) has the statutory 

responsibility for, among other things, ensuring that the pesticides used 

on food crops do not endanger public health. EPA has been updating its 

assessment of the health hazards of inorganic arsenic in the Integrated 

Risk Information System—an important source of toxicity information for 

federal agencies. The National Research Council (NRC) of the National 

Academy of Sciences has reviewed EPA’s approach to updating its 

toxicological assessment of inorganic arsenic and issued a report in 2013 

that provided key guidance and a preliminary survey of the literature on 

inorganic arsenic.7

For more than 4 decades, we have reported on the fragmented federal 

food safety oversight system, which has caused inconsistent oversight, 

ineffective coordination, and inefficient use of resources. In January 2007, 

because of risks to the economy and to public health and safety, we 

added transforming federal oversight of food safety to our list of areas at 

high risk for fraud, waste, abuse, and mismanagement, or most in need of 

 6

In this report, we use the term “rice” to encompass rice grain and products made with 

rice, such as infant rice cereal. 

7

National Research Council, Committee on Inorganic Arsenic, Critical Aspects of EPA’s 

IRIS Assessment of Inorganic Arsenic: Interim Report (Washington, D.C.: National 

Academies Press, 2013).
Page 3 GAO-18-199 Food Safety

transformation.8 In our February 2017 update to that list, we noted that 

HHS, USDA, and the Office of Management and Budget (OMB) have 

taken some positive steps to address fragmentation in the federal food 

oversight system but that additional steps are needed.9 In January 2017, 

to address ongoing fragmentation, we recommended that the Executive 

Office of the President, in consultation with relevant federal agencies and 

other stakeholders, develop a national strategy to improve the food safety 

oversight system.10 In addition, we have found shortcomings with FDA’s 

oversight of seafood, dietary supplements, and other matters.11 In 2012, 

we identified key issues to consider that could benefit interagency 

collaborative mechanisms, which may help reduce potentially duplicative, 

overlapping, and fragmented efforts.12

You asked us to review issues related to arsenic and rice. This report 

examines (1) what NRC and recent key scientific reviews have reported 

about the effects of ingestion of arsenic on human health, (2) the extent to 

which FDA and USDA have managed the risk to human health from 

arsenic in rice, and (3) the extent to which FDA has coordinated with 

USDA and other federal agencies on actions to manage the risk.

To determine what NRC and recent key scientific reviews have reported 

about the effects of ingestion of arsenic on human health, we analyzed 

NRC’s 2013 report on inorganic arsenic and 14 reviews of the scientific 

literature published from January 2015 through early June 2017 on the

human health effects of ingestion of arsenic. We identified the reviews by 

conducting a literature search of research databases, such as PubMed 

and Toxline, and selected English-language reviews that met certain 

 8

GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: Jan. 31, 2007).

9

GAO, High-Risk Series: Progress on Many High-Risk Areas, While Substantial Efforts 

Needed on Others, GAO-17-317 (Washington, D.C.: Feb. 15, 2017).

10GAO, Food Safety: A National Strategy Is Needed to Address Fragmentation in Federal 

Oversight, GAO-17-74 (Washington, D.C.: Jan. 13, 2017).

11See, for example, GAO, Imported Seafood Safety: FDA and USDA Could Strengthen 

Efforts to Prevent Unsafe Drug Residues, GAO-17-443 (Washington, D.C.: Sept. 15, 

2017); Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported 

Health Problems to Oversee Products, GAO-13-244 (Washington, D.C.: Mar. 18, 2013); 

and Imported Food Safety: FDA’s Targeting Tool Has Enhanced Screening, but Further 

Improvements Are Possible, GAO-16-399 (Washington, D.C.: May 26, 2016).

12GAO, Managing for Results: Key Considerations for Implementing Interagency 

Collaborative Mechanisms, GAO-12-1022 (Washington, D.C.: Sept. 27, 2012).
Page 4 GAO-18-199 Food Safety

criteria, such as relying on human, rather than animal, studies. We 

assessed the scientific and statistical credibility, reliability, and 

methodological soundness of the reviews and excluded reviews for which 

we could not clearly determine the methodology.

To determine the extent to which FDA and USDA have managed the risk 

to human health from arsenic in rice, we examined relevant provisions in 

the Federal Food, Drug, and Cosmetic Act, as amended;13 the Federal 

Agriculture Improvement and Reform Act of 1996;14 and other laws, 

regulations, and policies. We also reviewed our prior work on enterprise 

risk management and used the essential elements for managing risk that 

it identified.15 We identified information on agency actions for managing 

the risk from arsenic in rice by collecting documentation and interviewing 

officials from FDA and USDA, and we reviewed the information in light of 

the requirements, policies, and elements. We assessed FDA’s and 

USDA’s reported actions to determine the extent to which each agency’s 

actions aligned with the essential elements for managing risk. In 

assessing FDA’s and USDA’s actions against these essential elements, 

we used the terms “consistent” and “partially consistent” to reflect the 

extent to which each agency’s actions aligned with an essential element. 

We also interviewed 17 stakeholders, including university researchers, 

representatives of a consumer organization, and representatives of the 

rice industry, including rice mills and farms, to obtain their views on the 

extent to which FDA’s and USDA’s actions managed this risk. We 

identified stakeholders based on suggestions from agency officials and 

other stakeholders; through our site visit to Arkansas’ rice agricultural 

research and production areas and rice mills; and the stakeholders’

unique perspective or qualifications, such as membership in the NRC 

Committee on Inorganic Arsenic. The views we obtained in these 

interviews are not generalizable to all university researchers or consumer 

or rice industry organizations but they provide illustrative examples of the 

views of such stakeholders.

 1321 U.S.C. §§ 301, et seq.

14Pub. L. No. 104-127, 110 Stat. 888 (Apr. 4, 1996).

15GAO, Enterprise Risk Management: Selected Agencies’ Experiences Illustrate Good 

Practices in Managing Risk, GAO-17-63 (Washington, D.C.: Dec. 1, 2016). This report 

also identified good practices agencies are implementing that illustrate the essential 

elements of enterprise risk management.
Page 5 GAO-18-199 Food Safety

To determine the extent to which FDA coordinated with USDA and other 

federal agencies on actions to manage the risk from arsenic in rice, we 

identified actions for which coordination would be expected. Specifically, 

we identified actions for which the agencies shared similar goals in their 

strategic plans or relevant expertise. For these actions, we examined 

whether FDA developed interagency collaborative mechanisms. We had 

previously reported that such mechanisms could facilitate coordination 

between agencies.16 We also examined whether FDA considered a key 

issue we had identified when implementing one of these mechanisms: to 

clarify the roles and responsibilities of participating agencies. We selected 

this key issue because it was relevant to the challenges FDA and the 

other agencies faced. See appendix I for a detailed description of our 

objectives, scope, and methodology.

We conducted this performance audit from December 2016 to March 

2018 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

Arsenic is a naturally occurring element that is widely distributed in the 

earth’s crust in two general forms—organic and inorganic. It commonly 

enters the body through ingestion of food or water. Most data reported for 

arsenic in food describe the levels of total arsenic because analyses that 

provide information about the forms of arsenic present are more difficult 

to perform, and relatively few laboratories are able to perform these 

analyses. Data on the levels of specific forms of arsenic, however, are 

becoming increasingly important because, according to the Agency for 

Toxic Substances and Disease Registry, the two forms have different 

toxicities, with inorganic arsenic being considered the more toxic form. 

Further, foods may have different proportions of organic and inorganic 

arsenic as well as different levels of total arsenic. According to the 

European Food Safety Authority, plants generally contain low levels of 

both total and inorganic arsenic, but rice may contain significant levels of 

 16GAO-12-1022.

Background

Forms and Distribution of 

Arsenic
Page 6 GAO-18-199 Food Safety

total arsenic and inorganic arsenic. Levels of arsenic in groundwater, a 

major source of drinking water in many parts of the world, may be high in 

some areas; essentially all the arsenic in drinking water is inorganic 

arsenic.

The form and level of arsenic in rice may vary depending on the 

geographic region where rice is grown, conditions under which rice is 

grown, variety of the rice, and rice milling practices.17 In the United 

States—where, according to USDA, approximately 80 percent of the rice 

consumed domestically is grown—rice is primarily grown in six states: 

Arkansas, California, Louisiana, Mississippi, Missouri, and Texas. In 

2016, the latest year for which USDA data were available, about 47 

percent of the rice grown in the United States was grown in Arkansas, 

and about 21 percent was grown in California.18

The amount of arsenic rice absorbs varies by geographic region because 

of differing levels of arsenic in the soil and other factors. Arsenic levels in 

the soil vary both naturally and as a result of human activity. Natural 

processes that contribute to arsenic levels in the soil may include bedrock 

weathering, because arsenic is present in many rock-forming minerals. 

Human activities that contribute to arsenic levels in the soil may include 

the use of arsenic-based pesticides and animal drugs, the mining and 

smelting of metal, and coal combustion.19 Figure 1 shows the results of a 

2013 U.S. Geological Survey sampling of soils to measure the levels of 

arsenic in the contiguous United States.20 In addition, the figure shows 

the outlines of rice-growing counties based on 2016 data from USDA.

 17Milling is the extent to which the hull, bran, and germ have been removed from the rice 

seed. White rice results from the removal of the hull and practically all of the germ and the 

bran layer.

18According to our analysis of USDA data, shares of domestic rice production in 2016 for 

the remaining four states were: Louisiana, 13 percent; Missouri, 7 percent; and Mississippi 

and Texas, 6 percent each.

19One arsenic-based pesticide, monosodium methanearsonate, is currently permitted for 

use on cotton and turf grass (i.e., golf courses, sod farms, and highway rights-of-way). In 

December 2015, FDA issued a final rule withdrawing the approval of the last remaining 

arsenic-containing animal drug approved for use in food-producing animals. 80 Fed. Reg.

78,970 (Dec. 18, 2015).

20U.S. Geological Survey, Geochemical and Mineralogical Data for Soils of the 

Conterminous United States (Reston, VA: 2013). The 2013 data are the most recent 

available.
Page 7 GAO-18-199 Food Safety

Figure 1: Levels of Arsenic in the Soil Surface of the Contiguous United States, with Rice-Growing Counties Outlined

Note: Rice-growing counties are identified by USDA’s National Agricultural Statistics Service as the 

counties within the major rice-producing regions of the United States.

Compared to other plants, rice absorbs more arsenic from the 

environment, in part because of the physiology of rice. For example, rice 

may readily absorb certain compounds of arsenic because, among other 

reasons, these compounds are similar in size to compounds containing 

silicon, an essential nutrient for rice. The conditions under which rice is 
Page 8 GAO-18-199 Food Safety

grown may also cause it to absorb more arsenic than other plants. For 

instance, rice is often grown in flooded fields to control pests, grasses, 

and diseases, among other reasons. However, flooded conditions may 

promote the formation of arsenic compounds that may be easily absorbed 

by the rice plant. Even under the same growing conditions, some varieties 

of rice tend to have higher levels of arsenic in their grain, on average, 

than others, owing to a need for longer growing periods, among other 

factors. In addition, the concentrations of the two forms of arsenic may 

vary within the rice grain. While organic arsenic may be distributed 

throughout the rice grain, most of the inorganic arsenic is found in the 

bran layer. As seen in figure 2, the process of milling rice removes the 

bran layer; thus, levels of inorganic arsenic in white, or milled, rice may be 

lower than those in brown, or whole grain, rice.

