Fast Facts

The FDA warned in 2016 that infants face a higher health risk than adults from arsenic owing to their less-varied diets, and proposed guidance on arsenic levels in infant rice cereal.

We reviewed recent scientific work and FDA and USDA actions to manage the risk of arsenic in rice. We found the agencies have researched methods to detect arsenic in rice and taken other actions, but that FDA could better communicate the risk to the public and coordinate with other agencies.

We recommended that, among other things, FDA develop a timeline to finalize its guidance on infant rice cereal and work to better coordinate its actions.

Rice may be more susceptible to arsenic contamination due to the flooded conditions in which it is usually grown

Photograph of a man working in a flooded rice field

Photograph of a man working in a flooded rice field

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Highlights

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.

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.

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Recommendations

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.

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should develop a timeline for updating the risk assessment on arsenic in rice. (Recommendation 1)
Open
As of July 2021, FDA noted that as indicated in its Closer to Zero plan, it will be evaluating the evidence for risks posed by arsenic exposure over the next year, including by considering any data that may have been published since FDA issued its 2016 draft risk assessment. This review may result in FDA updating or finalizing the risk assessment on arsenic in rice. GAO will continue to monitor FDA's work in this area and will update the status of this recommendation if FDA develops a timeline for updating its risk assessment.
Food and Drug Administration The Commissioner of FDA should develop a timeline for finalizing the draft guidance on arsenic in infant rice cereal. (Recommendation 2)
Closed - Implemented
FDA issued the final guidance on arsenic in infant rice cereal in August 2020.
Food and Drug Administration 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)
Closed - Implemented
As of August 2019, the agency had provided information about the Interagency Risk Assessment Consortium, including a memo specifying how it would be used as a mechanism for working with relevant agencies on risk assessment of contaminants in food.
Food and Drug Administration
Priority Rec.
This is a priority recommendation.
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)
Closed - Implemented
FDA agreed with the recommendation. In its response, FDA noted, among other actions, that it would discuss common research needs with USDA at the FSIS-ARS Food Safety Research Meeting, which is held annually. During the 2020 meeting, FDA and USDA officials discussed research needs related to methods to detect arsenic in rice.
Department of Agriculture
Priority Rec.
This is a priority recommendation.
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)
Closed - Implemented
USDA agreed with the recommendation. In its response, USDA noted, among other actions, that its agencies would discuss common research needs with FDA at the FSIS-ARS Food Safety Research Meeting, which is held annually. During the February 2020 meeting, USDA and FDA officials discussed research needs related to methods to detect arsenic in rice.

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