November 21, 2011
Empire State Consumer Project
50 Lansdowne Lane
Rochester, New York 14618
Food & Water Watch
1616 P Street, N.W., Suite 300
Washington, DC 20036
Dear Ms. Braiman and Ms. Hauter:
Thank you for your July 21, 2011, letter to FDA Commissioner Margaret Hamburg regarding arsenic in apple products and testing of imported foods and for our subsequent meetings. FDA takes seriously your concerns about the presence of arsenic in food. We appreciate the opportunity to respond to the points you raise in your letter and to provide you with an update on our actions and our plans moving forward.
FDA has Enhanced its Surveillance
In your letter, you urge FDA to enhance the testing of imported food for heavy metals. As you know, FDA has been monitoring arsenic in apple juice and other foods for a number of years through the Toxic Elements Food and Foodware Program (TE Program) and our Total Diet Study (TDS). We agree that enhanced testing of imported food for heavy metals is needed. Thus, we have recently taken a series of steps to strengthen our ongoing surveillance efforts and to gather additional data.
In July 2011, we issued an Import Bulletin to significantly increase the number of juice products sampled and analyzed for arsenic under the Toxic Elements program. Importantly, of the 74 samples collected as a result of this import bulletin, all were from China. Of these, 1 sample (1.4%) was above 23 parts per billion (ppb) of total arsenic (our current level of concern for inorganic arsenic is 23 ppb) and 3 samples (4.1 %) were between 10 ppb and 23 ppb for total arsenic (one was 10 ppb and two were 11 ppb). The remainder, (almost 95 percent), were below 10 ppb total arsenic. We will continue enhanced sampling of juice products under this import bulletin.
In addition, FDA has issued one assignment to its field force and is in the process of issuing a second assignment to collect juice samples from retail establishments across the country and analyze them for arsenic. The purpose of these assignments is to collect more data on the prevalence of arsenic in juice and to better understand the species of arsenic found in juice.
The first assignment is for the collection and analysis of up to 90 baby food and general consumption apple juice samples. We expect to complete collection and preliminary analysis by the end of 2011. The second assignment will focus on arsenic measurement in juices other than apple juice. Analysis for arsenic in both assignments will include speciation as appropriate to determine both organic and inorganic forms of arsenic. FDA previously stated that the arsenic in most foods including juices is typically organic, but we do note that limited data consisting of a 2009 University of Arizona study on 5 samples of apple juice and FDA’s results for 4 apple juice samples found the arsenic in those instances to be mostly inorganic arsenic. The speciation analysis on the baby food and general consumption apple juice samples mentioned above will provide the more comprehensive information necessary to help us determine the ratio of inorganic and organic forms of arsenic in apple juice.
As additional results become available from the TE Program and the new assignments we will post our results on our web site.
Testing to Date Finds Arsenic Levels in Apple Juice Typically Low
Please note that FDA's recently enhanced sampling builds on monitoring of fruit juices (including apple juice) for total arsenic that FDA has been doing for many years as part of the Total Diet Study (TDS) and TE programs. FDA monitoring has found that total arsenic levels in apple juice are typically low.
For example, we now have a total of 160 apple juice samples collected through the TE program from 2005 to 2011. These include 70 samples posted by FDA on September 27, 2011 and an additional eight samples that were part of this data set. These eight samples, which had not been previously posted, all have total arsenic levels greater than 23 ppb and were in the process of being further verified. The data set also includes 82 new samples collected in the latter part of 2011 for which the data have just now become available. Of these 160 apple juice samples, almost 88 percent had fewer than 10 ppb total arsenic, and 95 percent had total arsenic levels below 23 ppb total arsenic.
Similarly, from the Total Diet Study program, nearly 77 percent of the 134 composite apple juice samples tested from 1991 to 2009 (including baby food and general consumption samples) had total arsenic levels below 10 ppb. Of these 134 TDS samples, 95 percent had total arsenic levels below 23 ppb.
Outside Testing Results are Inconsistent with FDA’s Results
Your letter also reports that testing commissioned by the Empire State Consumer Project and conducted by Paradigm Environmental Services, Inc., identified a sample of Mott’s Apple Juice with an arsenic level of 55 ppb, and noted that the Environmental Protection Agency has set a 10 ppb standard in drinking water. This result seemed inconsistent with the vast majority of the test results we have seen in the last two decades and so we followed up by collecting and analyzing two samples of Chinese apple juice concentrate from the Mott’s plant in Williamson, NY. FDA measured levels of total arsenic in the concentrate that correspond to 4 to 8 ppb total arsenic in single strength or ready to drink apple juice.
Similarly, FDA tested apple juice from the same lot as a Nestle/Gerber sample reported on the Dr. Oz show to contain 36 ppb total arsenic (as measured by EMSL Analytical, Inc.), as well as six additional samples from different lots of Nestle/Gerber apple juice. These results, which are available on the FDA website, ranged from 2 to 6 ppb total arsenic. We note that, on the apple juice lot that was reported on the Dr. Oz show to contain 36 ppb, our results for that sample were corroborated by three other independent laboratories.
FDA is Seriously Considering Setting Guidance or Other Level
You also request in your letter that FDA set tolerance levels for heavy metals, which includes arsenic, in apple products. Under Section 406 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 346), FDA may set tolerances for poisonous ingredients in food. Setting a tolerance level requires formal rulemaking and is a lengthy process. Also, tolerance levels are difficult to change in the future, in the event that our scientific understanding of an issue changes. For these reasons, FDA almost never uses tolerances for chemical contaminants, and instead considers other limits such as levels of concern or guidance or other levels.
Under Section 402(a)(1) of the FD&C Act (21 U.S.C. 342(a)(1)), a food is deemed adulterated if the food bears or contains any added poisonous or deleterious substance which may render the food injurious to health, and for substances that are not added substances, if the quantity of the substance ordinarily renders the food injurious to health. As such, in the event we find a contaminant in a food that poses a health hazard, such that the food is deemed to be adulterated, we can and intend to take appropriate enforcement action.
As we discussed when we met with you on October 14, 2011, we are seriously considering setting guidance or other level for inorganic arsenic in apple juice and are collecting all relevant information to evaluate and determine an appropriate level.
Once again, thank you for your interest in FDA activities on arsenic. As you can see, we are moving forward in strengthening our surveillance, gathering additional data, and seriously considering what guidance or other level is appropriate. Please let us know if you have further questions.
Michael M. Landa
Center for Food Safety and Applied Nutrition
 Speciation includes the identification and quantification of individual organic and inorganic arsenic species. Methods that measure total arsenic do not distinguish between the two forms of arsenic. Methods that speciate allow us to determine what proportion of the total arsenic is inorganic and organic.
 Roberge J, et al. 2009. Am J Env Sci 5(6): 688-694.
 Note that 74 of these 82 new samples are those from China that were a result of the recent import bulletin.