Figure 2: Rice Grain Before and After Milling

A number of federal agencies are responsible for ensuring the safety and 

quality of rice and for assessing the human health effects of ingestion of 

arsenic in rice. Within HHS, FDA has overall responsibility for 

implementing provisions of the Federal Food, Drug, and Cosmetic Act, as 

amended. Specifically, FDA is responsible for determining whether food, 

including rice, is deemed to be adulterated (i.e., whether it bears or 

contains any poisonous or deleterious substance that may render it 

injurious to health). Under its regulations, FDA may issue guidance to 

Federal Agencies’

Responsibilities for Rice
Page 9 GAO-18-199 Food Safety

establish a level of a contaminant that a food should not exceed.21 FDA 

would consider case-by-case whether a food that contains the 

contaminant is adulterated. For example, in 2013, FDA issued draft 

guidance for arsenic in apple juice, on the basis of its risk assessment 

that estimated the long-term cancer risk posed by inorganic arsenic. 

According to FDA, its Center for Food Safety and Applied Nutrition is 

responsible for regulatory and research programs that address the health 

risks associated with foodborne contaminants and is aided in this role by 

the Office of Regulatory Affairs, which is responsible for field-based 

activities such as inspections, sampling, and testing of regulated 

products. The Center for Food Safety and Applied Nutrition also conducts 

industry outreach and educates consumers, among other things.

Other agencies within HHS may also conduct research, collect data, and 

provide information on the health effects of arsenic. For example, the 

National Institutes of Health (NIH) sponsor research on the health effects 

of ingestion of arsenic. The Centers for Disease Control and Prevention 

(CDC) administer the National Health and Nutrition Examination Survey, 

which, among other things, collects data about diet and exposure to 

certain substances, such as arsenic. Under the Superfund Amendments 

and Reauthorization Act of 1986,22 the Agency for Toxic Substances and 

Disease Registry prepares toxicological profiles for certain hazardous 

substances, including arsenic.23

Agencies within USDA conduct and sponsor research to advance food 

safety and to help farmers market rice and manage the risk of growing it. 

Within USDA, ARS and NIFA conduct and sponsor research, to, among 

other things, maintain an adequate, nutritious, and safe supply of food to 

meet human nutritional needs and requirements. NIFA also distributes 

capacity grants that support research and extension programs at land-

 21FDA may establish such a level, referred to as an “action level,” when a contaminant 

cannot be avoided by good manufacturing practices and a technological or other change 

may be foreseeable. Such change may include anticipated improvements in good 

manufacturing practices or studies that may provide significant new toxicological or use 

data.

2242 U.S.C. § 9604 (i)(3).

23In 2007, the Agency for Toxic Substances and Disease Registry issued a peer-reviewed 

toxicological profile for arsenic and information regarding levels of significant human 

exposure and significant health effects. In 2016, it issued an addendum, providing a nonpeer reviewed supplement of the scientific data that were published since the release of 

the profile in 2007. 
Page 10 GAO-18-199 Food Safety

grant universities, which provide science-based information to farmers. 

The Agricultural Marketing Act of 1946 authorizes the Federal Grain 

Inspection Service (FGIS) to establish quality standards,24 including 

standards for rice.25 FGIS also offers inspection services for rice farmers 

and processors upon request. The Risk Management Agency manages 

the Federal Crop Insurance Corporation, which offers crop insurance to 

farmers for over 100 different crops, including rice. For the 2018 crop 

year, the rice crop insurance provisions generally require that the rice be 

flood-irrigated (i.e., intentionally covered with water at a uniform and 

shallow depth throughout the growing season).26

Other agencies play a role in managing the risk of arsenic. EPA regulates 

the presence of certain substances, such as arsenic, in drinking water 

under the Safe Drinking Water Act and conducts toxicological 

assessments.27 In 2001, EPA issued a rule limiting the level of arsenic in 

drinking water to 10 parts per billion (ppb) to protect consumers from the 

health effects of long-term exposure.28 Under its Integrated Risk 

Information System program, EPA conducts assessments that provide 

toxicity values—such as for increased cancer risk due to lifetime ingestion 

of a specified quantity of a substance. In accordance with congressional 

direction,29 EPA submitted a plan for developing a draft assessment and 

preliminary assessment materials for inorganic arsenic to NRC for review. 

In 2013, NRC released an interim report, which provided guidance to EPA 

and included a preliminary survey of the scientific literature.30 In addition, 

in accordance with Executive Order 13272, the Small Business 

Administration’s Office of Advocacy helps agencies assess the potential 

impacts of draft rules on small businesses—which could include members 

 247 U.S.C. § 1622(h)(1). 

25Federal Grain Inspection Service, United States Standards for Rice (Washington, D.C.: 

2009). 

26The Federal Crop Insurance Corporation also offers a sprinkler irrigated endorsement 

that, if purchased, allows farmers to irrigate rice with sprinklers rather than with continuous 

flooding. 

2742 U.S.C. § 300g–1(b)(12)(A).

2866 Fed. Reg. 6976 (Jan. 22, 2001). EPA defines chronic or long-term exposure as 

multiple exposures occurring over a significant portion of a lifetime.

29H. Conf. Rpt. 112-331 (2012).

30NRC has also previously issued reports in 1999 and 2001 to help evaluate the scientific 

validity of the risk assessment that EPA used in its rulemaking limiting arsenic in drinking 

water.
Page 11 GAO-18-199 Food Safety

of the rice industry—small governmental jurisdictions, and small 

organizations.31

Entities outside of the federal government have recently proposed or 

established limits or guidance for arsenic in rice. For example, in 2017, 

the Codex Alimentarius, an international standard-setting body, published 

a code of practice that provides guidance for preventing and reducing 

arsenic contamination in rice, as well as communicating the risk to 

stakeholders.32 In 2014 and 2016, the Codex Alimentarius established a 

standard for inorganic arsenic of 200 ppb for white rice and 350 ppb for 

brown rice.33 In 2015, the European Commission issued a regulation 

limiting inorganic arsenic in various rice-based foods, including limits of 

200 ppb in white rice, 250 ppb in brown rice, and 100 ppb in rice destined 

for food for infants and young children.34

Enterprise risk management allows agencies to assess threats and 

opportunities that could affect the achievement of their goals. In a 2016 

report, we updated our 2005 risk management framework to (1) reflect 

changes to OMB’s Circular A-123, which requires agencies to implement 

enterprise risk management;35 (2) incorporate recent federal experience; 

and (3) identify essential elements of federal enterprise risk 

management.36 Beyond traditional internal controls, enterprise risk 

management promotes risk management by considering its effect across 

 31Executive Order 13272, Proper Consideration of Small Entities in Agency Rulemaking

(Washington, D.C.: Aug. 13, 2002).

32Codex Alimentarius, Code of Practice for the Prevention and Reduction of Arsenic 

Contamination in Rice, CAC/RCP 77-2017.

33Codex Alimentarius, General Standard for Contaminants and Toxins in Food and Feed, 

Codex Standard 193-1995. The Codex Alimentarius standards are voluntary for nations 

but, according to the World Trade Organization, they are used as a benchmark for trade 

purposes. The World Trade Organization encourages reference to the standards in 

bilateral and multilateral trade agreements. Various federal agencies, including EPA, FDA, 

and USDA, participate in Codex Alimentarius activities.

34Commission Regulation (EU) 2015/1006 of 25 June 2015, amending Regulation (EC) 

No 1881/2006 as regards maximum levels of inorganic arsenic in foodstuffs.

35Office of Management and Budget, Management’s Responsibility for Enterprise Risk 

Management and Internal Control, OMB Circular No. A-123 (July 15, 2016).

36GAO-17-63. See also GAO, Risk Management: Further Refinements Needed to Assess 

Risks and Prioritize Protective Measures at Ports and Critical Infrastructure, GAO-06-91 

(Washington, D.C.: Dec. 15, 2005).

Enterprise Risk 

Management
Page 12 GAO-18-199 Food Safety

the entire organization and how it may interact with other identified risks. 

Additionally, it also addresses other topics such as setting strategy, 

governance, communicating with stakeholders, and measuring 

performance, and its principles apply at all levels of the organization and 

across all functions—such as those related to managing the risk of 

arsenic in rice. The six essential elements of enterprise risk management 

that we identified in December 2016 are as follows:37

• Align risk management process with goals and objectives.

Ensure the process maximizes the achievement of agency mission 

and results.

• Identify risks. Assemble a comprehensive list of risks, both threats 

and opportunities, that could affect the agency’s ability to achieve its 

goals and objectives.

• Assess risks. Examine risks, considering both the likelihood of the 

risk and the impact of the risk to help prioritize risk response.

• Respond to the risks. Select risk treatment response (based on risk 

appetite), including acceptance, avoidance, reduction, sharing, or 

transfer.

• Monitor risks. Monitor how risks are changing and whether 

responses are successful.

• Communicate and report on risks. Communicate risks with 

stakeholders and report on the status of addressing the risks.

 37In this report, we used “risk management” rather than “enterprise risk management”

because we examined FDA’s and USDA’s actions related to arsenic and rice, rather than 

their entire portfolio of activities related to food safety.
Page 13 GAO-18-199 Food Safety

NRC, in its 2013 report, and recent key scientific reviews reported 

evidence of associations between long-term ingestion of arsenic and 

adverse human health effects.38 NRC identified stronger evidence of 

these associations at higher arsenic levels—defined by NRC as 100 ppb 

or higher in drinking water—than at lower levels, which are more common 

in the United States. NRC reported greater uncertainty regarding the 

associations with some health effects at lower levels of arsenic and noted 

that research on the health effects of ingestion of lower levels of arsenic 

is ongoing. Many of the studies on which NRC based its conclusions were 

focused on the ingestion of arsenic from drinking water, but other studies 

were based on arsenic from all sources, including dietary sources such as 

rice.39 Further, NRC reported that evidence from CDC dietary surveys 

and related academic studies suggests that food, particularly rice, may be 

a significant source of inorganic arsenic, especially when arsenic levels in 

drinking water are lower; however, consumption of rice and levels of 

arsenic in rice vary widely, making it difficult to estimate arsenic intake 

from rice. NRC reported strong evidence of causal associations—that is, 

a potential cause and effect—between the long-term ingestion of arsenic 

from water or dietary sources, such as rice, and the following five health 

effects:

• Skin diseases.

