FDA proposes limit for inorganic arsenic in infant rice cereal
April 2, 2016 - 12:50 PM
WASHINGTON, D.C. - The U.S. Food and Drug Administration is taking steps to reduce
inorganic arsenic in infant rice cereal, a leading source of arsenic
exposure in infants. Relative to body weight, rice intake for infants,
primarily through infant rice cereal, is about three times greater than
for adults. Moreover, national intake data show that people consume the
most rice (relative to their weight) at approximately 8 months of age.
a draft guidance to industry, the FDA is proposing a limit or “action
level” of 100 parts per billion (ppb) for inorganic arsenic in infant
rice cereal. This is parallel to the level set by the European
Commission (EC) for rice intended for the production of food for infants
and young children. (The EC standard concerns the rice itself; the
FDA’s proposed guidance sets a draft level for inorganic arsenic in
infant rice cereal.) FDA testing found that the majority of infant rice
cereal currently on the market either meets, or is close to, the
proposed action level.
“Our actions are driven by our duty to
protect the public health and our careful analysis of the data and the
emerging science,” said Susan Mayne, Ph.D., director of the FDA’s Center
for Food Safety and Applied Nutrition. “The proposed limit is a prudent
and achievable step to reduce exposure to arsenic among infants.”
agency expects manufacturers can produce infant rice cereal that meet
or are below the proposed limit with the use of good manufacturing
practices, such as sourcing rice with lower inorganic arsenic levels.
The FDA takes an action level into account when considering an
Advice for Consumers
FDA continues to advise all consumers to eat a well-balanced diet for
good nutrition and to minimize potential adverse consequences from
consuming an excess of any one food. The agency is not advising the
general population of consumers to change their current rice consumption
patterns based on the presence of arsenic, but is providing targeted
information for pregnant women and infants to help reduce exposure.
agency recognizes that infant rice cereal is a common “starter” food
for infants and notes that the American Academy of Pediatrics
specifically encourages consumption of iron-fortified cereals for
infants and toddlers.
Based on the FDA’s findings with respect to
inorganic arsenic in rice, the agency offers the following advice to
parents and caregivers of infants:
Feed your baby iron-fortified cereals to be sure she or he is receiving enough of this important nutrient.
cereal fortified with iron is a good source of nutrients for your baby,
but it shouldn’t be the only source, and does not need to be the first
source. Other fortified infant cereals include oat, barley and
For toddlers, provide a well-balanced diet, which includes a variety of grains.
based on the FDA’s findings, it would be prudent for pregnant women to
consume a variety of foods, including varied grains (such as wheat,
oats, and barley), for good nutrition. This advice is consistent with
long-standing nutrition guidance to pregnant women from the American
Congress of Obstetricians and Gynecologists to have half of their grains
consist of whole grains.
Published studies, including new
research by the FDA, indicate that cooking rice in excess water (from
six to 10 parts water to one part rice), and draining the excess water,
can reduce from 40 to 60 percent of the inorganic arsenic content,
depending on the type of rice – although this method may also remove
some key nutrients.
Basis for Proposed Limit and Consumer Advice
proposed limit stems from extensive testing of rice and non-rice
products, a 2016 FDA risk assessment that analyzed scientific studies
showing an association between adverse pregnancy outcomes and
neurological effects in early life with inorganic arsenic exposure, and
an evaluation of the feasibility of reducing inorganic arsenic in infant
The FDA found that inorganic arsenic exposure in
infants and pregnant women can result in a child’s decreased performance
on certain developmental tests that measure learning, based on
epidemiological evidence including dietary exposures.
The FDA is
releasing data showing the levels of inorganic arsenic in 76 samples of
rice cereals for infants. The FDA’s data show that nearly half (47
percent) of infant rice cereals sampled from retail stores in 2014 met
the agency’s proposed action level of 100 ppb inorganic arsenic and a
large majority (78 percent) was at or below 110 ppb inorganic arsenic.
assess if there were other sources of inorganic arsenic in infant
foods, the FDA also tested more than 400 samples of other foods commonly
eaten by infants and toddlers. The agency found all the non-rice foods
to be well below 100 ppb inorganic arsenic, showing that other low-
arsenic options are available to be incorporated into a well-balanced
In addition to evaluating the health risks discussed above,
the agency developed a mathematical model for lung and bladder cancer
outcomes associated with consumption of inorganic arsenic in rice and
rice products. The FDA estimates that exposure to inorganic arsenic in
rice and rice products causes an additional four cases of lung and
bladder cancer over the lifetime for every 100,000 people in the United
States. This estimate would account for far less than 1 percent of the
nation’s lung and bladder cancer cases.
The FDA’s scientific
assessment of possible adverse health effects associated with inorganic
arsenic was subjected to external peer review as well as review by other
government agencies, including the U.S. Environmental Protection
Agency, the U.S. Health and Human Services’ National Institutes of
Health, and the U.S. Department of Agriculture.
Arsenic is an
element in the Earth’s crust and is present in water, air and soil.
Arsenic is naturally occurring in the soil and the water. Fertilizers
and pesticides also contribute to levels. Arsenic exists in two forms,
organic and inorganic. When encountered in the diet, inorganic arsenic
is considered to be the more toxic of the two forms. Rice has higher
levels of inorganic arsenic than other foods, in part because as rice
plants grow, the plant and grain tend to absorb arsenic from the
environment more than other crops.
agency is accepting public comments on the proposed action level and
the risk assessment for 90 days. The Federal Register notice will be
A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final.
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