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《Apple Juice》.pdf
A Quantitative Assessment of Inorganic Arsenic in
Apple Juice
Clark D. Carrington, Ph.D., D.A.B.T., Clarence Murray, Ph.D., and
Shirley Tao, Ph.D.
Chemical Hazards Assessment Team
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
Draft Report Dated July 1, 2013
Visit the FDA Arsenic in Apple Juice webpage for more information, 1
/Food/FoodborneIllnessContaminants/Metals/ucm280209.htm.
EXECUTIVE SUMMARY
The purpose of this assessment is to provide quantitative estimates of long-term cancer risk
presented by inorganic arsenic in apple juice. Inorganic arsenic is the primary toxic form of
arsenic and has been associated with both acute and chronic health effects. Sampling over the
past several years by the U.S. Food and Drug Administration (FDA) and others has revealed the
presence of inorganic arsenic in apple juice in varying concentrations. In response to these
findings, FDA conducted this assessment to quantify risk at various concentrations of inorganic
arsenic in apple juice that correspond to concentrations seen in the samples.
The assessment is intended to inform decision making by FDA on how best to manage the risk
and protect the public health. FDA selected long-term cancer risk to assess because it is the
outcome of greatest concern with lifetime exposure. Current FDA policy is based on evaluations
of shorter term exposures and future guidance for individual products where exposure is
expected to be temporary may continue to be based on noncancer endpoints.
Much of the data employed in the dose-response modeling in this assessment, and many of the
assumptions that were made, were d
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