• Skin lesions. Skin lesions due to arsenic ingestion predispose a 

person to some skin cancers and may indicate increased 

 38Studies report an association between exposure—for example, through ingestion—to a 

substance and a health effect if the occurrence of the health effect is significantly different 

between groups exposed to different levels of the substance. An association, however, 

does not necessarily mean that the exposure caused the health effect, but according to 

NRC, associations can help identify the hazards. The NRC report categorized health 

effects as follows: (1) strong evidence of causal association, (2) moderate evidence of 

association, and (3) limited but suggestive evidence of association. To categorize a health 

effect, according to the chair of the NRC committee that developed the report, the 

committee relied on nine factors such as strength and consistency. Health effects in the 

first category met all factors, those in the second met many of them, and those in the third 

met a few.

39NRC reviewed 257 studies as part of its preliminary review of the scientific literature on 

the epidemiologic evidence related to the most affected organ systems. In certain studies, 

researchers estimated the ingested level of arsenic based on levels of arsenic measured 

in urine, hair, or toenails. In such cases, the arsenic may have originated in water or food. 

According to NRC, after ingestion, inorganic arsenic in drinking water is rapidly and almost 

completely absorbed, and there is evidence that arsenic in rice is likewise almost 

completely absorbed. We did not examine the individual studies cited by the NRC report.

NRC and Recent Key 

Scientific Reviews 

Reported Evidence of 

Associations between 

Ingestion of Arsenic 

and Adverse Human 

Health Effects
Page 14 GAO-18-199 Food Safety

susceptibility to other cancer and noncancer diseases. Skin 

lesions have a well-established dose-response relationship with 

arsenic in drinking water.40

• Skin cancer. Arsenic is an established skin carcinogen, according 

to NRC. NRC stated that almost all published studies found 

evidence of an association between arsenic ingestion and 

nonmelanoma skin cancers.41

• Lung cancer. Arsenic from drinking water is an established lung 

carcinogen in humans, according to NRC. NRC cited studies 

conducted in Argentina, Chile, Japan, Taiwan, and the United States 

that reported associations between high levels of arsenic ingestion 

and lung cancer. NRC reviewed several studies that examined 

ingestion of lower levels of arsenic, some of which found evidence of 

an association, while others did not.42

• Cardiovascular disease. NRC stated that many studies found a 

causal association between the ingestion of arsenic and 

cardiovascular disease and mortality. Studies suggest that the 

ingestion of lower levels of arsenic in drinking water and possibly in 

food is associated with cardiovascular disease, but additional 

evidence is needed to fully understand the relationship.

• Bladder cancer. Arsenic is an established bladder carcinogen in 

humans, according to NRC. NRC cited a 2012 assessment by the 

International Agency for Research on Cancer that indicated higher 

mortality from bladder cancer in populations that are exposed to high 

 40A dose-response relationship, in this case, describes how the likelihood and severity of 

an adverse health effect (the response) is related to the amount and type of exposure to 

arsenic (the dose). NRC reported that, while some studies found that skin lesions occur 

only at high levels of arsenic, others found that lesions also occur at lower levels—that is, 

below 100 ppb of arsenic in drinking water.

41Some studies have found evidence that the risk of skin cancer increases with increasing 

levels of arsenic. Studies that examined ingestion of lower arsenic levels have generally 

been less conclusive, in part because of methodological limitations.

42One study in Japan found evidence of an increase in lung cancer incidence with 

increased consumption of foods containing arsenic. In addition, one study in Chile 

suggests that ingestion of arsenic in utero or in early life increases the risk of lung cancer 

mortality, and a study in the United States found a relationship between increased urinary 

arsenic levels and lung cancer mortality.
Page 15 GAO-18-199 Food Safety

levels of arsenic compared to those that are not based on studies in 

Argentina, Chile, and Taiwan.43

NRC reported that there was moderate evidence of association between 

the long-term ingestion of various levels of arsenic from water or dietary 

sources such as rice, and adverse health effects, although some studies 

found evidence of an association and others did not. Adverse health 

effects include, for example, neurodevelopmental toxicity and pregnancy 

outcomes related to infant illness, disease, or injury.44 NRC also reported 

that there was limited evidence of an association between the long-term 

ingestion of arsenic from water and dietary sources and adverse health 

effects, such as liver and pancreatic cancer and renal disease.

We analyzed 14 scientific reviews, published since NRC’s 2013 report, 

from January 2015 through early June 2017, that generally have 

supported NRC’s conclusions that long-term ingestion of arsenic is 

associated with the above-mentioned health effects. Two reviews 

reporting additional evidence related to cardiovascular disease suggested 

that there may be a threshold—an arsenic level below which there is no 

significant occurrence of cardiovascular disease.45 However, one of these 

reviews noted that the number of studies they examined was small, 

among other limitations. Regarding lung cancer, another recent review 

proposed a dose-response relationship, which NRC identified as a gap in 

the understanding of this adverse health effect.46 However, this review 

noted that the studies it included did not distinguish between the risk of 

lung cancer in smokers and non-smokers, which NRC reported may be a 

 43Officials from the National Cancer Institute provided us with a 2016 study that found a 

dose-response relationship between bladder cancer and ingestion of drinking water with 

lower levels of arsenic in the United States.

44NRC reported that there is increasing evidence that exposure to arsenic early in life, 

including during the prenatal and early childhood stages, when rice products are often 

ingested, can affect health early or later in life. During these more sensitive life stages, 

exposure may not necessarily be long-term. 

45D. Phung, D. Connell, S. Rutherford, and C. Chu. “Cardiovascular Risk from Water 

Arsenic Exposure in Vietnam: Application of Systematic Review and Meta-Regression 

Analysis in Chemical Health Risk Assessment,” Chemosphere, vol. 177 (2017); and M.S. 

Sidhu, K.P. Desai, H.N. Lynch, L.R. Rhomberg, B.D. Beck, and F.J. Venditti. “Mechanisms 

of Action for Arsenic in Cardiovascular Toxicity and Implications for Risk Assessment,”

Toxicology, vol. 331 (2015).

46S.H. Lamm, H. Ferdosi, E.K. Dissen, J. Li, and J. Ahn, “A Systematic Review and MetaRegression Analysis of Lung Cancer Risk and Inorganic Arsenic in Drinking Water,”

International Journal of Environmental Research and Public Health, vol. 12, no. 12 (2015).
Page 16 GAO-18-199 Food Safety

key confounding factor. The review also cited other limitations, including 

the small number of studies it used to model this relationship. See 

appendix II for additional information about the reviews we identified.

FDA and USDA have taken actions to manage the risk to human health 

from arsenic in rice, including assessing the type and prevalence of 

health effects that may result from long-term ingestion. These efforts were 

generally consistent with the six essential elements for managing risk, 

which we have found could help agencies assess threats that could affect 

the achievement of their goals. Specifically, FDA has taken actions that 

were consistent with five of the six essential elements, including: (1) 

aligning risk management process with goals and objectives, (2) 

identifying risks, (3) assessing risks, (4) responding to the risks, and (5) 

monitoring risks. However, FDA has not fully taken action on the sixth 

element of communicating and reporting on risks. FDA issued a risk 

assessment in 2016 for public comment and a draft guidance limiting the 

levels of arsenic in infant rice cereal, but it has not updated or finalized 

these key documents. USDA has taken actions consistent with five of the 

six essential elements but has not taken actions to monitor the risk 

because of its more limited, nonregulatory role.

FDA and USDA have aligned their actions to manage the risk to human 

health from arsenic in rice to goals in their strategic plans. According to 

FDA officials, FDA’s actions align with three of the six goals identified in 

the 2015–2018 research strategic plan for FDA’s Center for Food Safety 

and Applied Nutrition, including advancing diet and health research that 

contributes to the development of science-based policies and 

communication strategies.47 Regarding USDA’s actions, ARS officials 

stated that their research on arsenic in rice aligned with four goals in 

ARS’s fiscal year 2012–2017 strategic plan, such as protecting food from 

pathogens, toxins, and chemical contamination during production, 

 47Center for Food Safety and Applied Nutrition, Science and Research Strategic Plan, 

2015–2018. These goals are as follows: Goal 2, develop and implement screening 

methods for use in field laboratories to improve the capacity for detection of chemical 

contaminants; Goal 4, integrate and apply modern toxicological approaches to support 

regulatory and public health decision making on chemical hazards in foods, dietary 

supplements, and cosmetics; and Goal 5, advance diet and health research that 

contributes to the development of science-based policies and communication strategies.

FDA and USDA Have 

Taken Actions to 

Manage the Risk to 

Human Health from 

Arsenic in Rice

Aligning Risk Management 

Process with Goals and 

Objectives
Page 17 GAO-18-199 Food Safety

processing, and preparation.48 NIFA officials stated that the research they 

sponsored on arsenic in rice aligned with one of the sub-goals in NIFA’s 

fiscal year 2014–2018 strategic plan: to reduce the incidence of 

foodborne illness and provide a safer food supply.49 FGIS officials 

provided documentation showing that their actions aligned with one of the 

goals in their fiscal year 2016–2020 strategic plan: provide the 

environment for fair and competitive market practices between 

agricultural producers and buyers.50 FDA’s and USDA’s actions were 

consistent with the essential element of aligning risk management actions 

to their strategic plans.

FDA and USDA have taken actions to identify the risk of arsenic in rice. 

FDA has identified the risk of arsenic in rice through the Total Diet 

Study—an annual testing of contaminants and nutrients in food. As part of 

conducting the Total Diet Study, FDA collects samples of certain foods, 

including rice, and tests them for a variety of toxic chemicals, including 

total arsenic. From 2014 through 2015, the most recent years for which 

data are available, FDA tested six different categories of rice-based foods 

for arsenic.51 FDA officials told us that they identified arsenic in rice as a 

priority based, in part, on the results of the Total Diet Study, which 

indicated that rice had higher levels of arsenic compared to other foods. 

Some university researchers we interviewed stated that the Total Diet 

Study would be more helpful if it measured inorganic arsenic or had a 

more robust methodology. For example, one university researcher noted 

 48Agricultural Research Service, Strategic Plan FY 2012–FY 2017 (Washington, D.C.: 

2016). These goals are as follows: Goal 1.1, enable Americans to make health-promoting, 

science-based dietary choices; Goal 1.2, protect food from pathogens, toxins, and 

chemical contamination during production, processing, and preparation; Goal 2.1, 

integrated, effective, and safe water resource management; and Goal 3.1, protect, 

expand, and enhance the United States’ crop genetic resource base, increase scientific 

knowledge of crop genes, genomes, biological processes and systems, and deliver 

economically and environmentally sound technologies that improve the production 

efficiency, quality, health and value of the nation’s crops.

49National Institute of Food and Agriculture, Strategic Plan, FY 2014–FY 2018 (2014). 

50Grain Inspection, Packers and Stockyards Administration, Strategic Plan, FY 2016-

2020. In September 2017, the programs carried out by FGIS, formerly part of the Grain 

Inspection, Packers and Stockyards Administration, were realigned into USDA’s 

Agricultural Marketing Service.

