Under its regulations, FDA may issue guidance to  establish a level of a contaminant that a food should not exceed. 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. Cardiovascular disease. 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. 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. 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. 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 Developing a timeline for finalizing the draft guidance on arsenic in infant  rice cereal could also help FDA improve the transparency of its  decisions—such as by clarifying the effectiveness of the draft guidance.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. 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. We have noted in prior work that interagency mechanisms to coordinate  programs that address crosscutting issues may reduce potentially  duplicative efforts. 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. 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. 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. 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. 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. 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.
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.