SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a guidance for industry entitled “Action Level for Inorganic Arsenic in Apple Juice.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

In the Federal Register of July 15, 2013 (78 FR 42086), we announced the availability of a draft guidance for industry entitled “Arsenic in Apple Juice: Action Level.” We also announced the availability of two related scientific documents: a document entitled “Supporting Document for Action Level for Arsenic in Apple Juice” (supporting document), ( printed page 36320) and a risk assessment entitled “A Quantitative Assessment of Inorganic Arsenic in Apple Juice” (the risk assessment document). We gave interested parties an opportunity to submit comments by September 13, 2013.

This guidance finalizes FDA's action level for inorganic arsenic in apple juice of 10 micrograms per kilogram (µg/kg) or 10 parts per billion (ppb) and identifies FDA's intended sampling and enforcement approach. The basis for the action level is set forth in the guidance document, as well as the risk assessment document originally made available on July 15, 2013, that can be accessed in the docket referenced above at https://www.regulations.gov. The guidance reviews data on inorganic arsenic levels in apple juice, health effects from exposure to inorganic arsenic, and the ability of manufacturers to achieve different levels of inorganic arsenic in apple juice. It also explains FDA's rationale for identifying an action level of 10 µg/kg or 10 ppb for inorganic arsenic in apple juice.

Arsenic is present in the environment as a naturally occurring substance or as a result of contamination from human activity. In foods, arsenic may be present as inorganic arsenic (the primary toxic form of arsenic) or organic arsenic. Exposure to inorganic arsenic is associated with adverse human health effects, including cancer and neurodevelopmental effects. Apple juice is one source of exposure to arsenic from food, and a greater potential source of exposure for children than adults, because children's dietary patterns are often less varied than those of adults, and they consume more apple juice relative to their body weight than do adults. We expect that the 10 µg/kg or 10 ppb action level, though non-binding, will help protect public health by encouraging manufacturers to reduce levels of inorganic arsenic in apple juice and therefore reduce human exposure to inorganic arsenic. We also expect that this level is achievable by industry with the use of current good manufacturing practices. We intend to consider the action level of 10 µg/kg or 10 ppb inorganic arsenic as an important source of information for determining whether apple juice is adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)).

In finalizing the guidance, we incorporated data from the supporting document and added an analysis of new data on inorganic arsenic levels in apple juice, health effects from exposure to inorganic arsenic, and the ability of manufacturers to limit inorganic arsenic in apple juice, in evaluating the appropriate action level. We also made changes to the text for clarity, including explaining the term “added” in this context and that “apple juice” includes apple cider, and we have also revised the title of the guidance to more clearly show that we are setting an action level. In addition, we added information on our understanding of arsenical pesticide use in the United States and expanded the discussion of the rationale for setting an action level based on sampling and testing results and the discussion of FDA's sampling and enforcement approach. We also incorporated new references in support of these changes and to reflect the citation of recently published FDA data and a new reference to FDA's Closer to Zero action plan.

We also considered all comments received during the comment period in finalizing the document. Comments on the draft guidance requested that we consider establishing action levels for other foods containing arsenic, such as other apple products, other fruit juices, and rice; that the action level be lower than 10 ppb; that we consider additional risk management approaches; and that questioned the achievability of the action level of 10 ppb in apple juice. We did not receive new data from the comments supporting establishment of either a higher or lower action level. None of the comments caused us to change the approach set out in the draft guidance. We have clarified in the title of the final guidance that the action level of 10 ppb applies to inorganic arsenic.

Other comments suggested modifications to the risk assessment document. We note that the risk assessment report underwent peer review before we made it available to the public. (This can be found at https://www.fda.gov/​science-research/​peer-review-scientific-information-and-assessments/​completed-peer-reviews.) None of these comments supported a determination that the risk assessment document needs to be modified. We will continue to monitor research developments on adverse health effects of inorganic arsenic exposure to determine if new data support changes to the guidance.

II. Paperwork Reduction Act of 1995

This final guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/​FoodGuidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.