51FDA included three baby foods—turkey and rice; chicken and rice; and dry rice cereal, 

prepared with water—as well as cooked white enriched rice, crisped rice cereal, and 

meatless fried rice from restaurants that serve Chinese carry-out food. 

Identifying Risks

Total Diet Study 

The Food and Drug Administration’s (FDA) 

Total Diet Study, which began testing for 

arsenic in 1991, is an ongoing program that 

monitors the levels of about 800 contaminants 

and nutrients in the average U.S. diet. To 

conduct the study, FDA buys, prepares, and 

analyzes about 280 kinds of foods and 

beverages from representative areas of the 

country and estimates the average amounts 

of contaminants and nutrients the entire U.S. 

population, some subpopulations, and each 

person consumes annually. The sampling 

plan calls for purchasing each type of food 

four times a year, each time in a different 

region. Within each region, FDA purchases 

each food product from three different stores 

and combines them into a composite sample, 

for a total of four estimates each year. FDA 

makes results of the study, from 1991 through 

2015, available to the public in electronic form 

on its website.

Source: GAO analysis of FDA data. | GAO-18-199
Page 18 GAO-18-199 Food Safety

that the number of samples in the Total Diet Study is not big enough to be 

nationally representative. FDA officials told us that starting with the fiscal 

year 2018 Total Diet Study, they plan to begin testing rice-based foods for 

inorganic arsenic, increase the number of samples they collect, and make 

other improvements to the sampling methodology.

USDA officials have taken actions to identify the risk of arsenic in rice 

through a variety of research programs. ARS officials told us that they 

have conducted research on arsenic in rice under four national programs: 

(1) plant genetic resources, genomics, and genetic improvement; (2) 

water availability and watershed management; (3) human nutrition; and 

(4) food safety. For example, ARS researchers are examining whether 

changes in soil chemistry as a result of organic or conventional 

management practices affect arsenic levels in rice. NIFA officials stated 

that NIFA sponsors research on arsenic in rice through formula-based 

grants to universities and through competitive grants, such as those 

offered through the Agriculture and Food Research Initiative.52

To identify what research to undertake, ARS officials told us that they 

typically meet with industry to identify its highest priorities. For example, 

ARS officials from the Delta Water Management Research Unit in 

Arkansas stated that they started researching arsenic in rice after 

participating in a joint ARS-USA Rice Federation conference in 2012.53

FGIS officials told us that contaminants such as arsenic may affect the 

quality of a grain, such as rice, and hence its value. They stated that they 

work closely with the grain industry to develop new standards and tests to 

meet industry’s needs.

FDA and USDA have taken actions to assess the risk of arsenic in rice. In 

2012, FDA published its current method to detect inorganic arsenic in 

 52The Agriculture and Food Research Initiative is a competitive grant program that 

supports research, education, and extension activities in six priority areas. They include 

(1) plant health and production and plant products; (2) animal health and production and 

animal products; (3) food safety, nutrition, and health; (4) bioenergy, natural resources, 

and environment; (5) agriculture systems and technology; and (6) agriculture economics 

and rural communities. 

53USA Rice Federation is an organization that advocates for the U.S. rice industry, 

including rice farmers and millers. 

Assessing Risks
Page 19 GAO-18-199 Food Safety

rice.54 FDA officials told us that this method, though useful, is timeconsuming and expensive, and the agency continues to develop other 

methods to reduce cost and time. For example, in 2017, FDA developed 

another method to detect inorganic arsenic in wine and rice that takes 

less time than its current method.55 FDA officials told us they have an 

ongoing research project on a field-deployable method based on a 

commercially-available digital arsenic test kit for detecting arsenic in 

drinking water called the Arsenator. In addition, FDA has been using laser 

ablation, the process of removing a material from a solid using a laser 

beam so that it can be measured, as a way to study arsenic distribution in 

rice.56

From 2011 through 2014, FDA conducted targeted sampling of more than 

1,400 rice-based foods—including rice, rice beverages, cereals, and 

snacks—for inorganic arsenic. This targeted sampling and a literature 

review of articles published before February 2015 informed a risk 

assessment of arsenic in rice that FDA issued for public comment in April

2016.57 Specifically, the risk assessment used the results of the targeted 

sampling to identify levels of inorganic arsenic in rice and examined 

available scientific information to provide quantitative estimates of lung 

and bladder cancer risk—that is, the number of expected lung and 

bladder cancer cases per million people that may be attributable to longterm ingestion of inorganic arsenic in rice and a qualitative assessment of 

other adverse health effects. The risk assessment also analyzed 

alternative approaches to reducing the risk of arsenic in rice, such as 

instituting limits on the allowable level of arsenic in various rice-based 

 54Food and Drug Administration, Arsenic Speciation in Rice and Rice Products Using High 

Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric 

Determination, Elemental Analysis Manual for Food and Related Products, 4.11 (2012).

55Gray, Patrick, J., Courtney K. Tanabe, Susan E. Ebeler, and Jenny Nelson, “A Fast and 

Fit-for-Purpose Arsenic Speciation Method for Wine and Rice,” Journal of Analytical 

Atomic Spectrometry, vol. 32 (2017).

56Laser ablation is used with an analytical instrument that can measure the material, such 

as an inductively-coupled plasma mass spectrometer.

57Food and Drug Administration, Center for Food Safety and Applied Nutrition, Arsenic in 

Rice and Rice Products Risk Assessment Report, Version Released for Public Comment

(March 2016). 81 Fed. Reg. 19,976 (Apr. 6, 2016). FDA conducted a literature review on 

arsenic levels in U.S. rice and infant rice cereal published up to October 2013 as well an 

update of articles published from October 2013 to February 2014 on cancer-related health 

effects and another update of articles published from October 2013 to February 2015 on 

noncancer health effects for pregnant women, infants, and children.
Page 20 GAO-18-199 Food Safety

foods, limiting the amount and frequency of consumption of rice, and 

cooking practices.

FDA’s actions have helped assess the risk of arsenic in rice, although 

some stakeholders we interviewed have identified limitations to FDA’s 

actions. For example, one rice producer noted that because FDA’s 

current detection method is time-consuming and expensive, it is not 

widely used—companies only use it when tests for total arsenic reveal 

that the levels exceed the limit for inorganic arsenic that their customers 

request. Some stakeholders noted that the evidence FDA used to assess 

the risk of the ingestion of low levels of arsenic, which may be more 

relevant for rice consumption, is more uncertain.

USDA agencies have also taken actions to assess the risk by conducting 

research to develop faster and less expensive methods to detect 

inorganic arsenic in rice. In 2016, ARS developed a method using hydride 

generation, which uses an acid to convert the inorganic arsenic into a gas 

that can be detected by an instrument. ARS officials stated that they have 

conducted research on the hydride generation method for more than 5 

years and were able to further refine the method with funding from the 

Rice Foundation.58 Stakeholders from the rice industry and a university 

researcher we interviewed noted that, while the hydride generation 

method is faster and cheaper than FDA’s current detection method, it is 

too time-consuming and expensive for commercial purposes. For 

example, rice mills could not keep pace with trucks lining up to unload 

rice if they use the hydride generation method. However, ARS officials 

stated that researchers may use it if they need to analyze thousands of 

samples and are willing to trade off some accuracy for speed and cost. In 

addition, FGIS conducted some of its own development work on the 

Arsenator. Agency officials said that they began research on the 

Arsenator to help provide a rapid and inexpensive method of detecting 

inorganic arsenic at FGIS official testing locations that could include rice 

mills but have suspended their efforts because representatives of the rice 

industry have told them that these tests are not necessary.

FDA and USDA have taken actions to respond to the risk of arsenic in 

rice. In 2016, FDA issued draft guidance, which proposed an action level,

recommending that the rice industry not exceed a level of 100 ppb 

 58The Rice Foundation sponsors research and education programs for the rice industry.

Responding to the Risks
Page 21 GAO-18-199 Food Safety

inorganic arsenic in infant rice cereal, and FDA has conducted research 

on cooking methods that may reduce arsenic. In its draft guidance, FDA 

stated that it used its risk assessment, among other considerations, to 

identify the level of inorganic arsenic in infant rice cereal.59 FDA further 

noted that it selected 100 ppb because of the potential for human health 

risks associated with inorganic arsenic and because such a level is 

achievable with the use of current good manufacturing practices—

specifically, selecting sources of rice or rice-derived ingredients with lower 

inorganic arsenic levels.60 FDA officials told us that they focused on infant 

rice cereal because infants are at a higher risk of experiencing some of 

the health effects of ingesting inorganic arsenic, such as 

neurodevelopmental effects, and because the diet of infants is less varied 

than that of adults. FDA officials noted that the proposed guidance sets a 

limit for infant rice cereal that is generally consistent with the limit set by 

the European Commission and that other types of rice sold in the United 

States also generally meet the Codex Alimentarius standards.

University researchers and a group representing consumers we 

interviewed stated that FDA’s draft guidance is a good first step, but that 

FDA should establish limits for arsenic in other rice products, such as rice 

crackers and other foods that children eat. FDA officials noted that the 

next most susceptible group would likely be toddlers and young children, 

but because their diet is more diverse than that of infants, rice-based 

foods make up a smaller portion of their diet. FDA requested public 

comments on certain aspects of the draft guidance, such as its feasibility, 

and noted that when it is finalized, it will represent FDA’s current thinking 

on this topic. The public comments were due to FDA in July 2016, 

although FDA noted that the public may comment on its guidance at any 

time. University researchers and stakeholders from the rice industry we 

interviewed stated that FDA’s draft guidance has become a de facto 

industry standard for infant rice cereal. In 2016, FDA also published 

research on the effect that cooking methods, such as cooking rice in 

 59Food and Drug Administration, Inorganic Arsenic in Rice Cereals for Infants: Action 

Level Guidance for Industry, Draft Guidance (April 2016). 81 Fed. Reg. 19,976 (Apr. 6, 

2016). 

60A level of 100 ppb is equivalent to 100 micrograms of arsenic per kilogram of rice. In 

setting this level, FDA used information about the health effects of ingesting various levels 

of arsenic, as well as information about rice consumption patterns and levels of arsenic in 

rice based on its sampling efforts.
Page 22 GAO-18-199 Food Safety

excess water, may have on reducing the level of arsenic in rice.61 FDA 

officials told us that they provided advice to consumers on cooking 

methods that could reduce arsenic in rice on the FDA website but said 

FDA will not direct manufacturers to change the cooking instructions for 

rice because the alternative methods may reduce the nutritional value of 

the rice.62

Within USDA, ARS and NIFA have sponsored published and ongoing 

research that can help respond to the risk, such as research on ways to 

reduce the uptake of arsenic by rice through new rice varieties, water 

management practices, and soil additives, as well as research on the 

genetic mechanisms underlying the uptake and transport of arsenic in the 

rice plant. For example, ARS has been conducting research on rice 

varieties that can improve yield and grain quality, including lower levels of 

arsenic, at the Dale Bumpers National Rice Research Center in Arkansas 

for more than 30 years. In 2016, university and ARS researchers 

published a study showing that growing rice using a water management 

practice called alternate wetting and drying could decrease the levels of 

arsenic.63 Under this practice of growing rice, shown in figure 3 below, 

fields are periodically drained and re-flooded during the growing season.

