FDA Draft Guidance for Industry Action Level for Arsenic in Apple Juice

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Draft-Not for Implementation 1

Guidance for Industry Arsenic in Apple Juice: Action Level This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. I. Introduction This draft guidance document provides information to manufacturers on the action level for inorganic arsenic in apple juice that FDA considers protective of human health and achievable with the use of good manufacturing practices. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background Arsenic is an element that occurs in the environment from both natural and anthropogenic sources including erosion of arsenic-containing rocks, volcanic eruptions, contamination from 2

mining and smelting ores, and previous or current use of arsenic-containing pesticides (Ref. 1). Arsenic is found in both inorganic and organic forms (together referred to as total arsenic), and inorganic arsenic is generally considered more toxic than organic arsenic (Ref. 2). Consumption of inorganic arsenic has been associated with cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans (Ref. 2). In recent assessments, the Joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Expert 1

This guidance has been prepared by the Division of Plant and Dairy Food Safety, Office of Food Safety, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 2

Generally, it is not possible for FDA to identify the source of arsenic in food, including apple juice, when found. Therefore, for purposes of this guidance FDA is not distinguishing the presence of arsenic that may be due to prior pesticide use, such that the residues are pesticide chemical residues subject to a tolerance or tolerance exemption by EPA under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a)), or other environmental contamination. 3

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