I 

115TH CONGRESS 

1ST SESSION H. R. 4535 

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. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 4, 2017 

Ms. DELAURO (for herself, Ms. SLAUGHTER, and Mr. GUTIE ́RREZ) 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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Reducing food-based 

5 Inorganic Compounds Exposure Act of 2017’’ or the 

6 ‘‘RICE Act’’. 


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1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

3 (1) According to the World Health Organiza4 tion, arsenic is a natural component of the Earth’s 

5 crust and is widely and variably distributed through6 out the environment in the air, water, and land. It 

7 is also used commercially in herbicides and poultry 

8 feed. 

9 (2) Arsenic is most toxic in its inorganic form. 

10 (3) Inorganic arsenic is a known carcinogen 

11 and long-term oral exposure to high levels of inor12 ganic arsenic is associated with developmental de13 fects, cardiovascular disease, neurotoxicity, and dia14 betes, according to the World Health Organization. 

15 (4) According to the European Food Safety Au16 thority, the estimated exposure of young children to 

17 inorganic arsenic is 2 to 3 times the exposure of 

18 adults to inorganic arsenic. 

19 (5) According to the European Food Safety Au20 thority, diet is the main source of arsenic exposure 

21 for most individuals. 

22 (6) According to the Food and Drug Adminis23 tration, due to absorption from the soil and water, 

24 arsenic is present in many foods, including grains, 

25 fruits, and vegetables. 


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1 (7) Rice takes up inorganic arsenic from soil 

2 and water more readily than other grains, according 

3 to the Food and Drug Administration. 

4 (8) Rice is a staple food in the diet of many in5 dividuals in the United States and is often one of 

6 the first foods fed to infants. According to the Food 

7 and Drug Administration, inorganic arsenic has 

8 been detected in an infant’s first foods, such as in9 fant rice cereal and brown rice syrup used in an in10 creasing number of products including toddler for11 mula and snack bars. Inorganic arsenic is also found 

12 in other rice products including children’s breakfast 

13 cereals and rice itself. Rice may continue to be a 

14 large part of the diet of children who have swal15 lowing difficulties and gastrointestinal reflux, ac16 cording to the American Academy of Pediatrics. 

17 (9) The Food and Drug Administration’s anal18 ysis of approximately 1,300 samples found that the 

19 average levels of inorganic arsenic for various rice 

20 and rice products are 0.1 to 7.2 micrograms per 

21 serving. 

22 (10) The Environmental Protection Agency lim23 its concentrations of arsenic in all forms in drinking 

24 water to 10 parts per billion. The Food and Drug 

25 Administration has established a limit of 10 parts 


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1 per billion in bottled water, and has also proposed 

2 a limit of 10 parts per billion in apple juice. How3 ever, there are no Federal limits for arsenic in most 

4 foods, including rice for adults and children or baby 

5 foods. 

6 SEC. 3. ESTABLISHMENT OF LIMITATION ON INORGANIC 

7 ARSENIC IN RICE AND RICE PRODUCTS. 

8 (a) REGULATION REQUIRED.—For the purpose of 

9 protecting the public health, not later than the day that 

10 is 2 years after the date of the enactment of this Act, 

11 the Secretary of Health and Human Services, acting 

12 through the Commissioner of Food and Drugs and acting 

13 under the Secretary’s authority under chapter IV of the 

14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 

15 et seq.), shall promulgate a final regulation establishing 

16 the minimum quantity of inorganic arsenic contained in 

17 rice or a rice product which shall cause the rice or rice 

18 product, respectively, to be deemed to be adulterated 

19 under section 402 of such Act (21 U.S.C. 343). 

20 (b) SCOPE OF REGULATION.—The minimum quan21 tity established under subsection (a) shall apply to rice 

22 and rice products containing inorganic arsenic regardless 

23 of whether the arsenic is present as a result of a natural 

24 process, an ingredient added to a food, the use of a pes25 ticide, or other means. 


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1 (c) REGULATION INCLUDES TOLERANCES.—The reg2 ulation under subsection (a) shall include the establish3 ment of a tolerance under section 406 and section 408 

4 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

5 346; 346a). 

6 (d) MINIMUM STRINGENCY.—The standard estab7 lished under subsection (a) (and any subsequent revision 

8 thereto) for inorganic arsenic contained in rice or a rice 

9 product shall— 

10 (1) be based on the maximum achievable reduc11 tion in health risks to individuals, taking into ac12 count the cancer effects, neurodevelopmental effects, 

13 and other health effects of arsenic exposure; 

14 (2) be protective of the long-term health of chil15 dren, taking into account— 

16 (A) the differing eating patterns of chil17 dren; 

18 (B) the rate of brain development in chil19 dren; 

20 (C) any differences in the metabolization 

21 of arsenic in children, as compared to adults; 

22 and 

23 (D) the fact that children have a longer ex24 pected life span than adults; and 


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1 (3) include separate standards for rice milk and 

2 other frequently consumed rice-based foods, espe3 cially rice-based foods frequently consumed by in4 fants and children. 

5 (e) DEFINITIONS.—For purposes of this Act: 

6 (1) FOOD.—The term ‘‘food’’ has the meaning 

7 given such term in section 201(f) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)). 

9 (2) INORGANIC ARSENIC.—The term ‘‘inorganic 

10 arsenic’’ means inorganic arsenic and its metabo11 lites. 

12 (3) RICE.—The term ‘‘rice’’ means a food that 

13 is rice. 

14 (4) RICE PRODUCT.—The term ‘‘rice product’’ 

15 means a food that contains an ingredient made from 

16 rice. 

17 SEC. 4. REPORT ON INORGANIC ARSENIC IN RICE. 

18 (a) IN GENERAL.—Not later than 1 year after the 

19 date of the enactment of this Act, the Comptroller General 

20 of the United States shall submit a report to the Congress 

21 on inorganic arsenic in rice grown in the United States. 

22 (b) CONTENTS.—The report under subsection (a) 

23 shall include— 

24 (1) an analysis of— 


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1 (A) the agronomy and production manage2 ment practices that will reduce inorganic ar3 senic in rice; 

4 (B) the germplasm analysis and breeding 

5 that may reduce inorganic arsenic in rice; 

6 (C) the analytical technology improvements 

7 needed to address the issue of inorganic arsenic 

8 in rice; and 

9 (D) the current efforts of Federal agencies 

10 to reduce inorganic arsenic in the food supply; 

11 (2) recommendations for actions by the Federal 

12 Government in order to reduce the presence of inor13 ganic arsenic in rice grown in the United States; and 

14 (3) recommendations for additional research on 

15 inorganic arsenic in rice, including the estimated 

16 cost for such research. 

Æ 


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