 61Gray, Patrick J., Sean D. Conklin, Todor I. Todorov, and Sasha M. Kasko, “Cooking 

Rice in Excess Water Reduces Both Arsenic and Enriched Vitamins in the Cooked Grain,”

Food Additives and Contaminants: Part A, vol. 33, no. 1 (2016).

62Food and Drug Administration, Questions & Answers: Arsenic in Rice and Rice 

Products, accessed May 19, 2017, 

https://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm319948.htm. 

63LaHue, Gabriel T., Rufus L. Chaney, Maria Arlene Adviento-Borbe, Bruce A. Linquist, 

“Alternate Wetting and Drying in High Yielding Direct-Seeded Rice Systems Accomplishes 

Multiple Environmental and Agronomic Objectives,” Agriculture, Ecosystems and 

Environment, vol. 229 (2016).
Page 23 GAO-18-199 Food Safety

Figure 3: Alternate Wetting and Drying Water Management Practice in Arkansas 

Rice Fields

Note: The U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) and the 

University of Arkansas System Division of Agriculture, funded in part by USDA, conduct research on 

alternate wetting and drying, a water management practice illustrated above, to determine how to 

produce comparable rice yields to those from continuous flooding and reduce water use and levels of 

arsenic.

ARS officials stated that the alternate wetting and drying water 

management practice has been adopted to a limited extent in Arkansas, 

but pointed out that other benefits, such as reducing water use, may have 

been more influential to its adoption than the lowering of arsenic levels. 

They noted that there are a number of challenges that may preclude 

widespread use, including inadequate water-pumping capacity and the 

lack of crop insurance coverage for the practice. In addition, in 2015, 

university researchers and an ARS researcher, with a grant from NIFA, 

published a study on the effects of adding iron oxide to the soil on the 
Page 24 GAO-18-199 Food Safety

levels of arsenic in rice; they found that iron oxide resulted in significant 

reduction of arsenic for the two varieties of rice that the study examined.64

FDA, which is responsible for ensuring the safety of rice and rice-based 

foods, has taken actions to monitor the risk of arsenic in rice. USDA has 

not done so, because of its more limited, nonregulatory role. FDA has a 

compliance program designed to monitor over 1,400 products annually, 

including foods that are most likely to contribute to the dietary intake of 

toxic elements, among other contaminants.65 In fiscal years 2015 and 

2016, FDA monitored the risk of arsenic by assessing the levels in rice 

and rice-based foods under this compliance program, and FDA officials 

told us that they plan to continue to do so in fiscal years 2017 and 2018.66

FDA officials told us that they generally test the rice for total arsenic but 

have recently analyzed some samples for inorganic arsenic based on 

factors such as the level of total arsenic found. FDA considers whether to 

conduct follow-up actions, including enforcement actions, on a case-bycase basis. As a result of its monitoring in 2016 and 2017 FDA 

considered, but did not take, two enforcement actions for arsenic in infant 

rice cereal. FDA officials stated that the inorganic arsenic level in one 

case was close to the 100 ppb limit and within the margin of error of the 

detection method, and in the second case, FDA determined during its 

follow-up to the initial sample that the manufacturer destroyed the 

remaining product.

USDA agencies have not monitored arsenic in rice. The Food Safety and 

Inspection Service is USDA’s regulatory agency for food safety, but 

officials have told us they have not taken actions in this area because rice 

is not under the agency’s jurisdiction. ARS maintains a food composition 

 64Farrow, Eric, M., Jianmin Wang, Joel G. Burken, Honglan Shi, Wengui Yan, John Yang, 

Bin Hua, and Baolin Deng, “Reducing Arsenic Accumulation in Rice Grain through Iron 

Oxide Amendment,” Ecotoxicology and Environmental Safety, vol. 118 (2015). 

65The Toxic Elements in Food and Foodware, and Radionuclides in Food Compliance 

Program focuses on sampling and analyzing foods that can be significant dietary sources 

of toxic elements for young children.

66In fiscal year 2015, FDA tested eight samples of rice-based foods for arsenic; in fiscal 

year 2016, FDA tested 38 samples; and FDA officials provided plans to test 93 samples in 

fiscal years 2017 and 86 in fiscal year 2018. The samples include infant rice cereals; ricebased infant and toddler puffs and teething biscuits; and rice beverages, including those 

targeted to children.

Monitoring Risks
Page 25 GAO-18-199 Food Safety

database,67 but it does not monitor rice for contaminants such as arsenic 

because, according to ARS officials, that is not the database’s purpose. 

FGIS officials stated that they do not have an arsenic testing program for 

rice at this time. They told us that they considered establishing a testing 

program for rice intended for export at the request of the rice industry. 

However, FGIS officials stated that they suspended their efforts when 

industry determined that it did not need a testing program.

FDA and USDA have taken actions to communicate and report on the risk 

of arsenic in rice to the public. FDA has issued a risk assessment and 

draft guidance on arsenic in infant rice cereal, but it has not updated or 

finalized these documents. FDA’s 2016 risk assessment report provides 

information about the risk from long-term ingestion of arsenic in rice, and 

its draft guidance on arsenic in infant rice cereal includes a link to an FDA 

website with information for consumers, including pregnant women and 

parents.68 FDA has requested comments and received 22 public 

comments from 17 individuals and organizations on both documents. The 

comments have addressed a range of issues, including the methodology 

FDA used in its risk assessment; the 100 ppb limit and scope of the 

agency’s draft guidance; and the effectiveness of the agency’s 

communication to the public. However, FDA has not publicly issued 

versions of the guidance or the risk assessment that address these 

comments. In our prior work, we have found that sharing risk information 

and incorporating feedback from internal and external stakeholders can 

help organizations identify and better manage risks, as well as increase 

transparency and accountability to Congress and taxpayers.69

In the risk assessment, FDA stated that it will provide an update after 

considering public comments and any newly-available information. For 

example, FDA officials told us that they plan to consider newly-available 

information, such as any updates to EPA’s Integrated Risk Information 

System assessment for inorganic arsenic, and may update the risk 

 67USDA National Nutrient Database for Standard Reference contains food composition 

data for over 8,800 food items and components, including nutrients such as fiber, 

minerals, protein, and vitamins.

68FDA’s website provides information to consumers and FDA’s statement on testing and 

analysis of arsenic in rice and rice products. Food and Drug Administration, “Arsenic in 

Rice and Rice Products,” accessed May 19, 2017, 

https://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm319870.htm.

69GAO-17-63.

Communicating and 

Reporting on Risks
Page 26 GAO-18-199 Food Safety

assessment as a result. With regard to public comments, FDA officials 

told us that they do not intend to make any changes to the approach or 

findings of the risk assessment and that they are still considering whether 

to make changes to the draft guidance as a result of public comments. 

FDA officials stated that they are still reviewing comments and that, 

before publication, the guidance would have to undergo interagency 

review. FDA officials also stated that the agency is not required to provide 

a response to comments in the final guidance. Further, FDA officials 

stated that the agency does not need to finalize the guidance in order to 

sample foods for a contaminant or to take enforcement action when 

contamination may pose a health hazard.

Stakeholders we interviewed stated that updating the risk assessment 

and finalizing the draft guidance would improve FDA’s communication of 

the risk. For example, some stakeholders we interviewed told us that the 

information used in the risk assessment—both regarding the health 

effects of arsenic and the levels of arsenic in rice—may need to be 

updated to incorporate the results of more recent research. Further, two 

stakeholders we interviewed—one representing the rice industry and the 

other representing consumers—noted that it is not clear to them what 

actions FDA can take based on the draft guidance. However, FDA

officials could not give us a timeline for when they plan to update the risk 

assessment or finalize the guidance. By developing a timeline for 

updating the risk assessment on arsenic in rice to incorporate any newlyavailable information, FDA could help clarify when it will take action. 

Developing a timeline for finalizing the draft guidance on arsenic in infant 

rice cereal could also help FDA improve the transparency of its 

decisions—such as by clarifying the effectiveness of the draft guidance.

USDA has taken actions that can help communicate and report on the 

risk of arsenic in rice. ARS officials told us that they have communicated 

the results of their research on arsenic in rice in a number of ways, such 

as through presentations at conferences and through outreach to farmers, 

including in cooperation with extension programs at universities. For 

example, USDA researchers demonstrated automated irrigation systems 

that can be used for the alternate wetting and drying water management 

practice. In 2017, ARS researchers contributed to the development of a 

bulletin in conjunction with University of Arkansas researchers that 

contains recommended practices about irrigation methods that can 
Page 27 GAO-18-199 Food Safety

reduce the levels of arsenic in rice.70 ARS officials told us that their 

communication efforts could help increase farmers’ interest and adoption 

of methods they have researched. They also stated that they work with 

extension programs because these programs have good access to 

farmers.

FDA coordinated with USDA and other federal agencies on the actions to 

manage the risk of arsenic in rice for which coordination would be 

expected, to varying extents. FDA coordinated with USDA and several 

other federal agencies, including CDC, EPA, and NIH, on the 

development of the risk assessment and draft guidance on arsenic in 

infant rice cereal, but USDA raised concerns about the extent of the 

coordination. FDA and USDA coordinated to a limited extent to develop 

faster and less expensive methods to detect arsenic in rice.

FDA coordinated with several federal agencies on the development of the 

risk assessment and draft guidance on arsenic in infant rice cereal. 

According to FDA officials, in developing the risk assessment, FDA 

initially coordinated with EPA on two noncancer health effects—adverse 

pregnancy outcomes and developmental neurotoxicology effects in young 

children—to ensure consistency with the work EPA was doing to update 

its Integrated Risk Information System assessment for arsenic. When 

FDA completed the draft of the noncancer section of its risk assessment, 

the agency provided it to EPA and NIH’s National Institute of 

Environmental Health Sciences for review. FDA incorporated comments 

from EPA and NIH in the risk assessment document, which EPA, CDC, 

and NIH subsequently reviewed. From December 2014 through June 

2015, the risk assessment and draft guidance underwent HHS’s 

clearance process. Through this process, CDC and NIH, along with 

HHS’s Assistant Secretary for Legislation and its Office of the Assistant 

Secretary for Planning and Evaluation, reviewed the documents, and FDA 

revised the risk assessment and draft guidance to address their 

comments. CDC, EPA, and NIH officials told us that they were generally 

satisfied with FDA’s coordination efforts and the extent to which FDA 

addressed their comments. For example, CDC officials said that the 

 70University of Arkansas Division of Agriculture Research and Extension, Rice 

Information: Using Alternate Wetting and Drying (AWD) Rice Flood Management (July 

2017).

