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	Background

		Forms and Distribution of Arsenic

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  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. 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.
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. 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. In addition, the figure shows  the outlines of rice-growing counties based on 2016 data from USDA.
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  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.

		Federal Agencies’ Responsibilities for Rice

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  establish a level of a contaminant that a food should not exceed. 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, the Agency for Toxic Substances and  Disease Registry prepares toxicological profiles for certain hazardous  substances, including arsenic.
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- 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, including  standards for rice. 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).
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. 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. 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, 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. 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 of the rice industry—small governmental jurisdictions, and small  organizations.
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. 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. 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.

		Enterprise Risk Management

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; (2) incorporate recent federal experience;  and (3) identify essential elements of federal enterprise risk  management. Beyond traditional internal controls, enterprise risk  management promotes risk management by considering its effect across 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:
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.

	NRC and Recent Key Scientific Reviews Reported Evidence of Associations between Ingestion of Arsenic and Adverse Human Health Effects

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. 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. 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  susceptibility to other cancer and noncancer diseases. Skin  lesions have a well-established dose-response relationship with  arsenic in drinking water.
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.
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.
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  levels of arsenic compared to those that are not based on studies in  Argentina, Chile, and Taiwan.
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. 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. 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. 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 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

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.

		Aligning Risk Management Process with Goals and Objectives

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. 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,  processing, and preparation. 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. 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. FDA’s and USDA’s actions were  consistent with the essential element of aligning risk management actions  to their strategic plans.

		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.
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. 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  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.
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.  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.

		Assessing Risks

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  rice. FDA officials told us that this method, though useful, is time- consuming 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. 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.
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. 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 long- term 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  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. 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.

		Responding to the Risks

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  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. 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. 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  excess water, may have on reducing the level of arsenic in rice. 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.
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. Under this practice of growing rice, shown in figure 3 below,  fields are periodically drained and re-flooded during the growing season.
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  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.

		Monitoring Risks

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. 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.  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-by- case 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  database, 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.

		Communicating and Reporting on Risks

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. 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.
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  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 newly- available 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  reduce the levels of arsenic in rice. 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 Several Risk Management Actions with USDA and Other Federal Agencies to Varying Extents

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 Its Risk Assessment and Draft Guidance with Several Federal Agencies, but USDA Raised Concerns about the Extent of Coordination

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  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.  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.
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,  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. 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  should follow to coordinate its risk assessment. 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 Coordinated on Developing Methods to Detect Arsenic in Rice to a Limited Extent

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. ARS officials told us that from their perspective, there  was no reason to coordinate because ARS, FDA, and FGIS are trying to  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. 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. 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.

	Conclusions

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 newly- available 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.

	Recommendations for Executive Action

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)

	Agency Comments and Our Evaluation

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.
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.
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.

Appendix I: Objectives, Scope, and Methodology

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. 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. 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  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; the Federal  Agriculture Improvement and Reform Act of 1996; 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. 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  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.
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. 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; the Federal Agriculture Improvement and Reform Act  of 1996; 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  assessments; reviewed agencies’ comments on these documents;  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.

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

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.
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 Meta- Analysis.” 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

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

Appendix V: GAO Contact and Staff Acknowledgments

	GAO Contact

	Staff Acknowledgments

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.

Output:
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 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 newly-available 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 efficiently and avoid potentially duplicative efforts.

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.