Margaret A. Hamburg, commissioner of the Food and Drug Administration, said the agency 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, she added.
"We have been studying this issue comprehensively, and based on the agency's data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults," Hamburg said in a statement.
The assessment is based on lifetime exposure.
The FDA has monitored 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. However, new tools have allowed the agency to better understand the breakdown between organic and inorganic arsenic levels. Inorganic arsenic is a known carcinogen. It is associated with skin lesions, developmental effects, cardiovascular disease, neurotoxicity and diabetes.
Last year, the FDA released findings from 94 samples of arsenic in apple juice. The analysis showed that 95 percent of the apple juice samples tested were below 10 ppb total arsenic; 100 percent of the samples were below 10 ppb for inorganic arsenic, the carcinogenic form of arsenic, Hamburg said.
The proposed level of 10 ppb takes into account the sampling data and a recently completed, peer-reviewed risk assessment of inorganic arsenic in apple juice conducted by FDA scientists.
Inorganic arsenic might 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, Hamburg said.
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