FDA Coordinated 

Several Risk 

Management Actions 

with USDA and Other 

Federal Agencies to 

Varying Extents

FDA Coordinated Its Risk 

Assessment and Draft 

Guidance with Several 

Federal Agencies, but 

USDA Raised Concerns 

about the Extent of 

Coordination
Page 28 GAO-18-199 Food Safety

agency provided FDA several rounds of comments, and by the end of the 

process, all of its comments had been considered.

OMB also chose to review FDA’s risk assessment and draft guidance on 

arsenic in infant rice cereal through its interagency review process.71

According to FDA officials, as part of this process, which occurred from 

May 2015 through March 2016, FDA coordinated with EPA again, as well 

as with OMB’s Office of Information and Regulatory Affairs and the U.S. 

Trade Representative within the Executive Office of the President, the 

Small Business Administration’s Office of Advocacy, and USDA. Officials 

from the Small Business Administration’s Office of Advocacy said that 

they were generally satisfied with the review process and characterized 

the outcome as typical in that some, but not all, of their suggested 

changes were accepted.72

However, USDA officials raised concerns about FDA involving them too 

late in the coordination process and about the extent to which FDA 

addressed their comments. From May 2015 through July 2015, USDA 

conducted its first review of these documents and provided FDA with 

comments. USDA had offered to provide FDA with feedback on versions 

of the risk assessment on several occasions earlier in the process, but 

FDA did not accept USDA’s offers, according to a USDA official. As 

discussed below, FDA chose to engage USDA later in the process.

In their comments, USDA officials expressed concerns regarding 

uncertainties and data limitations in the risk assessment and draft 

guidance on arsenic in infant rice cereal. USDA also raised questions 

about whether sufficient data on the link to adverse health effects existed 

to warrant the draft guidance. Furthermore, USDA stated that because 

the documents focus solely on rice, instead of addressing risks to the diet 

as a whole, FDA needs to share clear, consistent, and understandable 

messages with the public to alleviate fear and misunderstanding related 

to the risk posed by arsenic in rice. According to USDA officials, FDA did 

not adequately address their comments in the revised documents, 

 71According to OMB staff, OMB’s Office of Information and Regulatory Affairs reviewed 

FDA’s risk assessment and draft guidance using its authority to review significant agency 

guidance documents under Executive Order 12866, as clarified under OMB memorandum 

M-09-13 (Mar. 4, 2009), and a 2007 bulletin for agency good guidance practices (72 Fed. 

Reg. 16, pp. 3432-3440 (Jan. 25, 2007)). 

72OMB staff stated that FDA provided responses to comments and made revisions based 

on these comments throughout OMB’s review. 
Page 29 GAO-18-199 Food Safety

including FDA’s communication strategy. However, according to a senior 

USDA official, in its response to USDA’s comments, FDA maintained that, 

overall, the comments it received from its external peer reviewers—five 

university researchers—were supportive of the risk assessment and that 

based on the peer review, FDA did not change its findings or conclusions. 

According to this USDA official, FDA also noted that there are insufficient 

data to accurately quantify the risk from arsenic in rice to pregnant 

women or children but that it decided moving forward with the draft 

guidance on arsenic in infant rice cereal would be prudent.

FDA and USDA did not agree on USDA’s role in developing the risk 

assessment and the point at which they should begin coordinating on the 

risk assessment. FDA officials told us that FDA generally considers 

agencies’ expertise in determining whether and when to include them in 

the development of risk assessments and related documents. FDA did 

not see USDA as having a role in developing the risk assessment; rather, 

FDA officials told us that they reached out to USDA after the risk 

assessment was drafted, when the agency began to consider how to 

reduce the levels of arsenic in rice during the growing process and the 

feasibility of industry meeting its draft guidance on arsenic in infant rice 

cereal. The officials said that FDA met with USDA officials on numerous 

occasions and invited them to attend additional meetings with various 

stakeholders. However, according to a senior USDA official, USDA has 

relevant scientific and technical expertise that should have played a role 

in developing the risk assessment. According to this official, if FDA had 

involved USDA earlier in the development process, FDA may have 

addressed USDA’s comments to a greater extent.

We have shown in prior work that agencies can facilitate their 

collaborative efforts by developing a mechanism for interagency 

coordination, and a key issue to consider when developing such a 

mechanism is whether participating agencies have clarified their roles and 

responsibilities.73 FDA officials stated that they were not aware of the 

existence of any mechanism for coordinating risk assessments of 

contaminants in food, including arsenic in rice, which among other things, 

could clarify the roles and responsibilities of participating agencies. FDA 

officials told us that they followed a 2002 report listing guiding principles 

when developing the risk assessment, but this report, which broadly 

applies to all foodborne contaminants, did not specify the process FDA 

 73GAO-12-1022.
Page 30 GAO-18-199 Food Safety

should follow to coordinate its risk assessment.74 However, our review of 

this 2002 report shows that it recommends that FDA encourage active 

participation and communication with other agencies and stakeholders 

and collaboration, when appropriate, as part of its risk assessment 

development process. Although FDA did reach out to USDA, those 

meetings were after the completion of the risk assessment. By developing 

a mechanism for working with relevant agencies to identify their roles and 

responsibilities for coordinating risk assessments of contaminants in food, 

including arsenic in rice, FDA could have better assurance that it fully 

utilizes the expertise of all participating federal agencies.

FDA and USDA’s FGIS and ARS coordinated on the development of 

detection methods to a limited extent. Officials from FDA and FGIS told 

us that they began to coordinate in March 2016, when they discovered, in 

the course of ongoing coordination in another area, that they were each 

working independently on developing a faster and less expensive 

detection method using the Arsenator. According to FDA officials, FDA 

became aware of FGIS’s interest in developing methods to detect arsenic 

in rice during a Codex Alimentarius meeting that researchers from both 

agencies attended. Therefore, the avoidance of potentially duplicative 

effort occurred as a result of an informal discussion that occurred during 

this meeting. With regard to ARS, FDA officials told us that FDA did not 

coordinate with ARS on the development of the hydride generation 

method but that FDA used its own validated method to provide ARS with 

actual arsenic concentrations of samples to help ARS test its method. 

According to ARS officials, ARS did not coordinate with FDA or FGIS 

when developing its method on hydride generation. According to an FDA 

official, FDA did not coordinate the development of its current method to 

detect inorganic arsenic in rice, the faster method for wine and rice, or the 

laser ablation method with FGIS, ARS, or any other federal agency.

We have shown in prior work that many of the meaningful results that the 

federal government seeks to achieve, such as those related to protecting 

food and agriculture, require the coordinated efforts of more than one 

federal agency.75 ARS officials told us that from their perspective, there 

was no reason to coordinate because ARS, FDA, and FGIS are trying to 

 74Food and Drug Administration, Center for Food Safety and Applied Nutrition, Initiation 

and Conduct of All ‘Major’ Risk Assessments within a Risk Analysis Framework (2002). 

75GAO-12-1022.

FDA and USDA 

Coordinated on 

Developing Methods to 

Detect Arsenic in Rice to a 

Limited Extent
Page 31 GAO-18-199 Food Safety

meet different needs with their research. Further, ARS officials told us 

that coordinating with FDA would blur the distinction between ARS’s 

scientific role and FDA’s regulatory role and may imply that ARS has 

regulatory responsibilities or expertise. However, all three agencies share 

a crosscutting strategic interest in developing methods for detecting 

foodborne contaminants, including arsenic in rice. The strategic plans for 

ARS and FDA’s Center for Food Safety and Applied Nutrition include 

outcomes and strategies related to the development of detection methods 

for chemical contaminants or residues. Further, FGIS’s strategic plan 

includes a strategy of developing innovative tests to measure grain 

quality, and according to FGIS officials, they have considered testing 

inorganic arsenic as part of measuring grain quality. According to FGIS 

officials, once they began coordinating with FDA on the Arsenator, they 

saw value in coordinating and did so for about 9 months before 

suspending work on the detection method.

We have noted in prior work that interagency mechanisms to coordinate 

programs that address crosscutting issues may reduce potentially 

duplicative efforts.76 However, neither FDA nor USDA has such a 

mechanism to coordinate the development of methods to detect arsenic 

in rice or other methods to detect contaminants in food. FDA officials told 

us that the agency works with USDA research agencies on food safety in 

an informal manner, and USDA officials told us that they are not aware of 

any mechanism for coordination and that coordination with FDA generally 

occurs at the secretarial level because it cuts across a number of USDA 

agencies. Recently, we also found another example in which FDA and 

USDA did not coordinate in developing detection methods for other 

contaminants in foods. FDA and another USDA agency—the Food Safety 

and Inspection Service—did not coordinate in developing detection 

methods for drug residues in seafood.77 By developing a mechanism to 

coordinate their crosscutting efforts to develop faster and less expensive 

methods for detecting contaminants in food, including arsenic in rice, FDA 

and USDA could enhance their ability to use their resources efficiently 

and avoid engaging in unnecessary and potentially duplicative efforts.

 76GAO-12-1022.

77GAO-17-443. In that report, we recommended that FDA and USDA’s Food Safety and 

Inspection Service coordinate and communicate in developing these methods. 
Page 32 GAO-18-199 Food Safety

NRC and key recent scientific reviews have indicated that long-term 

ingestion of arsenic may pose a significant risk to human health, and FDA 

and USDA have taken various actions to manage the risk to human 

health of arsenic in rice. Their actions are generally consistent with the 

essential elements we have identified for managing risk, which can help 

agencies assess threats that could affect the achievement of their goals. 

For example, both agencies have conducted research on arsenic 

detection methods, and FDA has issued for public comment a risk 

assessment on the human health effects from the long-term ingestion of 

arsenic in rice. In addition, according to FDA officials, because infants are 

at a higher risk of experiencing some of the health effects of ingesting 

arsenic, such as neurodevelopmental effects, and the diets of infants are 

less varied than that of adults, FDA issued a draft guidance regarding 

arsenic in infant rice cereal. However, FDA officials have not provided a 

specific timeline for updating the risk assessment in response to newlyavailable information or for finalizing the draft guidance for infant rice 

cereal in response to public comments. Both of these documents could 

help communicate to the public the risk of arsenic in rice, and updating or 

finalizing them could also help FDA demonstrate its commitment to 

increasing transparency and accountability by addressing public 

comments and clarifying its enforcement authority, among other things.

FDA coordinated the development and review of these key documents 

with several federal agencies, and these agencies were generally 

satisfied with FDA’s coordination efforts. However, USDA raised concerns 

about being involved too late in the process and the extent to which its 

comments were addressed. By developing a mechanism for working with 

relevant agencies to identify their roles and responsibilities for 

coordinating risk assessments of contaminants in food, including arsenic 

in rice, FDA could better ensure that it fully utilizes their expertise. 

