FDA proposes ‘action level’ for arsenic in apple juice

The U.S. Food and Drug Administration (FDA) has proposed an “action level” of 10 parts per billion (ppb) for inorganic arsenic in apple juice.

July 17, 2013

The U.S. Food and Drug Administration (FDA) has proposed an “action level” of 10 parts per billion (ppb) for inorganic arsenic in apple juice. This is the same level set by the U.S. Environmental Protection Agency (EPA) for arsenic in drinking water.

“While the levels of arsenic in apple juice are very low, the FDA is proposing an action level to help prevent public exposure to the occasional lots of apple juice with arsenic levels above those permitted in drinking water,” said Michael R. Taylor, the FDA’s Deputy Commissioner for Foods and Veterinary Medicine.

The FDA is establishing this threshold to provide guidance to industry. The agency takes the action level into account when considering an enforcement action, if it finds a food product exceeds the threshold.

The FDA has been monitoring the presence of arsenic in apple juice for the past 20 years and has consistently found that samples contain levels of arsenic that are low, with few exceptions. New tools, however, have allowed the agency to better understand the breakdown between organic and inorganic arsenic levels. Last year, the FDA released findings from its latest data collection and analysis of 94 samples of arsenic in apple juice. The analysis showed that 95% of the apple juice samples tested were below 10 ppb total arsenic; 100% of the samples were below 10 ppb for inorganic arsenic, the carcinogenic form of arsenic.

The proposed level of 10 ppb takes into account this sampling data plus a recently completed, peer-reviewed risk assessment of inorganic arsenic in apple juice conducted by FDA scientists. The assessment is based on lifetime exposure.

Inorganic arsenic may be found in foods because it is present in the environment, both as a naturally-occurring mineral and because of activity such as past use of arsenic-containing pesticides. A known carcinogen, inorganic arsenic also has been associated with skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes.

The agency will accept public comments on the proposed action level and the risk assessment for 60 days.

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