I 115th CONGRESS 1st Session H. R. 4535 IN THE HOUSE OF REPRESENTATIVES December 4, 2017 Ms. DeLauro (for herself, Ms. Slaughter , and Mr. Gutiérrez ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Agriculture , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To establish limitations on the quantity of inorganic arsenic in rice and rice products under chapter IV of the Federal Food, Drug, and Cosmetic Act.

1. Short title This Act may be cited as the Reducing food-based Inorganic Compounds Exposure Act of 2017 or the RICE Act . 2. Findings The Congress finds the following: (1) According to the World Health Organization, arsenic is a natural component of the Earth’s crust and is widely and variably distributed throughout the environment in the air, water, and land. It is also used commercially in herbicides and poultry feed. (2) Arsenic is most toxic in its inorganic form. (3) Inorganic arsenic is a known carcinogen and long-term oral exposure to high levels of inorganic arsenic is associated with developmental defects, cardiovascular disease, neurotoxicity, and diabetes, according to the World Health Organization. (4) According to the European Food Safety Authority, the estimated exposure of young children to inorganic arsenic is 2 to 3 times the exposure of adults to inorganic arsenic. (5) According to the European Food Safety Authority, diet is the main source of arsenic exposure for most individuals. (6) According to the Food and Drug Administration, due to absorption from the soil and water, arsenic is present in many foods, including grains, fruits, and vegetables. (7) Rice takes up inorganic arsenic from soil and water more readily than other grains, according to the Food and Drug Administration. (8) Rice is a staple food in the diet of many individuals in the United States and is often one of the first foods fed to infants. According to the Food and Drug Administration, inorganic arsenic has been detected in an infant’s first foods, such as infant rice cereal and brown rice syrup used in an increasing number of products including toddler formula and snack bars. Inorganic arsenic is also found in other rice products including children’s breakfast cereals and rice itself. Rice may continue to be a large part of the diet of children who have swallowing difficulties and gastrointestinal reflux, according to the American Academy of Pediatrics. (9) The Food and Drug Administration’s analysis of approximately 1,300 samples found that the average levels of inorganic arsenic for various rice and rice products are 0.1 to 7.2 micrograms per serving. (10) The Environmental Protection Agency limits concentrations of arsenic in all forms in drinking water to 10 parts per billion. The Food and Drug Administration has established a limit of 10 parts per billion in bottled water, and has also proposed a limit of 10 parts per billion in apple juice. However, there are no Federal limits for arsenic in most foods, including rice for adults and children or baby foods. 3. Establishment of limitation on inorganic arsenic in rice and rice products (a) Regulation required For the purpose of protecting the public health, not later than the day that is 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs and acting under the Secretary’s authority under chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq.), shall promulgate a final regulation establishing the minimum quantity of inorganic arsenic contained in rice or a rice product which shall cause the rice or rice product, respectively, to be deemed to be adulterated under section 402 of such Act ( 21 U.S.C. 343 ). (b) Scope of regulation The minimum quantity established under subsection (a) shall apply to rice and rice products containing inorganic arsenic regardless of whether the arsenic is present as a result of a natural process, an ingredient added to a food, the use of a pesticide, or other means. (c) Regulation includes tolerances The regulation under subsection (a) shall include the establishment of a tolerance under section 406 and section 408 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 346 ; 346a). (d) Minimum stringency The standard established under subsection (a) (and any subsequent revision thereto) for inorganic arsenic contained in rice or a rice product shall— (1) be based on the maximum achievable reduction in health risks to individuals, taking into account the cancer effects, neurodevelopmental effects, and other health effects of arsenic exposure; (2) be protective of the long-term health of children, taking into account— (A) the differing eating patterns of children; (B) the rate of brain development in children; (C) any differences in the metabolization of arsenic in children, as compared to adults; and (D) the fact that children have a longer expected life span than adults; and (3) include separate standards for rice milk and other frequently consumed rice-based foods, especially rice-based foods frequently consumed by infants and children. (e) Definitions For purposes of this Act: (1) Food The term food has the meaning given such term in section 201(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(f) ). (2) Inorganic arsenic The term inorganic arsenic means inorganic arsenic and its metabolites. (3) Rice The term rice means a food that is rice. (4) Rice product The term rice product means a food that contains an ingredient made from rice. 4. Report on inorganic arsenic in rice (a) In general Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall submit a report to the Congress on inorganic arsenic in rice grown in the United States. (b) Contents The report under subsection (a) shall include— (1) an analysis of— (A) the agronomy and production management practices that will reduce inorganic arsenic in rice; (B) the germplasm analysis and breeding that may reduce inorganic arsenic in rice; (C) the analytical technology improvements needed to address the issue of inorganic arsenic in rice; and (D) the current efforts of Federal agencies to reduce inorganic arsenic in the food supply; (2) recommendations for actions by the Federal Government in order to reduce the presence of inorganic arsenic in rice grown in the United States; and (3) recommendations for additional research on inorganic arsenic in rice, including the estimated cost for such research.