Furthermore, FDA and USDA coordinated on the development of arsenic 

detection methods to a limited extent. Developing a mechanism to 

coordinate their crosscutting efforts to develop methods to detect 

contaminants in food, including arsenic in rice, could help FDA and USDA 

manage their resources and avoid engaging in unnecessary and 

potentially duplicative efforts.

Conclusions
Page 33 GAO-18-199 Food Safety

We are making a total of five recommendations, including four to FDA 

and one to USDA. Specifically:

• The Commissioner of FDA should develop a timeline for updating the 

risk assessment on arsenic in rice. (Recommendation 1)

• The Commissioner of FDA should develop a timeline for finalizing the 

draft guidance on arsenic in infant rice cereal. (Recommendation 2)

• The Commissioner of FDA should develop a mechanism for working 

with relevant agencies to identify their roles and responsibilities for 

coordinating risk assessments of contaminants in food, including 

arsenic in rice. (Recommendation 3)

• The Commissioner of FDA should work with USDA to develop a 

mechanism to coordinate the development of methods to detect 

contaminants in food, including arsenic in rice. (Recommendation 4)

• The Secretary of Agriculture should work with FDA to develop a 

mechanism to coordinate the development of methods to detect 

contaminants in food, including arsenic in rice. (Recommendation 5)

We provided a draft of this report to EPA, HHS, OMB, and USDA for their 

review and comment. HHS and USDA provided written comments, which 

are summarized below and reproduced in appendix III and appendix IV, 

respectively. In addition, EPA, HHS, and USDA provided technical 

comments, which we incorporated as appropriate. OMB did not comment.

In its comments, HHS generally agreed with our findings and three of the 

four recommendations directed to it and partially agreed with the other 

recommendation. Specifically, HHS partially agreed with our first 

recommendation for FDA to develop a timeline for updating the risk 

assessment on arsenic in rice, noting that the evolving nature of science 

precludes it from committing to a specific timeline. We recognize that new 

scientific studies continue to add to the understanding of the risk of 

arsenic. However, we continue to believe that FDA should demonstrate 

its commitment to increasing transparency and accountability by 

developing a timeline to update the risk assessment, potentially in 

conjunction with finalizing the draft guidance on arsenic in infant rice 

cereal. Such an update may state that recent scientific studies or public 

comments have not resulted in a change to FDA’s assessment of the risk. 

Recommendations for 

Executive Action

Agency Comments 

and Our Evaluation
Page 34 GAO-18-199 Food Safety

HHS generally agreed with our findings about the actions it has taken to 

manage the risk from arsenic in rice and the extent of its coordination with 

USDA and other agencies. HHS noted that it anticipates developing a 

final guidance establishing an action level of 100 ppb of inorganic arsenic 

in infant rice cereal by the end of 2018, which will be consistent with our 

recommendation. HHS also noted that it will consider ways to enhance 

mechanisms—such as the Interagency Risk Assessment Consortium—to 

collaborate and coordinate in the development of risk assessments with 

agencies that have regulatory responsibility or specific expertise. Further, 

HHS stated that FDA agrees that a mechanism for better coordinating 

with USDA on the development of methods to detect contaminants in 

foods would be worthwhile. FDA will consider whether and how existing 

mechanisms, such as the lnteragency Residue Control Group and the 

annual meeting with USDA's ARS and the Food Safety and Inspection 

Service on food safety research, could be used to improve collaboration 

with USDA on method development. HHS’s plans to enhance or use 

existing interagency mechanisms may be responsive to our 

recommendations if they focus on enhancing coordination with other 

agencies that have expertise or similar goals in the areas of risk 

assessments and methods to detect foodborne contaminants. 

In its comments, USDA generally agreed with our findings and the one 

recommendation we directed to it. Specifically, USDA generally agreed 

with our findings about the extent to which FDA coordinated with USDA 

on the development of methods to detect contaminants in food, including 

arsenic in rice. It also generally agreed with our recommendation that 

USDA work with FDA to develop a mechanism to do so and stated that 

the USDA Office of the Chief Scientist will facilitate this effort. Further, 

USDA noted that the Interagency Risk Assessment Consortium may be 

an appropriate mechanism for addressing GAO’s recommendations. 

USDA’s proposal has the potential to be responsive to our 

recommendation if it focuses on enhancing coordination with FDA 

regarding the development of detection methods for foodborne 

contaminants.

As agreed with your office, unless you publicly announce the contents 

earlier, we plan no further distribution of this report until 30 days from the 

report date. At that time, we will send copies to the appropriate 

congressional committees; the Secretaries of Agriculture and Health and 

Human Services; the Administrator of EPA; the Director of OMB; and 

other interested parties. In addition, the report will be available at no 

charge on the GAO website at http://www.gao.gov.
Page 35 GAO-18-199 Food Safety

If you or your staff members have any questions regarding this report, 

please contact me at (202) 512-3841 or morriss@gao.gov. Contact points 

for our Offices of Congressional Relations and Public Affairs may be 

found on the last page of this report. GAO staff who made key 

contributions to this report are listed in appendix V.

Sincerely yours,

Steve D. Morris

Director, Natural Resources and Environment
Appendix I: Objectives, Scope, and 

Methodology

Page 36 GAO-18-199 Food Safety

This report examines (1) what the National Research Council (NRC) and 

recent key scientific reviews have reported about the effects of ingestion 

of arsenic on human health, (2) the extent to which the Food and Drug 

Administration (FDA) and U.S. Department of Agriculture (USDA) have 

managed the risk to human health from arsenic in rice, and (3) the extent 

to which FDA has coordinated with USDA and other federal agencies on 

actions to manage the risk. In this report, we use the term arsenic to refer 

to either total arsenic or inorganic arsenic. We use the term rice to 

encompass rice grain and products made with rice, such as infant rice 

cereal.

To determine what NRC and recent key scientific reviews have reported 

about the effects of ingestion of arsenic on human health, we analyzed 

NRC’s 2013 report on inorganic arsenic and 14 reviews of the scientific 

literature published from January 2015 through early June 2017 on the 

human health effects of ingestion of arsenic.1 We conducted a literature 

search of several research databases, such as PubMed and Toxline, to 

identify reviews that (1) were focused on the effects of ingestion of 

arsenic on human health; (2) were peer-reviewed; (3) relied on human, 

rather than animal, studies; (4) provided conclusions or summary 

statements related to more than one study, rather than just listing 

individual study findings; (5) included an abstract; and (6) were written in 

English. We assessed the scientific and statistical credibility, reliability, 

and methodological soundness of the reviews. We also contacted some 

of the authors for additional methodological information. Methodological 

information included, for example, criteria for selecting the studies used in 

the review; meta-analyses; or meta-regression approach.2 It also included 

limitations that the authors cited for the studies they reviewed or for any 

analyses they conducted. We excluded articles for which we could not 

clearly determine the methodology. We also reviewed the authors’

statements regarding conflicts of interest and determined that none of the 

articles should be excluded for this reason. We did not examine the 

references cited by these reviews as part of our analysis. We also did not 

 1

National Research Council, Committee on Inorganic Arsenic, Critical Aspects of EPA’s 

IRIS Assessment of Inorganic Arsenic: Interim Report (Washington, D.C.: National 

Academies Press, 2013).

2

Meta-analyses, including meta-regression, are statistical approaches that combine the 

results and pool the data from multiple, previous studies on a topic. These techniques 

allow researchers to draw conclusions and identify patterns that may not be apparent from 

individual studies.

Appendix I: Objectives, Scope, and 

Methodology
Appendix I: Objectives, Scope, and 

Methodology

Page 37 GAO-18-199 Food Safety

examine the studies cited by the NRC. The studies we reviewed are listed 

in appendix II.

To determine the extent to which FDA and USDA have managed the risk 

to human health from arsenic in rice, we examined relevant provisions in 

the Federal Food, Drug, and Cosmetic Act, as amended;3 the Federal 

Agriculture Improvement and Reform Act of 1996;4 and other relevant 

laws, regulations, and policies. We also used the essential elements for 

managing risk as identified in our prior work on enterprise risk 

management.5 These include: (1) align the risk management process with 

goals and objectives, (2) identify risks, (3) assess risks, (4) respond to the 

risks, (5) monitor the risks, and (6) communicate and report on the risks. 

We identified information on agency actions for managing the risk from 

arsenic in rice by collecting documentation and interviewing officials from 

FDA and USDA and we reviewed the information in light of the 

requirements, policies, and elements. We assessed FDA’s and USDA’s 

reported actions to determine the extent to which each agency’s actions 

aligned with these elements. In assessing FDA’s and USDA’s actions 

against these essential elements, we used the terms “consistent” and 

“partially consistent” to reflect the extent to which each agency’s actions 

aligned with an essential element. A determination of “consistent” meant 

that the agency provided evidence that it had taken major actions in 

alignment with that essential element. A determination of “partially 

consistent” meant that the agency provided evidence that it had taken 

some actions in alignment with that essential element.

We also interviewed 17 stakeholders to obtain their views on the extent to 

which FDA’s and USDA’s actions managed the risk, including university 

researchers (academics) specializing in relevant fields such as 

epidemiology and soil chemistry, representatives of a consumer

organization, and representatives of the rice industry, including rice mills 

and farms. We identified stakeholders based on suggestions from agency 

officials and other stakeholders; through our site visit in Arkansas’ rice 

agricultural research and production areas and rice mills; and based on 

 3

21 U.S.C. §§ 301, et seq.

4

Pub. L. No. 104-127, 110 Stat. 888 (Apr. 4, 1996). 

5

GAO, Enterprise Risk Management: Selected Agencies’ Experiences Illustrate Good 

Practices in Managing Risk, GAO-17-63 (Washington, D.C.: Dec. 1, 2016). This report 

also identified good practices agencies are implementing that illustrate the essential 

elements of enterprise risk management.
Appendix I: Objectives, Scope, and 

Methodology

Page 38 GAO-18-199 Food Safety

the stakeholders’ unique perspective or qualifications, such as 

membership in the NRC Committee on Inorganic Arsenic. The views we 

obtained from these interviews are not generalizable to all university 

researchers or consumer or rice industry organizations but they provide 

illustrative examples of the views of such stakeholders. Table 1 lists 

information about the 17 stakeholders we interviewed.

