Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice

The U.S. Food and Administration takes seriously its mandate to oversee the safety of domestic and imported foods and does this, in part, through the monitoring of contaminants in food, assessing potential exposure and risk, and taking steps to reduce consumer exposure to contaminants.

FDA experts have been testing for arsenic levels in foods for decades to learn about exposure levels and study possible health risks associated with arsenic in foods. For many years, we have partnered with other federal agencies and outside organizations to work on reducing consumer exposure to arsenic in rice and rice products.

Rice cereal is a common first food for infants, who, in proportion to their body weight, consume more rice than adults. FDA researchers found that exposure to inorganic arsenic, the more toxic form of arsenic, is associated with neurocognitive deficits in children.

In 2016, the FDA took steps to reduce exposure to inorganic arsenic from infant rice cereal.

FDA scientists developed and validated a method to distinguish organic from inorganic arsenic in rice. We conducted an extensive review of the peer-reviewed literature, and published a risk assessment on the potential health impacts associated with exposure to arsenic from rice and rice products, and tested more than 1000 samples of rice and rice products.

All of these data led us to issue a draft guidance for industry, in which we identified an “action level” of 100 parts per billion for inorganic arsenic in infant rice cereal. We asked food manufacturers to take this prudent measure, and found it is largely achievable. We continue to recommend that pregnant women and infants eat a variety of grains and note that non-rice infant cereal options are available for incorporation into a well-balanced diet.

Our work to reduce consumer exposure to arsenic from rice is part of a broader initiative underway to reduce the risks posed by arsenic and other toxic metals in food. As part of the initiative, we recently created a Toxic Elements Working Group that has been charged with identifying, targeting and prioritizing our efforts to achieve the public health goal of reducing exposure to toxic elements to the greatest extent possible. The working group aims to further reduce exposure to toxic elements in food, cosmetics and dietary supplements. This group is made up of senior leaders and risk managers in the FDA’s Center for Food Safety and Applied Nutrition with experience in toxicology, chemistry, medicine, epidemiology, policy and law.

The Government Accountability Office report on arsenic in rice recognizes the work we have done in this area, and affirms that we can still do more. Two recommendations urge us to develop timelines: to update our 2016 risk assessment; and to finalize our action level draft guidance on inorganic arsenic in infant rice cereal. The other two recommendations ask us to develop mechanisms for better interagency collaboration.

Overall, we concur with the recommendations with a note that an update to the FDA’s 2016 Arsenic in Rice and Rice Products Risk Assessment Report would be dependent on any new and evolving science that would impact our conclusions in the assessment. We continually monitor the scientific literature and collaborate with partners such as the Environmental Protection Agency, whose Integrated Risk Information System Program is an example of a scientific source we watch for updates. Should new science become available impacting the conclusions of our existing risk assessment, we will certainly initiate an update to our assessment.

As for our action level draft guidance for infant rice cereal, the FDA is committed to finalizing the guidance establishing an action level for inorganic arsenic in infant rice cereal. We intend to finalize the guidance by the end of this calendar year.

When it comes to interagency collaboration, we are considering ways to further improve and enhance our mechanisms for when and how better to engage with our counterparts at the U.S. Department of Agriculture and other agencies, including with respect to the roles and responsibilities for risk assessments and methods to detect contaminants in food.

Assessing and reducing consumer exposure to arsenic in rice and rice products through rigorous scientific research is just one way the agency is working to protect public health. We will continue to both lead and follow relevant scientific advances, collaborate with our partners, and communicate with consumers about making informed nutritional decisions as we fulfill our vital public health mission.

More information on arsenic in rice can be found on fda.gov.

Dr. Susan Mayne is the director of the FDA’s Center for Food Safety and Applied Nutrition.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.