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 consider-
ation 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Reducing food-based 
Inorganic Compounds Exposure Act of 2017’’ or the 
‘‘RICE Act’’. 
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SEC. 2. FINDINGS. 
The Congress finds the following: 
(1) According to the World Health Organiza-
tion, arsenic is a natural component of the Earth’s 
crust and is widely and variably distributed through-
out 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 inor-
ganic arsenic is associated with developmental de-
fects, cardiovascular disease, neurotoxicity, and dia-
betes, according to the World Health Organization. 
(4) According to the European Food Safety Au-
thority, 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 Au-
thority, diet is the main source of arsenic exposure 
for most individuals. 
(6) According to the Food and Drug Adminis-
tration, due to absorption from the soil and water, 
arsenic is present in many foods, including grains, 
fruits, and vegetables. 
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(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 in-
dividuals 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 in-
fant rice cereal and brown rice syrup used in an in-
creasing number of products including toddler for-
mula 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 swal-
lowing difficulties and gastrointestinal reflux, ac-
cording to the American Academy of Pediatrics. 
(9) The Food and Drug Administration’s anal-
ysis 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 lim-
its 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 
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per billion in bottled water, and has also proposed 
a limit of 10 parts per billion in apple juice. How-
ever, there are no Federal limits for arsenic in most 
foods, including rice for adults and children or baby 
foods. 
SEC. 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 quan-
tity 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 pes-
ticide, or other means. 
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(c) REGULATION INCLUDES TOLERANCES.—The reg-
ulation under subsection (a) shall include the establish-
ment 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 estab-
lished 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 reduc-
tion in health risks to individuals, taking into ac-
count the cancer effects, neurodevelopmental effects, 
and other health effects of arsenic exposure; 
(2) be protective of the long-term health of chil-
dren, taking into account— 
(A) the differing eating patterns of chil-
dren; 
(B) the rate of brain development in chil-
dren; 
(C) any differences in the metabolization 
of arsenic in children, as compared to adults; 
and 
(D) the fact that children have a longer ex-
pected life span than adults; and 
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