Table 1: Information about Selected Stakeholders 

Stakeholder Type of Stakeholder

1. Dr. Aaron Barchowsky, Department of 

Environmental and Occupational Health, 

University of Pittsburgh

Academic

2. Dr. Rebecca Fry, Gillings School of Global 

Public Health, University of North Carolina 

Academic

3. Dr. Jarrod Hardke, Division of Agriculture, 

University of Arkansas 

Academic 

4. Dr. Brian Jackson, Department of Earth 

Sciences, Dartmouth Collegea Academic

5. Dr. Margaret Karagas, Department of 

Epidemiology, Dartmouth Collegeb Academic

6. Dr. Keeve Nachman, Bloomberg School of 

Public Health, Johns Hopkins University

Academic

7. Dr. Ana Navas-Acien, Mailman School of Public 

Health, Columbia University

Academic

8. Dr. Angelia Seyfferth, Department of Plant and 

Soil Sciences, University of Delaware

Academic

9. Consumers Union Consumer organization

10. Organic Trade Association Rice industry

11. USA Rice Federation Rice industry

12. Nestlé Rice industry

13. Lundberg Family Farms Rice industry

14. Producers Rice Mill, Inc. Rice industry

15. Riceland Foods, Inc. Rice industry

16. Vaught Farms, Inc. Rice industry

17. Brantley Farming Company Rice industry

Source: GAO analysis of data from selected stakeholders. | GAO-18-199

Notes:

a

Dr. Jackson invited Dr. Tracy Punshon of Dartmouth College Department of Biological Sciences to 

join him in the interview. We incorporated her views as appropriate.

b

Dr. Karagas invited Dr. Carolyn Murray of the Dartmouth Geisel School of Medicine to join her in the 

interview. We incorporated her views as appropriate.
Appendix I: Objectives, Scope, and 

Methodology

Page 39 GAO-18-199 Food Safety

To determine the extent to which FDA has coordinated with USDA and 

other federal agencies on actions to manage the risk to human health 

from arsenic in rice, we identified relevant actions and examined whether 

FDA developed interagency collaborative mechanisms, which we have 

previously reported could help to facilitate coordination between 

agencies.6 To identify actions for which the agencies shared similar goals 

in their strategic plans or relevant expertise and for which FDA would be 

expected to coordinate with USDA and other federal agencies, we 

reviewed relevant provisions in the Federal Food, Drug, and Cosmetic 

Act, as amended;7 the Federal Agriculture Improvement and Reform Act 

of 1996;8 other relevant laws, regulations, and policies; the current 

science and research strategic plan for FDA’s Center for Food Science 

and Applied Nutrition and current strategic plans for USDA’s Agricultural 

Research Service (ARS) and Federal Grain Inspection Service (FGIS); 

and information about the agencies’ missions from their websites. These 

actions were the development of FDA’s risk assessment and draft 

guidance on arsenic in rice and FDA’s and USDA’s efforts to develop 

detection methods for arsenic in rice. We interviewed FDA officials and 

reviewed documentation they provided to identify the other federal 

agencies and offices with which FDA coordinated the development and 

review of its risk assessment and draft guidance on arsenic in infant rice 

cereal and the development of methods for detecting arsenic in rice. 

These agencies and offices included ARS, the Centers for Disease 

Control and Prevention, the Environmental Protection Agency (EPA), 

FGIS, National Institutes of Health’s National Institute of Environmental 

Health Sciences, the Department of Health and Human Services’

Assistant Secretary for Legislation and Office of the Assistant Secretary 

for Planning and Evaluation, Office of Management and Budget’s (OMB) 

Office of Information and Regulatory Affairs, the Small Business 

Administration’s Office of Advocacy, and the U.S. Trade Representative.

To determine the extent to which FDA coordinated its risk assessment 

and draft guidance on arsenic in rice with USDA and other federal 

agencies, we obtained and reviewed FDA’s framework for conducting risk 

 6

GAO, Managing for Results: Key Considerations for Implementing Interagency 

Collaborative Mechanisms, GAO-12-1022 (Washington, D.C.: Sept. 27, 2012).

7

21 U.S.C. §§ 301, et seq.

8

Pub. L. No. 104-127, 110 Stat. 888 (Apr. 4, 1996).
Appendix I: Objectives, Scope, and 

Methodology

Page 40 GAO-18-199 Food Safety

assessments; reviewed agencies’ comments on these documents;9

interviewed FDA officials regarding FDA’s efforts to coordinate with other 

agencies; and interviewed officials from the Centers for Disease Control 

and Prevention; EPA; the National Institutes of Health; OMB; the Small 

Business Administration’s Office of Advocacy; and USDA regarding the 

nature of their comments, their experiences coordinating with FDA, and 

the extent to which FDA addressed their comments.

To examine the extent to which FDA and USDA coordinated the 

development of arsenic detection methods, we obtained and reviewed 

documents, including those describing the detection methods that FDA, 

ARS, and FGIS have developed or have under development, and we 

interviewed officials from these agencies regarding their efforts to develop 

these methods and coordinate their development efforts. We also 

interviewed officials from these agencies to gather their views on the 

effectiveness of these coordination efforts. We then examined whether

FDA had interagency collaborative mechanisms for the development of its 

risk assessment and draft guidance, and its efforts with USDA to develop 

arsenic detection methods. We also examined whether participating 

agencies clarified their roles and responsibilities. Our prior work identified 

this as a key issue for agencies to consider when implementing 

coordination mechanisms. We selected this practice because it was 

relevant to the challenges the agencies faced.

We conducted this performance audit from December 2016 to March 

2018 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

 9

USDA and EPA provided us with copies of their comments on FDA’s risk assessment 

and draft guidance on arsenic in infant rice cereal.
Appendix II: Recent Reviews of the Health 

Effects of Ingestion of Arsenic

Page 41 GAO-18-199 Food Safety

The following list identifies recent key reviews of the health effects of 

ingestion of arsenic that we analyzed.

Amadi, C.N., Z.N. Igweze, and O.E. Orisakwe. “Heavy Metals in 

Miscarriages and Stillbirths in Developing Nations.” Middle East Fertility 

Society Journal, vol. 22, no. 2 (2017): 91-100.

Bardach, A.E., A. Ciapponi, N. Soto, M.R. Chaparro, M. Calderon, A. 

Briatore, N. Cadoppi, R. Tassara, and M.I. Litter. “Epidemiology of 

Chronic Disease Related to Arsenic in Argentina: A Systematic Review.”

The Science of the Total Environment, vol. 538, (2015): 802-16.

Karagas, M.R., A. Gossai, B. Pierce, and H. Ahsan. “Drinking Water 

Arsenic Contamination, Skin Lesions, and Malignancies: A Systematic 

Review of the Global Evidence.” Current Environmental Health Reports, 

vol. 2, no. 1 (2015): 52-68.

Khanjani, N., A. Jafarnejad, and L. Tavakkoli. “Arsenic and Breast 

Cancer: A Systematic Review of Epidemiologic Studies.” Reviews on 

Environmental Health (2017).

Lamm, S.H., H. Ferdosi, E.K. Dissen, J. Li, and J. Ahn. “A Systematic 

Review and Meta-Regression Analysis of Lung Cancer Risk and 

Inorganic Arsenic in Drinking Water.” International Journal of 

Environmental Research and Public Health, vol. 12, no. 12 (2015): 

15498-15515.

Mayer, J.E. and R.H. Goldman. “Arsenic and Skin Cancer in the USA: 

The Current Evidence regarding Arsenic-Contaminated Drinking Water.”

International Journal of Dermatology, vol. 55, no. 11 (2016): e585-e591.

Milton, A.H., S. Hussain, S. Akter, M. Rahman, T.A. Mouly, and K. 

Mitchell. “A Review of the Effects of Chronic Arsenic Exposure on 

Adverse Pregnancy Outcomes.” International Journal of Environmental 

Research and Public Health, vol. 14, no. 6 (2017).

Phung, D., D. Connell, S. Rutherford, and C. Chu. “Cardiovascular Risk 

from Water Arsenic Exposure in Vietnam: Application of Systematic 

Review and Meta-Regression Analysis in Chemical Health Risk 

Assessment.” Chemosphere, vol. 177 (2017): 167-175.

Appendix II: Recent Reviews of the Health 

Effects of Ingestion of Arsenic
Appendix II: Recent Reviews of the Health 

Effects of Ingestion of Arsenic

Page 42 GAO-18-199 Food Safety

Quansah, R., F.A. Armah, D.K. Essumang, I. Luginaah, E. Clarke, K. 

Marfoh, S.J. Cobbina, et al. “Association of Arsenic with Adverse 

Pregnancy Outcomes/Infant Mortality: A Systematic Review and MetaAnalysis.” Environmental Health Perspectives, vol. 123, no. 5 (2015): 

412-21.

Robles-Osorio, M.L., E. Sabath-Silva, and E. Sabath. “Arsenic-Mediated 

Nephrotoxicity.” Renal Failure, vol. 37, no. 4 (2015): 542-7.

Sidhu, M.S., K.P. Desai, H.N. Lynch, L.R. Rhomberg, B.D. Beck, and F.J. 

Venditti. “Mechanisms of Action for Arsenic in Cardiovascular Toxicity and 

Implications for Risk Assessment.” Toxicology, vol. 331 (2015): 78-99.

Sung, T., J. Huang, and H. Guo. “Association between Arsenic Exposure 

and Diabetes: A Meta-Analysis.” BioMed Research International, (2015).

Tsuji, J.S., M.R. Garry, V. Perez, and E.T. Chang. “Low-Level Arsenic 

Exposure and Developmental Neurotoxicity in Children: A Systematic 

Review and Risk Assessment.” Toxicology, vol. 337, (2015): 91-107.

Von Stackelberg, K., E. Guzy, T. Chu, and B.C. Henn. “Exposure to 

Mixtures of Metals and Neurodevelopmental Outcomes: A Review.” Risk 

Analysis, vol. 35, no. 6 (2015): 971-1016.
Appendix III: Comments from the Department 

of Health and Human Services

Page 43 GAO-18-199 Food Safety

Appendix III: Comments from the 

Department of Health and Human Services
Appendix III: Comments from the Department 

of Health and Human Services

Page 44 GAO-18-199 Food Safety
Appendix III: Comments from the Department 

of Health and Human Services

Page 45 GAO-18-199 Food Safety
Appendix III: Comments from the Department 

of Health and Human Services

Page 46 GAO-18-199 Food Safety
Appendix IV: Comments from the U.S. 

Department of Agriculture

Page 47 GAO-18-199 Food Safety

Appendix IV: Comments from the U.S. 

Department of Agriculture
Appendix IV: Comments from the U.S. 

Department of Agriculture

Page 48 GAO-18-199 Food Safety
Appendix IV: Comments from the U.S. 

Department of Agriculture

Page 49 GAO-18-199 Food Safety
Appendix V: GAO Contact and 

Staff Acknowledgments

Page 50 GAO-18-199 Food Safety

Steve D. Morris, (202) 512-3841 or morriss@gao.gov

In addition to the contact named above, Anne K. Johnson (Assistant 

Director), Ruth Solomon (Analyst in Charge), Kevin Bray, Stephen Cleary, 

Ellen Fried, Juan Garay, Rebecca Parkhurst, Beverly Peterson, Anne 

Rhodes-Kline, Sara Sullivan, Kiki Theodoropoulos, Sarah Veale, and 

Khristi Wilkins made key contributions to this report.

Appendix V: GAO Contact and 

Staff Acknowledgments

GAO Contact

Staff 

Acknowledgments

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